Medical Treatment vs. Invasive treatment for Coronary Artery Disease ?
A large number of medical studies (listed below ) compare invasive treatment with conservative treatment of coronary artery disease. They reveal that Invasive treatment with coronary bypass graft surgery, balloon angioplasty with stenting compared with conservative medical treatment with cardiac drugs yields similar clinical outcomes. These studies show that invasive treatment provides about the same results as conservative medical treatment with cardiac drugs.
Brain Damage from Cardiac Bypass
Follow up studies after Bypass Graft Operation reveal about half (50%) of patients having coronary bypass surgery suffer brain damage with permanent loss of memory and mental function from the procedure.(1-3)
Invasive treatment with bypass and angioplasty may not be the best treatment, yet is more likely to be offered because of financial considerations. The financial rewards for invasive procedures are greater than for medical treatment.
Limited Cases see Reduced Mortality with Cardiac Bypass
Coronary Bypass has been found to reduce mortality in certain cases, such as the left main coronary artery lesion (the Widow-Maker) and in those cases with reduced left ventricular ejection fraction.(62) However, Dr reports that no mortality benefit over and above medical treatment is obtained in surgical bypass of the left main lesion with normal LV ejection fraction.(62) In this case, mortality benefit is similar to medical treatment.(62)
Left above Image Cardiac Bypass courtesy of Wikimedia Commons
Recent Stent Era Trials
Acute Myocardial Infarction is a special case. Stenting after thrombolysis for acute Myocardial Infarction was found to reduce mortality: Schiller’s study in Germany showed that immediate stenting after using clot dissolving drugs gave better mortality results when compared to delayed stenting. Three more recent stent-era trials have shown favorable reduction in mortality with stenting. However, this has not been consistently demonstrated. However, for multivessel coronary disease, no advantage over medical treatment was seen with coronary stenting. Dr Richard Shemin writes in Circulation in 2008:
“Survival advantages of stent therapy for coronary artery disease over medical therapy have not been a consistent result in clinical trials.”
Compared to CABG, There is no advantage for stenting.
A five year trial published in 2005 comparing stenting to CABG for multivessel disease shows no difference in mortality for the two groups, stented vs bypassed.
Here is a list of drugs used in medical treatment for coronary artery disease:
Beta Blockers such as Inderal, calcium channel blockers include Cardizem, Procardia, and Norvasc.
Nitrates such as Isordil, Sorbitrate, Cardilate, Dilatrate, and Peritrate. Nitroglycerine skin patches include Minitran, Nitro-Dur and Transderm-Nitro. Diuretics and ACE inhibitors are used.
Why does medical therapy work?
Medical therapy reduces the oxygen demand of the heart muscle and allows time for the heart to develop microscopic collateral vessels which provides blood flow around the blocked arteries.
A Randomized Trial
Dr Hueb reported in 2004 on his randomized trial comparing Medical treatment to CABG, and PCI (percutaneous intervention with balloon and stenting).(64) 611 patients with stable angina and angiographically documented double or triple vessel disease were randomly assigned to one of the three treatments, 1) medical treatment, 2) CABG or 3) PCI. Here are the results as quoted from the authors:
“Our results are consistent with the Coronary Artery Surgery Study (CASS) trial, in which no difference was seen between patients in the surgical and medical groups in terms of mortality, Q-wave MI, or event-free survival rates after five years of follow-up. In the CASS trial, a subgroup of patients with preserved ventricular function and mild stable angina was more likely to experience event-free survival with MT alone, even in the presence of three-vessel CAD.”(64)
Figure 2 of the study illustrates outcomes after one year of follow up.(see figure 2 below showing cumulative mortality rates for the three forms of treatment (MT=medical treatment, CABG=coronary artery bypass graft, PCi = percutaneous intervention) . The authors state:
“There were no significant differences among the cumulative cardiac-related mortality curves associated with the three therapeutic strategies (Fig. 2). There were nine deaths in the PCI group, eight deaths in the CABG group, and three deaths in the MT group (p = 0.23). The cumulative survival rates at one year for patients assigned to each group were 96% for PCI, 96% for CABG, and 98% for MT.“(64)
Dr Chatzistamatiou’s 2011 report on “Stable Coronary Artery Disease, Latest Data in the Battle Between Conservative and Invasive Management.” in the Hellenic J Cardiololgy is an up to date summary of the cardiology literature with a handy Table 1 which lists indications for revascularization in stable angina patients. The authors conclude with:
“In patients with chronic stable CAD, OMT (optimal medical therapy) is the firstline treatment and should include all necessary ingredients in doses that can achieve the therapeutic goals.”(71)
In conclusion, the decision to undergo CABG, with its long recovery time and adverse effect on neuro-cognitive function, should not be taken lightly. With the exception of the Left Main lesion which is optimally treated with CABG (bypass), published studies support OMT, (optimal medical therapy), as the first line of treatment for chronic stable angina patients, with revascularization with CABG or stent reserved for selected patients after failure of OMT.
Articles with Related Interest:
Jeffrey Dach MD
7450 Griffin Road Suite 180
Davie, Florida 33314
Links and References
Cognitive Dysfunction after CABG
1) Longitudinal assessment of neurocognitive function after coronary-artery bypass surgery. Newman MF1, et al. N Engl J Med. 2001 Feb 8;344(6):395-402.
Cognitive decline complicates early recovery after coronary-artery bypass grafting (CABG) and may be evident in as many as three quarters of patients at the time of discharge from the hospital and a third of patients after six months. We sought to determine the course of cognitive change during the five years after CABG and the effect of perioperative decline on long-term cognitive function.
METHODS:In 261 patients who underwent CABG, neurocognitive tests were performed preoperatively (at base line), before discharge, and six weeks, six months, and five years after CABG surgery. Decline in postoperative function was defined as a drop of 1 SD or more in the scores on tests of any one of four domains of cognitive function. (A reduction of 1 SD represents a decline in function of approximately 20 percent.) Overall neurocognitive status was assessed with a composite cognitive index score representing the sum of the scores for the individual domains. Factors predicting long-term cognitive decline were determined by multivariable logistic and linear regression.
RESULTS:Among the patients studied, the incidence of cognitive decline was 53 percent at discharge, 36 percent at six weeks, 24 percent at six months, and 42 percent at five years. We investigated predictors of cognitive decline at five years and found that cognitive function at discharge was a significant predictor of long-term function (P<0.001).
CONCLUSIONS:These results confirm the relatively high prevalence and persistence of cognitive decline after CABG and suggest a pattern of early improvement followed by a later decline that is predicted by the presence of early postoperative cognitive decline. Interventions to prevent or reduce short- and long-term cognitive decline after cardiac surgery are warranted.
2) Adverse cerebral outcomes after coronary bypass surgery. Multicenter Study of Perioperative Ischemia Research Group and the Ischemia Research and Education Foundation Investigators.
Roach GW et al. N Engl J Med. 1996 Dec 19;335(25):1857-63.
Acute changes in cerebral function after elective coronary bypass surgery is a difficult clinical problem. We carried out a multicenter study to determine the incidence and predictors of — and the use of resources associated with — perioperative adverse neurologic events, including cerebral injury.
METHODS:In a prospective study, we evaluated 2108 patients from 24 U.S. institutions for two general categories of neurologic outcome: type I (focal injury, or stupor or coma at discharge) and type II (deterioration in intellectual function, memory deficit, or seizures).
RESULTS:Adverse cerebral outcomes occurred in 129 patients (6.1 percent). A total of 3.1 percent had type I neurologic outcomes (8 died of cerebral injury, 55 had nonfatal strokes, 2 had transient ischemic attacks, and 1 had stupor), and 3.0 percent had type II outcomes (55 had deterioration of intellectual function and 8 had seizures). Patients with adverse cerebral outcomes had higher in-hospital mortality (21 percent of patients with type I outcomes died, vs. 10 percent of those with type II and 2 percent of those with no adverse cerebral outcome; P<0.001 for all comparisons), longer hospitalization (25 days with type I outcomes, 21 days with type II, and 10 days with no adverse outcome; P<0.001), and a higher rate of discharge to facilities for intermediate- or long-term care (69 percent, 39 percent, and 10 percent ; P<0.001). Predictors of type I outcomes were proximal aortic atherosclerosis, a history of neurologic disease, and older age; predictors of type II outcomes were older age, systolic hypertension on admission, pulmonary disease, and excessive consumption of alcohol.
CONCLUSIONS:Adverse cerebral outcomes after coronary bypass surgery are relatively common and serious; they are associated with substantial increases in mortality, length of hospitalization, and use of intermediate- or long-term care facilities. New diagnostic and therapeutic strategies must be developed to lessen such injury.
3) van Dijk, Diederik, et al. “Neurocognitive dysfunction after coronary artery bypass surgery: a systematic review.” The Journal of Thoracic and Cardiovascular Surgery 120.4 (2000): 632-639.
4) ‘Alternative’ Medicine Is Mainstream
The evidence is mounting that diet and lifestyle are the best cures for our worst afflictions. By Deepak Chopra , Dean Ornish ,Rustum Roy and Andrew Weil Jan. 9, 2009 Wall Street Journal Jan 2009
In 2006, for example, according to data provided by the American Heart Association, 1.3 million coronary angioplasty procedures were performed at an average cost of $48,399 each, or more than $60 billion; and 448,000 coronary bypass operations were performed at a cost of $99,743 each, or more than $44 billion. In other words, Americans spent more than $100 billion in 2006 for these two procedures alone.
Despite these costs, a randomized controlled trial published in April 2007 in The New England Journal of Medicine found that angioplasties and stents do not prolong life or even prevent heart attacks in stable patients (i.e., 95% of those who receive them). Coronary bypass surgery prolongs life in less than 3% of patients who receive it. So, Medicare and other insurers and individuals pay billions for surgical procedures like angioplasty and bypass surgery that are usually dangerous, invasive, expensive and largely ineffective. Yet they pay very little — if any money at all — for integrative medicine approaches that have been proven to reverse and prevent most chronic diseases that account for at least 75% of health-care costs. The INTERHEART study, published in September 2004 in The Lancet, followed 30,000 men and women on six continents and found that changing lifestyle could prevent at least 90% of all heart disease.
5) Boden, William E., et al. “Optimal medical therapy with or without PCI for stable coronary disease.” New England Journal of Medicine 356.15 (2007): 1503-1516.
In patients with stable coronary artery disease, it remains unclear whether an initial management strategy of percutaneous coronary intervention (PCI) with intensive pharmacologic therapy and lifestyle intervention (optimal medical therapy) is superior to optimal medical therapy alone in reducing the risk of cardiovascular events.
We conducted a randomized trial involving 2287 patients who had objective evidence of myocardial ischemia and significant coronary artery disease at 50 U.S. and Canadian centers. Between 1999 and 2004, we assigned 1149 patients to undergo PCI with optimal medical therapy (PCI group) and 1138 to receive optimal medical therapy alone (medical-therapy group). The primary outcome was death from any cause and nonfatal myocardial infarction during a follow-up period of 2.5 to 7.0 years (median, 4.6).
There were 211 primary events in the PCI group and 202 events in the medical-therapy group. The 4.6-year cumulative primary-event rates were 19.0% in the PCI group and 18.5% in the medical-therapy group (hazard ratio for the PCI group, 1.05; 95% confidence interval [CI], 0.87 to 1.27; P=0.62). There were no significant differences between the PCI group and the medical-therapy group in the composite of death, myocardial infarction, and stroke (20.0% vs. 19.5%; hazard ratio, 1.05; 95% CI, 0.87 to 1.27; P=0.62); hospitalization for acute coronary syndrome (12.4% vs. 11.8%; hazard ratio, 1.07; 95% CI, 0.84 to 1.37; P=0.56); or myocardial infarction (13.2% vs. 12.3%; hazard ratio, 1.13; 95% CI, 0.89 to 1.43; P=0.33).
As an initial management strategy in patients with stable coronary artery disease, PCI did not reduce the risk of death, myocardial infarction, or other major cardiovascular events when added to optimal medical therapy.
In summary, our trial compared optimal medical therapy alone or in combination with PCI as an initial management strategy in patients with stable coronary artery disease. Although the addition of PCI to optimal medical therapy reduced the prevalence of angina, it did not reduce long-term rates of death, nonfatal myocardial infarction, and hospitalization for acute coronary syndromes.
6) Angioplasty Fails Again and Again (8 out of 8 times) by John McDougal MD April 2000 Newsletter
7) Pursnani, Seema, et al. “Percutaneous Coronary Intervention Versus Optimal Medical Therapy in Stable Coronary Artery Disease A Systematic Review and Meta-Analysis of Randomized Clinical Trials.” Circulation: Cardiovascular Interventions 5.4 (2012): 476-490.
Background—The role of percutaneous coronary intervention (PCI) in the management of stable coronary artery disease remains controversial. Given advancements in medical therapies and stent technology over the last decade, we sought to evaluate whether PCI, when added to medical therapy, improves outcomes when compared with medical therapy alone.
Methods and Results—We performed a systematic review and meta-analysis, searching PubMed, EMBASE, and CENTRAL databases, until January 2012, for randomized clinical trials comparing revascularization with PCI to optimal medical therapy (OMT) in patients with stable coronary artery disease. The primary outcome was all-cause mortality, and secondary outcomes included cardiovascular death, nonfatal myocardial infarction, subsequent revascularization, and freedom from angina. Primary analyses were based on longest available follow-up with secondary analyses stratified by trial duration, with short-term (≤1 year), intermediate (1–5 years), and long-term (≥5 years) time points. We identified 12 randomized clinical trials enrolling 7182 participants who fulfilled our inclusion criteria. For the primary analyses, when compared with OMT, PCI was associated with no significant improvement in mortality (risk ratio [RR], 0.85; 95% CI, 0.71–1.01), cardiac death (RR, 0.71; 95% CI, 0.47–1.06), nonfatal myocardial infarction (RR, 0.93; 95% CI, 0.70–1.24), or repeat revascularization (RR, 0.93; 95% CI, 0.76–1.14), with consistent results over all follow-up time points. Sensitivity analysis restricted to studies in which there was >50% stent use showed attenuation in the effect size for all-cause mortality (RR, 0.93; 95% CI, 0.78–1.11) with PCI. However, for freedom from angina, there was a significant improved outcome with PCI, as compared with the OMT group (RR, 1.20; 95% CI, 1.06–1.37), evident at all of the follow-up time points.
Conclusions—In this most rigorous and comprehensive analysis in patients with stable coronary artery disease, PCI, as compared with OMT, did not reduce the risk of mortality, cardiovascular death, nonfatal myocardial infarction, or revascularization. PCI, however, provided a greater angina relief compared with OMT alone, larger studies with sufficient power are required to prove this conclusively.
8) Loder E. Curbing Medical Enthusiasm. BMJ 2007, April 7; 334: doi:10.1136/bmj.39175.409132.3A
9) Hochman JS, Coronary intervention for persistent occlusion after myocardial infarction. N Engl J Med. 2006 Dec 7;355(23):2395-407.
10) Hochman JS, Steg PG. Does preventive PCI work? N Engl J Med. 2007 Apr 12;356(15):1572-4.
11) Treatment of chronic stable angina. NEJM Volume 297:621-627 September 22, 1977 Number 12. A preliminary report of survival data of the randomized Veterans Administration cooperative study ML Murphy, HN Hultgren, K Detre, J Thomsen, and T Takaro
We evaluated the effect of saphenous-vein-bypass grafting on survival in patients with chronic stable angina by comparing medical and surgical treatment in a large-scale, prospective randomized study. Excluding patients with left-main-coronary-artery disease who have already been reported, a total of 596 patients were entered into this study; when randomized into a medical group (310 patients) and a surgical group (286 patients), entry clinical and angiographic base lines were comparable. Operative mortality at 30 days was 5.6 per cent. At an average of one year after operation, 69 per cent of all grafts were patent, and 88 per cent of the surgical patients had atleast one patent graft. There was no statistically significant difference in survival, at a minimal follow-up interval of 21 months, between patients treated medically and those treated with saphenous-vein-bypass grafting. At 36 months, 87 per cent of the medical group and 88 per cent of the surgical group were alive.
12) Myocardial infarction and mortality in the coronary artery surgery study (CASS) randomized trial. NEJM 1984 Mar 22;310(12):750-8
The long-term benefit of coronary bypass surgery in terms of longevity and prevention of major ischemic events in patients who have mild angina is not well defined. The randomized Coronary Artery Surgery Study (CASS) was designed to evaluate this issue; it consists of 780 patients who were considered operable and who had mild stable angina pectoris or who were free of angina after infarction. As a result of the randomization process there were no significant differences in base-line variables between patients randomly assigned to medical and to surgical therapy. The likelihood of death in the five-year period after randomization was only 8 per cent in the medical cohort, as compared with 5 per cent in the surgical cohort (not significant). The likelihood of nonfatal Q-wave myocardial infarction was 11 and 14 per cent, respectively (not significant). The five-year probability of remaining alive and free of infarction was 82 per cent in the patients assigned to medical therapy and 83 per cent in the patients assigned to surgery (not significant). There were no statistically significant differences in the survival rate or in the myocardial-infarction rate between subgroups of patients randomly assigned to medical and to surgical therapy when they were analyzed according to initial group assignment, number of diseased vessels, or ejection fraction. Therefore, as compared with medical therapy, coronary bypass surgery appears neither to prolong life nor to prevent myocardial infarction in patients who have mild angina or who are asymptomatic after infarction in the five-year period after coronary angiography.
13) Lancet 1982 Nov 27;2(8309):1173-80. Long-term results of prospective randomised study of coronary artery bypass surgery in stable angina pectoris. European Coronary Surgery Study Group.
This report presents the final results (follow-up 5–8 years) of a prospective study in 768 men aged under 65 with mild to moderate angina, 50% or greater stenosis in at least two major coronary arteries, and good left ventricular function. 395 were randomised to coronary artery bypass surgery, 373 to no treatment; 1 patient in the surgery group was lost to follow-up. These original groups were compared, whatever subsequently happened to the patients. Survival was improved significantly by surgery in the total population, in patients with three-vessel disease, and in patients with stenosis in the proximal third of the left anterior descending artery constituting a component of either two or three vessel disease, and non-significantly in patients with left main coronary disease. An abnormal electrocardiogram at rest, ST-segment depression greater than or equal to 1.5 mm during exercise, peripheral arterial disease, and increasing age independently point to a better chance of survival with surgery. In the absence of these prognostic variables in patients with either two or three vessel disease the outlook is so good that early surgery is unlikely to increase the prospect of survival. In terms of anginal attacks, use of beta-adrenergic blockers and nitrates, and exercise performance the surgical group did significantly better than the medical group throughout the 5 years of follow-up, but the difference between the two treatments tended to decrease.
(15) Non-Q-wave Myocardial Infarction Following Thrombolytic Therapy: A Comparison of Outcomes in Patients Randomized to Invasive or Conservative Post-Infarct Assessment Strategies in the Veterans Affairs Non-Q-Wave Infarction Strategies In-Hospital (VANQWISH) Trial.. Wexler,LF, Blaustein, AS, Philip W. Lavori, PW, et al. Journal of the American College of Cardiology. ; 2001; 37: 19-25. (Circulation. 1998;97:444-450.)
Overall event rates (death or recurrent nonfatal heart attack ) were considerably more with invasive strategies than in patients with conservative treatment following thrombolytic therapy. Mortality rate in patients managed conservatively is low (3.5%), and routine invasive management was associated with an increased risk of death.
(16) Percutaneous Transluminal Angioplasty Versus Medical Treatment For Non-Acute Coronary Heart Disease. BMJ. 2000 July 8; 321(7253): 73–77. The procedure may lead to an increase in coronary bypass grafting compared with medical treatment and is unlikely to reduce non-fatal myocardial infarction, death, or repeated angioplasty.
(17) An Invasive Strategy Reduced Death, Myocardial Infarction and Readmissions in Unstable Coronary Artery Disease. Wallentin L, Lagerqvist B, Husted E, et al., for the FRISC II Investigators. Lancet. 2000; 356: 9-16.
2,457 patients from 58 Scandinavian centers who had unstable symptomatic coronary artery disease were divided into 2 groups. Group 1 consisted of 1222 patients who underwent an invasive strategy were compared to 1235 patients (Group 2) who were treated noninvasively. The mortality rate at the end of one year was 2.2% in the invasive group compared to 3.9 % in the noninvasively treated group. The 1.7 % difference between the 2 groups calculates out to 60 patients who would have to undergo an invasive form of treatment to benefit one patient. Similarly, the frequency of a heart attack was 9% in the invasive group vs. 12% in the noninvasive group. This calculates out to 35 patients that would have to be invasively treated to benefit one patient. This is the only study that has shown any benefit from aggressive interventional treatment and the difference is too small to be considered clinically significant. Certainly it would be hard to justify operating on 60 patients just to benefit one.
(18) 5 year outcomes in the FRISC-II randomised trial of an invasive versus a non-invasive strategy in non-ST-elevation acute coronary syndrome: a follow-up study. Lagerqvist B, Husted S, Kontny F, Ståhle E, Swahn E, Wallentin L; Fast Revascularisation during InStability in Coronary artery disease (FRISC-II) Investigators. Department of Cardiology and Uppsala Clinical Research Center, University Hospital, S-751 85 Uppsala, Sweden.
FINDINGS: At 5 years the groups differed in terms of the primary composite endpoint of death, myocardial infarction, or both (invasive 217, 19.9 %; noninvasive 270, 24.5 %; risk ratio 0.81; 95% CI 0.69-0.95; p=0.009).
5-year mortality was 117 (9.7%) in the invasive group compared with 124 (10.1%) in the noninvasive group (0.95; 0.75 -1.21; p=0.693).
Rates of myocardial infarction were 141 (12.9 %) in the invasive and 195 (17.7%) in the non-invasive group (0.73; 0.60-0.89; p=0.002).
The benefit of the invasive strategy was confined to male patients, non-smokers, and patients with two or more risk indicators.
INTERPRETATION: The 5-year outcome of this trial indicates sustained benefit of an early invasive strategy in patients with non-ST-elevation acute coronary syndrome at moderate to high risk.
(19) Intensive Medical Therapy Versus Coronary Angioplasty for Suppression of Myocardial Ischemia in Survivors of an Acute Myocardial Infarction (Circulation. 1998;98:2017-2023.)
Management of Stable Coronary Artery Disease
20) Pflieger, Matthew, et al. “Medical management of stable coronary artery disease.” American family physician 83.7 (2011): 819-826.
21) Boden, William E. “Medical Management of Stable Coronary Artery Disease.” Evidence-Based Cardiology, Third Edition: 343-356.
(22) Outcome In Patients with Acute Non-Q Wave Myocardial Infarction Randomly Assigned to An Invasive As Compared with a Conservative Management Strategy William E. Boden, M.D., Robert A. O’Rourke, M.D., Michael H. Crawford, M.D., Alvin S. Blaustein, M.D., Prakash C. Deedwania, M.D., Robert G. Zoble, M.D., Ph.D., Laura F. Wexler, M.D., Robert E. Kleiger, M.D., Carl J. Pepine, M.D., David R. Ferry, M.D., Bruce K. Chow, M.S., Philip W. Lavori, Ph.D., for The Veterans Affairs Non–Q-Wave Infarction Strategies in Hospital (VANQWISH) Trial Investigators
Conclusions Most patients with non–Q-wave myocardial infarction do not benefit from routine, early invasive management consisting of coronary angiography and revascularization. A conservative, ischemia-guided initial approach is both safe and effective. Not only do most patients not benefit from aggressive invasive treatment after their heart attack, but it is harmful.
(23) Twenty-two Year Follow-up in the VA Cooperative Study of Coronary artery bypass surgery for Stable Angina Am J Cardiol. 1998 Jun 15;81(12):1393-
In total, there were twice as many bypass procedures performed in the group assigned to surgery without any long-term survival or symptomatic benefit
(24) A Prospective Randomized Trial of Triage Angiography in Acute Coronary Syndromes Ineligible for Trombolytic Therapy. Results of the Medicine Versus Angiography in Thrombolytic Exclusion (MATE) Trial. McCullough PA, O’Neill WW, Graham M, et al. Journal of the American College of Cardiology. 1998; 32: 596-605.
The endpoint of a repeat heart attack or death at 21 months was seen in 14% of those undergoing revascularization versus 12% of the medically treated patients.
Long-term follow-up at a median of 21 months revealed no significant differences in the endpoints of late revascularization, recurrent myocardial infarction, or all-cause mortality.
Conclusions. Despite more frequent early revascularization after triage angiography, we found no long-term benefit in cardiac outcomes compared with conservative medical therapy with revascularization prompted by recurrent ischemia.
(25) Danish Multicenter Randomized Study of Invasive Versus Conservative Treatment In Patients With Inducible Ischemia After Thrombolysis In Acute Myocardial Infarction. DANAMI) Madsen JK, Grande P, Saunamaki K, et al. Circulation. 1997; 96: 748-755.
The aim of the DANish trial in Acute Myocardial Infarction (DANAMI) study was to compare an invasive strategy of percutaneous transluminal coronary angioplasty (PTCA) or coronary artery bypass grafting (CABG) with a conservative strategy in patients with inducible myocardial ischemia who received thrombolytic treatment for a first acute myocardial infarction (AMI).
At 2.4 years’ follow-up (median), mortality was 3.6% in the invasive treatment group and 4.4% in the conservative treatment group (not significant)
(26) Coronary Angioplasty Versus Medical Therapy For Angina:
The Second Randomized Intervention Treatment of Angina (RITA-2) Trial. RITA-2 Trial Participants. Lancet. 1997; 350: 461-468.
Death or definite myocardial infarction occurred in 32 patients (6.3%) treated with PTCA and in 17 patients (3.3%) with medical care (absolute difference 3.0% [95% CI 0.4-5.7%]. p = 0.02).
(27) Seven-year outcome in the RITA-2 trial: coronary angioplasty versus medical therapy. J Am Coll Cardiol. 2003 Oct 1;42(7):1161-70.
CONCLUSIONS: In RITA-2 an initial strategy of PTCA did not influence the risk of death or MI, but it improved angina and exercise tolerance.
(28) One Year Results of the Thrombolysis in Myocardial Infarction (TIMI) IIIB Clinical Trial. A randomized Comparison of Tissue-Type Plasminogen Activator Versus Placebo and Early Invasive Versus Early Conservative Strategies in Unstable Angina and Non-Q Wave Myocardial Infarction. Anderson HV, Cannon CP, Stone PH, et al. Journal of The American College of Cardiology. 1995; 26: 1643-1650.
The incidence of death or nonfatal infarction, or both, did not differ after 1 year by strategy assignment.
RESULTS. The incidence of death or nonfatal infarction for the t-PA- and placebo-treated groups was similar after 1 year (12.4% vs. 10.6%, p = 0.24). The incidence of death or nonfatal infarction was also similar after 1 year for the early invasive and early conservative strategies (10.8% vs. 12.2%, p = 0.42).
(29) The Medicine, Angioplasty or Surgery Study (MASS): A Prospective Randomized Trial of Medical Therapy, Balloon Angioplasty or Bypass Surgery for Single Proximal Left Anterior Descending Artery Stenosis. Hueb WA, Bellotti G, Oliveira SA et al. Journal of the American College of Cardiology. 1995; 26: 1600-1605.
At a single center, 214 patients with stable angina, normal ventricular function and a proximal stenosis of the left anterior descending coronary artery > 80% were randomly assigned to undergo mammary bypass surgery (n = 70), balloon angioplasty (n = 72) or medical therapy alone (n = 72). However, all three strategies resulted in a similar incidence of death and infarction during an average follow-up period of 3 years.
(30) Five-Year Follow-Up of the Medicine, Angioplasty, or Surgery Study (MASS)
A Prospective, Randomized Trial of Medical Therapy, Balloon Angioplasty, or Bypass Surgery for Single Proximal Left Anterior Descending Coronary Artery Stenosis. (Circulation. 1999;100:II-107.)
However, the 3 treatment regimens yielded a similar incidence of acute myocardial infarction and death.
(31) The TIMI IIIB Investigators. Effects of tissue plasminogen activator and a comparison of early invasive and conservative strategies in unstable angina and non-Q wave myocardial infarction. Results of the TIMI IIIB Trial. Circulation. 1994; 89: 1545-1556.
CONCLUSIONS: In the overall trial, patients with unstable angina and NQMI were managed with low rates of mortality (2.4%) and myocardial infarction or reinfarction (6.3%) at the time of the 6-week visit. These results can be achieved using either an early conservative or early invasive strategy, the latter resulting in a reduced incidence of days of hospitalization and of rehospitalization and in the use of antianginal drugs. The addition of a thrombolytic agent is not beneficial and may be harmful.
(32) Two and Three Year Results of the Thrombolysis in Myocardial Infarction (TIMI) Phase II Clinical Trial. Terrin ML, Williams DO, Kleiman, NS et al. Journal of the American College of Cardiology. 1993;22; 1763-1772.
Patients enrolled in TIMI II were randomly assigned to an invasive (1,681 patients) or a conservative (1,658 patients) management strategy to follow receipt of intravenous recombinant tissue-type plasminogen activator for acute myocardial infarction.
RESULTS. Complete 2-year follow-up data are available for 3,187 patients (95.4%). Cumulative life-table rates of death or reinfarction were 17.6% for the invasive strategy group and 17.9% for the conservative strategy group (p = NS) and mortality was 8.9% and 8.7% (p = NS), respectively.
(34) Randomized Trial of Late Angioplasty Versus Conservative Management For Patients with Residual Stenosis After Thrombolytic Treatment of Myocardial Infarction. Ellis, SG, Mooney, MR. George, BS, et al. Circulation. 1992: 86; 1400-1406.
BACKGROUND. After thrombolytic therapy for patients with acute myocardial infarction (MI), percutaneous transluminal coronary angioplasty (PTCA) is frequently performed because of the presence of a “significant” infarct vessel stenosis demonstrated at predischarge coronary angiography. Several studies have shown PTCA performed early after thrombolysis to be unnecessary or even harmful. Actuarial 12-month infarct-free survival was 97.8% in the no-PTCA group and 90.5% in the PTCA group (p = 0.07).
CONCLUSIONS. There was no functional or clinical benefit from routine late PTCA after MI treated with thrombolytic therapy in this relatively low-risk cohort of patients. These data strongly suggest that patients with an uncomplicated MI after thrombolytic therapy, even if they have a “significant” residual stenosis of the infarct vessel, should be treated medically if they are without evidence of ischemia on stress testing before hospital discharge.
35) A Comparison of Angioplasty With Medical Therapy in the Treatment of Single Vessel Coronary Artery Disease. Parisi AF, Folland ED, Hartigan P. New Engl J Med. 1992; 326: 10-16.
CONCLUSIONS. For patients with single-vessel coronary artery disease, PTCA offers earlier and more complete relief of angina than medical therapy and is associated with better performance on the exercise test. However, PTCA initially costs more than medical treatment and is associated with a higher frequency of complications
Seven of the angioplasty treated patients had to undergo coronary artery bypass surgery during the study period versus none of the medically treated group while 19 repeat angioplasty procedures had to be performed in the angioplasty group. Thus, overall angioplasty conveyed no benefit in this group of patients.
36) SWIFT Trial of Delayed Elective Intervention v. Conservative Treatment After Thrombolysis With Anistreplase in Acute Myocardial Infarction. Should We Intervene Following Thrombolysis? SWIFT Study Group Trial Study Group. British Medical Journal. 1991: 302: 555-560.
By 12 months mortality (5.8% (23 patients) in the intervention group v 5.0% (20) in the conservative care group; p = 0.6) and rates of reinfarction (15.1% (60 patients) v 12.9% (52); p = 0.4) were similar in the two groups. No significant differences in rates of angina or rest pain were found at 12 months. Left ventricular ejection fraction at three and 12 months was the same in both groups. Both mortality and repeat heart attack were greater in the group receiving invasive treatment.
37) Comparison of Immediate Invasive, Delayed Invasive and Conservative Strategies After Tissue-Type Plasminogen Activator. Rogers, WJ, Baim, DS, Gore, JM et al. Circulation. 1990: 81; 1457-1476.
At 1-year follow-up, the three treatment groups had similar cumulative rates of mortality (8.7%, pooled over all groups), fatal and nonfatal reinfarction (8.5%), combined death and reinfarction (14.5%), and CABG (17.2%), although the cumulative performance rate of PTCA remained higher in the invasive groups
(immediate invasive strategy group, 75.8%; delayed invasive strategy group, 64.3%; and conservative strategy group, 23.9%; p less than 0.001). Thus, because conservative strategy achieves equally good short- and long-term outcome with less morbidity and a lower use of PTCA, it seems to be the preferred initial management strategy.
38) Randomized Controlled Trial of Late In-Hospital Angiography and Angioplasty Versus Conservative Management After Treatment With Recombinant Tissue-Type Plasminogen Activator in Acute Myocardial Infarction. Barbash GI, Roth A, Hanoch H., et al. American Journal of Cardiology. 1990; 66: 538-545.
Total mortality after a mean follow-up of 10 months was 8 of 97 in the invasive and 4 of 104 in the conservative groups (p = 0.15).
39) Comparison of Invasive and Conservative Strategies After Treatment With Intravenous Tissue Plasminogen Activator in Acute Myocardial Infarction. The TIMI study Group. N. Engl J Med 1989; 320: 618-627.
Angioplasty for patients having chest pain from a heart attack was of no benefit, and resulted in greater number of repeat heart attacks and higher death rate compared to medical treatment alone. ANother complication:Clot busting drugs were associated with intra-cranial bleeding.
40) Lancet. 1988 Jan 30;1(8579):197-203
Thrombolysis with tissue plasminogen activator in acute myocardial infarction: no additional benefit from immediate percutaneous coronary angioplasty. Simoons ML, Arnold AE, Betriu A, de Bono DP, Col J, Dougherty FC, von Essen R,
Lambertz H, Lubsen J, Meier B, et al.
At 2 weeks, the mortality in the angioplasty group was 7% compared to 3% in the non-invasive treatment group. Since immediate PTCA does not provide additional benefit there seems to be no need for immediate angiography and PTCA in patients with acute myocardial infarction treated with rTPA.
41) Comparison of Medical and Surgical Treatment for Unstable Angina Pectoris. Luchi, RJ, Scott SM, Deupree RH, et al. N. Engl. J. Medicine 1987; 316: 977-984.
“We conclude that patients with unstable angina pectoris have a similar outcome after two years whether they receive medical therapy alone or coronary bypass surgery plus medical therapy. However, patients with reduced left ventricular ejection fractions may have a better two-year survival rate after coronary bypass surgery.”
(43) Outcome Study of Two Large Populations With Different Rates of Cardiac Interventions. Mahrer, PR. Cardiovascular Reviews and Reports, December 2000 638-651
44) Piegas, Leopoldo S., et al. “The Organization to Assess Strategies for Ischemic Syndromes (OASIS) registry in patients with unstable angina.” The American journal of cardiology 84.5 (1999): 7-12.
Clinical approaches to the prevention of the potentially catastrophic consequences of coronary ischemic phenomena such as unstable angina and suspected non-Q-wave myocardial infarction (MI) differ across the world. In addition to prevailing physician beliefs in different societies, the level of access to catheterization laboratories largely determines whether an interventionist or conservative strategy is adopted. The Organization to Assess Strategies for Ischemic Syndromes (OASIS)–a prospective registry of approximately 8,000 patients with acute myocardial ischemia with no ST elevation, treated in 95 hospitals across 6 countries–furnished a unique window into regional differences in clinical management and the frequency and timing of invasive procedures (i.e., angiography, percutaneous transluminal coronary angioplasty [PTCA], and coronary artery bypass graft [CABG] surgery), as well as the outcomes of these trends. At 6 months after symptom onset, patients in the United States and Brazil, where the catheterization laboratory facilities are more accessible, underwent significantly (p <0.001) more angiography (69.4%), PTCA (23.6%), and CABG (25.2%) than in Canada and Australia, where the corresponding rates were 48.4%, 17.0%, and 16.8% (p <0.001), respectively; and in Hungary and Poland, where the respective rates were 23.5%, 5.8%, and 10.9% (p <0.001). This relatively aggressive approach led at 6 months to a more substantial decrease in refractory angina in the United States and Brazil than in Canada and Australia (20.4% vs 13.9%; p <0.001), but no improvement in rates of cardiovascular mortality and MI (10.5% versus 10.5%; p = 0.36). There was a significant (p < or = 0.012) increase in stroke, (1.9% vs 1.3%; p = 0.010) and major bleeding (1.9% vs 1.1%; p = 0.009) events. Furthermore, an inverse correlation emerged between baseline cardiovascular risk status and frequency of angiography and PTCA interventions preferentially for low-risk compared with high-risk patients. In concert with findings from other recent randomized trials, the OASIS Registry data suggest that although there are fewer hospital readmissions for unstable angina, there is a trend toward increased rates of death, MI, and stroke. These data urge a cautious approach to the use of invasive procedures in patients with unstable angina unless future trials demonstrate a clear benefit with an aggressive approach.
(45) Use of Cardiac Procedures and Outcomes in Elderly Patients with Myocardial Infarction in the United States and Canada Tu JV, Pashos CL, Naylor Color Doppler, et al. N Engl J Med 1997; 336: 1500-1505.
CONCLUSIONS: Short-term mortality after an acute myocardial infarction was slightly lower in the United States than in Ontario, but these differences did not persist through one year of follow-up. The strikingly higher rates of use of cardiac procedures in the United States, as compared with Canada, do not appear to result in better long-term survival rates for elderly U.S. patients with acute myocardial infarction.
(46) Comparison of Medical Care and One and 12 Month Mortality of Hospitalized patients with Acute Myocardial Infarction in Minneapolis-St. Paul, Minnesota, United States of America and Goteborg, Sweden. McGovern OG, Herlitz J, Pankow JS, et al. Am. J Cardiol. 1997; 80: 557-562
We compared medical care and mortality through 1-year of hospitalized acute myocardial infarction (AMI) patients in 2 large metropolitan areas in the United States and Sweden. All hospitalized AMI discharges (International Classification of Diseases, 9th revision [ICD9] codes 410) occurring among 30 to 74-year-old residents of the Minneapolis-St. Paul metropolitan area in 1990 and Göteborg, Sweden, in 1990 to 1991 were identified and their medical records examined. There were dramatic differences in medical care during the index hospitalization of AMI patients between Minneapolis-St. Paul and Göteborg. Use of thrombolytic therapy, coronary angioplasty, bypass surgery, calcium antagonists and lidocaine was more common in Minneapolis-St. Paul; beta blockers were more frequently used in Göteborg, and aspirin use was similar. Despite these large differences, neither 28-day nor 1-year mortality of hospitalized AMI patients differed significantly. The marked differences found in the early treatment of AMI between Minneapolis-St. Paul and Göteborg, combined with the negligible differences observed in short- and long-term mortality, raise questions about the most effective and efficient allocation of medical resources.
48) Coronary Stenting or Percutaneous Transluminal Coronary Angioplasty Prior to Noncardiac Surgery Increases Adverse Events: The Evidence is Mounting, Van Norman GA, and Posner, K. Journal of the American College of Cardiology. 2000; 36: 2351
49) Catastrophic Outcomes of Noncardiac Surgery Soon After Coronary Stenting. Kaluza GL, Joseph J, Lee JR, et al. Journal of the American College of Cardiology. 2000; 35: 1288-1294.
(50) Two to Eight Year Survival Rates in Patients Who Refused Coronary Artery Bypass Grafting. Hueb W, Bellotti G. Ramired J, et al. American Journal Cardiology. 1989;63: 155-159.
One hundred and fifty patients with coronary artery disease (CAD) who refused bypass grafting were followed prospectively from 2 to 8 years. Mean age was 57 +/- 8 (standard deviation) years. Ejection fraction averaged 70 +/- 14%. Eight percent of patients had 1-vessel CAD and 92% had multiple-vessel CAD. Medical treatment included propranolol, nifedipine, isosorbide dinitrate, dipyridamole and aspirin. Annual mortality was 0% for 1- and 2-vessel CAD and 1.3% for left main equivalent disease, 3-vessel and left main CAD. Treatment significantly reduced the incidence of stable and unstable angina. Fifty-two patients (34%) had a second hemodynamic study 4.2 +/- 1.3 years after initial evaluation. Stenosis progression or new significant obstructions (greater than or equal to 70%) in previously normal coronary arteries occurred in 61% of 123 arteries studied, whereas new occlusions were observed in 12% of the arteries. Nonfatal acute myocardial infarction incidence was 8%. No significant changes occurred in ejection fraction. In conclusion, proper medical treatment in selected patients with advanced CAD but preserved ventricular function is associated with good long-term survival and remission of symptoms, although progression of coronary atherosclerosis does occur in some patients.
(51) Prognosis of Medically Treated Patients with Coronary Artery Disease With Profound ST-Segment Depression During Exercise Testing. Podrif, PD, Graboys, TB, Lown, B. N Engl J Med. 1981; 305:1111-1116.
Reproducible and profound (greater than 2 mm) ST-segment depression during exercise testing in patients with coronary heart disease is associated with multivessel involvement. In these patients, coronary-artery bypass surgery has been recommended even when symptoms are absent. However, there are few long-term follow-up data regarding the prognosis when such patients are treated medically. Among 212 men with coronary-artery disease in whom profound ST-segment depression could be reproduced with exercise, 142 who had no other type of heart disease and were not receiving digitalis drugs had a mean ST-segment depression of 2.9 mm. Follow-up has lasted an average of 59 months: 11 patients have died (annual mortality, 1.4 per cent), and nine have had bypass operations (1.3 per cent per year). Survival correlated with exercise tolerance but not with degree of ST depression, peak heart rate, or peak blood pressure during exercise. We conclude that such ST-segment depression is not associated with a poor prognosis. There is rarely a need to resort to cardiac surgery; medical management is highly successful and associated with a low mortality.
52) Exercise Performance-Based Outcomes of Medically Treated Patients with Coronary Artery Disease and Profound ST Segment Depression. Thompson, CA, Jabbour S, Goldberg, RJ, et al. Journal of the American College of Cardiology. 2000; 36: 2140-2145. From Harvard Medical School, the Lown Cardiovascular Research Foundation, and the University of Massachusetts Medical School
CONCLUSIONS:Optimal medical management in stable patients with CAD with profound exercise-induced ST segment depression but good ETT duration is an appropriate alternative to coronary revascularization and is associated with low rates of MI and death.
53) Circulation. 2005;111:2906-2912. Percutaneous Coronary Intervention Versus Conservative Therapy in Nonacute Coronary Artery Disease A Meta-Analysis Demosthenes G. Katritsis, MD, PhD; John P.A. Ioannidis, MD
Conclusions— In patients with chronic stable CAD, in the absence of a recent myocardial infarction, PCI does not offer any benefit in terms of death, myocardial infarction, or the need for subsequent revascularization compared with conservative medical treatment.
Invasive approach for acute MI does not reduce mortality
54) Am Heart J. 2005 Feb;149(2):194-9 Invasive versus noninvasive management of ST-elevation acute myocardial infarction: a review of clinical trials and observational studies .Beck CA, Eisenberg MJ, Pilote L.
Division of Clinical Epidemiology, McGill University Health Centre, McGill University, Montreal, Quebec, Canada.
BACKGROUND: Despite decades of research, it is still unclear whether patients with uncomplicated ST-segment elevation acute myocardial infarction (AMI) should be managed with an invasive or a noninvasive approach after successful thrombolysis.
METHODS: We reviewed randomized trials in which patients were randomized to a strategy of routine cardiac catheterization after thrombolysis (invasive) or a strategy whereby patients received cardiac catheterization only if they demonstrated reversible ischemia by noninvasive testing (noninvasive).
RESULTS: Evidence to date suggests that invasive approach does not result in mortality or reinfarction benefits for patients with uncomplicated ST-segment elevation AMI.
Early invasive with stenting reduces mortality
55) Am Heart J. 2008 Sep;156(3):564-572, 572.e1-2. Epub 2008 Jun 30.
An early invasive strategy versus ischemia-guided management after fibrinolytic therapy for ST-segment elevation myocardial infarction: a meta-analysis of contemporary randomized controlled trials.Wijeysundera HC, et al.
BACKGROUND: Although the use of an early invasive strategy among patients with ST-segment elevation myocardial infarctions (STEMI) who are treated initially with fibrinolytic therapy is common, the safety and efficacy of this approach remains uncertain. We performed a meta-analysis to best estimate the benefits and harms of an early invasive strategy in STEMI patients treated initially with full-dose intravenous fibrinolytic therapy, as compared to a traditional strategy of ischemia-guided management.
METHODS: We included contemporary randomized controlled trials, defined a priori as those with >50% stent use during percutaneous coronary intervention (PCI). Outcomes extracted from the published results of eligible trials included all-cause mortality, reinfarction, stroke, and in-hospital major bleeding.
RESULTS: We identified 5 contemporary trials enrolling 1,235 patients who met our inclusion criteria. Of the patients randomized to an early invasive strategy, 86% underwent PCI with 87% receiving stents. Follow-up duration ranged from 30 days to 1 year. An early invasive strategy was associated with significant reductions in mortality (odds ratio [OR] 0.55, 95% CI 0.34-0.90) and reinfarction (OR 0.53, 95% CI 0.33-0.86) compared with ischemia-guided management. There were no significant differences in the risk of stroke (OR 1.31, 95% CI 0.42-4.10) or major bleeding (OR 1.41, 95% CI 0.74-2.69).
CONCLUSIONS: An early invasive strategy after fibrinolytic therapy is associated with significant reductions in mortality and reinfarction. Our results suggest a potentially important role for this strategy in the management of STEMI patients but should be confirmed by large randomized trials.
3 stent era trials show improvement in mortality compared to medical treatment
56) CMAJ. 2005 December 6; 173(12): 1473–1481. Immediate angioplasty after thrombolysis: a systematic review Warren J. Cantor, Fabrice Brunet, Carolyn P. Ziegler, Alex Kiss, and Laurie J. Morrison.
Results We found 13 articles that were supportive of immediate or early PCI after thrombolysis and 16 that were neutral or provided evidence opposing it. The largest randomized trials and meta-analyses showed no benefit of routine PCI immediately or shortly after thrombolysis.
The studies that were supportive were generally more recent and more frequently involved coronary stents. One large trial supported early PCI after thrombolysis for patients with myocardial infarction complicated by cardiogenic shock. Overall, the difference in mortality rates between the invasive strategy and conservative care was nonsignificant. The 3 stent-era trials showed a significantly lower mortality among patients randomly assigned to the invasive strategy (5.8% v. 10.0%, odds ratio 0.55, 95% confidence interval 0.32–0.92).
Analysis of variance found a significant difference in treatment effect between stent-era and pre–stent-era trials.
“Overall, there were no statistically significant differences in mortality (OR 0.89, 95% confidence interval [CI] 0.67–1.19; Fig. 2) or in a composite of death and reinfarction (OR 0.81, 95% CI 0.65– 1.01; Fig. 3) within 12 months (6 mo, for SIAM-321) between the “invasive” strategy (immediate or early PCI after thrombolysis) and the “conservative,” noninvasive strategy.
Similarly, among the 5 pre– stent- era trials there were no significant differences in mortality or in combined death and reinfarction within 12 months.
However, in the 3 stent-era trials, there were significantly lower rates of death (OR 0.55, 95% CI 0.32–0.92; Fig. 2) and death or reinfarction (OR 0.59, 95% CI 0.39–0.89; Fig. 3) within 12 months for patients randomly assigned to the invasive strategy.”
Immediate stenting found to reduce mortality compared to delayed stenting
57) J Am Coll Cardiol. 2003 Aug 20;42(4):634-41.
Beneficial effects of immediate stenting after thrombolysis in acute myocardial infarction. Scheller B, Hennen B, Hammer B, Walle J, Hofer C, Hilpert V, Winter H, Nickenig G, Böhm M; SIAM III Study Group.
OBJECTIVES: The Southwest German Interventional Study in Acute Myocardial Infarction (SIAM III) investigated potentially beneficial effects of immediate stenting after thrombolysis as opposed to a more conservative treatment regimen. BACKGROUND: Treatment of acute myocardial infarction (AMI) by thrombolysis is compromised by Thrombolysis In Myocardial Infarction (TIMI) 3 flow rates of only 60% and high re-occlusion rates of the infarct-related artery (IRA).
Older studies showed no benefit of coronary angioplasty after thrombolysis compared with thrombolytic therapy alone. This observation has been challenged by the superiority of primary stenting over balloon angioplasty in AMI. METHODS: The SIAM III study was a multicenter, randomized, prospective, controlled trial in patients receiving thrombolysis in AMI (<12 h). Patients of group I were transferred within 6 h after thrombolysis for coronary angiography, including stenting of the IRA. Group II received elective coronary angiography two weeks after thrombolysis with stenting of the IRA. RESULTS: A total of 197 patients were randomized, 163 patients fulfilled the secondary (angiographic) inclusion criteria (82 in group I, 81 in group II). Immediate stenting was associated with a significant reduction of the combined end point after six months (ischemic events, death, reinfarction, target lesion revascularization 25.6% vs. 50.6%, p = 0.001). CONCLUSIONS: Immediate stenting after thrombolysis leads to a significant reduction of cardiac events compared with a more conservative approach including delayed stenting after two weeks.
Immediate stenting was associated with a significant reduction of the combined end point after six months (ischemic events, death, reinfarction, target lesion revascularization 25.6% vs. 50.6%, p = 0.001). CONCLUSIONS: Immediate stenting after thrombolysis leads to a significant reduction of cardiac events compared with a more conservative approach including delayed stenting after two weeks.
CABG vs. Medical Treatment
58) Circulation. 1992 Jul;86(1):121-30. Eighteen-year follow-up in the Veterans Affairs Cooperative Study of Coronary Artery Bypass Surgery for stable angina. The VA Coronary Artery Bypass Surgery Cooperative Study Group.
The 18-year effect of bypass surgery compared with medical therapy on survival, incidence of myocardial infarction, and relief of angina was evaluated in 686 randomized patients with stable angina in the Veterans Affairs Cooperative Study of Coronary Artery Bypass Surgery.
Regardless of risk, surgery also did not reduce the incidence of myocardial infarction or the combined incidence of infarction or death.
(Circulation. 2008;118:2326-2329.) Coronary Artery Bypass Grafting Versus Stenting for Unprotected Left Main Coronary Artery Disease Where Lies the Body of Proof? Richard J. Shemin, MD
Survival advantages of stent therapy for coronary artery disease over medical therapy have not been a consistent result in clinical trials.
61) J Am Coll Cardiol, 2005; 46:575-581, CLINICAL RESEARCH: CLINICAL TRIALS. Five-Year Outcomes After Coronary Stenting Versus Bypass Surgery for the Treatment of Multivessel Disease The Final Analysis of the Arterial Revascularization Therapies Study (ARTS) Randomized Trial Patrick W. Serruys, MD
CONCLUSIONS: At five years there was no difference in mortality between stenting and surgery for multivessel disease. Furthermore, the incidence of stroke or myocardial infarction was not significantly different between the two groups.
62) Caracciolo, Eugene A., et al. “Comparison of surgical and medical group survival in patients with left main coronary artery disease long-term CASS experience.” Circulation 91.9 (1995): 2325-2334.
63) Boden, William E. “Surgery, angioplasty, or medical therapy for symptomatic multivessel coronary artery disease: Is there an indisputable “winning strategy” from evidence-based clinical trials?.” Journal of the American College of Cardiology 43.10 (2004): 1752-1754.
Hueb et al. (8) report the one-year follow-up results of the second Medicine, Angioplasty, or Surgery Study (MASS-II), which randomized 611 stable angina patients with multivessel CAD to CABG surgery, PCI, or medical therapy. In this relatively small, single-site study, the authors demonstrated a statistically significant lower rate of one-year mortality in the medical therapy group (1.5%), whereas the death rates for the PCI (4.5%) andCABG surgery (4.0%) groups were comparable.The majority of patients with mild-to-moderate angina can be safely managed medically, but PCI is appropriate if symptoms are not adequately controlled by medication or if other high-risk features are apparent.
64) Hueb, Whady, et al. “The medicine, angioplasty, or surgery study (MASS-II): a randomized, controlled clinical trial of three therapeutic strategies for multivessel coronary artery disease: one-year results.” Journal of the American College of Cardiology 43.10 (2004): 1743-1751.
Our results are consistent with the Coronary Artery Surgery Study (CASS) trial, in which no difference was seen between patients in the surgical and medical groups in terms of mortality, Q-wave MI, or event-free survival rates after five years of follow-up. In the CASS trial, a subgroup of patients with preserved ventricular function and mild stable angina was more likely to experience event-free survival with MT alone, even in the presence of three-vessel CAD.
65) Hueb W, Lopes N, Gersh BJ, et al. Ten-year follow-up survival of the medicine, angioplasty, or surgery study (MASS II): A randomized controlled clinical trial of 3 therapeutic strategies for multivessel coronary artery disease. Circulation. 2010;122:949-957.
66) Williams DO, Vasaiwala SC, Boden WE. Is optimal medical therapy “optimal therapy” for multivessel coronary artery disease? Optimal management of multivessel coronary artery disease. Circulation. 2010;122:943-945.
67) Manché, Alexander. ” optimal treatment multivessel coronary artery disease “ (2014).
68) Smith, Peter K. “Treatment selection for coronary artery disease : the collision of a belief system with evidence.” The Annals of thoracic surgery 87.5 (2009): 1328-1331.
69) IZQUIERDA, ARTERIA CORONARIA, and UN DEBATE EN CURSO. “CORONARY ARTERY-BYPASS GRAFT OR PERCUTANEOUS CORONARY INTERVENTION FOR LEFT MAIN CORONARY ARTERY LESIONS: AN ONGOING DISCUSSION.” CorSalud 2012 Oct-Dec;4(4):228-231 CORONARY BYPASS OR PERCUTANEOUS INTERVENTION LEFT MAIN LESIONS IZQUIERDA CorSalud 2012
70) ElGuindy, Ahmed M., and Ahmed Afifi. “PCI versus CABG in patients with complex coronary artery disease: Time for reconciliation?.” Global cardiology science & practice 2012.2 (2012): 18.
71) CHATZISTAMATIOU, EVANGELOS I., et al. “Stable Coronary Artery Disease: Latest Data in the Battle Between Conservative and Invasive Management.” Hellenic J Cardiol 52 (2011): 516-524. Stable Coronary Artery Disease Conservative Invasive CHATZISTAMATIOU 2011. Conclusions: In patients with chronic stable CAD, OMT is the firstline treatment and should include all necessary ingredients in doses that can achieve the therapeutic goals.
72) Bypassing Bypass Surgery by Elmer M. Cranton, M.D.
73) Am J Cardiol. 1998 Jun 15;81(12):1393-9.
Twenty-two-year follow-up in the VA Cooperative Study of Coronary Artery Bypass Surgery for Stable Angina. Peduzzi P1, Kamina A, Detre K.
We evaluated the 22-year results of initial coronary artery bypass surgery with saphenous vein grafts compared with initial medical therapy on survival, incidence of myocardial infarction, reoperation, and symptomatic status in 686 patients (average age 51) with stable angina in the Veterans Affairs Cooperative Study of Coronary Artery Bypass Surgery. Between 1972 and 1974, 354 patients were assigned to medical treatment and 332 to surgical revascularization. In the surgical cohort, 312 patients underwent operation (operative mortality 5.8%) and 25% subsequently underwent repeat operation (operative mortality 10.3%). In the medical cohort, 160 patients crossed over to surgery (operative mortality 4.4%) and 21% of these patients had reoperation (operative mortality 9.1%). Neither crossover nor reoperation was predictable by angiographic or clinical risk factors measured at baseline. The overall 22-year cumulative survival rates were 25% and 20% in the medical and surgical cohorts (p = 0.24). Corresponding rates in low-risk patients who had 1 or 2 vessels diseased, or 3 vessels diseased with normal left ventricular function were 31% and 24% (p = 0.024). Although significant at 10 years, there was also no long-term survival benefit for high-risk patients assigned to bypass surgery. The probabilities of remaining free of myocardial infarction and of being alive without infarction were significantly higher with initial medical therapy, 57% versus 41% (p = 0.02) and 18% versus 11% (p = 0.0031), respectively. This trial provides strong evidence that initial bypass surgery did not improve survival for low-risk patients, and that it did not reduce the overall risk of myocardial infarction. Although there was an early survival benefit with surgery in high-risk patients (up to a decade), long-term survival rates became comparable in both treatment groups. In total, there were twice as many bypass procedures performed in the group assigned to surgery without any long-term survival or symptomatic benefit.
74) Am J Med. 2011 Aug;124(8):681-8.
Medical therapy versus myocardial revascularization in chronic coronary syndrome and stable angina.
Deedwania PC1, Carbajal EV.Division of Cardiology, Department of Medicine, Veterans Affairs Central California Health Care System, University of California, San Francisco, School of Medicine, Fresno, USA. firstname.lastname@example.org
Coronary artery disease is a leading cause of death in the United States. Angina is encountered frequently in clinical practice. Effective management of patients with coronary artery disease and stable angina should consist of therapy aimed at symptom control and reduction of adverse clinical outcomes. Therapeutic options for angina include antianginal drugs: nitrates, beta-blockers, calcium channel blockers, ranolazine, and myocardial revascularization. Recent trials have shown that although revascularization is slightly better in controlling symptoms, optimal medical therapy that includes aggressive risk factor modification is equally effective in reducing the risk of future coronary events and death. On the basis of the available data, it seems appropriate to prescribe optimal medical therapy in most patients with coronary artery disease and stable angina, and reserve myocardial revascularization for selected patients with disabling symptoms despite optimal medical therapy.
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