Cardiac Bypass, Angioplasty and Stenting



The following thirty nine medical studies compare invasive treatment with conservative treatment of coronary artery disease. Invasive treatment with bypass surgery, stent or angioplasty is compared with conservative treatment with drugs. These Thirty Nine Studies show that invasive treatment fails to reduce mortality or heart attacks, when compared to conservative medical treatment with drugs.

Brain Damage from Cardiac Bypass

Three studies in 1000 patients found that 50% of patients having bypass surgery have brain damage with permanent loss of memory and mental function.

Economic Benefits Make it Popular



Invasive treatment with bypass and angioplasty may not be the best treatment, yet is more likely to be offered because of the economic benefits.

Limited Cases see Reduced Mortality with Cardiac Bypass

Coronary Bypass has been found to prolong life in the limited number of cases who have both left main coronary disease and reduced ejection fraction. However, if Left Ventricular function is normal (i.e. normal ejection fraction), then bypass does not affect over all mortality compared to medical treatment.

Left Image Cardiac Bypass courtesy of Wikimedia Commons



Recent Stent Era Trials



Acute MI is a special case



Stenting after thrombolysis for acute Myocardial Infarction found to reduce mortality:



Schiller's study in Germany showed that immediate stenting after using clot busting 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 seen with 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, no advantage for stenting



A five year trial published in 2005 comparing stenting to CABG for multivessel disease shows no difference in mortality.



Medical Treatment for Heart Disease



Drugs used: 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.



Natural Thereapies to prevent and Reverse Heart Disease and For Related Content See:





Articles with Related Interest:

Reversing Heart Disease with DeToxMax Plus and Lipophos EDTA



Heart of the Matter, Maryanne Demasi, the Cholesterol Myth-Video Series

39 Reason to Avoid Stenting and Bypass

Choirboy Turns Disbeliever on Cholesterol Drugs

Vitamin E, Heart Disease and Tocotrienols

Calcium Tablets Cause Heart Disease

Familial Hypercholesterolemia

Saving Time Russert and George Carlin

Healthy Men Should Not Take Statin Drugs

Heart Disease Vitamin C and Linus Pauling

Getting Off Statin Drug Stories

How to Reverse Heart Disease with the Coronary Calcium Score (part one)

Reversing Heart Disease Part Three

Cholesterol Lowering Drugs for the Elderly, Bad Idea

Cholesterol Lowering Statin Drugs for Women Just Say No

Thanks and credit for much of the information in this article is given to Howard H. Wayne, M.D.

Non-Q-wave Myocardial Infarction Following Thrombolytic Therapy

Percutaneous Transluminal Angioplasty Versus Medical Treatment For Non-Acute Coronary Heart Disease

An Invasive Strategy Reduced Death, Myocardial Infarction and Readmissions in Unstable Coronary Artery Disease

Intensive Medical Therapy Versus Coronary Angioplasty for Suppression of Myocardial Ischemia in Survivors of an Acute Myocardial Infarction

Outcome In Patients with Acute Non-Q Wave Myocardial Infarction Randomly Assigned to An Invasive As Compared with a Conservative Management Strategy

Twenty-two Year Follow-up in the VA Cooperative Study of Coronary artery bypass surgery for Stable Angina

A Prospective Randomized Trial of Triage Angiography in Acute Coronary Syndromes Ineligible for Trombolytic Therapy

Danish Multicenter Randomized Study of Invasive Versus Conservative Treatment In Patients With Inducible Ischemia After Thrombolysis In Acute Myocardial Infarction

Coronary Angioplasty Versus Medical Therapy For Angina

One Year Results of the Thrombolysis in Myocardial Infarction (TIMI)IIIB Clinical Trial

The Medicine, Angioplasty or Surgery Study (MASS)

The TIMI IIIB Investigators

Two and Three Year Results of the Thrombolysis in Myocardial Infarction (TIMI) Phase II Clinical Trial

Randomized Trial of Late Angioplasty Versus Conservative Management For Patients with Residual Stenosis After Thrombolytic Treatment of Myocardial Infarction

A Comparison of Angioplasty With Medical Therapy in the Treatment of Single Vessel Coronary Artery Disease

SWIFT Trial of Delayed Elective Intervention v. Conservative Treatment After Thrombolysis With Anistreplase in Acute Myocardial Infarction

Comparison of Immediate Invasive, Delayed Invasive and Conservative Strategies After Tissue-Type Plasminogen Activator

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

Comparison of Invasive and Conservative Strategies After Treatment With Intravenous Tissue Plasminogen Activator in Acute Myocardial Infarction

Thrombolysis With Tissue Plasminogen Activator in Acute Myocardial Infarction: No Additional Benefit From Immediate Percutaneous Coronary Angioplasty

Comparison of Medical and Surgical Treatment for Unstable Angina Pectoris

Racial Differences in the Use of Invasive Cardiac Procedures and 1 Year Clinical Outcomes for Non-Q-Wave Myocardial Infarction Patients Randomized to Invasive vs. Conservative Management

A Comparison of the Impact of Practice Patterns on Outcome of Patients With Acute Coronary Syndromes in the USA and Canada: Post Hoc Analysis of ESSENCE and TIMI IIB

Outcome Study of Two Large Populations With Different Rates of Cardiac Interventions

Piegas, IS, Flather, M, Pogue J. et al. for the OASIS Registry Investigators

Comparison of Medical Care and Survival of Hospitalized Patients with Acute Myocardial Infarction in Poland and the United States

Use of Coronary Angiography and Revascularization Procedures Following Acute Myocardial Infarction: A European perspective

Use of Cardiac Procedures and Outcomes in Elderly Patients with Myocardial Infarction in the United States and Canada

Variation in the Use of Cardiac Procedures After Acute Myocardial Infarction

A Comparison of Management Patterns After Acute Myocardial Infarction in Canada and in the United States

Differences in the Treatment of Myocardial Infarction in the United States and Canada. A Comparison of Two University Hospitals

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

Longitudinal Assessment of Neurocognitive Function After Coronary Artery Bypass Surgery

Coronary Stenting or Percutaneous Transluminal Coronary Angioplasty Prior to Noncardiac Surgery Increases Adverse Events: The Evidence is Mounting

Catastrophic Outcomes of Noncardiac Surgery Soon After Coronary Stenting

Results of a Second-Opinion Trial Among Patients Recommended For Coronary Angiography

Two to Eight Year Survival Rates in Patients Who Refused Coronary Artery Bypass Grafting

Prognosis of Medically Treated Patients with Coronary Artery Disease With Profound ST-Segment Depression During Exercise Testing

Exercise Performance-Based Outcomes of Medically Treated Patients with Coronary Artery Disease and Profound ST Segment Depression

References



http://online.wsj.com/article/SB123146318996466585.html

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.

http://www.drmcdougall.com/misc/2007nl/apr/fav5.htm Angioplasty Fails Again and Again (8 out of 8 times)

Optimal Medical Therapy with or without PCI for Stable Coronary Disease by William Boden in the April 12, 2007 issue of the New England Journal of Medicine found after studying 2287 patients, “As an initial management strategy in patients with stable coronary artery disease, PCI (angioplasty) did not reduce the risk of death, myocardial infarction,

or other major cardiovascular events when added to optimal medical therapy.”1

In 2004, more than 1 million coronary stent procedures were performed in the United States, and recent registry data indicate that approximately 85% of all PCI procedures are undertaken electively in patients with stable coronary artery disease.

1) http://content.nejm.org/cgi/content/short/NEJMoa070829

Boden WE, et al. Optimal medical therapy with or without PCI for stable coronary disease. N Engl J Med. 2007 Apr 12;356(15):1503-16.

2) http://www.bmj.com/cgi/content/full/334/7596/0-a

Loder E. Curbing Medical Enthusiasm. BMJ 2007, April 7; 334: doi:10.1136/bmj.39175.409132.3A

3) http://content.nejm.org/cgi/content/abstract/NEJMoa066139

Hochman JS, Coronary intervention for persistent occlusion after myocardial infarction. N Engl J Med. 2006 Dec 7;355(23):2395-407.

4) http://content.nejm.org/cgi/content/extract/356/15/1572

Hochman JS, Steg PG. Does preventive PCI work? N Engl J Med. 2007 Apr 12;356(15):1572-4.

The study I am now writing about in this newsletter brings the total to 8 studies reported to date that show angioplasty fails to save lives—there are no others showing otherwise.

http://content.nejm.org/cgi/content/short/NEJMoa070829

Optimal Medical Therapy with or without PCI for Stable Coronary Disease William E. Boden, M.D., the COURAGE Trial Research Group



Background 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.

Methods 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).

Results 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).

Conclusions 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. (ClinicalTrials.gov number,

http://content.nejm.org/cgi/content/abstract/297/12/621

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.

http://www.ncbi.nlm.nih.gov/pubmed/6608052?dopt=Abstract

NEJM 1984 Mar 22;310(12):750-8

Myocardial infarction and mortality in the coronary artery surgery study (CASS) randomized trial.

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.

http://www.ncbi.nlm.nih.gov/pubmed/6128492?dopt=Abstract

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.

http://www.heartprotect.com/comparison-studies.shtml

COMPARISON OF INVASIVE VS. NONINVASIVE THERAPIES AND RELATED STUDIES

http://content.nejm.org/cgi/content/abstract/297/12/621

Treatment of chronic stable angina. A preliminary report of survival data of the randomized Veterans Administration cooperative study ML Murphy, HN Hultgren, K Detre, J Thomsen, and T Takaro Abstract

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.

Volume 297:621-627 September 22, 1977 Number 12

http://www.heartprotect.com/comparison-studies.shtml

COMPARISON OF INVASIVE VS. NONINVASIVE THERAPIES AND RELATED STUDIES

(1) http://content.nejm.org/cgi/content/abstract/338/25/1785

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.

(2) http://www.pubmedcentral.nih.gov/articlerender.fcgi?artid=27425 BMJ. 2000 July 8; 321(7253): 73–77.

Percutaneous Transluminal Angioplasty Versus Medical Treatment For Non-Acute Coronary Heart Disease. 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.

(3) http://www.ncbi.nlm.nih.gov/pubmed/10892758



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.

(3A) http://www.ncbi.nlm.nih.gov/pubmed/16980115



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.



(4) http://circ.ahajournals.org/cgi/content/full/98/19/2017

(Circulation. 1998;98:2017-2023.)

Intensive Medical Therapy Versus Coronary Angioplasty for Suppression of Myocardial Ischemia in Survivors of an Acute Myocardial Infarction

(5) http://content.nejm.org/cgi/content/abstract/338/25/1785

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.

(6) http://www.ncbi.nlm.nih.gov/pubmed/9645886

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

(7) http://content.onlinejacc.org/cgi/content/abstract/32/3/596

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.

(8) http://circ.ahajournals.org/cgi/content/full/96/3/748

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)

(9) http://www.ncbi.nlm.nih.gov/pubmed/9274581

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).

(9A)http://www.ncbi.nlm.nih.gov/pubmed/14522473

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.

(10) http://www.ncbi.nlm.nih.gov/pubmed/7594098

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).

(11) http://www.ncbi.nlm.nih.gov/pubmed/7594092

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.

(11a)

http://circ.ahajournals.org/cgi/content/full/100/suppl_2/II-107

(Circulation. 1999;100:II-107.)

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

However, the 3 treatment regimens yielded a similar incidence of acute myocardial infarction and death.

(12) http://www.ncbi.nlm.nih.gov/pubmed/8149520

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.

(13)http://content.onlinejacc.org/cgi/content/abstract/22/7/1763

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.

(14) http://www.ncbi.nlm.nih.gov/pubmed/1423952

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.

(15) http://www.ncbi.nlm.nih.gov/pubmed/1345754

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.

(16) http://www.pubmedcentral.nih.gov/articlerender.fcgi?tool=pubmed&pubmedid=2021717

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.

(17) http://www.ncbi.nlm.nih.gov/pubmed/2110033

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.

(18) http://www.ncbi.nlm.nih.gov/pubmed/2118299

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).

(19) http://www.ncbi.nlm.nih.gov/pubmed/2563896

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.

(20) http://www.ncbi.nlm.nih.gov/pubmed/2893037

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.

(21) http://www.ncbi.nlm.nih.gov/pubmed/2882420

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."

(22)

Racial Differences in the Use of Invasive Cardiac Procedures and 1 Year Clinical Outcomes for Non-Q-Wave Myocardial Infarction Patients Randomized to Invasive vs. Conservative Management.

Samar H, Heggunje PS, Deedwania PC et al. Journal of the American College Cardiology, Supplement, 2001; 37: 15A

(23) A Comparison of the Impact of Practice Patterns on Outcome of Patients With Acute Coronary Syndromes in the USA and Canada: Post Hoc Analysis of ESSENCE and TIMI IIB. Batchelor, WB, Radley D, Cohen M, et al. Journal of the American College Cardiology, Supplement, 2001; 37: 359A

(24) Outcome Study of Two Large Populations With Different Rates of Cardiac Interventions. Mahrer, PR. Cardiovascular Reviews and Reports, December 2000 638-651

(25) Piegas, IS, Flather, M, Pogue J. et al. for the OASIS Registry Investigators. The Organization to Access Strategies for Ischemic Syndromes (OASIS) registry in patients with Unstable Angina. Am J. of Cardiology. 1999; 84(suppl): 7M-12M.

(26) Comparison of Medical Care and Survival of Hospitalized Patients with Acute Myocardial Infarction in Poland and the United States. Rosamond W, Broda G, Kawalec E, et al. American J. Cardiology 1999; 83: 1180-1185.

(27) Use of Coronary Angiography and Revascularization Procedures Following Acute Myocardial Infarction: A European perspective. Woods, KL, Ketley D, Agusti, A, et al European Heart Journal. 1998; 19; 1348-1354.

(28) 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.

(29) Variation in the Use of Cardiac Procedures After Acute Myocardial Infarction. Guadagnoli E, Hauptman BJ, Ayanian JZ, et al. N Engl J Med 1995; 333: 573-578.

(30) A Comparison of Management Patterns After Acute Myocardial Infarction in Canada and in the United States Rouleau JL, Moye LA, Pfeffer, MA et al. N Engl J Med 1993;328: 779-784.

(31) Differences in the Treatment of Myocardial Infarction in the United States and Canada. A Comparison of Two University Hospitals. Pilote L, Racine N, Hlatky MA. Arch Intern Medication 1994; 154: 1090-1096.

(32) 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

(33) Longitudinal Assessment of Neurocognitive Function After Coronary Artery Bypass Surgery. Newman MF, Kirchner JL, Phillips-Bute B, et al. N Engl J Medication 2001; 344: 395-402.

(34) 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

(35) 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.

(36) Results of a Second-Opinion Trial Among Patients Recommended For Coronary Angiography. Graboys TB, Biegelsen B, Lampert S, Blatt CM, Lown B. JAMA; 1992: 268 2537-2540.

(37) 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.

(38) 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.

(39) 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

____________

more recent

http://circ.ahajournals.org/cgi/content/full/111/22/2906

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.

The present meta-analysis shows that compared with conservative medical treatment, PCI does not decrease mortality or the risk of MI during follow-up in patients with chronic CAD except in the context of a recent MI.



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Invasive approach for acute MI does not reduce mortality

http://www.ncbi.nlm.nih.gov/pubmed/15846255

1: 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.

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Early invasive with stenting reduces mortality

http://www.ncbi.nlm.nih.gov/pubmed/18760142

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.

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3 stent era trials show improvement in mortality compared to medical treatment



http://www.pubmedcentral.nih.gov/articlerender.fcgi?tool=pubmed&pubmedid=16330637

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



http://www.ncbi.nlm.nih.gov/pubmed/12932593

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

__________________________

http://www.ncbi.nlm.nih.gov/pubmed/1617765

Circulation. 1992 Jul;86(1):121-30.Links

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.

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http://kulwant.blog.co.in/2008/08/08/blockages-in-arteries-better-be-left-alone/

http://circ.ahajournals.org/cgi/content/full/118/23/2326

(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.

Drug eluting stents found to increase mortality

http://www.usatoday.com/news/health/2007-09-04-1812171944_x.htm

International study shows stent risks

By Maria Cheng, AP Medical Writer The study, presented Tuesday, showed that heart attack patients who received drug-coated stents in an emergency situation were five times more likely to die after two years than those who received bare metal stents.

http://content.onlinejacc.org/cgi/content/full/46/4/575

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.

Jeffrey Dach MD

