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COMPARISON OF INVASIVE VS. NONINVASIVE THERAPIES AND RELATED STUDIES

SUMMARY

The following pages report on a large number of studies (# 39) comparing invasive treatment of coronary artery disease (coronary artery bypass surgery or angioplasty) with conservative medical treatment using only drugs. Many of the studies have what is called a selection bias in that the patients were selected in such a way so as to favor a predetermined type of treatment. For example, angioplasty was performed only in hearts that had reasonably healthy arteries (i.e. localized narrowing in an otherwise normal coronary artery as compared to a diffusely diseased artery). Thus, hearts with "bad arteries" are not "candidates" for angioplasty, and are either excluded from a study or relegated to conservative medical treatment. Similarly, patients who have multiple diseases in addition to their coronary artery disease may not be considered acceptable for coronary artery bypass surgery. Such patients, like the angioplasty rejects, also are either excluded from the study or allowed to be treated medically.

The other selection bias involves treatment. Almost all studies comparing the two treatments fail to describe the medical treatment used. Or, the study will state that medical treatment was used as prescribed by the patient's doctor. It is now common knowledge that the majority of patients with coronary artery disease are grossly undertreated when it comes to medical treatment. In the few studies below in which medical treatment is outlined, approximately half of the medically treated patients did not receive adequate medication.

In spite of these selection biases heavily favoring surgical intervention, almost every single study described in the following pages clearly and unequivocally demonstrates that invasive treatment, be it bypass surgery or angioplasty, fail to reduce heart attacks and mortality when compared to patients who have been conservatively treated with medication. In addition, there is a clear increase in mortality, heart attack rate, cardiovascular events, repeat angioplasty and bypass surgery in the invasively treated patients. Currently, cardiologists are pushing stents and saying the results are better than with angioplasty. Stents have been with us for more than 10 years now, and there has yet to be a study comparing stent treatment with conservative medical therapy. In view of the dismal results with angioplasty described in the following pages, it is doubtful such a study will ever appear. No doubt such comparisons have already been made but negative results tend not to be published.

The studies described on the following pages are as follows: There are 21 studies dealing with approximately 20,000 patients approximately half of whom were treated with bypass surgery or angioplasty, while the other half were treated conservatively with medication. There are an additional 11 population studies involving almost 2 million people comparing the difference in treatment between populations who tend to be treated conservatively versus populations who are treated more aggressively. For example, patients in the United States are subjected to far more angiograms, angioplasty and bypass surgery than their Canadian neighbors, yet there is no difference between the two groups in heart attack rates or mortality . There are also 4 second opinion studies involving 663 patients who had been urged to undergo bypass surgery but refused and found doctors who would treat them conservatively with medication. In every study the mortality is considerably less that what the surgical mortality would have been. Finally, there are 3 complication studies in nearly a 1000 patients dealing with the high rate of complications after bypass surgery. For example, the most recent study published in February, 2001 found that 50% of patients undergoing bypass surgery have brain damage with cognitive defects with permanent loss of memory and reasoning. It is hard to escape the conclusion that although invasive treatment is far more popular and widely used than medical treatment, it is not because it is the best treatment. It is also hard to ignore the fact that the economic benefits that accompany recommendations for immediate angiograms, angioplasty or bypass surgery have heavily influenced the doctor's recommendations.

Howard H. Wayne, M.D. F.A.C.C., F.A.C.P.

INDEX

  1. Non-Q-wave Myocardial Infarction Following Thrombolytic Therapy

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

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

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

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

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

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

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

  9. Coronary Angioplasty Versus Medical Therapy For Angina

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

  11. The Medicine, Angioplasty or Surgery Study (MASS)

  12. The TIMI IIIB Investigators

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

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

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

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

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

  18. 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

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

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

  21. Comparison of Medical and Surgical Treatment for Unstable Angina Pectoris

  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

  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

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

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

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

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

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

  29. Variation in the Use of Cardiac Procedures After Acute Myocardial Infarction

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

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

  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

  33. Longitudinal Assessment of Neurocognitive Function After Coronary Artery Bypass Surgery

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

  35. Catastrophic Outcomes of Noncardiac Surgery Soon After Coronary Stenting

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

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

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

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

DIRECT COMPARISON STUDIES OF INVASIVELY TREATED PATIENTS (BYPASS SURGERY or ANGIOPLASTY) WITH CONSERVATIVELY TREATED MEDICAL PATIENTS

  1. 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.

    This study attempted to determine the effect of post heart attack management strategy on event rates (death or recurrent heart attack) in patients following thrombolytic (clot dissolving) therapy.

    Background:

    Patients who have heart attacks following thrombolytic therapy are often considered to be at high risk and are frequently managed with routine early invasive testing despite a lack of data supporting improved outcome.

    Methods:

    We compared the event rates in patients randomized to routine early coronary angiography with those in patients randomized to a conservative strategy of noninvasive functional assessment, with angiography reserved for patients with spontaneous or induced ischemia.

    Results:

    During an average follow-up of 23 months, 19 of 58 patients (33%) randomized to the invasive management strategy died or suffered recurrent nonfatal heart attack compared with 11 of 57 patients (19%) randomized to the conservative strategy (p = 0.152). Equivalent numbers of patients were subjected to revascularization (coronary angioplasty or coronary artery bypass surgery). There were more deaths in the invasive management group than in the conservative management group (11 vs. 2). Excess deaths could not be attributed to periprocedural mortality.

    Conclusions:

    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. Percutaneous Transluminal Angioplasty Versus Medical Treatment For Non-Acute Coronary Heart Disease: Meta-Analysis of Randomized Controlled Trials. Bucher, HC, Hengstler, P, Schindler, C, Gordon, H, Guyatt, GH. British Medical Journal. 2000; 321: 73-77.

    Objective:

    To determine whether coronary angioplasty is superior to medical treatment in non-acute coronary artery disease.

    Design:

    Meta-analysis of randomized controlled trials.

    Setting:

    Randomized controlled trials conducted worldwide and published between 1979 and 1998.

    Participants:

    953 patients treated with angioplasty and 951 with medical treatment from six randomized controlled trials, three of which included patients with multivessel disease and pre-existing myocardial infarction.

    Main outcome measures:

    Angina, fatal and non-fatal myocardial infarction (heart attack), death, repeated angioplasty, and coronary artery bypass grafting.

    Results:

    Patients treated with angioplasty compared with medical treatment had less angina, but significantly more fatal and non-fatal myocardial infarction, death, coronary artery bypass grafting, and repeated angioplasty. There were more deaths in the angioplasty group (15) versus the medical group (11). There were 41 heart attacks in the angioplasty group compared to 29 in the group treated only with medication.

    Conclusions:

    Coronary angioplasty may lead to a greater reduction in angina in patients with coronary heart disease than medical treatment but at the cost of more coronary artery bypass grafting, and fatal and nonfatal myocardial infarction.

  3. 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.

  4. Intensive Medical Therapy Versus Coronary Angioplasty for Suppression of Myocardial Ischemia in Survivors of an Acute Myocardial Infarction. Dakik HA, Kleiman NS, Farmer, JA et al. Circulation, 1998; 98: 2017-2023.

    In this study on 44 stable survivors of a heart attack, 21 underwent coronary angioplasty while 23 were allowed to have intensive medical therapy. At the end of the study period the cardiac event rate and mortality were similar in both groups. There was no advantage of angioplasty over medical treatment.

  5. Outcome In Patients with Acute Non-Q Wave Myocardial Infarction Randomly Assigned to An Invasive As Compared with a Conservative Management Strategy. Boden WE, O'Rourke RA, Crawford MH, et al. New Engl J. Medicine. 1998; 338: 1785-1792.

    In this multicenter study from 15 medical centers, a total of 920 patients were studied after their acute myocardial infarction. 462 patients underwent invasive management while 458 had conservative treatment and were followed for an average of 23 months. Death or non-fatal myocardial infarction made up the end point. At one month there were 36 patients in the invasive group who had suffered a heart attack or death versus only 15 in the medically treated group. The difference in death was even more striking at the end of one year: 21 of the invasively treated patients had died vs. only 6 of the medically treated patients. At the end of the 12-44 month study period there were 152 events in 138 patients assigned to invasive treatment (80 deaths and 72 non-fatal heart attacks) compared to 139 events in 123 patients assigned to conservative medical treatment (59 deaths and 80 non fatal heart attacks). Thus, 17.3% of the invasively treated group died vs. 12.9 of the conservatively treated group. Not only do most patients not benefit from aggressive invasive treatment after their heart attack, but it is harmful.

  6. Twenty-two Year Follow-up in the VA Cooperative Study of Coronary artery bypass surgery for Stable Angina. Peduzzi, P, Kamina A, Detrie, K, American Journal of Cardiology. 1998; 81; 1393-1399.

    Between 1972 and 1974 354 patients with symptomatic coronary artery disease were assigned to conservative medical treatment and 332 with similar symptomatic coronary artery disease were assigned to surgical revascularization. The overall 22 year cumulative survival rate for the medically treated group was 25% while it was 20% in the surgically treated group. The probability of being free of heart attack was significantly higher in the medically treated group (57% vs. 41%). The authors conclude that the trial "provides strong evidence" that initial bypass surgery does not improve survival or reduce the overall risk of a future heart attack. On the contrary, invasively treated patients were much more likely to suffer a heart attack or die compared to patients who are not treated surgically.

  7. 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.

    In this multicenter study, 64 patients underwent revascularization with either angioplasty or coronary artery bypass surgery while 54 patients were treated conservatively with medication. There was a selection bias in that revascularization was only carried out in patients with "suitable anatomy". At the end of 21 months 4% of the revascularization group had died vs. only 2% of the medically treated patients. The composite 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.

  8. 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 this study was to compare an invasive strategy (coronary angioplasty or coronary artery bypass surgery) with a conservative strategy of just medical treatment in patients with inducible ischemia afte thrombolytic therapy for their first acute myocardial infarction. 503 patients were randomized to an invasive strategy and 505 to a conservative strategy. Angioplasty was performed in 52.9% and coronary artery bypass surgery in 29.2%. The patients were followed for 1-4.5 years with a mean of 2.4 years. At 2.4 years the mortality in the invasive group was 3.6% while in the conservatively treated group the mortality was 4.4%. This difference was not significant. It should be pointed out that medical treatment was left in the hands of the local doctor. Only 40% received beta blocker while only 28% received calcium channel blockers. No mention is made of nitrates or diuretics. It also should be noted that there was some selection bias in that 7% of the patients in the conservatively treated group had more severe ischemia. There was also selection bias in the invasive group in that only patients with suitable anatomy were allowed to enter the study. Thus, the invasive strategy failed to prevent heart attacks or death when compared to medical treatment.

  9. 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.

    The Second Randomized Intervention Treatment of Angina (RITA-2) Trial recruited 1018 patients from 20 cardiology centers in the United Kingdom and Ireland to either angioplasty or medical treatment. There were 504 patients in the angioplasty and 514 in the medical therapy group. They were followed for an average of 2.7 years. The primary study endpoint was the combined frequency of death and a myocardial infarction (heart attack). Median patient age was 58 years and 18% were women. At the median of 2.7 years 11 patients (2.2%) in the angioplasty had died vs. 7 (1.4%) in the medically treated group had died. There were 21 and 10 definite myocardial infarctions in the the angioplasty and medically treated groups respectively. Clearly, patients undergoing coronary angioplasty fared worse than those undergoing medical treatment.

  10. 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.

    There were 1473 patients enrolled in this study with ages varying from 21 to 79. 740 underwent early invasive treatment with angioplasty or coronary artery bypass surgery while 733 underwent conservative medical treatment. At one year there was no significant difference in death or repeat heart attack. 4.1% of the invasively treated patients died versus 4.4% of the conservatively treated patients. At one year 8.3% of the invasively treated patients had a recurrent heart attack versus 9.3% of the medically treated patients. None of these differences were considered significant. Thus, early invasive treatment of patients with unstable angina or non Q-wave myocardial infarction are not benefited in comparison to conservative medical treatment.

  11. 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.

    In this trial 214 patients with narrowing of only the left anterior descending coronary artery were randomly assigned to coronary artery bypass surgery (n=70), coronary angioplasty (n= 72) or medical treatment alone (n=72) and were followed for an average of three years. At the end of the study period, in the medically treated group 2 patients had a heart attack and no patient died. In the bypass surgery group one patient died and one had a heart attack. In the angioplasty group 2 had a heart attack and one patient died; however, 37% of the these patients had to undergo repeat angioplasty. Thus, after three years, in these patients with good cardiac function, neither bypass surgery or angioplasty showed any benefit over conservative medical treatment.

  12. 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.

    The TIMI IIIB Trial was designed to investigate the role of tissue plasminogen activator added to conventional medical therapy and to compare an early invasive approach to an early conservative strategy in 1,473 patients diagnosed with unstable angina or non-Q wave myocardial infarction. Early revascularization was carried out only when the anatomy was appropriate. All patients received conventional medical therapy. At the end of the 6 week study period there was no difference between the two groups in mortality or frequency of non fatal heart attack.

  13. 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.

    This report describes the 2 and 3 year survival and heart attack rate in the Thrombolysis in Myocardial Infarction (TIMI) Phase II Clinical Trial. Patients enrolled in the trial were randomly assigned to an invasive strategy (1681 patients) or to a conservative management strategy (1658 patients) after receiving a thrombolytic (clot dissolving drug) for an acute myocardial infarction (heart attack). The invasive strategy group underwent angiograms 18-48 hours after entry into the study, and when appropriate, angioplasty or coronary artery bypass surgery. The conservatively treated medical group underwent medical therapy of that day (1992). Two year follow up data showed. Mortality at 2 years was 8.9 % for the invasive group vs. 8.7 % for the medically treated group. Death or heart attack occurred in 17.6% of the invasive group and 17.9% of the conservatively treated group. At three years mortality was 11.5 % in the invasively treated group vs. 11.0 % in the medically treated group. Rates of death or heart attack at three years was 21 % in the invasively treated group vs. 20 % in the medically treated patients. Thus, there was no advantage of an invasive treatment following a heart attack; indeed, mortality and heart attack rate was slightly greater in this group of patients. Note again, there was probably a selection bias in favor of the angioplasty or bypass surgery surgery group because it required suitable anatomy.

  14. 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.

    In this study from the Cleveland Clinic, 87 patients who had a myocardial infarction and who were treated with thrombolytic therapy(clot busting drugs) were randomized to treatment with angioplasty 4-14 days after their heart attack, or to conservative medical therapy. At the end of one year survival in the conservative medical therapy was 97.8% vs. only 90.5% in the angioplasty treated group. Comparison of the functional state of the heart showed no difference between the 2 groups. The authors conclude that "these data strongly suggest that patients with an uncomplicated myocardial infarction after thrombolytic therapy, even if they have significant narrowing of a coronary artery, should be treated medically.

  15. 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.

    A total of 212 patients were with single vessel coronary artery disease randomly assigned to treatment with either angioplasty (107 patients) or medical therapy (105 patients). It should be noted that only 50% of the medically treated patients actually received nitrates and only 50% received beta blockers. At the end of 6 months 5 of the angioplasty treated patients had suffered a heart attack versus 3 in the medically treated group. There were no deaths in the angioplasty group and there was one death in the medically treated group; however, this patient was one who decided to refuse medical treatment and elected to have angioplasty following which he died. 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. 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.

    From 21 hospitals in Britain and Ireland 800 patients with an acute myocardial infarction who were treated with thrombolytic drugs were randomized to receive coronary angioplasty or bypass surgery (397 patients) or conservative medical treatment (403 patients) with analysis of results over 12 months. Mortality at 12 months was 5.8% in the intervention group compared to 5.0% in the medical treatment group. The rates of reinfarction (repeat heart attack) was 15.1% in the intervention group vs. 12.9% in the conservative medically treated group. There was no difference in symptoms such as angina or cardiac function between the two groups at 12 months. Thus, both mortality and repeat heart attack were greater in the group receiving invasive treatment.

  17. 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.

    586 patients who had a myocardial infarction were randomized to one of three groups. Group 1 (#195) had immediate angioplasty following a myocardial infarction. Group 2 (# 194) had delayed angioplasty 18-48 hours after their myocardial infarction. Group 3 (# 197) had primarily conservative medical treatment with drug therapy after their heart attack. At 1 year follow-up, the three treatment groups had similar cumulative rates of mortality (8,7%), fatal and non-fatal reinfarction (8.5%), combined death and reinfarction (14.5%), and coronary artery bypass surgery (17.2%). There was a marked difference in the in the frequency of repeat angioplasty in the invasive groups (76 % and 64% in Groups 1 and 2 vs 23% in the conservatively treated medication group. The authors conclude "Thus, because conservative strategy achieves equally good short and long term outcomes with less morbidity and a lower use of angioplasty, it seems to be the preferred initial management strategy."

  18. 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.

    201 patients who had an acute myocardial infarction underwent either angioplasty or conservative medical treatment. After a mean follow up of 10 months, total mortality in the angioplasty treated group was 8.2 % compared to only 3.8% in the conservatively medically treated group. The investigators conclude that conservative medical treatment is preferable to intervention invasive treatment with angioplasty.

  19. 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.

    The TIMI (Thrombolysis in Myocardial Infarction) Study group treated 3,262 patients with the clot dissolving drug called tissue plasminogen activator within 4 hours after the onset of chest pain thought to be due to an acute myocardial infarction. Of this group 1,636 were assigned to an invasive strategy. Of these 1,636 patients coronary angioplasty was attempted in 838 patients with suitable anatomy while 1,626 patients were treated conservatively.

    Results:

    The primary endpoint, reinfarction (repeat heart attack) or death within 6 weeks occurred in 10.9% of the patients treated with angioplasty and in 9.7% of the conservatively treated patients. Death alone occurred in 5.2% of the angioplasty patients versus 4.7% of the conservatively treated patients. There was no significant difference in cardiac function and the ejection fraction between the two groups either at rest or during exercise either at the time of hospital discharge or at 6 weeks. Thus, not only was angioplasty for patients having chest pain thought to be due to a heart attack of no benefit, it actually resulted in a a greater frequency of repeat heart attacks and death.

  20. Thrombolysis With Tissue Plasminogen Activator in Acute Myocardial Infarction: No Additional Benefit From Immediate Percutaneous Coronary Angioplasty. Simoons, ML, Betriu, A, Collateral, J et al. The Lancet. January 30, 1988; 197-203.

    This was a multicenter study in which 364 patients with an acute myocardial infarction were allocated to two treatment groups: Group 1 (# 180) were treated with immediate angioplasty while Group 2 (# 184) were treated non-invasively with medication. The clinical course was more favorable with the non-invasive therapy with a lower incidence of recurrent ischemia, bleeding complications, hypotension and cardiac arrest. There was no difference in the 2 groups in terms of muscle damage from the heart attack, At 14 days the mortality in the angioplasty group was 7% compared to 3% in the non-invasive treatment group. The authors conclude "Since immediate angioplasty does not provide additional benefit, there seems to be no need for immediate angiograms and angioplasty in patients with acute myocardial infarction treated with tissue plasminogen activator."

  21. Comparison of Medical and Surgical Treatment forh Unstable Angina Pectoris. Luchi, RJ, Scott SM, Deupree RH, et al. N. Engl. J. Medicine 1987; 316: 977-984.

    A total of 468 patients were randomly assigned to coronary artery bypass surgery (N=231) or conservative medical therapy (N=237) between the years 1976 and 1982. Note that medical therapy of that day was somewhat limited. At the end of the two year study period 9.3% of the medically treated patients had died versus 7.8% of the surgically treated patients---a difference that was not considered significant. During this time period 12.2 % of the medically treated patients had nonfatal heart attack versus 11.7% of the surgically treated patients. Again this difference was not considered significant.

    RELATED ARTICLES POPULATION STUDIES

  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

    There were 682 whites and 207 non-whites involved in this study comparing the frequency of invasive procedures vs. conservative medical treatment in patients sustaining a heart attack. Invasive treatment was undertaken in 47% of the whites compared to 26% of the non-whites. At 1 year 23% of the whites and 15% of the non-whites had sustained a cardiovascular event of either death or a heart attack. Thus, there was a significantly greater risk of complications in patients undergoing invasive cardiac treatment.

  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

    The practice patterns and long term outcomes were compared in 1522 U.S. patients and 2001 Canadian patients with acute coronary syndromes. At 3 months the incidence of heart attacks or death was 9.1% in the US patients vs. 8.9% in the Canadian patients. At 1 year the incidence of these endpoints were almost identical at 12.9 and 12.7%. Thus, despite the much more frequent use of revascularization in the US patients, there was no reduction in the frequency of heart attacks or death in the conservatively treated Canadian patients.

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

    The rates of cardiovascular interventions for 1.73 million of the 14.0 million population in the Los Angeles Basin who receive their health care from Kaiser Permanente Health Plan was compared to the remainder of the population during the years 1994 and 1995. Data on cardiac mortality, mortality from acute myocardial infarction, and hospitalizations for cardiac causes were analyzed for Kaiser and Non-Kaiser populations in the same area.

    Results:

    In 1994 and 1995, the rate of cardiac catheterization for the Kaiser patients was 250 and 270 per 100,000 population for 1994 and 1995 vs. 400 and 425 per 100,000 for the non-Kaiser patients. The angioplasty rates were 50 and 70 for the Kaiser patients vs. 110 and 115 for the non-Kaiser patients. For coronary artery bypass surgery the rates were 70 and 78 for Kaiser patients vs. 90 and 100 for non-Kaiser patients. In-hospital mortality was higher for the non-Kaiser patients (5.5%) than for the Kaiser patients (4.4%). There was more hospitalizations for congestive heart failure for the non-Kaiser patients (6.0/1000) than for the Kaiser patients (4.1/1000). Total number of hospitalizations was also greater for the non-Kaiser patients than for the non-Kaiser patients.

    Conclusions:

    These figures show that the greater the number of interventions, the greater the mortality, the frequency of congestive heart failure and the frequency of hospitalizations.

  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.

    This was a prospective registry of approximately 7,987 patients with non ST elevation acute coronary syndrome from 95 hospitals in 6 countries. The registry examined regional difference in in the clinical management, frequency and timing of invasive procedures such as angioplasty and bypass surgery. There was a wide range in coronary angiograms ranging from 60% in Brazil (fee for service medical care) and 58% in the United States to 15% in Hungary and 2% in Poland. Despite this wide range in cardiac procedures, the frequency of major cardiac events was similar. The composite end point of death or myocardial infarction after 7 days was 4.7% in all countries. At 6 months the rates were also similar with an average of 10.7% for all countries. Rates of stroke were highest in Brazil and the United States compared to countries with lower intervention rates. No significant advantage was found for routine angiograms. Aggressive procedures were associated with increased bleeding complications.

  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.

    Comparison was made of patients who were hospitalized with an acute myocardial infarction in both Poland and the United States from 1987-1993. A total 0f 3,694 patients were hospitalized in Poland, and 4,801 in the United States. Over 50% of all United States hospitalized patients underwent coronary angiography while coronary angioplasty was performed in more than 20% of patients. In contrast, less than 1% of Polish patients received these procedures. In contrast to the difference in the use of invasive procedures, there was little difference in medical therapies between the two countries. Anti-platelet therapies, nitrates, angiotensin converting enzyme inhibitors and beta blocker were used with similar frequencies. However, thrombolytic agents and calcium channel blockers were used more often in the United States. Despite these differences 28 day case fatality rates between the two countries were almost identical. For men it was 6% in the United States and 7% in Poland. For women it was 8% for women in the United States and 9% in Poland. These differences were not considered significant. Thus, there were no benefits to the high rates of doing coronary angiography and angioplasty in the United States.

  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.

    This was a population based study to determine routine practice pattern among cardiologists from 11 European countries during the 6 months that followed after their patients had suffered an acute heart attack. Eleven geographically defined European regions each with an average population of 1.6 million and with a total population of 19.8 million containing a mixture of urban and rural areas, and a mix of teaching and non teaching hospitals were studied between January 1993 and June 1994. Data was available on 2,807 patients. There was a marked disparity in the utilization rates of coronary angiography, angioplasty and coronary artery bypass surgery. The proportion of patients having coronary angiography in the 6 month following their heart attack varied from 8% to 61%. The proportion of patients having coronary angioplasty in the 6 month following their heart attack varied from 1% to 28%, and for bypass surgery from 1% to 20%. While the authors don't list the accompanying mortality rates, other studies (see below) that have found similar wide disparities in the utilization rates of these interventions have failed to find a difference in mortality or the frequency of heart attacks. In other words, there appears to be no advantage in terms of preventing heart attack or death by performing either angioplasty or bypass surgery.

  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.

    This study compares the use of invasive cardiac procedures and mortality rates among 224,258 Medicare patients in the United States and 9,944 elderly patients in Ontario, Canada each of whom had a new heart attack in 1991. United States patients were much more likely to undergo coronary angiograms than their Canadian counterparts (34.9% vs. 6.7%), angioplasty (11.7% vs.1.5%), and coronary artery bypass surgery (10.6% vs. 1.4%) during the first 30 days after their heart attack. The 30 day mortality for the United States patients was 21.4% vs. 22.3% for Canadian patients. At one year the mortality rates were virtually identical (34.3% in the United States vs. 34.4% in Canada. The authors conclude that "the strikingly rates of the use of cardiac procedures in the United States as compared to Canada, do not appear to result in better long term survival rates for elderly United States patients with acute myocardial; infarction.

  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.

    Medicare patients between the ages of 65 and 79 who were admitted to 478 hospitals in Texas and New York with an acute myocardial Infarction were compared as to the rate of use. There were 1852 patients from New York and 1837 patients from Texas. The overall rate of angiograms within 90 days was 45% in Texas and 30% in New York, The rate of coronary artery bypass surgery was 15% in Texas and 13% in New York. The rate of death at 90 days was the same in both states at 23%. At 2 years the death rate was 36% in New York and 37% in Texas. Patients treated in Texas were 41% more likely to experience chest pain at follow up compared to New York patients. Patients in Texas were also were less likely to perform tasks requiring energy expenditure than patients in New York. Thus, in spite of the more frequent use of interventional procedures and surgery in Texas compared to New York, there was no apparent advantage of performing these procedures; indeed, the outcome was somewhat worse.

  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.

    A comparison of the management patterns was made in 1573 United States patients and 658 Canadian patients with an acute myocardial infarction from 93 United States participating hospitals and 19 Canadian hospitals between 1987 and 1990. The patients were followed for a mean of 43 months in the United States and 39 months in Canada. The average age in both countries was 59 years. Coronary angiograms were performed in 68% of the United States patients vs. 35% of the Canadian patients. Coronary artery bypass surgery or angioplasty was performed in 31% of the United States patients vs. 12% of the Canadians. There was no difference in mortality during the study period (23% in the United States vs 22% in Canada) or in the rate of repeat heart attack (13% in the United States vs 14% in Canada). Thus, the increased use of interventional procedures is not associated with any improvement in survival or protection from future heart attacks.

  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.

    This was a retrospective study involving the period from January 1, 1989 to December 31, 1990 in which all patients (n=518) with acute myocardial infarction treated in the coronary care unit of Stanford and McGill University Hospitals were followed during and after their hospitalization. There were 233 patients treated at Stanford and 285 at McGill. During hospitalization angiograms and revascularization procedures were done much more frequently at Stanford than at McGill. 53% of the patients had coronary angiography at Stanford vs. 34% at McGill. 30% of the patients at Stanford had angioplasty vs, 13% at McGill and 10% had bypass surgery at Stanford vs. 4% at McGill. Cardiac arrhythmias were much more common at Stanford than at McGill (ventricular tachycardia, 28% vs. 13%; atrial fibrillation, 15% vs. 8%). During a mean follow-up of 20 months, reinfarction (repeat heart attack) was seen more frequently at Stanford than at McGill (13% vs. 8%) while mortality was about the same (28% vs. 27%}. Thus, there was no benefit of aggressive interventional treatment as carried out at Stanford compared to a more conservative approach in Canada. Indeed, there was a negative effect with a higher rate of rhythm disturbances at repeat heart attack rates at Stanford.

  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

    All patients having an acute myocardial infarction between the ages of 30 and 74 from 1990 and 1991 in all 25 hospitals in Minneapolis-St. Paul, and the 2 large hospitals in Goteborg were studied as to medical care and mortality. There were 802 men and 295 women from Goteborg and there were 1,065 men and 836 women from Minneapolis-St. Paul. 10% of the patients from Goteborg underwent coronary angiograms versus 49% of the patients from Minneapolis-St. Paul. 5% of the men and 3% of the women from Goteborg underwent angioplasty versus 20% of the men and 15% of the women from Minneapolis-St. Paul. 1% of both men and women from Goteborg underwent coronary artery bypass surgery versus 12% and 10% of the men and women from Minneapolis-St. Paul. At the end of one year there was no significant difference in the mortality for both men and women in Minneapolis-St. Paul compared to Goteborg despite the wide differences in the use of angioplasty and bypass surgery in the United States compared to Goteborg, Sweden.

    COMPLICATION STUDIES

  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.

    Background:

    Cognitive decline complicates early recovery from coronary artery bypass surgery and may be evident in as many as 75% pf patients at the time of discharge from the hospital and a third of the patients after 6 months. These investigators set out to determine the course of cognitive changes during the 5 years after coronary artery bypass surgery.

    Methods:

    Neurocognitive tests were performed in 261 patients preoperatively, before hospital discharge, at 6 weeks, 6 months and 5 years after surgery.

    Results:

    Among the patients studied the incidence of cognitive decline was 53% at hospital discharge, 365 at 6 weeks. 24% at 6 months and 42% at 5 years.

    Conclusions:

    These results confirm the relatively high prevalence and persistence of cognitive decline after coronary artery bypass surgery.

  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

    These investigators studied 686 patients who underwent coronary angioplasty before noncardiac surgery, 686 matched surgery patients with uncorrected coronary artery disease, and 2,155 matched normal control subjects. Patients undergoing coronary angioplasty had twice the rate of adverse outcomes as normal subjects, seven times the rate of angina, almost four times the number of heart attacks, and twice the rate of congestive heart failure. 26% of the patients undergoing coronary angioplasty less than 90 days before their noncardiac surgery had adverse cardiac events. The conclusion here is that coronary angioplasty does not prophylactically reduce cardiovascular risk before noncardiac surgery but significantly increases that risk and should not be done.

  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.

    Perioperative complications were reviewed in 40 patients who underwent noncardiac surgery within 6 weeks following the implantation of coronary stents. 18% of the patients had heart attacks, 28% had bleeding episodes and 20% died. These complications rates are far beyond what is to be expected from routine noncardiac surgery.

    The above reports compare revascularization (angioplasty or coronary artery bypass surgery) in 10,503 patients with 10,733 patients who were treated conservatively with medication. There are 25 such reports. None of these reports show any benefit of revascularization compared to medical treatment. In addition, there are 6 reports of population studies comparing those populations who had revascularization with those who did not. Again, morbidity and mortality were less in patients who did not receive any revascularization procedure. Finally, there are 3 reports dealing with the delayed harmful effects of surgery.

    SECOND OPINION STUDIES

  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.

    168 patients average age 60 (36-88) were advised to undergo angiograms. 134 (80%) were judged not to need angiograms. The patients were followed for a mean of 46 months. The were 7 cardiac deaths for an average mean mortality of 1.1%, and 19 patients experienced a new myocardial infarction (annual event rate = 2.7%. Thus, both the mortality rate and new heart attack rate are considerable less that what is seen with either angioplasty or coronary artery bypass surgery.

  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.

    150 patients (average age 57) who refused to undergo coronary angiograms were followed for 2-8 years. 92% had multivessel disease. Medical treatment consisted of beta blocker, calcium channel blockers, nitrates and aspirin. Annual mortality was 0% for 1 and 2 vessel coronary artery disease and 1.3% for 3 vessel and left main coronary artery disease. Nonfatal acute myocardial infarction incidence was 8%. The authors conclude that even with advanced coronary artery disease but with good left ventricular function, there is good long term survival with conservative medical treatment.

  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.

    Patients with strongly positive exercise tests are typical "rushed in" the hospital for emergency coronary artery bypass surgery on the belief they are about to have a heart attack and that conservative medical treatment will not save them. Among 142 patients with such an exercise test who were followed for an average of 59 months, only 11 patients died (average mortality 1.4%). Keep in mind that the medical treatment used was that of 20-25 years ago. Considering the fact that the average immediate mortality of coronary artery bypass surgery today is 5.5%, and the annual mortality following such surgery is about 3% a year, the 5 year mortality of coronary artery bypass surgery is approximately 20% vs 5% for conservative medical therapy.

  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

    Objectives:

    We sought to determine the relationship between exercise duration and cardiovascular outcomes in patients with profound (2 mm) ST segment depression during exercise treadmill testing (ETT).

    Background:

    Patients with stable symptoms but profound ST segment depression during ETT are often referred for a coronary intervention on the basis that presumed severe coronary artery disease (CAD) will lead to unfavorable cardiovascular outcomes, irrespective of symptomatic and functional status. We hypothesized that good exercise tolerance in such patients treated medically is associated with favorable long-term outcomes.

    Methods:

    We prospectively followed, for an average of 41 months, 203 consecutive patients (181 men; mean age 73 years) with known stable CAD and 2 mm ST segment depression who performed ETT according to the Bruce protocol. The primary end point was occurrence of myocardial infarction (MI) or death.

    Results:

    Eight (20%) of 40 patients with an initial ETT exercise duration 6 min developed MI or died, as compared with five (6%) of 84 patients who exercised between 6 and 9 min and three (3.8%) of 79 patients who exercised 9 min (p = 0.01). Compared with patients who exercised 6 min, increased ETT duration was significantly associated with a reduced risk of MI/death (6 to 9 min: relative risk [RR] = 0.25, 95% confidence interval [CI] 0.08 to 0.76; >9 min: RR = 0.14, 95% CI 0.04 to 0.53). This protective effect persisted after adjustment for potentially confounding variables. We observed a 23% reduction in MI/death for each additional minute of exercise the patient was able to complete during the index ETT.

    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. The annualized mortality rate for the entire study group was only 1.1% (compared to 3% for patients undergoing coronary artery bypass surgery.)