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ABSTRACT: The Angina With Extremely Serious Operative Mortality Evaluation (AWESOME) study was a multicenter Veterans Affairs randomized trial and registry that compared long-term survival of percutaneous coronary intervention with coronary artery bypass graft surgery for the treatment of patients with medically refractory myocardial ischemia and at least one additional risk factor for an adverse outcome with bypass. Both the randomized trial and the registry demonstrated comparable 3-year survival. The purpose of this study was to compare bypass and percutaneous intervention survival of AWESOME patients who were older than 70 years of age.
Over a 5-year period (1995 to 2000), 2,431 patients with medically refractory myocardial ischemia and at least one of the following five risk factors (prior heart surgery, myocardial infarction within 7 days, left ventricular ejection fraction less than 35%, age > 70 years, intraaortic balloon pump requirement to stabilize) were identified. Of these patients, 1,278 were older than 70 years of age. Eight hundred, seventy-one patients were turned down by at least one physician, 407 were acceptable to both physician and surgeon for randomization, and 236 (60%) consented to randomization. Of the 1,042 eligible patients who were not randomized, 871 had their revascularization directed by a physician who was not involved in the study. One hundred, seventy-one patients who were acceptable for randomization by both the interventional cardiologist and the cardiac surgeon refused consent.
Bypass and percutaneous intervention survival were compared using Kaplan-Meier curves and log rank tests. Bypass and percutaneous intervention 36-month survival rates for patients older than 70 years of age were 76% and 75%, respectively, among the eligible patients. Survival was 71% and 78% among those patients who were randomized and 76% and 67% in the physician-directed subgroup. Of those patients who chose their revascularization techniques, the survivals were 79% and 85%, respectively. The survival differences are not large, and none of the global log rank tests of bypass compared with percutaneous intervention survival showed a statistically significant difference over 5 years.
Both the randomized and registry subgroups of patients who were older than 70 years of age support the trial conclusions that either bypass or percutaneous intervention effectively relieves medically refractory ischemia among high-risk unstable angina patients whose age was greater than 70 years.
The Annals of thoracic surgery 10/2005; 80(4):1340-6. · 3.74 Impact Factor
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ABSTRACT: This retrospective observational review compares patient characteristics and in-hospital and long-term outcomes of cohorts of patients undergoing percutaneous coronary intervention (PCI) for cardiogenic shock complicating acute myocardial infarction (MI) prior to the use of stents (as well as glycoprotein IIb/IIIa inhibitor and dual-antiplatelet therapy) with PCI in the stent era. Cardiogenic shock remains the leading cause of hospital mortality from acute MI. This is a report of consecutive patients with cardiogenic shock complicating acute MI, without mechanical complication, referred for emergency catheterization to a single operator at two consecutive Veterans Affairs medical centers over a 15-year period (1988 to August 2003). PCI was attempted in all 93 cases: 44 consecutive patients in the present era and 49 consecutive patients in the stent era. Patients with comparable extent of coronary disease, more ST elevation myocardial infarction, multiple areas of infarction, and greater comorbidity underwent PCI in the stent era. Nevertheless, PCI in the stent era was associated with higher rates of acute success and improved in-hospital survival. Kaplan-Meier curves and log-rank testing showed highly significant improvement in overall survival (P < 0.0001). Logistic regression of in-hospital survival demonstrated that stent use (colinear with glycoprotein IIb/IIIa use and dual-antiplatelet therapy) was significantly associated with survival in a model adjusting for extent of coronary disease and comorbidities (P = 0.007). Stents and abciximab have been associated with improved acute angiographic and procedural success of PCI for cardiogenic shock, leading to improved survival.
Catheterization and Cardiovascular Interventions 05/2005; 65(1):25-33. · 2.29 Impact Factor
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ABSTRACT: The recently concluded Angina With Extremely Serious Operative Mortality Evaluation (AWESOME) was a randomized clinical trial of percutaneous coronary intervention versus coronary bypass graft surgery among patients with medically refractory ischemia who were at high risk for coronary bypass graft surgery because of > or =1 risk factors that included severely reduced left ventricular (LV) function, defined as LV ejection fraction <35%. This study reports the outcome of patients with LV ejection fraction <35% in the randomized clinical trial and the physician-directed and patient choice registries of the AWESOME study.
The American Journal of Cardiology 07/2004; 94(1):118-20. · 3.37 Impact Factor
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ABSTRACT: We compared six-month health-related quality of life (HRQL) for high-risk patients with medically refractory ischemia randomized to percutaneous coronary intervention (PCI) versus coronary artery bypass graft (CABG) surgery.
Mortality rates after PCI and CABG surgery are similar. Therefore, differences in HRQL outcomes may help in the selection of a revascularization procedure.
Patients were enrolled in a Veterans Affairs multicenter randomized trial comparing PCI versus CABG for patients with medically refractory ischemia and one or more risk factors for adverse outcome; 389 of 423 patients (92%) alive six months after randomization completed an Short Form-36 (SF-36) health status survey. Primary outcomes were the Physical Component Summary (PCS) and Mental Component Summary (MCS) scores from the SF-36. Multivariable analyses were used to evaluate whether PCI or CABG surgery was associated with better PCS or MCS scores after adjusting for over 20 baseline variables.
There were no significant differences in either PCS scores (38.7 vs. 37.3 for PCI and CABG, respectively; p = 0.23) or MCS scores (45.5 vs. 46.1, p = 0.58) between the treatment arms. In multivariable models, there remained no difference in HRQL for post-PCI versus post-CABG patients (for PCS, absolute difference = 0.56 +/- standard error of 1.14, p = 0.63; for MCS, absolute difference = -1.23 +/- 1.12, p = 0.27). We had 97% power to detect a four-point difference in scores, where four to seven points is a clinically important difference.
High-risk patients with medically refractory ischemia randomized to PCI versus CABG surgery have equivalent six-month HRQL. Therefore, HRQL concerns should not drive decision-making regarding selection of a revascularization procedure for these patients.
Journal of the American College of Cardiology 06/2003; 41(10):1732-8. · 14.16 Impact Factor
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ABSTRACT: This report compares long-term percutaneous coronary intervention (PCI) and coronary artery bypass graft (CABG) survival among post-CABG patients included in the Angina With Extremely Serious Operative Mortality Evaluation (AWESOME) randomized trial and prospective registry.
Repeat CABG surgery is associated with a higher risk of mortality than first-time CABG. The AWESOME is the first randomized trial comparing CABG with PCI to include post-CABG patients.
Over a five-year period (1995 to 2000), patients at 16 hospitals were screened to identify a cohort of 2,431 individuals who had medically refractory myocardial ischemia and at least one of five high-risk factors. There were 454 patients in the randomized trial, of whom 142 had prior CABG. In the physician-directed registry of 1,650 patients, 719 had prior CABG. Of the 327 patient-choice registry patients, 119 had at least one prior CABG. The CABG and PCI survivals for the three groups were compared using Kaplan-Meier curves and log-rank tests.
The CABG and PCI three-year survival rates were 73% and 76% respectively for the 142 randomized patients (75 and 67 patients) (log-rank = NS). In the physician-directed registry, 155 patients were assigned to reoperation and 357 to PCI (207 received medical therapy); 36-month survivals were 71% and 77% respectively (log-rank = NS). In the patient-choice registry, 32 patients chose reoperation and 74 chose PCI (13 received medical therapy); 36-month survivals were 65% and 86% respectively (log-rank test p = 0.01).
Percutaneous coronary intervention is preferable to CABG for many post-CABG patients.
Journal of the American College of Cardiology 01/2003; 40(11):1951-4. · 14.16 Impact Factor
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Steven P Sedlis,
Douglass A Morrison,
Jeffrey D Lorin,
Rick Esposito,
Gulshan Sethi, Jerome Sacks,
William Henderson,
Frederick Grover,
K B Ramanathan,
Darryl Weiman, [......],
Walter Wolfe,
John C Lucke,
Sundeep Mediratta,
David Booth,
Edward Murphy,
Herbert Ward,
LaWayne Miller,
Stefan Kiesz,
Charles Barbiere,
Dan Lewis
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ABSTRACT: This study compared survival after percutaneous coronary intervention (PCI) with survival after coronary artery bypass graft surgery (CABG) among diabetics in the Veterans Affairs AWESOME (Angina With Extremely Serious Operative Mortality Evaluation) study randomized trial and registry of high-risk patients.
Previous studies indicate that CABG may be superior to PCI for diabetics, but no comparisons have been made for diabetics at high risk for surgery.
Over five years (1995 to 2000), 2,431 patients with medically refractory myocardial ischemia and at least one of five risk factors (prior CABG, myocardial infarction within seven days, left ventricular ejection fraction <0.35, age >70 years, or an intra-aortic balloon being required to stabilize) were identified. A total of 781 were acceptable for CABG and PCI, and 454 consented to be randomized. The 1,650 patients not acceptable for both CABG and PCI constitute the physician-directed registry, and the 327 who were acceptable but refused to be randomized constitute the patient-choice registry. Diabetes prevalence was 32% (144) among randomized patients, 27% (89) in the patient-choice registry, and 32% (525) in the physician-directed registry. The CABG and PCI survival rates were compared using Kaplan-Meier curves and log-rank tests.
The respective CABG and PCI 36-month survival rates for diabetic patients were 72% and 81% for randomized patients, 85% and 89% for patient-choice registry patients, and 73% and 71% for the physician-directed registry patients. None of the differences was statistically significant.
We conclude that PCI is a relatively safe alternative to CABG for diabetic patients with medically refractory unstable angina who are at high risk for CABG.
Journal of the American College of Cardiology 12/2002; 40(9):1555-66. · 14.16 Impact Factor
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Douglass A Morrison,
Gulshan Sethi, Jerome Sacks,
William Henderson,
Frederick Grover,
Steven Sedlis,
Rick Esposito,
Kodagundi B Ramanathan,
Darryl Weiman,
J David Talley, [......],
Sarah Vernon,
Vladimir Birjiniuk,
Frederick Welt,
Mitchell Krucoff,
Walter Wolfe,
John C Lucke,
Sundeep Mediratta,
David Booth,
Charles Barbiere,
Dan Lewis
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ABSTRACT: This study was designed to compare the three-year survival after percutaneous coronary intervention (PCI) or coronary artery bypass graft surgery (CABG) in physician-directed and patient-choice registries with the Angina With Extremely Serious Operative Mortality Evaluation (AWESOME) randomized trial results.
The AWESOME multicenter randomized trial and registry compared the long-term survival after PCI and CABG for the treatment of patients with medically refractory myocardial ischemia and at least one additional risk factor for adverse outcome with CABG. The randomized trial demonstrated comparable three-year survival.
Over a five-year period (1995 to 2000), 2,431 patients with medically refractory myocardial ischemia and at least one of five risk factors (prior heart surgery, myocardial infarction within seven days, left ventricular ejection fraction <0.35, age >70 years, intra-aortic balloon required to stabilize) were identified. By physician consensus, 1,650 patients formed a physician-directed registry assigned to CABG (692), PCI (651) or further medical therapy (307), and 781 were angiographically eligible for random allocation; 454 of these patients constitute the randomized trial, and the remaining 327 constitute a patient choice registry. Survival for CABG and PCI was compared using Kaplan-Meier curves and log-rank tests.
The CABG and PCI 36-month survival rates for randomized patients were 79% and 80%, respectively. The CABG and PCI 36-month survival rates were both 76% for the physician-directed subgroup; comparable survival rates for the patient-choice subgroup were 80% and 89%, respectively. None of the global log-rank tests for survival demonstrated significant differences.
Both registries support the randomized trial conclusion: PCI is an alternative to CABG for some medically refractory high-risk patients.
Journal of the American College of Cardiology 01/2002; 39(2):266-73. · 14.16 Impact Factor
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Douglass A Morrison,
Gulshan Sethi, Jerome Sacks,
William Henderson,
Frederick Grover,
Steven Sedlis,
Rick Esposito,
Kodangudi Ramanathan,
Darryl Weiman,
Jorge Saucedo, [......],
Sarah Vernon,
Vladimir Birjiniuk,
Frederick Welt,
Mitchell Krucoff,
Walter Wolfe,
John C Lucke,
Sundeep Mediratta,
David Booth,
Charles Barbiere,
Daniel Lewis
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ABSTRACT: BACKGROUNDPercutaneous coronary intervention (PCI) and coronary artery bypass graft surgery (CABG) are being applied to high-risk populations, but previous randomized trials comparing revascularization methods have excluded a number of important high-risk groups.OBJECTIVESThis five-year, multicenter, randomized clinical trial was designed to compare long-term survival among patients with medically refractory myocardial ischemia and a high risk of adverse outcomes assigned to either a CABG or a PCI strategy, which could include stents.METHODSPatients from 16 Veterans Affairs Medical Centers were screened to identify myocardial ischemia refractory to medical management and the presence of one or more risk factors for adverse outcome with CABG, including prior open-heart surgery, age >70 years, left ventricular ejection fraction <0.35, myocardial infarction within seven days or intraaortic balloon pump required. Clinically eligible patients (n = 2,431) underwent coronary angiography; 781 were angiographically acceptable; 454 (58% of eligible) patients consented to random assignment between CABG and PCI.RESULTSA total of 232 patients was randomized to CABG and 222 to PCI. The 30-day survivals for CABG and PCI were 95% and 97%, respectively. Survival rates for CABG and PCI were 90% versus 94% at six months and 79% versus 80% at 36 months (log-rank test, p = 0.46).CONCLUSIONSPercutaneous coronary intervention is an alternative to CABG for patients with medically refractory myocardial ischemia and a high risk of adverse outcomes with CABG.
Journal of the American College of Cardiology.
