CLINICAL STUDY: INTERVENTIONAL CARDIOLOGY
Percutaneous coronary intervention versus coronary bypass graft surgery for patients with medically refractory myocardial ischemia and risk factors for adverse outcomes with bypass
the VA AWESOME multicenter registry: comparison with the randomized clinical trial
Investigators of the Department of Veterans Affairs Cooperative Study #385 the Angina With Extremely Serious Operative Mortality Evaluation (AWESOME),
Douglass A. Morrison, MD, FACC*,*,
Gulshan Sethi, MD, FACC,*,
Jerome Sacks, PhD, ,
William Henderson, PhD,,
Frederick Grover, MD, FACC, ,
Steven Sedlis, MD, FACC, ,
Rick Esposito, MD,,
Kodagundi B. Ramanathan, MD, FACC,||,
Darryl Weiman, MD,||,
J. David Talley, MD, FACC,¶,
Jorge Saucedo, MD,¶,
Tamim Antakli, MD,¶,
Venki Paramesh, MD,*,
Stuart Pett, MD,#,
Sarah Vernon, MD, FACC,#,
Vladimir Birjiniuk, MD,**,
Frederick Welt, MD,**,
Mitchell Krucoff, MD, FACC,,
Walter Wolfe, MD, FACC,,
John C. Lucke, MD,,
Sundeep Mediratta, MD,,
David Booth, MD, FACC,,
Charles Barbiere, CCRN,
Dan Lewis, MDFACC||||
* Tucson VA Medical Center, Tucson, Arizona, USA
CSPCC Hines VA Hospital, Hines, Illinois, USA
Denver VA Medical Center, Denver, Colorado, USA
New York VA Medical Center, New York, New York, USA
|| Memphis VA Medical Center, Memphis, Tennessee, USA
¶ Little Rock VA Medical Center, Little Rock, Arkansas, USA
# Albuquerque VA Medical Center, Albuquerque, New Mexico, USA
** West Roxbury VA Medical Center, West Roxbury, Massachusetts, USA
Durham VA Medical Center, Durham, North Carolina, USA
Asheville VA Medical Center, Asheville, North Carolina, USA
Lexington VA Medical Center, Lexington, Kentucky, USA
|||| Kansas City VA Medical Center, Kansis City, Kansas, USA
Manuscript received April 27, 2001;
revised manuscript received September 25, 2001,
accepted October 23, 2001.
* Reprint requests and correspondence: Dr. Douglass A. Morrison, Director, Cardiac Catheterization Laboratory Tucson VAMC (111 C), Professor of Medicine and Radiology, University of Arizona SAVAHCS, 3601 S. Sixth Ave, Tucson, Arizona 85723 USA.
OBJECTIVES: 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.
BACKGROUND: 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.
METHODS: 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.
RESULTS: 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.
CONCLUSIONS: Both registries support the randomized trial conclusion: PCI is an alternative to CABG for some medically refractory high-risk patients.
|
Abbreviations and Acronyms
| | ACC/AHA | | American College of Cardiology/American Heart Association class of lesion grading | | AWESOME | | Angina With Extremely Serious Operative Mortality Evaluation | | CABG | | coronary artery bypass graft surgery | | CAD | | coronary artery disease | | IABP | | intra-aortic balloon pump | | LVEF | | left ventricular ejection fraction | | MI | | myocardial infarction | | NYHA | | New York Heart Association class of heart failure | | PCI | | percutaneous coronary intervention (may include stents or atherectomy, in addition or in place of balloon angioplasty only) | | SVG | | saphenous vein graft | | TIMI | | Thrombolysis In Myocardial Infarction | | VA | | U.S. Department of Veterans Affairs |
|
This article has been cited by other articles:
|
|
|
|
 
S. H Wong, S. Wan, and M. J Underwood
Myocardial Revascularization: Surgery or Stenting?
Asian Cardiovasc Thorac Ann,
June 1, 2007;
15(3):
264 - 269.
[Abstract]
[Full Text]
[PDF]
|
|
|
|
|
|
|
M. J. Radford
Percutaneous Coronary Intervention "Dominates" Coronary Artery Bypass Graft Surgery for High-Risk Patients: Good News for Patients, a Challenge for Healthcare Planners
Circulation,
September 19, 2006;
114(12):
1229 - 1231.
[Full Text]
[PDF]
|
|
|
|
|
|
|
K. T. Stroupe, D. A. Morrison, M. A. Hlatky, P. G. Barnett, L. Cao, C. Lyttle, D. M. Hynes, W. G. Henderson, and for the Investigators of Veterans Affairs Cooperat
Cost-Effectiveness of Coronary Artery Bypass Grafts Versus Percutaneous Coronary Intervention for Revascularization of High-Risk Patients
Circulation,
September 19, 2006;
114(12):
1251 - 1257.
[Abstract]
[Full Text]
[PDF]
|
|
|
|
|
|
|
O. Ben-Yehuda
Physician Judgment in Cardiology: The Art of Medicine Lives On
J. Am. Coll. Cardiol.,
September 5, 2006;
48(5):
954 - 955.
[Full Text]
[PDF]
|
|
|
|
|
|
|
M. S. Lee, N. Kapoor, F. Jamal, L. Czer, J. Aragon, J. Forrester, S. Kar, S. Dohad, R. Kass, N. Eigler, et al.
Comparison of Coronary Artery Bypass Surgery With Percutaneous Coronary Intervention With Drug-Eluting Stents for Unprotected Left Main Coronary Artery Disease
J. Am. Coll. Cardiol.,
February 21, 2006;
47(4):
864 - 870.
[Abstract]
[Full Text]
[PDF]
|
|
|
|
|
|
|
K. B. Ramanathan, D. S. Weiman, J. Sacks, D. A. Morrison, S. Sedlis, G. Sethi, and W. G. Henderson
Percutaneous Intervention Versus Coronary Bypass Surgery for Patients Older Than 70 Years of Age With High-Risk Unstable Angina
Ann. Thorac. Surg.,
October 1, 2005;
80(4):
1340 - 1346.
[Abstract]
[Full Text]
[PDF]
|
|
|
|
|
|
|
S. B. King III, G. Dangas, J. W. Moses, S. B. King III, G. Dangas, and J. W. Moses
Surgery Is Preferred for the Diabetic With Multivessel Disease
Circulation,
September 6, 2005;
112(10):
1500 - 1515.
[Full Text]
[PDF]
|
|
|
|
|
|
|
G W Mikhail, F Airoldi, D Tavano, A Chieffo, R Rogacka, M Carlino, M Montorfano, G Sangiorgi, N Corvaja, I Michev, et al.
The use of drug eluting stents in single and multivessel disease: results from a single centre experience
Heart,
September 1, 2004;
90(9):
990 - 994.
[Abstract]
[Full Text]
[PDF]
|
|
|
|
|
|
|
D. A. Morrison, G. Sethi, J. Sacks, W. G. Henderson, F. Grover, S. Sedlis, R. Esposito, and Investigators of the Department of Veterans Affair
Percutaneous coronary intervention versus repeat bypass surgery for patients with medically refractory myocardial ischemia: AWESOME randomized trial and registry experience with post-CABG patients
J. Am. Coll. Cardiol.,
December 4, 2002;
40(11):
1951 - 1954.
[Abstract]
[Full Text]
[PDF]
|
|
|
|
|
|
|
S. P. Sedlis, D. A. Morrison, J. D. Lorin, R. Esposito, G. Sethi, J. Sacks, W. Henderson, F. Grover, K. B. Ramanathan, D. Weiman, et al.
Percutaneous coronary intervention versus coronary bypass graft surgery for diabetic patients with unstable angina and risk factors for adverse outcomes with bypass: outcome of diabetic patients in the AWESOME randomized trial and registry
J. Am. Coll. Cardiol.,
November 6, 2002;
40(9):
1555 - 1566.
[Abstract]
[Full Text]
[PDF]
|
|
|
|
|
|
|
PCI vs. CABG in High-Risk Patients
Journal Watch Cardiology,
March 22, 2002;
2002(322):
2 - 2.
[Full Text]
|
|
|
|
