CLINICAL STUDY
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
Steven P. Sedlis, MD, FACC*,*,
Douglass A. Morrison, MD, FACC ,
Jeffrey D. Lorin, MD, FACC*,
Rick Esposito, MD*,
Gulshan Sethi, MD, FACC ,
Jerome Sacks, PhD ,
William Henderson, PhD ,
Frederick Grover, MD, FACC ,
K. B. Ramanathan, MD, FACC||,
Darryl Weiman, MD||,
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||||,
Edward Murphy, MD, FACC¶¶,
Herbert Ward, MD, FACC***,
LaWayne Miller, MD  ,
Stefan Kiesz, MD, FACC  ,
Charles Barbiere, CCRN ,
Dan Lewis, MD, FACC  Investigators of the Department of Veterans Affairs Cooperative Study #385, the Angina With Extremely Serious Operative Mortality Evaluation (AWESOME)
* New York VA Medical Center, New York, New York, USA
Tucson VA Medical Center, Tucson, Arizona, USA
CSPCC Hines VA Hospital, Hines, Illinois, USA
Denver VA Medical Center, Denver, Colorado, 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
¶¶ Portland VA Medical Center, Portland, Oregon, USA
*** Minneapolis VA Medical Center, Minneapolis, Minnesota, USA
  San Antonio VA Medical Center, San Antonio, Texas, USA
  Kansas City VA Medical Center, Kansas City, Kansas, USA
Manuscript received February 27, 2002;
revised manuscript received April 30, 2002,
accepted May 31, 2002.
* Reprint requests and correspondence: Dr. Steven P. Sedlis, Section of Cardiology, 12W, VA Medical Center, 423 East 23rd Street, New York, New York 10010, USA. steven.sedlis{at}med.va.gov
 |
Abstract
|
|---|
OBJECTIVES: 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.
BACKGROUND: 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.
METHODS: 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.
RESULTS: 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.
CONCLUSIONS: 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.
|
Abbreviations and Acronyms
| | AWESOME | | Angina With Extremely Serious Operative Mortality Evaluation | | CABG | | coronary artery bypass graft surgery | | CAD | | coronary artery disease | | LVEF | | left ventricular ejection fraction | | MI | | myocardial infarction | | PCI | | percutaneous coronary intervention | | TIMI | | Thrombolysis In Myocardial Infarction |
|
Randomized clinical trials comparing percutaneous coronary intervention (PCI) with coronary artery bypass graft surgery (CABG) have demonstrated comparable long-term survival (111) in most patient populations, with the important exception of diabetics. The Bypass Angioplasty Revascularization Investigation (BARI) study (12,13) showed a significant and sustained survival benefit for CABG at five years in treated diabetics, and similar findings were noted in other randomized studies and large databases (2,14). These findings are reflected in current guidelines which favor CABG over PCI in most diabetics with two- or three-vessel coronary artery disease (CAD) who require revascularization (15,16). Such recommendations are not universally accepted because contemporary PCI, characterized by widespread use of stents and glycoprotein IIb/IIIa receptor blocking drugs, is more effective in diabetics than the balloon angioplasty techniques used in BARI.
The choice of revascularization remains uncertain. Several studies have failed to demonstrate a survival benefit for CABG over PCI in diabetics (3,17). Even the BARI registry showed comparable survival for diabetics who chose PCI over CABG (18). The choice of revascularization for diabetic patients who are at high risk for CABG is also uncertain. These patients might have equivalent or superior outcomes with a less invasive PCI procedure. The recently concluded, Angina With Extremely Serious Operative Mortality Evaluation (AWESOME), was a randomized clinical trial of PCI versus CABG among patients with medically refractory ischemia who were at high risk for CABG because of one or more of the following high-risk factors: prior heart surgery; myocardial infarction (MI) within seven days; left ventricular ejection fraction (LVEF) <0.35; age >70 years; intra-aortic balloon being required to stabilize (19,20). Eligible patients who were deemed by study physicians to be suitable for both CABG and PCI were asked to participate in the randomized trial. Eligible patients who were acceptable to study physicians for either CABG or PCI but who refused to be randomized were entered into a prospective patient-choice registry. Eligible patients who were directed by physicians not to participate were entered into a physician-directed registry. This article reports the outcomes of the high-risk diabetic patients in the randomized clinical trial and the physician-directed and patient-choice registries of the AWESOME study.
 |
Methods
|
|---|
The AWESOME was a nationwide, prospective, randomized clinical trial designed to compare CABG and PCI survival for patients with medically refractory unstable angina and at high risk of adverse outcomes with CABG. Patients were enrolled at 16 Veterans Affairs medical centers over a five-year period (1995 to 2000). The AWESOME protocol, baseline characteristics, and survival for the randomized patients have been previously reported (19,20).
Screening identified 2,431 clinically eligible patients who met the three criteria (medically refractory, unstable angina, at least one additional high-risk factor). Medically refractory was defined as anginal symptoms despite aspirin and/or heparin and control of heart rate and blood pressure as previously described (19). Unstable angina was defined as rest angina with electrocardiographic changes or known CAD; recurrent rest angina; or stabilized rest angina with a subsequent positive stress test. High risk for CABG was defined as age >70 years, one or more prior open-heart operations, LVEF <0.35, MI within seven days, or intra-aortic balloon pump necessary. The diagnosis of MI required hospitalization and cardiac enzyme or troponin elevation. After coronary angiography had been reviewed by both interventional cardiologist and surgeon, 781 (32%) who were acceptable to both operators as candidates for CABG or PCI were approached for informed consent, and 454 (58%) consented to a randomized choice of revascularization. Randomization was stratified by age and prior heart surgery. The 327 patients who refused random allocation were entered into a patient-choice registry. The 1,650 patients for whom physician consensus would not allow random assignments were entered into a physician-directed registry. Patient data, including the presence or absence of diabetes, were entered by the study nurses into an interactive data management system as previously described (19).
Statistical analysis.
Differences in baseline variable frequencies were judged by chi-square tests. Long-term survival was measured by Kaplan-Meier survival estimates, which were plotted. The statistical significance of global differences between survival curves was judged by log-rank tests. Differences between CABG and PCI 36-month survival were computed along with z tests of the differences. All comparisons of randomized patients are based on intention to treat.
 |
Results
|
|---|
Patients treated with either insulin or oral hypoglycemic drugs were classified as diabetic for the purposes of this study. Among the 144 randomized diabetic patients, 79 were assigned to CABG and 65 to PCI. Among the 525 physician-directed diabetic patients, 238 were selected for CABG, 194 for PCI, and 93 received medical care. Among the 89 patient-choice diabetic patients, 20 chose CABG, 65 chose PCI, and four patients chose medical care.
Table 1 presents baseline characteristics of randomized, all registry, physician-directed, and patient-choice diabetic patients. The randomized and registry diabetic patients have similar baseline profiles except for prior CABG and Thrombolysis in Myocardial Infarction (TIMI) no flow, which have higher rates in the registry, and the differences are statistically significant (chi-square; p < 0.05). The physician-directed and patient-choice patients have similar baseline profiles except for number of vessel diseases, which has a higher rate of three-vessel disease in the physician-directed patients and for which the difference is statistically significant (chi-square; p < 0.01).
Table 2 presents baseline characteristics of randomized, physician-directed, and patient-choice diabetic patients assigned to CABG or PCI. The baseline characteristics of diabetic patients randomized to CABG or PCI are similar, and none of the differences is statistically significant. Both physician-directed and patient-choice patients assigned to CABG have significantly higher rates of older patients. Physician-directed patients assigned to CABG have significantly higher rate of three-vessel disease and lower rates of prior PCI, prior CABG, prior MI, and TIMI no flow relative to physician-directed patients assigned to PCI. Patient-choice patients assigned to CABG have significantly lower rates of three-vessel disease and show lower rates relative to those assigned to PCI for prior CABG, prior MI, and TIMI no flow, but the differences are not statistically significant. The lower rate of prior CABG in both physician-directed and in patient-choice registries was also observed among the non-diabetic patients. This pattern may reflect the reluctance of physicians to operate on patients with a patent left internal mammary artery to the left anterior descending coronary artery.
Table 3 presents short-term outcomes of randomized and registry patients assigned to CABG or PCI. The large majority of patients assigned to revascularization were revascularized, and over 96% were revascularized as assigned (94% assigned to CABG received CABG; 98% assigned to PCI received PCI). Approximately 80% of the CABG patients received left internal mammary artery (78%, 78%, and 79% of the randomized, physician-directed, and patient-choice, respectively); the corresponding right internal mammary artery frequencies were 3%, 2%, and 0% for the randomized, physician-directed, and patient-choice, respectively. The CABG and PCI survival to 30 days and to six months did not differ significantly. Overall in-hospital mortality in the 324 diabetic patients treated by PCI did not differ significantly from the in-hospital mortality in the 337 diabetics treated by CABG (4% vs. 7%).
Table 4 presents 36-month CABG and PCI survival, survival free of recurrent unstable angina, and survival free of unstable angina or a repeated revascularization for the randomized, physician-directed, and patient-choice diabetic patients. The table also shows the CABG-PCI differences and the standard errors of the differences.
View this table:
[in this window]
[in a new window]
|
Table 4 CABG and PCI 36-Month Diabetic Patient Survival, Survival Free of Unstable Angina, and Survival Free of Unstable Angina or Repeat Revascularizations
|
|
Figures 1 to 3 present the five-year Kaplan-Meier survival curves and a global log-rank test of CABG versus PCI survival differences over the five-year period for randomized patients and the two registry cohorts. The CABG and PCI number of patients (N) for each time period are shown at the bottom of the plots. None of the three log-rank tests is statistically significant.

View larger version (17K):
[in this window]
[in a new window]
|
Figure 1 Kaplan-Meier five-year survival curves of coronary artery bypass graft surgery (CABG) (circle) and percutaneous coronary intervention (PCI) (cross) for randomized patients.
|
|

View larger version (18K):
[in this window]
[in a new window]
|
Figure 2 Kaplan-Meier five-year survival curves of CABG (circle) and PCI (cross) for physician-directed patients. Abbreviations as in Figure 1.
|
|
Figures 4 to 6 present the five-year Kaplan-Meier survival free of unstable angina and a global log-rank test of CABG versus PCI survival differences over the five-year period for randomized patients and the two registry cohorts. The CABG and PCI number of patients (N) for each time period are shown at the bottom of the plots. The log-rank test for the physician-directed cohort is statistically significant (p < 0.0001).

View larger version (17K):
[in this window]
[in a new window]
|
Figure 4 Kaplan-Meier curves of CABG (circle) and PCI (cross) five-year survival free of unstable angina for randomized patients. Abbreviations as in Figure 1.
|
|

View larger version (18K):
[in this window]
[in a new window]
|
Figure 5 Kaplan-Meier curves of CABG (circle) and PCI (cross) five-year survival free of unstable angina for physician-directed patients. Abbreviations as in Figure 1.
|
|

View larger version (18K):
[in this window]
[in a new window]
|
Figure 6 Kaplan-Meier curves of CABG (circle) and PCI (cross) five-year survival free of unstable angina for the patient-choice cohort. Abbreviations as in Figure 1.
|
|
Figures 7 to 9 present the five-year Kaplan-Meier survival free of unstable angina and repeat revascularizations and a global log-rank test of CABG versus PCI survival differences over the five-year period for randomized patients and the two registry cohorts. The CABG and PCI number of patients (N) for each time period are shown at the bottom of the plots. The log-rank test for the physician-directed cohort is statistically significant (p < 0.0001).

View larger version (18K):
[in this window]
[in a new window]
|
Figure 7 Kaplan-Meier curves of CABG (circle) and PCI (cross) five-year survival free of unstable angina and repeat revascularizations for randomized patients. Abbreviations as in Figure 1.
|
|

View larger version (18K):
[in this window]
[in a new window]
|
Figure 8 Kaplan-Meier curves of CABG (circle) and PCI (cross) five-year survival free of unstable angina and repeat revascularizations for physician-directed patients. Abbreviations as in Figure 1.
|
|

View larger version (18K):
[in this window]
[in a new window]
|
Figure 9 Kaplan-Meier curves of CABG (circle) and PCI (cross) five-year survival free of unstable angina and repeat revascularizations for the patient-choice cohort. Abbreviations as in Figure 1.
|
|
Table 5 shows the percent of diabetic patients allocated to CABG overall and for selected high-risk subsets. The percent allocated to PCI is the complement of the percent allocated to CABG. For example, the 55% of all physician-directed diabetic patients allocated to CABG implies that the remaining 45% were allocated to PCI. Table 5 shows that the choice of CABG differs greatly between the two registry cohorts (55% in physician-directed vs. 24% in patient-choice). The difference between these two cohorts is large and statistically significant (p < 0.01). Table 5 also shows how the presence of other high-risk factors influences the choice of revascularization within the two registry cohorts. Within the physician-directed cohort, 77% of the age >70 patients were allocated to CABG versus 44% for the younger patients. This large and statistically significant difference suggests that physicians favor CABG over PCI for older patients. Physicians appear to favor PCI over CABG for patients with prior CABG or prior PCI. The other high-risk factors do not appear to change preferences in the physician-directed cohort. Among the patient-choice cohort, older patients are more likely to receive CABG than younger diabetic patients (33% vs. 14%), but both age groups favor PCI over CABG. The other high-risk factors do not appear to change patient preference for PCI in the patient-choice cohort.
View this table:
[in this window]
[in a new window]
|
Table 5 Percentage Allocation to CABG Among Randomized, Physician-Directed, and Patient-Choice Diabetic Patients by High-Risk Baseline Subsets
|
|
 |
Discussion
|
|---|
The outcome of diabetic patients in the AWESOME randomized trial and registry suggests that PCI is a reasonable option for diabetics with two- or three-vessel CAD and medically refractory angina who are at risk for adverse outcomes with CABG because of prior CABG, recent MI, poor left ventricular function, age >70, or instability necessitating intra-aortic balloon pump (1921). There is no survival advantage with CABG, but there is less recurrent unstable angina and the need for repeat revascularization with surgery.
Diabetes is associated with adverse outcomes for both CABG and PCI (17). Operative mortality for CABG is higher for diabetics than for non-diabetics (2229), and diabetes is an important risk factor for the development of serious postoperative complications, including renal failure and sternal wound infection (3033). Complications of CABG in diabetics result in a significant clinical and economic burden (3438), underscoring the importance of alternative therapies for diabetic patients, especially for diabetic patients at high risk for CABG. Unfortunately, mortality for PCI is also higher for diabetics than for non-diabetics (3945), and restenosis rates are significantly higher for diabetics than for non-diabetics (with restenosis rates for balloon angioplasty approaching 50%). Previously reported data do not provide support for either CABG or PCI as an initial strategy for diabetics with multivessel CAD who are at high risk for adverse outcomes with CABG.
There are important differences between the AWESOME study and earlier studies such as BARI and the Emory Angioplasty Surgery Trial (EAST) which showed a benefit for CABG in diabetics. The AWESOME study enrolled patients at higher risk for adverse outcomes with CABG than were enrolled in BARI and EAST. For example, patients with prior CABG were excluded from BARI and EAST. This may have had an important influence on the outcome of the study. A recent analysis of mortality in the BARI study showed that approximately 50% of the survival benefit for CABG in the diabetic patients could be explained by a lower mortality during Q-wave MI. In contrast, there was no difference in the incidence of Q-wave MI between diabetics undergoing CABG or PCI (46). Although Q-wave MI was relatively rare in diabetics enrolled in the study (8% incidence in five-year follow-up), the mortality rate strikingly was sevenfold higher in diabetics randomized to angioplasty compared with CABG (46). Importantly, this survival benefit for CABG was almost entirely limited to patients who received at least one internal mammary artery graft (46). These findings have therapeutic implications. Firstly, diabetic patients with prior CABG (especially those with durable patent internal mammary grafts) might be expected to retain a survival benefit from their first operation and so conceivably would have less benefit from a re-operation compared with the benefit of angioplasty. This hypothesis was not tested in BARI because all patients with prior CABG were excluded from the trial. Secondly, the outcome of MI in diabetics has improved in recent years (even in very high-risk groups) as a result of intensive therapy with angiotensin-converting enzyme inhibitors (47), insulin (48), and early revascularization (49). These advances in therapy of MI would be expected to narrow the difference in survival between diabetics with CAD treated by an initial strategy of CABG or PCI.
Another major cause of the difference between the outcomes in the BARI study and the outcomes that can be expected today with PCI in diabetics is the widespread use of stents and glycoprotein IIb/IIIa receptor blockers in contemporary practice. The BARI study enrolled patients between 1988 and 1991, and balloon angioplasty was the only procedure performed in patients randomized to the PCI arm of BARI. It has now been recognized that stents and glycoprotein IIb/IIIa receptor blockers reduce restenosis and long-term mortality in diabetics with multi-vessel disease. Diabetic patients were a prospectively defined subset in the multicenter Evaluation of Platelet IIb/IIIa Inhibitor for Stenting Trial (EPISTENT) in which patients were randomized to stent-placebo, stent-abciximab, or balloon-abciximab (50). The combined six-month rate of death, MI, or target-vessel revascularization occurred in 25.2% of stent-placebo, 23.4% of balloon-abciximab, and only 13.0% of stent-abciximab patients in that study (p = 0.005). The one-year mortality rate for diabetics in EPISTENT was 4.1% for stent-placebo and 1.2% for stent-abciximab patients (p = 0.11). In the AWESOME study, overall use of stents was 54% and overall use of glycoprotein IIB/IIIa antagonists was 11% (20,21).
The outcome of diabetic patients randomized between April 1997 and June 1998 to either CABG or PCI with stenting in the Arterial Revascularization Therapy Study (ARTS) trial has been recently published (50). In that study, event-free one-year survival in diabetics treated with stenting was 63.4% compared with 84.4% with CABG (p < 0.001). In contrast, there was no difference in outcomes at one year among non-diabetics. Importantly, ARTS excluded all patients with prior CABG, MI within one week, ejection fraction <30%, and prior stroke. Thus the findings of ARTS cannot be extrapolated to the high-risk population enrolled in AWESOME. Furthermore, the long-term outcome of diabetics enrolled in ARTS is still unknown.
 |
Appendix
|
|---|
Participants in veterans affairs cooperative study #385: awesome.
Executive Committee
Douglass Morrison, MD, Stewart Scott, MD (deceased), Gulshan Sethi, MD, Jerome Sacks, PhD, William Henderson, PhD, Steven Sedlis, MD, Rick Esposito, MD, Dan Lewis, MD, Edward Folland, MD, David Talley, MD.
Data Monitoring Board
Spencer King III, MD (Chairman), Cindy Grines, MD, Sidney Levitsky, MD, Bruce Lytle, MD, Daniel Seigel, ScD.
Death Review Committee
David Holmes, MD, Hartzell V. Schaff, MD.
Department of Veterans Affairs Headquarters Staff
John R. Feussner, MD, Chief Research and Development Officer; Steven Berkowitz, PhD, Assistant Director, Cooperative Studies Program; Joseph Gough, MA, Program Assistant, Cooperative Studies Program.
Participating Sites
Albuquerque, NM: Sarah Vernon, MD, Stuart Pett, MD, Mathew R. Holland, MD, Seth Krauss, MD, Jeannie Collatz, RN; Ann Arbor, MI: Mark Starling, MD, Mauro Moscucci, MD, Marvin Kirsh, MD, Eric Bates, MD, Anita Bargardi, RN, MA, CCRN, Elizabeth Hicks, RN, Judy Luckhardt, RN; Asheville, NC: Stewart Scott, MD, John C. Lucke, MD, Stewart Levine, MD, Sundeep Mediratta, MD, Riaz Baqir, MD, Vladimer Curk-ovic, MD, Miltiadis Leon, MD, Ahrnad M. Zia, MD, Nicholas Xenopoulos, MD, Gautum Patel, MD, Valerie Allen, RN; Dallas, TX: Eric Eichorn, MD, Michael Jessen, MD, Charles Landau, MD, Asad Karim, MD, Annie John, RN, Lucille Marcoux, RN; Denver, CO: Douglass A. Morrison, MD, Fred Grover, MD, Dave Fullerton, MD, Brack Hattler, MD, Nancy Thorbes, RN, CCRN, Rhonda Olmstead, RN, Charles C. Barbiere, CCRN, RT, EMT; Durham, NC: Mitchell Krucoff, MD, Walter Wolfe, MD, Francis Duhaylongsod, MD, Kevin P. Landolfo, MD, Suzanne Crater, RN; Lexington, KY: Dave Booth, MD, Peter Sapin, MD, M. Clive Robinson, MD, Amita Rastogi, MD, Lynne Shockey, RN, Margaret Price, RN, Kim Meadors, RN; Little Rock, AR: Jorge Saucedo, MD, J. David Talley, MD, Joseph Bissett, MD, Thomas D. Conley, MD, Stephen VandeVanter, MD, Gareth Tobler, MD, Tamim Antakli, MD, James Harrell, MD, Kwabena Mawulawde, MD, Rebecca Pacheco, RN, Karen Scott, RN; Memphis, TN: K. B. Ramanathan, MD, Darryl Weiman, MD, William A. Walker, MD, Zoe Qualls, RN, Lillie Johnson, RN; Minneapolis, MN: Herbert Ward, MD, Edward McFalls, MD, Bridget Wennerstrom, RN; New York, NY: Steven Sedlis, MD, Rick Esposito, MD, Jeff Lorin, MD, Mary Keary, RN; Portland, OR: Edward Murphy, MD, Gregory Larsen, MD, Harkness Floten, MD, Kathy Avalos, MA, Lori Gray, RN, Wendy Nicholson, RN; San Antonio, TX: LaWayne Miller, MD, Stephan Kiesz, MD, Julia Sepeda, RN; Tucson, AZ: Douglass A. Morrison, MD, Gulshan Sethi, MD, Venki Paramesh, MD, Steven Goldman, MD, Craig Hoover, MD, Thomas Raya, MD, Gayle Murad, RN, Catherine Z. Akbari, RN, BSN; West Los Angeles, CA: Jaime Altamirano, MD, Vishva Dev, MD, Fardad Esmailian, MD, Ralph Hutchings, MD, Kobus Louw, MD, Davis Drinkwater, MD, Dominique La Pagé, RN, Teresita Corvera, RN, MS; West Roxbury, MA: Vladimir Birjiniuk, MD, Frederick Welt, MD, William Daley, MD, C. Michael Gibson, MD, Diane Lapsley, RN.
 |
Footnotes
|
|---|
This study was funded by the Cooperative Studies Program of the U.S. Department of Veterans Affairs Research and Development Service.
 |
References
|
|---|
- RITA Trial Participants. Coronary angioplasty versus coronary artery bypass surgery: the Randomized Intervention Treatment of Angina (RITA) trial. Lancet. 1993;341:573580[CrossRef][Medline]
- CABRI Trial Participants. First year results of CABRI (Coronary Angioplasty vs Bypass Revascularization Investigation). Lancet. 1995;346:11791184[CrossRef][Medline]
- King SB, Lembo NJ, Kosinski AS, et al. A randomized trial comparing coronary angioplasty with coronary bypass surgery. N Engl J Med. 1994;331:10441050[Abstract/Free Full Text]
- Hamm CW, Riemers J, Ischinger T, et al. A randomized study of coronary angioplasty compared with bypass surgery in patients with symptomatic multi-vessel coronary disease. N Engl J Med. 1994;331:10371043[Abstract/Free Full Text]
- Rodriguez A, Boullon F, Perez-Balino N, et al. Argentine randomized trial of percutaneous transluminal coronary angioplasty versus coronary artery bypass surgery in multi-vessel disease (ERACI): in-hospital results and 1 year follow-up. J Am Coll Cardiol. 1993;22:10601067[Abstract]
- BARI Investigators. Protocol for the Bypass Angioplasty Revascularization Investigation. Circulation. 1991;84(Suppl 5):127[Abstract/Free Full Text]
- Frye RL, King SB III, Sopko G, Detre KM, editors. A symposium: multi-vessel PTCA versus CABG: baseline data from the Bypass Angioplasty Revascularization Investigation (BARI) and the Emory Angioplasty Surgery Trial (EAST). Am J Cardiol 1995;75:1c59c
- Pocock SJ, Henderson RA, Rickards AF, et al. Meta-analysis of randomized trials comparing coronary angioplasty with bypass surgery. Lancet. 1995;346:11841189[CrossRef][Medline]
- Sim I, Gupta M, McDonald K, Bourassa M, Hlatky MA. A meta-analysis of randomized trials comparing coronary artery bypass grafting with percutaneous transluminal coronary angioplasty in multi-vessel coronary artery disease. Am J Cardiol. 1995;76:10251029[CrossRef][Medline]
- Rodriguez A, Bernardi V, Navia J, et al. Argentine randomized study: coronary angioplasty with stenting versus coronary bypass surgery in patients with multiple-vessel disease (ERACI II): 30-day and one-year follow-up results. J Am Coll Cardiol. 2001;37:5158[Abstract/Free Full Text]
- Ryan TJ. Editorial: a randomized comparison with a different focus and a new result. J Am Coll Cardiol. 2001;37:5962[Free Full Text]
- BARI Investigators. Comparison of coronary bypass surgery with angioplasty in patients with multivessel disease. N Engl J Med. 1996;335:217225[Abstract/Free Full Text]
- BARI Investigators. Seven-year outcome in the Bypass Angioplasty Revascularization Investigation (BARI) by treatment and diabetic status. J Am Coll Cardiol. 2000;35:11221129[Abstract/Free Full Text]
- Weintraub WS, Stein B, Kosinski A, et al. Outcome of coronary bypass surgery versus coronary angioplasty in diabetic patients with multivessel coronary artery disease. J Am Coll Cardiol 31:109
- Committee to revise the 1991 guidelines for Coronary Artery Bypass Graft Surgery. ACC/AHA guidelines for coronary artery bypass graft surgery. J Am Coll Cardiol. 1999;34:12631347
- Braunwald E, Antman EM, Beasley JW, et al. ACC/AHA guidelines for the management of patients with unstable angina and nonST-segment elevation myocardial infarction: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Committee on the Management of Patients with Unstable Angina). J Am Coll Cardiol. 2000;36:9701062[Free Full Text]
- Barsness GW, Peterson ED, Ohman EM, et al. Relationship between diabetes mellitus and long-term survival after coronary bypass and angioplasty. Circulation. 1997;96:25512556[Abstract/Free Full Text]
- Detre KM, Guo P, Holubkov R, et al. Coronary revascularization in diabetic patients: a comparison of the randomized and observational components of the Bypass Angioplasty Revascularization Investigation (BARI). Circulation. 1999;99:633640[Abstract/Free Full Text]
- Morrison DA, Sethi G, Sacks J, et al. A multi-center, randomized trial of percutaneous coronary intervention versus bypass surgery in high-risk unstable angina patients. Controlled Clin Trials. 1999;20:601619[CrossRef][Medline]
- Morrison DA, Sethi G, Sacks J, et al. Percutaneous coronary intervention versus coronary artery bypass graft surgery for patients with medically refractory myocardial ischemia and risk factors for adverse outcomes with bypass: a multicenter, randomized trial. J Am Coll Cardiol. 2001;38:143149[Abstract/Free Full Text]
- Morrison DA, Sethi G, Sacks J, et al. A multi-center, randomized trial of percutaneous coronary intervention versus bypass surgery in high-risk unstable angina patients. The VA AWESOME Multicenter Registry: comparison with the randomized clinical trial. J Am Coll Cardiol. 2002;39:266273[Abstract/Free Full Text]
- Kirklin JW, Akins CW, Blackstone EH, et al. ACC/AHA task force report: guidelines and indications for coronary artery bypass graft surgery. J Am Coll Cardiol. 1991;17:543589[Medline]
- Edwards FH, Grover FL, Shroyer AL, Schwartz M, Bero J. The Society of Thoracic Surgeons National Cardiac Surgery Database: current risk assessment. Ann Thorac Surg. 1997;63:903908[Abstract/Free Full Text]
- Hannan EL, Racz MJ, McCallister BD, et al. A comparison of three-year survival after coronary artery bypass graft surgery and percutaneous transluminal coronary angioplasty. J Am Coll Cardiol. 1999;33:6372[Abstract/Free Full Text]
- Higgins TL, Estafanous FG, Loop FD, Beck GJ, Blum JM, Paranandi L. Stratification of morbidity and mortality outcome by preoperative risk factors in coronary artery bypass patients: a clinical severity score. JAMA. 1992;267:23442348[Abstract]
- Parsonnet V, Bernstein AD, Gera M. Clinical usefulness of risk-stratified outcome analysis in cardiac surgery in New Jersey. Ann Thorac Surg. 1996;61(Suppl):S811[CrossRef][Medline]
- Shroyer AL, Plomondon ME, Grover FL, Edwards FH. The 1996 coronary artery bypass risk model: the Society of Thoracic Surgeons Adult Cardiac National Database. Ann Thorac Surg. 1999;67:12051208[Abstract/Free Full Text]
- Hammermeister KE, Burchfiel C, Johnson R, Grover FL. Identification of patients at greatest risk for developing major complications at cardiac surgery. Circulation. 1990;82(Suppl):IV380389
- Hammermeister KE, Johnson R, Marshall G, Grover FL. Continuous assessment and improvement in quality of care: a model from the Department of Veterans Affairs Cardiac Surgery. Ann Surg. 1994;219:281290[Medline]
- Mangano CM, Diamondstone LS, Ramsay JG, Aggarwal A, Herskowitz A, Mangano DT. Renal dysfunction after myocardial revascularization: risk factors, adverse outcomes, and hospital resource utilization. The Multicenter Study of Perioperative Ischemia Research Group. Ann Intern Med. 1998;128:194203[Abstract/Free Full Text]
- Milano CA, Kesler K, Archibald N, Sexton DJ, Jones RH. Mediastinitis after coronary artery bypass graft surgery: risk factors and long-term survival. Circulation. 1995;92:22452251[Abstract/Free Full Text]
- Slaughter MS, Olson MM, Lee JTJ, Ward HB. A fifteen-year wound surveillance study after coronary artery bypass. Ann Thorac Surg. 2001;56:10631068
- Spelman DW, Russo P, Harrington G, Davis BB, Rabinov M, Smith JA, et al. Risk factors for surgical wound infection and bacteraemia following coronary artery bypass surgery. Aust N Z J Surg. 2000;70:4751[CrossRef][Medline]
- MacLeod KM, Tooke JE. Direct and indirect costs of cardiovascular and cerebrovascular complications of type II diabetes. Pharmacoeconomics. 1995;8(Suppl 1):4651[Medline]
- Lazar HL, Fitzgerald C, Gross S, Heeren T, Aldea GS, Shemin RJ. Determinants of length of stay after coronary artery bypass graft surgery. Circulation. 1995;92(Suppl):II2024
- Mauldin PD, Becker ER, Phillips VL, Weintraub WS. Hospital resource utilization during coronary artery bypass surgery. J Interv Cardiol. 1994;7:379384[Medline]
- Stewart RD, Lahey SJ, Levitsky S, Sanchez C, Campos CT. Clinical and economic impact of diabetes following coronary artery bypass. J Surg Res. 1998;76:124130[CrossRef][Medline]
- Stewart RD, Campos CT, Jennings B, Lollis SS, Levitsky S, Lahey SJ. Predictors of 30-day hospital readmission after coronary artery bypass. Ann Thorac Surg. 2000;70:169174[Abstract/Free Full Text]
- Abizaid A, Kornowski R, Mintz GS, et al. The influence of diabetes mellitus on acute and late clinical outcomes following coronary stent implantation. J Am Coll Cardiol. 1998;32:584589[Abstract/Free Full Text]
- Elezi S, Kastrati A, Pache J, et al. Diabetes mellitus and the clinical and angiographic outcome after coronary stent placement. J Am Coll Cardiol. 1998;32:18661873[Abstract/Free Full Text]
- Bhatt DL, Marso SP, Lincoff AM, Wolski KE, Ellis SG, Topol EJ. Abciximab reduces mortality in diabetics following percutaneous coronary intervention. J Am Coll Cardiol. 2000;35:922928[Abstract/Free Full Text]
- The Epic Investigators. Use of a monoclonal antibody directed against the platelet glycoprotein IIb/IIIa receptor in high-risk coronary angioplasty. N Engl J Med. 1997;330:956961
- The Epilog Investigators. Platelet glycoprotein IIb/IIIa receptor blockade and low-dose heparin during percutaneous coronary revascularization. N Engl J Med. 1997;336:16891696[Abstract/Free Full Text]
- The Epistent investigators. (Evaluation of platelet glycoprotein IIb/IIIa inhibitor for stenting). Randomized placebo-controlled and balloon-angioplasty-controlled trial to assess safety of coronary stenting with use of platelet glycoprotein IIb/ IIIa blockade. Lancet. 1998;352:8792[Medline]
- Detre KM, Lombardero MS, Brooks MM, et al. The effect of previous coronary-artery bypass surgery on the prognosis of patients with diabetes who have acute myocardial infarction. Bypass Angioplasty Revascularization Investigation Investigators. N Engl J Med. 2000;342:989997[Abstract/Free Full Text]
- Zuanetti G, Latini R, Maggioni AP, Franzosi M, Santoro L, Tognoni G. Effect of the ACE inhibitor lisinopril on mortality in diabetic patients with acute myocardial infarction: data from the GISSI-3 study. Circulation. 1997;96:42394245[Abstract/Free Full Text]
- Malmberg K. Prospective randomised study of intensive insulin treatment on long term survival after acute myocardial infarction in patients with diabetes mellitus. DIGAMI (Diabetes Mellitus, Insulin Glucose Infusion in Acute Myocardial Infarction) Study Group. Br Med J. 1997;314:15121515[Abstract/Free Full Text]
- Shindler DM, Palmeri ST, Antonelli TA, et al. Diabetes mellitus in cardiogenic shock complicating acute myocardial infarction: a report from the SHOCK Trial Registry. SHould we emergently revascularize Occluded Coronaries for cardiogenic shocK? J Am Coll Cardiol. 2000;36(Suppl A):10971103
- Marso SP, Lincoff AM, Ellis SG, et al. Optimizing the percutaneous interventional outcomes for patients with diabetes mellitus: results of the EPISTENT (Evaluation of Platelet IIb/IIIa Inhibitor for Stenting Trial) diabetic substudy. Circulation. 1999;100:24772484[Abstract/Free Full Text]
- Abizaid A, Costa MA, Centemero M, et al. Clinical and economic impact of diabetes mellitus on percutaneous and surgical treatment of multivessel coronary disease patients: insights for the Arterial Revascularization Therapy Study (ARTS) Trial. Circulation. 2001;104:533538[Abstract/Free Full Text]
This article has been cited by other articles:

|
 |

|
 |
 
D.-W. Park, S.-C. Yun, S.-W. Lee, Y.-H. Kim, C. W. Lee, M.-K. Hong, J.-J. Kim, S. J. Choo, H. Song, C. H. Chung, et al.
Long-Term Mortality After Percutaneous Coronary Intervention With Drug-Eluting Stent Implantation Versus Coronary Artery Bypass Surgery for the Treatment of Multivessel Coronary Artery Disease
Circulation,
April 22, 2008;
117(16):
2079 - 2086.
[Abstract]
[Full Text]
[PDF]
|
 |
|

|
 |

|
 |
 
D. M. Bravata, A. L. Gienger, K. M. McDonald, V. Sundaram, M. V. Perez, R. Varghese, J. R. Kapoor, R. Ardehali, D. K. Owens, and M. A. Hlatky
Systematic Review: The Comparative Effectiveness of Percutaneous Coronary Interventions and Coronary Artery Bypass Graft Surgery
Ann Intern Med,
November 20, 2007;
147(10):
703 - 716.
[Abstract]
[Full Text]
[PDF]
|
 |
|

|
 |

|
 |
 
Authors/Task Force Members, J.-P. Bassand, C. W. Hamm, D. Ardissino, E. Boersma, A. Budaj, F. Fernandez-Aviles, K. A.A. Fox, D. Hasdai, E. M. Ohman, et al.
Guidelines for the diagnosis and treatment of non-ST-segment elevation acute coronary syndromes: The Task Force for the Diagnosis and Treatment of Non-ST-Segment Elevation Acute Coronary Syndromes of the European Society of Cardiology
Eur. Heart J.,
July 1, 2007;
28(13):
1598 - 1660.
[Full Text]
[PDF]
|
 |
|

|
 |

|
 |
 
Authors/Task Force Members, L. Ryden, E. Standl, M. Bartnik, G. V. d. Berghe, J. Betteridge, M.-J. de Boer, F. Cosentino, B. Jonsson, M. Laakso, et al.
Guidelines on diabetes, pre-diabetes, and cardiovascular diseases: full text: The Task Force on Diabetes and Cardiovascular Diseases of the European Society of Cardiology (ESC) and of the European Association for the Study of Diabetes (EASD)
Eur. Heart J. Suppl.,
June 1, 2007;
9(suppl_C):
C3 - C74.
[Full Text]
[PDF]
|
 |
|

|
 |

|
 |
 
C. Berry, J.-C. Tardif, and M. G. Bourassa
Coronary Heart Disease in Patients With Diabetes: Part II: Recent Advances in Coronary Revascularization
J. Am. Coll. Cardiol.,
February 13, 2007;
49(6):
643 - 656.
[Abstract]
[Full Text]
[PDF]
|
 |
|

|
 |

|
 |
 
Authors/Task Force Members, L. Ryden, E. Standl, M. Bartnik, G. Van den Berghe, J. Betteridge, M.-J. de Boer, F. Cosentino, B. Jonsson, M. Laakso, et al.
Guidelines on diabetes, pre-diabetes, and cardiovascular diseases: executive summary: The Task Force on Diabetes and Cardiovascular Diseases of the European Society of Cardiology (ESC) and of the European Association for the Study of Diabetes (EASD)
Eur. Heart J.,
January 1, 2007;
28(1):
88 - 136.
[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]
|
 |
|

|
 |

|
 |
 
M. Roffi
Early invasive strategy in the diabetic patient with non-ST-segment elevation acute coronary syndromes
Eur. Heart J. Suppl.,
October 1, 2005;
7(suppl_K):
K19 - K22.
[Abstract]
[Full Text]
[PDF]
|
 |
|

|
 |

|
 |
 
J. D. Flaherty and C. J. Davidson
Diabetes and Coronary Revascularization
JAMA,
March 23, 2005;
293(12):
1501 - 1508.
[Abstract]
[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]
|
 |
|
|