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Comparison of Stent Implantation and Off-Pump Bypass Surgery in Patients Referred for Coronary Angioplasty - Comparison of Stent Implantation and Off-Pump Bypass Surgery in Patients Referred for Coronary Angioplasty
Description:
The goal of the trial was to compare the use of off-pump coronary bypass surgery versus stenting in patients referred for coronary angioplasty.
Study Design
Study Design:
Patients Screened: 581
Patients Enrolled: 280
Mean Follow Up: One year
Mean Patient Age: Mean age 60 years
Female: 29
Patient Populations:
Referred for coronary angioplasty; stable or unstable angina (Braunwald class I–IIB) and/or documented ischemia, irrespective of the extent of vessel disease; both stenting and off-pump surgery were considered technically feasible and expected to lead to a similar degree of revascularization.
Exclusions:
Left main stem stenosis; totally occluded artery supplying an akinetic myocardial area; in-stent restenosis; the need of >1 graft for complete revascularization of the left circumflex artery; poor ventricular function; emergency revascularization; Q-wave MI in the previous 6 weeks; angioplasty in the previous 6 months; previous bypass surgery; hemorrhagic disorder; hypercoagulability; intolerance to acetylsalicylic acid or ticlopidine.
Primary Endpoints:
Survival from composite of all-cause mortality, stroke, MI, and repeat coronary revascularization.
Secondary Endpoints:
Free from angina at one year; free from medication use at one year; quality of life; and cost-effectiveness.
Drug/Procedures Used:
Patients who were referred for coronary angioplasty were randomized to either coronary stenting (n=138) or off-pump coronary bypass surgery (n=142).
Principal Findings:
Most patients enrolled in the trial were low-risk patients: single disease 68% in stent arm and 74% in off-pump surgery arm; diabetes 9% in stent arm and 14% in off-pump surgery arm; and normal left ventricular (LV) function 91% in stent arm and 89% in off-pump arm. Glycoprotein IIb/IIIa inhibitor was used in 12.2% of patients in the stent arm. Event-free survival at one year was 85.5% in the stent arm and 91.5% in the off-pump surgery arm (relative risk 0.93, 95% confidence interval 0.86-1.02, p=0.1). Repeat revascularization occurred more frequently in the stent arm compared with the off-pump bypass arm (15.2% vs. 4.2%, RR 4.80, 95% CI 1.41–16.34, p<0.01).
There was no significant difference in death (0% vs. 2.8%) or myocardial infarction (MI; 4.4% vs. 4.9%) between the stent and off-pump arms, respectively. Freedom from angina was 78.3% in the stent arm and 87.0% in the off-pump surgery arm (p=0.06), and freedom from antianginal medication use was 41% in the stent arm versus 57% in the off-pump arm (p=0.01). During the initial hospitalization, costs were lower in the stent arm ($5,013 vs. $7,508, p<0.01), but there were no differences during the one-year follow-up ($2,030 vs. $2,010, p=NS), resulting in lower overall one-year costs ($7,043 vs. $9,518, p<0.01).
Interpretation:
Among patients referred for coronary angioplasty, treatment with off-pump coronary artery surgery was not associated with a significant difference in event-free survival at one year compared with coronary stenting.
The goal of this trial was to determine if off-pump bypass sugery, which is associated with a lower length of hospital stay and improved clinical outcomes compared with conventional coronary bypass sugery, is an alternative to coronary stenting in patients referred for coronary angiography. The majority of patients in the trial were low risk and had single vessel disease and normal LV function.
The study population and the goal of the trial should be kept in mind when interpreting the results. The study was not to designed to assess the efficacy in higher risk patients. Both short- and long-term costs were significantly lower in stented patients.
References:
Eefting F, et al. Randomized Comparison Between Stenting and Off-Pump Bypass Surgery in Patients Referred for Angioplasty. Circulation. 2003;108:2870-2876.
Presented at Late-Breaking Clinical Trials, ACC 2003.
Presented at the European Society of Cardiology, Vienna, Austria, September 2003.
Keywords: Myocardial Infarction, Coronary Angiography, Disease-Free Survival, Coronary Vessels, Coronary Artery Bypass, Angioplasty, Balloon, Coronary, Diabetes Mellitus, Stents, Length of Stay
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