CONTINUED BENEFIT OF CORONARY STENTING VERSUS BALLOON ANGIOPLASTY - ONE-YEAR CLINICAL FOLLOW-UP OF BENESTENT TRIAL

Objectives. This study sought to determine the I year clinical follow- up of patients included in the Benestent trial. Background. The Benest ent trial is a randomized study comparing elective Palmaz-Schatz stent implantation with balloon angioplasty in patients with stable angina and a de novo coronary artery lesion. Seven month follow-up data have shown a decreased rate of restenosis and fewer clinical events in the stent group. It is not established whether this favorable clinical out come is maintained for longer periods or,whether coronary stenting def ers restenosis and its subsequent clinical manifestations. Methods. To clarify this uncertainty, we updated clinical information on all but 1 of 516 patients enrolled in the Benestent trial (257 in balloon grou p, 259 in stent group) at least 12 months after the intervention. Majo r clinical events (primary clinical end point) were tabulated accordin g to the intention to treat principle and included death, the occurren ce of a cerebrovascular accident, myocardial infarction, the need for bypass surgery or a further percutaneous intervention in the previousl y treated lesion. Results. After 1 year, no significant differences in mortality (1.2% vs. 0.8%), stroke (0.0% vs. 0.8%), myocardial infarct ion (5.0% vs. 4.2%) or coronary bypass graft surgery (6.9% vs. 5.1%) w ere found between the stent and balloon angioplasty groups, respective ly. However, the requirement for a repeat angioplasty procedure was si gnificantly lower in the stent group (10%) than the balloon angioplast y group (21%, relative risk [RR] 0.49, 95% confidence interval [CI] 0. 31 to 0.75, p = 0.001), and overall primary end points were less frequ ently reached by stent group patients (23.2%) than those in the balloo n group (31.5%, RR 0.74, 95% CI 0.55 to 0.98, p = 0.04). No difference s were found between groups with respect to functional class angina an d prescribed medication at the time of follow-up. Conclusions. These c linical follow up data show that the benefit of elective native corona ry artery stenting in patients with stable angina is maintained to at least 1 year after the procedure and results in a significantly reduce d requirement for repeat intervention.