792-1 One Year Clinical Follow-up of the Benestent Trial

The Benestent Trial is a randomized study comparing elective Palmaz-Schatz stent implantation vs balloon angioplasty in de novo lesions in patients with stable angina. Data at 7 months have shown a decreased restenosis rate and reduced clinical events in the Stent group. However, it is not established if this favourable clinical outcome is maintained at one year. Consequently we have updated clinical information from 516 patients enrolled in the Benestent Trial (257 PTCA; 259 Stent). FU information was obtained in all but 4 patients 12 in the Stent group and 2 in the Balloon groupl. Mean follow-up was 12 months (0.3–34 months). At FU no differences were found in the 2 groups with respect to medications and functional class (CCS). Major clinical events are tabulated according to the Intention to treat principle and assigning each patient only the highest ranked event. 7 Months 12 Months Stent Balloon Stent Balloon Death 2(0.8%) 1(0.4%) 3(1.2%) 1(0.4%) Stroke 0 2(08%) 0 2(0.8%) MI 11(4.2%) 10(3.9%) 13(5.0%) 11 (4.3%) CABG 13(5.0%) 10(3.9%) 18(6.9%) 13(5.1%) Re-PTCA 26(10.0%) 53(210%)* 26(10.0%) 54(21.0%)* Any 52(20.0%) 76(30.0%) ‡ 60(23.0%) 81(31.5%) † * Relative risk (RR) 0.48, 95% CI (0.31-0.74), p=0.001 ‡ RR 068, 95% CI (0.50-0.92) p=0.02 † RR 0.74, 95% CI (055-098), p=0.04 This FU clinical data suggest that the benefit of elective coronary stenting is maintained at least for 1 year and results from a significantly reduced need for repeat PTCA.