Abstract 2162: Effect of Sirolimus-Eluting Stents versus Bare-Metal Stents on Outcomes Related to Restenosis and Disease Progression in Remote Coronary Segments
Background: Drug-eluting stents reduce restenosis but their long-term effect on overall cardiac outcomes related to remote coronary segments is unknown.
Methods: We examined 5-year outcomes in the randomized SIRIUS trial related to the index target lesion (TL), any segment of the same target vessel (TV), or other non-target vessels (NTV). Of 1058 patients randomized to sirolimus-eluting (SES) or bare-metal stents (BMS), 7 were excluded due to multi-vessel or vein graft stenting, leaving 533 SES and 518 BMS. We hypothesized 5-year NTV outcomes would be similar for SES and BMS. All events were adjudicated by an independent committee and lesion attribution was assigned for MI and repeat revascularization (RR). Deaths were adjudicated as cardiac unless there was a clear non-cardiac cause, but were not assigned to a specific lesion. The primary endpoint was the composite of cardiac death, any MI or RR. The secondary endpoints were cardiac death, TV MI, NTV MI and NTV Revascularization (NTVR). Event rates were estimated using the Kaplan-Meier method and groups were compared using log-rank. Multivariate assessment was performed by Cox proportional hazards regression.
Results: The primary endpoint occurred in 39.6% SES vs. 51.2% BMS (log-rank p<0.001). This difference was due to a statistically significant reduction in TLR for SES (9.9% vs. 24.1%, p<0.001) that was present at year 1 and maintained to 5 years. There were no significant differences for SES vs. BMS in the 5-year KM estimates of all death (8.5% vs. 8.6%, p=0.99) cardiac death (4.0% vs. 3.7%, p=0.79) TVMI (8.6% vs. 10.7%, p=0.59), NTV MI (4.2% vs. 3.2%, p=0.45) or NTVR (22.5% vs. 22.7%, p=0.88). The independent predictors of the primary endpoint were prior MI (HR 1.4, 95% CI 1.2–1.6), diabetes (HR 1.3, 95% CI 1.1–1.5), prior CABG (HR 1.4, 95% CI 1.1–1.7), smaller diameter target vessel (HR 0.77, 95% CI 0.57–0.97), and target lesion length (HR 1.03, 95% CI 1.01–1.05). SES was protective (HR 0.7, 95% CI 0.5–0.9).
Conclusions: The benefit of SES in reducing TLR was maintained for 5 years. There was no increased risk of SES at 5 years for cardiac death, non-cardiac death, or coronary events resulting in MI or requiring revascularization within either the target vessel or remote non-target vessels.