Background: Sirolimus-eluting stents (SES) prevent restenosis and repeat percutaneous coronary intervention (PCI), but safety data in unselected patients are limited, especially for intermediate-term follow-up.
Methods: All patients undergoing SES implantation at 4 Italian centers were enrolled into a dedicated database. Baseline, procedural, and outcome data at discharge and at follow-up were abstracted. Outcomes of interest were the occurrence of major adverse cerebrocardiovascular events (MACCE) at 6 months, as well as long-term event-free survival and multivariable event predictors.
Results: One thousand four hundred twenty-four patients were enrolled (2,915 lesions, treated with 3,305 stents). Specifically, 1,074 (75.4%) subjects had multivessel disease, 399 (28.1%) had diabetes, 89 (6.3%) had ST-elevation myocardial infarction, and 44 (3.1%) underwent unprotected left main intervention. At 6 months, MACCE had occurred in 121 (9.0%) patients. After a median of 48.7 months (first-third quartile 41.8-55.3), MACCE-free survival was 69.2%+/-2.6%, with definite stent thrombosis occurring acutely in 6 (0.4%), subacutely in 11 (0.8%), after 30 days in 12 (0.8%), and cumulatively in 28 (2.0%). Major multivariable outcome predictors were diabetes (target lesion revascularization [TLR], MACCE), ejection fraction (TLR, MACCE), and maximal balloon length (TLR).
Conclusions: This large cohort of unselected patients supports the overall safety of unrestricted percutaneous SES implantation, as shown by the low rates of stent thrombosis. Event attrition remains, however, high at long-term follow-up, driven mainly by target vessel revascularization, with diabetes and ejection fraction as the most important prognostic factors.
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