Long-term clinical, angiographic, and intravascular ultrasound outcomes of biodegradable polymer-coated sirolimus-eluting stents.

BACKGROUND: The residual drug carriers on drug-eluting stents (DES) surfaces are considered to be one of the most significant reasons causing late thrombosis. There is no documented data currently available on the safety/benefit profile beyond 6 months of EXCEL stent, a novel sirolimus-eluting stent with biodegradable polymer coating, in treating patients with coronary artery disease (CHD).

OBJECTIVE: To evaluate the long-term efficacy and safety of EXCEL stent on treating CHD patients.

METHODS: Between February and March 2006, a consecutive cohort of complex patients treated with the EXCEL stent was prospectively enrolled in this single-center registry. Antiplatelet protocol was 6-month dual antiplatelet therapy with clopidogrel and aspirin followed by aspirin alone indefinitely. The primary outcome was major adverse cardiac events (MACE) at 12 months. Secondary outcomes included in-segment and in-stent late lumen loss and binary restenosis rate measured by quantitative coronary angiography (QCA) analysis at 8 months postindex PCI procedure.

RESULTS: A total of 100 patients with 153 lesions were included in this analysis. Most lesions (83.0%) were classified as complex (B2/C). At 12 months, four patients (4.0%) experienced MACE, which were four target-lesion revascularizations due to in-stent restenosis (ISR). All patients received follow-up up to 24 +/- 0.4 months and no cardiac death, MI, and in-stent thrombosis occurred during the 6 months of dual antiplatelet therapy or the subsequent 15 months of aspirin treatment alone. QCA analysis of 112 lesions from 75 patients showed 3.6% (4/112) in-stent lesion restenosis, 5.4% (6/112) in-segment lesion restenosis, 0.12 +/- 0.34 mm in-stent late lumen loss, and 0.08 +/- 0.35 mm in-segment late lumen loss.

CONCLUSIONS: In this single-center experience with complex patients and lesions, the EXCEL stent implantation with 6-month dual antiplatelet treatment proved to markedly reduce the incidence of 24-month ISR and MACE. These preliminary findings require further validation by large scale, randomized trials.