Real-world five-year outcomes of FlexyRap^® cobalt-chromium rapamycin-eluting stents with biodegradable polymer in patients with de-novo coronary artery disease

Background: The use of biodegradable polymer drug-eluting stents (BP-DES) has been proven to minimize restenosis and stent thrombosis. The current post-marketing monitoring was observed at the 5-year clinical outcomes of individuals who had been treated with FlexyRap^® DES in the real world.

Aim: To assess the safety and effectiveness of FlexyRap^® DES at the 5-year follow-up in real-world settings.

Methods: Findings from a retrospective, multi-center, observational, post-market clinical follow-up study of patients treated with FlexyRap^® DES for de novo coronary artery disease (CAD) were reported. During the 12-mo follow-up, the primary endpoint was target lesion failure, which was defined as the composite of cardiovascular death, target vessel myocardial infarction (TV-MI), and clinically driven target lesion revascularization.

Results: The data of 500 patients received with FlexyRap^® DES was obtained at the completion of the surveillance timeline of 5-year. After the implantation of FlexyRap^® DES, the device success rate was 100%. Adverse events that led to major bleeding, permanent disability, or death were not experienced in the patients. The major adverse cardiac event rate at 12-mo, 3-year, and 5-year follow-up was 1 (0.2%), 0 (0%), and 1 (0.2%) respectively with 0 (0%) cardiovascular death, 2 (0.4%) TV-MI, and 0 (0%) TLR compositely. Furthermore, late stent thrombosis was found in 2 (0.4%) patients at the follow-up of 12-mo, very late stent thrombosis was observed in 2 patients (0.4%) at 3-year follow-up.

Conclusion: FlexyRap^® DES was proved to be safe and efficacious in real-world patients with de novo CAD, indicating a lowered rate of cardiac events and stent thrombosis at 5-year follow-up.