Real-world five-year outcomes of FlexyRap® cobalt-chromium rapamycin-eluting stents with biodegradable polymer in patients with de-novo coronary artery disease.
World J Cardiol
; 15(3): 84-94, 2023 Mar 26.
Article
em En
| MEDLINE
| ID: mdl-37033681
ABSTRACT
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.
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Base de dados:
MEDLINE
Tipo de estudo:
Clinical_trials
/
Observational_studies
/
Prognostic_studies
Idioma:
En
Ano de publicação:
2023
Tipo de documento:
Article