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.

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

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.

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.

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.

• Coronary artery disease
• Drug-eluting stents
• Percutaneous coronary intervention
• Rapamycin
• Sirolimus

• BioMatrix
• XIENCE
• coronary artery disease
• major adverse cardiovascular events
• primary percutaneous coronary intervention

Biodegradable polymer drug-eluting stents (BP-DES) have shown to reduce restenosis rates and have low rates of stent thrombosis. The present postmarketing surveillance assessed 1-year clinical outcomes of patients who had received NeoHexa DES in real practice.

To investigate 1-year clinical outcomes of Neohexa DES in real practice.

Data obtained from a single-center cohort of patients who had received NeoHexa stents as part of routine treatment of coronary artery disease (CAD) were retrospectively investigated. The primary study endpoint was the rate of major adverse cardiac events (MACEs) defined as the composite of death, myocardial infarction (MI), and target lesion revascularization (TLR) during the follow-up at 1 mo, 6 mo, and 1 year after the index procedure.

A total of 129 patients with 172 lesions were enrolled. The most common comorbid conditions were hypertension (49.61%) and diabetes mellitus (39.53%). Procedural success was achieved in all patients, and no in-hospital MACE was reported. The incidence of composite MACE at 30 d, 6 mo, and 1 year was 0.78%, 3.94%, and 4.87%, respectively. The rate of possible and probable late stent thrombosis was 0.78%. The cumulative incidences of death, MI, and TLR at 1 year were 2.44%, 0.81%, and 1.63%, respectively.

The relatively low rates of MACE and stent thrombosis in this study support safety and performance of NeoHexa stents, suggesting it to be an effective alternative to other contemporary stents for the treatment of de novo lesions in native coronary arteries.

• Sirolimus
• Drug-eluting stent
• Myocardial infarction
• Thrombosis
• Coronary artery disease