5-Year Outcomes With a Novel Coronary Sirolimus-Eluting Bioresorbable Scaffold: The NeoVas Randomized Trial

Area of Science:

• Cardiovascular Medicine
• Interventional Cardiology
• Biomaterials Science

Background:

• Previous poly-l-lactic acid-based bioresorbable scaffolds (BRS) showed higher 5-year adverse event risks than cobalt chromium everolimus-eluting stents (CoCr EES).
• The NeoVas BRS is a novel sirolimus-eluting scaffold designed to overcome limitations of earlier BRS technologies.

Purpose of the Study:

• To compare the 5-year clinical outcomes of the sirolimus-eluting NeoVas BRS versus traditional CoCr EES.
• To assess the safety and efficacy of NeoVas BRS in patients with de novo native coronary artery lesions.

Main Methods:

• A randomized controlled trial involving 560 patients with single de novo coronary lesions.
• Patients were assigned 1:1 to receive either NeoVas BRS or CoCr EES.
• Follow-up extended to 5 years, with optical coherence tomography and fractional flow reserve assessments in a subgroup at 3 years.

Main Results:

• Five-year target lesion failure rates were similar between NeoVas BRS (9.5%) and CoCr EES (7.2%) (P=0.33).
• Device thrombosis rates were also comparable at 5 years (1.5% vs 0.7%, P=0.45).
• At 3 years, NeoVas BRS showed substantial absorption (72.3%), and fractional flow reserve did not differ significantly between groups.

Conclusions:

• NeoVas BRS implantation resulted in comparable 5-year target lesion failure and stent thrombosis rates versus CoCr EES in noncomplex coronary lesions.
• While outcomes appear comparable, further investigation in larger randomized trials is warranted to fully assess NeoVas BRS safety and efficacy.
• The study highlights the potential of advanced bioresorbable scaffolds in coronary interventions.