Early and Late Outcomes with the Absorb Bioresorbable Vascular Scaffold: Final Report f rom the ABSORB Clinical Trial Program ( JACC Cardiovascular Interventions January 2025)-Article: Early and Late Outcomes with the Absorb Bioresorbable Vascular Scaffold: Final Report from the ABSORB Clinical Trial Program

Article: Early and Late Outcomes with the Absorb Bioresorbable Vascular Scaffold: Final Report from the ABSORB Clinical Trial Program

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The final report from the ABSORB clinical trial program investigates the outcomes of the Absorb bioresorbable vascular scaffold (BVS) compared to conventional cobalt-chromium everolimus-eluting stents (EES) over a 5-year follow-up period. This trial involved the pooling of individual patient data from five randomized studies, involving 5,988 patients who underwent percutaneous coronary intervention. The study aimed to evaluate the hazards associated with BVS vs. EES, focusing on target lesion failure (TLF)—a composite of cardiac death, target vessel myocardial infarction, or ischemia-driven target lesion revascularization—and device thrombosis (DT).<br /><br />Initial results indicated that between 0 to 3 years post-procedure, BVS was associated with higher TLF and DT rates than EES, revealing early safety and efficacy concerns. Specifically, TLF occurred in 12.4% of BVS patients compared to 9.3% of EES patients, with DT detected in 2.0% vs. 0.6%, respectively. However, after the 3-year mark, when complete bioresorption of the BVS's poly-L-lactic acid scaffold occurs, these adverse event rates decreased significantly. Between 3 to 5 years, TLF rates were comparable between the two devices, and DT rates were notably lower in the BVS group at 0.2%, compared to 0.4% in the EES group.<br /><br />This suggests that the excess risks associated with BVS diminish after the scaffold fully resorbs, potentially leveling the playing field in terms of risk compared to EES. While there is no significant difference in total adverse events by the 5-year point, the spline analysis suggested a potential future advantage for BVS in the reduction of TLF rates post-resorption. These findings underscore the need for next-generation BVS with improved design and implantation techniques to reduce early procedural risks and capitalize on the longer-term benefits observed.

Keywords

ABSORB clinical trial

bioresorbable vascular scaffold

cobalt-chromium everolimus-eluting stents

percutaneous coronary intervention

target lesion failure

device thrombosis

bioresorption

poly-L-lactic acid scaffold

adverse event rates

next-generation BVS