A drug-eluting coronary stent made from bioresorbable material showed similar efficacy and safety results compared to a metal stent in patients undergoing percutaneous coronary intervention (PCI), according to results of the ABSORB Japan study.  The findings, reported in a Hot Line session at ESC congress 2015, were published simultaneously in the European Heart Journal.

"These results support the feasibility of bioresorbable vascular scaffolds (BVS) to potentially improve the long-term outcomes of patients," said principal investigator Takeshi Kimura MD, PhD, from Kyoto University Hospital, Kyoto, Japan.

However, to date there has been little long-term clinical and angiographic follow-up of BVS compared to metal stents, said Dr. Kimura.  ABSORB Japan, a prospective, 38-centre trial comparing BVS with metal stents was designed to show non-inferiority of BVS to support regulatory approval in Japan.

The study included 400 patients (mean age 67.2 years) randomized to PCI using either a bioresorbable (266 patients)  or metal stent (134 patients) – both types coated with everolimus – a medication to help prevent re-blockage of the artery.
The primary endpoint of the study was target lesion failure (TLF) - a composite of cardiac death, myocardial infarction attributable to target vessel, or ischemia-driven target lesion revascularization at one year.

This endpoint occurred in 4.2% of BVS patients and 3.8% of patients with metal stents (relative risk [RR] 1.10, 95% confidence interval 0.39-3.11), demonstrating non-inferiority of BVS (P <0.0001), reported Dr. Kimura.

The major secondary endpoint, measured at 13 months, was angiographic in-segment late lumen loss (LLL) – which is the amount of re-blockage that occurs in the stented vessel.

This endpoint was comparable in both arms, again demonstrating non-inferiority of BVS (P <0.0001).

"BVS demonstrated a similar 12-month clinical safety and efficacy profile as the metal stent, with comparable 13-month angiographic outcomes," concluded Dr. Kimura. "These results are consistent with a few previous studies reporting either 12-month clinical outcome or 9-month angiographic outcome, supporting the feasibility of BVS use to potentially improve the long-term outcomes of patients undergoing PCI."

The study was sponsored by Abbott Vascular, Santa Clara, California.  Dr. Kimura and some of his co-investigators are members of the Advisory Board of Abbott Vascular, Santa Clara, California and Abbott Vascular Japan. Other co-investigators for this study are employees of Abbott Vascular. Dr. Gregg Stone, senior author, is a consultant to Reva Corp.