September 1, 2015 — A bioresorbable drug-eluting coronary stent 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 the European Society of Cardiology (ESC) 2015 congress.
“These results support the feasibility of bioresorbable vascular scaffolds (BVS) to potentially improve the long-term outcomes of patients,” said principal investigator Takeshi Kimura M.D., Ph.D., 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, Kimura said. ABSORB Japan, a prospective, 38-center 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 stents were coated with everolimus.
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 percent of BVS patients and 3.8 percent of patients with metal stents (relative risk [RR] 1.10, 95 percent confidence interval 0.39-3.11), demonstrating non-inferiority of BVS (P <0.0001), reported 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,” Kimura concluded. “These results are consistent with a few previous studies reporting either 12-month clinical outcome or nine-month angiographic outcome, supporting the feasibility of BVS use to potentially improve the long-term outcomes of patients undergoing PCI.”
SOURCES OF FUNDING: The study was sponsored by Abbott Vascular
DISCLOSURES: Kimura and some of his co-investigators are members of the Advisory Board of Abbott Vascular 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.
For more information: www.escardio.org