The findings, reported in a Hot Line session at ESC congress 2015 today, were published simultaneously in the European Heart Journal (to be confirmed).
“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) randomised 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
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.”
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Notes to editor
SOURCES OF FUNDING: The study was sponsored by Abbott Vascular, Santa Clara, California.
DISCLOSURES: 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.
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