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LONDON, England – A drug-eluting coronary stent, or “scaffold” 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.
EMBARGO : 1 Septembre 2015 at 09:00 BST
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 <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.” -- END –
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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About the European Society of CardiologyThe European Society of Cardiology (ESC) represents more than 90 000 cardiology professionals across Europe and worldwide. Its mission is to reduce the burden of cardiovascular disease in Europe. About ESC Congress 2015ESC Congress is the world’s largest and most influential cardiovascular event contributing to global awareness of the latest clinical trials and breakthrough discoveries. ESC Congress 2015 takes place 29 August to 2 September at ExCel London in London, UK. Access the scientific programme. More information is available from the ESC Press Office at firstname.lastname@example.org.To access all the scientific resources from the sessions during the congress, visit ESC Congress 365. This press release accompanies both a presentation and an ESC press conference at the ESC Congress 2015. Edited by the ESC from material supplied by the investigators themselves, this press release does not necessarily reflect the opinion of the European Society of Cardiology. The content of the press release has been approved by the presenter.
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