News | Stents Bioresorbable | September 01, 2015

Dissolving Stent Compares Favorably Against Metal Stent in Japanese Trial

Absorb, BVS, bioresorbable stent

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

Related Content

Videos | Cath Lab| January 04, 2018
Bernadette Speiser, BSN, MSN, CCRN, RCIS, a cardiac cath/EP nurse at Palo Alto Veterans Hospital, Palo Alto, Calif.,
FDA Initiates Class I Recall of Sterilmed Reprocessed Agilis Steerable Introducer Sheath
News | Cath Lab| January 04, 2018
The U.S. Food and Drug Administration (FDA) announced a Class I recall of Sterilmed’s Agilis Steerable Introducer...
The California Heart & Vascular Clinic in El Centro, Calif., treated the first post-FDA clearance patient with a DABRA atherectomy system. Athar Ansari, M.D.

The California Heart & Vascular Clinic in El Centro, Calif., treated the first post-FDA clearance patient with a DABRA system. 

Feature | Cath Lab| November 24, 2017 | Athar Ansari, M.D., FACC
As debates about the current state and future of healthcare rage in Congress, the media and healthcare settings acros
Videos | Cath Lab| November 08, 2017
Juan Granada, M.D., Cardiovascular Research Foundation president and chief executive officer, shares his insights on
Results of the ORBITA study found no difference in exercise time after six weeks in patients with stable angina who received percutaneous coronary intervention (PCI) versus a placebo treatment. TCT 2017
Feature | Cath Lab| November 06, 2017
November 6, 2017 – Results from ORBITA, a prospective multi-center randomized blinded placebo-controlled study, found
Culprit Lesion-Only PCI Improves Outcomes for Cardiogenic Shock Patients Compared to Multivessel PCI
News | Cath Lab| November 01, 2017
November 1, 2017 — Results from the prospective, randomized, multicenter CULPRIT-SHOCK trial found an initial strateg
Three-Year Quality of Life Improvements Similar for PCI and CABG in Left Main Disease
News | Cath Lab| October 30, 2017
October 30, 2017 — New study results from the EXCEL trial comparing the quality of life (QoL) of patients with left m
Corindus Evaluates Incorporating HeartFlow Technology With CorPath GRX System
Technology | Cath Lab| October 26, 2017
Corindus Vascular Robotics Inc. announced that it will incorporate the HeartFlow FFRct (fractional flow reserve-...
Shockwave Medical Announces $35 Million in New Financing
News | Cath Lab| October 24, 2017
October 24, 2017 — Shockwave Medical reported $35 million in new financing, an extension of the company’s previously
Overlay Init