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

Shockwave Launches Coronary Intravascular Lithotripsy in Europe
News | Cath Lab | May 30, 2018
Shockwave Medical recently announced the European commercial availability of Intravascular Lithotripsy (IVL) for...
FFR software on the GE Centricity CVIS. A trial from the 2018 EuroPCR meeting showed FFR improves long-term outcomes.
News | Cath Lab | May 29, 2018
May 29, 2018 — Ongoing controversy exists regarding the role of percutaneous coronary intervention (PCI) for stable c
SCAI Updates Consensus on Length of Stay for Percutaneous Coronary Intervention
News | Cath Lab | May 15, 2018
Revised guidelines incorporating new data on discharge criteria for patients undergoing elective percutaneous coronary...
No Benefit Found Using Sodium Bicarbonate, Acetylcysteine to Prevent Kidney Injury, the result of the PRESERVE Trial to prevent acute kidney injury (AKI), presented at SCAI 2018.  #SCAI, #SCAI2018,
Feature | Cath Lab | May 15, 2018
May 15, 2018 – The large-scale, international randomized PRESERVE clinical trial found high-risk patients for renal c
Angiogram of a STEMI patient.
News | Cath Lab | May 15, 2018
May 15, 2018 — A contemporary, real-world analysis shows lower mortality rates when culprit-only intervention is used
Recent Acquisitions Eroding Prices in Billion Dollar European Interventional Cardiology cath lab Market.
Feature | Cath Lab | May 07, 2018 | Simon Trinh and Jeffrey Wong
The European interventional cardiology market is currently valued at nearly $1.4 billion.
Videos | Cath Lab | May 07, 2018
Imran Ahmad, M.D., medical director of interventional cardiology, explains some of the new technologies his labs have
360 Photos | Cath Lab | April 20, 2018
A 360 degree view of the newest cath lab at Northwestern Medicine Central DuPage Hospital in Winfield, Ill., located
SCAI Announces Global Lecture Series for 2018 Scientific Sessions
News | Cath Lab | April 18, 2018
Many of the world’s leading interventional cardiologists and cardiovascular professionals will convene in San Diego,...
Serial coronary angiograms of the representative case treated with shockwave intravascular lithotripsy.

Figure 1. Serial coronary angiograms of the representative case treated with shockwave intravascular lithotripsy.

Feature | Cath Lab | April 16, 2018 | Azeem Latib, M.D.
Over the last decade, there have been considerable developments in procedural techniques and technology facilitating
Overlay Init