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Globally largest registry with clinical outcomes for bioresorbable scaffolds – findings from the European ABSORB Consortium

ESC Congress News 2018 - Munich, Germany

In a late-breaking abstract presentation yesterday, Professor Holger Nef (University of Giessen, Giessen, Germany) presented data from the European ABSORB Consortium (EAC) in patients undergoing percutaneous coronary intervention (PCI) with the ABSORB bioresorbable vascular scaffold (BVS).

The EAC is the globally largest prospective registry of bioresorbable vascular scaffold use in PCI.

Interventional Cardiology


nef-holger-esc-congress-news-2018.jpg“Entering the European market in 2011, the ABSORB BVS was considered to be opening up a new era in stent technology,” says Prof. Nef. “However, it became beset by technical issues and safety concerns. In 2017, three-year data from the randomised ABSORB study in just over 2,000 patients revealed higher event rates with the BVS than with metallic drug-eluting stents, with statistically significantly more instances of target vessel myocardial infarction (MI) and scaffold thrombosis.(1) In September of the same year, sales of ABSORB BVS stopped were halted, but physicians were still allowed to implant existing stock and patients in clinical trials continued to be monitored according to plans.(2)”

Within the EAC—which is made up of five European registries: GABI-R, UK Registry, ABSORB France, RAIRegistry and REPARA—patients are followed up systematically by scheduled telephone interview and clinical outcome data are collected and adjudicated by an independent clinical event committee. The primary clinical endpoint is 12-month target lesion failure (TLF) (cardiac death, MI and target lesion revascularisation [TLR]) with secondary endpoints including death, TLR and definite/probable stent thrombosis (ST).

“Between 2013 and 2016, 10,312 patients underwent BVS implantation and had a 12-month follow-up,” reports Prof. Nef. “The TLF rate was 3.6% and the rates of death and cardiac death were 1.2% and 0.6%. Target vessel MI, TLR and target vessel revascularisation (TVR) were reported in 1.8%, 2.6% and 3.2% of cases, respectively.” These real-world data show that BVS is associated with acceptable clinical outcomes, thinks Prof. Nef. “Particularly noteworthy is the TLF rate, which is comparable to registry data gained with second-generation drug-eluting stents (DES) a number of years ago.” He notes, “In this, the largest pooled dataset globally to date, we found a 1.6% rate of definite/probable ST.”

The 12-month rate of definite/probable stent thrombosis was concerning but was reduced by an improved implantation protocol.

The cumulative incidence curve of definite/probable Academic Research Consortium-defined ST showed an initial steep rise: about 60% of cases were observed within the first 30 days. “To exclude a learning curve,” says Prof. Nef, “we compared patients who were implanted before and after 2015. This particular cut-off was chosen because the instructions for use were changed by the manufacturers in November 2014 with regard to implantation technology.” Although not adjusted for confounding factors, most notably, the composite endpoints for target vessel failure (TVF) and TLF were reduced. “Moreover, the ST rate was somewhat lower in the population implanted in the more recent period—1.8% to 1.4% after 12 months, without reaching statistical significance,” says Prof. Nef.

He concludes, “The EAC reports large-scale, real-world clinical outcome data for BVS. Outcome seems to depend on implantation protocols and BVS technology. This includes ST, which remains high in this registry.”

1. Kereiakes DJ, et al. J Am Coll Cardiol 2017;70:2852–2862.
2. www.vascular.abbott/us/products/coronary-intervention/absorb-bioresorbable-scaffold-dissolving-stent.html

 

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Notes to editor

About the European Society of Cardiology

The European Society of Cardiology brings together healthcare professionals from more than 150 countries, working to advance cardiovascular medicine and help people lead longer, healthier lives.

About ESC Congress 2018

ESC 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 2018 takes place 25 to 29 August at the Messe München in Munich, Germany. Explore the scientific programme