The Beginning of the End for Bioresorbable Coronary Scaffolds?

May 10, 2017

The Beginning of the End for Bioresorbable Coronary Scaffolds?

  1. Pascal Meier, MD

A worrying increase is seen in thrombosis risk with bioresorbable coronary scaffolds compared to standard metallic stents in a large randomized controlled trial.

  1. Pascal Meier, MD

Coronary angioplasty was performed for years by simple balloon angioplasty, which brought problems of recoil and high restenosis rates. The invention of stents dramatically reduced the restenosis risk but at the price of stent thrombosis. Therefore, the concept of bioresorbable vascular scaffolds was intriguing, and the first one (ABSORB) was widely used, despite scarce data. Now, researchers have reported results from one of the largest randomized, controlled trials evaluating bioresorbable scaffolds.

The industry-funded trial randomized 1845 patients to percutaneous coronary intervention with an everolimus-eluting bioresorbable scaffold or an everolimus-eluting metallic stent (stable coronary artery disease, 40% of patients; ST-segment elevation myocardial infarction, 25%; non–ST-segment elevation acute coronary syndrome, 35%).

At 2 years, no significant group differences were seen on the primary endpoint (a composite of cardiac death, target-vessel myocardial infarction, or target-vessel revascularization; scaffold group, 11.7%; stent group, 10.7%) or on most secondary endpoints. However, the scaffold group experienced an about 3.5-fold higher rate of definite or probable device thrombosis (3.5% vs. 0.9%). The safety monitoring board recommended early data reporting because of safety concerns.

Comment — Cardiology

Although disappointing for most cardiologists and patients, these results fall in line with previous data indicating higher thrombosis rates with scaffolds (NEJM JW Cardiol Jan 2017 and Lancet 2016; 388:2479). The present study, showing a clearly significant elevation in thrombosis rates, will definitely change clinical practice. Scaffolds have further disadvantages such as longer procedure times involving additional radiation and costs; there is currently no rationale for using scaffolds. The manufacturer has decided to restrict use of the scaffold in Europe to clinical studies exclusively, starting May 31, 2017. The concept itself remains interesting and should not be abandoned. Future-generation scaffolds with thinner struts might improve outcomes.

Comment — General Medicine

  1. Allan S. Brett, MD

Some cardiology groups and hospitals still are promoting bioresorbable scaffolds, even after publication of these results. For example, the website of a hospital in my geographic area boasts that it is the first local hospital to offer the device, and it calls the device “the most significant advancement in cardiology since stenting began decades ago.” Primary care clinicians and hospitalists should be aware of this trial, so that patients can be directed to interventional cardiologists who acknowledge these findings. The FDA is currently investigating the safety of the Absorb scaffold, which was used in this study.

Editor Disclosures at Time of Publication

  • Disclosures for Pascal Meier, MD at time of publication Editorial boards Open Heart Leadership positions in professional societies European Society of Cardiology (Communication Committee), European Association of Percutaneous Cardiovascular Interventions (Chair, Web & Communication Committee)


Reader Comments (2)

Rajeev Gupta, MD, DM Physician, Cardiology, Mediclinic Al Jowhara hospital, Al Ain, UAE

Even though theoretically attractive, the BVS are inferior on long-term results. More thrombosis with this bulkier device could be explained easily. We were all excited about the thrombus aspiration in STEMI initially. It reminds me to critically analyse and see the performance before use. The same may happen with PCSK9 inhibitors.

mehrdad bohloli Physician, Cardiology

Every new comings at first has a lot of hurly but after scrutinize and passing of time you see that the first concept was wrong and I wonder so these materials havn,t gone extensive trials before going to market.

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