Survey of Interventional Cardiologists With Absorb BVS Expertise Gives Snapshot of Attitudes, Usage
In a survey of interventional cardiologists considered “experts” or “experienced” operators with the Absorb fully bioresorbable vascular scaffold (Abbott Vascular), 60% do not consider scaffold thrombosis to be an issue, at least not any more so than the risk of stent thrombosis with contemporary drug-eluting stents.
The survey, conducted by Bernardo Cortese, MD (Ospedale Fatebenefratelli, Milan, Italy), and colleagues and published June 13, 2016 in the Journal of the American College of Cardiology, included interventional cardiologists with documented experience of 50 or more Absorb stent implantations as well as those listed as the first/corresponding author on an Absorb-related publication in a medical journal. A list of operators/centers using the Absorb stent was provided by Abbott Vascular.
In the past year, several reports have highlighted an increased risk of scaffold thrombosis with the bioresorbable stent. As reported by TCTMD, one meta-analysis of six clinical trials, including the ABSORB studies, found an approximately two-fold higher risk of definite or probable scaffold thrombosis after a median of 12 months. An expanded meta-analysis of data from clinical trials and registries also showed a two-fold higher risk of definite/probable stent thrombosis compared with patients receiving a drug-eluting stent.
In contrast, a patient-level meta-analysis found comparable safety and efficacy between Absorb and drug-eluting stents.
For the survey, 152 cardiologists responded to the questionnaire. Of these, 40% had implanted 100 or more Absorb stents—half had at least two years’ experience—but 36% said they used the Absorb stent only “rarely.” Roughly half believe that use will increase in the next 12 months while 44% expect usage to remain stable. Regarding implantation techniques, 83% of the experts consider lesion preparation mandatory with Absorb but only half consider post-dilation a requirement. Intracoronary imaging is used in less than 20% of all cases by approximately half of the surveyed physicians.
Nearly all sampled—90%—consider 12 months of dual antiplatelet therapy mandatory and just 2% believe a six-month DAPT course sufficient. More than half stated that treatment with Absorb requires longer DAPT than contemporary DES.
Regarding safety, one-third of respondents had never observed early scaffold thrombosis with the stent, while 63% and 72%, respectively, had never observed late or very late thrombotic events. The survey also assessed how operators deal with scaffold thrombosis when it occurs. Two-thirds said they will perform intracoronary imaging to look for possible mechanical causes underlying the thrombotic event and 67% will perform some type of thrombus aspiration. In total, 48% of physicians will implant a drug-eluting stent in cases of scaffold thrombosis and 33% will perform balloon angioplasty. Regarding pharmacological treatment, just 29% will use a glycoprotein IIb/IIIa inhibitor and 23% will switch from clopidogrel to a more potent oral platelet inhibitor.
In March, a US Food and Drug Administration advisory panel voted to approve the Absorb stent for clinical use, and while the FDA typically follows the advice of their advisory committees, the stent has not yet been approved by the agency. Absorb has been commercially available in Europe since 2011.
- FDA Panel Overwhelmingly Supports Absorb Bioresorbable Stent
- Increased Risk of Device Thrombosis With Bioresorbable Scaffold, but Some Say Risks Can Be Mitigated
- Increased Early Risk of Stent Thrombosis with the Absorb Bioresorbable Scaffold
Cortese B, Buccheri D, Stefanini GG, Mehran R. The contemporary pulse of bioresorbable-scaffold thrombosis among expert operators. J Am Coll Cardiol 2016;Epub ahead of print.
- Cortese has received consultant fees from Abbott Vascular, Hexacath, Kardia, Movi, AB Medica, and Stentys.