Physicians should not use bioresorbable scaffolds in place of current-generation drug-eluting stents, according to a report from the European Society of Cardiology and European Association of Percutaneous Cardiovascular Inventions.
The ECS/EAPCI report says that as long as concerns remain about the increased risk of myocardial infarction and scaffold thrombosis linked with bioresorbable scaffolds, physicians should favor using drug-eluting stents.
The report, published in EuroIntervention, focused on five bioresorbable scaffolds that held CE Mark approval in Europe while the report was compiled. In the meantime, however, Abbott (NYSE:ABT) pulled its Absorb device from the market, leaving behind Elixir Medical‘s DESolve, Reva Medical‘s (ASX:RVA) Fantom, Biotronik‘s Magmaris and Arterial Remodeling Technologies bioresorbable scaffold.
Abbott’s product boasts the most clinical trial data out of all its competitors and longer-term outcomes have shown an risk of target-vessel MI and scaffold thrombosis compared to Abbott’s Xience everolimus-eluting stent.
In July, Boston Scientific announced it would terminate its Renuvia bioresorbable coronary stent program, saying that the company wanted to focus its development efforts elsewhere.
The report also gives recommendations for how physicians should use dual antiplatelet therapy in patients who have been treated with a bioresorbable scaffold, according to TCTMD.
The task force said that treating a patient with aspirin and a P2Y12 inhibitor is mandatory after the patient has been implanted with a bioresorbable scaffold to reduce the risk of thrombosis. But the report cautions that the optimal duration of such a treatment is not yet known.
The report recommended that patients currently taking DAPT after scaffold implantation should continue for at least three years with Absorb.
If any of the approved bioresorbable scaffolds are used, the task force recommended lesion assessment with intravascular imaging and other steps.
The report also says that clinical studies can use a non-inferiority study design with a one year endpoint, but longer-term follow-up should include a superiority assessment.
See the best minds in medtech live at DeviceTalks West, Dec. 11–12 in Orange County, Calif.
