It is unknown whether the LEADERS trial results are specific to the stents used in the trial or apply to other biodegradable stents, which vary in their rates of degradation from 3 months to up to 2 years. The biodegradable polymer in the BioMatrix stent metabolizes to water and carbon dioxide in 6-9 months.
It’s also unclear how biodegradable stents stack up against second-generation drug-eluting stents, which produce fewer adverse events. The long-term results of LEADERS are encouraging, but it will take another 5 years or more of studies to determine if they are superior to second-generation drug-eluting stents, Dr. Waksman and Dr. Maluenda said.
Dr. Stefanini and his associates wrote that the LEADERS results provide "the basis of a proof of concept" for better clinical outcomes with the biodegradable stent versus the durable stent by reducing the risk of very late stent thrombosis. This may have implications for recommendations regarding the duration of dual antiplatelet therapy after stent implantation, they added.
A 5-year follow-up of patients in the LEADERS trial is planned. Dr. Serruys said a global LEADERS study is underway that will compare two antiplatelet therapy regimens after implantation of the BioMatrix stent. Patients will be randomized to very short dual antiplatelet therapy combining 1 month of aspirin and 23 months of ticagrelor monotherapy or to dual therapy with those two drugs for 12 months followed by aspirin monotherapy for 12 months.
In the LEADERS trial, adherence to dual antiplatelet therapy did not differ between groups.
The study was funded by Biosensors Europe, which makes the BioMatrix stent. Dr. Serruys, Dr. Ischinger, Dr. Stefanini, and Dr. Maluenda reported having no relevant financial disclosures. For other investigators in the study, disclosures can be found in the Lancet article. Dr. Waksman has been a consultant to and speaker for Biotronik, Medtronic, Boston Scientific, the Medicines Company, and AstraZeneca, and has received research funding from most of those companies plus Schering-Plough, Sanofi-Aventis, and GlaxoSmithKline.