SAN DIEGO — A biodegradable-polymer sirolimus-eluting stent (Supraflex) from India proved to be a worthy match of the Xience stent, according to the TALENT non-inferiority trial.
The device-oriented endpoint of combined cardiac death, target vessel MI, and clinically-indicated target lesion revascularization at 1 year was observed in 4.9% and 5.3% of Supraflex and Xience recipients, respectively (P=0.801), reported Patrick Serruys, MD, PhD, of Imperial College London and Erasmus University Rotterdam in the Netherlands.
None of these individual components showed an advantage to either stent, though patients randomized to the Supraflex did trend toward more cardiac deaths (1.0% vs 0.3%, P=0.097), Serruys said during a late-breaking trial presentation at the Transcatheter Cardiovascular Therapeutics (TCT) conference.
The 0.6% all-cause mortality rate among those who got the Xience everolimus-eluting stent gave this device an edge versus 2.0% for Supraflex (P=0.019). However, Serruys highlighted the all-comers population in this study, and also noted that Xience had previously been associated with more than 2.0% death rates in similar all-comers populations from the TARGET, BIOSCIENCE, TWENTE, and RESOLUTE trials.
“Since clinical outcomes of contemporary drug-eluting stents [DES] are reaching a ‘safety’ plateau; it is likely that cost-effectiveness will influence in the near future ‘the stent market,'” Serruys said. “The study results have important economic implications in countries with capped stent prices, such as India, and in some European countries with competitive pricing and different models of healthcare cost savings.”
In India, the cost of DES went from $1,800 to being capped at no more than $440 in 2017. This country is projected to be the second largest international stent market after China by 2020, according to the investigator.
If the Supraflex is that inexpensive, “people will want to use it … Any $440 stent that works as well has got to be pretty good,” according to David Cohen, MD, of Saint Luke’s Health System in Kansas City, Missouri, in a TCT press conference.
Based on TALENT, operators now have another good DES available and the lower cost can mean more patients are able to receive treatment, suggested TCT session discussant Marie-Claude Morice, MD, of the Institut Cardiovasculaire Paris Sud.
Trial participants (n=1,435) were enrolled from 23 participating sites across Europe. Patients randomized to the Xience arm were more likely to have had previous coronary artery bypass grafting at baseline (7.7% vs 4.6%).
Procedure and device success was slightly lower in the Supraflex group. Some operators had a tendency to cross over to a more familiar stent technology, Serruys said, noting that pushability was perhaps an issue with this device.
“I think what we have to emphasize is that initially the [stent] technology came from the U.S. It’ll be interesting to see what the Chinese and Indian technology is coming to,” he said.
Stents from these countries are a long time coming, suggested Sunil Rao, MD, of Duke University School of Medicine in Durham, North Carolina. But for many U.S. companies, stents are still the major source of revenue, he noted during the press conference.
One question is whether Indian and Chinese companies can support the same R&D programs as U.S. companies once their stents enter the market, according to Cohen.
TALENT was supported by the European Clinical Research Institute with a grant from SMT, the developer of Supraflex.
Serruys disclosed relevant relationships with Abbott, Biosensors, Medtronic, Micell, Sinomedical Sciences Technology, Philips/Volcano, Xeltis, and HeartFlow.