The Supraflex sirolimus-eluting stent with ultra-thin struts and a biodegradable polymer coating was noninferior to the Xience everolimus-eluting stent with a durable polymer coating for reducing the risk of cardiac death, target-vessel myocardial infarction, or clinically indicated target lesion revascularization at 12 months in patients with atherosclerotic lesions. Findings from this study were recently published in the Lancet.
In this prospective, randomized clinical trial, researchers enrolled a total of 1435 patients with ≥1 coronary artery stenosis of ≥50% in a native coronary artery, saphenous venous graft, or arterial bypass conduit from 23 centers across the United Kingdom and 6 countries in Europe (TALENT; ClinicalTrials.gov identifier: NCT02870140). Patients underwent percutaneous coronary intervention and were subsequently randomly assigned to receive either the Supraflex (n=720) or the Xience (n=715) stents. A device-oriented composite end point, comprised of cardiac death, target-vessel myocardial infarction, or clinically indicated target lesion revascularization, was assessed at 12 months after implantation for noninferiority. A margin of 4.0% was deemed appropriate for determining noninferiority between the 2 devices, based on an 8.3% prevalence of a 1-year composite end point.
Device success per lesion was higher in the Supraflex vs the Xience group (97.6% vs 99.5%, respectively; difference, -1.9%; 95% CI, -3.0 to -0.9; P =.0003). According to the researchers, the main reason for a higher success rate with the Supraflex was the higher crossover to non-allocated stent in with the device relative to the Xience.
At 12-month follow-up, a lower proportion of patients in the Supraflex group met the primary end point compared with the Xience group (4.9% vs 5.3%, respectively; absolute difference, -0.3% [one-sided 95% upper confidence bound, 1.6%]; P <.0001). Despite this finding, the difference between the 2 groups met the predefined criteria for non-inferiority (Psuperiority =.801). No difference was found between the 2 groups with regard to the prevalence of definite or probable stent thrombosis.
A limitation of the study, according to the investigators, was using a noninferiority margin that may be too wide for this type of analysis.
“Whether the benefit of drugeluting stents with thin struts could improve clinical outcomes remains to be assessed by studies with longer followup periods,” concluded the researchers.
Zaman A, de Winter RJ, Kogame N, et al; TALENT trial investigators. Safety and efficacy of a sirolimus-eluting coronary stent with ultra-thin strut for treatment of atherosclerotic lesions (TALENT): a prospective multicentre randomised controlled trial. Lancet. 2019;393(10175):987-997.