The primary endpoint of the study was a composite of cardiac death, target vessel myocardial infarction, and clinically indicated target lesion revascularization (CI-TLR). At 3 years, 5.3% of the Xience group experienced the composite outcome versus 4.9% of the Supraflex group, a nonsignificant difference. The result confirmed the noninferiority of Supraflex at a margin of 4% (P less than .001). When the adverse events were broken down individually in a per-protocol analysis, the only significant difference between the two groups was with respect to CI-TLR, which favored Supraflex (1.2% versus 3.1%; P = .021). There were seven deaths in the Supraflex arm versus two in the Xience group. However, there was no apparent explanation for the difference, and it may have been because of chance, according to Dr. Serruys.
“The performance of Xience was excellent in this trial, at 5.3% it had one of the lowest (adverse outcome rates) I have seen so far, but the Supraflex also did very well,” said Dr. Serruys at a press conference.
The results of the study have implications in countries with capped stent prices or where there are models for competitive pricing. “Market competitiveness may influence future decisions on which stent you use,” said Dr. Serruys.