Cre8 EVO Stents Noninferior for PCI in Diabetes Patients With CAD

TUESDAY, Nov. 23, 2021 (HealthDay News) — For patients with diabetes mellitus and coronary artery disease who require percutaneous coronary intervention, the Cre8 EVO stent, which releases a formulation of sirolimus with an amphiphilic carrier from laser-dug wells, is noninferior to Resolute Onyx stents for a composite outcome of target-lesion failure, according to a study published online Nov. 4 in the European Heart Journal to coincide with the annual Transcatheter Cardiovascular Therapeutics Conference (TCT 2021).

Rafael Romaguera, M.D., from the University of Barcelona in Spain, and colleagues randomly assigned 1,175 patients with diabetes who required percutaneous coronary intervention to receive Cre8 EVO or Resolute Onyx stents (a polymer-based zotarolimus-eluting stent). The primary end point was target-lesion failure (composite of cardiac death, target-vessel myocardial infarction, and clinically indicated target-lesion revascularization at one-year follow-up); the trial had a noninferiority design with a 4 percent margin for the primary end point.

The researchers identified 106 primary events: 42 and 64 in the Cre8 EVO and Resolute Onyx groups, respectively (7.2 versus 10.9 percent; hazard ratio, 0.65; 95 percent confidence interval, 0.44 to 0.96; P_{noninferiority} < 0.001; P_superiority = 0.030). The rate of target-vessel failure was significantly lower with Cre8 EVO stents versus Resolute Onyx stents (7.5 versus 11.1 percent; hazard ratio, 0.67; 95 percent confidence interval, 0.46 to 0.99; P = 0.042).

“The study found that amphilimus-eluting stents were superior to Onyx-zotarolimus-eluting stents with a 35 percent reduction in the risk of target lesion failure at one year,” Romaguera said in a statement.

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