A Multicenter Randomized Trial Comparing Amphilimus- With Paclitaxel-Eluting Stents in De Novo Native Coronary Artery Lesions
What is the comparative efficacy of polymer-free amphilimus-eluting stents versus permanent-polymer paclitaxel-eluting stents in de novo percutaneous coronary intervention (PCI)?
Patients undergoing PCI for de novo lesions in the NEXT trial were randomly assigned 1:1 to Cre8 or Taxus Liberté stents. The primary endpoint was 6-month angiographic in-stent late lumen loss (LLL) within a noninferiority scope. Six-month intravascular ultrasound (IVUS) was performed in 20% of the patients. Kaplan-Meier cumulative incidence estimates were used to analyze outcome events, which were compared between groups using the log-rank test.
Out of 323 patients enrolled, 162 received Cre8 and 161 received Taxus Liberté stents. In-stent LLL was significantly lower in the Cre8 group (0.14 ± 0.36 mm vs. 0.34 ± 0.40 mm, p noninferiority < 0.0001, p superiority < 0.0001). Clinical endpoints (cardiac death, myocardial infarction, target lesion revascularization, and stent thrombosis) up to 12 months did not differ significantly between the groups.
The authors concluded that the Cre8 stent in de novo lesions showed significantly lower in-stent LLL at 6 months than the Taxus Liberté stent did, with a trend toward better 12-month clinical safety and efficacy results.
This study suggests that that the polymer-free Cre8 was noninferior, and even superior, to permanent polymer Taxus in terms of 6-month late lumen loss. The IVUS analysis further supported the superior antirestenotic efficacy of Cre8, demonstrating significantly lower neointimal hyperplasia and volume obstruction. Larger adequately powered studies with longer follow-up and hard clinical endpoints are indicated to appropriately assess this new technology.
Keywords: Neointima, Myocardial Infarction, Follow-Up Studies, Coronary Restenosis, Drug-Eluting Stents, Hyperplasia, Angioplasty, Balloon, Coronary, Percutaneous Coronary Intervention, Paclitaxel, Coronary Angiography, Thrombosis, Polymers, Coronary Vessels
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