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A Multicenter Randomized Trial Comparing Amphilimus- With Paclitaxel-Eluting Stents in De Novo Native Coronary Artery Lesions
Study Questions:
What is the comparative efficacy of polymer-free amphilimus-eluting stents versus permanent-polymer paclitaxel-eluting stents in de novo percutaneous coronary intervention (PCI)?
Methods:
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.
Results:
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.
Conclusions:
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.
Perspective:
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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