Polymer-free sirolimus- and probucol-eluting stents versus durable polymer-based everolimus-eluting stents for...

Owing to the advent of new generation drug-eluting stents, percutaneous coronary intervention (PCI) outcomes are improving. However, the polymers, which have been the most common type of coatings used in drug-eluting stents, have some issues. The study aim was to evaluate the clinical outcomes of patients undergoing PCI with polymer-free sirolimus- and probucol-eluting stents (NP023).

This clinical trial was a prospective multicenter single-blind noninferiority randomized study performed at 22 hospitals in Japan. We randomly assigned patients in a 2:1 ratio to undergo PCI with either NP023 or durable polymer-based everolimus-eluting stents (control stents) with a 5-year follow-up. The primary outcome was freedom from target lesion failure (TLF) at 9 months, defined as patient-oriented composite of cardiac death, ischemia-driven target vessel-related myocardial infarction, or ischemia-driven target lesion revascularization. The secondary outcome included adverse outcomes at 5 years following the index procedure.

Overall, 432 patients (463 lesions) were treated at 22 sites in Japan [mean age, 68 years; males, 345 (80 %); chronic coronary artery diseases, 322 (74.5 %)]. Of the participants, 91 % completed the 5-year follow-up. The Kaplan-Meier estimates of the percentages of patients who were free from TLF were 95.8 % and 97.3 % with NP023 and control stents, respectively (hazard ratio, 0.98; 95 % confidential interval, 0.80-1.21; p < 0.01 for noninferiority). At the 5-year follow-up, the secondary endpoint for safety was not different between the two groups.

The results of this study showed similar outcomes for polymer-free sirolimus- and probucol-eluting stents and durable polymer-based everolimus-eluting stents regarding freedom from TLF at 9 months and other outcomes at 5 years among patients undergoing PCI.