Comparison of Thick Biolimus A9-Eluting Stent and Thin Zotarolimus-Eluting Stent in Multi-Vessel Percutaneous Coronary Intervention.

Abstract

Background and objectives: There are limited randomized studies on patients undergoing multi-vessel percutaneous coronary intervention (PCI) comparing the outcomes between stent thickness and polymer types. To compare the clinical outcomes of thick biodegradable polymer-based biolimus A9-eluting stents (BESs) and thin durable polymer-based zotarolimus-eluting stents (ZESs) in patients undergoing multi-vessel PCI.

Methods: A total of 936 patients who underwent multi-vessel coronary artery stenting were randomly assigned to the BES (n=472) or ZES (n=464) groups. The primary endpoint was 2-year major adverse cardiac events (MACEs), a composite of all-cause death, myocardial infarction (MI), and any revascularization at the 2-year follow-up.

Results: Fifty-two (11.2%) of 472 patients in BES group and 50 (10.9%) of the 464 patients in ZES group met the 2-year primary endpoint of MACE (hazard ratio, 1.00; 90% confidence interval, 0.72, 1.38; p=0.994). All-cause death (BES vs. ZES: 2.8% vs. 2.7%, p=0.758), MI (2.1% vs. 2.6%, p=0.483), and repeat revascularization (6.7% vs. 6.9%, p=0.876) were not significantly different between the 2 groups. Although there was no significant outcome difference in any subgroup analysis, the technical failure rate leading to the use of other stents was higher in BES than in ZES (3.2% vs. 0.9%, p=0.023).

Conclusions: In patients who underwent multi-vessel PCI, BES and ZES showed comparable 2-year clinical outcomes. However, BES was not established to demonstrate non-inferiority to ZES in terms of the incidence of the primary endpoint at the 2-year. The technical success rate of the index PCI with the assigned stent was higher for thinner ZES.

Trial registration: ClinicalTrials.gov Identifier: NCT01947439.