Abstract
Objective In this study, we sought to compare the efficacy and safety of the Xience Prime/Xience V/Promus EES and Biomatrix/Biomatrix Flex/Nobori BES with resolute integrity/resolute ZES using the grand drug-eluting stent (Grand-DES) registry. Background Currently, new-generation drug-eluting stents (DESs) are used as the standard of care in patients undergoing percutaneous coronary intervention. No study has simultaneously compared everolimus-eluting stent (EES), biolimus-eluting stent (BES), and zotarolimus-eluting stent (ZES). Methods Stent-related composite outcomes (target lesion failure) and patient-related composite outcomes were compared in crude and propensity score-matched analysis. Results Of the 17,286 patients in the Grand-DES group, 5,137, 2,970, and 4,990 patients in the EES, BES, and ZES groups completed a three-year follow-up. In the propensity score-matched cohort, the stent-related outcome (EES vs. BES vs. ZES; 5.9% vs. 6.7% vs. 7.1%, P = 0.226) and patient-related outcomes (12.7% vs. 13.5% vs. 14.3%, P = 0.226) and patient-related outcomes (12.7% vs. 13.5% vs. 14.3%, P = 0.226) and patient-related outcomes (12.7% vs. 13.5% vs. 14.3%, P = 0.226) and patient-related outcomes (12.7% vs. 13.5% vs. 14.3%, Conclusions In this robust real-world registry with unrestricted use of EES, BES, and ZES, the three stent groups showed comparable safety and efficacy at the 3-year follow-up.
Highlights
The restenosis rate of bare metal stent is high, restenosis or stent thrombosis (ST) is known to be low after one year of revascularization [1]
13,172 patients were treated with new-generation drugeluting stents (DESs). e newgeneration stent used in this trial includes everolimus-eluting stent (EES) (Xience Prime/Xience V/Promus) with durable polymer, biolimus-eluting stent (BES) (Biomatrix/Biomatrix Flex/Nobori) with biodegradable polymer, and RES with durable polymer. e study complied with the provisions of the Declaration of Helsinki, and the study was approved by the institutional review board at each center
Of the 17,286 patients in the Grand-DES cohorts, 13,172 (76.2%) patients were treated with second-generation DESs, and the remaining 4,114 (23.8%) patients were treated with first-generation DESs
Summary
The restenosis rate of bare metal stent is high, restenosis or stent thrombosis (ST) is known to be low after one year of revascularization [1]. Ere are multiple studies reporting the short-term outcome within two years of real-world use of second-generation DESs, but there is significantly less data on the long-term outcomes from real-world use [3,4,5]. In the TWENTE II trial, the 5-year clinical outcome was similar between EES and ZES [7]. It remains to be seen whether the outcomes among different types of second-generation DESs are different including those that have biodegradable and biocompatible durable polymers. Ere are only a few reports on comparison of short-term data of biodegradable polymer and durable polymer-coated stents [8]. Previous trials are limited to evaluating low-frequency adverse events, in particular very late ST, and long-term data are limited [4, 9, 10]
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