Safety and Efficacy of Two Ultrathin Biodegradable Polymer Sirolimus-Eluting Stents in Real-World Practice: Genoss DES Stents Versus Orsiro Stents From a Prospective Registry.

Background: The Orsiro and Genoss DES stents are biodegradable polymer drug-eluting stents (DESs) with ultrathin struts.

Objective: To investigate the safety and efficacy of these two ultrathin DESs in real-world practice.

Methods: From a single-center prospective registry, we included 751 and 931 patients treated with the Genoss DES and Orsiro stents, respectively. After propensity score matching, we compared 483 patients in each group with respect to a device-oriented composite outcome (DOCO), which comprised cardiac death, target vessel myocardial infarction, and clinically indicated target lesion revascularization up to 2 follow-up years.

Results: After propensity score matching, there were no significant between-group differences in clinical and angiographic characteristics. During the median follow-up period of 730 days (interquartile range, 427-730 days), there was no significant between-group difference in the DOCO rate (3.1% in the Genoss DES group vs. 2.9% in the Orsiro group, log-rank p = 0.847).

Conclusions: This study demonstrated comparable safety and efficacy between the Orsiro and Genoss DES stents during a 2-year follow-up period in real-world practice. However, this result should be confirmed in a large randomized controlled trial.

Trial Registration: ClinicalTrials.gov Identifier: NCT02038127.