Clinical outcomes of an ultrathin-strut sirolimus-eluting stent in all-comers population: Thailand Orsiro registry

Abstract

Background: Despite numerous studies supporting the outperformance of ultrathin-strut bioresorbable polymer sirolimus-eluting stent (Orsiro SES, Biotronik AG), the generalizability of the study results remains unclear in the Asian population. We sought to evaluate the clinical outcomes of the Orsiro SES in unselected Thai population. Methods: The Thailand Orsiro registry was a prospective, open-label clinical study evaluating all patients with obstructive coronary artery disease implanted with Orsiro SES. The primary endpoint was target lesion failure (TLF) at 12 months. TLF is defined as a composite of cardiac death, target vessel myocardial infarction (TVMI), emergent coronary artery bypass graft (CABG), and clinically driven target lesion revascularization (CD-TLR). Patients with diabetes, small vessels (≤ 2.75 mm), chronic total occlusions (CTOs), and acute myocardial infarction (AMI) were pre-specified subgroups for statistical analysis. Result: A total of 150 patients with 235 lesions were included in the analysis. Half of the patients (53.3%) presented with AMI, and 24% had diabetes. Among 235 lesions, 93(39.4%) were small vessels, and 24(10.2%) were chronic total occlusions. The primary endpoint, TLF at 12 months, occurred in eight patients (5.3%), predominately caused by cardiac death. By contrast, the incidences of TVMI and CD-TLR were null. The outcomes in pre-specified subgroup were not different from the overall population (all p > 0.05). One definite late stent thrombosis(0.7%) was incidentally observed during primary percutaneous coronary intervention to the non-target vessel. Conclusion: The safety and efficacy of the ultrathin strut sirolimus-eluting stent in unselected cases are confirmed in the Thailand Orsiro registry. Despite the high proportion of pre-specified high-risk subgroups, the excellent stent performance was consistent with the overall population. Trial Registration TCTR20190325001.