Abstract
BackgroundDespite 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.MethodsThe 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.ResultA 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.ConclusionThe 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.
Highlights
Despite numerous studies supporting the outperformance of ultrathin-strut bioresorbable polymer sirolimus-eluting stent (Orsiro Sirolimus eluting stent (SES), Biotronik AG), the generalizability of the study results remains unclear in the Asian population
Despite the high proportion of pre-specified high-risk subgroups, the excellent stent performance was consistent with the overall population
Patients characteristics A total of 150 patients were included between March 2019 and January 2020 (Fig. 1)
Summary
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. One of the remarkable DES modification was the reduction of strut thickness with the preservation of radial strength [2]. The Orsiro bioresorbable polymer sirolimus-eluting stent (Orsiro SES) (Biotronik AG, Bülach, Switzerland) is one of the ultrathin stents platforms. The active coating is a layer of bioresorbable drug-polymer that released sirolimus. Orsiro SES has shown a superior reduction of TLF and late or very late stent thrombosis at the three-year followup compared with durable-polymer everolimus-eluting stents [9]. The real-world clinical performance of Orsiro SES showed favorable medium-(17) and long-term [18, 19] clinical outcomes
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