One-year Outcomes of Biodegradable Polymer-coated Sirolimus-eluting Coronary Stent in Acute Coronary Syndrome - A Patient-level Pooled Analysis from Two Indian Registries.

Abstract

This pooled analysis was conducted to assess the clinical safety and performance of the Supra family (Sahajanand Medical Technologies Ltd., Surat, India) of sirolimus-eluting stents (SES) in patients with acute coronary syndromes (ACS) including ST segment elevation myocardial infarction (STEMI) from two real-world all-comers Indian registries at one-year. We evaluated 1824 patients with ACS who underwent percutaneous coronary intervention with the Supra family of SES from two real-world Indian registries (891 patients from T-Flex registry and 933 patients from Tetriflex real-world registry). The primary endpoint was the incidence of target lesion failure (TLF) defined as a composite of cardiac death, target vessel myocardial infarction (TV-MI), and target lesion revascularization (TLR) at one-year follow-up. The safety endpoint was stent thrombosis at one-year follow-up. Among a total of 1824 patients with ACS, 689 (37.8%) patients presented with STEMI. In ACS and STEMI groups, 47.6% and 41.8% patients had multi-vessel disease, respectively. Of 2128 lesions in ACS group, 76.7% lesions were type B2/C and 16.2% lesions were totally occluded. In the STEMI group, out of 784 treated lesions, 76.7% were type B2/C lesions and 21.9% were totally occluded. At one-year follow-up, incidence of TLF was 5.3% (cardiac death: 0.9%, TV-MI: 2.5%, TLR: 1.9%) in patients with ACS and 6.2% (cardiac death: 1.4%, TV-MI: 2.1%, TLR: 2.7%) in patients with STEMI. The one-year rate of definite/probable stent thrombosis were 0.3% and 0.7% in patients with ACS and STEMI, respectively. This patient-level pooled analysis provides evidence for the safe and effective use of the Supra family of SES in complex patient populations such as ACS and even in STEMI with favourable rates of TLF and stent thrombosis at one-year follow-up.