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Abstract

Objective- Aim of study was to evaluate safety and efficacy of abluminal Mitigator DES+ Sirolimus Eluting Stent (Envision Scientific, Surat, India) incorporating novel technology of fusion coating of bioresorbable polymer on both abluminal surface of stent and exposed parts of balloon among real world patients specially focusing younger patients ( < 35 years). Method- 1293 patients received Mitigator DES+ at LPS Institute of Cardiology, Kanpur, India. Primary outcome was target lesion failure (TLF)- composite of cardiovascular death, target vessel myocardial infarction (TVMI), and target lesion revascularization (TLR) and secondary end points including peri-procedural device failure (failure of stent delivery, change of stent, stent fracture), target vessel failure (TVF), and patient oriented composite end point (POCE)- composite of all deaths, MI, and revascularization and stent thrombosis (ST) at 1-year follow-up. Result- Younger population comprised of 374(29%) patients. Various indications of interventions were STEMI (n=614, 47.4%), NSTEMI (n=416, 32.2%), UA (n=161, 12.5%), and CCS (n=102, 7.9%). TLF at 1 year in overall population was 3.5% which was driven by TVMI and TLR in 1.3% and 1.1% patients respectively. POCE was observed in 9.5% mainly contributed by any revascularization (3.9%). Failure of stent delivery (1.1%) and edge dissection (0.5%) caused stent failure (2.2%). Definite and probable ST was observed in 1% and 0.8% patients respectively. Young patients showed insignificantly lower TLF, TVF, ST and POCE and significantly lower device failure (1.3% vs. 2.6%, p=0.04) when compared to patients >35 years. Conclusion- Mitigator DES+™ is safe among real world patients especially young population.

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Creative Commons Attribution-Noncommercial-No Derivative Works 4.0 License
This work is licensed under a Creative Commons Attribution-Noncommercial-No Derivative Works 4.0 License.

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