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Submitted: 16 Jan 2021
Accepted: 30 Apr 2021
ePublished: 19 May 2021
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J Cardiovasc Thorac Res. 2021;13(2): 162-168.
doi: 10.34172/jcvtr.2021.31

Scopus ID: 85106453670
  Abstract View: 426
  PDF Download: 174

Original Article

Two-year safety and efficacy of Indigenous Abluminus Sirolimus Eluting Stent. Does it differ amongst diabetics? – Data from en-ABLe- REGISTRY

Kamal Sharma 1* ORCID logo, Sameer Dani 2, Devang Desai 3, Prathap Kumar 4, Nirav Bhalani 5, Apurva Vasavada 6, Rutvik Trivedi 7

1 Department of Cardiology, UNMICRC, BJ Medical College, Ahmedabad (Gujarat), India
2 Apollo Hospitals Ahmedabad and Limsar, Ahmedabad (Gujarat), India
3 Unicare Hospital, Mahavir Hospital, Surat (Gujarat) India
4 ESIC Hospital Kollam and Meditrina Hospital, Kerala, India
5 Rhythm Hopsital and Sunshine Global, Vadodara (Gujarat), India
6 Tristar Hopsital and Care Hopsitals, Surat(Gujarat), India
7 Zydus Hospital, Anand (Gujarat), India

Abstract

Introduction: To evaluate the efficacy/safety profile of the Abluminus DES+ over 2-years follow-up in the “real-world” scenario in diabetics as compared to non-diabetics.
Methods: In prospective, all-comers, open-label registry conducted at 31 sites, patients were analyzed for 1 & 2-year outcomes with the primary endpoint defined as 3P-MACE of CV death, target vessel related myocardial infarction (TV-MI), ischemia-driven target lesion revascularization (TLR)/target vessel revascularization (TVR) apart from Stent thrombosis (ST).
Results: Of 2500 patients of PCI with 3286 Abluminus-DES+, 1641 (65.64%) were non-diabetics while859 (34.36%) were diabetics. The 3-P MACE for the cohort at 1 & 2 years were 2.9%, and 3.16%; TLR/TVR - 1.4% at both the intervals for 2493 patients at 2 yrs. follow-up. TV-MI & ST were 0.36% and0.56% at 1st and 2nd year respectively. The 3P-MACE was lower in non-diabetics at 1 & 2 years (2.3%vs 4.2%; 2.4% vs 4.7% respectively). For components of MACE, CV mortality (0.9 vs 1.9% at 1 yr ; 1.0vs 2.1% at 2 years) was significant (P < 0.05) while TLR (1.1 vs 1.9% at 1 yr. & 1.1 vs 2.1% at 2 yrs.) and TV-MI (0.9 vs 1.9% at 1 yr. & 1 vs 2.1% at 2 years) were similar for diabetics and non-diabetics so was ST (P > 0.05).
Conclusion: Abluminus-DES+ showed excellent 2-year safety and efficacy with low 3-P MACE which was higher in diabetics driven by higher CV death but similar TLR, TV-MI and ST.
Keywords: Percutaneous Coronary, Interventions, Sirolimus Eluting Stent, Diabetes Mellitus, Abluminus DES+
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