1. Two-year safety and efficacy of Indigenous Abluminally Sirolimus Eluting stent. Does it differ amongst diabetics? -- Data from en-ABL e-REGISTRY.
- Author
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Sharma, Kamal, Dani, Sameer, Desai, Devang, Kumar, Prathap, Bhalani, Nirav, Vasavada, Apurva, and Trivedi, Rutvik
- Subjects
CARDIOVASCULAR disease related mortality ,DRUG delivery systems ,DRUG efficacy ,PATIENT aftercare ,RAPAMYCIN ,DRUG-eluting stents ,DIABETES ,MYOCARDIAL infarction ,TREATMENT effectiveness ,MYOCARDIAL revascularization ,DESCRIPTIVE statistics ,PATIENT safety - 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 vesselrelated 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 while 859 (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 years. follow-up. TV-MI & ST were 0.36% and 0.56% 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 ; 1.0 vs 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. [ABSTRACT FROM AUTHOR]
- Published
- 2021
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