Key result
In patients receiving the Abluminus DES+, the 2-year rate of 3P-MACE was significantly higher in diabetics compared to non-diabetics (4.7% vs 2.4%, p=0.002), driven by cardiovascular mortality.
Why the study?
The study evaluated the 2-year efficacy and safety profile of the Abluminus DES+ in real-world diabetics compared to non-diabetics.
Does the efficacy and safety of the Abluminus sirolimus-eluting stent differ between diabetic and non-diabetic patients undergoing PCI?
Cohort (n=2,500)
Open-label
Yes
Does the efficacy and safety of the Abluminus sirolimus-eluting stent differ between diabetic and non-diabetic patients undergoing PCI?
The Abluminus sirolimus-eluting stent demonstrated low overall 2-year MACE rates; although diabetics had higher MACE driven by cardiac death, their rates of target lesion revascularization and stent thrombosis were comparable to non-diabetics.
May warrant closer surveillance for cardiac death in diabetics post-PCI; leaves open randomized confirmation of Abluminus stent performance across glycemic status.
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.
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Sharma et al. (2021) conducted a cohort in Coronary artery disease requiring percutaneous coronary intervention (n=2,500). Diabetes Mellitus vs. Non-diabetics was evaluated on 3-point major adverse cardiac events (3P-MACE) at 2 years (p=0.002). In patients receiving the Abluminus DES+, the 2-year rate of 3P-MACE was significantly higher in diabetics compared to non-diabetics (4.7% vs 2.4%, p=0.002), driven by cardiovascular mortality.
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