In patients with peripheral vascular disease (PVD), the presence of diabetes has been significantly associated with increased failure of critical lower limb ischemia (CLI) treatment, and higher incidence of amputation. This relationship has been attributed mainly to comorbidities and patient characteristics, concomitant peripheral neuropathy and marked microvascular alteration. Also, a high proportion of these patients have chronic renal disease (CRD).
Antithrombotic treatment and measures such as supervised exercise have been established as a fundamental pillar for the therapeutic management of this complex pathology. Current clinical recommendations include at least one month dual antiaggregation therapy (DAPT) with aspirin and clopidogrel after endovascular revascularization. However, little is known about the impact of DAPT on diabetic patients.
Cilostazol, an antiplatelet agent that selectively inhibits phosphodiesterase III, has shown sustained benefits in most claudication symptoms in patients with PVD. Recent systematic revisions have highlighted its beneficial effects on artery patency and limb related major adverse events (MALE) in diabetic patients.
This study aims at assessing the effect of a triple antiplatelet therapy (TAPT) with cilostazol on clinical events after endovascular revascularization in diabetic patients with PVD.
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The study used data from the K-VIS ELLA registry, which included patients over 20, with PVD, and excluded patients with acute lower limb ischemia, Buerger disease and prior peripheral revascularization.
Primary end point was MALE, with secondary end points including all-cause mortality, major and minor amputation, reintervention and major bleeding.
The analysis included 990 diabetic patients receiving antiaggregation after being treated for PVD, divided in groups TAPT (35.4%) and DAPT (64.6%).
Mean age was 68.7±8.7 years and 77% were men. Patients with TAPT generally presented more CAD and lower incidence of CRD; also lower ankle-brachial index and higher prevalence of total occlusion, the most common location being the femoropopliteal.
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At mean 499 day followup, there was lower MALE incidence in the TAPT group vs. DAPT (16.6% vs. 21.2%; log-rank P=0.045). However, after propensity score, no significant differences were found (16.6% vs. 19.4%; log-rank P=0.260). The TAPT group also showed a lower incidence of minor amputation both at global analysis and after propensity score. There were no differences in total mortality, major amputation, reintervention or major bleeding at followup.
At multivariable analysis, CRD, coronary artery disease and congestive cardiac failure were identified as independent predictors of MALE. A subanalysis was done according to clinical presentation, showing that patients with CLI treated with TAPT showed a tendency towards lower MALE incidence.
Conclusions
In conclusion, adding cilostazol to standard DAPT was associated to lower amputation rate in patients receiving endovascular treatment of PVD.
Outcomes showed in this registry with hard events such as MALE, might position cilostazol as part of the standard, beyond its well-known effect on claudication.
Dr. Omar Tupayachi.
Member of the Editorial Board of SOLACI.org.
Original Title: Effect of Cilostazol on Patients With Diabetes Who Underwent Endovascular Treatment for Peripheral Artery Disease.
Reference: Cha JJ, Cho JY, Lim S, Kim JH, Joo HJ, Park JH, Hong SJ, Lim DS, Kook H, Lee SH, Ko YG, Min PK, Lee JH, Yoon CH, Chae IH, Lee SW, Lee SR, Choi SH, Koh YS, Yu CW. Effect of Cilostazol on Patients With Diabetes Who Underwent Endovascular Treatment for Peripheral Artery Disease. J Am Heart Assoc. 2023 Jun 20;12(12):e027334. doi: 10.1161/JAHA.122.027334. Epub 2023 Jun 10. PMID: 37301738; PMCID: PMC10356016.
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