Diabetes and Peripheral Vascular Disease: Old Drugs, New Evidence

This paper, recently published in JAHA, showed that patients with type 2 diabetes mellitus exhibiting lower-limb vascular disease benefit from combining cilostazol and clopidogrel.

Diabetes y enfermedad vascular periférica

Treatment for at least 6 months with clopidogrel (75 mg/QD) plus cilostazol (100 mg/BID) significantly reduces ischemic events—including stroke, infarction, and death from vascular causes—compared with clopidogrel monotherapy.

Adding cilostazol reduces ischemic events, but that is not all: it also improves the ankle‐brachial index and the walking distance without claudication. Last, but not least, adding cilostazol did not increase the risk of total bleeding, major bleeding, or life-threatening bleeding compared with the group that received clopidogrel alone.

In this open study, patients were randomized 1:1 to either continuing their clopidogrel monotherapy (391 patients) or to additionally receive cilostazol (403 patients).

Read also: New Valvular Heart Disease Guidelines with Key TAVI and Mitral Regurgitation Updates.

After a median follow-up of 27 months, there was a significant reduction in the primary endpoint—a composite of stroke, infarction, and death from cardiovascular causes—in the clopidogrel + cilostazol arm (hazard ratio [HR]: 0.468; 95% confidence interval [CI]: 0.252-0.870; p = 0.016).

This drug combination also reduced the rates for ischemic stroke and transient ischemic attack (HR: 0.38; 95% CI: 0.15-0.98; p = 0.046), ankle-brachial index, and pain-free walking distance (p < 0.001 for both).

There were no differences in bleeding, as defined by Bleeding Academic Research Consortium criteria.


Prescribing clopidogrel plus cilostazol in patients with type 2 diabetes mellitus with symptomatic lower-limb arterial disease lowers the risk of ischemic events and improves claudication symptoms, without increasing the bleeding risk, compared with clopidogrel monotherapy.

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Original Title: Efficacy and Safety of Adjunctive Cilostazol to Clopidogrel-Treated Diabetic Patients With Symptomatic Lower Extremity Artery Disease in the Prevention of Ischemic Vascular Events.

Reference: Kallirroi Kalantzi et al. J Am Heart Assoc. 2021;10:e018184.  DOI: 10.1161/JAHA.120.018184.

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