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Cilostazol improves outcomes in patients with PAD on hemodialysis
Patients with peripheral artery disease on hemodialysis had a significantly reduced risk for major adverse CV and limb outcomes when treated with cilostazol in addition to standard care, researchers reported in the Journal of Cardiology.
The analysis included data from 595 hemodialysis recipients with PAD who underwent successful endovascular treatment between 1999 and 2010. Patients were retrospectively grouped according to whether they had received 100 mg cilostazol twice daily for at least 1 month before treatment in addition to standard care (n = 249), or standard care alone (n = 346). Outcomes data were collected via chart review and patient interviews, with a median follow-up of 41 months.
The primary endpoint was MACE, including all-cause mortality, stroke and nonfatal MI after endovascular therapy. Incidence of major adverse limb events (MALE), including target lesion revascularization and major amputation, was the secondary endpoint.
Results from Kaplan-Meier analysis indicated significantly higher 10-year rates of freedom from MACE and MALE among cilostazol recipients (58.3% vs. 43.6%; HR = 0.57; 95% CI, 0.41-0.8 for MACE; 59.5% vs. 53.5%; HR = 0.63; 95% CI, 0.46-0.87 for MALE). Freedom from all-cause stroke also was significantly more common in the cilostazol group (82% vs. 74.3%; HR = 0.46; 95% CI, 0.24-0.88). The incidence rate of hemorrhagic stroke did not differ significantly according to cilostazol use (1.6% vs. 1.3%), Hideki Ishii, MD, PhD, of Nagoya University Graduate School of Medicine in Japan, and colleagues wrote.
After adjustment for propensity score, the rate of freedom from MACE was 58.6% among patients in the cilostazol group vs. 43.7% among controls (HR = 0.57; 95% CI, 0.41-0.79). Factors independently associated with MACE on multivariate analysis included cilostazol therapy (HR = 0.58; 95% CI, 0.41-0.83), prior stroke (HR = 1.79; 95% CI, 1.18-2.7) and the prevalence of ulcers or gangrene (HR = 1.54; 95% CI, 1.08-2.2). Cilostazol use also was significantly associated with reduced stroke risk (HR = 0.5; 95% CI, 0.26-0.96).
The rate of freedom from MALE remained higher in the cilostazol group after adjustment for propensity score (59.5% vs. 53.5% among controls; P = .0058). Results from multivariate analysis indicated that cilostazol (HR = 0.64; 95% CI, 0.46-0.88) and stent use (HR = 0.63; 95% CI, 0.46-0.86) significantly lowered MALE risk, whereas male sex (HR = 1.44; 95% CI, 1.01-2.07) and prevalence of ulcer or gangrene (HR = 1.73; 95% CI, 1.23-2.43) were associated with increased risk.
“Treatment with cilostazol improved long-term clinical outcomes, including the prevention of both stroke and all-cause mortality,” the researchers concluded. “We believe that administration of cilostazol may have substantial potential for improving outcomes due to its effect in preventing atherosclerotic events in [hemodialysis] patients.” – by Adam Taliercio
Disclosure: Ishii reports receiving lecture fees from Astellas Pharma, Daiichi Sankyo and Otsuka Pharma. Please see the full study for a list of all other researchers’ relevant financial disclosures.