This article is more than 5 years old. Information may no longer be current.
Cilostazol lowers restenosis rate after DES implant for femoropopliteal lesions
Click Here to Manage Email Alerts
In patients with femoropopliteal lesions, additional treatment with cilostazol after implantation of a drug-eluting stent is associated with significantly lower restenosis rates at 1 year, according to recent findings.
The study was a subanalysis of ZEPHYR, a prospective, multicenter study of femoropopliteal lesions treated with a paclitaxel-eluting stent (Zilver PTX, Cook Medical) between July 2012 and April 2013. For the present analysis, researchers assessed 399 patients (459 limbs, 475 lesions) who completed 1-year follow-up and maintained therapy with aspirin and thienopyridine, with (n = 93) or without cilostazol. Duplex ultrasonography (peak systolic velocity ratio > 2.4) or angiography (≥ 50 diameter stenosis) was used to evaluate restenosis rates at 1 year, and this outcome was compared in the groups with or without cilostazol. Intergroup differences were minimized through propensity matching. Propensity matching yielded 91 matched pairs.
The researchers defined the primary endpoint as the rate of restenosis at 12 months as assessed on duplex ultrasound imaging or follow-up angiography, with a tolerance of 62 months. Restenosis automatically included the need for any reintervention or major amputation ≤ 1 year. Major adverse limb events, defined as a major amputation or any reintervention, was the secondary endpoint.
There was a 76% prevalence of de novo lesions, and 15% of lesions were due to in-stent restenosis. The researchers found that 71% of the patients had diabetes, 31% were on dialysis and 29% had critical limb ischemia.
Restenosis lower
At 1 year, the cilostazol-treated group had a lower rate of restenosis vs. the patients not treated with cilostazol (31% vs. 51%; OR = 0.5; 95% CI, 0.3-0.8), according to the researchers.
The cilostazol group had a lower but not statistically lower 1-year incidence rate of major adverse limb events (20% vs. 30%; OR = 0.6; 95% CI, 0.3-1.1).
No major amputations occurred in either group, and all major adverse limb events in the matched population were driven by target lesion revascularization. As a result, the incidence rate of major adverse limb events was equal to the rate of clinically driven TLR, the researchers wrote.
Of the patients deemed restenosis-positive, 58% (95% CI, 43-73) of patients in the cilostazol-free group and 61% (95% CI, 43-80) in the cilostazol-treated group underwent repeat revascularization, with no significant difference found between the groups, according to the data.
Before propensity matching in the baseline population, there was no significant difference in the 1-year restenosis incidence between the cilostazol-treated group (20%; 95% CI, 13-29) and the cilostazol-free group (26%; 95% CI, 21-31). Moreover, there was no significant difference in the 1-year rate of major adverse limb events between the cilostazol-treated group (33%; 95% CI, 23-43) and the cilostazol-free group (42%; 95% CI, 37-47), the researchers wrote.
More study needed
“Even with the use of DES, triple-antiplatelet therapy, including cilostazol, definitely reduces restenosis after stenting for an [femoropopliteal] lesion rather than dual antiplatelet therapy,” they wrote. “Further investigation should be performed to estimate this theory in the real-world population with a proper method for establishing better treatment strategies for [femoropopliteal] disease.” – by Jennifer Byrne
Disclosure: The researchers report no relevant financial disclosures.
Click Here to Manage Email Alerts