STOP-IC: Cilostazol Improves Angiographic Restenosis for Femoropopliteal Lesions After Stenting

MIAMI BEACH, FLA.—Patients with femoropopliteal lesions who receive 12 months of cilostazol after endovascular stenting experience restenosis rates 50% lower than those in patients who do not receive the drug.

Hiroyoshi Yokoi, MD, of Kansai Rosai Hospital Cardiovascular Center, presented findings at TCT 2012 from the STOP-IC trial, which examined whether cilostazol can reduce binary restenosis after endovascular therapy in patients with symptomatic leg ischemia.

The prospective, multi-center, open-label trial was conducted in 17 centers in Japan. Patients were randomly assigned aspirin/ticlopidine or aspirin, ticlopidine and cilostazol, then treated with endovascular stenting. Both groups were taken off ticlopidine at the 1-month mark, and either aspirin alone or aspirin and cilostazol was continued up to 12 months.

The primary endpoint of angiographic restenosis at 12 months verified by an independent core lab was significantly lower in the cilostazol group, whether ascessed by per-protocol or intention-to-treat analysis (see Figure).

The secondary endpoint of 12-month per-protocol restenosis assessed by angiography or duplex was 19% of 93 patients in the cilostazol group and 41% of 97 patients in the non-cilostazol group (P=.001). These results were similar to those observed in the intention-to-treat analysis. The differences were not apparent at 3 or 6 months.

At 1 year, cilostazol patients showed a lower rate of TLR, while other clinical outcomes including bypass conversion, stent fracture, amputation and mortality were equivalent (see Table).

A total of eleven patients died during follow-up. Subanalysis showed that cilostazol was effective in the prevention of restenosis across multiple subgroups.

“We emphasize that cilostazol therapy should be a first-line therapy for preventing restenosis after superficial femoral artery stent implantation,” Yokoi said. He added that late clinical failure, especially angiographic restenosis, is an important concern with high restenosis rate, and while cilostazol therapy after endovascular stenting for femoropopliteal lesions may improve outcomes, it has been unclear whether the drug can reduce angiographic restenosis after such therapy.

Study details

Eligibility criteria included Rutherford classification 2-4 with de novo femoropopliteal lesions presenting >50% stenosis by angiographic follow-up. Baseline lesion characteristics such as TASC II classification and reference vessel diameter were similar between the groups. Other baseline data indicated statin treatment in about 35% of patients, diabetes in 56% and end-stage renal disease in 16%. Baseline procedural characteristics also were similar.