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STOP-IC: Cilostazol safe, effective in endovascular treatment
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Cilostazol treatment is safe and effective in patients with femoropopliteal disease undergoing endovascular treatment, according to results published in the Journal of Endovascular Therapy.
“Several studies have reported favorable primary patency after endovascular therapy using self-expanding nitinol stents for femoropopliteal occlusive disease compared with balloon angioplasty,” Yoshimitsu Soga, MD, PhD, from the department of cardiology at Kokura Memorial Hospital in Kitakyushu, Japan, and colleagues wrote in the study background. “In recent years, advances in devices and improved therapeutic outcomes have expanded the applicability of [endovascular therapy] to more patients. However, post-[endovascular therapy] restenosis remains a major limitation.”
Researchers for the STOP-IC trial investigated the midterm safety and effectiveness of cilostazol treatment in adults with claudication undergoing endovascular therapy by enrolling 200 patients treated for femoropopliteal disease at 13 CV centers in Japan between March 2009 and April 2011.
Patients were randomly assigned 1:1 to oral aspirin with or without cilostazol.
Seven patients in the cilostazol group and two patients in the no-cilostazol group were withdrawn from the study without undergoing endovascular treatment, leaving 93 patients in the cilostazol group and 98 patients in the no-cilostazol group for follow-up analysis.
The primary outcome of STOP-IC was primary patency, and the secondary outcome measures were freedom from clinically driven target lesion revascularization and overall survival.
The researchers used an intension-to-treat analysis using the Kaplan-Meier method to analyze outcomes, and estimates were compared with the log-rank test.
At a median follow-up of 38.1 months, among the 93 patients in the cilostazol cohort, seven died and 26 withdrew from administration 1 year after the endovascular procedure. Discontinuation of cilostazol was not a significant factor for restenosis.
At 3 years, there was a higher primary patency rate among those in the cilostazol group vs. those in the no-cilostazol group (69% vs. 54%; P = .026).
Rates of freedom from clinically driven TLR were also higher among patients in the cilostazol group at 3 years (78% vs. 63%; P = .014), but overall survival estimates did not differ between the two cohorts (P = .95).
According to the researchers, whether restenosis 1 year after endovascular therapy would increase after discontinuation of cilostazol remains unclear, and further research is needed.
“In [the] future, it will be necessary to clarify the role of cilostazol treatment in PAD patients who have undergone [endovascular therapy],” Soga and colleagues wrote. “Further discussions will be necessary regarding the patients who generally are considered to have a high risk of restenosis, such as those with diabetes, chronic total occlusion, dialysis, long lesions and small vessel diameter.” − by Dave Quaile
Disclosures: The STOP-IC trial was funded by the Association for Establishment of Evidence in Interventions. One author reports consultancy relationships with Kaneka Medix Corp. and St. Jude Medical Japan Co. Ltd.
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