A Pilot Study of Cilostazol to Improve Patient Centered Outcomes after Open or Endovascular Revascularization for Peripheral Artery Disease
Christopher E. Yi, MD1, Kelly Kempe, MD1, Thomas E. Brothers, MD2, Donna R. Keith, MSP, MHA, CCRP1, Tim Craven1, Gabriela Velazquez-Ramirez, MD1, Justin Hurie, MD1, Randolf Geary, MD1, Matthew Edwards, MD1, Nitin Garg, MBBS, MPH1.
1Wake Forest School of Medicine, Winston-Salem, NC, USA, 2Medical University of South Carolina, Charleston, SC, USA.
Cilostazol is used in peripheral arterial disease (PAD) patients to reduce claudication symptoms. Multiple studies demonstrate Cilostazol can improve patency after endovascular interventions. Cilostazol was also shown to be equivalent to warfarin anticoagulation in a small, randomized trial for femoral-popliteal bypass for graft patency. To date, no studies have been conducted in North America to estimate the endpoints of patient quality of life (QOL) and patency with use of Cilostazol after any lower extremity revascularization. We hypothesize that Cilostazol would improve QOL and stent/graft patency after infrainguinal interventions and planned a pilot study to test the feasibility of performing such a trial.
We conducted a single center, randomized, prospective, open-label, non-placebo controlled pilot study. Patients that met the inclusion criteria were randomized to Cilostazol or non-Cilostazol treatment groups. Preoperative and 6 week post-operative QOL evaluations were measured using the EQ-5D, EACH-Qc, and Visual Analog Scale scoring systems. Primary patency was evaluated with ankle brachial indices and/or duplex ultrasound. Twenty patients were enrolled, from February 2015 to March 2017.
Nineteen patients were included in analysis, 10 in Cilostazol group and 9 in non-Cilostazol group. There was a 2:1 ratio of males to females, with mean age of 63. Comorbidities included diabetes (47%), tobacco use (58%), 33% had prior revascularization and 26% underwent prior amputation. There was no difference in EQ-5D and EACH-Q scores between the treatment groups. Non-Cilostazol treatment group showed significant (p=0.04) improvement in Visual Analog scale. Lastly, there were 3 patency failures in the Cilostazol group and 2 patency failures in the non-Cilostazol group.
Cilostazol is not associated with any improvement in quality of life or patency after infrainguinal interventions for PAD. A better powered trial is feasible if there are no competing PAD trials to test this hypothesis further.
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