Aim: Cilostazol is a phosphodiesterase III inhibitor with a firm evidence base for use in intermittent claudication. We aimed to assess outcomes using cilostazol in critical limb ischemia (CLI).
Methods: Prospective consecutive observational study of local practice. Twenty-three patients (26 lower limbs) with CLI defined by the TASC II Inter-Society Consensus for the Management of Peripheral Arterial Disease. None were considered suitable for radiological or surgical revascularisation. Oral cilostazol starting at 100 mg twice daily was used in combination with best medical therapy (BMT).
Results: Mean follow-up time was 13.7 months (median 11.8 months). One patient died (5% of patients). There was one major amputation (4% of limbs). Six limbs (26%) improved, 5 reverting to a diagnosis of intermittent claudication and 1 becoming asymptomatic. The remaining 15 limbs remained ischemic, with some clinical improvement and without major amputation.
Conclusions: In this study, there was one major amputation and one death in a mean period of a year following a diagnosis of non-reconstructible limb ischemia. The use of cilostazol was associated with marked improvement in 26%, and may have at least deferred major amputation in those with ongoing ischaemia. Further study using cilostazol in this context is recommended.