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20.06.2020 | Original Research | Ausgabe 8/2020 Open Access

Diabetes Therapy 8/2020

Long-Term Cilostazol Treatment and Predictive Factors on Outcomes of Endovascular Intervention in Patients with Diabetes Mellitus and Critical Limb Ischemia

Zeitschrift:
Diabetes Therapy > Ausgabe 8/2020
Autoren:
Chiu-Yang Lee, Tao-Cheng Wu, Shing-Jong Lin
Wichtige Hinweise

Electronic Supplementary Material

The online version of this article (https://​doi.​org/​10.​1007/​s13300-020-00860-8) contains supplementary material, which is available to authorized users.

Digital Features

To view digital features for this article go to https://​doi.​org/​10.​6084/​m9.​figshare.​12453116.

Abstract

Introduction

Despite improvements in endovascular interventions and multidisciplinary approaches, improving clinical outcomes and increasing limb salvage have become increasingly challenging. This prospective study investigated the associations of cilostazol treatment with clinical outcomes and predictive factors in patients with diabetes mellitus (DM) and critical limb ischemia (CLI) after endovascular revascularization of the affected angiosome.

Methods

In this study, 172 consecutive patients with CLI (Fontaine levels III–IV) received cilostazol treatment after successful endovascular intervention according to the angiosome concept, and their primary patency rates and cardiovascular and amputation events during a 24-month follow-up period were assessed.

Result

The 24-month primary patency rate, mortality rate, and amputation rate were better in the patients under long-term cilostazol treatment (P < 0.001, P = 0.029, and P = 0.014). Weighted multivariate Cox analyses with a propensity scoring-based method showed that long-term cilostazol treatment [hazard ratio (HR) 0.2, 95% confidence interval (CI) 0.11–0.36, P < 0.001], direct revascularization (DR) (HR 0.46, 95% CI 0.28–0.74, P = 0.002), and supervised exercise (HR 0.4, 95% CI 0.24–0.66, P < 0.001) were independently associated with primary patency. Patients with lower-extremity amputation (LEA) had a higher risk of coronary artery disease (CAD) and mortality. Cellulitis and neuropathy were independently associated with LEA events (cellulitis: HR 2.89, 95% CI 1.66–5.05, P < 0.001; neuropathy: HR 2.2, 95% CI 1.31–3.7, P = 0.003).

Conclusion

Our results showed that patients with DM who received cilostazol treatment for more than 3 months had significantly better outcomes and decreased amputation and mortality rates after DR, and cellulitis and neuropathy were highly associated with the risk of limb loss. A large-scale randomized trial should be conducted in the future to confirm these results.

Trial Registration

Taipei Veterans General Hospital (TVGH) IRB no. 2013-08-020B. Registered 30 August 2013.
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