Diabetes Is Associated With Decreased Limb Survival in Patients With Critical Limb Ischemia: Pooled Data From Two Randomized Controlled Trials.
Although never assessed prospectively, diabetes mellitus (DM) is assumed to negatively affect the outcomes of critical limb ischemia (CLI). DM was highly prevalent in two recently conducted randomized controlled trials in CLI patients, the PADI (Percutaneous Transluminal Balloon Angioplasty [PTA] and Drug Eluting Stents for Infrapopliteal Lesions in Critical Limb Ischemia) and JUVENTAS (Rejuvenating Endothelial Progenitor Cells via Transcutaneous Intra-Arterial Supplementation) trials. To determine the implications of DM in a population of patients with infrapopliteal CLI, clinical outcomes were compared in patients with and without DM.



Individual data from patients with CLI (Rutherford category ≥4) were pooled. Patients were considered to have DM when this diagnosis was reported in the hospital electronic medical records. Rates of major amputation (above ankle level) and major events (major amputation or death) were compared between CLI patients with and without DM. Hazard ratios (HRs) were calculated.



Of a total of 281 patients, DM was present in 49.1%. The major amputation rate at 5 years of follow-up was higher in patients with DM than in patients without DM (34.1% vs. 20.4%, P = 0.015). The major event and death rate did not differ. The unadjusted HR of DM for the major amputation risk was 1.87 (95% CI 1.12-3.12). Model factors with significant HRs in the multivariate analysis were baseline Rutherford category (HR 1.95; 95% CI 1.24-3.06) and ankle-brachial index (ABI) >1.4 (HR 2.78; 95% CI 1.37-5.64).



CLI patients with DM are at a significantly higher risk of major amputation than CLI patients without DM. This increased risk is associated with a higher prevalence of baseline ABI >1.4 and more severe ischemia at initial presentation in patients with DM.
Department of Radiology, Haga Teaching Hospital, The Hague, the Netherlands m.spreen@hagaziekenhuis.nl.
Marlon I
MI
Spreen
Department of Nephrology & Hypertension, University Medical Center Utrecht, Utrecht, the Netherlands.
Hendrik
H
Gremmels
Department of Vascular Surgery, University Medical Center Utrecht, Utrecht, the Netherlands.
Martin
M
Teraa
Department of Radiology, University Medical Center Utrecht, Utrecht, the Netherlands.
Ralf W
RW
Sprengers
Department of Nephrology & Hypertension, University Medical Center Utrecht, Utrecht, the Netherlands.
Marianne C
MC
Verhaar
Department of Vascular Surgery, Haga Teaching Hospital, The Hague, the Netherlands.
Randolph G
RG
Statius van Eps
Department of Vascular Surgery, St. Antonius Hospital, Nieuwegein, the Netherlands.
Jean-Paul P M
JP
de Vries
Department of Radiology, University Medical Center Utrecht, Utrecht, the Netherlands.
Willem P Th M
WP
Mali
Department of Radiology, Haga Teaching Hospital, The Hague, the Netherlands.
Hans
H
van Overhagen
D000368:Aged; D000369:Aged, 80 and over; D000671:Amputation, Surgical / Q000401:mortality; D055109:Ankle Brachial Index; D003920:Diabetes Mellitus / Q000401:mortality* / Q000473:pathology; D004311:Double-Blind Method; D023381:Endpoint Determination; D005121:Extremities / Q000473:pathology*; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007511:Ischemia / Q000401:mortality* / Q000473:pathology; D008297:Male; D008875:Middle Aged; D015999:Multivariate Analysis; D011379:Prognosis; D016016:Proportional Hazards Models; D012307:Risk Factors; D016896:Treatment Outcome