Amputation-free survival in patients treated with critical limb ischemia - 21/02/23
, Joël Constans 1, 2, Carine Boulon 1, Caroline Caradu 1, François-Xavier Labépie 3, 6, Alessandra Bura-Rivière 3, 6, Lucie Chastaingt 4, Philippe Lacroix 4, Julien Bezin 1, 2, 5, Antoine Pariente 1, 2, 5Résumé |
Introduction & objectifs |
Iloprost has been proposed as an alternative to amputation when revascularization was unsuccessful or not possible for critical limb ischemia (CLI) patients. Nevertheless, there is limited evidence of its benefit in CLI patients. Our main objective was to evaluate the effectiveness of iloprost in CLI patients; the secondary objective was to evaluate its safety.
Méthodologie |
We performed a cohort study using data collected prospectively from the French multicentre COPART (COhorte des Patients ARTériopathes) registry of patients hospitalized with CLI from 01/10/2006 to 31/12/2020. Patients exposed to iloprost were matched with up to three unexposed patients according to age, sex and propensity score (PS) for exposure to iloprost. The main outcome combined the occurrence of all-cause death and major amputation; survival was assessed over 1 year using Kaplan-Meier Curve and multivariate Cox models. The safety analysis outcome was major adverse cardio-vascular events (MACE); its association to iloprost use was estimated using a logistic regression model.
Résultats |
Among the 1850 COPART patients included in the study, 201 were exposed to iloprost (71.6% men, median age : 72 years vs. 72.13% men, median age: 75 years for unexposed). One hundred and forty-six exposed patients were matched to 397 unexposed patients. Regarding effectiveness analysis, 14 major amputations and 24 deaths occurred in exposed patients (26%) vs. 33 and 46 respectively in unexposed patients (20%). unadjusted hazard ratio (HR) for the association to iloprost was of 1.49 (95% Confidence Interval: 1.01–2.2) and adjusted HR of 1.46 (0.98–2.18). Regarding safety analysis, 21 (10.7%) exposed patients experienced MACE vs. 146 (9.41%) in the unexposed group. The association to iloprost was non-significant (unadjusted Odds Ratio [OR]: 1.17 [0.72-1.90], adjusted OR: 1.23 [0.72-2.11]).
Discussion |
The risk of major amputation and all-cause death was increased in the iloprost group. Iloprost is assumed to improve circulation by dilating systemic vascular beds but its pharmacodynamic effects in serious patients as CLI patients is uncertain.
Conclusion |
Our study did not evidence benefit of iloprost treatment in CLI in real-world setting and do not support the use of iloprost in CLI patients.
Le texte complet de cet article est disponible en PDF.Mots clés : Critical limb ischemia, Iloprost
Plan
Vol 48 - N° S
P. S32 - mars 2023 Retour au numéro
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