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Efficacy of CilostAzol for Below-the-Knee Artery Disease after Balloon AnGioplasty in PatiEnts with Severe Limb Ischemia (CABBAGE Trial).
- Source :
-
Annals of vascular surgery [Ann Vasc Surg] 2017 Nov; Vol. 45, pp. 22-28. Date of Electronic Publication: 2017 Jun 06. - Publication Year :
- 2017
-
Abstract
- Background: Optimal medical therapy after endovascular therapy in patients with critical limb ischemia (CLI) remains unclear. Therefore, we investigated whether cilostazol reduce restenosis after balloon angioplasty for infrapopliteal lesions in CLI patients.<br />Methods: This study was performed as a multicenter, prospective, randomized, open-label, blinded-end point study with independent angiographic core laboratory adjudication. Sixty patients were eligible and 53 patients were enrolled and allocated. The primary end point was 3-month angiographic restenosis. The main secondary end points included major adverse limb event (MALE defined as requirement of any reintervention or major amputation), perioperative complications, major amputation, all-cause death, and hemorrhagic events.<br />Results: A total of 53 patients were randomized and all received their allocated intervention. Two patients in the cilostazol plus aspirin group and 1 in the aspirin group did not undergo any angioplasty for infrapopliteal stenotic lesions, and therefore were excluded from analysis. Finally, 38 vessels in 25 patients in the cilostazol plus aspirin group and as many cases in the aspirin group were included in the analysis. There were no significant differences in baseline characteristics between the 2 groups. The 3-month restenosis rate was 82% in the cilostazol + aspirin group and 81% in the aspirin group, with no significant difference (P = 0.91). The MALE rate was 11% in the cilostazol plus aspirin group and 8% in the aspirin group (P = 0.73). In addition, no significant difference was observed in any secondary points.<br />Conclusions: Cilostazol did not reduce 3-month angiographic restenosis after balloon angioplasty for below-the-knee lesion in CLI patients.<br /> (Copyright © 2017 Elsevier Inc. All rights reserved.)
- Subjects :
- Aged
Aged, 80 and over
Amputation, Surgical
Angiography
Cardiovascular Agents adverse effects
Cilostazol
Female
Humans
Ischemia diagnosis
Ischemia mortality
Ischemia physiopathology
Japan
Limb Salvage
Male
Middle Aged
Peripheral Arterial Disease diagnosis
Peripheral Arterial Disease mortality
Peripheral Arterial Disease physiopathology
Prospective Studies
Recurrence
Severity of Illness Index
Tetrazoles adverse effects
Time Factors
Treatment Outcome
Angioplasty, Balloon adverse effects
Angioplasty, Balloon mortality
Cardiovascular Agents therapeutic use
Ischemia therapy
Leg blood supply
Peripheral Arterial Disease therapy
Tetrazoles therapeutic use
Subjects
Details
- Language :
- English
- ISSN :
- 1615-5947
- Volume :
- 45
- Database :
- MEDLINE
- Journal :
- Annals of vascular surgery
- Publication Type :
- Academic Journal
- Accession number :
- 28600024
- Full Text :
- https://doi.org/10.1016/j.avsg.2017.05.029