Peer-Reviewed Journal Details
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Sultan, S,Hynes, N
2009
June
J Endovasc Ther
Five-Year Irish Trial of CLI Patients With TASC II Type C/D Lesions Undergoing Subintimal Angioplasty or Bypass Surgery Based on Plaque Echolucency
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critical limb ischemia subintimal angioplasty bypass grafting outcome analysis restenosis amputation complications cost effectiveness quality of life CRITICAL LIMB ISCHEMIA QUALITY-OF-LIFE PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY PERIPHERAL VASCULAR-DISEASE PALMAZ STENT PLACEMENT ENDOVASCULAR TREATMENT INFRAINGUINAL BYPASS REPORTING STANDARDS FUNCTIONAL OUTCOMES DIABETIC-PATIENTS
16
270
283
Purpose: To report a 5-year observational parallel group study comparing the effectiveness of subintimal angioplasty (SIA) to bypass grafting (BG) for treatment of TASC II type C/D lesions in the lower limb arteries of patients with critical limb ischemia (CLI).Methods: Of 1076 patients referred with PVD from 2002 to 2007, 206 SIAs in 190 patients (104 women; mean age 73 +/- 13 years) and 128 bypass grafts in 119 patients (77 men; mean lage 70 +/- 14 years) were enrolled in the study. All patients had Rutherford classification 4-6 ischemia manifested as rest pain and/or tissue loss. Primary endpoints were (1) survival free from amputation and (2) sustained clinical improvement [+2 Rutherford category and/or ABI increase >0.15 without target lesion revascularization (TLR)]. Secondary endpoints were major adverse events (MAE), the binary restenosis rate, freedom from TLR, and a special quality-adjusted life year (QALY) endpoint (Q-TWiST) that incorporated both length and quality of life to evaluate treatments. A cost analysis was also performed.Results: At 5 years, clinical improvement was sustained in 82.8% of the SIA group versus 68.2% of the BG patients (p=0.106). Five-year all-cause survival was similar for SIA (78.6%) and BG (80.1%; p=0.734), as was amputation-free survival (SIA 72.9% versus BG 71.2%; p=0.976). Hyperfibrinogenemia (p=0.009) and C-reactive protein (p=0.019) had negative effects on survival without amputation. Five-year freedom from binary restenosis rates were 72.8% for SIA versus 65.3% for BG (P=0.700). While the 5-year freedom from TLR rates (SIA 85.9% versus BS 72.1%, p=0.262) were not statistically significant, the risk of MAE (p0.05) and mean number of procedures (p=0.078) were similar.Conclusion: Five-year freedom from MAE was enhanced by 20% in the SIA group, with substantial cost reduction and better Q-TWiST. SIA is a minimally invasive technique that expands amputation-free and symptom-free survival. SIA is poised to bring about a paradigm shift in the management of CLI. J Endovasc Ther. 2009;16:270-283
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