PURPOSE: To evaluate the role of orbital atherectomy in calcified infrapopliteal arteries in patients with critical limb ischemia compared to balloon angioplasty (BA) alone. METHODS: A randomized multicenter study was undertaken to evaluate short and 1-year outcomes in 50 patients (32 men; mean age 71 years, range 40-90) with confirmed calcified lesions using 1∶1 randomization to the Diamondback 360° Orbital Atherectomy System followed by BA vs. BA alone. All patients had severe (≥50% stenosis) peripheral artery disease (Rutherford classification 4-6) in the popliteal, tibial, and/or peroneal arteries. The primary endpoint was defined as restoration of a normal lumen (residual stenosis ≤30%) with no bailout stenting or dissection types C through F. Scheduled follow-up visits were conducted according to a common protocol at 1, 6, and 12 months. RESULTS:Procedural success was 93.1% (27/29 lesions) for atherectomy + BA patients and 82.4% (28/34 lesions) for BA alone (p = 0.27). Bailout stenting was needed in 2 (6.9%) of the 29 atherectomy + BA lesions and in 5 (14.3%) of the 35 BA-treated lesions (p = 0.44). At 1 year, there were no amputations in either group related to the index procedure. Estimates for freedom from target vessel revascularization and all-cause mortality were 93.3% and 100% in the atherectomy + BA group vs. 80.0% (p = 0.14) and 68.4% (p = 0.01) in the BA group, respectively. Proportional hazard models evaluating survival time vs. status of residual stenosis determined a hazard ratio for major adverse events of 5.6 for patients with an acute post-procedure residual stenosis >30% (p = 0.01). CONCLUSION: Debulking with orbital atherectomy appeared to increase the chance of reaching a desirable angioplasty result, with less acute need for bailout stenting and a higher procedure success. A negative association between procedure success and risk of serious adverse outcomes should encourage larger confirmatory studies.
RCT Entities:
PURPOSE: To evaluate the role of orbital atherectomy in calcified infrapopliteal arteries in patients with critical limb ischemia compared to balloon angioplasty (BA) alone. METHODS: A randomized multicenter study was undertaken to evaluate short and 1-year outcomes in 50 patients (32 men; mean age 71 years, range 40-90) with confirmed calcified lesions using 1∶1 randomization to the Diamondback 360° Orbital Atherectomy System followed by BA vs. BA alone. All patients had severe (≥50% stenosis) peripheral artery disease (Rutherford classification 4-6) in the popliteal, tibial, and/or peroneal arteries. The primary endpoint was defined as restoration of a normal lumen (residual stenosis ≤30%) with no bailout stenting or dissection types C through F. Scheduled follow-up visits were conducted according to a common protocol at 1, 6, and 12 months. RESULTS: Procedural success was 93.1% (27/29 lesions) for atherectomy + BA patients and 82.4% (28/34 lesions) for BA alone (p = 0.27). Bailout stenting was needed in 2 (6.9%) of the 29 atherectomy + BA lesions and in 5 (14.3%) of the 35 BA-treated lesions (p = 0.44). At 1 year, there were no amputations in either group related to the index procedure. Estimates for freedom from target vessel revascularization and all-cause mortality were 93.3% and 100% in the atherectomy + BA group vs. 80.0% (p = 0.14) and 68.4% (p = 0.01) in the BA group, respectively. Proportional hazard models evaluating survival time vs. status of residual stenosis determined a hazard ratio for major adverse events of 5.6 for patients with an acute post-procedure residual stenosis >30% (p = 0.01). CONCLUSION: Debulking with orbital atherectomy appeared to increase the chance of reaching a desirable angioplasty result, with less acute need for bailout stenting and a higher procedure success. A negative association between procedure success and risk of serious adverse outcomes should encourage larger confirmatory studies.
Authors: Bright Benfor; Kavya Sinha; Christof Karmonik; Alan B Lumsden; Trisha L Roy Journal: J Cardiovasc Transl Res Date: 2022-09-14 Impact factor: 3.216
Authors: Caitlin W Hicks; Courtenay M Holscher; Peiqi Wang; Chen Dun; Christopher J Abularrage; James H Black; Kim J Hodgson; Martin A Makary Journal: JACC Cardiovasc Interv Date: 2021-03-22 Impact factor: 11.075
Authors: Anna Franzone; Marco Ferrone; Giuseppe Carotenuto; Andreina Carbone; Laura Scudiero; Federica Serino; Fernando Scudiero; Raffaele Izzo; Raffaele Piccolo; Savio Saviano; Bruno Amato; Cinzia Perrino; Bruno Trimarco; Giovanni Esposito Journal: BMC Surg Date: 2012-11-15 Impact factor: 2.102