OBJECTIVE: This study compares treatment results of orbital atherectomy (OA) vs balloon angioplasty (BA) for calcified femoropopliteal (FP) disease. BA for calcified FP disease is associated with increased dissection rates and suboptimal results. OA is hypothesized to decrease these acute complications via lesion compliance change. METHODS:Fifty patients (65 lesions) with calcified FP disease were randomized to OA plus BA vs. BA alone and followed for 12 months. The primary endpoint was freedom from target lesion revascularization (TLR), including adjunctive stenting, or restenosis as evidenced by duplex ultrasound at 6 months. RESULTS:Mean maximum balloon pressure was 4.0 atm in the OA arm vs. 9.1 atm in the BA arm (P<.001). In subjects with residual stenosis >30%, the operator chose to stent 2/38 lesions (5.3%) in the OA arm vs 21/27 lesions (77.8%) in the BA arm (P<.001). Freedom from TLR (including adjunctive stenting) or restenosis was achieved in 77.1% of lesions in the OA group vs. 11.5% in the BA group (P<.001) at 6 months, and 81.2% vs. 78.3% at 12 months, excluding adjunctive stenting (P>.99). CONCLUSIONS: Compared to BA alone, OA plus BA yields better luminal gain by improving lesion compliance and decreases adjunctive stenting in the treatment of calcified FP disease. At 12 months, the occurrence of TLR or restenosis was similar in both groups despite the large disparity in stent usage at the time of initial treatment.
RCT Entities:
OBJECTIVE: This study compares treatment results of orbital atherectomy (OA) vs balloon angioplasty (BA) for calcified femoropopliteal (FP) disease. BA for calcified FP disease is associated with increased dissection rates and suboptimal results. OA is hypothesized to decrease these acute complications via lesion compliance change. METHODS: Fifty patients (65 lesions) with calcified FP disease were randomized to OA plus BA vs. BA alone and followed for 12 months. The primary endpoint was freedom from target lesion revascularization (TLR), including adjunctive stenting, or restenosis as evidenced by duplex ultrasound at 6 months. RESULTS: Mean maximum balloon pressure was 4.0 atm in the OA arm vs. 9.1 atm in the BA arm (P<.001). In subjects with residual stenosis >30%, the operator chose to stent 2/38 lesions (5.3%) in the OA arm vs 21/27 lesions (77.8%) in the BA arm (P<.001). Freedom from TLR (including adjunctive stenting) or restenosis was achieved in 77.1% of lesions in the OA group vs. 11.5% in the BA group (P<.001) at 6 months, and 81.2% vs. 78.3% at 12 months, excluding adjunctive stenting (P>.99). CONCLUSIONS: Compared to BA alone, OA plus BA yields better luminal gain by improving lesion compliance and decreases adjunctive stenting in the treatment of calcified FP disease. At 12 months, the occurrence of TLR or restenosis was similar in both groups despite the large disparity in stent usage at the time of initial treatment.
Authors: Karla Maria Treitl; Benedikt Woerner; Regina Schinner; Michael Czihal; Susan Notohamiprodjo; Ulrich Hoffmann; Marcus Treitl Journal: Eur Radiol Date: 2017-02-06 Impact factor: 5.315
Authors: Manesh R Patel; Michael S Conte; Donald E Cutlip; Nabil Dib; Patrick Geraghty; William Gray; William R Hiatt; Mami Ho; Koji Ikeda; Fumiaki Ikeno; Michael R Jaff; W Schuyler Jones; Masayuki Kawahara; Robert A Lookstein; Roxana Mehran; Sanjay Misra; Lars Norgren; Jeffrey W Olin; Thomas J Povsic; Kenneth Rosenfield; John Rundback; Fadi Shamoun; James Tcheng; Thomas T Tsai; Yuka Suzuki; Pascal Vranckx; Bret N Wiechmann; Christopher J White; Hiroyoshi Yokoi; Mitchell W Krucoff Journal: J Am Coll Cardiol Date: 2015-03-10 Impact factor: 24.094
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