The COMPLIANCE 360° Trial: a randomized, prospective, multicenter, pilot study comparing acute and long-term results of orbital atherectomy to balloon angioplasty for calcified femoropopliteal disease.

医学 再狭窄 血管成形术 气球 动脉切除术 支架 靶病变 狭窄 病变 临床终点 放射科 切割气球 外科 辅助治疗 随机对照试验 内科学 经皮冠状动脉介入治疗 心肌梗塞
作者
Raymond Dattilo,Stevan I. Himmelstein,Robert Cuff
出处
期刊:PubMed 卷期号:26 (8): 355-60 被引量:114
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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.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.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).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.

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