From the Universitäts-Herzzentrum Bad Krozingen, Germany (T.Z.); Sankt Getrauden-Krankenhaus, Berlin, Germany (R.L.); Prairie Heart Institute at St. John's Hospital, Springfield, IL (K.J.R.-S.); VasCore-the Vascular Ultrasound Core Laboratory, Massachusetts General Hospital, Boston (M.R.J.); SRH Klinikum Karlsbad-Langensteinbach, Germany (E.B.); Clinic for Angiology, University Hospital Zurich, Switzerland (B.A.-V.); Zakład Leczniczy Angio-Medicus, Krakow, Poland (M.K.); Department of Cardiovascular and Thoracic Surgery, Imelda Hospital, Bonheiden, Belgium (P.P.); Department of Interventional Angiology, University Hospital Leipzig, Germany (D.S.); University Hospital Muenster, Klinik for Vascular and Endovascular Surgery, Germany (G. Torsello); Swiss Cardiovascular Center, Division of Angiology, University Hospital, Inselspital Bern, Switzerland (S.S.); and Klinikum Rosenheim, Germany (G. Tepe).
Circ Cardiovasc Interv. 2017 Sep;10(9):e004848. doi: 10.1161/CIRCINTERVENTIONS.116.004848.
Studies assessing drug-coated balloons (DCB) for the treatment of femoropopliteal artery disease are encouraging. However, challenging lesions, such as severely calcified, remain difficult to treat with DCB alone. Vessel preparation with directional atherectomy (DA) potentially improves outcomes of DCB.
DEFINITIVE AR study (Directional Atherectomy Followed by a Paclitaxel-Coated Balloon to Inhibit Restenosis and Maintain Vessel Patency-A Pilot Study of Anti-Restenosis Treatment) was a multicenter randomized trial designed to estimate the effect of DA before DCB to facilitate the development of future end point-driven randomized studies. One hundred two patients with claudication or rest pain were randomly assigned 1:1 to DA+DCB (n=48) or DCB alone (n=54), and 19 additional patients with severely calcified lesions were treated with DA+DCB. Mean lesion length was 11.2±4.0 cm for DA+DCB and 9.7±4.1 cm for DCB (=0.05). Predilation rate was 16.7% for DA+DCB versus 74.1% for DCB; postdilation rate was 6.3% for DA+DCB versus 33.3% for DCB. Technical success was superior for DA+DCB (89.6% versus 64.2%; =0.004). Overall bail-out stenting rate was 3.7%, and rate of flow-limiting dissections was 19% for DCB and 2% for DA+DCB (=0.01). One-year primary outcome of angiographic percent diameter stenosis was 33.6±17.7% for DA+DCB versus 36.4±17.6% for DCB (=0.48), and clinically driven target lesion revascularization was 7.3% for DA+DCB and 8.0% for DCB (=0.90). Duplex ultrasound patency was 84.6% for DA+DCB, 81.3% for DCB (=0.78), and 68.8% for calcified lesions. Freedom from major adverse events at 1 year was 89.3% for DA+DCB and 90.0% for DCB (=0.86).
DA+DCB treatment was effective and safe, but the study was not powered to show significant differences between the 2 methods of revascularization in 1-year follow-up. An adequately powered randomized trial is warranted.
http://www.clinicaltrials.gov. Unique Identifier: NCT01366482.
评估药物涂层球囊（DCB）治疗股腘动脉疾病的研究结果令人鼓舞。然而，严重钙化等挑战性病变仍然难以单独用 DCB 治疗。定向旋切术（DA）血管预备可能会改善 DCB 的治疗效果。
DEFINITIVE AR 研究（定向旋切术后继以紫杉醇涂层球囊抑制再狭窄和维持血管通畅——抗再狭窄治疗的一项先导研究）是一项多中心随机试验，旨在评估 DCB 前行 DA 对促进未来终点驱动的随机研究的效果。102 例跛行或静息痛患者按 1:1 随机分为 DA+DCB（n=48）或 DCB 组（n=54），19 例严重钙化病变患者接受 DA+DCB 治疗。DA+DCB 组的平均病变长度为 11.2±4.0cm，DCB 组为 9.7±4.1cm（P=0.05）。DA+DCB 组预扩张率为 16.7%，DCB 组为 74.1%；DA+DCB 组后扩张率为 6.3%，DCB 组为 33.3%。DA+DCB 组技术成功率更高（89.6%比 64.2%；P=0.004）。整体紧急支架置入率为 3.7%，DCB 组的血流限制型夹层发生率为 19%，DA+DCB 组为 2%（P=0.01）。DA+DCB 组和 DCB 组的 1 年主要终点——血管造影测量的百分比狭窄程度分别为 33.6±17.7%和 36.4±17.6%（P=0.48），临床驱动的靶病变血运重建率分别为 7.3%和 8.0%（P=0.90）。DA+DCB 组和 DCB 组的超声随访通畅率分别为 84.6%、81.3%（P=0.78）和 68.8%。1 年时无主要不良事件发生率为 89.3%，DA+DCB 组和 DCB 组分别为 90.0%（P=0.86）。
DA+DCB 治疗有效且安全，但本研究未在 1 年随访中显示出两种血运重建方法之间的显著差异。需要进行充分的随机试验。
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