Department of Cardiology, Prairie Heart Institute at St. John's Hospital, Springfield, Illinois, USA.
Department of Cardiology, Rex Medical Center, Raleigh, North Carolina, USA.
Catheter Cardiovasc Interv. 2021 Sep;98(3):549-558. doi: 10.1002/ccd.29777. Epub 2021 Jun 3.
Drug coated balloon (DCB) angioplasty significantly reduces reintervention rates in patients with symptomatic femoropopliteal peripheral artery disease (PAD). However, stand-alone DCB use in long, severely calcified lesions is frequently associated with vessel recoil and/or high-grade dissections necessitating provisional stent implantation.
Assess the safety and effectiveness of a vessel preparation strategy with directional atherectomy (DA) prior to DCB angioplasty in patients with symptomatic severely calcified femoropopliteal PAD.
REALITY (NCT02850107) prospectively enrolled subjects at 13 multinational centers with 8-36 cm femoropopliteal stenoses or occlusions with bilateral vessel wall calcification treated with DA prior to DCB angioplasty. The primary effectiveness endpoint was 12-month primary patency, and the primary safety endpoint was freedom from major adverse events through 30 days. Independent angiographic and duplex core laboratories assessed outcomes and a Clinical Events Committee adjudicated events.
A total of 102 subjects were enrolled; one lesion was treated per subject. The mean lesion length was 17.9 ± 8.1 cm, 39.0% were chronic total occlusions (mean lesion length 22.6 ± 8.6 cm); 86.2% of lesions exhibited moderate to severe bilateral calcification. Provisional stents were implanted in 8.8% (9/102) of subjects. Twelve-month primary patency rate was 76.7% (66/86) and freedom from CD-TLR rate was 92.6% (87/94). No device or procedure related deaths and one index-limb major amputation were reported.
Plaque excision with DA in patients with symptomatic severely calcified femoropopliteal arterial disease prior to DCB angioplasty is a safe and effective treatment strategy with a low provisional stent rate.
药物涂层球囊（DCB）血管成形术可显著降低有症状的股腘周围动脉疾病（PAD）患者的再介入率。然而，在长段、严重钙化病变中单独使用 DCB 常伴有血管回缩和/或高级别夹层，需要临时支架植入。
评估在有症状的严重钙化股腘 PAD 患者中，在 DCB 血管成形术前使用定向旋切术（DA）进行血管准备的安全性和有效性。
REALITY（NCT02850107）前瞻性地在 13 个多国家中心招募了 102 名患者，这些患者的股腘段 8-36cm 狭窄或闭塞伴双侧血管壁钙化，使用 DA 预处理后再行 DCB 血管成形术。主要有效性终点为 12 个月的一期通畅率，主要安全性终点为 30 天内无重大不良事件。独立的血管造影和双功能超声核心实验室评估了结果，临床事件委员会判定了事件。
共纳入 102 名患者，每位患者接受了 1 处病变的治疗。平均病变长度为 17.9±8.1cm，39.0%为慢性完全闭塞（平均病变长度 22.6±8.6cm）；86.2%的病变存在中重度双侧钙化。8.8%（9/102）的患者植入了临时支架。12 个月的一期通畅率为 76.7%（66/86），无 CD-TLR 率为 92.6%（87/94）。无器械或手术相关死亡和 1 例索引肢体主要截肢。
在有症状的严重钙化股腘动脉疾病患者中，在 DCB 血管成形术前使用 DA 切除斑块是一种安全有效的治疗策略，临时支架率较低。
