Department of Surgery, West Virginia University, Charleston, WVa.
Department of Surgery, West Virginia University, Charleston, WVa.
J Vasc Surg. 2019 Dec;70(6):1950-1959. doi: 10.1016/j.jvs.2019.03.072. Epub 2019 Aug 8.
Several multicenter industry-sponsored clinical trials reported satisfactory results in the use of drug-coated balloons (DCBs) for treatment of femoropopliteal occlusive disease. However, few single-center studies have been published to verify the outcome from real-world experience.
In this study, 228 patients treated with DCB angioplasty (Lutonix 0.35; Bard, Tempe, Arizona) were analyzed. Perioperative major adverse events (death, amputation, target lesion thrombosis or reintervention) were calculated. Kaplan-Meier analysis was used to estimate primary patency rates (based on duplex ultrasound with or without ankle-brachial index) and limb salvage rates.
Lesions treated were primarily TransAtlantic Inter-Society Consensus (TASC) type C and D lesions. Indications included claudication (Rutherford classes 2 and 3) in 40% and critical limb ischemia (CLI; Rutherford classes 4 and 5) in 60%. Lesions treated included 61% in the superficial femoral artery, 15% in the popliteal artery, and 24% in both superficial femoral artery and popliteal artery. Mean follow-up was 12.2 months (range, 1-42 months). Overall perioperative morbidity and mortality rates were 13% and 1%. The perioperative major adverse event rate was 3%. Symptom relief (improvement of one Rutherford category or more) was obtained in 64%. Primary patency rates were 56% and 39% at 1 year and 2 years, respectively. Limb salvage rates were 92% and 83% at 1 year and 2 years. Patients with claudication had a lower rate of early perioperative complications (4% vs 19%; P = .001). Symptom improvement was 76% for claudication vs 49% for CLI (P < .001). Overall, major amputation rate was 0% for claudication vs 13% for CLI (P < .001). The primary patency rates at 1 year and 2 years were 59% and 41% for claudication vs 54% and 37% for CLI (P = .307). The assisted primary patency rates at 1 year and 2 years were 72% and 52% for claudication vs 64% and 46% for CLI (P = .223). Primary patency rates at 1 year and 2 years were 82% and 71% for TASC A to C lesions vs 29% and 14% for TASC D lesions (P < .001). Limb salvage rates at 1 year and 2 years were 100% and 100% for claudication vs 85% and 74% for CLI (P < .001).
Clinical outcomes after DCB angioplasty in femoropopliteal lesions were inferior to what has been reported in previous studies, particularly for TASC D lesions. Further investigation from real-world experience with long-term follow-up is needed to confirm these results.
几项多中心的行业赞助的临床试验报告了药物涂层球囊（DCB）治疗股腘动脉闭塞性疾病的令人满意的结果。然而，很少有单中心的研究发表来验证真实世界的经验。
在这项研究中，分析了 228 例接受 DCB 血管成形术（Lutonix 0.35；Bard，Tempe，Arizona）治疗的患者。计算围手术期主要不良事件（死亡、截肢、靶病变血栓形成或再干预）。Kaplan-Meier 分析用于估计主要通畅率（基于超声或超声联合踝肱指数）和肢体存活率。
治疗的病变主要是 TransAtlantic Inter-Society Consensus（TASC）C 和 D 型病变。适应证包括跛行（Rutherford 分级 2 级和 3 级）占 40%，严重肢体缺血（CLI；Rutherford 分级 4 级和 5 级）占 60%。治疗的病变包括 61%的股浅动脉病变、15%的腘动脉病变和 24%的股浅动脉和腘动脉病变。平均随访时间为 12.2 个月（范围 1-42 个月）。总体围手术期发病率和死亡率分别为 13%和 1%。围手术期主要不良事件发生率为 3%。64%的患者获得了症状缓解（至少改善一个 Rutherford 分级）。1 年和 2 年的主要通畅率分别为 56%和 39%。1 年和 2 年的肢体存活率分别为 92%和 83%。跛行患者的早期围手术期并发症发生率较低（4% vs 19%；P =.001）。跛行患者的症状改善率为 76%，CLI 为 49%（P <.001）。总的来说，CLI 的主要截肢率为 13%，而跛行的为 0%（P <.001）。1 年和 2 年的主要通畅率分别为跛行 59%和 41%，CLI 54%和 37%（P =.307）。1 年和 2 年的辅助通畅率分别为跛行 72%和 52%，CLI 64%和 46%（P =.223）。1 年和 2 年的 TASC A 至 C 病变的主要通畅率分别为 82%和 71%，TASC D 病变的主要通畅率分别为 29%和 14%（P <.001）。1 年和 2 年的 CLI 跛行患者的肢体存活率分别为 100%和 100%，CLI 为 85%和 74%（P <.001）。
股腘动脉病变接受 DCB 血管成形术后的临床结果逊于以往研究报告的结果，特别是对于 TASC D 型病变。需要从真实世界的经验中进行进一步的长期随访研究来证实这些结果。
