University of Vermont Medical Center, Division of Vascular Surgery, Burlington, VT.
Your Third Opinion, Chapel Hill, NC.
J Vasc Surg. 2021 May;73(5):1702-1714.e11. doi: 10.1016/j.jvs.2020.09.030. Epub 2020 Oct 17.
The Superficial Femoral Artery-Popliteal EvidencE Development Study Group developed contemporary objective performance goals (OPGs) for peripheral vascular interventions (PVI) for superficial femoral artery (SFA)-popliteal artery disease using the Registry Assessment of Peripheral Interventional Devices.
The Society for Vascular Surgery Vascular Quality Initiative PVI registry from January 2010 to October 2016 was used to develop OPGs based on SFA-popliteal procedures (n = 21,377) for intermittent claudication and critical limb ischemia (CLI). OPGs included 1-year rates for target lesion revascularization (TLR), major amputation, and 1 and 4-year survival rates. OPGs were calculated for the SFA and popliteal arteries and stratified by four treatments: angioplasty alone (percutaneous transluminal angioplasty [PTA]), self-expanding stenting, atherectomy, and any treatment type. Outcomes were illustrated by unadjusted Kaplan-Meier analyses.
Cohorts included PTA (n = 7505), stenting (n = 9217), atherectomy (n = 2510) and any treatment (n = 21,377). The mean age was 69 years, 58% were male, 79% were White, and 52% had CLI. The freedom from TLR OPGs at 1 year in the SFA were 80.3% (PTA), 83.2% (stenting), 83.9% (atherectomy), and 81.9% (any treatments). The freedom from TLR OPGs at 1 year in the popliteal were 81.3% (PTA), 81.3% (stenting), 80.2% (atherectomy), and 81.1% (any treatments). The freedom from major amputation OPGs at 1 year after SFA PVI were 93.4% (PTA), 95.7% (stenting), 95.1% (atherectomy), and 94.8% (any treatments). The freedom from major amputation OPG at 1 year after popliteal PVI were 90.5% (PTA), 93.7% (stenting), 91.8% (atherectomy), and 91.8%, (any treatments). The 4-year survival OPGs after SFA PVI were 76% (PTA), 80% (stenting), 82% (atherectomy), and 79% (any treatments), and for the popliteal artery were 72% (PTA), 77% (stenting), 82% (atherectomy), and 75% (any treatment). On a multivariable analysis, which included patient-level, leg-level, and lesion-level covariates, CLI was the single independent factor associated with increased TLR, amputation, and mortality.
The Superficial Femoral Artery-Popliteal EvidencE Development OPGs define a new, contemporary benchmark for SFA-popliteal interventions using a large subset of real-world evidence to inform more efficient peripheral device clinical trial designs to support regulatory and clinical decision-making. It is appropriate to discuss proposals intended for regulatory approval with the US Food and Drug Administration to refine the OPG to match the specific trial population. The OPGs may be updated using coordinated registry networks to assess long-term real-world device performance.
浅表股动脉-腘动脉证据发展研究组使用外周血管介入（PVI）注册表评估外周介入设备，为股浅动脉（SFA）-腘动脉疾病制定了当代客观绩效目标（OPG）。
利用 2010 年 1 月至 2016 年 10 月的血管外科学会血管质量倡议（SVS VQI）PVI 登记处，基于 SFA-腘动脉病变间歇性跛行和严重肢体缺血（CLI）患者的 SFA-腘动脉介入程序（n=21377）制定 OPG。OPG 包括 1 年靶病变血运重建（TLR）、大截肢和 1 年和 4 年生存率的发生率。根据四种治疗方法（单纯经皮腔内血管成形术[PTA]、自膨式支架、旋切术和任何治疗类型）对 SFA 和腘动脉的 OPG 进行了计算。通过未调整的 Kaplan-Meier 分析来描绘结果。
队列包括 PTA（n=7505）、支架（n=9217）、旋切术（n=2510）和任何治疗（n=21377）。平均年龄为 69 岁，58%为男性，79%为白人，52%为 CLI。SFA 中 1 年 TLR 无复发生存率 OPG 分别为 80.3%（PTA）、83.2%（支架）、83.9%（旋切术）和 81.9%（任何治疗）。1 年时 PTV 后腘动脉 TLR 无复发生存率 OPG 分别为 81.3%（PTA）、81.3%（支架）、80.2%（旋切术）和 81.1%（任何治疗）。SFA-PVI 后 1 年大截肢无复发生存率 OPG 分别为 93.4%（PTA）、95.7%（支架）、95.1%（旋切术）和 94.8%（任何治疗）。PTV 后 1 年 POP 大截肢无复发生存率 OPG 分别为 90.5%（PTA）、93.7%（支架）、91.8%（旋切术）和 91.8%（任何治疗）。SFA-PVI 后 4 年生存率 OPG 分别为 76%（PTA）、80%（支架）、82%（旋切术）和 79%（任何治疗），POP 分别为 72%（PTA）、77%（支架）、82%（旋切术）和 75%（任何治疗）。多变量分析包括患者水平、肢体水平和病变水平的协变量，CLI 是唯一与 TLR、截肢和死亡率增加相关的独立因素。
浅表股动脉-腘动脉证据发展 OPG 使用了大量真实世界的数据，为股浅动脉-腘动脉介入制定了新的当代基准，以支持更有效的外周设备临床试验设计，为监管和临床决策提供信息。与美国食品和药物管理局讨论旨在获得监管批准的提议，以细化 OPG 以匹配特定的试验人群是合适的。可以使用协调的注册网络来更新 OPG，以评估长期真实世界设备性能。
