Rocha-Singh Krishna J, Beckman Joshua A, Ansel Gary, Lyden Sean P, Schneider Peter, Mehta Manish, Dake Michael, Mullin Christopher M, Jaff Michael R
Prairie Heart Institute at St. John's Hospital, Springfield, Illinois.
Vanderbilt University Medical Center, Nashville, Tennessee.
Catheter Cardiovasc Interv. 2017 Jun 1;89(7):1250-1256. doi: 10.1002/ccd.27029. Epub 2017 Mar 17.
The factors that impact the clinical effectiveness of bare nitinol stents in claudicants with symptomatic femoropopliteal atherosclerosis are incompletely known. The authors analyzed variables that may influence stent durability and provide a benchmark for their effectiveness. Data analyzed from six studies (999 patients) included baseline noninvasive hemodynamic tests, angiographic characteristics, ultrasound defined stent patency and target lesion revascularization through 12-months. Baseline ankle-brachial index and lesion length predicted stent patency and target lesion revascularization and when combined interacted significantly to better predict outcomes. This meta-analysis provides an important comparator against which emerging therapies that treat claudicants with femoropopliteal atherosclerosis can be assessed.
Peripheral Artery Disease BACKGROUND: The performance of bare metal nitinol stents in patients with symptomatic femoropopliteal peripheral artery disease (PAD) is not well defined.
Patient-level data from six large prospective trials sponsored by medical device manufacturers was abstracted and analyzed to identify a cohort of patients with claudication and femoropopliteal artery occlusive disease. Twelve-month binary patency and target lesion revascularization (TLR) rates were primary outcomes. Stent patency was assessed by duplex ultrasonography (DUS) and TLR was a clinically driven intervention. To characterize the effects of patient characteristics on the outcomes, meta-regression was performed via mixed effects logistic regression models with patient-level covariates.
About 999 patients were analyzed; the mean ABI was 0.68 ± 0.18, the mean lesion length was 84 ± 53 mm, the mean lesion stenosis was 78%, and nearly two thirds of patients had mild to severe calcification. The mean Rutherford clinical category was 2.7 ± 0.6 and ranged from 2.6 to 2.8 in all studies. The 12-month patency across all studies was 69.8% and TLR rates ranged from 9.2% to 19.7%. Multivariable analysis demonstrated that baseline ABI and baseline target lesion length predicted both primary patency and TLR. Further, these two variables interacted significantly to better predict TLR outcomes when used in combination.
The 12-month clinical effectiveness of bare nitinol stents to treat patients with symptomatic femoropopliteal PAD is acceptable and is impacted by clinical and lesion-specific characteristics. These data provide an important and useful benchmark to compare the clinical benefit of emerging endovascular PAD therapies. © 2017 Wiley Periodicals, Inc.
影响单纯镍钛诺支架治疗有症状的股腘动脉粥样硬化患者临床疗效的因素尚不完全清楚。作者分析了可能影响支架耐久性的变量，并为其有效性提供了一个基准。对六项研究（999例患者）的数据进行分析，包括基线无创血流动力学检查、血管造影特征、超声定义的支架通畅情况以及12个月内的靶病变血管重建情况。基线踝肱指数和病变长度可预测支架通畅情况和靶病变血管重建情况，二者结合时相互作用显著，能更好地预测预后。这项荟萃分析提供了一个重要的对照标准，可据此评估治疗有症状的股腘动脉粥样硬化患者的新兴疗法。
外周动脉疾病 背景：单纯金属镍钛诺支架在有症状的股腘动脉外周动脉疾病（PAD）患者中的性能尚不明确。
提取并分析了由医疗器械制造商赞助的六项大型前瞻性试验的患者水平数据，以确定一组患有间歇性跛行和股腘动脉闭塞性疾病的患者。12个月的二元通畅率和靶病变血管重建（TLR）率为主要结局指标。通过双功超声（DUS）评估支架通畅情况，TLR是一项基于临床的干预措施。为了描述患者特征对结局的影响，通过具有患者水平协变量的混合效应逻辑回归模型进行荟萃回归分析。
共分析了约999例患者；平均踝肱指数为0.68±0.18，平均病变长度为84±53mm，平均病变狭窄率为78%，近三分之二的患者有轻度至重度钙化。平均卢瑟福临床分级为2.7±0.6，在所有研究中范围为2.6至2.8。所有研究中12个月的通畅率为69.8%，TLR率范围为9.2%至19.7%。多变量分析表明，基线踝肱指数和基线靶病变长度可预测初次通畅率和TLR。此外，这两个变量结合使用时相互作用显著，能更好地预测TLR结局。
单纯镍钛诺支架治疗有症状的股腘动脉PAD患者12个月的临床疗效是可接受的，且受临床和病变特异性特征的影响。这些数据为比较新兴的血管内PAD疗法的临床益处提供了一个重要且有用的基准。©2017威利期刊公司
