Vascular Medicine Outcomes (VAMOS) Program, Section of Cardiovascular Medicine, Department of Internal Medicine, Yale University School of Medicine, New Haven, CT.
Vascular Medicine Outcomes (VAMOS) Program, Section of Cardiovascular Medicine, Department of Internal Medicine, Yale University School of Medicine, New Haven, CT; Department of Psychiatry, Psychology Section, Yale University School of Medicine, New Haven, CT.
J Vasc Surg. 2024 Sep;80(3):780-790.e10. doi: 10.1016/j.jvs.2024.04.061. Epub 2024 May 10.
To analyze the impact of noninvasive and early invasive treatments on health status in patients with lower extremity peripheral arterial disease (PAD) without and with chronic total occlusions (CTOs) after 12 months of follow-up.
Using the international (the United States, the Netherlands, and Australia) observational longitudinal Patient-Centered Outcomes Related to Treatment Practices in Peripheral Arterial Disease: Investigating Trajectories registry, we included patients with recent PAD symptoms between June 2011 and December 2015. We assessed the PAD-specific health status at initial visit and the 3-, 6-, and 12-month follow-up using the Peripheral Arterial Questionnaire. On a propensity matched-weighted cohort, we compared patients' characteristics by CTO status and treatment groups as early invasive (revascularization in the 3 months) vs noninvasive (exercise, medical therapies, or smoking cessation). We then assessed the health status trajectory over 12 months, as a three-way interaction between CTO status, treatment groups, and months, using a multilevel generalized linear regression model for repeated measures adjusted for baseline health status with random effects at the site and patient levels.
We included 581 participants, with a mean age of 66.62 ± 9.33 years, 34.3% female, and 90.8% White, of whom 353 (60.8%) were without and 228 (39.2%) had a CTO lesion. Respectively, 96 (27.2%) and 70 (30.7%) patients underwent early invasive treatment (d = 0.07). Although patients with CTO were more likely to have lower resting ABI, multilevel disease, and to experience severe claudication vs their counterparts (|d| ≥ 0.20), patient health status at baseline with CTO was not different from those without CTO, with mean summary scores of 45.14 ± 20.26 vs 45.90 ± 21.24 (d = 0.04), respectively. The trajectory did not differ by CTO status (interaction CTO status × month; P = .517) and was higher in early invasive vs noninvasive treatment (treatment × month; P < .001), regardless of CTO status (CTO status × treatment; P = .981 and CTO status × treatment × month; P = .264). The score increased over time with the largest improvement occurring at 3 months in both noninvasive (non-CTO, +7.82 [95% confidence interval (CI), 4.03-11.60] and CTO, +9.27 95% CI, 4.45-14.09) and early invasive (non-CTO, +26.17 [95% CI, 20.06-32.28] and CTO, +24.52 [95% CI, 17.40-31.64] groups. The mean score in CTO vs non-CTO groups did not differ at each timepoint, with a 12-month mean score of 70.26 (95% CI, 67.87-74.65) vs 71.17 (95% CI, 65.91-76.44) (P = .99) in the noninvasive treatment and 84.93 (95% CI, 78.90-90.97) vs 79.20 (95% CI, 72.77-86.14) (P = .31) in the early invasive treatment.
Patients with symptomatic PAD undergoing early revascularization exhibited better health status over time vs those undergoing noninvasive treatment strategy, irrespective of the presence of CTOs. The degree of the improvement was greater in the 3 months after the initial visit, especially in patients undergoing early revascularization.
分析下肢外周动脉疾病（PAD）患者在无和有慢性完全闭塞（CTO）情况下，12 个月随访时非侵入性和早期侵入性治疗对健康状况的影响。
使用国际（美国、荷兰和澳大利亚）观察性纵向与治疗实践相关的患者中心结局：外周动脉疾病的轨迹研究，我们纳入了 2011 年 6 月至 2015 年 12 月期间近期出现 PAD 症状的患者。我们使用外周动脉问卷在初始就诊时和第 3、6、12 个月随访时评估 PAD 特异性健康状况。在基于倾向评分的加权队列中，我们比较了 CTO 状态和治疗组（早期侵入性[在 3 个月内行血运重建]与非侵入性[运动、药物治疗或戒烟]）的患者特征。然后，我们使用多水平广义线性重复测量回归模型评估了 12 个月内的健康状况轨迹，模型考虑了 CTO 状态、治疗组和月份之间的三向交互作用，同时在患者和地点水平上进行了随机效应调整。
我们纳入了 581 名参与者，平均年龄为 66.62±9.33 岁，女性占 34.3%，白人占 90.8%，其中 353 名（60.8%）无 CTO 病变，228 名（39.2%）有 CTO 病变。分别有 96 名（27.2%）和 70 名（30.7%）患者接受了早期侵入性治疗（d=0.07）。尽管 CTO 患者更有可能有较低的静息踝肱指数、多发性疾病和严重跛行，但与无 CTO 患者相比，患者的基线健康状况并无不同，平均综合评分分别为 45.14±20.26 与 45.90±21.24（d=0.04）。轨迹不因 CTO 状态而异（CTO 状态×月的交互作用；P=0.517），早期侵入性治疗优于非侵入性治疗（治疗×月；P<0.001），无论 CTO 状态如何（CTO 状态×治疗；P=0.981 和 CTO 状态×治疗×月；P=0.264）。评分随时间增加，最大改善发生在 3 个月时，无论是非侵入性治疗（非 CTO 组，+7.82[95%置信区间（CI），4.03-11.60]和 CTO 组，+9.27[95% CI，4.45-14.09]）还是早期侵入性治疗（非 CTO 组，+26.17[95% CI，20.06-32.28]和 CTO 组，+24.52[95% CI，17.40-31.64]）。在每个时间点，CTO 组和非 CTO 组的平均评分没有差异，非侵入性治疗的 12 个月平均评分分别为 70.26（95% CI，67.87-74.65）和 71.17（95% CI，65.91-76.44）（P=0.99），早期侵入性治疗分别为 84.93（95% CI，78.90-90.97）和 79.20（95% CI，72.77-86.14）（P=0.31）。
患有有症状 PAD 且接受早期血运重建的患者在时间上的健康状况改善优于接受非侵入性治疗策略的患者，无论是否存在 CTO 病变。在初始就诊后 3 个月内改善程度更大，尤其是在接受早期血运重建的患者中。
