Importance It is unclear whether counseling to promote walking reduces the risk of major adverse cardiovascular events (MACE) in people with peripheral artery disease (PAD). Objective To test whether a counseling intervention designed to increase walking reduced the risk of MACE in patients with PAD. Design, Setting, and Participants The BIP trial was a randomized clinical trial, with recruitment performed between January 2015 and July 2018 and follow-up concluded in August 2023. Participants with walking impairment due to PAD from vascular departments in the Australian cities of Brisbane, Sydney, and Townsville were randomly allocated 1:1 to the intervention or control group. Data were originally analyzed in March 2024. Intervention Four brief counseling sessions aimed to help patients with the challenges of increasing physical activity. Main Outcomes and Measures The primary outcome was the between-group difference in risk of MACE, which included myocardial infarction (MI), stroke, and cardiovascular death. The relationship between Intermittent Claudication Questionnaire (ICQ) scores, PAD Quality of Life (PADQOL) scores, and MACE was examined with Cox proportional hazard regression analyses. Results A total of 200 participants were included, with 102 allocated to the counseling intervention (51.0%) and 98 to the control group (49.0%).Participants were followed up for a mean (SD) duration of 3.5 (2.6) years. Median (IQR) participant age was 70 (63-76) years, and 56 of 200 participants (28.0%) were female. A total of 31 individuals had a MACE (composed of 19 MIs, 4 strokes, and 8 cardiovascular deaths). Participants allocated to the intervention were significantly less likely to have a MACE than participants in the control group (10 of 102 participants [9.8%] vs 21 of 98 [21.4%]; hazard ratio [HR], 0.43; 95% CI, 0.20-0.91; P = .03). Greater disease-specific quality of life (QOL) scores at 4 months (ICQ: HR per 1-percentage point increase, 0.97; 95% CI, 0.95-0.99; P < .001; PADQOL factor 3 [symptoms and limitations in physical functioning]: HR per 1-unit increase, 0.91; 95% CI, 0.84-0.98; P = .01) and at 12 months (ICQ: HR per 1-percentage point increase, 0.97; 95% CI, 0.95-0.99; P = .003; PADQOL factor 3: HR per 1-unit increase, 0.91; 95% CI, 0.84-0.98; P = .02) were associated with a lower risk of MACE. In analyses adjusted for ICQ or PADQOL factor 3 scores at either 4 or 12 months, allocation to the counseling intervention was no longer significantly associated with a lower risk of MACE. Conclusions and Relevance This post hoc exploratory analysis of the BIP randomized clinical trial suggested that the brief counseling intervention designed to increase walking may reduce the risk of MACE, possibly due to improvement in QOL. Trial Registration anzctr.org.au Identifier: ACTRN12614000592640.

中文翻译：

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外周动脉疾病患者的咨询干预和心血管事件：BIP 随机临床试验的事后分析。


重要性 目前尚不清楚促进步行的咨询是否能降低外周动脉疾病 （PAD） 患者发生主要不良心血管事件 （MACE） 的风险。目的 测试旨在增加步行的咨询干预是否降低了 PAD 患者发生 MACE 的风险。设计、设置和参与者 BIP 试验是一项随机临床试验，招募于 2015 年 1 月至 2018 年 7 月进行，随访于 2023 年 8 月结束。来自澳大利亚城市布里斯班、悉尼和汤斯维尔的血管科因 PAD 而行走障碍的参与者被 1：1 随机分配到干预组或对照组。数据最初是在 2024 年 3 月进行的分析。干预 四次简短的咨询会议旨在帮助患者应对增加身体活动的挑战。主要结局和指标 主要结局是 MACE 风险的组间差异，包括心肌梗死 （MI） 、中风和心血管死亡。通过 Cox 比例风险回归分析检查间歇性跛行问卷 （ICQ） 评分、PAD 生活质量 （PADQOL） 评分和 MACE 之间的关系。结果 共纳入 200 名参与者，其中 102 名 （51.0%） 分配给咨询干预组，98 名分配给对照组 （49.0%）。参与者的平均随访 （SD） 持续时间为 3.5 （2.6） 年。参与者的中位年龄为 70 （63-76） 岁，200 名参与者中有 56 名 （28.0%） 是女性。共有 31 例患有 MACE （包括 19 例 MIs、4 例中风和 8 例心血管死亡）。与对照组的参与者相比，分配到干预组的参与者发生 MACE 的可能性显著降低（102 名参与者中的 10 名 [9.8%] vs 98 人中的 21 人 [21.4%];风险比 [HR]，0.43;95% CI，0.20-0.91;P = .03）。4 个月时疾病特异性生活质量 （QOL） 评分更高 （ICQ：HR 每增加 1 个百分点，0.97;95% CI，0.95-0.99;P < .001;PADQOL 因子 3 [身体机能的症状和限制]： 每 1 个单位增加 HR 0.91;95% CI，0.84-0.98;P = .01）和 12 个月时（ICQ：HR 每增加 1 个百分点，0.97;95% CI，0.95-0.99;P = .003;PADQOL 因子 3：每 1 个单位增加的 HR 为 0.91;95% CI，0.84-0.98;P = .02） 与 MACE 风险较低相关。在 4 个月或 12 个月时根据 ICQ 或 PADQOL 因子 3 评分进行调整的分析中，咨询干预组的分配不再与 MACE 风险降低显著相关。结论和相关性 这项对 BIP 随机临床试验的事后探索性分析表明，旨在增加步行的简短咨询干预可能会降低 MACE 的风险，这可能是由于 QOL 的改善。试验注册 anzctr.org.au 标识符： ACTRN12614000592640.