与阿司匹林单药治疗相比，P2Y12 抑制剂单药治疗与慢性肢体威胁性缺血的更好结局相关。
P2Y12 inhibitor monotherapy is associated with superior outcomes as compared with aspirin monotherapy in chronic limb-threatening ischemia.
机构信息
Division of Vascular Surgery, Department of Surgery, SUNY at Buffalo, Buffalo, NY.
Division of Vascular Surgery, Department of Surgery, SUNY at Buffalo, Buffalo, NY.
出版信息
J Vasc Surg. 2022 Oct;76(4):1053-1059. doi: 10.1016/j.jvs.2022.04.047. Epub 2022 Jun 13.
OBJECTIVE
Antiplatelet therapy is recommended in patients with peripheral arterial disease to reduce cardiovascular risk and improve outcomes. However, issues including the drug of choice and use of dual antiplatelet therapy (DAPT) vs monotherapy remain unclear. This study aims to compare the impact of aspirin (ASA) monotherapy, P2Y12 monotherapy, and DAPT on limb salvage (LS), amputation-free survival (AFS), and overall survival (OS) in patients undergoing lower extremity peripheral endovascular intervention (PVI) for chronic limb-threatening ischemia (CLTI).
METHODS
The Vascular Quality Initiative PVI registry was used to identify index procedures completed for CLTI between March 1, 2010 and September 30, 2017. Patients were categorized by antiplatelet use at the time of last follow-up. Patients not on antiplatelet therapy were compared with ASA, P2Y12 monotherapy, and DAPT. Propensity score-matched samples were created for direct ASA vs P2Y12 and P2Y12 vs DAPT comparisons; veracity was confirmed by χ and Hosmer-Lemeshow tests. Kaplan-Meier and Cox regression were performed for OS, AFS, and LS.
RESULTS
A total of 12,433 index PVI were completed for CLTI in 11,503 subjects in the pre-matched sample. Antiplatelet use at follow-up was: 12% none, 31% ASA, 14% P2Y12, and 43% DAPT. Median follow-up was 1389 days. P2Y12 monotherapy was associated with improved outcomes as compared with ASA monotherapy, OS (87.8% vs 85.5%l P = .026; Cox hazard ratio [HR], 0.82; 95% confidence interval [CI], 0.68-0.98; P = .03), AFS (79.6% vs 74.8%; P < .001; Cox HR, 0.75; 95% CI, 0.65-0.86; P < .001) and LS (89.5% vs 86.8%; P = .013; Cox HR, 0.74; 95% CI, 0.60-0.91; P = .004). P2Y12 monotherapy and DAPT had comparable OS (87.8% vs 88.9%; P = .62; Cox HR, 0.94; 95% CI, 0.77-1.14; P = .50), AFS (79.6% vs 81.5%; P = .33; Cox HR, 0.92; 95% CI, 0.78-1.07; P = .28), and LS (91.7% vs 89.4; P = .03; Cox HR, 0.80; 95% CI, 0.64-1.00; P = .06).
CONCLUSIONS
P2Y12 monotherapy was associated with superior OS, AFS, and LS as compared with ASA monotherapy, and comparable OS, LS, and AFS with DAPT in patients undergoing PVI for CLTI. P2Y12 monotherapy may be considered over ASA monotherapy and DAPT in patients with CLTI, especially in patients with high bleeding risk.
目的
抗血小板治疗被推荐用于外周动脉疾病患者，以降低心血管风险并改善预后。然而，在选择药物以及双联抗血小板治疗（DAPT）与单药治疗的应用方面仍存在一些问题。本研究旨在比较阿司匹林（ASA）单药治疗、P2Y12 单药治疗和 DAPT 对慢性肢体威胁性缺血（CLTI）患者行下肢外周血管腔内介入（PVI）后肢体挽救（LS）、免于截肢的存活率（AFS）和总体存活率（OS）的影响。
方法
使用血管质量倡议（Vascular Quality Initiative，VQI）PVI 登记处，确定 2010 年 3 月 1 日至 2017 年 9 月 30 日期间为 CLTI 完成的索引手术。根据最后一次随访时的抗血小板使用情况对患者进行分类。未接受抗血小板治疗的患者与 ASA、P2Y12 单药治疗和 DAPT 进行比较。为了进行直接 ASA 与 P2Y12 以及 P2Y12 与 DAPT 的比较，创建了倾向评分匹配样本；通过 χ 和 Hosmer-Lemeshow 检验验证真实性。使用 Kaplan-Meier 和 Cox 回归进行 OS、AFS 和 LS 的分析。
结果
在未匹配的样本中，共有 11503 例患者完成了 12433 次 CLTI 的索引 PVI。随访时抗血小板药物的使用情况如下：12%未使用、31%使用 ASA、14%使用 P2Y12 和 43%使用 DAPT。中位随访时间为 1389 天。与 ASA 单药治疗相比，P2Y12 单药治疗与更好的 OS（87.8%比 85.5%，P=.026；Cox 风险比 [HR]，0.82；95%置信区间 [CI]，0.68-0.98；P=.03）、AFS（79.6%比 74.8%，P<.001；Cox HR，0.75；95% CI，0.65-0.86；P<.001）和 LS（89.5%比 86.8%，P=.013；Cox HR，0.74；95% CI，0.60-0.91；P=.004）相关。P2Y12 单药治疗和 DAPT 的 OS（87.8%比 88.9%，P=.62；Cox HR，0.94；95% CI，0.77-1.14；P=.50）、AFS（79.6%比 81.5%，P=.33；Cox HR，0.92；95% CI，0.78-1.07；P=.28）和 LS（91.7%比 89.4%，P=.03；Cox HR，0.80；95% CI，0.64-1.00；P=.06）相当。
结论
与 ASA 单药治疗相比，P2Y12 单药治疗与更好的 OS、AFS 和 LS 相关，与 DAPT 相比，与 OS、LS 和 AFS 相当。在 CLTI 患者中，与 ASA 单药治疗和 DAPT 相比，P2Y12 单药治疗可能是一种更好的选择，特别是在高出血风险的患者中。
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