Department of Hospital Medicine Cleveland Clinic Cleveland OH.
Internal Medicine Residency Program Cleveland Clinic Cleveland OH.
J Am Heart Assoc. 2021 Sep 7;10(17):e020609. doi: 10.1161/JAHA.120.020609. Epub 2021 Aug 28.
Background Long-term outcomes of percutaneous coronary intervention (PCI) based on patients' decision-making ability have not been studied. Our objective was to assess long-term outcomes after PCI in patients who provided individual versus surrogate consent. Methods and Results Data were collected retrospectively for patients who underwent PCI at Cleveland Clinic between January 1, 2015 and December 31, 2016. Inclusion criteria consisted of hospitalized patients aged ≥20 years who had PCI. Patients with outpatient PCI, or major surgery 30 days before or 90 days after PCI, were excluded. Patients who underwent PCI with surrogate consent versus individual consent were matched using the propensity analysis. Kaplan-Meier, log rank, -statistic, and χ tests were used for statistical analysis. The study was approved by the Institutional Review Board at Cleveland Clinic, Ohio. Of 3136 patients who underwent PCI during the study period, 183 had surrogate consent. Propensity matching yielded 149 patients from each group. Two-year all-cause mortality was significantly higher in the surrogate consent group (38 [25.5%] versus 16 [10.7%] deaths, log-rank =10.16, <0.001). The 2-year major adverse cardiac events rate was also significantly higher in the surrogate consent group (60 versus 36 events, log-rank =8.36, =0.003). Conclusions Patients with surrogate consent had significantly higher all-cause mortality and higher major adverse cardiac events when compared with patients with individual consent. This study emphasizes the fact that patients with an inability to give consent are at high risk and may need special attention in postprocedural and postdischarge care.
基于患者决策能力的经皮冠状动脉介入治疗(PCI)的长期结果尚未得到研究。我们的目的是评估在患者提供个体同意与代理同意的情况下进行 PCI 的长期结果。
数据是从 2015 年 1 月 1 日至 2016 年 12 月 31 日期间在克利夫兰诊所接受 PCI 的患者中回顾性收集的。纳入标准包括年龄≥20 岁、接受 PCI 的住院患者。排除门诊 PCI 患者或 PCI 前 30 天或后 90 天进行大手术的患者。使用倾向分析对接受代理同意与个体同意的 PCI 患者进行匹配。使用 Kaplan-Meier、对数秩、-检验和 χ 检验进行统计分析。本研究得到了俄亥俄州克利夫兰诊所机构审查委员会的批准。在研究期间接受 PCI 的 3136 名患者中,有 183 名患者接受了代理同意。倾向匹配得到了每组 149 名患者。代理同意组的 2 年全因死亡率显著更高(38 [25.5%] 例死亡与 16 [10.7%] 例死亡,对数秩=10.16,<0.001)。代理同意组的 2 年主要不良心脏事件发生率也显著更高(60 例与 36 例事件,对数秩=8.36,=0.003)。
与个体同意的患者相比,代理同意的患者全因死亡率和主要不良心脏事件发生率显著更高。本研究强调了这样一个事实,即无法同意的患者风险较高,可能需要在术后和出院后护理中给予特别关注。