From the Department of General Anesthesiology and the Center for Anesthesiology Education, Anesthesiology Institute.
Center for Anesthesiology Education, Anesthesiology Institute.
Anesth Analg. 2020 Apr;130(4):890-898. doi: 10.1213/ANE.0000000000004115.
Data on testosterone replacement therapy and cardiovascular outcomes are conflicting, with the Food and Drug Administration requiring prescription testosterone preparations to indicate a possible increased cardiovascular risk. Whether patients on testosterone replacement therapy undergoing cardiac surgery have an increased risk of postoperative in-hospital mortality and cardiovascular events remains unknown. We therefore sought to identify the impact of testosterone replacement on the incidence of a composite of postoperative in-hospital mortality and cardiovascular events in men undergoing cardiac surgery.
After institutional review board approval, data from male American Society of Anesthesiologists III/IV patients ≥40 years of age who underwent cardiac surgery between May 2005 and March 2017 at the Cleveland Clinic (Cleveland, OH) main campus were included. The primary exposure was preoperative testosterone use. The primary outcome was a collapsed composite of postoperative in-hospital mortality and cardiovascular events, including myocardial infarction, stroke, and pulmonary embolism. The secondary outcome was a collapsed composite of minor cardiovascular events, including postoperative rhythm disturbance requiring permanent device, atrial fibrillation, and deep venous thrombosis. We compared patients who received testosterone and those who did not, using propensity score matching within surgical procedure matches. Moreover, as a sensitivity analysis, we used a multivariable logistic regression model to assess the association between testosterone replacement therapy and major or minor cardiovascular events adjusted for potential baseline and intraoperative confounders by including all eligible patients.
Among 20,604 patients who met inclusion and exclusion criteria, 301 patients who used testosterone routinely within 1 month before the surgery were matched to 1505 of 20,303 patients who did not use testosterone. Among the matched cohort, 8 (2.7%) patients in the testosterone group and 45 (3.0%) in the nontestosterone group had ≥1 major cardiovascular adverse event after surgery. The adjusted odds ratio was 0.89 (95% CI, 0.41-1.90; P = .756), comparing testosterone to nontestosterone patients. As for the secondary outcomes, 89 (30%) patients in the testosterone group and 525 (35%) patients in the nontestosterone group had ≥1 minor cardiovascular event. The odds of minor events were not significantly different, with an odds ratio of 0.78 (95% CI, 0.60-1.02; P = .074) comparing testosterone to nontestosterone patients.
Preoperative testosterone is not associated with a statistically significant increased incidence of a composite of postoperative in-hospital mortality and cardiovascular events after cardiac surgery.
关于睾丸激素替代疗法和心血管结局的数据相互矛盾，美国食品和药物管理局要求处方睾丸激素制剂表明可能增加心血管风险。接受心脏手术的睾丸激素替代疗法患者是否有术后住院期间死亡率和心血管事件增加的风险尚不清楚。因此，我们试图确定睾丸激素替代疗法对接受心脏手术的男性术后住院期间死亡率和心血管事件复合发生率的影响。
在机构审查委员会批准后，纳入 2005 年 5 月至 2017 年 3 月在克利夫兰诊所（克利夫兰，俄亥俄州）主校区接受心脏手术的年龄≥40 岁的美国麻醉医师协会 III/IV 级男性患者的数据。主要暴露因素为术前使用睾丸激素。主要结局是术后住院期间死亡率和心血管事件的复合发生率，包括心肌梗死、卒中和肺栓塞。次要结局是术后心律失常需要永久性装置、心房颤动和深静脉血栓形成等轻微心血管事件的复合发生率。我们使用手术匹配内的倾向评分匹配比较了使用睾丸激素的患者和未使用睾丸激素的患者。此外，作为敏感性分析，我们使用多变量逻辑回归模型评估了睾丸激素替代疗法与主要或次要心血管事件之间的关联，该模型通过纳入所有符合条件的患者，针对潜在的基线和术中混杂因素进行了调整。
在符合纳入和排除标准的 20604 名患者中，301 名患者在手术前 1 个月内常规使用睾丸激素，与 20303 名未使用睾丸激素的患者中的 1505 名相匹配。在匹配队列中，睾丸激素组有 8 名（2.7%）患者和非睾丸激素组有 45 名（3.0%）患者在手术后有≥1 个主要心血管不良事件。调整后的优势比为 0.89（95%CI，0.41-1.90；P=0.756），睾丸激素组与非睾丸激素组比较。对于次要结局，睾丸激素组有 89 名（30%）患者和非睾丸激素组有 525 名（35%）患者有≥1 个轻微心血管事件。轻微事件的几率没有显著差异，睾丸激素组与非睾丸激素组的优势比为 0.78（95%CI，0.60-1.02；P=0.074）。
术前睾丸激素与心脏手术后住院期间死亡率和心血管事件复合发生率的增加无统计学意义相关。
