Department of Cardiology and Intensive Care, Medical Campus Lake Constance, Friedrichshafen, Germany.
Department of Interventional Cardiology, Brest university hospital, Brest, France.
Am J Cardiol. 2022 Oct 1;180:108-115. doi: 10.1016/j.amjcard.2022.06.035. Epub 2022 Aug 4.
Gender-based differences in outcomes after successful transcatheter aortic valve implantation (TAVI) in patients without an indication for oral anticoagulation have not been well studied. We aim to evaluate gender-based differences in clinical outcomes after TAVI. In the present analysis of the GALILEO (Global study comparing a rivaroxaban-based antithrombotic strategy to an antiplatelet-based strategy after transcatheter aortic valve replacement to optimize clinical outcomes) trial, patients with symptomatic severe aortic stenosis and who underwent successful TAVI were stratified by gender. The primary outcome was major adverse cardiac and cerebrovascular events (MACCEs), a composite of all-cause mortality or thromboembolic events (including any stroke, myocardial infarction, symptomatic valve thrombosis, systemic embolism, deep-vein thrombosis, or pulmonary embolism). Major bleeding was defined as a composite of major, life-threatening, or disabling Valve Academic Research Consortium-2 bleeding. Of 1,644 patients, 813 were female, and 831 were male. At baseline, female patients were older and at higher surgical risk (Society of Thoracic Surgeons risk score: 4.7 ± 3.6 versus 3.6 ± 3.0, p <0.0001) than male patients. After adjustment for differences in baseline clinical and procedural parameters, female patients had lower rates of MACCE (hazard ratio [HR] 0.69, 95% confidence interval [CI] 0.49 to 0.96), all-cause mortality (HR 0.54, 95% CI 0.34 to 0.87), and noncardiovascular mortality (HR 0.33, 95% CI 0.15 to 0.75) at a median of 17 months of follow-up. By landmark analyses, these differences appeared to emerge with a longer follow-up time. No significant differences in major, life-threatening, or disabling bleeding, cardiovascular mortality, and stroke were noted. In conclusion, compared with male patients, female patients with severe symptomatic aortic stenosis had a lower risk of MACCE and mortality but a similar risk of bleeding events after TAVI.
在没有口服抗凝指征的患者中，经导管主动脉瓣植入术（TAVI）后成功的性别差异对结果的影响尚未得到很好的研究。我们旨在评估 TAVI 后临床结果的性别差异。在 GALILEO（全球研究比较利伐沙班为基础的抗血栓策略与抗血小板为基础的策略后经导管主动脉瓣置换术，以优化临床结果）试验的本次分析中，根据性别对有症状的严重主动脉瓣狭窄且 TAVI 成功的患者进行分层。主要终点是主要不良心脑血管事件（MACCE），包括全因死亡率或血栓栓塞事件（包括任何卒、心肌梗死、有症状的瓣膜血栓形成、全身性栓塞、深静脉血栓形成或肺栓塞）的复合终点。主要出血定义为重大、危及生命或致残性 Valve Academic Research Consortium-2 出血的复合终点。在 1644 名患者中，813 名女性，831 名男性。基线时，女性患者年龄较大，手术风险较高（胸外科医师协会风险评分：4.7 ± 3.6 比 3.6 ± 3.0，p <0.0001）。在调整了基线临床和手术参数的差异后，女性患者的 MACCE 发生率较低（风险比 [HR] 0.69，95%置信区间 [CI] 0.49 至 0.96），全因死亡率（HR 0.54，95% CI 0.34 至 0.87）和非心血管死亡率（HR 0.33，95% CI 0.15 至 0.75）在中位随访 17 个月时。通过里程碑分析，这些差异似乎随着随访时间的延长而出现。在主要、危及生命或致残性出血、心血管死亡率和卒中等方面没有显著差异。总之，与男性患者相比，严重有症状的主动脉瓣狭窄的女性患者在 TAVI 后发生 MACCE 和死亡率的风险较低，但出血事件的风险相似。
