ACTION Study Group, Sorbonne Université, INSERM UMR_S 1166, Institut de Cardiologie, Pitié-Salpêtrière Hospital (AP-HP), Paris, France.
Statistician Unit, StatEthic, Levallois-Perret, France.
J Am Coll Cardiol. 2019 Jan 8;73(1):13-21. doi: 10.1016/j.jacc.2018.08.1045. Epub 2018 Aug 25.
The optimal antithrombotic treatment after transcatheter aortic valve replacement (TAVR) remains a matter of debate. Although dual antiplatelet therapy is recommended, single antiplatelet therapy or oral anticoagulation is frequently used according to the patient profile. Whether this approach may affect clinical outcome is unknown.
FRANCE TAVI (French Transcatheter Aortic Valve Implantation) is a prospective, multicenter, nationwide French registry. The study objectives were to identify independent correlates of long-term all-cause mortality and early bioprosthetic valve dysfunction (BVD), defined as increased prosthetic gradient ≥10 mm Hg or new gradient ≥20 mm Hg.
To account for missing values, multiple imputations were performed. Stepwise multivariable Cox regression and logistic regression were used for all-cause mortality and bioprosthesis valve dysfunction was used, respectively. Sensitivity analysis retaining only patients with complete data were also performed.
Of 12,804 patients included in the registry between January 1, 2013, and December 31, 2015, a total of 11,469 (mean ± SE age: 82.8 ± 0.07 years; logistic European System for Cardiac Operative Risk Evaluation: 17.8 ± 0.1%; mean duration of follow-up: 495 ± 3.5 days) were alive at discharge with known antithrombotic treatment and were analyzed for mortality. A total of 2,555 patients had at least 2 echocardiographic evaluations and were eligible for BVD assessment. One-third of patients had a history of atrial fibrillation, and the same proportion had oral anticoagulation at discharge (n = 3,836). Neither aspirin nor clopidogrel was independently associated with mortality. Male sex (adjusted hazard ratio [aHR]: 1.63; 95% confidence interval [CI]: 1.44 to 1.84; p < 0.001), history of atrial fibrillation (aHR: 1.41; 95% CI: 1.23 to 1.62; p < 0.001), and chronic renal failure (aHR: 1.37; 95% CI: 1.23 to 1.53; p < 0.001) were the strongest independent correlates of mortality. Anticoagulation at discharge (adjusted odds ratio [aOR]: 0.54; 95% CI: 0.35 to 0.82; p = 0.005) and a nonfemoral approach (aOR: 0.53; 95% CI: 0.28 to 1.02; p = 0.049) were independently associated with lower rates of BVD, whereas chronic renal failure (aOR: 1.46; 95% CI: 1.03 to 2.08; p = 0.034) and prosthesis size ≤23 mm (aOR: 3.43; 95% CI: 2.41 to 4.89; p < 0.001) yielded higher risk of BVD.
Sex, renal failure, and atrial fibrillation affected mortality the most at the 3-year follow-up. In contrast, anticoagulation (mostly given for atrial fibrillation) decreased the risk of BVD after TAVR.
经导管主动脉瓣置换术（TAVR）后的最佳抗栓治疗仍存在争议。尽管推荐双联抗血小板治疗，但根据患者情况，常采用单联抗血小板治疗或口服抗凝治疗。尚不清楚这种方法是否会影响临床结局。
FRANCE TAVI（法国经导管主动脉瓣植入术）是一项前瞻性、多中心、全国性的法国注册研究。本研究的目的是确定长期全因死亡率和早期生物瓣功能障碍（BVD）的独立相关因素，定义为人工瓣膜跨瓣压差增加≥10mmHg或新压差增加≥20mmHg。
为了处理缺失值，进行了多次插补。采用逐步多变量Cox 回归和逻辑回归分别对全因死亡率和生物假体瓣膜功能障碍进行分析。还进行了仅保留完整数据患者的敏感性分析。
在 2013 年 1 月 1 日至 2015 年 12 月 31 日期间，共纳入 12804 例患者，其中 11469 例（平均年龄±SE：82.8±0.07 岁；欧洲心脏手术风险评估系统的逻辑评分：17.8±0.1%；平均随访时间：495±3.5 天）在出院时存活并已知抗栓治疗，用于死亡率分析。共有 2555 例患者至少有 2 次超声心动图评估，符合 BVD 评估条件。三分之一的患者有房颤病史，出院时同样比例的患者接受口服抗凝治疗（n=3836）。阿司匹林和氯吡格雷均与死亡率无关。男性（校正危险比[aHR]：1.63；95%置信区间[CI]：1.44 至 1.84；p<0.001）、房颤病史（aHR：1.41；95% CI：1.23 至 1.62；p<0.001）和慢性肾功能衰竭（aHR：1.37；95% CI：1.23 至 1.53；p<0.001）是死亡率的最强独立相关因素。出院时抗凝治疗（校正比值比[aOR]：0.54；95% CI：0.35 至 0.82；p=0.005）和非股动脉入路（aOR：0.53；95% CI：0.28 至 1.02；p=0.049）与较低的 BVD 发生率相关，而慢性肾功能衰竭（aOR：1.46；95% CI：1.03 至 2.08；p=0.034）和假体尺寸≤23mm（aOR：3.43；95% CI：2.41 至 4.89；p<0.001）则与较高的 BVD 风险相关。
在 3 年随访中，性别、肾功能衰竭和房颤对死亡率的影响最大。相比之下，抗凝治疗（主要用于房颤）降低了 TAVR 后的 BVD 风险。
