Durand Eric, Verrez Thibault, Gillibert Andre, Levesque Thomas, Barbe Thomas, Koning René, Motreff Pascal, Eltchaninoff Hélène, Collet Jean-Philippe, Rangé Gregoire
Department of Cardiology, Normandie Univ, UNIROUEN, U1096, CHU Rouen, Rouen, France.
Department of Biostatistics, Normandie Univ, CHU Rouen, Rouen, France.
Front Cardiovasc Med. 2024 Jan 16;10:1320001. doi: 10.3389/fcvm.2023.1320001. eCollection 2023.
Dual antithrombotic therapy (DAT) combining oral anticoagulation (OAC), preferentially Non-vitamin K antagonist OAC (NOAC) and single antiplatelet therapy (SAPT) for a period of 6-12 months is recommended after percutaneous coronary intervention (PCI) in patients with an indication for OAC.
To compare outcomes between vitamin K antagonist (VKA) and NOAC-treated patients in the nation-wide France PCI registry.
All consecutive patients from the France PCI registry treated by PCI and discharged with OAC between 2014 and 2020 were included and followed one-year. Major bleeding was defined as Bleeding Academic Research Consortium (BARC) classification ≥3 and major adverse cardiac events (MACE) as the composite of all-cause mortality, myocardial infarction (MI), and ischemic stroke. A propensity-score analysis was used.
Of the 7,277 eligible participants, 2,432 (33.4%) were discharged on VKA and 4,845 (66.6%) on NOAC. After propensity-score adjustment, one-year major bleeding was less frequent in NOAC vs. VKA-treated participants [3.1% vs. 5.2%, -2.1% (-3.6% to -0.6%), = 0.005 as well as the rate of MACE [9.2% vs. 11.9%, -2.7% (-5.0% to -0.4%), = 0.02]. One-year mortality was also significantly decreased in NOAC vs. VKA-treated participants [7.4% vs. 9.9%, -2.6% (-4.7% to -0.5%), = 0.02]. The area under ROC curves of the anticoagulant treatment propensity score was estimated at 0.93, suggesting potential indication bias.
NOAC seems to have a better efficacy and safety profile than VKA. However, potential indication bias were found.
对于有口服抗凝治疗（OAC）指征的患者，经皮冠状动脉介入治疗（PCI）后推荐采用双抗血栓治疗（DAT），即口服抗凝药（OAC）联合单药抗血小板治疗（SAPT），优先选用非维生素K拮抗剂口服抗凝药（NOAC），疗程为6至12个月。
在法国全国性PCI注册研究中比较维生素K拮抗剂（VKA）和接受NOAC治疗患者的结局。
纳入2014年至2020年间法国PCI注册研究中所有接受PCI治疗并出院时接受OAC治疗的连续患者，并随访一年。大出血定义为出血学术研究联盟（BARC）分类≥3级，主要不良心脏事件（MACE）定义为全因死亡、心肌梗死（MI）和缺血性卒中的复合事件。采用倾向评分分析。
在7277名符合条件的参与者中，2432名（33.4%）出院时接受VKA治疗，4845名（66.6%）接受NOAC治疗。经过倾向评分调整后，接受NOAC治疗的参与者1年大出血发生率低于接受VKA治疗的参与者[3.1%对5.2%，-2.1%（-3.6%至-0.6%），P = 0.005]，MACE发生率也较低[9.2%对11.9%，-2.7%（-5.0%至-0.4%），P = 0.02]。接受NOAC治疗的参与者1年死亡率也显著低于接受VKA治疗的参与者[7.4%对9.9%，-2.6%（-4.7%至-0.5%），P = 0.02]。抗凝治疗倾向评分的ROC曲线下面积估计为0.93，提示可能存在指征偏倚。
NOAC似乎比VKA具有更好的疗效和安全性。然而，发现了潜在的指征偏倚。
