Department of Cardiovascular Medicine, Kurashiki Central Hospital, Kurashiki, Okayama, Japan
Department of Cardiology, Keio University, Tokyo, Japan.
Open Heart. 2023 Jan;10(1). doi: 10.1136/openhrt-2022-002172.
Postprocedural ischaemic and bleeding risks after transcatheter aortic valve replacement (TAVR) remain a major concern. Nevertheless, no reliable risk models incorporating both possibilities are currently available. We aimed to assess the accuracy of percutaneous coronary intervention (PCI)-derived models and the performance of a recalibrated model that included variables more applicable to TAVR.
This study included 26 869 patients who had been enrolled in a national registry. Ischaemic events were defined as myocardial infarction, stroke, transient ischaemic attack or peripheral embolism at 1 year. Bleeding events were defined as any bleeding based on the Valve Academic Research Consortium-2 consensus document at 1 year. Patterns of Non-adherence to Anti-Platelet Regimen in Stented Patients (PARIS) and Coronary Revascularisation Demonstrating Outcome Study in Kyoto (CREDO-Kyoto) integer scoring systems were tested. The models were recalibrated by applying new variables using the Fine and Gray method.
The 1-year cumulative incidences for ischaemic and bleeding events were 2.7% and 3.1%. Patients with high PARIS and CREDO-Kyoto risk scores had higher incidences of both ischaemic (3.3% vs 2.4% vs 2.4%, p<0.001 and 2.8% vs 2.0% vs 0.8%, p<0.001) and bleeding events (3.3% vs 2.5% vs 0.8%, p<0.001 and 3.7% vs 3.0% vs 2.4%, p<0.001) when compared with intermediate and low-risk patients. The receiver operating characteristic area under the curves for these models were 0.53, 0.58, 0.56 and 0.55, respectively. After the models were recalibrated to incorporate variables more applicable to TAVR, the performance of ischaemic and bleeding models modestly improved (0.58 and 0.61, respectively).
The PCI-derived models demonstrated modest accuracy but was inadequate for risk stratification of TAVR patients at 1-year follow-up.
经导管主动脉瓣置换术(TAVR)后,缺血和出血风险仍然是一个主要关注点。然而,目前尚无可靠的风险模型能够同时考虑这两种可能性。我们旨在评估经皮冠状动脉介入治疗(PCI)衍生模型的准确性,并评估包含更适用于 TAVR 的变量的重新校准模型的性能。
本研究纳入了 26869 名已登记于全国注册中心的患者。缺血事件定义为 1 年内心肌梗死、卒中和短暂性脑缺血发作或外周栓塞。出血事件定义为 1 年内基于 Valve Academic Research Consortium-2 共识文件的任何出血。测试了支架患者抗血小板治疗方案依从性模式(PARIS)和京都冠状动脉血运重建研究(CREDO-Kyoto)整数评分系统。通过应用 Fine 和 Gray 方法的新变量对模型进行重新校准。
1 年缺血和出血事件的累积发生率分别为 2.7%和 3.1%。PARIS 和 CREDO-Kyoto 风险评分高的患者,缺血(3.3%比 2.4%比 2.4%,p<0.001 和 2.8%比 2.0%比 0.8%,p<0.001)和出血事件(3.3%比 2.5%比 0.8%,p<0.001 和 3.7%比 3.0%比 2.4%,p<0.001)的发生率均较高。这些模型的受试者工作特征曲线下面积分别为 0.53、0.58、0.56 和 0.55。在重新校准模型以纳入更适用于 TAVR 的变量后,缺血和出血模型的性能略有改善(分别为 0.58 和 0.61)。
PCI 衍生模型的准确性一般,但不足以对 TAVR 患者 1 年随访时的风险分层。