Department of Internal Medicine (Di.M.I.), University of Genoa, Genoa, Italy.
Department of Translational Medical Sciences, University of Campania "Luigi Vanvitelli", Caserta, Italy; Division of Clinical Cardiology, Azienda Ospedaliera di Rilievo Nazionale "Sant'Anna e San Sebastiano", Caserta, Italy.
Int J Cardiol. 2024 Dec 15;417:132568. doi: 10.1016/j.ijcard.2024.132568. Epub 2024 Sep 14.
Tools for precise prediction of bleeding risk in patients undergoing percutaneous coronary intervention (PCI) with cangrelor are lacking.
Consecutive patients undergoing PCI and treated with cangrelor in 7 centers were retrospectively enrolled. The primary endpoint was Bleeding Academic Research Consortium (BARC) BARC 2, 3, or 5 bleeding 48 h after PCI. Predictors of BARC 2-5 bleeding were identified in a derivation cohort and combined into a numerical risk score. Discrimination and calibration were assessed in the derivation and validation cohorts. A threshold to define high bleeding risk (HBR) was identified and its diagnostic accuracy was compared with that of currently recommended bleeding risk scores.
1071 patients undergoing PCI with cangrelor were included. Fifty-four patients (5 %) experienced a BARC 2-5 bleeding, of whom 24 (44 %) from the access site. Age ≥ 75 years (odds ratio [OR] 2.58, 95 % confidence interval [CI] 1.21-5.48, p = 0.01), acute coronary syndrome at presentation (OR 8.14, 95 % CI 2.28-52, p = 0.01), and femoral access (OR 6.21, 95 % CI 2.71-14, p < 0.001) independently predicted BARC 2-5 bleeding at 48 h after PCI. The three items were combined to form a new risk score, the ICARUS score, showing good discrimination in both the derivation (area under the curve [AUC] 0.78) and internal validation (AUC 0.77) cohorts, and excellent calibration. An ICARUS score > 9 points accurately identified patients at HBR, showing better discrimination than other risk scores.
A risk score based on age, clinical presentation and access site, predicts the risk of periprocedural bleeding in patients receiving cangrelor (ClinicalTrials.gov ID: NCT05505591).
目前缺乏能够精确预测接受坎格雷洛经皮冠状动脉介入治疗(PCI)的患者出血风险的工具。
连续纳入 7 个中心接受 PCI 并接受坎格雷洛治疗的患者。主要终点是 PCI 后 48 小时内发生的 Bleeding Academic Research Consortium(BARC)BARC 2、3 或 5 型出血。在推导队列中确定 BARC 2-5 出血的预测因素,并将其组合成一个数值风险评分。在推导和验证队列中评估区分度和校准度。确定一个定义高出血风险(HBR)的阈值,并将其诊断准确性与目前推荐的出血风险评分进行比较。
共纳入 1071 例接受坎格雷洛 PCI 的患者。54 例(5%)发生 BARC 2-5 型出血,其中 24 例(44%)来自入路部位。年龄≥75 岁(比值比[OR]2.58,95%置信区间[CI]1.21-5.48,p=0.01)、就诊时为急性冠状动脉综合征(OR 8.14,95%CI 2.28-52,p=0.01)和股动脉入路(OR 6.21,95%CI 2.71-14,p<0.001)独立预测 PCI 后 48 小时的 BARC 2-5 型出血。这三个项目被组合成一个新的风险评分,即 ICARUS 评分,在推导(曲线下面积[AUC]0.78)和内部验证(AUC 0.77)队列中均具有良好的区分度,并且具有很好的校准度。ICARUS 评分>9 分准确识别出高危出血患者,比其他风险评分具有更好的区分度。
基于年龄、临床表现和入路部位的风险评分可预测接受坎格雷洛治疗的患者围手术期出血风险(临床试验注册号:NCT05505591)。