BACKGROUND Accurate bleeding risk stratification after percutaneous coronary intervention (PCI) is important for treatment individualization. However, there is still an unmet need for a more precise and standardized identification of high bleeding risk patients. We derived and validated a novel bleeding risk score by augmenting the PRECISE-DAPT score with the Academic Research Consortium for High Bleeding Risk (ARC-HBR) criteria. METHODS The derivation cohort comprised 29,188 patients undergoing PCI, of whom 1136 (3.9%) had a Bleeding Academic Research Consortium (BARC) 3 or 5 bleeding at 1 year, from four contemporary real-world registries and the XIENCE V USA trial. The PRECISE-DAPT score was refitted with a Fine-Gray model in the derivation cohort and extended with the ARC-HBR criteria. The primary outcome was BARC 3 or 5 bleeding within 1 year. Independent predictors of BARC 3 or 5 bleeding were selected at multivariable analysis (p<0.01). The discrimination of the score was internally assessed with apparent validation and cross-validation. The score was externally validated in 4578 patients from the MASTER DAPT trial and 5970 patients from the STOPDAPT-2 total cohort. RESULTS The PRECISE-HBR score (age, estimated glomerular filtration rate, hemoglobin, white-blood-cell count, previous bleeding, oral anticoagulation, and ARC-HBR criteria) showed an area under the curve (AUC) for 1-year BARC 3 or 5 bleeding of 0.73 (95% CI, 0.71-0.74) at apparent validation, 0.72 (95% CI, 0.70-0.73) at cross-validation, 0.74 (95% CI, 0.68-0.80) in the MASTER DAPT, and 0.73 (95% CI, 0.66-0.79) in the STOPDAPT-2, with superior discrimination than the PRECISE-DAPT (cross-validation: Δ AUC, 0.01; p=0.02; MASTER DAPT: Δ AUC, 0.05; p=0.004; STOPDAPT-2: Δ AUC, 0.02; p=0.20) and other risk scores. In the derivation cohort, a cut-off of 23 points identified 11,414 patients (39.1%) with a 1-year BARC 3 or 5 bleeding risk ≥4%. An alternative version of the score, including acute myocardial infarction on admission instead of white-blood-cell count, showed similar predictive ability. CONCLUSIONS The PRECISE-HBR score is a contemporary, simple 7-item risk score to predict bleeding after PCI, offering a moderate improvement in discrimination over multiple existing scores. Further evaluation is required to assess its impact on clinical practice.

中文翻译：

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推导和验证 PRECISE-HBR 评分以预测经皮冠状动脉介入治疗后出血。


背景 经皮冠状动脉介入治疗 （PCI） 后准确的出血风险分层对于治疗个体化很重要。然而，对于更精确和标准化的高出血风险患者识别，仍然存在未满足的需求。我们通过使用高出血风险学术研究联盟 （ARC-HBR） 标准增加 PRECISE-DAPT 评分来推导出并验证了一种新的出血风险评分。方法 衍生队列包括 29,188 名接受 PCI 的患者，其中 1136 名 （3.9%） 在 1 年时出血学术研究联盟 （BARC） 3 或 5 次出血，来自四个当代真实世界登记处和 XIENCE V USA 试验。在推导队列中使用 Fine-Gray 模型对 PRECISE-DAPT 评分进行拟合，并使用 ARC-HBR 标准进行扩展。主要结局是 1 年内 BARC 3 或 5 出血。在多变量分析中选择 BARC 3 或 5 出血的独立预测因子 （p<0.01）。分数的区分度通过明显的验证和交叉验证进行内部评估。该评分在 MASTER DAPT 试验的 4578 例患者和 STOPDAPT-2 总队列的 5970 例患者中进行了外部验证。结果 PRECISE-HBR 评分（年龄、估计肾小球滤过率、血红蛋白、白细胞计数、既往出血、口服抗凝治疗和 ARC-HBR 标准）显示，1 年 BARC 3 或 5 出血的曲线下面积 （AUC） 为表观验证时为 0.73 （95% CI，0.71-0.74），交叉验证时为 0.72 （95% CI，0.70-0.73），MASTER DAPT 为 0.74 （95% CI，0.68-0.80）， 和 0.73 （95% CI，0.66-0.79） 在 STOPDAPT-2 中，比 PRECISE-DAPT 具有更好的鉴别力 （交叉验证： Δ AUC，0.01;p=0.02;主 DAPT：Δ AUC，0.05;p = 0.004;STOPDAPT-2： Δ AUC， 0.02;p=0。20） 和其他风险评分。在派生队列中，23 个点的临界值确定了 11,414 名患者 （39.1%） 具有 1 年 BARC 3 或 5 出血风险 ≥4%。该评分的替代版本，包括入院时的急性心肌梗死而不是白细胞计数，显示出类似的预测能力。结论 PRECISE-HBR 评分是一种现代的、简单的 7 项风险评分，用于预测 PCI 后出血，与多个现有评分相比，鉴别能力有中等程度的改善。需要进一步评估以评估其对临床实践的影响。