Pinxterhuis Tineke H, Ploumen Eline H, Kok Marlies M, Schotborgh Carl E, Anthonio Rutger L, Roguin Ariel, Danse Peter W, Benit Edouard, Aminian Adel, Hartmann Marc, Linssen Gerard C M, Geelkerken Robert H, Doggen Carine J M, von Birgelen Clemens
Department of Cardiology, Thoraxcentrum Twente, Medisch Spectrum Twente, University of Twente, Koningsplein 1, 7512 KZ, Enschede, The Netherlands.
Health Technology and Services Research, Faculty BMS, Technical Medical Centre, University of Twente, Enschede, The Netherlands.
Cardiovasc Interv Ther. 2025 Apr;40(2):287-295. doi: 10.1007/s12928-024-01073-7. Epub 2024 Dec 19.
Patients undergoing percutaneous coronary intervention (PCI) may experience bleeding events. Bleeding risk is increased in patients with comorbid peripheral arterial disease (PADs). To evaluate whether PCI patients with PADs have worse outcome after bleeding, we assessed pooled patient-level data of 5,989 randomized all-comer trial participants and identified those who had a bleeding (BIO-RESORT:NCT01674803, BIONYX:NCT02508714). Major adverse cardiac events (MACE) and mortality were assessed from bleeding until 3 years after PCI. Of all 313 PCI patients with bleeding events, patients with PADs (n = 34, 10.9%) were older and had more complex lesions than those without PADs (n = 279, 89.1%). In patients with PADs, bleeding occurred more often during the first year after PCI (79.4% vs. 57.3%, p = 0.013). The proportion of major bleeding, and the severity and location of bleeding were similar between both groups. Multivariate analysis found no statistically significant between-group difference in MACE (43.1% vs. 34.7%, p = 0.53; adj.HR:0.86, 95%CI 0.45-1.63, p = 0.64) and mortality (33.5% vs. 22.3%, p = 0.12; adj.HR:1.45, 95%CI 0.73-2.91, p = 0.29). Bleeding occurred significantly more often during the first year after PCI in all-comer patients with concomitant PADs than in those without PADs, while we observed no significant between-group difference in bleeding severity and location, and the risk of adverse events after bleeding.
接受经皮冠状动脉介入治疗（PCI）的患者可能会发生出血事件。合并外周动脉疾病（PADs）的患者出血风险会增加。为了评估患有PADs的PCI患者出血后是否有更差的预后，我们评估了5989名随机入选的所有患者试验参与者的汇总患者水平数据，并确定了那些发生出血的患者（BIO-RESORT：NCT01674803，BIONYX：NCT02508714）。评估从出血到PCI后3年的主要不良心脏事件（MACE）和死亡率。在所有313例发生出血事件的PCI患者中，患有PADs的患者（n = 34，10.9%）比没有PADs的患者（n = 279，89.1%）年龄更大且病变更复杂。在患有PADs的患者中，出血更常发生在PCI后的第一年（79.4%对57.3%，p = 0.013）。两组之间的大出血比例、出血严重程度和部位相似。多变量分析发现，两组之间在MACE（43.1%对34.7%，p = 0.53；校正风险比：0.86，95%置信区间0.45 - 1.63，p = 0.64）和死亡率（33.5%对22.3%，p = 0.12；校正风险比：1.45，95%置信区间0.73 - 2.91，p = 0.29）方面没有统计学上的显著差异。在所有伴有PADs的患者中，出血在PCI后的第一年明显比没有PADs的患者更频繁发生，而我们观察到两组之间在出血严重程度和部位以及出血后不良事件风险方面没有显著差异。
