Lima Fabio V, Gruberg Luis, Aslam Usman, Ramgadoo Melissa, Clase Kydanis, Trevisan Alessandra, Jeremias Allen
Department of Medicine, Brown University Rhode Island Hospital, Providence, Rhode Island.
Department of Cardiology, Hofstra Northwell School of Medicine, Northwell Health, Southside Hospital, Bay Shore, New York.
J Interv Cardiol. 2018 Apr;31(2):177-184. doi: 10.1111/joic.12462. Epub 2017 Dec 4.
To compare bleeding and clinical events of patients with stable angina or silent ischemia undergoing percutaneous coronary intervention (PCI) treated with unfractionated heparin (UFH) or bivalirudin.
Few direct comparisons between UFH monotherapy versus bivalirudin exist for patients with stable ischemic heart disease undergoing PCI.
A prospective, investigator-initiated, single-center, single-blinded, randomized trial of UFH versus bivalirudin was conducted. The primary endpoint was all bleeding (major and minor) from index-hospitalization to 30 days post discharge. Secondary endpoints included major adverse cerebral and cardiovascular events (MACCE) and net adverse clinical events (NACE).
Two-hundred-sixty patients were randomized for treatment with either UFH (n = 123) (47%) or bivalirudin (n = 137) (53%) There were no significant differences in baseline clinical and angiographic characteristics between the two groups. Primary endpoint was similar in both groups (10.9% with bivalirudin vs 7.3% with UFH [P = 0.31]). Major bleeding rates were 5.8% and 2.4%, respectively (P = 0.17). There was a higher MACCE (3.5% vs 0%, P = 0.03) and NACE (8.8% vs 2.4%, P = 0.03) rate with bivalirudin compared to UFH, respectively. Bivalirudin had increased odds of NACE (OR = 3.65, 95% CI: 1.00-13.3.6). Death and stent thrombosis rates were low and similar in both groups. Radial access was associated with fewer bleeding events compared to femoral access but not statistically significant (P = 0.29).
Among patients with stable angina or silent ischemia, there was no difference between UFH and bivalirudin in bleeding rates up to 30-days post-PCI. MACCE and NACE were higher among the bivalirudin group. Radial access was associated with a numerically lower rate of bleeding compared with femoral access.
比较接受普通肝素（UFH）或比伐卢定治疗的稳定性心绞痛或无症状性心肌缺血患者在接受经皮冠状动脉介入治疗（PCI）时的出血情况和临床事件。
对于接受PCI的稳定性缺血性心脏病患者，UFH单药治疗与比伐卢定之间的直接比较较少。
开展一项由研究者发起的前瞻性、单中心、单盲、随机试验，比较UFH与比伐卢定。主要终点是从住院到出院后30天的所有出血（大出血和小出血）。次要终点包括主要不良脑和心血管事件（MACCE）和净不良临床事件（NACE）。
260例患者被随机分为UFH治疗组（n = 123）（47%）或比伐卢定治疗组（n = 137）（53%）。两组间基线临床和血管造影特征无显著差异。两组主要终点相似（比伐卢定组为10.9%，UFH组为7.3% [P = 0.31]）。大出血率分别为5.8%和2.4%（P = 0.17）。与UFH相比，比伐卢定组的MACCE（3.5% 对0%，P = 0.03）和NACE（8.8% 对2.4%，P = 0.03）发生率更高。比伐卢定的NACE发生几率增加（OR = 3.65，95% CI：1.00 - 13.36）。两组的死亡率和支架血栓形成率较低且相似。与股动脉入路相比，桡动脉入路的出血事件较少，但无统计学意义（P = 0.29）。
在稳定性心绞痛或无症状性心肌缺血患者中，PCI术后30天内UFH和比伐卢定的出血率无差异。比伐卢定组的MACCE和NACE较高。与股动脉入路相比，桡动脉入路的出血率在数值上较低。
