Department of Cardiology, Bern University Hospital, Bern, Switzerland; Department of Advanced Biomedical Sciences, Federico II University of Naples, Naples, Italy.
Department of Cardiology, Bern University Hospital, Bern, Switzerland.
Rev Esp Cardiol (Engl Ed). 2020 Nov;73(11):893-901. doi: 10.1016/j.rec.2020.01.005. Epub 2020 Mar 6.
Patients who are vulnerable to hemodynamic or electrical disorders (VP) are often excluded from clinical trials and data on the optimal access-site or antithrombotic treatment are limited. We assessed outcomes of transradial vs transfemoral access and bivalirudin vs unfractionated heparin (UFH) in VP with acute coronary syndrome undergoing invasive management.
The MATRIX trial randomized 8404 patients to radial or femoral access and 7213 patients to bivalirudin or UFH. Among them, 934 (11.1%) were deemed VP due to advanced Killip class (n = 808), cardiac arrest (n = 168), or both (n = 42). The 30-day coprimary outcomes were major adverse cardiovascular and cerebrovascular events (MACE: death, myocardial infarction, or stroke) and net adverse clinical events (NACE: MACE or major bleeding).
MACE and NACE were similarly reduced with radial vs femoral access in VP and non-VP. Transradial access was also associated with consistent relative benefits in all-cause and cardiovascular mortality or Bleeding Academic Research Consortium (BARC) 3 or 5 bleeding with greater absolute benefits in VP. The effects of bivalirudin vs UFH on MACE and NACE were consistent in VP and non-VP. Bivalirudin was associated with lower all-cause and cardiovascular mortality in VP but not in non-VP, with borderline interaction testing. Bivalirudin reduced bleeding in both VP and non-VP with a larger absolute benefit in VP.
In acute coronary syndrome patients undergoing invasive management, the effects of randomized treatments were consistent in VP and non-VP, but absolute risk reduction with radial access and bivalirudin were greater in VP, with a 5- to 10-fold lower number needed to treat for benefits. Trial registry number: NCT01433627.
易发生血流动力学或电紊乱（VP）的患者通常被排除在临床试验之外，关于最佳入路或抗血栓治疗的数据也有限。我们评估了接受介入治疗的急性冠脉综合征合并 VP 患者行经桡动脉与经股动脉入路及比伐卢定与普通肝素（UFH）的治疗结局。
MATRIX 试验将 8404 例患者随机分为桡动脉或股动脉入路组，7213 例患者分为比伐卢定或 UFH 组。其中，934 例（11.1%）因高级 Killip 分级（n=808）、心搏骤停（n=168）或两者均有（n=42）被认为是 VP。30 天的主要复合终点是主要不良心血管和脑血管事件（MACE：死亡、心肌梗死或卒）和净不良临床事件（NACE：MACE 或主要出血）。
VP 和非 VP 患者中，经桡动脉入路与经股动脉入路相比，MACE 和 NACE 发生率均降低。在所有原因和心血管死亡率或 Bleeding Academic Research Consortium（BARC）3 或 5 级出血方面，经桡动脉入路也与相对获益一致，VP 患者的绝对获益更大。VP 和非 VP 患者中，比伐卢定与 UFH 相比，MACE 和 NACE 的效果一致。VP 患者中，比伐卢定与较低的全因和心血管死亡率相关，但非 VP 患者中无此相关性，有边缘交互检验。在 VP 和非 VP 患者中，比伐卢定降低了出血风险，VP 的绝对获益更大。
在接受介入治疗的急性冠脉综合征患者中，随机治疗的效果在 VP 和非 VP 患者中一致，但经桡动脉入路和比伐卢定的绝对风险降低在 VP 患者中更大，获益的治疗人数需要减少 5 至 10 倍。试验注册号：NCT01433627。
