Landi Antonio, Branca Mattia, Vranckx Pascal, Leonardi Sergio, Frigoli Enrico, Heg Dik, Calabro Paolo, Esposito Giovanni, Sardella Gennaro, Tumscitz Carlo, Garducci Stefano, Andò Giuseppe, Limbruno Ugo, Sganzerla Paolo, Santarelli Andrea, Briguori Carlo, de la Torre Hernandez Jose M, Pedrazzini Giovanni, Windecker Stephan, Valgimigli Marco
Division of Cardiology, Cardiocentro Ticino Institute, Ente Ospedaliero Cantonale, Lugano, Switzerland.
Clinical Trials Unit, Faculty of Medicine, University of Bern, Bern, Switzerland.
Can J Cardiol. 2022 Oct;38(10):1488-1500. doi: 10.1016/j.cjca.2022.06.014. Epub 2022 Jun 24.
The comparative effectiveness of transradial (TRA) compared with transfemoral (TFA) access in acute coronary syndrome (ACS) patients undergoing complex percutaneous coronary intervention (PCI) remains unclear.
Among 8404 ACS patients in the Minimising Adverse Haemorrhagic Events by Transradial Access Site and Systemic Implementation of AngioX (MATRIX)-Access trial, 5233 underwent noncomplex (TRA: n = 2590; TFA: n = 2643) and 1491 complex (TRA: n = 777; TFA: n = 714) PCI. Co-primary outcomes were major adverse cardiovascular events (MACE, the composite of all-cause mortality, myocardial infarction, or stroke) and the composite of MACE and Bleeding Academic Research Consortium (BARC) type 3 or 5 bleeding (net adverse cardiovascular events [NACE]) at 30 days.
Rates of 30-day MACE (HR 0.94, 95% CI 0.72-1.22) or NACE (HR 0.89, 95% CI 0.69-1.14) did not significantly differ between groups in the complex PCI group, whereas both primary end points were lower (HR 0.84, 95% CI 0.70-1.00; HR 0.83, 95% CI 0.70-0.98; respectively) with TRA among noncomplex PCI patients, with negative interaction testing (P = 0.473 and 0.666, respectively). Access-site BARC type 3 or 5 bleeding was lower with TRA, consistently among complex (HR 0.18, 95% CI 0.05-0.63) and noncomplex (HR 0.41, 95% CI 0.20-0.85) PCI patients, whereas the former group had a greater absolute risk reduction of 1.7% (number needed to treat: 59) owing to their higher absolute risk.
Among ACS patients, PCI complexity did not affect the comparative efficacy and safety of TRA vs TFA, whereas the absolute risk reduction of access-site major bleeding was greater with TRA compared with TFA in complex as opposed to noncomplex PCI.
在接受复杂经皮冠状动脉介入治疗(PCI)的急性冠状动脉综合征(ACS)患者中,经桡动脉(TRA)与经股动脉(TFA)入路的相对有效性仍不明确。
在“通过桡动脉入路部位及AngioX系统实施最小化不良出血事件”(MATRIX-Access)试验的8404例ACS患者中,5233例接受了非复杂PCI(TRA:n = 2590;TFA:n = 2643),1491例接受了复杂PCI(TRA:n = 777;TFA:n = 714)。共同主要结局为30天时的主要不良心血管事件(MACE,全因死亡、心肌梗死或中风的复合终点)以及MACE与出血学术研究联盟(BARC)3型或5型出血的复合终点(净不良心血管事件[NACE])。
在复杂PCI组中,两组间30天MACE(风险比[HR]0.94,95%置信区间[CI]0.72 - 1.22)或NACE(HR 0.89,95% CI 0.69 - 1.14)发生率无显著差异,而在非复杂PCI患者中,TRA组的两个主要终点均较低(分别为HR 0.84,95% CI 0.70 - 1.00;HR 0.83,95% CI 0.70 - 0.98),交互检验为阴性(P分别为0.473和0.666)。TRA组的入路部位BARC 3型或5型出血较低,在复杂PCI患者(HR 0.18,95% CI 0.05 - 0.63)和非复杂PCI患者(HR 0.41,95% CI 0.20 - 0.85)中均如此,而前一组由于其绝对风险较高,绝对风险降低幅度更大,为1.7%(需治疗人数:59)。
在ACS患者中,PCI的复杂性不影响TRA与TFA的相对疗效和安全性,而与非复杂PCI相比,在复杂PCI中TRA导致的入路部位大出血绝对风险降低幅度更大。