Population Health Research Institute, Hamilton, Ontario, Canada.
McMaster University, Hamilton, Ontario, Canada.
JAMA Cardiol. 2022 Nov 1;7(11):1110-1118. doi: 10.1001/jamacardio.2022.3399.
A significant limitation of femoral artery access for cardiac interventions is the increased risk of vascular complications and bleeding compared with radial access. Strategies to make femoral access safer are needed.
To determine whether routinely using ultrasonography guidance for femoral arterial access for coronary angiography/intervention reduces bleeding or vascular complications.
DESIGN, SETTING, AND PARTICIPANTS: The Routine Ultrasound Guidance for Vascular Access for Cardiac Procedures (UNIVERSAL) randomized clinical trial is a multicenter, prospective, open-label trial of ultrasonography-guided femoral access vs no ultrasonography for coronary angiography or intervention with planned femoral access. Patients were randomized from June 26, 2018, to April 26, 2022. Patients with ST-elevation myocardial infarction were not eligible.
Ultrasonography guidance vs no ultrasonography guidance for femoral arterial access on a background of fluoroscopic landmarking.
The primary composite outcome is the composite of major bleeding based on the Bleeding Academic Research Consortium 2, 3, or 5 criteria or major vascular complications within 30 days.
A total of 621 patients were randomized at 2 centers in Canada (mean [SD] age, 71 [10.24] years; 158 [25.4%] female). The primary outcome occurred in 40 of 311 patients (12.9%) in the ultrasonography group vs 50 of 310 patients (16.1%) without ultrasonography (odds ratio, 0.77 [95% CI, 0.49-1.20]; P = .25). The rates of Bleeding Academic Research Consortium 2, 3, or 5 bleeding were 10.0% (31 of 311) vs 10.7% (33 of 310) (odds ratio, 0.93 [95% CI, 0.55-1.56]; P = .78). The rates of major vascular complications were 6.4% (20 of 311) vs 9.4% (29 of 310) (odds ratio, 0.67 [95% CI, 0.37-1.20]; P = .18). Ultrasonography improved first-pass success (277 of 311 [86.6%] vs 222 of 310 [70.0%]; odds ratio, 2.76 [95% CI, 1.85-4.12]; P < .001) and reduced the number of arterial puncture attempts (mean [SD], 1.2 [0.5] vs 1.4 [0.8]; mean difference, -0.26 [95% CI, -0.37 to -0.16]; P < .001) and venipuncture (10 of 311 [3.1%] vs 37 of 310 [11.7%]; odds ratio, 0.24 [95% CI, 0.12-0.50]; P < .001) with similar times to access (mean [SD], 114 [185] vs 129 [206] seconds; mean difference, -15.1 [95% CI, -45.9 to 15.8]; P = .34). All prerandomization prespecified subgroups were consistent with the overall finding.
In this randomized clinical trial, use of ultrasonography for femoral access did not reduce bleeding or vascular complications. However, ultrasonography did reduce the risk of venipuncture and number of attempts. Larger trials may be required to demonstrate additional potential benefits of ultrasonography-guided access.
ClinicalTrials.gov Identifier: NCT03537118.
与桡动脉入路相比，股动脉入路进行心脏介入治疗的一个显著局限性是增加了血管并发症和出血的风险。需要制定使股动脉入路更安全的策略。
确定常规使用超声引导进行冠状动脉造影/介入治疗的股动脉入路是否减少出血或血管并发症。
设计、设置和参与者：常规超声引导用于心脏手术的血管入路（UNIVERSAL）是一项多中心、前瞻性、开放标签的临床试验，比较了超声引导与无超声引导用于计划股动脉入路的冠状动脉造影或介入治疗。患者于 2018 年 6 月 26 日至 2022 年 4 月 26 日随机分组。ST 段抬高型心肌梗死患者不符合条件。
股动脉入路的超声引导与透视标志下的无超声引导。
主要复合结局是基于 Bleeding Academic Research Consortium 2、3 或 5 标准的主要出血或 30 天内主要血管并发症的复合。
在加拿大的 2 个中心共随机分配了 621 名患者（平均[标准差]年龄 71[10.24]岁；158[25.4%]名女性）。在超声组，311 名患者中有 40 名（12.9%）发生主要结局，而 310 名无超声组患者中有 50 名（16.1%）（比值比，0.77[95%CI，0.49-1.20]；P = .25）。Bleeding Academic Research Consortium 2、3 或 5 级出血的发生率分别为 10.0%（31/311）和 10.7%（33/310）（比值比，0.93[95%CI，0.55-1.56]；P = .78）。主要血管并发症的发生率分别为 6.4%（20/311）和 9.4%（29/310）（比值比，0.67[95%CI，0.37-1.20]；P = .18）。超声检查提高了初次通过成功率（277/311[86.6%] vs 222/310[70.0%]；比值比，2.76[95%CI，1.85-4.12]；P < .001），减少了动脉穿刺次数（平均[标准差]，1.2[0.5] vs 1.4[0.8]；平均差异，-0.26[95%CI，-0.37 至-0.16]；P < .001）和静脉穿刺（311 例中 10 例[3.1%] vs 310 例中 37 例[11.7%]；比值比，0.24[95%CI，0.12-0.50]；P < .001），但到达时间相似（平均[标准差]，114[185] vs 129[206]秒；平均差异，-15.1[95%CI，-45.9 至 15.8]；P = .34）。所有预先设定的亚组均与总体结果一致。
在这项随机临床试验中，股动脉入路使用超声检查并没有减少出血或血管并发症。然而，超声检查确实降低了静脉穿刺和尝试次数的风险。可能需要更大规模的试验来证明超声引导入路的额外潜在益处。
ClinicalTrials.gov 标识符：NCT03537118。
