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Distal Radial Access vs Transradial Access in Patients With ST-Segment Elevation Myocardial Infarction: The DRAMI
Jun-Won Lee1, Chan Joon Kim2, Bong-Ki Lee3
1Division of Cardiology, Department of Internal Medicine, Wonju Severance Christian Hospital, Yonsei University Wonju College of Medicine, Wonju, South Korea.
Insights
Distal radial access (DRA) was not found to be noninferior to transradial access (TRA) for puncture success in ST-elevation myocardial infarction (STEMI) patients. However, both methods demonstrated similar safety and effectiveness in primary percutaneous coronary intervention (PCI).
Area of Science:
- Cardiology
- Interventional Cardiology
- Vascular Access
Background:
- Distal radial access (DRA) is an emerging alternative to transradial access (TRA) for coronary procedures.
- Limited evidence exists for DRA's efficacy in ST-segment elevation myocardial infarction (STEMI) patients.
Purpose of the Study:
- To evaluate if DRA is noninferior to TRA in STEMI patients undergoing primary percutaneous coronary intervention (PCI).
Main Methods:
- A multicenter, open-label, randomized controlled trial involving 354 STEMI patients.
- Patients were randomized to DRA or TRA, with puncture success rate as the primary endpoint.
- Noninferiority was tested using intention-to-treat, per-protocol, and as-treated analyses.
Main Results:
- The puncture success rate was 94.3% for DRA versus 96.1% for TRA (intention-to-treat analysis).
- DRA failed to demonstrate noninferiority in intention-to-treat and per-protocol analyses.
- Noninferiority was observed in the as-treated population; procedural success and safety were comparable between groups.
Conclusions:
- Distal radial access (DRA) did not meet noninferiority criteria for puncture success compared to transradial access (TRA) in STEMI patients.
- Both access routes exhibited similar procedural efficacy and safety profiles.
- Larger, powered studies are needed to confirm these findings and further validate DRA in STEMI.
Background:
Distal radial access (DRA) has emerged as an alternative to transradial access (TRA) in coronary procedures. However, evidence supporting its use in ST-segment elevation myocardial infarction (STEMI) remains limited.
Objectives:
The purpose of this study was to assess whether DRA is noninferior to TRA in patients undergoing primary percutaneous coronary intervention (PCI) for STEMI.
Methods:
This multicenter, open-label, randomized controlled trial was conducted at 3 centers in South Korea. Patients undergoing primary PCI for STEMI were randomly assigned to either the DRA or TRA group. The primary endpoint was the puncture success rate. A noninferiority testing with a prespecified margin of 5.65% was performed in the intention-to-treat, per-protocol, and as-treated populations (NCT03611725).
Results:
From August 2018 to February 2023, 354 patients were randomized to DRA (n = 176) or TRA (n = 178). The primary endpoint, puncture success rate was 94.3% in DRA and 96.1% in TRA (difference -1.75%; 95% CI -6.20% to 2.71%) in the intention-to-treat analysis. The per-protocol analysis also failed to demonstrate noninferiority (difference -1.72%; 95% CI -5.99% to 2.54%). DRA demonstrated noninferiority to TRA in the as-treated population (difference -1.17%; 95% CI -5.56% to 3.22%). The rates of successful coronary angiography and PCI, access-site crossover, and bleeding complications were comparable between groups. One radial artery occlusion occurred in TRA group at 1-month follow-up.
Conclusions:
In STEMI patients, DRA failed to demonstrate noninferiority to TRA in terms of puncture success. However, both access routes showed comparable procedural efficacy and safety. Further validation with a larger, adequately powered study is required to confirm these findings.
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