Comparison of puncture success rate between distal radial access and transradial access in patients with ST-elevation myocardial infarction (DRAMI)
Reported from TCT 2024
Aaysha Cader provides her take on the DRAMI trial presented by Jun-Won Lee at TCT 2024 in Washington.
Why this study - the rationale/objective?
Distal radial access (DRA) has emerged as an alternative access for coronary interventions, with advantages of reduced radial artery occlusion (RAO) and haematoma, as compared to conventional transradial access (TRA)1. However, DRA is associated with longer puncture times and a higher number of puncture attempts1. In STEMI and emergency procedures such as primary PCI, wherein rapid access and short door to wire time is paramount, the rationale for DRA is less clear.
The DRAMI trial was designed to address the initial step of puncture success rates between DRA and TRA2.
How was it executed - the methodology
The DRAMI trial included STEMI patients undergoing PCI with palpable distal radial & radial arteries. Cardiogenic shock and prior thrombolytic therapy were excluded. Operators required at least 100 DRA puncture experience to participate, and they were advised to switch access site if puncture was not successful within 5 minutes.
The trial was powered for a non-inferiority margin of 5.64 % on the hypothesis that puncture success rate of DRA would be non-inferior to TRA.
The primary endpoint was puncture success rate. Secondary endpoints included bleeding complications, puncture time, procedure time, fluoroscopic time and dose, haemostasis time and MACE (all-cause death, any MI, any revascularisation) during 1 month.
What is the main result?
A total of 354 patients were randomised 1:1 to DRA vs TRA. Mean age was 63.3 ± 12.0 years, 80.8 % were men, 27.7 % were diabetic and 29.1 % had CKD. The majority (76 %) underwent left sided access initially (91.5 % DRA and 60.7 % TRA).
The primary endpoint, puncture success rate for DRA was 94.3 % vs 96.1 % for TRA, which did not meet non-inferiority in the intention-to-treat (p = 0.043) and per protocol (p = 0.036) analyses. However, in the as-treated analysis DRA was found to be non-inferior to TRA (p = 0.023) [P values for non-inferiority are < 0.025].
Angiography success rate was 100 % in both arms, with no differences in PCI success rate (99.4 % vs 100 % for DRA vs TRA, p = 0.371). A 5.4 % rate of crossover to alternate access was observed overall, which was numerically higher in the DRA arm (6.8 % vs 3.9 %, p = 0.228), predominantly owing to puncture failure. There were no differences in puncture time, the length of the procedure, fluoroscopic time or dose, haemostasis time, MACE or all-cause death.
Overall, no differences were observed in access site bleeding (2.3 % vs 3.4 % for DRA vs TRA, p = 0.492) and BARC types 1,2,3b bleeding. Radial artery occlusion was 0 % vs 0.6 % for DRA vs TRA at 1-month follow-up.
Critical reading and the relevance for clinical practice
The DRAMI trial investigated the important question of DRA in STEMI patients, which is a data-naïve space, as STEMI patients have been typically excluded from previous trials looking at DRA vs TRA. Given that the trial was designed for non-inferiority with an estimated puncture failure rate of 15 % of TRA in STEMI, the trial is essentially underpowered, as the actual TRA failure rate in the trial was only 3.9 %. Further statistical issues arise from a fixed non-inferiority margin in this setting, wherein actual event rates that are much lower than the anticipated event rates.
Nevertheless, the DRAMI trial demonstrated that DRA was safe and feasible in STEMI patients. However, operator experience is of paramount importance (the trial only allowed operators with at least > 100 DRA experience), particularly as rapid access is required in STEMI, and thus operators are likely encouraged to gather sufficient experience in DRA punctures in elective cases prior to embarking on STEMI. Interestingly, left radial access was more commonly used in this trial, both in DRA and TRA arm, which is not universal practice.
Finally, TRA is a Class I recommendation in STEMI as per guidelines3. In DRAMI, crossover rate of DRA and TRA overall to femoral access was only 2 %, with the majority of crossover (2.5 %) occurring on to ipsilateral TRA or DRA. Thus, one can infer that DRA is a safe secondary access over femoral access in STEMI.
References
- Ferrante G, Condello F, Rao SV, Maurina M, Jolly S, Stefanini GG, et al. Distal vs Conventional Radial Access for Coronary Angiography and/or Intervention: A Meta-Analysis of Randomized Trials. JACC Cardiovasc Interv. 2022 Nov 28;15(22):2297-2311.
- Presented at TCT 2024. Slides: https://www.tctmd.com/slide/comparison-puncture-success-rate-between-distal-radial-access-and-transradial-access-0
- Byrne RA, Rossello X, Coughlan JJ, Barbato E, Berry C, Chieffo A, et al; ESC Scientific Document Group. 2023 ESC Guidelines for the management of acute coronary syndromes. Eur Heart J. 2023 Oct 12;44(38):3720-3826. doi: 10.1093/eurheartj/ehad191. Erratum in: Eur Heart J. 2024 Apr 1;45(13):1145.
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