In an intention-to-treat and per-protocol analyses, Distal Radial Access’ (DRA) puncture success rate does not demonstrate non-inferiority to Transradial Access (TRA), according to results outlined in the DRAMI Trial. In more findings revealed at this year’s Transcatheter Cardiovascular Therapeutics (TCT) conference in Washington, DC, the investigative team also found in the as-treated analysis, DRA was shown to be significantly non-inferior to TRA regarding puncture success. Presented on Monday at TCT by Jun-Won Lee MD, PhD, of the Yonsei University Wonju College of Medicine, Wonju, South Korea, on behalf of the investigative team, this finding supports the use of DRA as a viable option for certain patients with ST-Segment Elevation Myocardial Infarction (STEMI) undergoing percutaneous coronary intervention (PCI). “TRA has long been the preferred access route for STEMI patients, effectively reducing bleeding and mortality,” said Lee from Yonsei University Wonju College of Medicine in South Korea. “However, the evidence for DRA remains sparse. Our goal with DRAMI was to fill this gap by providing a robust comparison and potentially expanding our toolkit for treating these critical cases.” Main findings The data showed that the puncture success rate, the primary endpoint, for DRA was inconclusive compared to TRA for the Intention-to-Treat analyses (Risk Difference [RD]: 95% Confidence Interval [CI]; -1.75 (-6.20 – 2.71); P=0.043). For the Per-Protocol Analyses the RD was -1.72 (-5.99 – 2.54) and P=0.036, suggesting that DRA did not consistently meet the strict non-inferiority threshold in these analyses. Findings for the as-treated Analysis suggested that DRA achieved significant non-inferiority relative to TRA (RD; -1.17 (-5.56 – 3.22); P=0.023). These findings also implied that in practical terms, DRA could be a viable access route, achieving similar puncture success rates to TRA. In discussing the results of the trial, Lee said, “To truly understand DRA’s potential in STEMI cases, we need a larger-scale, well-designed randomized controlled trial. Only then can we solidify the role of DRA in our clinical guidelines.” Background Historically, TRA has been the standard access route in PCI for STEMI patients, aiming to minimize bleeding complications and lower mortality rates. However, the evidence for DRA in emergency STEMI scenarios remains limited. TRA’s longstanding use has shown benefits, but DRA offers a potentially less invasive approach with similar outcomes. Dr. Lee referred to one study, featured in JACC Cardiovascular Interventions, where researchers assessed the efficacy of DRA compared to TRA for coronary angiography and interventions. The meta-analysis, which included 14 studies with 6,208 participants, found that DRA had a significantly lower risk of radial artery occlusion (RAO) both during hospitalization and at follow-up, with a number needed to treat (NNT) of approximately 30. However, DRA required more puncture attempts, longer procedural time and had a higher rate of access site crossover compared to TRA. Overall, DRA reduced the risk of RAO and EASY II hematomas, supporting its potential benefits despite the need for longer cannulation time. Study methods The trial enrolled 389 patients from three hospitals, where participants were aged 19 or older, diagnosed with STEMI, and scheduled for PCI with palpable distal radial and radial arteries. Of the initial 389 screened, 354 were randomized to either the DRA or TRA groups. After screening and exclusions, 178 patients were assigned to TRA and 176 to DRA, with intention-to-treat, per-protocol, and as-treated analyses conducted to assess outcomes. The trial’s primary endpoint was the puncture success rate, while secondary endpoints included the success rates of coronary angiography (CAG) and PCI among others. Image Caption: Jun-Won Lee, MD, PhD, speaks during a news conference Monday at the Transcatheter Cardiovascular Therapeutics (TCT) conference in Washington, DC. Image Credit: Bailey G. Salimes/CRTonline.org