• Short-Term Use of Rivaroxaban Can Reduce RAO Incidences by Half, Trial Suggests

    Short-term use of rivaroxaban can reduce incidences of radial artery occlusion (RAO) by 50%, according to a study presented at the Transcatheter Cardiovascular Therapeutics (TCT) 2022 conference in Boston.

    The RIVARAD trial found a 10-mg dose of rivaroxaban given to patients for 7 days after undergoing a transradial coronary procedure did reduce RAO incidences at 30 days vs. control group (6.9% versus 13%; p=0.011, odds ratio [OR], 0.5; 95% confidence interval [CI], 0.27–0.91).

    “It could be a good option to prevent RAO, considering the increase in the number of ambulatory procedures,” said Rania Hammami, MD, from Hedi Chaker Hospital, Sfax, Tunisia.

    “However, interventional cardiologists must make more effort in respect of preventive measures for this complication by implementing the guidelines of TRA best practices.”

    RAO remains the most frequent complication of transradial access (TRA). However, once the radial artery is occluded, its use as an access site for coronary procedures or as a conduit for coronary bypass grafting or fistula for hemodialysis is limited.

    The incidence of RAO post-TRA ranges between 0.8% and 33% in observational and randomized trials and is dependent on the timing and the assessment method of radial artery patency.

    Study details

    The Philadelphia Pharma-funded trial adopted an interventional, prospective, open-label, randomized approach that took place in five Tunisian public centers between November 2021 and March 2022.

    Patients were aged between 18 and 80 years and underwent either a coronary angiography or percutaneous coronary intervention (PCI) by TRA.

    Mean age for the rivaroxaban group was 59.41±10 years, and for the control group was 60.1±9 years. Out of the 521 patients eligible for the study, 169, or 32%, were female.

    These patients were then randomly assigned to either the rivaroxaban group (n=259) or the control group (n=262, receiving standard treatment care with no rivaroxaban given).

    The primary endpoint identified was the rate of RAO at 30 days, assessed by ultrasound examination in the wrist.

    The secondary endpoints were the incidence of hemorrhagic events at 30 days, as defined by Bleeding Academic Research Consortium (BARC) criteria and classification, and local complications identified at the puncture point (aneurysm, hematoma, arterio-veinous fistula) also at 30 days.

    RAO incidences

    The study team found RAO incidence in the rivaroxaban group at 30 days to be 6.9% compared to 13% RAO incidence in the control group (OR, 0.5; 95% CI 0.27-0.91]; p=0.011). Overall RAO incidence was 10%.

    Further findings revealed the proportion of patients without a palpable radial pulse at 30 days was 5.8% in the rivaroxaban group and 12.2% in the control group (P=0.01).

    “There was a discrepancy between clinical examination findings and ultrasound findings in 19 patients (3.6%),” Hammami said.

    “In 12 patients, we were able to palpate a radial pulse, but the Doppler ultrasound showed an occlusion of the artery, while in seven patients, we did not find a radial pulse even though the artery was patent on ultrasound examination.”

    Bleeding events

    Commenting on bleeding events observed during the trial, the study team noted 12 cases (2.3%) of minor bleeding (BARC 1) (epistaxis [n=7], gingivorrhagia [n=2] and hemoptotic sputum [n=3]).

    Minor bleeding occurred in four patients, who were treated with dual antiplatelet therapy (DAPT) and rivaroxaban, three patients were treated with aspirin and rivaroxaban, while another three patients were treated with DAPT. Only two patients were treated with aspirin only.

    “We did not observe any hemorrhagic complications in patients treated with rivaroxaban alone,” Hammami added.

    Incidences and hemorrhagic complications at 30 days occurred in 2.7% of patients in the rivaroxaban group and 1.9% in the control group (OR, 1.4; 95% CI, 0.44-4.5; p=0.54).

    “RIVARAD is the first multicentric randomized trial with 30-day RAOs as the primary endpoint, which proved the efficacy of short-term use of rivaroxaban in preventing RAO in real-world daily practice  using the radial approach,” Hammami concluded.

    Image Credit: Jason Wermers/CRTonline.org

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