By John P. Vavalle, MD
The RADAR trial examined the safety and efficacy of the novel REG1 anticoagulation system, as compared to heparin, in patients with acute coronary syndrome being treated with an invasive approach. The REG1 anticoagulation system is comprised of a novel, aptamer-based factor IXa inhibitor (pegnivacogin) and its Watson-Crick base-pair antidote (anivamersen). This system allows for very rapid high-level anticoagulation that is titratable or even completely reversible within minutes depending on the dosing of the antidote. RADAR demonstrated that at least 50% reversal is needed for safe sheath removal from the femoral artery.
Our study sought to examine the differences in femoral arterial sheath management between the REG1 and heparin arms, and to explore whether REG1 could allow for very early safe sheath removal without an increase in vascular-access complications. Indeed, this study demonstrated that those randomized to REG1, as opposed to heparin, had much shorter times to sheath removal (26 min [18, 46]) vs. (210 min [102, 342]) without an increase in the median time to hemostasis, increased rates of vascular-access bleeding complications, or time to ambulation. Further studies are needed to determine if the shorter times to removal of the arterial sheath will lead to reductions in hospital length of stays or reduced costs in patients being treated invasively for acute coronary syndrome.
- Vavalle JP, Povsic TJ, Aberle LH, et al. Safety of Very Early Sheath Removal in Patients Treated With REG1 for Acute Coronary Syndromes: Insights From the RADAR Trial. J INVASIVE CARDIOL 2013;25(11):593-599.
A selection of articles on Anticoagulation and Arterial Sheath Removal:
- Weeks PA, Alkhateeb HM, Michaud SE, Diez JG. Evaluation of Bivalirudin Hyper- and Hypo-ACT Responses in the Setting of Percutaneous Coronary Intervention. J INVASIVE CARDIOL 2013;25(5):250-253.
- Cogar BD, Wayangankar SA, Abu-Fadel M, et al. Clinical Safety of Bivalirudin in Patients Undergoing Carotid Stenting. J INVASIVE CARDIOL 2012;24(5):202-205.
- Aronow HD. Heparin dose and harm: absence of evidence or evidence of absence? J Invasive Cardiol. 2012 Apr;24(4):157-8.J Invasive Cardiol. 2012 Apr;24(4):157-8.
- Arsanjani R, Khitri A, Hashemzadeh M, Movahed MR. Low-dose unfractionated heparin administration during intravascular ultrasound studies is safe even shortly after endomyocardial biopsy in cardiac transplant patients. J Invasive Cardiol. 2012 Apr;24(4):154-6.
- Singh A, Edasery D, Noor A, Bhasin N, Kaplan B, Jauhar R. Use of low-dose heparin with bivalirudin for ad-hoc transradial coronary interventions: experience from a single center. J Invasive Cardiol. 2011 Mar;23(3):101-4.