Coronary angiography is performed to evaluate for obstructive coronary artery disease. This is commonly performed via the transfemoral or transradial approach with the latter increasing in frequency. One of the most common complications of transradial access is radial artery occlusion occurring in \~5% of patients which prohibits the use of the radial artery in the future. There is evidence to support the use of intraprocedural anticoagulation to mitigate the risk of radial artery occlusion however the role of post-procedural anticoagulation has not been previously evaluated. Rivaroxaban is a direct oral anticoagulant (DOAC) with a safety profile superior to that of vitamin K antagonists. Given the safety profile, ease of use, and feasibility of DOAC therapy, our study will endeavor to evaluate the use of rivaroxaban 15mg orally once daily for 7 days after transradial access and the impact this has on the rate of radial artery occlusion.
Assessment of the coronary artery anatomy is commonly performed by coronary angiography (CA), which is the gold standard for evaluation of obstructive coronary artery disease (CAD). Coronary revascularization, opening of obstructed vessels, is most commonly performed by percutaneous coronary intervention (PCI) in patients with obstructive CAD. Traditionally, PCI is performed with implantation of one or more permanent metallic stents which act as a scaffold for arterial recoil and, in the case of drug eluting stents (DES), provide a platform for delivery of anti-proliferative agents. The transradial access (TRA) has rapidly emerged as the preferred vascular access site for CA and PCI with more than 50% of all coronary angiograms being performed via this approach. There are several advantages to TRA for angiography including rapid hemostasis, early ambulation after the procedure thereby improving patient comfort and experience, and a decrease in the length of hospital stay. There is also a reported reduction in all-cause mortality, major adverse cardiovascular events, major bleeding, and vascular complications with TRA as compared to transfemoral access. However, radial artery occlusion (RAO) remains an important complication of this procedure as it precludes the reuse of this artery for future transradial approaches as well as the use of the vessel as a conduit for coronary artery bypass grafting. Reports of RAO post-TRA has varied in the literature from \~4-10% in observational and randomized trials. In the largest systematic review published to date, the overall rate of RAO was 5.2% amongst the 46,631 subjects across 92 studies between 1989 and 2016. This systematic review also noted that the rate of early (i.e. \<7 days) vs. late (i.e. \>7 days) RAO was significantly higher which is suggestive of late recanalization in some patients. The factors which affect recanalization are not clear however standard of care involves administration of heparin during the procedure and patent hemostasis following the procedure. Patent hemostasis is performed by applying a delicate balance of pressure to prevent bleeding but not to the point of completely occlude the blood vessel and cessation of blood flow distally. Numerous trials have explored the role of anticoagulation during angiography to reduce RAO and a recently published systematic review and meta-analysis demonstrated more intensive anticoagulation is protective. Indeed, this remains an active area of research with numerous ongoing trials evaluating the effect of intensive or higher dose anticoagulation during the procedure for prevention of RAO. Additionally, there were higher rates of RAO with diagnostic angiography as opposed to PCI purportedly as the latter involves higher doses of anticoagulation. Direct oral anticoagulant (DOAC) therapy has provided a safer alternative with an improved bleeding profile over vitamin K antagonist anticoagulation therapy. The use of DOACs in cardiovascular medicine ranges from various conditions including stroke prevention in atrial fibrillation7-12 to venous thromboembolism13-16 to stable cardiovascular disease. While intraprocedural anticoagulation has been studied extensively, a course of anticoagulation therapy post-TRA has not been studied. Given the safety profile, ease of use, and feasibility of DOAC therapy, our study will endeavor to evaluate the use of rivaroxaban 15mg orally once daily for 7 days after transradial access and the impact this has on the rate of RAO. Should this study prove to be positive, this could impact our routine standard of care with respect to having a strategy which could reduce the rate of this complication thereby preserving the radial artery for future access and/or as a conduit for coronary artery bypass grafting.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
930
Patients will receive rivaroxaban 15mg orally daily for 7 days following transradial access.
Mayo Clinic
Rochester, Minnesota, United States
Kingston Health Sciences Center
Kingston, Ontario, Canada
University of Ottawa Heart Institute
Ottawa, Ontario, Canada
Primary efficacy outcome - rate of radial artery occlusion
Presence of radial artery occlusion at 30 days post-transradial access as determined by Doppler ultrasound assessment of the participant's radial artery in the wrist.
Time frame: 30 days
Primary safety outcome - International Society on Thrombosis and Haemostasis definition of major bleeding
Bleeding as defined by the International Society on Thrombosis and Haemostasis at 30 days.
Time frame: 30 days
All cause mortality
Death from any cause as determined by the treating physician
Time frame: 30 days
Stroke (ischemic or uncertain)
Stroke (ischemic or uncertain) as defined by a treating neurologist
Time frame: 30 days
Stroke (hemorrhagic)
Stroke (hemorrhagic) as defined by a treating neurologist
Time frame: 30 days
Fatal bleeding
Bleeding resulting in death as defined by treating physician
Time frame: 30 days
Symptomatic bleeding in a critical area or organ
Intracranial, intraspinal, intraocular, retroperitoneal, intra-articular or pericardial bleeding or intramuscular bleeding with compartment syndrome
Time frame: 30 days
Bleeding requiring medical attention
Any bleeding that requires participant to seek medical attention
Time frame: 30 days
GUSTO bleeding criteria
Bleeding as defined by the Global Utilization Of Streptokinase And Tpa For Occluded Arteries (GUSTO) criteria
Time frame: 30 days
TIMI bleeding criteria
Bleeding as defined by the Thrombolysis in Myocardial Infarction (TIMI) criteria
Time frame: 30 days
BARC bleeding criteria
Bleeding as defined by the Bleeding Academic Research Consortium (BARC) criteria
Time frame: 30 days
Myocardial infarction
Myocardial infarction as defined by the third universal definition of myocardial infarction.
Time frame: 30 days
Stent thrombosis
Stent thrombosis as determined by the academic research consortium criteria.
Time frame: 30 days
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