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Published on: October 12, 2012
Clinical Performance and Persistence on Dual Pathway Inhibition with Rivaroxaban and Aspirin in Real-World Setting
Vincenzo Russo1, Dario Fabiani1, Egidio Imbalzano2
1Cardiology Unit, Department of Medical Translational Sciences, University of Campania "Luigi Vanvitelli" - Monaldi Hospital, Naples, Italy.
Insights
Dual pathway inhibition (DPI) using low-dose rivaroxaban and aspirin is safe and effective for patients with coronary artery disease (CAD) and peripheral artery disease (PAD). This real-world study showed high adherence and persistence with minimal bleeding events.
Area of Science:
- Cardiology
- Vascular Medicine
- Pharmacology
Background:
- Dual pathway inhibition (DPI) with low-dose rivaroxaban and aspirin demonstrates efficacy in reducing cardiovascular events in stable atherosclerotic vascular disease.
- Real-world data on the clinical performance, adherence, and persistence of DPI therapy in patients with coronary artery disease (CAD) and peripheral artery disease (PAD) is limited.
Purpose of the Study:
- To evaluate the real-world clinical performance, adherence, and persistence of DPI therapy in patients diagnosed with CAD and/or PAD.
- To assess the safety profile, including bleeding events, associated with DPI therapy in this patient population.
Main Methods:
- Prospective observational study including consecutive patients with established CAD and/or PAD treated with aspirin (100 mg daily) and rivaroxaban (2.5 mg twice daily).
- Clinical evaluations were conducted at baseline, 1 month, and every 6 months post-initiation of DPI therapy.
- Data collected included adherence, persistence, and incidence of major and minor bleeding events, as well as major adverse cardiovascular events.
Main Results:
- A total of 202 patients were included, with a mean follow-up of 664 days.
- The incidence rate of major bleeding was 0.8 per 100 patients/year, and major adverse cardiovascular events was 1.1 per 100 patients/year.
- Adherence to pharmacological treatment was high at 99%, with 13.4% of patients discontinuing DPI therapy, primarily due to minor bleedings.
Conclusions:
- DPI with low-dose rivaroxaban and aspirin is safe and effective in a real-world setting for patients with CAD and PAD.
- The therapy demonstrates high persistence and adherence, with a low incidence of major bleeding events.
- Minor bleedings were the main reason for treatment discontinuation, highlighting the importance of monitoring and management.
Abstract:
The dual pathway inhibition (DPI) with low-dose rivaroxaban and aspirin in patients with stable atherosclerotic vascular disease reduces the occurrence of cardiovascular events, with no significant increase of intracranial or other critical organ bleedings. Our observational study aimed to describe the clinical performance, adherence, and persistence of DPI therapy among a real-world setting of patients with an established diagnosis of coronary artery (CAD) and/or peripheral artery disease (PAD). We prospectively included all consecutive patients with an established diagnosis of CAD and/or PAD treated with aspirin (ASA) 100 mg once daily and rivaroxaban 2.5 mg twice daily. Clinical evaluation was performed at baseline, before starting treatment, at 1 month, and every 6 months after the study drug administration. A total of 202 consecutive patients (mean age 66 ± 10 years; male 80%) eligible to DPI therapy were included. During a mean follow-up of 664 ± 177 days, the incidence rate of major bleedings and of major adverse cardiovascular events was 0.8 and 1.1 per 100 patients/year, respectively. The adherence to pharmacological treatment was 99%. Additionally, 13.4% of patients suspended the DPI therapy during the follow-up. Minor bleedings resulted the most common cause of both temporary and permanent DPI therapy discontinuation. This observational study supports the safety of DPI with low-dose rivaroxaban and aspirin among patients with CAD and PAD in a real-world setting, showing high persistence and maximum adherence to medical treatment.
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