Low dose rivaroxaban therapy in aspirin allergic patients undergoing percutaneous coronary intervention

Abstract

Abstract Aspirin in combination with a P2Y12 inhibitor is the mainstay of treatment post percutaneous coronary intervention (PCI) for coronary artery disease (CAD). However, patients who are allergic to or intolerant to aspirin pose a therapeutic challenge especially when encountered in the setting of acute coronary syndrome. Aspirin desensitization strategies have been used in clinical practice to build tolerance prior to coronary intervention but clearly are not practical in the setting of ACS or significant symptomatic CAD. Low dose rivaroxaban (2.5 mg twice a day) has been previously shown to be safe in combination with a P2Y12 inhibitor post ACS compared to aspirin. We therefore sought to see if low dose rivaroxaban is a safe and effective alternative to aspirin in patients post PCI who are unable to take aspirin.This study aims to compare the efficacy (Major adverse cardiovascular events (MACE)) and safety (Bleeding events as defined by Bleeding Academic Research Consortium (BARC) criteria) in patients with confirmed aspirin allergy who were treated with low dose rivaroxaban therapy in place of aspirin in combination with P2Y12 inhibitors post PCI. Methods This was a single center observational study which looked at 50 cases of patients with aspirin allergy (47 cases) or significant confirmed aspirin intolerance (3 cases) who underwent PCI between December 2017 and February 2022. Patients were advised to take low dose rivaroxaban 2.5 mg twice a day as an alternative to aspirin 75 mg once a day. A comparator group of 50 matched patients without aspirin allergy who underwent PCI during the same time period and treated with standard aspirin therapy (75mg) along with a P2Y12 inhibitor. Outcomes over follow-up were MACE (mortality, myocardial infarction, stroke, and unscheduled revascularisation) and bleeding events defined by–BARC criteria. Results The median age of the aspirin allergy cohort was 62 years old with typical comorbidities associated with CAD. The cohort included a case mix of ACS and stable angina.The P2Y12 inhibitor in the majority of cases (76%) was Clopidogrel; Ticagrelor was used in 20% of cases and Prasugrel in 4% cases. No differences existed between the rivaroxaban and matched patient groups. The median follow-up as 626 days (Interquartile range 237–549). The duration of low dose rivaroxaban therapy was for 12 months with a P2Y12 in 72%, 1–3 months for 22% and finally continued long term (with P2Y12 discontinuation at 12 months) in 6%. No difference existed in the incidence of MACE between the low dose rivaroxaban group (12%) compared to the matched cohort (10% p=0.266). No difference in bleeding outcomes (any bleeding event BARC type >0) were seen (14% in rivaroxaban and 16% in control, p=0.329). Conclusions This study provides more supporting evidence that low dose rivaroxaban therapy is an alternative to aspirin when used in combination with a P2Y12 inhibitor post PCI. Funding Acknowledgement Type of funding sources: None.