PARIS Coronary Thrombosis Risk Score Combined With D-dimer to Guide New Oral Anticoagulant Antithrombotic Therapy in Patients With Acute Coronary Syndrome After Percutaneous Coronary Intervention: Rationale and design of the PRIDE-ACS trial

Abstract

AbstractBackgroundResidual thrombosis risk is an important contributor to ischemic events in patients with Acute Coronary Syndrome (ACS) after Percutaneous Coronary Intervention (PCI). Although previous studies have shown that rivaroxaban 2.5mg twice daily in ACS patients with high ischemic risk can significantly reduce the risk of ischemic recurrence and mortality, individualized treatment with low-dose rivaroxaban is still rare.AimUsing D-dimer and PARIS coronary thrombosis risk score to identify ACS patients at high ischemic risk, we aim to investigate whether 3-month low-dose rivaroxaban therapy on the basis of dual antiplatelet therapy (DAPT) could result in reduced ischemic events without increasing bleeding.DesignThis study is a multi-center, prospective, open-label, randomized controlled trial involving 3,944 ACS patients undergoing PCI from more than 40 tertiary hospitals in China (ClinicalTrials.govNCT05638867). Patients with PARIS coronary thrombosis score ≥ 3 and D-dimer ≥ 0.28μg/ml will be 1:1 randomized to experiment group (rivaroxaban 2.5mg twice daily for 3 months on the basis of one-year standard DAPT) or control group (one-year standard DAPT only). The primary endpoint of this study was Major Adverse Cardiovascular and Cerebrovascular Events (MACCE), a composite of death, myocardial infarction, ischemia driven revascularization, stent thrombosis and systemic embolic events. The safety endpoint was BARC type 3 and 5 bleeding events.SummaryIn ACS patients with higher PARIS coronary thrombosis risk score and elevated D-dimer level, results of the PRIDE-ACS trial will reveal whether short-duration low-dose rivaroxaban can reduce MACCE events without increasing severe bleeding.