open access publication

Article, 2024

Efficacy and Safety of Combination Therapy with Low-Dose Rivaroxaban in Patients with Cardiovascular Disease: A Systematic Review and Meta-Analysis of Randomized Controlled Trials

Journal of Clinical Medicine, ISSN 2077-0383, Volume 13, 7, Page 2033, 10.3390/jcm13072033

Contributors

Bucci, Tommaso 0000-0003-2895-6234 [1] [2] Del Sole, Francesco 0000-0002-7781-6636 [1] Menichelli, Danilo 0000-0001-9467-5903 [1] Galardo, Gioacchino 0000-0001-5941-9947 [1] Biccirè, Flavio Giuseppe 0000-0001-7094-6596 [1] Farcomeni, Alessio 0000-0002-7104-5826 [3] Lip, Gregory Yoke Hong [2] [4] Pignatelli, Pasquale 0000-0002-2265-7455 (Corresponding author) [1] Pastori, Daniele 0000-0001-6357-5213 [1] [2]

Affiliations

  1. [1] Sapienza University of Rome
    2. [NORA names: Italy; Europe, EU; OECD];
  2. [2] Liverpool Heart and Chest Hospital
    3. [NORA names: United Kingdom; Europe, Non-EU; OECD];
  3. [3] University of Rome Tor Vergata
    4. [NORA names: Italy; Europe, EU; OECD];
  4. [4] Aalborg University
    5. [NORA names: AAU Aalborg University; University; Denmark; Europe, EU; Nordic; OECD]

Abstract

Objectives: To review the evidence on the effectiveness and safety of low-dose-rivaroxaban 2.5 mg twice daily (LDR) in patients with coronary artery disease (CAD) and/or peripheral artery disease (PAD) taking antiplatelets. Methods: We performed a systematic review and meta-analysis of randomized controlled trials (RCTs). Efficacy endpoints were cardiovascular events (CVEs), myocardial infarction, stroke, all-cause, and cardiovascular death. Any, major, fatal bleeding, and intracranial hemorrhage (ICH) were safety endpoints. Numbers needed to treat (NNT), and numbers needed to harm (NNH) were also calculated. Results: Seven RCTs were included with 45,836 patients: 34,276 with CAD and 11,560 with PAD. Overall, 4247 CVEs and 3082 bleedings were registered. LDR in association with either any antiplatelet drug or aspirin (ASA) alone reduced the risk of CVEs (hazard ratio [HR] 0.86, 95% confidence interval [95%CI] 0.78-0.94) and ischemic stroke (HR 0.68, 95%CI 0.55-0.84). LDR + ASA increased the risk of major bleeding (HR 1.71, 95%CI 1.38-2.11) but no excess of fatal bleeding or ICH was found. The NNT to prevent one CVE for LDR + ASA was 63 (43-103) and the NNH to cause major bleeding was 107 (77-193). Conclusions: The combination of LDR with either antiplatelet drugs or low-dose aspirin reduces CVEs and ischemic stroke in patients with CAD/PAD. There was an increased risk of major bleeding but no excess of fatal or ICH was found. LDR seems to have a favorable net clinical benefit compared to ASA treatment alone.

Keywords

ASA, ASA treatment, CAD/PAD, Cardiovascular, LDR, NNH, NNT, all-cause, antiplatelet, antiplatelet drugs, artery disease, aspirin, association, bleeding, cardiovascular death, cardiovascular disease, cardiovascular events, combination, combination therapy, controlled trials, coronary artery disease, death, disease, drug, effect, efficacy, efficacy endpoint, endpoint, events, evidence, fatal bleeding, hemorrhage, increased risk, infarction, intracranial hemorrhage, ischemic stroke, low dose rivaroxaban, low-dose, low-dose aspirin, low-dose rivaroxaban, meta-analysis, meta-analysis of randomized controlled trials, myocardial infarction, patients, peripheral arterial disease, randomized controlled trials, review, risk, risk of cardiovascular events, rivaroxaban, safety, safety endpoints, safety of combination therapy, stroke, systematic review, therapy, treatment, trials

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