Commentary: Cost-Effectiveness Analysis of Rivaroxaban Plus Aspirin Compared With Aspirin Alone in Patients With Coronary and Peripheral Artery Diseases in Italy.
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SUBMITTER: Rawal S
PROVIDER: S-EPMC9260166 | biostudies-literature | 2022
REPOSITORIES: biostudies-literature
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Commentary: Cost-Effectiveness Analysis of Rivaroxaban Plus Aspirin Compared With Aspirin Alone in Patients With Coronary and Peripheral Artery Diseases in Italy.
Rawal Shalin S Sharma Kamal K Shah Aditya A Bavishi Shriya S Christian Cleris C Bhatt Parjanya P Konat Ashwati A
Frontiers in cardiovascular medicine 20220623
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Project description:BackgroundRivaroxaban is a selective inhibitor of coagulation factor Xa and its combination with aspirin showed better outcomes in the prevention of recurrent cardiovascular disease than aspirin alone.ObjectiveThis analysis aimed to economically compare the cost effectiveness of rivaroxaban (2.5 mg twice daily) plus aspirin (100 mg once daily) with aspirin alone in patients with coronary artery disease (CAD) or peripheral artery disease (PAD) and related subgroups.MethodsThe analysis simulates the perspective of the Italian National Healthcare Service and used a state-transition decision Markov model. Clinical efficacy data and health events risks were gathered from the COMPASS trial. Health outcomes and costs (in Euros) were evaluated over a lifetime horizon and were discounted at 3.5% per annum. Direct healthcare costs entered the analysis. Results were expressed in terms of incremental cost-effectiveness ratio (ICER), defined as cost per quality-adjusted life-year (QALY) gained. One-way deterministic and probabilistic sensitivity analyses were performed.ResultsFor the CAD or PAD population, rivaroxaban plus aspirin was more effective and costly compared with aspirin alone. Incremental costs and efficacy produced an ICER of €16,522 per QALY gained. Analyses found similar trends for the PAD and CAD groups, with respective ICERs of €8003 and €18,599, while ICERs for the other groups were lower than €13,000 per QALY. Sensitivity analyses confirmed these findings.ConclusionCompared with aspirin alone, rivaroxaban plus aspirin is cost effective in preventing recurrent cardiovascular events in all patients with CAD or PAD, from the Italian perspective. These results could help clinicians and decision makers to develop improved strategies for cardiovascular disease prevention.
| S-EPMC8149345 | biostudies-literature
Project description:BackgroundRivaroxaban 2.5 mg twice daily with aspirin 100 mg daily was shown to be better than aspirin 100 mg daily for preventing cardiovascular (CV) death, stroke or myocardial infarction in patients with either stable coronary artery disease (CAD) or peripheral artery disease (PAD). The cost-effectiveness of this regimen in this population is essential for decision-makers to know.MethodsUS direct healthcare system costs (in USD) were applied to hospitalized events, procedures and study drugs utilized by all patients. We determined the mean cost per participant for the full duration of the trial (mean follow-up of 23 months) plus quality-adjusted life years (QALYs) and the incremental cost-effectiveness ratio (ICER) over a lifetime using a two-state Markov model with 1-year cycle length. Sensitivity analyses were performed on the price of rivaroxaban and the annual discontinuation rate.ResultsThe costs of events and procedures were reduced for Cardiovascular Outcomes for People Using Anticoagulation Strategies (COMPASS) patients who received rivaroxaban 2.5 mg orally (BID) plus acetylsalicylic acid (ASA) compared with ASA alone. Total costs were higher for the combination group ($7426 versus $4173) after considering acquisition costs of the study drug. Over a lifetime, patients receiving rivaroxaban plus ASA incurred $27,255 more and gained 1.17 QALYs compared with those receiving ASA alone resulting in an ICER of $23,295/QALY. ICERs for PAD only and polyvascular disease subgroups were lower.ConclusionRivaroxaban 2.5 mg BID plus ASA compared with ASA alone was cost-effective (high value) in the USA. COMPASS ClinicalTrials.gov identifier: NCT01776424.
| S-EPMC10806169 | biostudies-literature
Project description: Not available
| S-EPMC10665835 | biostudies-literature
Project description:BackgroundPatients with chronic coronary artery disease (CAD) and/or peripheral artery disease (PAD) have increased risks for cardiovascular (CV)-related morbidity and mortality. In the Cardiovascular Outcomes for People Using Anticoagulation Strategies (COMPASS) clinical trial of such patients, rivaroxaban plus aspirin demonstrated a significant reduction in major adverse CV events (MACE), a composite of stroke, myocardial infarction, and CV death, and major adverse limb events (MALE), a composite of chronic and acute limb ischemia, and major amputation resulting from vascular events, versus aspirin alone.ObjectiveTo estimate the 1-year economic implications of preventing MACE and MALE with the use of rivaroxaban plus aspirin versus aspirin alone among patients with chronic CAD and/or PAD in a US commercial health plan.MethodA cost-consequence model was developed to evaluate the economic impact of rivaroxaban plus aspirin in a hypothetical 1-million-member health plan. The model inputs were taken from the COMPASS study (ie, the efficacy and safety of rivaroxaban plus aspirin vs aspirin), Optum Integrated Database (ie, the prevalence of chronic CAD and/or PAD, incidence rates, and healthcare costs of MACE, MALE, and major bleeding), and the RED BOOK (ie, wholesale drug acquisition costs). The cost inputs were in 2019 US dollars. One-way sensitivity analyses and subgroup analyses were conducted.ResultsA 1-year treatment with rivaroxaban plus aspirin resulted in reductions of MACE and MALE, which balance the increased risk for bleeding versus aspirin alone and indicate a net health benefit for this drug regimen. These reductions were achieved at an incremental per-member per-month (PMPM) cost of $0.16, mainly because of rivaroxaban's acquisition cost. In patients with ≥2 MACE or MALE risk factors, the incremental PMPM cost was $0.09, given the increased offset in rivaroxaban's acquisition cost by reduced rates of MACE or MALE.ConclusionsIn an era of emerging thrombocardiology, treatment with rivaroxaban plus aspirin offers an effective thrombotic risk management strategy for healthcare stakeholders in the management of chronic CAD and/or PAD. The contribution of rivaroxaban would be greater in patients with ≥2 risk factors for MACE or MALE.
| S-EPMC7741174 | biostudies-literature
Project description: Not available
| S-EPMC6486024 | biostudies-literature
Project description:BackgroundPatients with chronic coronary artery disease or peripheral artery disease and history of heart failure (HF) are at high risk for major adverse cardiovascular events. We explored the effects of rivaroxaban with or without aspirin in these patients.MethodsThe COMPASS trial (Cardiovascular Outcomes for People Using Anticoagulation Strategies) randomized 27 395 participants with chronic coronary artery disease or peripheral artery disease to rivaroxaban 2.5 mg twice daily plus aspirin 100 mg daily, rivaroxaban 5 mg twice daily alone, or aspirin 100 mg alone. Patients with New York Heart Association functional class III or IV HF or left ventricular ejection fraction (EF) <30% were excluded. The primary major adverse cardiovascular events outcome comprised cardiovascular death, stroke, or myocardial infarction, and the primary safety outcome was major bleeding using modified International Society of Thrombosis and Haemostasis criteria. Investigators recorded a history of HF and EF at baseline, if available. We examined the effects of rivaroxaban on major adverse cardiovascular events and major bleeding in patients with or without a history of HF and an EF <40% or ≥40% at baseline.ResultsOf the 5902 participants (22%) with a history of HF, 4971 (84%) had EF recorded at baseline, and 12% had EF <40%. Rivaroxaban and aspirin had similar relative reduction in major adverse cardiovascular events compared with aspirin in participants with HF (5.5% versus 7.9%; hazard ratio [HR], 0.68; 95% CI, 0.53-0.86) and those without HF (3.8% versus 4.7%; HR, 0.79; 95% CI, 0.68-0.93; P for interaction 0.28) but larger absolute risk reduction in those with HF (HF absolute risk reduction 2.4%, number needed to treat=42; no HF absolute risk reduction 1.0%, number needed to treat=103). The primary major adverse cardiovascular events outcome was not statistically different between those with EF <40% (HR, 0.88; 95% CI, 0.55-1.42) and ≥40% (HR, 0.81; 95% CI, 0.67-0.98; P for interaction 0.36). The excess hazard for major bleeding was not different in participants with HF (2.5% versus 1.8%; HR, 1.36; 95% CI, 0.88-2.09) than in those without HF (3.3% versus 1.9%; HR, 1.79; 95% CI, 1.45-2.21; P for interaction 0.26). There were no significant differences in the primary outcomes with rivaroxaban alone.ConclusionsIn patients with chronic coronary artery disease or peripheral artery disease and a history of mild or moderate HF, combination rivaroxaban and aspirin compared with aspirin alone produces similar relative but larger absolute benefits than in those without HF.Clinical trial registrationURL: https://www.clinicaltrials.gov. Unique identifier: NCT01776424.
| S-EPMC6693980 | biostudies-literature
Project description:BackgroundDual pathway inhibition with 2.5 mg rivaroxaban twice daily plus 100 mg aspirin once daily may be a promising alternative to 100 mg aspirin antiplatelet therapy for the prevention of cardiovascular events in patients with coronary artery disease and/or peripheral arterial disease. However, treatment costs and bleeding risks are higher, and there is another treatment option for peripheral arterial disease, 75 mg clopidogrel. A comprehensive assessment of benefits, risks and costs of dual pathway inhibition versus standard of care is needed.MethodsWe used a state transition model including cardiovascular, ischaemic limb and bleeding events to compare dual pathway inhibition to aspirin antiplatelet therapy in coronary artery disease, and additionally to clopidogrel antiplatelet therapy in peripheral arterial disease patients. We calculated the incremental cost-effectiveness ratio from costs and quality-adjusted life-years of lifelong treatment, and the cost-effectiveness probability at a €50,000/quality-adjusted life-year threshold.ResultsQuality-adjusted life-years and costs of dual pathway inhibition were highest, the incremental cost-effectiveness ratios versus aspirin were €32,109 in coronary artery disease and €26,381 in peripheral arterial disease patients, with 92% and 56% cost-effectiveness probability, respectively (clopidogrel was extendedly dominated). Incremental cost-effectiveness ratios were below €20,000 in comorbid peripheral arterial disease patients and coronary artery disease patients younger than 65 years, incremental cost-effectiveness ratios were above €50,000 in carotid artery disease patients and coronary artery disease patients older than 75 years.ConclusionLifelong preventive treatment of coronary artery disease and peripheral arterial disease patients at risk of cardiovascular events with dual pathway inhibition improves health outcomes and seems overall cost-effective relative to aspirin antiplatelet therapy and also to clopidogrel antiplatelet therapy for peripheral arterial disease, particularly in comorbid patients, but not in older patients and in carotid artery disease patients. These findings may warrant a targeted approach.
| S-EPMC7457457 | biostudies-literature
Project description:Importance:The effect of ticagrelor with or without aspirin on saphenous vein graft patency in patients undergoing coronary artery bypass grafting (CABG) is unknown. Objective:To compare the effect of ticagrelor + aspirin or ticagrelor alone vs aspirin alone on saphenous vein graft patency 1 year after CABG. Design, Setting, and Participants:Randomized, multicenter, open-label, clinical trial among 6 tertiary hospitals in China. Eligible patients were aged 18 to 80 years with indications for elective CABG. Patients requiring urgent revascularization, concomitant cardiac surgery, dual antiplatelet or vitamin K antagonist therapy post-CABG, and who were at risk of serious bleeding were excluded. From July 2014 until November 2015, 1256 patients were identified and 500 were enrolled. Follow-up was completed in January 2017. Interventions:Patients were randomized (1:1:1) to start ticagrelor (90 mg twice daily) + aspirin (100 mg once daily) (n = 168), ticagrelor (90 mg twice daily) (n = 166), or aspirin (100 mg once daily) (n = 166) within 24 hours post-CABG. Neither patients nor treating physicians were blinded to allocation. Main Outcomes and Measures:Primary outcome was saphenous vein graft patency 1 year after CABG (FitzGibbon grade A) adjudicated independently by a committee blinded to allocation. Saphenous vein graft patency was assessed by multislice computed tomographic angiography or coronary angiography. Results:Among 500 randomized patients (mean age, 63.6 years; women, 91 [18.2%]), 461 (92.2%) completed the trial. Saphenous vein graft patency rates 1 year post-CABG were 88.7% (432 of 487 vein grafts) with ticagrelor + aspirin; 82.8% (404 of 488 vein grafts) with ticagrelor alone; and 76.5% (371 of 485 vein grafts) with aspirin alone. The difference between ticagrelor + aspirin vs aspirin alone was statistically significant (12.2% [95% CI, 5.2% to 19.2%]; P < .001), whereas the difference between ticagrelor alone vs aspirin alone was not statistically significant (6.3% [95% CI, -1.1% to 13.7%]; P = .10). Five major bleeding episodes occurred during 1 year of follow-up (3 with ticagrelor + aspirin; 2 with ticagrelor alone). Conclusions and Relevance:Among patients undergoing elective CABG with saphenous vein grafting, ticagrelor + aspirin significantly increased graft patency after 1 year vs aspirin alone; there was no significant difference between ticagrelor alone and aspirin alone. Further research with more patients is needed to assess comparative bleeding risks. Trial Registration:clinicaltrials.gov Identifier: NCT02201771.
| S-EPMC5933396 | biostudies-literature
Project description:AimsThis study aimed to compare the effects of the combination of rivaroxaban and aspirin with aspirin alone on health-related quality of life in the Cardiovascular Outcomes for People Using Anticoagulation Strategies (COMPASS) trial.Methods and resultsHealth-related quality of life assessed using the EQ-5D-3L. The treatment effects on health utility and EQ visual analogue scale (EQ VAS) scores were compared between rivaroxaban plus aspirin and aspirin alone in terms of adjusted mean difference in change from baseline and odds ratio of having deterioration events. Nine thousand forty-nine (98.9%) and 6916 (75.5%) completed the EQ-5D-3L at baseline and at final visit, respectively. Nine thousand twenty-eight (98.9%) and 6887 (76.3%) completed the EQ-5D-3L at baseline and final visit, respectively. Mean (standard deviation) health utility and EQ VAS scores at baseline were 0.871 (0.141) and 76.0 (15.3), respectively, for the rivaroxaban plus aspirin group, compared with 0.873 (0.139) and 75.8 (15.1) for the aspirin group. Adjusted mean difference in change from baseline utility was -0.002 [95% confidence interval (CI), -0.006, 0.002, P = 0.30] between the combination therapy group and the aspirin group. The odds ratio (95% CI) of experiencing deterioration in health utility was 1.01 (95% CI, 0.93, 1.10, P = 0.81) between the two groups. Adjusted mean difference in change from baseline EQ VAS was 0.02 (95% CI, -0.43, 0.47, P = 0.93) between the two groups.ConclusionThis analysis of the COMPASS trial demonstrated that the quality of life of patients was similar between the rivaroxaban plus aspirin group and the aspirin alone group.RegistrationTrial registration number: ClinicalTrials.gov number (NCT01776424). Trial protocol and statistical analysis plan: https://www.nejm.org/doi/full/10.1056/NEJMoa1709118#APPNEJMoa1709118PRO.
| S-EPMC11495100 | biostudies-literature
Project description:Background and purposeGiven the high risk of stroke after TIA (transient ischemia attack) or stroke and the adverse reaction of bleeding of antiplatelets, we undertook a meta-analysis, reviewed randomized controlled trials (RCTs) comparing aspirin plus clopidogrel with aspirin alone to determine the efficacy and adverse reaction of bleeding of the two protocols in the prevention of stroke.MethodsWe analyzed the incidences of stroke, bleeding and severe bleeding by using fixed-effect model or random-effect model on the basis of the result of heterogeneity test.ResultsFive qualified RCTs satisfied the inclusion criteria. We found that treatment with aspirin plus clopidogrel was associated with lower incidence of stroke (Risk Ratio (RR), 0.66, 95% confidence interval (CI), 0.47 to 0.93), higher incidence of bleeding (RR, 1.75, 95% CI, 1.48 to 2.05) as compared with aspirin-alone treatment. In terms of severe bleeding, no statistical difference existed between them (RR, 2.21, 95% CI, 0.25 to 19.52).ConclusionThe combined use of aspirin and clopidogrel is more effective than aspirin alone for patients with previous TIA or stroke for the prevention of stroke, with risk of bleeding being higher. No statistical difference was found in severe bleeding between the two treatment protocols.
| S-EPMC3688690 | biostudies-literature