A critical analysis of the COMPASS trial with respect to benefit-risk assessment using the numbers needed to treat: Applicability and relevance in Indian patients with stable cardiovascular disease

Kerkar, Prafulla; Bose, Debdipta; Nishandar, Tushar B; Sabnis, Girish; Kumar, Dhiraj; Thatte, Urmila M; Gogtay, Nithya J

doi:10.1016/j.ihj.2018.06.006

Cited by 3 publications

(2 citation statements)

References 16 publications

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“… 24 – 28 , 48 – 52 Importantly, a great proportion of patients with PAD in clinical practice meet the inclusion criteria of the COMPASS trial, indicating that the results of this study can be extended to this population. 65 – 67 As a result, all these data strongly suggest that the rivaroxaban plus aspirin approach should be considered as the first choice for the treatment of patients with PAD to achieve the double target of MACE and MALE. In fact, current guidelines recommend the use of the combination of aspirin plus rivaroxaban, 2.5 mg, twice daily in different clinical settings.…”

Section: Discussionmentioning

confidence: 99%

Reducing residual thrombotic risk in patients with peripheral artery disease: impact of the COMPASS trial

Hernández¹,

Lozano²,

Riambau³

et al. 2020

DIC

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Patients with peripheral artery disease (PAD) are at a high risk not only for the classical cardiovascular (CV) outcomes (major adverse cardiovascular events; MACE) but also for vascular limb events (major adverse limb events; MALE). Therefore, a comprehensive approach for these patients should include both goals. However, the traditional antithrombotic approach with only antiplatelet agents (single or dual antiplatelet therapy) does not sufficiently reduce the risk of recurrent thrombotic events. Importantly, the underlying cause of atherosclerosis in patients with PAD implies both platelet activation and the initiation and promotion of coagulation cascade, in which Factor Xa plays a key role. Therefore, to reduce residual vascular risk, it is necessary to address both targets. In the Cardiovascular Outcomes for People Using Anticoagulation Strategies (COMPASS) trial that included patients with stable atherosclerotic vascular disease, the rivaroxaban plus aspirin strategy ( versus aspirin) markedly reduced the risk of both CV and limb outcomes, and related complications, with a good safety profile. In fact, the net clinical benefit outcome composed of MACE; MALE, including major amputation, and fatal or critical organ bleeding was significantly reduced by 28% with the COMPASS strategy, (hazard ratio: 0.72; 95% confidence interval: 0.59–0.87). Therefore, the rivaroxaban plus aspirin approach provides comprehensive protection and should be considered for most patients with PAD at high risk of such events.

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Section: Discussionmentioning

confidence: 99%

Reducing residual thrombotic risk in patients with peripheral artery disease: impact of the COMPASS trial

Hernández¹,

Lozano²,

Riambau³

et al. 2020

DIC

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“…4 A subgroup analysis revealed a number needed to treat of 91 and a number needed to harm of 63 in the ≥ 65 years age group. 7 Generalizability is limited because of the exclusion of patients at high risk for bleeding and patients intolerant or nonadherent to therapy. The benefit of this combination is offset by the significant increase in major bleeds.…”

mentioning

confidence: 99%

Add-On Therapies in Cardiovascular Disease: Reviewing ICER’s Report and the Potential Effect on Payers

Magness

Arnwine

Lockwood

et al. 2020

JMCP

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Cardiovascular disease (CVD) accounted for over 17.6 million deaths in 2016 and is expected to exceed 23.6 million by 2030. 1,2 Between 2014 and 2016, the direct and indirect costs associated with this burdensome disease reached $351.2 billion. CVD is a disease of concern, given the associated clinical and financial hardships. In October 2019, the Institute for Clinical and Economic Review (ICER) released a final evidence report on the effectiveness and value of 2 additive therapies used to reduce the risk of major adverse cardiovascular events (MACE): rivaroxaban and icosapent ethyl. Rivaroxaban, a direct-acting oral anticoagulant, has been approved as adjunct to aspirin to reduce the risk of MACE in patients with chronic coronary artery disease (CAD) or peripheral artery disease (PAD). 3 These indications are supported by the COMPASS trial, which showed that the combination of rivaroxaban and aspirin reduced the rate of MACE compared with aspirin alone. 4 Icosapent ethyl, an ethyl ester of eicosapentaenoic acid, was approved to reduce the risk of MACE among patients on statin therapy with elevated triglycerides and established CVD or at high risk for CVD. 5 The indication is supported by the REDUCE-IT trial, which showed icosapent ethyl reduced composite outcomes (cardiovascular death, myocardial infarction (MI), stroke, coronary revascularization, or unstable angina) versus placebo. 6 Rivaroxaban's COMPASS trial is representative of a Medicare population with CVD, with 75% of patients aged ≥ 65 years and taking multiple medications (e.g., angiotensin-converting enzyme inhibitors, beta blockers, and statins). 4 The reduction in the primary outcome yielded a number needed to treat of 76. Conversely, COMPASS found a 1.2% absolute increased risk in major bleeding, and a number needed to harm of 83 was reported. However, there was no significant difference in the rate of severe bleeding events. ICER reports with high certainty that rivaroxaban and aspirin "provides a small-to-substantial net health benefit in patients with CAD, PAD, or both

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Residual risk reduction opportunities in patients with chronic coronary syndrome. Role of dual pathway inhibition

González-Juanàtey

Almendro‐Delia

Cosı́n-Sales

et al. 2020

Expert Review of Clinical Pharmacology

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A critical analysis of the COMPASS trial with respect to benefit-risk assessment using the numbers needed to treat: Applicability and relevance in Indian patients with stable cardiovascular disease

Cited by 3 publications

References 16 publications

Reducing residual thrombotic risk in patients with peripheral artery disease: impact of the COMPASS trial

Reducing residual thrombotic risk in patients with peripheral artery disease: impact of the COMPASS trial

Add-On Therapies in Cardiovascular Disease: Reviewing ICER’s Report and the Potential Effect on Payers

Residual risk reduction opportunities in patients with chronic coronary syndrome. Role of dual pathway inhibition

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