Optimizing vascular protection in high-risk patients: What do the 2019 ESC guidelines say?
New guidelines published by the ESC in 2019
The 2019 meeting of the European Society of Cardiology (ESC) saw the release of several new clinical practice guidelines, providing valuable advice on best practice to clinicians around Europe. Of particular interest for many cardiologists were the guidelines on the management of ‘chronic coronary syndromes’ (CCS),1 which replaced the previous guidelines on stable coronary artery disease (CAD). The change in terminology reflects the fact that patients with atherosclerosis have a continuing risk of serious events such as heart attack, stroke and death (for more information see our article here). The CCS guidelines recommend that a second antithrombotic, such as rivaroxaban vascular dose 2.5 mg twice daily (bid), should be considered in addition to aspirin for the treatment of patients with CCS at high risk of further events and without high bleeding risk.
Another 2019 ESC guideline focused on the management of patients with diabetes, pre-diabetes and cardiovascular (CV) disease.2 As well as echoing the advice of the CCS guidelines for patients with CCS and diabetes, these guidelines included a recommendation for rivaroxaban 2.5 mg bid plus aspirin in patients with diabetes and lower extremity arterial disease.
The updated guidelines were presented at the 2019 ESC congress in Paris
What do the 2019 guidelines mean for your daily practice?
Higher risk, higher benefit
Assessment of the balance of benefit and risk lies at the heart of every prescribing decision. The 2019 CCS guidelines recognize the importance of risk stratification by providing a graded recommendation: a second antithrombotic drug should be considered in patients at high risk of ischaemic events, and may be considered in those at moderately increased ischaemic risk.1 This provides a clear message to clinicians to consider the risk profile of the patient at every stage in their treatment – aspirin alone may not be enough.
Recommendations for intensified antithrombotic therapy according to the 2019 ESC guidelines for the management of CCS1
Perhaps unsurprisingly, the markers of high and moderate ischaemic risk identified by the guidelines overlap substantially with those identified based on the COMPASS data. In an exploratory analysis, the patients at highest ischaemic risk were shown to be those with polyvascular disease, diabetes, renal impairment or heart failure, and these patients are likely to derive the greatest benefit from rivaroxaban 2.5 mg bid plus aspirin (for more information, see our article here).3 The guidelines additionally include ‘diffuse multivessel CAD’ in the criteria for high ischaemic risk,1 reflecting the progressive, systemic nature of atherosclerotic disease.
What options are available for intensified antithrombotic therapy?
Treatment options for dual antithrombotic therapy in combination with aspirin 75–100 mg od1
Three key studies have demonstrated the efficacy of adding a second antithrombotic therapy alongside aspirin in patients with chronic CAD: the Dual Antiplatelet Therapy (DAPT) study, which investigated up to 30 months of therapy with either clopidogrel or prasugrel after a placement of a drug-eluting stent;4 PEGASUS-TIMI 54, which investigated ticagrelor 60 mg bid plus aspirin 1–3 years after a myocardial infarction (MI);5 and COMPASS, which investigated rivaroxaban 2.5 mg bid plus aspirin in patients with peripheral artery disease or with multivessel CAD or up to 20 years after a MI.6
Reflecting this breadth of evidence, the CCS guidelines have recommended all four of these options, but with different indications according to the eligibility criteria of the studies.1 Within the first year after a MI, physicians are presented with a range of options – but if the patient has multivessel CAD with no prior MI, or if they have not tolerated dual antiplatelet therapy for at least 1 year, the only available option for intensified antithrombotic therapy is rivaroxaban 2.5 mg bid plus aspirin. Rivaroxaban is also the only option among the four to have data on long-term use post-MI and to be approved for long-term use in Europe.7,8
Insights on the management of diabetic patients
In addition to the ESC guidelines on CCS, 2019 saw the release of updated guidelines on the management of diabetes, pre-diabetes and CV disease from the ESC and the European Association for the Study of Diabetes (EASD).2 Confirming the recommendation in the CCS guidelines, the diabetes guidelines state that in patients with diabetes and CCS, a second antithrombotic should be considered for long-term secondary prevention. The guidelines also specifically recommend rivaroxaban 2.5 mg bid plus aspirin in patients with diabetes and chronic symptomatic lower extremity arterial disease, providing a new treatment option to offer greater protection to these patients.
Recommendations for intensified antithrombotic therapy in the 2019 ESC-EASD guidelines on diabetes, pre-diabetes and CV disease2
Summary
Taken together, what do these recommendations mean for the prescribing physician? The guidelines provide a clear message that aspirin is not always enough to protect patients with chronic CAD from ischaemic events. As Professor Martin Cowie puts it in this video:
“These are really important changes and we owe it to our patients to makes sure we’re thinking about this at every contact point we have with them if they have arterial disease.”
What is new in the ESC guidelines?
Martin Cowie on the new CCS Guidelines
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References
- Knuuti J, et al. Eur Heart J. 2019;ehz425. doi:10.1093/eurheartj/ehz425. Knuuti J, et al. Eur Heart J. 2019;ehz425. doi:10.1093/eurheartj/ehz425. Return to content
- Cosentino S., Grant PJ., Aboyans V. et al. 2019 ESC Guidelines on diabetes, pre-diabetes, and cardiovascular diseases developed in collaboration with the EASD: The Task Force for diabetes, pre-diabetes, and cardiovascular diseases of the European Society of Cardiology (ESC) and the European Association for the Study of Diabetes (EASD). Eur Heart J. 2019;ehz486. doi:10.1093/eurheartj/ehz486. Return to content
- Anand SS, Eikelboom JW, Dyal L, et al. Rivaroxaban Plus Aspirin Versus Aspirin in Relation to Vascular Risk in the COMPASS Trial. J Am Coll Cardiol. 2019;73(25):3271-3280. Anand SS, Eikelboom JW, Dyal L, et al. Rivaroxaban Plus Aspirin Versus Aspirin in Relation to Vascular Risk in the COMPASS Trial. J Am Coll Cardiol. 2019;73(25):3271-3280. Return to content
- Mauri L, Kereiakes DJ, Yeh RW et al. Twelve or 30 months of dual antiplatelet therapy after drug-eluting stents. N Engl J Med 2014;371:2155–2166. Return to content
- Bonaca MP, Bhatt DL, Cohen M et al. Long-term use of ticagrelor in patients with prior myocardial infarction. N Engl J Med 2015;372:1791–1800. Return to content
- Bosch J, Eikelboom JW, Connolly SJ et al. Rationale, design and baseline characteristics of participants in the Cardiovascular OutcoMes for People using Anticoagulation StrategieS (COMPASS) trial. Can J Cardiol. 2017;33(8):1027-35. Return to content
- Bayer AG. Xarelto® (rivaroxaban) Summary of Product Characteristics. 2019. Available at: https://www.ema.europa.eu/documents/product-information/xarelto-epar-product-information_en.pdf [accessed 14 November 2019]. Bayer AG. Xarelto® (rivaroxaban) Summary of Product Characteristics. 2019. Available at: https://www.ema.europa.eu/documents/product-information/xarelto-epar-product-information_en.pdf [accessed 14 November 2019]. Return to content
- Connolly SJ, Eikelboom JW, Bosch J et al. Rivaroxaban with or without aspirin in patients with stable coronary artery disease: an international, randomised, double-blind, placebo-controlled trial. Lancet 2018;391:205–218. Return to content
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Updated date 10/10/2022
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