Vascular protection in 2019: A year in review
This year saw several major changes in how arterial diseases are perceived and treated. By revising terminology from stable coronary artery disease (CAD) to chronic coronary syndromes and introducing new guidance for high-risk patients, the European Society of Cardiology (ESC) has recognised that enhanced protection with vascular dose rivaroxaban plus aspirin could offer patients a more certain future without fear of a devastating cardiovascular (CV) event. Furthermore, several new guidelines for the treatment of PAD were published in 2019 giving clinicians a new standard of care and a different approach to preserve limbs, prevent life-threatening events and save lives. But what informed these changes in guidance and how will practice be affected?
What have we learnt from the COMPASS post-hoc analyses this year?
Risk stratification of patients with stable atherosclerosis
In the COMPASS trial, the overall protective benefit of rivaroxaban 2.5 mg bid plus aspirin against ischaemic events has been demonstrated across patients with CAD and/or PAD, regardless of risk level.1 As we discussed in our newsletter in August, a recent risk stratification analysis identified polyvascular disease, history of heart failure (HF), renal insufficiency and a history of diabetes as characteristics that could be used to identify patients who stand to gain the greatest absolute benefit from this regimen. Given the lack of increased risk of the most severe bleeding events, the addition of rivaroxaban 2.5 mg bid to aspirin is associated with a benefit that outweighs the risk in patients with any of these four high-risk features to reduce their risk of catastrophic ischaemic events.2
High-risk features for ischaemic events identified in the COMPASS risk stratification analysis
Patients with CAD and HF or kidney disease: managing the risks
The results from the risk stratification analysis have been supported by two dedicated subanalyses.3,4 The presence of HF and kidney disease increases CV risk in patients with CAD.5,6 For example, patients with HF have a 71% greater 4-year risk of major adverse CV events (MACE; comprising myocardial infarction, stroke or CV death) than patients without HF.5
In the newsletters from June and July, we highlighted the recent analyses from COMPASS that investigated the effect of rivaroxaban 2.5 mg bid plus aspirin versus aspirin alone in CAD patients with and without HF or renal impairment.1,3 The new analyses demonstrated that patients with CAD and HF were among those who received the highest benefit from rivaroxaban 2.5 mg bid plus aspirin versus aspirin alone.3 Since the newsletter in July, a dedicated renal subanalysis has been published.4 The analysis demonstrated that patients with CAD and an estimated glomerular filtration rate (eGFR) 2, who are at high risk of MACE, can also benefit greatly from rivaroxaban 2.5 mg bid plus aspirin compared with aspirin alone.4
Outcomes in patients with and without heart failure/renal impairment in the COMPASS trial
How has the evidence from the COMPASS trial informed clinical recommendations in 2019?
Chronic coronary syndromes
The 2019 ESC guidelines for the management of chronic coronary syndromes now recognise the importance of risk stratification and that aspirin alone may not be sufficient in patients who are at greater risk of ischaemic events. It is now recommended to add a second antithrombotic drug, such as the COMPASS regimen, to aspirin for long-term secondary prevention, in patients with a high risk of ischaemic events and without high bleeding risk (Class IIa, Level of evidence A). For those at moderately increased risk of ischaemic events and without high bleeding risk, a second antithrombotic drug may also be considered (Class IIb, Level of evidence A)7
2019 clinical recommendations for the use of rivaroxaban 2.5 mg bid in patients with PAD
Peripheral artery disease
2019 saw a number of clinical recommendation updates for the treatment of PAD as of a result of the COMPASS trial. The 2019 European Society for Vascular Medicine (ESVM) guidelines now recommend combination therapy with rivaroxaban 2.5 mg bid and aspirin 100 mg od in patients with PAD without a high risk of bleeding or other contraindications (Class IIa, Level of evidence B), reflecting the high risk in patients with PAD across subgroups.8 This recommendation is supported by the 2019 European Society of Cardiology/European Association for the Study of Diabetes (ESC/EASD) guidelines, which now include a Class IIa- Level of evidence B recommendation for dual pathway inhibition in patients with lower-extremity arterial disease.9 Finally, The Global Vascular Guidelines on chronic limb-threatening ischaemia also recommend rivaroxaban plus aspirin (Class 2, Level of evidence B) in patients with chronic limb-threatening ischaemia.10
2019 clinical recommendations for the use of rivaroxaban 2.5 mg bid in patients with PAD
Looking ahead to 2020
It is promising to see that 2 years on from the primary publication of the COMPASS trial, new analyses from the trial are still informing clinical recommendation in 2019. In the first quarter of 2020 we will see the publication of the highly anticipated VOYAGER-PAD trial.11 It is hoped that new data from this trial, among others, will continue to shape clinical recommendations for CV disease, and in turn, improve patient outcomes.
References
- Eikelboom JW, et al. N Engl J Med. 2017;377:1319–1330. Eikelboom JW, et al. N Engl J Med. 2017;377:1319–1330. 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
- Branch K. Rivaroxaban plus aspirin compared with aspirin in patients with and without heart failure. European Society of Cardiology Heart Failure Congress. Vienna, Austria, 26–29 May 2018, Abstract 1591. Return to content
- Fox KAA, Eikelboom JW, Shestakovska O et al. Rivaroxaban plus aspirin in patients with vascular disease and renal dysfunction: From the COMPASS trial. J Am Coll Cardiol 2019;73:2243–2250. Return to content
- Bhatt D.L., Eagle K.A., Ohman E.M., and the REACH Registry Investigators. J Am Med Assoc. 2010; 304(12):1350–7. Return to content
- Dumaine RL, Montalescot G, Steg PG et al. Renal function, atherothrombosis extent, and outcomes in high-risk patients. Am Heart J 2009;158:141–148 e141. Return to content
- 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
- Frank U, Nikol S, Belch J. 5 Conservative treatment for PAD - Risk factor management. Vasa 2019: doi:10.1024/0301-1526/a000835:1-12. 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
- Conte MS, Bradbury AW, Kolh P et al. Global vascular guidelines on the management of chronic limb-threatening ischemia. J Vasc Surg 2019;69:3S–125S.e140. Return to content
- Capell WH, Bonaca MP, Nehler MR et al. Rationale and design for the Vascular Outcomes study of ASA along with rivaroxaban in endovascular or surgical limb revascularization for peripheral artery disease (VOYAGER PAD). Am Heart J 2018;199:83–91. Return to content
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Updated date 10/10/2022
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