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Patients with coronary artery disease should receive P2Y12 inhibitor instead of aspirin

PANTHER analysis presented in a Hot Line Session today at ESC Congress 2022

Coronary Artery Disease (Chronic)
Cardiovascular Pharmacotherapy

Barcelona, Spain – 29 Aug 2022: P2Y12 inhibitor monotherapy lowers the risk of ischaemic events compared with aspirin alone in patients with coronary artery disease without increasing bleeding risk, according to late breaking research presented in a Hot Line session today at ESC Congress 2022.1

Professor Marco Valgimigli of the Cardiocentro Ticino Foundation, Lugano, Switzerland said: “The findings from our analysis, which included all available randomised evidence, challenge the central role of aspirin and support a paradigm shift toward single P2Y12 inhibition for secondary prevention in the long-term antithrombotic management of patients with coronary artery disease.”

Long-term antiplatelet therapy with aspirin is a cornerstone of secondary prevention in patients with established atherosclerosis.2 Life-long aspirin is the standard of care after an initial course of dual antiplatelet therapy (DAPT) with a P2Y12 inhibitor plus aspirin in patients with an acute coronary syndrome or undergoing percutaneous coronary intervention.3-5 The CAPRIE randomised trial found a significant, yet mild, reduction of cardiovascular events with clopidogrel monotherapy compared with aspirin monotherapy in patients with coronary, cerebrovascular, and/or peripheral atherosclerosis.6 Studies comparing P2Y12 inhibitor monotherapy with clopidogrel or ticagrelor versus aspirin monotherapy have yielded mixed results.7-12

PANTHER aimed to address this uncertainty with the most comprehensive individual participant data meta-analysis to date of randomised controlled trials evaluating the effect of monotherapy with currently recommended oral P2Y12 inhibitors (clopidogrel, prasugrel, or ticagrelor) versus aspirin on adjudicated ischaemic and bleeding outcomes in patients with established coronary artery disease. The analysis included 24,325 patients from seven randomised controlled trials, of which 12,178 were assigned to P2Y12 inhibitor monotherapy (clopidogrel in 7,545 [62.0%], ticagrelor in 4,633 [38.0%]) and 12,147 were assigned to aspirin monotherapy. The median treatment duration was 557 days. The average age of participants was 64.3 years and 21.7% were women.

The risk of the primary efficacy outcome of cardiovascular death, myocardial infarction, and stroke was lower with P2Y12 inhibitor monotherapy compared with aspirin monotherapy (5.5% vs. 6.3%; hazard ratio [HR] 0.88; 95% confidence interval [CI] 0.79–0.97; p=0.014). The number needed to treat to prevent one adverse outcome was 123 patients.

Regarding secondary outcomes, the risk of major bleeding was similar between P2Y12 inhibition and aspirin (1.2% vs. 1.4%; HR 0.87; 95% CI 0.70–1.09; p=0.23). The risk of net adverse clinical events, defined as the composite of the primary efficacy endpoint and major bleeding, was reduced with P2Y12 inhibitor monotherapy compared with aspirin monotherapy (6.4% vs. 7.2%; HR 0.89; 95% CI 0.81–0.98; p=0.020), for a number needed to treat of 121 patients.

P2Y12 inhibitor monotherapy was associated with a lower risk of myocardial infarction compared with aspirin monotherapy (2.3% vs. 3.0%; HR 0.77; 95% CI 0.66–0.90; p<0.001). The number needed to treat to prevent one myocardial infarction with a P2Y12 inhibitor was 136 patients. There was evidence supporting a pronounced reduction in myocardial infarction with P2Y12 inhibitor monotherapy versus low-dose aspirin (HR 0.59; 95% CI 0.43–0.79) rather than high-dose aspirin (HR 0.85; 95% CI 0.71–1.01; p for interaction=0.040).

Professor Valgimigli said: “The relative risk of the primary composite endpoint was reduced by 12% in patients receiving a P2Y12 inhibitor, primarily driven by a 23% relative reduction of myocardial infarction and, secondarily, by numerically but not significantly lower rates of stroke. The overall risk of major bleeding did not differ, whereas gastrointestinal bleeding and haemorrhagic stroke occurred less frequently in patients receiving a P2Y12 inhibitor than aspirin monotherapy.”



Notes to editor

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This press release accompanies both a presentation and an ESC press conference at ESC Congress 2022. It does not necessarily reflect the opinion of the European Society of Cardiology.


Funding: The study was not funded.


Disclosures: Marco Valgimigli received consulting or speaker fees from AstraZeneca, Terumo, Alvimedica/CID, Abbott Vascular, Daiichi Sankyo, Bayer, CoreFLOW, IDORSIA PHARMACEUTICALS LTD, Universität Basel | Dept. Klinische Forschung, Vifor, Bristol Myers Squibb SA, Biotronik, Boston Scientific, Medtronic, Vesalio, Novartis, Chiesi, PhaseBio, ECRI.


References and notes

1PANTHER will be discussed during Hot Line Session 9 on Monday 29 August at 14:00 to 15:15 CEST in the Barcelona auditorium.

2Gargiulo G, Windecker S, Vranckx P, et al. A critical appraisal of aspirin in secondary prevention: Is less more? Circulation. 2016;134:1881–1906.

3Valgimigli M, Bueno H, Byrne RA, et al. 2017 ESC focused update on dual antiplatelet therapy in coronary artery disease developed in collaboration with EACTS. Eur Heart J. 2018;39:213–254.

4Knuuti J, Wijns W, Saraste A, et al. 2019 ESC Guidelines for the diagnosis and management of chronic coronary syndromes. Eur Heart J. 2020;41:407–477.

5Collet JP, Thiele H, Barbato E, et al. 2020 ESC Guidelines for the management of acute coronary syndromes in patients presenting without persistent ST-segment elevation. Eur Heart J. 2021;42:1289–1367.

6CAPRIE Steering Committee. A randomised, blinded, trial of clopidogrel versus aspirin in patients at risk of ischaemic events (CAPRIE). Lancet. 1996;348:1329–1339.

7Woodward M, Lowe GDO, Francis LMA, et al. A randomized comparison of the effects of aspirin and clopidogrel on thrombotic risk factors and C-reactive protein following myocardial infarction: the CADET trial. J Thromb Haemost. 2004;2:1934–1940.

8Pettersen AÅR, Seljeflot I, Abdelnoor M, Arnesen H. High on-aspirin platelet reactivity and clinical outcome in patients with stable coronary artery disease: Results from ASCET (Aspirin Nonresponsiveness and Clopidogrel Endpoint Trial). J Am Heart Assoc. 2012;1:e000703.

9Zhao Q, Zhu Y, Xu Z, et al. Effect of ticagrelor plus aspirin, ticagrelor alone, or aspirin alone on saphenous vein graft patency 1 year after coronary artery bypass grafting. JAMA. 2018;319:1677–1686.

10Franzone A, McFadden E, Leonardi S, et al. Ticagrelor alone versus dual antiplatelet therapy from 1 month after drug-eluting coronary stenting. J Am Coll Cardiol. 2019;74:2223–2234.

11Schunkert H, Boening A, von Scheidt M, et al. Randomized trial of ticagrelor vs. aspirin in patients after coronary artery bypass grafting: the TiCAB trial. Eur Heart J. 2019;40:2432–2440.

12Koo BK, Kang J, Park KW, et al. Aspirin versus clopidogrel for chronic maintenance monotherapy after percutaneous coronary intervention (HOST-EXAM): an investigator-initiated, prospective, randomised, open-label, multicentre trial. Lancet. 2021;397:2487–2496.


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