Platelet function monitoring to adjust antiplatelet therapy in elderly patients stented for an acute coronary syndrome (ANTARCTIC): an open-label, blinded-endpoint, randomised controlled superiority trial

The Lancet

Volumn 388, Issue 10055, 2016, Pages 2015-2022

  Cayla, Guillaume ^a   Cuisset, Thomas ^b,c   Silvain, Johanne ^d   Leclercq, Florence ^e   Manzo Silberman, Stephane ^f   Saint Etienne, Christophe ^g   Delarche, Nicolas ^h   Bellemain Appaix, Anne ⁱ   Range, Grégoire ^j   El Mahmoud, Rami ^k   Carrié, Didier ^l   Belle, Loic ^m   Souteyrand, Geraud ⁿ   Aubry, Pierre ^o   Sabouret, Pierre ^d   du Fretay, Xavier Halna ^o   Beygui, Farzin ^p   Bonnet, Jean Louis ^b,c   Lattuca, Benoit ^a   Pouillot, Christophe ^q   Varenne, Olivier ^r   Boueri, Ziad ^s   Van Belle, Eric ^t   Henry, Patrick ^f   Motreff, Pascal ⁿ   Elhadad, Simon ^u   Salem, Joe Elie ^v   Abtan, Jérémie ^o   Rousseau, Hélène ^w   Collet, Jean Philippe ^d   Vicaut, Eric ^w   Montalescot, Gilles ^d   more..

^a NÎMES UNIVERSITY HOSPITAL   (France)

^b TIMONE HOSPITAL   (France)

^c AIX MARSEILLE UNIVERSITY   (France)

^d SORBONNE UNIVERSITÉ   (France)

^e MONTPELLIER UNIVERSITY HOSPITAL   (France)

^f HÔPITAL LARIBOISIÈRE   (France)

^g UNIVERSITY HOSPITAL OF TOURS   (France)

^h HÔPITAL DU BOCAGE   (France)

ⁱ Centre Hospitalier Antibes Juan les Pins   (France)

^j Les Hopitaux de Chartres   (France)

^k HÔPITAL AMBROISE PARÉ   (France)

^l TOULOUSE UNIVERSITY HOSPITAL   (France)

^m Centre Hospitalier de la Region d'Annecy   (France)

ⁿ UNIVERSITY HOSPITAL OF CLERMONT FERRAND   (France)

^o BICHAT HOSPITAL   (France)

^p CAEN UNIVERSITY HOSPITAL   (France)

^q Clinique Sainte Clotilde   (France)

^r Institut Cochin   (France)

^s Centre Hospitalier de Bastia   (France)

^t LILLE UNIVERSITY HOSPITAL   (France)

^u Centre hospitalier de Lagny Marne la Vallee   (France)

^v PITIÉ SALPÊTRIÈRE HOSPITAL   (France)

^w ACTION Study Group   (France)

more..

Author keywords

[No Author keywords available]

Indexed keywords

ACETYLSALICYLIC ACID; CLOPIDOGREL; PRASUGREL; ANTITHROMBOCYTIC AGENT;

ACUTE CORONARY SYNDROME; AGED; ARTICLE; CEREBROVASCULAR ACCIDENT; CLINICAL OUTCOME; CONTROLLED STUDY; CORONARY STENTING; DRUG SUBSTITUTION; DRUG WITHDRAWAL; FEMALE; FOLLOW UP; HEART INFARCTION; HUMAN; INTENTION TO TREAT ANALYSIS; LOW DRUG DOSE; MAINTENANCE THERAPY; MAJOR CLINICAL STUDY; MALE; MULTICENTER STUDY; NON ST SEGMENT ELEVATION MYOCARDIAL INFARCTION; PERCUTANEOUS CORONARY INTERVENTION; PLATELET REACTIVITY; POSTOPERATIVE HEMORRHAGE; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; ST SEGMENT ELEVATION; ST SEGMENT ELEVATION MYOCARDIAL INFARCTION; STENT THROMBOSIS; THROMBOCYTE FUNCTION; TREATMENT OUTCOME; BLOOD CLOTTING PARAMETERS; CLINICAL TRIAL; DRUG ADMINISTRATION; PHYSIOLOGIC MONITORING; RISK ASSESSMENT; STENT; VERY ELDERLY;

ACUTE CORONARY SYNDROME; AGED; AGED, 80 AND OVER; DRUG ADMINISTRATION SCHEDULE; FEMALE; HUMANS; MALE; MONITORING, PHYSIOLOGIC; PERCUTANEOUS CORONARY INTERVENTION; PLATELET AGGREGATION INHIBITORS; PLATELET FUNCTION TESTS; PRASUGREL HYDROCHLORIDE; RISK ASSESSMENT; STENTS;

EID: 84992563924     PISSN: 01406736     EISSN: 1474547X     Source Type: Journal    
DOI: 10.1016/S0140-6736(16)31323-X     Document Type: Article

References (36)

1. 1 Alexander, KP, Newby, LK, Cannon, CP, et al. Acute coronary care in the elderly, part I: non-ST-segment-elevation acute coronary syndromes: a scientific statement for healthcare professionals from the American Heart Association Council on Clinical Cardiology: in collaboration with the Society of Geriatric Cardiology. Circulation 115 (2007), 2549–2569.
2. 2 Schoenenberger, AW, Radovanovic, D, Windecker, S, et al. Temporal trends in the treatment and outcomes of elderly patients with acute coronary syndrome. Eur Heart J 37 (2016), 1304–1311.
3. 3 Trial of invasive versus medical therapy in elderly patients with chronic symptomatic coronary-artery disease (TIME): a randomised trial. Lancet 358 (2001), 951–957.
4. 4 Tegn, N, Abdelnoor, M, Aaberge, L, et al. Invasive versus conservative strategy in patients aged 80 years or older with non-ST-elevation myocardial infarction or unstable angina pectoris (After Eighty study): an open-label randomised controlled trial. Lancet 387 (2016), 1057–1065.
5. 5 Price, MJ, Berger, PB, Teirstein, PS, et al. Standard- vs high-dose clopidogrel based on platelet function testing after percutaneous coronary intervention: the GRAVITAS randomized trial. JAMA 305 (2011), 1097–1105.
6. 6 Trenk, D, Stone, GW, Gawaz, M, et al. A randomized trial of prasugrel versus clopidogrel in patients with high platelet reactivity on clopidogrel after elective percutaneous coronary intervention with implantation of drug-eluting stents: results of the TRIGGER-PCI (Testing Platelet Reactivity In Patients Undergoing Elective Stent Placement on Clopidogrel to Guide Alternative Therapy With Prasugrel) study. J Am Coll Cardiol 59 (2012), 2159–2164.
7. 7 Collet, JP, Cuisset, T, Range, G, et al. Bedside monitoring to adjust antiplatelet therapy for coronary stenting. N Engl J Med 367 (2012), 2100–2109.
8. 8 Roe, MT, Goodman, SG, Ohman, EM, et al. Elderly patients with acute coronary syndromes managed without revascularization: insights into the safety of long-term dual antiplatelet therapy with reduced-dose prasugrel versus standard-dose clopidogrel. Circulation 128 (2013), 823–833.
9. 9 Cayla, G, Cuisset, T, Silvain, J, et al. Platelet function monitoring in elderly patients on prasugrel after stenting for an acute coronary syndrome: design of the randomized antarctic study. Am Heart J 168 (2014), 674–681.
10. 10 Stone, GW, Witzenbichler, B, Weisz, G, et al. Platelet reactivity and clinical outcomes after coronary artery implantation of drug-eluting stents (ADAPT-DES): a prospective multicentre registry study. Lancet 382 (2013), 614–623.
11. 11 Campo, G, Parrinello, G, Ferraresi, P, et al. Prospective evaluation of on-clopidogrel platelet reactivity over time in patients treated with percutaneous coronary intervention relationship with gene polymorphisms and clinical outcome. J Am Coll Cardiol 57 (2011), 2474–2483.
12. 12 Tantry, US, Bonello, L, Aradi, D, et al. Consensus and update on the definition of on-treatment platelet reactivity to adenosine diphosphate associated with ischemia and bleeding. J Am Coll Cardiol 62 (2013), 2261–2273.
13. 13 Wiviott, SD, Braunwald, E, McCabe, CH, et al. Prasugrel versus clopidogrel in patients with acute coronary syndromes. N Engl J Med 357 (2007), 2001–2015.
14. 14 Price, MJ, Angiolillo, DJ, Teirstein, PS, et al. Platelet reactivity and cardiovascular outcomes after percutaneous coronary intervention: a time-dependent analysis of the Gauging Responsiveness with a VerifyNow P2Y12 assay: Impact on Thrombosis and Safety (GRAVITAS) trial. Circulation 124 (2011), 1132–1137.
15. 15 Montalescot, G, Range, G, Silvain, J, et al. High on-treatment platelet reactivity as a risk factor for secondary prevention after coronary stent revascularization: a landmark analysis of the ARCTIC study. Circulation 129 (2014), 2136–2143.
16. 16 Breet, NJ, van Werkum, JW, Bouman, HJ, et al. Comparison of platelet function tests in predicting clinical outcome in patients undergoing coronary stent implantation. JAMA 303 (2010), 754–762.
17. 17 Sibbing, D, Schulz, S, Braun, S, et al. Antiplatelet effects of clopidogrel and bleeding in patients undergoing coronary stent placement. J Thromb Haemost 8 (2010), 250–256.
18. 18 Bonello, L, Mancini, J, Pansieri, M, et al. Relationship between post-treatment platelet reactivity and ischemic and bleeding events at 1-year follow-up in patients receiving prasugrel. J Thromb Haemost 10 (2012), 1999–2005.
19. 19 Aradi, D, Kirtane, A, Bonello, L, et al. Bleeding and stent thrombosis on P2Y12-inhibitors: collaborative analysis on the role of platelet reactivity for risk stratification after percutaneous coronary intervention. Eur Heart J 36 (2015), 1762–1771.
20. 20 Montalescot, G, Vicaut, E, Collet, JP, Bedside monitoring of antiplatelet therapy for coronary stenting. N Engl J Med 368 (2013), 871–872.
21. 21 Erlinge, D, Gurbel, PA, James, S, et al. Prasugrel 5 mg in the very elderly attenuates platelet inhibition but maintains noninferiority to prasugrel 10 mg in nonelderly patients: the GENERATIONS trial, a pharmacodynamic and pharmacokinetic study in stable coronary artery disease patients. J Am Coll Cardiol 62 (2013), 577–583.
22. 22 Savonitto, S, Cavallini, C, Petronio, AS, et al. Early aggressive versus initially conservative treatment in elderly patients with non-ST-segment elevation acute coronary syndrome: a randomized controlled trial. JACC Cardiovasc Interv 5 (2012), 906–916.
23. 23 Rich, MW, Chyun, DA, Skolnick, AH, et al. Knowledge Gaps in Cardiovascular Care of the Older Adult Population: A Scientific Statement From the American Heart Association, American College of Cardiology, and American Geriatrics Society. J Am Coll Cardiol 67 (2016), 2419–2440.
24. 24 Andreotti, F, Rocca, B, Husted, S, et al. Antithrombotic therapy in the elderly: expert position paper of the European Society of Cardiology Working Group on Thrombosis. Eur Heart J 36 (2015), 3238–3249.
25. 25 Food and Drug Administration, HHS. International Conference on Harmonisation; Guidance on E7 Studies in Support of Special Populations; Geriatrics; Questions and Answers; availability. Notice. Fed Regist 77 (2012), 9948–9949.
26. 26 Mehta, SR, Bassand, JP, Chrolavicius, S, et al. Dose comparisons of clopidogrel and aspirin in acute coronary syndromes. N Engl J Med 363 (2010), 930–942.
27. 27 Wallentin, L, Becker, RC, Budaj, A, et al. Ticagrelor versus clopidogrel in patients with acute coronary syndromes. N Engl J Med 361 (2009), 1045–1057.
28. 28 Capodanno, D, Angiolillo, DJ, Antithrombotic therapy in the elderly. J Am Coll Cardiol 56 (2010), 1683–1692.
29. 29 Silvain, J, Cayla, G, Hulot, JS, et al. High on-thienopyridine platelet reactivity in elderly coronary patients: the SENIOR-PLATELET study. Eur Heart J 33 (2012), 1241–1249.
30. 30 Kolh, P, Windecker, S, ESC/EACTS myocardial revascularization guidelines 2014. Eur Heart J 35 (2014), 3235–3236.
31. 31 Levine, GN, Bates, ER, Blankenship, JC, et al. 2011 ACCF/AHA/SCAI Guideline for Percutaneous Coronary Intervention. A report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines and the Society for Cardiovascular Angiography and Interventions. J Am Coll Cardiol 58 (2011), e44–122.
32. 32 Aradi, D, Komocsi, A, Price, MJ, et al. Efficacy and safety of intensified antiplatelet therapy on the basis of platelet reactivity testing in patients after percutaneous coronary intervention: systematic review and meta-analysis. Int J Cardiol 167 (2013), 2140–2148.
33. 33 Bonello, L, Camoin-Jau, L, Arques, S, et al. Adjusted clopidogrel loading doses according to vasodilator-stimulated phosphoprotein phosphorylation index decrease rate of major adverse cardiovascular events in patients with clopidogrel resistance: a multicenter randomized prospective study. J Am Coll Cardiol 51 (2008), 1404–1411.
34. 34 Mayer, K, Schulz, S, Bernlochner, I, et al. A comparative cohort study on personalised antiplatelet therapy in PCI-treated patients with high on-clopidogrel platelet reactivity. Results of the ISAR-HPR registry. Thromb Haemost 112 (2014), 342–351.
35. 35 Aradi, D, Tornyos, A, Pinter, T, et al. Optimizing P2Y12 receptor inhibition in patients with acute coronary syndrome on the basis of platelet function testing: impact of prasugrel and high-dose clopidogrel. J Am Coll Cardiol 63 (2014), 1061–1070.
36. 36 Gurbel, PA, Erlinge, D, Ohman, EM, et al. Platelet function during extended prasugrel and clopidogrel therapy for patients with ACS treated without revascularization: the TRILOGY ACS platelet function substudy. JAMA 308 (2012), 1785–1794.