Efficacy and Safety of Cangrelor in Women Versus Men during Percutaneous Coronary Intervention: Insights from the Cangrelor versus Standard Therapy to Achieve Optimal Management of Platelet Inhibition (CHAMPION PHOENIX) Trial

Circulation

Volumn 133, Issue 3, 2016, Pages 248-255

  O'Donoghue, Michelle L ^a   Bhatt, Deepak L ^a   Stone, Gregg W ^b   Steg, Ph Gabriel ^c,d,e   Gibson, C Michael ^f   Hamm, Christian W ^g   Price, Matthew J ^h   Prats, Jayne ⁱ   Liu, Tiepu ⁱ   Deliargyris, Efthymios N ⁱ   Mahaffey, Kenneth W ^j   White, Harvey D ^k   Harrington, Robert A ^j  

^a BRIGHAM AND WOMEN S HOSPITAL   (United States)

^b Och Spine at New York Presbyterian Hospitals   (United States)

^c UNIVERSITÉ PARIS DESCARTES   (France)

^d INSERM   (France)

^e ROYAL BROMPTON HOSPITAL   (United Kingdom)

^f BETH ISRAEL DEACONESS MEDICAL CENTER   (United States)

^g Kerckhoff Heart and Thorax Center   (Germany)

^h SCRIPPS TRANSLATIONAL SCIENCE INSTITUTE   (United States)

ⁱ MEDICINES COMPANY   (United States)

^j STANFORD UNIVERSITY SCHOOL OF MEDICINE   (United States)

^k Green Lane Cardiovascular Service ^*  (New Zealand)

more..

Author keywords

ADP receptor antagonist; cangrelor; clopidogrel; percutaneous coronary intervention

Indexed keywords

CANGRELOR; CLOPIDOGREL; ADENOSINE PHOSPHATE; ANTITHROMBOCYTIC AGENT;

ADULT; AGED; ANTICOAGULANT THERAPY; ARTICLE; BLEEDING; CONTROLLED STUDY; DEATH; DISEASE SEVERITY; DRUG EFFICACY; DRUG SAFETY; FEMALE; HEART INFARCTION; HUMAN; ISCHEMIA; LOADING DRUG DOSE; MAJOR CLINICAL STUDY; MALE; PERCUTANEOUS CORONARY INTERVENTION; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; STENT THROMBOSIS; TREATMENT OUTCOME; ANALOGS AND DERIVATIVES; CHEMICALLY INDUCED; COMPARATIVE STUDY; DISEASE MANAGEMENT; MIDDLE AGED; MYOCARDIAL INFARCTION; PROCEDURES; SEXUAL DEVELOPMENT; TRENDS; VERY ELDERLY;

ADENOSINE MONOPHOSPHATE; AGED; AGED, 80 AND OVER; DISEASE MANAGEMENT; FEMALE; HEMORRHAGE; HUMANS; MALE; MIDDLE AGED; MYOCARDIAL INFARCTION; PERCUTANEOUS CORONARY INTERVENTION; PLATELET AGGREGATION INHIBITORS; SEX CHARACTERISTICS; TREATMENT OUTCOME;

EID: 84955648782     PISSN: 00097322     EISSN: 15244539     Source Type: Journal    
DOI: 10.1161/CIRCULATIONAHA.115.017300     Document Type: Article

References (27)

1. Kim ES, Carrigan TP, Menon V, Enrollment of women in National Heart, Lung, and Blood Institute-funded cardiovascular randomized controlled trials fails to meet current federal mandates for inclusion. J Am Coll Cardiol 2008 52 672 673. doi: 10.1016/j.jacc.2008.05.025
2. Melloni C, Berger JS, Wang TY, Gunes F, Stebbins A, Pieper KS, Dolor RJ, Douglas PS, Mark DB, Newby LK, Representation of women in randomized clinical trials of cardiovascular disease prevention. Circ Cardiovasc Qual Outcomes 2010 3 135 142. doi: 10.1161/CIRCOUTCOMES.110.868307
3. Boersma E, Harrington RA, Moliterno DJ, White H, Simoons ML, Platelet glycoprotein IIb/IIIa inhibitors in acute coronary syndromes. Lancet 2002 360 342 343
4. Iakovou I, Dangas G, Mehran R, Lansky AJ, Kobayashi Y, Adamian M, Polena S, Collins MB, Roubin GS, Stone GW, Leon MB, Moses JW, Gender differences in clinical outcome after coronary artery stenting with use of glycoprotein IIb/IIIa inhibitors. Am J Cardiol 2002 89 976 979
5. Berger JS, Roncaglioni MC, Avanzini F, Pangrazzi I, Tognoni G, Brown DL, Aspirin for the primary prevention of cardiovascular events in women and men: a sex-specific meta-Analysis of randomized controlled trials. JAMA 2006 295 306 313. doi: 10.1001/jama.295.3.306
6. Wang TY, Angiolillo DJ, Cushman M, Sabatine MS, Bray PF, Smyth SS, Dauerman HL, French PA, Becker RC, Platelet biology and response to antiplatelet therapy in women: implications for the development and use of antiplatelet pharmacotherapies for cardiovascular disease. J Am Coll Cardiol 2012 59 891 900. doi: 10.1016/j.jacc.2011.09.075
7. Angiolillo DJ, Schneider DJ, Bhatt DL, French WJ, Price MJ, Saucedo JF, Shaburishvili T, Huber K, Prats J, Liu T, Harrington RA, Becker RC, Pharmacodynamic effects of cangrelor and clopidogrel: the platelet function substudy from the cangrelor versus standard therapy to achieve optimal management of platelet inhibition (CHAMPION) trials. J Thromb Thrombolysis 2012 34 44 55. doi: 10.1007/s11239-012-0737-3
8. Storey RF, Oldroyd KG, Wilcox RG, Open multicentre study of the P2T receptor antagonist AR-C69931MX assessing safety, tolerability and activity in patients with acute coronary syndromes. Thromb Haemost 2001 85 401 407
9. Akers WS, Oh JJ, Oestreich JH, Ferraris S, Wethington M, Steinhubl SR, Pharmacokinetics and pharmacodynamics of a bolus and infusion of cangrelor: a direct, parenteral P2Y12 receptor antagonist. J Clin Pharmacol 2010 50 27 35. doi: 10.1177/0091270009344986
10. Bhatt DL, Stone GW, Mahaffey KW, Gibson CM, Steg PG, Hamm CW, Price MJ, Leonardi S, Gallup D, Bramucci E, Radke PW, Widimský P, Tousek F, Tauth J, Spriggs D, McLaurin BT, Angiolillo DJ, Généreux P, Liu T, Prats J, Todd M, Skerjanec S, White HD, Harrington RA, CHAMPION PHOENIX Investigators Effect of platelet inhibition with cangrelor during PCI on ischemic events. N Engl J Med 2013 368 1303 1313. doi: 10.1056/NEJMoa1300815
11. Leonardi S, Mahaffey KW, White HD, Gibson CM, Stone GW, Steg GW, Hamm CW, Price MJ, Todd M, Dietrich M, Gallup D, Liu T, Skerjanec S, Harrington RA, Bhatt DL, Rationale and design of the Cangrelor versus standard therapy to acHieve optimal Management of Platelet InhibitiON PHOENIX trial. Am Heart J 2012 163 768 776.e2. doi: 10.1016/j.ahj.2012.02.018
12. Généreux P, Stone GW, Harrington RA, Gibson CM, Steg PG, Brener SJ, Angiolillo DJ, Price MJ, Prats J, Lasalle L, Liu T, Todd M, Skerjanec S, Hamm CW, Mahaffey KW, White HD, Bhatt DL, CHAMPION PHOENIX Investigators Impact of intraprocedural stent thrombosis during percutaneous coronary intervention: insights from the CHAMPION PHOENIX Trial (Clinical Trial Comparing Cangrelor to Clopidogrel Standard of Care Therapy in Subjects Who Require Percutaneous Coronary Intervention). J Am Coll Cardiol 2014 63 619 629. doi: 10.1016/j.jacc.2013.10.022
13. The GUSTO investigators An international randomized trial comparing four thrombolytic strategies for acute myocardial infarction. N Engl J Med 1993 329 673 82
14. Chesebro JH, Knatterud G, Roberts R, Borer J, Cohen LS, Dalen J, Dodge HT, Francis CK, Hillis D, Ludbrook P, Thrombolysis in Myocardial Infarction (TIMI) Trial, Phase I: A comparison between intravenous tissue plasminogen activator and intravenous streptokinase. Clinical findings through hospital discharge. Circulation 1987 76 142 154. doi: 10.1161/01.CIR.76.1.142
15. Stone GW, McLaurin BT, Cox DA, Bertrand ME, Lincoff AM, Moses JW, White HD, Pocock SJ, Ware JH, Feit F, Colombo A, Aylward PE, Cequier AR, Darius H, Desmet W, Ebrahimi R, Hamon M, Rasmussen LH, Rupprecht HJ, Hoekstra J, Mehran R, Ohman EM, ACUITY Investigators Bivalirudin for patients with acute coronary syndromes. N Engl J Med 2006 355 2203 2216. doi: 10.1056/NEJMoa062437
16. Escolar G, Bastida E, Garrido M, Rodríguez-Gómez J, Castillo R, Ordinas A, Sex-related differences in the effects of aspirin on the interaction of platelets with subendothelium. Thromb Res 1986 44 837 847
17. Johnson M, Ramey E, Ramwell PW, Sex and age differences in human platelet aggregation. Nature 1975 253 355 357
18. Becker DM, Segal J, Vaidya D, Yanek LR, Herrera-Galeano JE, Bray PF, Moy TF, Becker LC, Faraday N, Sex differences in platelet reactivity and response to low-dose aspirin therapy. JAMA 2006 295 1420 1427. doi: 10.1001/jama.295.12.1420
19. Kurrelmeyer K, Becker L, Becker D, Yanek L, Goldschmidt-Clermont P, Bray PF, Platelet hyperreactivity in women from families with premature atherosclerosis. J Am Med Womens Assoc 2003 58 272 277
20. Jochmann N, Stangl K, Garbe E, Baumann G, Stangl V, Female-specific aspects in the pharmacotherapy of chronic cardiovascular diseases. Eur Heart J 2005 26 1585 1595. doi: 10.1093/eurheartj/ehi397
21. Sarma A, Wiviott SD, Antman EM, Mega JL, Murphy SA, Hoffman E, Sabatine MS, O'Donoghue ML, Pharmacodynamic response to clopidogrel in men versus women: insights from the PRINCIPLE-TIMI 44 Trial. Circulation 2012 126 A17455
22. Baigent C, Blackwell L, Collins R, Emberson J, Godwin J, Peto R, Buring J, Hennekens C, Kearney P, Meade T, Patrono C, Roncaglioni MC, Zanchetti A, Aspirin in the primary and secondary prevention of vascular disease: collaborative meta-Analysis of individual participant data from randomised trials. Lancet 2009 373 1849 60
23. Berger JS, Bhatt DL, Cannon CP, Chen Z, Jiang L, Jones JB, Mehta SR, Sabatine MS, Steinhubl SR, Topol EJ, Berger PB, The relative efficacy and safety of clopidogrel in women and men a sex-specific collaborative meta-Analysis. J Am Coll Cardiol 2009 54 1935 1945. doi: 10.1016/j.jacc.2009.05.074
24. Chiu JH, Bhatt DL, Ziada KM, Chew DP, Whitlow PL, Lincoff AM, Ellis SG, Topol EJ, Impact of female sex on outcome after percutaneous coronary intervention. Am Heart J 2004 148 998 1002. doi: 10.1016/j.ahj.2004.05.045
25. O'Gara PT, Kushner FG, Ascheim DD, Casey DE Jr, Chung MK, de Lemos JA, Ettinger SM, Fang JC, Fesmire FM, Franklin BA, Granger CB, Krumholz HM, Linderbaum JA, Morrow DA, Newby LK, Ornato JP, Ou N, Radford MJ, Tamis-Holland JE, Tommaso CL, Tracy CM, Woo YJ, Zhao DX, Anderson JL, Jacobs AK, Halperin JL, Albert NM, Brindis RG, Creager MA, DeMets D, Guyton RA, Hochman JS, Kovacs RJ, Kushner FG, Ohman EM, Stevenson WG, Yancy CW, American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines 2013 ACCF/AHA guideline for the management of ST-elevation myocardial infarction: a report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines. Circulation 2013 127 e362 e425. doi: 10.1161/CIR.0b013e3182742cf6
26. Amsterdam EA, Wenger NK, Brindis RG, Casey DE Jr, Ganiats TG, Holmes DR Jr, Jaffe AS, Jneid H, Kelly RF, Kontos MC, Levine GN, Liebson PR, Mukherjee D, Peterson ED, Sabatine MS, Smalling RW, Zieman SJ, ACC/AHA Task Force Members 2014 AHA/ACC guideline for the management of patients with non-ST-elevation acute coronary syndromes: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines. Circulation 2014 130 e344 e426. doi: 10.1161/CIR.0000000000000134
27. Hamm CW, Bassand JP, Agewall S, Bax J, Boersma E, Bueno H, Caso P, Dudek D, Gielen S, Huber K, Ohman M, Petrie MC, Sonntag F, Uva MS, Storey RF, Wijns W, Zahger D, ESC Committee for Practice Guidelines ESC Guidelines for the management of acute coronary syndromes in patients presenting without persistent ST-segment elevation: The Task Force for the management of acute coronary syndromes (ACS) in patients presenting without persistent ST-segment elevation of the European Society of Cardiology (ESC). Eur Heart J 2011 32 2999 3054. doi: 10.1093/eurheartj/ehr236