Efficacy and safety of vorapaxar in non-ST-segment elevation acute coronary syndrome patients undergoing noncardiac surgery

Journal of the American Heart Association

Volumn 4, Issue 12, 2015, Pages

  van Diepen, Sean ^a,b   Tricoci, Pierluigi ^c   Podder, Mohua ^b   Westerhout, Cynthia M ^b   Aylward, Philip E ^d   Held, Claes ^e   Van de Werf, Frans ^f   Strony, John ^g   Wallentin, Lars ^e   Moliterno, David J ^h   White, Harvey D ⁱ   Mahaffey, Kenneth W ^j   Harrington, Robert A ^j   Armstrong, Paul W ^a,b  

^a UNIVERSITY OF ALBERTA   (Canada)

^b UNIVERSITY OF ALBERTA   (Canada)

^c DUKE UNIVERSITY MEDICAL CENTER   (United States)

^d FLINDERS UNIVERSITY   (Australia)

^e UPPSALA CLINICAL RESEARCH CENTER   (Sweden)

^f UNIVERSITY OF LEUVEN   (Belgium)

^g MERCK RESEARCH LABORATORIES   (United States)

^h UNIVERSITY OF KENTUCKY   (United States)

ⁱ AUCKLAND CITY HOSPITAL   (New Zealand)

^j STANFORD UNIVERSITY   (United States)

more..

Author keywords

Coronary disease; Hemorrhage; Non ST segment elevation acute coronary syndromes; Noncardiac surgery; Surgery; Vorapaxar

Indexed keywords

ACETYLSALICYLIC ACID; PLACEBO; THIENOPYRIDINE DERIVATIVE; VORAPAXAR; LACTONE; PROTEINASE ACTIVATED RECEPTOR 1; PYRIDINE DERIVATIVE;

ADULT; AGED; ARTICLE; BLEEDING; CARDIOVASCULAR MORTALITY; CONTROLLED STUDY; DISEASE SEVERITY; DOUBLE BLIND PROCEDURE; DRUG EFFICACY; DRUG SAFETY; FEMALE; HEART INFARCTION; HEART MUSCLE ISCHEMIA; HIGH RISK POPULATION; HUMAN; MAJOR CLINICAL STUDY; MALE; MULTICENTER STUDY; NON ST SEGMENT ELEVATION ACUTE CORONARY SYNDROME; NONCARDIAC SURGERY; OUTCOME ASSESSMENT; PERIOPERATIVE PERIOD; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; REVASCULARIZATION; STENT THROMBOSIS; SURGICAL TECHNIQUE; ACUTE CORONARY SYNDROME; ANTAGONISTS AND INHIBITORS; CLINICAL TRIAL; COMPLICATION; HEMORRHAGE; MIDDLE AGED; PROCEDURES; SURGERY; TREATMENT OUTCOME;

ACUTE CORONARY SYNDROME; AGED; DOUBLE-BLIND METHOD; FEMALE; HEMORRHAGE; HUMANS; LACTONES; MALE; MIDDLE AGED; PYRIDINES; RECEPTOR, PAR-1; SURGICAL PROCEDURES, OPERATIVE; TREATMENT OUTCOME;

EID: 85006215994     PISSN: None     EISSN: 20479980     Source Type: Journal    
DOI: 10.1161/JAHA.115.002546     Document Type: Article

References (38)

1. Hawn MT, Graham LA, Richman JS, Itani KF, Henderson WG, Maddox TM. Risk of major adverse cardiac events following noncardiac surgery in patients with coronary stents. JAMA. 2013;310:1462-1472.
2. To AC, Armstrong G, Zeng I, Webster MW. Noncardiac surgery and bleeding after percutaneous coronary intervention. Circ Cardiovasc Interv. 2009;2:213-221.
3. Wijeysundera DN, Wijeysundera HC, Yun L, Wazsowicz M, Beattie WS, Velianou JL, Ko DT. Risk of elective major noncardiac surgery after coronary stent insertion: a population-based study. Circulation. 2012;126:1355-1362.
4. Goldman L, Caldera DL, Nussbaum SR, Southwick FS, Krogstad D, Murray B, Burke DS, O'Malley TA, Goroll AH, Caplan CH, Nolan J, Carabello B, Slater EE. Multifactorial index of cardiac risk in noncardiac surgical procedures. N Engl J Med. 1977;297:845-850.
5. Detsky AS, Abrams HB, McLaughlin JR, Drucker DJ, Sasson Z, Johnston N, Scott JG, Forbath N, Hilliard JR. Predicting cardiac complications in patients undergoing non-cardiac surgery. J Gen Intern Med. 1986;1:211-219.
6. Lee TH, Marcantonio ER, Mangione CM, Thomas EJ, Polanczyk CA, Cook EF, Sugarbaker DJ, Donaldson MC, Poss R, Ho KK, Ludwig LE, Pedan A, Goldman L. Derivation and prospective validation of a simple index for prediction of cardiac risk of major noncardiac surgery. Circulation. 1999;100:1043-1049.
7. Capodanno D, Angiolillo DJ. Management of antiplatelet therapy in patients with coronary artery disease requiring cardiac and noncardiac surgery. Circulation. 2013;128:2785-2798.
8. Burger W, Chemnitius JM, Kneissl GD, Rucker G. Low-dose aspirin for secondary cardiovascular prevention-cardiovascular risks after its perioperative withdrawal versus bleeding risks with its continuation-review and metaanalysis. J Intern Med. 2005;257:399-414.
9. Oscarsson A, Gupta A, Fredrikson M, Järhult J, Nyström M, Pettersson E, Darvish B, Krook H, Swahn E, Eintrei C. To continue or discontinue aspirin in the perioperative period: a randomized, controlled clinical trial. Br J Anaesth. 2010;104:305-312.
10. Mantz J, Samama CM, Tubach F, Devereaux PJ, Collet JP, Albaladejo P, Cholley B, Nizard R, Barré J, Piriou V, Poirier N, Mignon A, Schlumberger S, Longrois D, Aubrun F, Fařese ME, Ravaud P, Steg PG; Stratagem Study Group. Impact of preoperative maintenance or interruption of aspirin on thrombotic and bleeding events after elective non-cardiac surgery: the multicentre, randomized, blinded, placebo-controlled, STRATAGEM trial. Br J Anaesth. 2011;107:899-910.
11. Tricoci P, Huang Z, Held C, Moliterno DJ, Armstrong PW, Van de Werf F, White HD, Aylward PE, Wallentin L, Chen E, Lokhnygina Y, Pei J, Leonardi S, Rorick TL, Kilian AM, Jennings LH, Ambrosio G, Bode C, Cequier A, Cornel JH, Diaz R, Erkan A, Huber K, Hudson MP, Jiang L, Jukema JW, Lewis BS, Lincoff AM, Montalescot G, Nicolau JC, Ogawa H, Pfisterer M, Prieto JC, Ruzyllo W, Sinnaeve PR, Storey RF, Valgimigli M, Whellan DJ, Widimsky P, Strony J, Harrington RA, Mahaffey KW; TRACER Investigators. Thrombin-receptor antagonist vorapaxar in acute coronary syndromes. N Engl J Med. 2012;366:20-33.
12. TRA*CER Executive and Steering Committees. The Thrombin Receptor Antagonist for Clinical Event Reduction in Acute Coronary Syndrome (TRA*CER) trial: study design and rationale. Am Heart J. 2009;158:327-334.e4.
13. Berger PB, Kleiman NS, Pencina MJ, Hsieh WH, Steinhubl SR, Jeremias A, Sonel A, Browne K, Barseness G, Cohen DJ; EVENT Investigators. Frequency of major noncardiac surgery and subsequent adverse events in the year after drugeluting stent placement results from the EVENT (Evaluation of Drug-Eluting Stents and Ischemic Events) Registry. JACC Cardiovasc Interv. 2010;3:920-927.
14. Brilakis ES, Cohen DJ, Kleiman NS, Pencina M, Nassif D, Saucedo J, Piana RN, Banerjee S, Keyes MJ, Yen CH, Berger PB. Incidence and clinical outcome of minor surgery in the year after drug-eluting stent implantation: results from the Evaluation of Drug-Eluting Stents and Ischemic Events Registry. Am Heart J. 2011;161:360-366.
15. Whellan DJ, Tricoci P, Chen E, Huang Z, Leibowitz D, Vranckx P, Marhefka GD, Held C, Nicolau JC, Storey RF, Ruzyllo W, Huber K, Sinnaeve P, Weiss AT, Dery JP, Moliterno DJ, Van de Werf F, Aylward PE, White HD, Armstrong PW, Wallentin L, Strony J, Harrington RA, Mahaffey KW. Vorapaxar in acute coronary syndrome patients undergoing coronary artery bypass graft surgery: subgroup analysis from the TRACER trial (Thrombin Receptor Antagonist for Clinical Event Reduction in Acute Coronary Syndrome). J Am Coll Cardiol. 2014;63:1048-1057.
16. Fleisher LA, Beckman JA, Brown KA, Calkins H, Chaikof EL, Fleischmann KE, Freeman WK, Froehlich JB, Kasper EK, Kersten JR, Riegel B, Robb JF, Smith SC Jr, Jacobs AK, Adams CD, Anderson JL, Antman EM, Buller CE, Creager MA, Ettinger SM, Faxon DP, Fuster V, Halperin JL, Hiratzka LF, Hunt SA, Lytle BW, Nishimura R, Ornato JP, Page RL, Riegel B, Tarkington LG, Yancy CW; American College of Cardiology; American Heart Association Task Force on Practice Guidelines (writing Committee to Revise the 2002 Guidelines on Perioperative Cardiovascular Evaluation for Noncardiac Surgery); American Society of Echocardiography; American Society of Nuclear Cardiology; Heart Rhythm Society; Society of Cardiovascular Anesthesiologists; Society for Cardiovascular Angiography and Interventions; Society for Vascular Medicine and Biology; Society for Vascular Surgery. ACC/AHA 2007 guidelines on perioperative cardiovascular evaluation and care for noncardiac surgery: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Writing Committee to Revise the 2002 Guidelines on Perioperative Cardiovascular Evaluation for Noncardiac Surgery) developed in collaboration with the American Society of Echocardiography, American Society of Nuclear Cardiology, Heart Rhythm Society, Society of Cardiovascular Anesthesiologists, Society for Cardiovascular Angiography and Interventions, Society for Vascular Medicine and Biology, and Society for Vascular Surgery. J Am Coll Cardiol. 2007;50:e159-e241.
17. Hammill BG, Curtis LH, Bennett-Guerrero E, O'Connor CM, Jollis JG, Schulman KA, Hernandez AF. Impact of heart failure on patients undergoing major noncardiac surgery. Anesthesiology. 2008;108:559-567.
18. Hernandez AF, Whellan DJ, Stroud S, Sun JL, O'Connor CM, Jollis JG. Outcomes in heart failure patients after major noncardiac surgery. J Am Coll Cardiol. 2004;44:1446-1453.
19. van Diepen S, Bakal JA, McAlister FA, Ezekowitz JA. Mortality and readmission of patients with heart failure, atrial fibrillation, or coronary artery disease undergoing noncardiac surgery: an analysis of 38 047 patients. Circulation. 2011;124:289-296.
20. Livhits M, Ko CY, Leonardi MJ, Zingmond DS, Gibbons MM, de Virgilio C. Risk of surgery following recent myocardial infarction. Ann Surg. 2011;253:857-864.
21. Conroy M, Bolsin SN, Black SA, Orford N. Perioperative complications in patients with drug-eluting stents: a three-year audit at Geelong Hospital. Anaesth Intensive Care. 2007;35:939-944.
22. Cruden NL, Harding SA, Flapan AD, Graham C, Wild SH, Slack R, Pell JP, Newby DE; Scottish Coronary Revascularisation Register Steering Committee. Previous coronary stent implantation and cardiac events in patients undergoing noncardiac surgery. Circ Cardiovasc Interv. 2010;3:236-242.
23. Gandhi NK, Abdel-Karim A-RR, Banerjee S, Brilakis ES. Frequency and risk of noncardiac surgery after drug-eluting stent implantation. Catheter Cardiovasc Interv. 2011;77:972-976.
24. Devereaux PJ, Mrkobrada M, Sessler DI, Leslie K, Alonso-Coello P, Kurz A, Villar JC, Sigamani A, Biccard BM, Meyhoff CS, Parlow JL, Guyatt G, Robinson A, Garg AX, Rodseth RN, Botto F, Lurati Buse G, Xavier D, Chan MT, Tiboni M, Cook D, Kumar PA, Forget P, Malaga G, Fleischmann E, Amir M, Eikelboom J, Mizera R, Torres D, Wang CY, VanHelder T, Paniagua P, Berwanger O, Srinathan S, Graham M, Pasin L, Le Manach Y, Gao P, Pogue J, Whitlock R, Lamy A, Kearon C, Baigent C, Chow C, Pettit S, Chrolavicius S, Yusuf S; POISE-2 Investigators. Aspirin in patients undergoing noncardiac surgery. N Engl J Med. 2014;370:1494-1503.
25. Howard-Alpe GM, de Bono J, Hudsmith L, Orr WP, Foex P, Sear JW. Coronary artery stents and non-cardiac surgery. Br J Anaesth. 2007;98:560-574.
26. Ernst A, Eberhardt R, Wahidi M, Becker HD, Herth FJ. Effect of routine clopidogrel use on bleeding complications after transbronchial biopsy in humans. Chest. 2006;129:734-737.
27. Albaladejo P, Marret E, Samama CM, Collet JP, Abhay K, Loutrel O, Charbonneau H, Jaber S, Thoret S, Bosson JL, Piriou V. Non-cardiac surgery in patients with coronary stents: the RECO study. Heart. 2011;97:1566-1572.
28. Vicenzi MN, Meislitzer T, Heitzinger B, Halaj M, Fleisher LA, Metzler H. Coronary artery stenting and non-cardiac surgery-a prospective outcome study. Br J Anaesth. 2006;96:686-693.
29. Chintala M, Vemulapalli S, Kurowski S, Sabin C, Reynolds D, Prevete K, Friedrichs G. SCH 530348, a novel oral antiplatelet agent, demonstrated no bleeding risk alone or in combination with aspirin and clopidogrel in cynomolgus monkeys (abstract P579). Arterioscler Thromb Vasc Biol. 2008;28:e138-e139. Available at: http://atvb.ahajournals.org/content/28/6/e32.full.pdf+html. Accessed May 21, 2014.
30. Rao TL, Jacobs KH, El-Etr AA. Reinfarction following anesthesia in patients with myocardial infarction. Anesthesiology. 1983;59:499-505.
31. Kaluza GL, Joseph J, Lee JR, Raizner ME, Raizner AE. Catastrophic outcomes of noncardiac surgery soon after coronary stenting. J Am Coll Cardiol. 2000;35:1288-1294.
32. Wilson SH, Fasseas P, Orford JL, Lennon RJ, Horlocker T, Charnoff NE, Melby S, Berger PB. Clinical outcome of patients undergoing non-cardiac surgery in the two months following coronary stenting. J Am Coll Cardiol. 2003;42:234-240.
33. Reddy PR, Vaitkus PT. Risks of noncardiac surgery after coronary stenting. Am J Cardiol. 2005;95:755-757.
34. Holcomb CN, Graham LA, Richman JS, Rhyne RR, Itani KM, Maddox TM, Hawn MT. The incremental risk of noncardiac surgery on adverse cardiac events following coronary stenting. J Am Coll Cardiol. 2014;64:2730-2739.
35. Johnston KW. Multicenter prospective study of nonruptured abdominal aortic aneurysm. Part II. Variables predicting morbidity and mortality. J Vasc Surg. 1989;9:437-447.
36. Mor E, Jennings L, Gonwa TA, Holman MJ, Gibbs J, Solomon H, Goldstein RM, Husberg BS, Watemberg IA, Klintmalm GB. The impact of operative bleeding on outcome in transplantation of the liver. Surg Gynecol Obstet. 1993;176:219-227.
37. Moulton MJ, Creswell LL, Mackey ME, Cox JL, Rosenbloom M. Reexploration for bleeding is a risk factor for adverse outcomes after cardiac operations. J Thorac Cardiovasc Surg. 1996;111:1037-1046.
38. Douketis JD, Spyropoulos AC, Spencer FA, Mayr M, Jaffer AK, Eckman MH, Dunn AS, Kunz R; American College of Chest Physicians. Perioperative management of antithrombotic therapy: antithrombotic therapy and prevention of thrombosis, 9th ed: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines. Chest. 2012;141:e326S-e350S.