ISAR-REACT 3A: A study of reduced dose of unfractionated heparin in biomarker negative patients undergoing percutaneous coronary intervention

European Heart Journal

Volumn 31, Issue 20, 2010, Pages 2482-2491

  Schulz, Stefanie ^a   Mehilli, Julinda ^a   Neumann, Franz Josef ^b   Schuster, Tibor ^c   Massberg, Steffen ^a   Valina, Christian ^b   Seyfarth, Melchior ^a   Pache, Jürgen ^a   Laugwitz, Karl Ludwig ^c   Büttner, Hans Joachim ^b   Ndrepepa, Gjin ^a   Schömig, Albert ^a,c   Kastrati, Adnan ^a  

^a TECHNICAL UNIVERSITY OF MUNICH   (Germany)

^b UNIVERSITY HEART CENTER FREIBURG BAD KROZINGEN   (Germany)

^c TECHNICAL UNIVERSITY OF MUNICH   (Germany)

Author keywords

Bivalirudin; Clopidogrel; Heparin; Stent

Indexed keywords

BIOLOGICAL MARKER; CLOPIDOGREL; HEPARIN; HIRULOG;

ADULT; AGED; ARTICLE; BLEEDING; CLINICAL ASSESSMENT; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DRUG DOSE REDUCTION; FEMALE; FOLLOW UP; HEART INFARCTION; HEART MUSCLE REVASCULARIZATION; HUMAN; MAJOR CLINICAL STUDY; MALE; MORTALITY; MULTICENTER STUDY; OUTCOME ASSESSMENT; PERCUTANEOUS CORONARY INTERVENTION; PRIORITY JOURNAL; PROSPECTIVE STUDY; RANDOMIZED CONTROLLED TRIAL;

AGED; ANGINA PECTORIS; ANGIOPLASTY, BALLOON, CORONARY; ANTICOAGULANTS; BIOLOGICAL MARKERS; DEATH, SUDDEN, CARDIAC; DRUG THERAPY, COMBINATION; FEMALE; FOLLOW-UP STUDIES; HEPARIN; HUMANS; MALE; MIDDLE AGED; MYOCARDIAL INFARCTION; MYOCARDIAL REVASCULARIZATION; PLATELET AGGREGATION INHIBITORS; POSTOPERATIVE HEMORRHAGE; PROSPECTIVE STUDIES; TICLOPIDINE; TREATMENT OUTCOME;

EID: 77958140630     PISSN: 0195668X     EISSN: 15229645     Source Type: Journal    
DOI: 10.1093/eurheartj/ehq330     Document Type: Article

References (35)

1. Gruntzig AR, Senning A, Siegenthaler WE. Nonoperative dilatation of coronary-artery stenosis: percutaneous transluminal coronary angioplasty. N Engl J Med 1979;301:61-68. (Pubitemid 9229695)
2. Smith SC Jr, Feldman TE, Hirshfeld JW Jr, Jacobs AK, Kern MJ, King SB 3rd, Morrison DA, O'Neill WW, Schaff HV, Whitlow PL, Williams DO, Antman EM, Smith SC Jr, Adams CD, Anderson JL, Faxon DP, Fuster V, Halperin JL, Hiratzka LF, Hunt SA, Jacobs AK, Nishimura R, Ornato JP, Page RL, Riegel B. ACC/AHA/SCAI 2005 guideline update for percutaneous coronary intervention: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (ACC/AHA/SCAI Writing Com-mittee to Update the 2001 Guidelines for Percutaneous Coronary Intervention). JAm Coll Cardiol 2006;47:e1-e121.
3. Silber S, Albertsson P, Aviles FF, Camici PG, Colombo A, Hamm C,Jorgensen E, Marco J, Nordrehaug JE, Ruzyllo W, Urban P, Stone GW, Wijns W. Guidelines for percutaneous coronary interventions. The Task Force for Percutaneous Coron-ary Interventions of the European Society of Cardiology. Eur Heart J 2005;26: 804-847.
4. Vainer J, Fleisch M, Gunnes P, Ramamurthy S, Garachemani A, Kaufmann UP, Meyer BJ, Luscher TF, Meier B. Low-dose heparin for routine coronary angio-plasty and stenting. Am J Cardiol 1996;78:964-966.
5. Boccara A, Benamer H, Juliard JM, Aubry P, Goy P, Himbert D, Karrillon GJ, Steg PG. A randomized trial of a fixed high dose vs a weight-adjusted low dose of intravenous heparin during coronaryangioplasty. Eur Heart J 1997;18:631-635.
6. Swanson N, Hogrefe K, Stephens Lloyd A, Gershlick A. Current perspectives on British use of adjunctive therapies during coronary interventions. Int J Cardiol 2001;79:119-125 (discussion 126-117).
7. Brener SJ, Moliterno DJ, Lincoff AM, Steinhubl SR, Wolski KE, Topol EJ. Relation-ship between activated clotting time and ischemic or hemorrhagic complications: analysis of 4 recent randomized clinical trials of percutaneous coronary interven-tion. Circulation 2004;110:994-998.
8. Lincoff AM, Bittl JA, Harrington RA, Feit F, Kleiman NS, Jackman JD, Sarembock IJ, Cohen DJ, Spriggs D, Ebrahimi R, Keren G, Carr J, Cohen EA, Betriu A, Desmet W, Kereiakes DJ, Rutsch W, Wilcox RG, de Feyter PJ, Vahanian A, Topol EJ. Bivalirudin and provisional glycoprotein IIb/IIIa blockade compared with heparin and planned glycoprotein IIb/IIIa blockade during percutaneous cor-onary intervention: REPLACE-2 randomized trial. JAMA 2003;289:853-863.
9. 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. Bivalirudin for patients with acute coronary syndromes. N Engl J Med 2006;355:2203-2216.
10. Stone GW, Witzenbichler B, Guagliumi G, Peruga JZ, Brodie BR, Dudek D, Kornowski R, Hartmann F, Gersh BJ, Pocock SJ, Dangas G, Wong SC, Kirtane AJ, Parise H, Mehran R. Bivalirudin during primary PCI in acute myocardial infarction. N Engl J Med 2008;358:2218-2230.
11. Kastrati A, Neumann FJ, Mehilli J, Byrne RA, Iijima R, Buttner HJ, Khattab AA, Schulz S, Blankenship JC, Pache J, Minners J, Seyfarth M, Graf I, Skelding KA, Dirschinger J, Richardt G, Berger PB, Schomig A. Bivalirudin versus unfractionated heparin during percutaneous coronary intervention. N Engl J Med 2008;359: 688-696.
12. The TIMI Study Group. Definitions used in TIMI trials Available at: http://www. timi.org, (last accessed April 10 2010).
13. Cutlip DE, Windecker S, Mehran R, Boam A, Cohen DJ, van Es GA, Steg PG, Morel MA, Mauri L, Vranckx P, McFadden E, Lansky A, Hamon M, Krucoff MW, Serruys PW. Clinical end points in coronary stent trials: a case for standardized definitions. Circulation 2007;115:2344-2351.
14. Fleiss JL, Tytun A, Ury HK.A simple approximation forcalculating sample sizes for comparing independent proportions. Biometrics 1980;36:343-346.
15. Liang KY, Zeger L Longitudinal data analysis using generalized linear models. Bio-metrika 1986;73:13-22.
16. Grambsch P, Therneau T Proportional hazards tests and diagnostics based on weighted residuals. Biometrika 1994;81:515-526.
17. FinnDiane. Match controls to cases. available at http://www.artemis.kll. helsinki.fi/misc/match.php (last accessed 11 August 2010).
18. Chow S-C, Liu J-P. Design and Analysis ofBioavailability and Bioequivalence Studies. New York: Marcel Dekker; 1992.
19. Bull BS, Korpman RA, Huse WM, Briggs BD. Heparin therapyduring extracorpor-eal circulation. I. Problems inherent in existing heparin protocols. J Thorac Cardio-vasc Surg 1975;69:674-684.
20. Koch KT, Piek JJ, de Winter RJ, David GK, Mulder K, Tijssen JG, Lie KI. Safety of low dose heparin in elective coronary angioplasty. Heart 1997;77:517-522.
21. Kaluski E, Krakover R, Cotter G, Hendler A, Zyssman I, Milovanov O, Blatt A, Zimmerman E, Goldstein E, Nahman V, Vered Z. Minimal heparinization in cor-onary angioplasty\how much heparin is really warranted? Am J Cardiol 2000; 85:953-956.
22. Tolleson TR, O'Shea JC, Bittl JA, Hillegass WB, Williams KA, Levine G, Harrington RA, Tcheng JE. Relationship between heparin anticoagulation and clinical outcomes in coronary stent intervention: observations from the ESPRIT trial. J Am Coll Cardiol 2003;41:386-393.
23. Valencia R, Price MJ, Sawhney N, Lee SS, Wong GB, Gollapudi RR, Banares M, Schatz RA, Teirstein PS. Efficacy and safety of triple antiplatelet therapy with and without concomitant anticoagulation during elective percutaneous coronary intervention (the REMOVE trial). Am J Cardiol 2007;100:1099-1102.
24. Denardo SJ, Davis KE, Tcheng JE. Elective percutaneous coronary intervention using broad-spectrum antiplatelet therapy (eptifibatide, clopidogrel, and aspirin) alone, without scheduled unfractionated heparin or other antithrombin therapy. Am Heart J 2005;149:138-144.
25. Stabile E, Nammas W, Salemme L, Sorropago G, Cioppa A, Tesorio T, Ambrosini V, Campopiano E, Popusoi G, Biondi Zoccai G, Rubino P. The CIAO (Coronary Interventions Antiplatelet-based Only) Study: a randomized study comparing standard anticoagulation regimen to absence of anticoagulation for elective percutaneous coronary intervention. J Am Coll Cardiol 2008;52: 1293-1298.
26. Chew DP, Bhatt DL, Lincoff AM, Moliterno DJ, Brener SJ, Wolski KE, Topol EJ. Defining the optimal activated clotting time during percutaneous coronary inter-vention: aggregate results from 6 randomized, controlled trials. Circulation 2001; 103:961-966.
27. Montalescot G, Cohen M, Salette G, Desmet WJ, Macaya C, Aylward PE, Steg PG, White HD, Gallo R, Steinhubl SR. Impact of anticoagulation levels on outcomes in patients undergoing elective percutaneous coronary intervention: insights from the STEEPLE trial. Eur Heart J 2008;29:462-471.
28. Pinto DS, Lorenz DP, Murphy SA, Marble SJ, DiBattiste PM, Demopoulos LA, Cannon CP, Gibson CM. Association of an activated clotting time or\250 sec with adverse event rates after percutaneous coronary intervention using tirofiban and heparin (a TACTICS-TIMI 18 substudy). Am J Cardiol 2003; 91: 976-978.
29. Bertrand OF, Rodes-Cabau J, Rinfret S, Larose E, Bagur R, Proulx G, Gleeton O, Costerousse O, De Larochelliere R, Roy L Impact of final activated clotting time after transradial coronary stenting with maximal antiplatelet therapy. Am J Cardiol 2009;104:1235-1240.
30. Narins CR, Hillegass WB Jr, Nelson CL, Tcheng JE, Harrington RA, Phillips HR, Stack RS, Califf RM. Relation between activated clotting time during angioplasty and abrupt closure. Circulation 1996;93:667-671.
31. Rao SV, Melloni C, Myles-Dimauro S, Broderick S, Kosinski AS, Kleiman NS, Dzavik V, Tanguay JF, Chandna H, Gammon R, Rivera E, Alexander JH, Fier I, Roach J, Becker RC. Evaluation of a new heparin agent in percutaneous coronary intervention: results of the phase 2 evaluation ofM118 IN pErcuta Neous Coron-ary intErvention (EMINENCE) Trial. Circulation 121:1713-1721.
32. Cohen M, Bhatt DL, Alexander JH, Montalescot G, Bode C, Henry T, Tamby JF, Saaiman J, Simek S, De Swart J. Randomized, double-blind, dose-ranging study of otamixaban, a novel, parenteral, short-acting direct factor Xa inhibitor, in percu-taneous coronary intervention: the SEPIA-PCI trial. Circulation 2007;115: 2642-2651.
33. Ndrepepa G, Berger PB, Mehilli J, Seyfarth M, Neumann FJ, Schomig A, Kastrati A. Periprocedural bleeding and 1-year outcome after percutaneous coronary inter-ventions: appropriateness of including bleeding as a component of a quadruple end pointJ Am Coll Cardiol 2008;51:690-697.
34. Xiao Z, Theroux P. Platelet activation with unfractionated heparin at therapeutic concentrations and comparisons with a low-molecular-weight heparin and with a direct thrombin inhibitor. Circulation 1998;97:251-256.
35. Vavalle JP, Rao SV. Impact of bleeding complications on outcomes after percuta-nous coronary interventions. Int Cardiol 2009;1:51-62.