Bivalirudin versus heparin in patients treated with percutaneous coronary intervention: A meta-analysis of randomised trials

EuroIntervention

Volumn 11, Issue 2, 2015, Pages 196-203

  Cassese, Salvatore ^a   Byrne, Robert A ^a   Laugwitz, Karl Ludwig ^b,c   Schunkert, Heribert ^a,c   Berger, Peter B ^d   Kastrati, Adnan ^a,b,c  

^a TECHNICAL UNIVERSITY OF MUNICH   (Germany)

^b TECHNICAL UNIVERSITY OF MUNICH   (Germany)

^c DZHK GERMAN CENTRE FOR CARDIOVASCULAR RESEARCH   (Germany)

^d GEISINGER MEDICAL CENTER   (United States)

Author keywords

Anticoagulation; Bivalirudin; Heparin; Meta analysis; Percutaneous coronary intervention

Indexed keywords

ACETYLSALICYLIC ACID; CLOPIDOGREL; ENOXAPARIN; HEPARIN; HIRULOG; PRASUGREL; PROTAMINE SULFATE; TICAGRELOR; ANTICOAGULANT AGENT; ANTITHROMBIN; ANTITHROMBOCYTIC AGENT; HIRUDIN DERIVATIVE; PEPTIDE FRAGMENT; RECOMBINANT PROTEIN;

ARTICLE; BLEEDING; CORONARY ARTERY DISEASE; CORONARY STENT; DRUG EFFICACY; DRUG MEGADOSE; DRUG SAFETY; DRUG USE; HEART INFARCTION; HEART MUSCLE REVASCULARIZATION; HIGH RISK PATIENT; HUMAN; INCIDENCE; META ANALYSIS; MORTALITY; OUTCOME ASSESSMENT; PERCUTANEOUS CORONARY INTERVENTION; RANDOMIZED CONTROLLED TRIAL (TOPIC); RECOMMENDED DRUG DOSE; STENT THROMBOSIS; SYSTEMATIC REVIEW; TREATMENT RESPONSE; AGED; CHEMICALLY INDUCED; CLINICAL TRIAL; COMBINATION DRUG THERAPY; FACTUAL DATABASE; FEMALE; MALE; MIDDLE AGED; MULTICENTER STUDY; MYOCARDIAL INFARCTION; PROCEDURES;

AGED; ANTICOAGULANTS; ANTITHROMBINS; DATABASES, FACTUAL; DRUG THERAPY, COMBINATION; FEMALE; HEMORRHAGE; HEPARIN; HIRUDINS; HUMANS; MALE; MIDDLE AGED; MYOCARDIAL INFARCTION; PEPTIDE FRAGMENTS; PERCUTANEOUS CORONARY INTERVENTION; PLATELET AGGREGATION INHIBITORS; RANDOMIZED CONTROLLED TRIALS AS TOPIC; RECOMBINANT PROTEINS;

EID: 84979838213     PISSN: 1774024X     EISSN: 19696213     Source Type: Journal    
DOI: 10.4244/EIJY14M08_01     Document Type: Article

References (37)

1. Levine GN, Bates ER, Blankenship JC, Bailey SR, Bittl JA, Cercek B, Chambers CE, Ellis SG, Guyton RA, Hollenberg SM, Khot UN, Lange RA, Mauri L, Mehran R, Moussa ID, Mukherjee D, Nallamothu BK, Ting HH; American College of Cardiology Foundation; American Heart Association Task Force on Practice Guidelines; Society for Cardiovascular Angiography and Interventions. 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. 2011;58:e44-122.
2. Busch G, Steppich B, Sibbing D, Braun SL, Stein A, Groha P, Schomig A, Kastrati A, von Beckerath N, Ott I. Bivalirudin reduces platelet and monocyte activation after elective percutaneous coronary intervention. Thromb Haemost. 2009;101:340-4.
3. 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; HORIZONSAMI Trial Investigators. Bivalirudin during primary PCI in acute myocardial infarction. N Engl J Med. 2008;358:2218-30.
4. Task Force on Myocardial Revascularization of the European Society of Cardiology (ESC) and the European Association for Cardio-Thoracic Surgery (EACTS); European Association for Percutaneous Cardiovascular Interventions (EAPCI), Wijns W, Kolh P, Danchin N, Di Mario C, Falk V, Folliguet T, Garg S, Huber K, James S, Knuuti J, Lopez-Sendon J, Marco J, Menicanti L, Ostojic M, Piepoli MF, Pirlet C, Pomar JL, Reifart N, Ribichini FL, Schalij MJ, Sergeant P, Serruys PW, Silber S, Sousa Uva M, Taggart D. Guidelines on myocardial revascularization. Eur Heart J. 2010;31:2501-55.
5. Steg PG, van 't Hof A, Hamm CW, Clemmensen P, Lapostolle F, Coste P, Ten Berg J, Van Grunsven P, Eggink GJ, Nibbe L, Zeymer U, Campo dell' Orto M, Nef H, Steinmetz J, Soulat L, Huber K, Deliargyris EN, Bernstein D, Schuette D, Prats J, Clayton T, Pocock S, Hamon M, Goldstein P; EUROMAX Investigators. Bivalirudin started during emergency transport for primary PCI. N Engl J Med. 2013;369:2207-17.
6. Ebrahimi R, Lincoff AM, Bittl JA, Chew D, Wolski K, Wadhan N, Toggart EJ, Topol EJ. Bivalirudin vs heparin in percutaneous coronary intervention: a pooled analysis. J Cardiovasc Pharmacol Ther. 2005;10:209-16.
7. De Luca G, Cassetti E, Verdoia M, Marino P. Bivalirudin as compared to unfractionated heparin among patients undergoing coronary angioplasty: A meta-analyis of randomised trials. Thromb Haemost. 2009;102:428-36.
8. Bertrand OF, Jolly SS, Rao SV, Patel T, Belle L, Bernat I, Parodi G, Costerousse O, Mann T. Meta-analysis comparing bivalirudin versus heparin monotherapy on ischemic and bleeding outcomes after percutaneous coronary intervention. Am J Cardiol. 2012;110:599-606.
9. Tarantini G, Brener SJ, Barioli A, Gratta A, Parodi G, Rossini R, Navarese EP, Niccoli G, Frigo AC, Musumeci G, Iliceto S, Stone GW. Impact of baseline hemorrhagic risk on the benefit of bivalirudin versus unfractionated heparin in patients treated with coronary angioplasty: a meta-regression analysis of randomized trials. Am Heart J. 2014;167:401-412.e6.
10. Nairooz R, Sardar P, Amin H, Swaminathan RV, Kim LK, Chatterjee S, Feldman DN. Meta-analysis of randomized clinical trials comparing bivalirudin versus heparin plus glycoprotein IIb/ IIIa inhibitors in patients with ST-segment elevation myocardial infarction. Am J Cardiol. 2014;114:250-9.
11. Higgins JP, Thompson SG, Deeks JJ, Altman DG. Measuring inconsistency in meta-analyses. BMJ. 2003;327:557-60.
12. Jüni P, Witschi A, Bloch R, Egger M. The hazards of scoring the quality of clinical trials for meta-analysis. JAMA. 1999;282:1054-60.
13. Cassese S, Byrne RA, Ott I, Ndrepepa G, Nerad M, Kastrati A, Fusaro M. Paclitaxel-coated versus uncoated balloon angioplasty reduces target lesion revascularization in patients with femoropopliteal arterial disease: a meta-analysis of randomized trials. Circ Cardiovasc Interv. 2012;5:582-9.
14. Sterne JA, Egger M, Smith GD. Systematic reviews in health care: Investigating and dealing with publication and other biases in meta-analysis. BMJ. 2001;323:101-5.
15. Moher D, Liberati A, Tetzlaff J, Altman DG: PRISMA Group. Preferred reporting items for systematic reviews and meta-analyses: the PRISMA statement. Ann Intern Med. 2009;151:264-9, W64.
16. Bittl JA, Chaitman BR, Feit F, Kimball W, Topol EJ. Bivalirudin versus heparin during coronary angioplasty for unstable or postinfarction angina: Final report reanalysis of the Bivalirudin Angioplasty Study. Am Heart J. 2001;142:952-9.
17. 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; ISAR-REACT 3 Trial. Bivalirudin versus unfractionated heparin during percutaneous coronary intervention. N Engl J Med. 2008;359:688-96.
18. Parodi G, Migliorini A, Valenti R, Bellandi B, Signorini U, Moschi G, Buonamici P, Cerisano G, Antoniucci D. Comparison of bivalirudin and unfractionated heparin plus protamine in patients with coronary heart disease undergoing percutaneous coronary intervention (from the Antithrombotic Regimens aNd Outcome [ARNO] trial). Am J Cardiol. 2010;105:1053-9.
19. Patti G, Pasceri V, D'Antonio L, D'Ambrosio A, Macri M, Dicuonzo G, Colonna G, Montinaro A, Di Sciascio G. Comparison of safety and efficacy of bivalirudin versus unfractionated heparin in high-risk patients undergoing percutaneous coronary intervention (from the Anti-Thrombotic Strategy for Reduction of Myocardial Damage During Angioplasty-Bivalirudin vs Heparin study). Am J Cardiol. 2012;110:478-84.
20. Schulz S, Richardt G, Laugwitz KL, Morath T, Neudecker J, Hoppmann P, Mehran R, Gershlick AH, Tölg R, Fiedler KA, Abdel-Wahab M, Kufner S, Schneider S, Schunkert H, Ibrahim T, Mehilli J, Kastrati A; and for the Bavarian Reperfusion Alternatives Evaluation (BRAVE) 4 Investigators. Prasugrel plus bivalirudin vs. clopidogrel plus heparin in patients with ST-segment elevation myocardial infarction. Eur Heart J. 2014 May 9. [Epub ahead of print].
21. Lincoff AM, Bittl JA, Kleiman NS, Sarembock IJ, Jackman JD, Mehta S, Tannenbaum MA, Niederman AL, Bachinsky WB, Tift-Mann J 3rd, Parker HG, Kereiakes DJ, Harrington RA, Feit F, Maierson ES, Chew DP, Topol EJ; REPLACE-1 Investigators. Comparison of bivalirudin versus heparin during percutaneous coronary intervention (the Randomized Evaluation of PCI Linking Angiomax to Reduced Clinical Events [REPLACE]-1 trial). Am J Cardiol. 2004;93:1092-6.
22. Shahzad A, Kemp I, Mars C, Wilson K, Roome C, Cooper R, Andron M, Appleby C, Fisher M, Khand A, Kunadian B, Mills JD, Morris JL, Morrison WL, Munir S, Palmer ND, Perry RA, Ramsdale DR, Velavan P, Stables RH; for the HEAT-PPCI trial investigators. Unfractionated heparin versus bivalirudin in primary percutaneous coronary intervention (HEAT-PPCI): an open-label, single centre, randomised controlled trial. Lancet. 2014 Jul 4. [Epub ahead of print].
23. Han Y. BRIGHT: A Prospective, Randomized Trial of Bivalirudin vs. Heparin Monotherapy and Glycoprotein IIb/IIIa plus Heparin for Patients with Acute Myocardial Infarction Undergoing Coronary Stenting. China Interventional Therapeutics Congress, Shanghai, China, March 21 2014.
24. Briguori C. Novel Approaches in Preventing and Limiting Events III Trial (NAPLES III). American College of Cardiology Congress, Washington, DC, USA, March 29 2014.
25. Rao AK, Pratt C, Berke A, Jaffe A, Ockene I, Schreiber TL, Bell WR, Knatterud G, Robertson TL, Terrin ML. Thrombolysis in Myocardial Infarction (TIMI) Trial-phase I: hemorrhagic manifestations and changes in plasma fibrinogen and the fibrinolytic system in patients treated with recombinant tissue plasminogen activator and streptokinase. J Am Coll Cardiol. 1988;11:1-11.
26. 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; Academic Research Consortium. Clinical end points in coronary stent trials: a case for standardized definitions. Circulation. 2007;115:2344-51.
27. 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; REPLACE-2 Investigators. Bivalirudin and provisional glycoprotein IIb/IIIa blockade compared with heparin and planned glycoprotein IIb/IIIa blockade during percutaneous coronary intervention: REPLACE-2 randomized trial. JAMA. 2003;289:853-63.
28. 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: 2203-16.
29. Lee MS, Liao H, Yang T, Dhoot J, Tobis J, Fonarow G, Mahmud E. Comparison of bivalirudin versus heparin plus glycoprotein IIb/IIIa inhibitors in patients undergoing an invasive strategy: a meta-analysis of randomized clinical trials. Int J Cardiol. 2011;152:369-74.
30. Ndrepepa G, Berger PB, Mehilli J, Seyfarth M, Neumann FJ, Schomig A, Kastrati A. Periprocedural bleeding and 1-year outcome after percutaneous coronary interventions: appropriateness of including bleeding as a component of a quadruple end point. J Am Coll Cardiol. 2008;51:690-7.
31. Ndrepepa G, Neumann FJ, Richardt G, Schulz S, Tolg R, Stoyanov KM, Gick M, Ibrahim T, Fiedler KA, Berger PB, Laugwitz KL, Kastrati A. Prognostic value of access and nonaccess sites bleeding after percutaneous coronary intervention. Circ Cardiovasc Interv. 2013;6:354-61.
32. Palmerini T, Brener SJ, Mehran R, Dangas G, Genereux P, Riva DD, Mariani A, Xu K, Stone GW. Leukocyte count is a modulating factor for the mortality benefit of bivalirudin in ST-segmentelevation acute myocardial infarction: the HORIZONS-AMI trial. Circ Cardiovasc Interv. 2013;6:518-26.
33. Stone GW, Clayton T, Deliargyris EN, Prats J, Mehran R, Pocock SJ. Reduction in cardiac mortality with bivalirudin in patients with and without major bleeding: The HORIZONS-AMI trial (Harmonizing Outcomes with Revascularization and Stents in Acute Myocardial Infarction). J Am Coll Cardiol. 2014;63:15-20.
34. Schulz S, Mehilli J, Neumann FJ, Schuster T, Massberg S, Valina C, Seyfarth M, Pache J, Laugwitz KL, Buttner HJ, Ndrepepa G, Schomig A, Kastrati A; Intracoronary Stenting and Antithrombotic Regimen: Rapid Early Action for Coronary Treatment (ISARREACT) 3A Trial Investigators. ISAR-REACT 3A: a study of reduced dose of unfractionated heparin in biomarker negative patients undergoing percutaneous coronary intervention. Eur Heart J. 2010;31:2482-91.
35. Parodi G, Valenti R, Bellandi B, Migliorini A, Marcucci R, Comito V, Carrabba N, Santini A, Gensini GF, Abbate R, Antoniucci D. Comparison of prasugrel and ticagrelor loading doses in ST-segment elevation myocardial infarction patients: RAPID (Rapid Activity of Platelet Inhibitor Drugs) primary PCI study. J Am Coll Cardiol. 2013;61:1601-6.
36. Bangalore S, Kumar S, Fusaro M, Amoroso N, Attubato MJ, Feit F, Bhatt DL, Slater J. Short-and long-term outcomes with drug-eluting and bare-metal coronary stents: a mixed-treatment comparison analysis of 117 762 patient-years of follow-up from randomized trials. Circulation. 2012;125:2873-91.
37. McAuley L, Pham B, Tugwell P, Moher D. Does the inclusion of grey literature influence estimates of intervention effectiveness reported in meta-analyses? Lancet. 2000;356:1228-31.