percutaneous coronary intervention - anticoagulant - all type of patients clinical trials results meta-analysis

<h1> <a href="TM33-6-anticoagulant-percutaneous coronary intervention" > <strong>percutaneous coronary intervention</strong> - anticoagulant </a> - all type of patients trial results systematic overview and meta-analysis </h1> <h2>Main characteristics of the included studies</h2> <table> <tr> <th>Trial</th> <th>Treatments</th> <th>Patients</th> <th>Methods</th> </tr> <tr> <td> <a href="../TRC_t6736.htm"> ISAR-REACT 3, 2008 </a> <br> NCT00262054 </td> <td> UFH bolus of 140 U/kg<br>  <i>versus</i> <br> bivalirudin (bolus of 0.75 mg/kg, followed by infusion of 1.75 mg/kg/hr) </td> <td> troponin-negative patients undergoing PCI </td> <td> follow-up 30 days (mean)<br> n=2289/2281<br> Parallel groups<br> double blind <br> </td> </tr> <tr> <td> <a href="../TRC_t6739.htm"> STEEPLE, 2006 </a> <br> NCT00077844 </td> <td> enoxaparin (0.5 or 0.75 mg per kilogram of body weight)<br>  <i>versus</i> <br> unfractionated heparin (adjusted for activated clotting time) </td> <td> elective percutaneous coronary intervention. </td> <td> follow-up <br> n=-9/-9<br> Parallel groups<br> open <br> </td> </tr> <tr> <td> <a href="../TRC_t7372.htm"> REPLACE-2, 2003 </a> <br> </td> <td> bivalirudin, with glycoprotein IIb/IIIa (Gp IIb/IIIa) inhibition on a provisional basis for complications during PCI<br>  <i>versus</i> <br> heparin plus planned Gp IIb/IIIa blockade </td> <td> patients undergoing urgent or elective PCI </td> <td> follow-up 30 days<br> n=2994/3008<br> Parallel groups<br> double blind <br> 9 countries </td> </tr> <tr> <td> <a href="../TRC_t8384.htm"> HORIZONS-AMI (Stone), 2008 </a> <br> NCT00433966 </td> <td> Bivalirudin<br>  <i>versus</i> <br> Heparin plus GP IIb/IIIa inhibitor </td> <td> patients with ST-segment elevation myocardial infarction who presented within 12 hours after the onset of symptoms and who were undergoing primary PCI </td> <td> follow-up 30 days<br> n=1800/1802<br> Parallel groups<br> open <br> 11 countries </td> </tr> <tr> <td> <a href="../TRC_t8387.htm"> ACUITY (Stone) (bivalirudin alone), 2006 </a> <br> NCT00093158 </td> <td> bivalirudin alone<br>  <i>versus</i> <br> unfractionated heparin or enoxaparin plus a glycoprotein IIb/IIIa inhibitor </td> <td> patients with acute coronary syndromes </td> <td> follow-up 30 days<br> n=9216/4603<br> Parallel groups<br> open <br> </td> </tr> <tr> <td> <a href="../TRC_t8388.htm"> REPLACE-1, 2004 </a> <br> </td> <td> bivalirudin (0.75 mg/kg bolus, 1.75 mg/kg/h infusion during the procedure<br>  <i>versus</i> <br> heparin (70 U/kg initial bolus) adjusted to ACT of 200 to 300s </td> <td> patients undergoing elective or urgent revascularization </td> <td> follow-up hospital stay (48h min)<br> n=532/524<br> Parallel groups<br> <br> US </td> </tr> <tr> <td> <a href="../TRC_t8390.htm"> Kleiman, 2002 </a> <br> </td> <td> bivalirudin + eptifibatide<br>  <i>versus</i> <br> heparin + eptifibatide </td> <td> patients who underwent elective percutaneous coronary intervention </td> <td> follow-up <br> n=-9/-9<br> Parallel groups<br> open <br> </td> </tr> <tr> <td> <a href="../TRC_t8391.htm"> BAT (Bittl), 1995 </a> <br> </td> <td> bivalirudin immediately before angioplasty.<br>  <i>versus</i> <br> heparin immediately before angioplasty </td> <td> patients undergoing urgent angioplasty for unstable or postinfarction angina </td> <td> follow-up hospital stay<br> n=2059/2039<br> Parallel groups<br> double blind <br> US </td> </tr> <tr> <td> <a href="../TRC_t8480.htm"> REDUCE, 1996 </a> <br> </td> <td> Reviparin 7,000 IU anti-Xa<br>  <i>versus</i> <br> UFH 10,000 IU bolus </td> <td> PTCA with stable/unstable angina </td> <td> follow-up 3 days<br> n=306/306<br> Parallel groups<br> double blind <br> Europe and Canada </td> </tr> <tr> <td> <a href="../TRC_t8481.htm"> Rabah, 1999 </a> <br> </td> <td> Enoxaparin 1 mg/kg bolus<br>  <i>versus</i> <br> UFH 10,000 IU bolus, then titrated to ACT > 300 </td> <td> PCI for stable angina </td> <td> follow-up <br> n=30/30<br> Parallel groups<br> open <br> </td> </tr> <tr> <td> <a href="../TRC_t8482.htm"> CRUISE, 2003 </a> <br> </td> <td> Enoxaparin 0.75 mg/kg bolus<br>  <i>versus</i> <br> UFH 60 IU/kg bolus, then titrated to ACT > 200 </td> <td> Urgent or elective PCI </td> <td> follow-up 2,7 +30 days<br> n=129/132<br> Parallel groups<br> open <br> </td> </tr> <tr> <td> <a href="../TRC_t8483.htm"> Galeote, 2001 </a> <br> </td> <td> Enoxaparin 0.75 mg/kg bolus<br>  <i>versus</i> <br> UFH 70 U/kg bolus, then titrated to ACT > 200 </td> <td> PTCA patients with stable/unstable angina or AMI </td> <td> follow-up <br> n=50/49<br> <br> <br> </td> </tr> <tr> <td> <a href="../TRC_t8484.htm"> Dudek, 2000 </a> <br> </td> <td> Enoxaparin 1 mg/kg bolus<br>  <i>versus</i> <br> UFH titrated to ACT > 300 </td> <td> PCI </td> <td> follow-up 3à days<br> n=200/200<br> <br> <br> </td> </tr> <tr> <td> <a href="../TRC_t8485.htm"> Dudek b (enox alone), 2000 </a> <br> </td> <td> Enoxaparin 1 mg/kg bolus<br>  <i>versus</i> <br> UFH titrated to ACT > 300 </td> <td> PTCA complex lesionsCI </td> <td> follow-up <br> n=-9/50<br> <br> <br> </td> </tr> <tr> <td> <a href="../TRC_t8486.htm"> Drozd, 2001 </a> <br> </td> <td> Enoxaparin 1 mg/kg bolus<br>  <i>versus</i> <br> UFH 100 IU/kg bolus </td> <td> PCI for stable angina </td> <td> follow-up 24hrs, 30 days<br> n=50/50<br> <br> <br> </td> </tr> <tr> <td> <a href="../TRC_t8487.htm"> Natarajan (without antiGp2b3a), 2003 </a> <br> </td> <td> Dalteparin 100 IU/kg bolus<br>  <i>versus</i> <br> UFH 100 IU/kg bolus </td> <td> Elective or urgent PCI </td> <td> follow-up <br> n=-9/-9<br> <br> <br> </td> </tr> <tr> <td> <a href="../TRC_t8488.htm"> Dubek b (+abciximal), 2001 </a> <br> </td> <td> Enoxaparin 0.75 mg/kg bolus + abciximab<br>  <i>versus</i> <br> UFH titrated to ACT > 300 </td> <td> </td> <td> follow-up <br> n=-9/50<br> <br> <br> </td> </tr> <tr> <td> <a href="../TRC_t8489.htm"> Natarajan (+ antiGp2b3a), 2003 </a> <br> </td> <td> Dalteparin 70 IU/kg bolus + GP IIb/IIIa inhibitorse/p<br>  <i>versus</i> <br> UFH 70 IU/kg bolus +GPIIb/IIIa inhibitors </td> <td> </td> <td> follow-up <br> n=-9/-9<br> <br> <br> </td> </tr> <tr> <td> <a href="../TRC_t10153.htm"> NAPLES (Tavano), 2009 </a> <br> </td> <td> bivalirudin monotherapy<br>  <i>versus</i> <br> unfractionated heparin plus tirofiban </td> <td> patients with diabetes mellitus undergoing elective percutaneous coronary intervention </td> <td> follow-up 30 days<br> n=167/168<br> Parallel groups<br> open <br> Italy </td> </tr> </table> <h2>References</h2> <p> <b>ISAR-REACT 3, 2008 : </b> Kastrati A, Neumann FJ, Mehilli J, Byrne RA, Iijima R, Büttner HJ, Khattab AA, Schulz S, Blankenship JC, Pache J, Minners J, Seyfarth M, Graf I, Skelding KA, Dirschinger J, Richardt G, Berger PB, Schömig ABivalirudin versus Unfractionated Heparin during Percutaneous Coronary Intervention. <i>N Engl J Med 2008 Aug 14;359:688-696</i> [PMID 18703471] </p> <p> <b>STEEPLE, 2006 : </b> Montalescot G, White HD, Gallo R, Cohen M, Steg PG, Aylward PE, Bode C, Chiariello M, King SB 3rd, Harrington RA, Desmet WJ, Macaya C, Steinhubl SREnoxaparin versus unfractionated heparin in elective percutaneous coronary intervention. <i>N Engl J Med 2006;355:1006-17</i> [PMID 16957147] </p> <p> <b>REPLACE-2, 2003 : </b> Gibson CM, Ten Y, Murphy SA, Ciaglo LN, Southard MC, Lincoff AM, Waksman R, Association of prerandomization anticoagulant switching with bleeding in the setting of percutaneous coronary intervention (A REPLACE-2 analysis). <i>Am J Cardiol 2007;99:1687-90.</i> [PMID 17560876] 10.1016/j.amjcard.2007.01.053 </p> <p> <b>REPLACE-2, 2003 : </b> Cohen DJ, Lincoff AM, Lavelle TA, Chen HL, Bakhai A, Berezin RH, Jackman D, Sarembock IJ, Topol EJ, Economic evaluation of bivalirudin with provisional glycoprotein IIB/IIIA inhibition versus heparin with routine glycoprotein IIB/IIIA inhibition for percutaneous coronary intervention: results from the REPLACE-2 trial. <i>J Am Coll Cardiol 2004;44:1792-800.</i> [PMID 15519009] 10.1016/j.jacc.2004.05.085 </p> <p> <b>REPLACE-2, 2003 : </b> Lincoff AM, Kleiman NS, Kereiakes DJ, Feit F, Bittl JA, Jackman JD, Sarembock IJ, Cohen DJ, Spriggs D, Ebrahimi R, Keren G, Carr J, Cohen EA, Betriu A, Desmet W, Rutsch W, Wilcox RG, de Feyter PJ, Vahanian A, Topol EJ, , Long-term efficacy of bivalirudin and provisional glycoprotein IIb/IIIa blockade vs heparin and planned glycoprotein IIb/IIIa blockade during percutaneous coronary revascularization: REPLACE-2 randomized trial. <i>JAMA 2004;292:696-703.</i> [PMID 15304466] 10.1001/jama.292.6.696 </p> <p> <b>REPLACE-2, 2003 : </b> 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 EJBivalirudin and provisional glycoprotein IIb/IIIa blockade compared with heparin and planned glycoprotein IIb/IIIa blockade during percutaneous coronary intervention: REPLACE-2 randomized trial. <i>JAMA 2003 Feb 19;289:853-63</i> [PMID 12588269] </p> <p> <b>HORIZONS-AMI (Stone), 2008 : </b> Mehran R, Brodie B, Cox DA, Grines CL, Rutherford B, Bhatt DL, Dangas G, Feit F, Ohman EM, Parise H, Fahy M, Lansky AJ, Stone GW, The Harmonizing Outcomes with RevasculariZatiON and Stents in Acute Myocardial Infarction (HORIZONS-AMI) Trial: study design and rationale. <i>Am Heart J 2008;156:44-56.</i> [PMID 18585496] 10.1016/j.ahj.2008.02.008 </p> <p> <b>HORIZONS-AMI (Stone), 2008 : </b> 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 RBivalirudin during primary PCI in acute myocardial infarction. <i>N Engl J Med 2008 May 22;358:2218-30</i> [PMID 18499566] </p> <p> <b>HORIZONS-AMI (Stone) doublons à effacer, 2008 : </b> 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. <i>N Engl J Med 2008;358:2218-30.</i> [PMID 18499566] 10.1056/NEJMoa0708191 </p> <p> <b>ACUITY (sub groups, bivalirudin alone), 2007 : </b> Stone GW, Ware JH, Bertrand ME, Lincoff AM, Moses JW, Ohman EM, White HD, Feit F, Colombo A, McLaurin BT, Cox DA, Manoukian SV, Fahy M, Clayton TC, Mehran R, Pocock SJ, , Antithrombotic strategies in patients with acute coronary syndromes undergoing early invasive management: one-year results from the ACUITY trial. <i>JAMA 2007;298:2497-506.</i> [PMID 18056903] 10.1001/jama.298.21.2497 </p> <p> <b>ACUITY (sub groups, bivalirudin alone), 2007 : </b> Stone GW, White HD, Ohman EM, Bertrand ME, Lincoff AM, McLaurin BT, Cox DA, Pocock SJ, Ware JH, Feit F, Colombo A, Manoukian SV, Lansky AJ, Mehran R, Moses JW, , Bivalirudin in patients with acute coronary syndromes undergoing percutaneous coronary intervention: a subgroup analysis from the Acute Catheterization and Urgent Intervention Triage strategy (ACUITY) trial. <i>Lancet 2007;369:907-19.</i> [PMID 17368152] 10.1016/S0140-6736(07)60450-4 </p> <p> <b>ACUITY (sub groups, bivalirudin alone), 2007 : </b> Stone GW, Bertrand M, Colombo A, Dangas G, Farkouh ME, Feit F, Lansky AJ, Lincoff AM, Mehran R, Moses JW, Ohman M, White HD, Acute Catheterization and Urgent Intervention Triage strategY (ACUITY) trial: study design and rationale. <i>Am Heart J 2004;148:764-75.</i> [PMID 15523305] 10.1016/j.ahj.2004.04.036 </p> <p> <b>ACUITY (Stone) (bivalirudin alone), 2006 : </b> 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. <i>N Engl J Med 2006;355:2203-16.</i> [PMID 17124018] 10.1056/NEJMoa062437 </p> <p> <b>REPLACE-1, 2004 : </b> Lincoff AM, Bittl JA, Kleiman NS, Sarembock IJ, Jackman JD, Mehta S, Tannenbaum MA, Niederman AL, Bachinsky WB, Tift-Mann J, Parker HG, Kereiakes DJ, Harrington RA, Feit F, Maierson ES, Chew DP, Topol EJ, , Comparison of bivalirudin versus heparin during percutaneous coronary intervention (the Randomized Evaluation of PCI Linking Angiomax to Reduced Clinical Events [REPLACE]-1 trial). <i>Am J Cardiol 2004;93:1092-6.</i> [PMID 15110198] 10.1016/j.amjcard.2004.01.033 </p> <p> <b>CACHET (without abciximab), 2002 : </b> Lincoff AM, Kleiman NS, Kottke-Marchant K, Maierson ES, Maresh K, Wolski KE, Topol EJ, Bivalirudin with planned or provisional abciximab versus low-dose heparin and abciximab during percutaneous coronary revascularization: results of the Comparison of Abciximab Complications with Hirulog for Ischemic Events Trial (CACHET). <i>Am Heart J 2002;143:847-53.</i> [PMID 12040347] </p> <p> <b>Kleiman, 2002 : </b> Kleiman NS, Klem J, Fernandes LS, Rubin H, Challa S, Solomon S, Maresh K, Arora U, Klem E, Buergler J, Mathew S, Browning A, DeLao T, Pharmacodynamic profile of the direct thrombin antagonist bivalirudin given in combination with the glycoprotein IIb/IIIa antagonist eptifibatide. <i>Am Heart J 2002;143:585-93.</i> [PMID 11923794] </p> <p> <b>BAT (Bittl), 1995 : </b> Bittl JA, Feit F, A randomized comparison of bivalirudin and heparin in patients undergoing coronary angioplasty for postinfarction angina. Hirulog Angioplasty Study Investigators. <i>Am J Cardiol 1998;82:43P-49P.</i> [PMID 9809891] </p> <p> <b>BAT (Bittl), 1995 : </b> Shah PB, Ahmed WH, Ganz P, Bittl JA, Bivalirudin compared with heparin during coronary angioplasty for thrombus-containing lesions. <i>J Am Coll Cardiol 1997;30:1264-9.</i> [PMID 9350925] </p> <p> <b>BAT (Bittl), 1995 : </b> Bittl JA, Strony J, Brinker JA, Ahmed WH, Meckel CR, Chaitman BR, Maraganore J, Deutsch E, Adelman B, Treatment with bivalirudin (Hirulog) as compared with heparin during coronary angioplasty for unstable or postinfarction angina. Hirulog Angioplasty Study Investigators. <i>N Engl J Med 1995;333:764-9.</i> [PMID 7643883] </p> <p> <b>BAT (Bittl), 1995 : </b> Bittl JA, Comparative safety profiles of hirulog and heparin in patients undergoing coronary angioplasty. The Hirulog Angioplasty Study Investigators. <i>Am Heart J 1995;130:658-65.</i> [PMID 7668214] </p> <p> <b>BAT (Bittl), 1995 : </b> Bittl JA, Chaitman BR, Feit F, Kimball W, Topol EJBivalirudin versus heparin during coronary angioplasty for unstable or postinfarction angina: Final report reanalysis of the Bivalirudin Angioplasty Study. <i>Am Heart J 2001;142:952-9</i> [PMID 11717596] </p> <p> <b>REDUCE, 1996 : </b> Karsch KR, Preisack MB, Baildon R, Eschenfelder V, Foley D, Garcia EJ, Kaltenbach M, Meisner C, Selbmann HK, Serruys PW, Shiu MF, Sujatta M, Bonan RLow molecular weight heparin (reviparin) in percutaneous transluminal coronary angioplasty. Results of a randomized, double-blind, unfractionated heparin and placebo-controlled, multicenter trial (REDUCE trial). Reduction of Restenosis After PTCA, Early Administration of Reviparin in a Double-Blind Unfractionated Heparin and Placebo-Controlled Evaluation. <i>J Am Coll Cardiol 1996;28:1437-43</i> [PMID 8917255] </p> <p> <b>Rabah, 1999 : </b> Rabah MM, Premmereur J, Graham M, Fareed J, Hoppensteadt DA, Grines LL, Grines CLUsefulness of intravenous enoxaparin for percutaneous coronary intervention in stable angina pectoris. <i>Am J Cardiol 1999;84:1391-5</i> [PMID 10606110] </p> <p> <b>CRUISE, 2003 : </b> Bhatt DL, Lee BI, Casterella PJ, Pulsipher M, Rogers M, Cohen M, Corrigan VE, Ryan TJ Jr, Breall JA, Moses JW, Eaton GM, Sklar MA, Lincoff AMSafety of concomitant therapy with eptifibatide and enoxaparin in patients undergoing percutaneous coronary intervention: results of the Coronary Revascularization Using Integrilin and Single bolus Enoxaparin Study. <i>J Am Coll Cardiol 2003;41:20-5</i> [PMID 12570939] </p> <p> <b>Galeote, 2001 : </b> Galeote G, Hussein M, Sobrino N, Calvo L, Yunda H, Sa´nchez-Combination abciximab and enoxaparin or unfractionated heparin during percutaneous coronary intervention: a randomised study <i>Eur Heart J 2001;22(Suppl):663</i> [PMID ] </p> <p> <b>Dudek, 2000 : </b> Dudek D, Dabrowski M, Ochala A, Lesaik M, Wnek A, BryniarskiMulticenter, prospective, double-blind randomized comparison of enoxaparin versus unfractionated heparin for percutaneous coronary interventions <i>Am J Cardiol 2000;86(Suppl 8A):15i. imag</i> [PMID ] </p> <p> <b>Dudek b (enox alone), 2000 : </b> Dudek D, Bartus S, Zymek P, Legutko J, Rzeszutko L, Janion M,Abciximab and enoxaparin administration during elective high-risk PTCA in patients with more than 3 days of ticlopidine pretreatment. <i>J Am Coll Cardiol 2000;35(Suppl):91A</i> [PMID ] </p> <p> <b>Drozd, 2001 : </b> Drozd J, Opalin´ska E, Wojcik J, Madejczyk A.PagThe use of enoxaparin during percutaneous coronary angioplasty in patients with stable angina <i>Kardiol Pol 2001;55:520–524</i> [PMID ] </p> <p> <b>Natarajan (without antiGp2b3a), 2003 : </b> NatarajanMK, Turpie GA, Raco DL, Velianon JL,Mehta SR, AfzalA randomized comparison of dalteparin versus unfractioned heparin during percutaneous coronary interventions. <i>J Am Coll Cardiol 2003;41(Suppl A):68A–69A.xtPag</i> [PMID ] </p> <p> <b>Topol, 1993 : </b> Topol EJ, Bonan R, Jewitt D, Sigwart U, Kakkar VV, Rothman M, de Bono D, Ferguson J, Willerson JT, Strony JUse of a direct antithrombin, hirulog, in place of heparin during coronary angioplasty. <i>Circulation 1993;87:1622-9</i> [PMID 8491018] </p> <p> <b>Leon, 1998 : </b> Leon MB, Baim DS, Popma JJ, Gordon PC, Cutlip DE, Ho KK, Giambartolomei A, Diver DJ, Lasorda DM, Williams DO, Pocock SJ, Kuntz REA clinical trial comparing three antithrombotic-drug regimens after coronary-artery stenting. Stent Anticoagulation Restenosis Study Investigators. <i>N Engl J Med 1998;339:1665-71</i> [PMID 9834303] </p> <p> <b>NAPLES (Tavano), 2009 : </b> Tavano D, Visconti G, D'Andrea D, Focaccio A, Golia B, Librera M, Caccavale M, Ricciarelli B, Briguori CComparison of bivalirudin monotherapy versus unfractionated heparin plus tirofiban in patients with diabetes mellitus undergoing elective percutaneous coronary intervention. <i>Am J Cardiol 2009;104:1222-8</i> [PMID 19840566] </p>