Bivalirudin versus unfractionated heparin during percutaneous coronary intervention
Adnan Kastrati, Franz-Josef Neumann, Julinda Mehilli, Robert A Byrne, Raisuke Iijima, Heinz Joachim Büttner, Ahmed A Khattab, Stefanie Schulz, James C Blankenship, Jürgen Pache, Jan Minners, Melchior Seyfarth, Isolde Graf, Kimberly A Skelding, Josef Dirschinger, Gert Richardt, Peter B Berger, Albert Schömig, ISAR-REACT 3 Trial Investigators, A Schömig, A Kastrati, F-J Neumann, J Mehilli, S Schulz, H Holle, F Maimer-Rodrigues, K Hösl, C Peterle, E Türk, M Dirlewanger, N Sargon, S Kufner, C Roth, J Mann, F Hoffmann, M Schwaiger, K Ulm, R Iijima, R Byrne, O Bruskina, S Piniek, S Hurt, J Pache, M Seyfarth, D Zohlnhöfer, M Karch, J Hausleiter, S Massberg, I Graf, L Pavlovic, F-J Neumann, H-J Büttner, J Minners, H P Bestehorn, K D Werner, M Gick, T Comberg, M Ferenc, J Rothe, J Allgeier, K Peitz, S Waldmann, J Korb, J Dirschinger, N von Beckerath, I Ott, K L Laugwitz, S Meyer, G Richardt, A Khattab, V Geist, M Abdel-Wahab, F Dotzer, C Glatthor, M Fleckenstein, M Adelt, M Deters, M Schneider, S Kerber, B Schumacher, G Rosshirt, P B Berger, J Blankenship, K A Skelding, T Scott, D Zimmerman, A Temple, L Belles, Adnan Kastrati, Franz-Josef Neumann, Julinda Mehilli, Robert A Byrne, Raisuke Iijima, Heinz Joachim Büttner, Ahmed A Khattab, Stefanie Schulz, James C Blankenship, Jürgen Pache, Jan Minners, Melchior Seyfarth, Isolde Graf, Kimberly A Skelding, Josef Dirschinger, Gert Richardt, Peter B Berger, Albert Schömig, ISAR-REACT 3 Trial Investigators, A Schömig, A Kastrati, F-J Neumann, J Mehilli, S Schulz, H Holle, F Maimer-Rodrigues, K Hösl, C Peterle, E Türk, M Dirlewanger, N Sargon, S Kufner, C Roth, J Mann, F Hoffmann, M Schwaiger, K Ulm, R Iijima, R Byrne, O Bruskina, S Piniek, S Hurt, J Pache, M Seyfarth, D Zohlnhöfer, M Karch, J Hausleiter, S Massberg, I Graf, L Pavlovic, F-J Neumann, H-J Büttner, J Minners, H P Bestehorn, K D Werner, M Gick, T Comberg, M Ferenc, J Rothe, J Allgeier, K Peitz, S Waldmann, J Korb, J Dirschinger, N von Beckerath, I Ott, K L Laugwitz, S Meyer, G Richardt, A Khattab, V Geist, M Abdel-Wahab, F Dotzer, C Glatthor, M Fleckenstein, M Adelt, M Deters, M Schneider, S Kerber, B Schumacher, G Rosshirt, P B Berger, J Blankenship, K A Skelding, T Scott, D Zimmerman, A Temple, L Belles
Abstract
Background: Whether bivalirudin is superior to unfractionated heparin in patients with stable or unstable angina who undergo percutaneous coronary intervention (PCI) after pretreatment with clopidogrel is unknown.
Methods: We enrolled 4570 patients with stable or unstable angina (with normal levels of troponin T and creatine kinase MB) who were undergoing PCI after pretreatment with a 600-mg dose of clopidogrel at least 2 hours before the procedure; 2289 patients were randomly assigned in a double-blind manner to receive bivalirudin, and 2281 to receive unfractionated heparin. The primary end point was the composite of death, myocardial infarction, urgent target-vessel revascularization due to myocardial ischemia within 30 days after randomization, or major bleeding during the index hospitalization (with a net clinical benefit defined as a reduction in the incidence of the end point). The secondary end point was the composite of death, myocardial infarction, or urgent target-vessel revascularization.
Results: The incidence of the primary end point was 8.3% (190 patients) in the bivalirudin group as compared with 8.7% (199 patients) in the unfractionated-heparin group (relative risk, 0.94; 95% confidence interval [CI], 0.77 to 1.15; P=0.57). The secondary end point occurred in 134 patients (5.9%) in the bivalirudin group and 115 patients (5.0%) in the unfractionated-heparin group (relative risk, 1.16; 95% CI, 0.91 to 1.49; P=0.23). The incidence of major bleeding was 3.1% (70 patients) in the bivalirudin group and 4.6% (104 patients) in the unfractionated-heparin group (relative risk, 0.66; 95% CI, 0.49 to 0.90; P=0.008).
Conclusions: In patients with stable and unstable angina who underwent PCI after pretreatment with clopidogrel, bivalirudin did not provide a net clinical benefit (i.e., it did not reduce the incidence of the composite end point of death, myocardial infarction, urgent target-vessel revascularization, or major bleeding) as compared with unfractionated heparin, but it did significantly reduce the incidence of major bleeding. (ClinicalTrials.gov number, NCT00262054.)
2008 Massachusetts Medical Society
Source: PubMed