Comparison of bivalirudin versus heparin during percutaneous coronary intervention (the Randomized Evaluation of PCI Linking Angiomax to Reduced Clinical Events [REPLACE]-1 trial)☆
Section snippets
Patient selection
REPLACE-1 was a pilot randomized study performed in preparation for the REPLACE-2 trial. Patients undergoing PCI with an approved device were enrolled at 77 hospitals throughout the United States between November 2000 and February 2001. Patients were excluded for ongoing acute myocardial infarction or conditions of elevated bleeding risk,3 or if they had received unfractionated heparin within 6 hours (unless activated partial thromboplastin time measured within 2 hours before randomization was
Baseline and procedural characteristics
In all, 1,056 patients were enrolled. There were no appreciable differences in baseline characteristics (Table 1) or procedural factors (Table 2) between the treatment groups. Heparin bolus doses were lower among patients who received concomitant GP IIb/IIIa inhibitors (mean 5,834 ± 1,828 IU with vs 6,827 ± 1,980 IU without GP IIb/IIIa blockade, p <0.001). Immediately before the device (balloon, stent, and so forth) activation, the median ACT was 66 seconds longer among patients treated with
Discussion
This large-scale, multicenter, randomized pilot trial assessed the outcome of replacing heparin with the direct thrombin inhibitor bivalirudin during contemporary PCI. Among 1,056 patients, most of whom underwent stenting with a background of clopidogrel therapy and planned platelet GP IIb/IIIa blockade, rates of ischemic and hemorrhagic end points tended to be approximately 20% lower among those randomized to bivalirudin rather than to heparin. This trial represents the largest prospective
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A systematic review and meta-analysis of bivalirudin application in peripheral endovascular procedures
2019, Journal of Vascular SurgeryCitation Excerpt :The subgroup analyses indicated that, depending on the procedures conducted, the patients who received BIV will have a decreases or comparable odds of perioperative mortality, MI, MACE, and NACE, as well as major and minor vascular complications. Data from multiple RCTs in PCIs indicated that BIV had an advantage over, or was not inferior to, UFH in providing reliable procedural anticoagulation with reduced periprocedural mortality, blood loss, and ischemic complications.8,31-34 Intraoperative management was much less labor intensive because BIV was given via continuous intravenous infusion and frequent ACT monitoring was unnecessary.
Randomized Controlled Trial of Heparin Versus Bivalirudin Anticoagulation in Acyanotic Children Undergoing Open Heart Surgery
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This study was supported by The Medicines Company, Cambridge, Massachusetts.