Clinical Investigations: Interventional Cardiology
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)*,**,,★★

https://doi.org/10.1067/mhj.2002.122173Get rights and content

Abstract

Background The direct thrombin inhibitor bivalirudin has previously been associated with better efficacy and lower hemorrhage risk than heparin during balloon angioplasty. This agent has not yet been tested with stenting or in combination with platelet glycoprotein IIb/IIIa antagonists. Methods and Results In a pilot trial, 268 patients who underwent coronary intervention were randomized in 3 sequential phases to treatment with bivalirudin (with or without abciximab) or the control regimen of low-dose weight-adjusted heparin with abciximab. Patients in the bivalirudin arms received bivalirudin (1.0 mg/kg bolus, infusion of 2.5 mg/kg/h for 4 hours) plus abciximab in phase A, bivalirudin (0.5 mg/kg bolus, infusion of 1.75 mg/kg/h for the procedure duration) plus provisional (“rescue”) abciximab in phase B, or bivalirudin (0.75 mg/kg bolus, infusion of 1.75 mg/kg/h for the procedure duration) plus provisional abciximab in phase C. Abciximab was necessitated on a provisional basis in 24% of the patients in the bivalirudin arms of phases B and C. A composite clinical endpoint of death, myocardial infarction, repeat revascularization, or major bleeding by 7 days occurred in 3.3%, 5.9%, 0, and 10.6% of the patients in the bivalirudin phase A, bivalirudin phase B, bivalirudin phase C, and heparin plus planned abciximab arms, respectively (P =.018 for the pooled bivalirudin groups versus the heparin group). Conclusion Bivalirudin with planned or provisional abciximab may be at least as safe and effective as low-dose heparin plus abciximab during percutaneous coronary intervention. (Am Heart J 2002;143:847-53.)

Section snippets

Patient population

The study was conducted at 2 clinical sites between December 1998 and February 2000. Patients who were undergoing elective coronary balloon angioplasty or stenting were eligible for enrollment if they were 21 years of age or older. Exclusion criteria included planned atherectomy; acute myocardial infarction (MI) within the previous 24 hours; coronary intervention performed within the previous 6 months; warfarin therapy or a baseline prothrombin time > 1.2 times control; stroke within the

Baseline and procedural characteristics

A total of 268 patients were enrolled and received the study drug to form the basis of this analysis. One patient (bivalirudin phase B group) did not undergo an index interventional procedure despite having received the study drug. There were no significant differences in baseline or procedural variables among the bivalirudin and heparin treatment groups (Table II).

. Baseline and procedural characteristics

Empty CellPhase A bivalirudin (1.0 mg/kg bolus, 2.5 mg/kg/h inf) + planned abciximab (N = 30)Phase B

Discussion

This randomized pilot trial is the first evaluation in man of the feasibility of combination of a direct thrombin inhibitor with a platelet glycoprotein IIb/IIIa antagonist during percutaneous coronary revascularization and is the first prospective assessment of bivalirudin as an adjunct to stenting. In the initial phase of the trial, patients randomized to high-dose bivalirudin plus abciximab had peak ACT values that were an average of 150 seconds longer than those of their counterparts who

Acknowledgements

We thank Christina Correia, Ian Fier, and Phyllis Collins of The Medicines Company (Cambridge, Mass) for their key contributions to this trial.

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*

Supported by The Medicines Company, Cambridge, Mass.

**

Guest Editor for this manuscript was Dean J. Kereiakes, MD, FACC, Lander Center, Cincinnati, Ohio.

Reprint requests: A. Michael Lincoff, MD, Associate Professor of Medicine, Department of Cardiovascular Medicine, Desk F25, The Cleveland Clinic Foundation, 9500 Euclid Ave, Cleveland, OH 44195.

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