Clinical Investigations: Interventional CardiologyBivalirudin 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)*,**,★,★★
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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).Empty Cell Phase 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.
References (21)
- et al.
Platelet glycoprotein IIb/IIIa blockade in coronary artery disease
J Am Coll Cardiol
(2000) - et al.
“Rescue” abciximab for complicated percutaneous transluminal coronary angioplasty
Am J Cardiol
(1998) - et al.
“Rescue” utilization of abciximab for the dissolution of coronary thrombus developing as a complication of coronary angioplasty
J Am Coll Cardiol
(1997) - et al.
Enhanced survival with platelet glycoprotein IIb/IIIa blockade in patients undergoing coronary stenting: one year outcomes and health care economic implications from a multicenter, randomized trial
Lancet
(1999) - et al.
Relation between abrupt vessel closure and the anticoagulant response to heparin and bivalirudin during coronary angioplasty
Am J Cardiol
(1998) - et al.
Aspirin and dipyridamole in the prevention of restenosis after percutaneous transluminal coronary angioplasty
N Engl J Med
(1988) - et al.
Relation between activated clotting time during angioplasty and abrupt closure
Circulation
(1996) - et al.
Treatment with bivalirudin (hirulog) as compared with heparin during coronary angioplasty for unstable or postinfarction angina
N Engl J Med
(1995) - et al.
Bivalirudin versus heparin during coronary angioplasty for unstable or postinfarction angina: final report reanalysis of the Bivalirudin Angioplasty Study
Am Heart J
(2001) - et al.
Identification and preliminary validation of predictors of major bleeding in hospitalized patients starting anticoagulant therapy
Am J Med
(1987)
Cited by (0)
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Supported by The Medicines Company, Cambridge, Mass.
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Guest Editor for this manuscript was Dean J. Kereiakes, MD, FACC, Lander Center, Cincinnati, Ohio.
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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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E-mail: [email protected]