A randomised clinical trial investigating the effect of bivalirudin versus UFH in patients undergoing urgent angioplasty for unstable or postinfarction angina
Studied treatment |
bivalirudin immediately before angioplasty. bivalirudin bolus dose of 1.0 mg per kilogram of body weight, followed by a 4-hour infusion at a rate of 2.5 mg per kilogram per hour and a 14-to-20-hour infusion at a rate of 0.2 mg per kilogram per hour. If the clotting time was less than 350 seconds, saline was given |
Control treatment |
heparin immediately before angioplasty bolus dose of 175 units per kilogram followed by an 18-to-24-hour infusion at a rate of 15 units per kilogram per hour. If the clotting time was less than 350 seconds a bolus dose of 60 units of heparin per kilogram to those treated with heparin |
Concomittant treatment | Aspirin (300 to 325 mg), |
Age (mean), years | 62.5y |
male (%) | 67.5% |
Patients | patients undergoing urgent angioplasty for unstable or postinfarction angina |
Group sizes | 2059 / 2039 |
Inclusion criteria | patients urgently scheduled to undergo angioplasty for unstable angina defined as crescendo angina, angina of new onset, or angina at rest or for postinfarction angina less than two weeks after myocardial infarction; |
Exclusion criteria | serum creatinine concentrations exceeded 3.0 mg per deciliter (265µmol per liter); thrombolytic therapy within the previous 24 hours; coronary atherectomy, stenting, or laser angioplasty; staged angioplasty procedure; possibly pregnant; intolerance to aspirin or heparin |
Diabetes (%) | 21% |
Previous myocardial infarction (%) | |
Previous PCI | 26.5% |
Previous CABG | 9.5% |
Weight (kg) | |
Hypertension (%) | |
Hyperlipidaemia | |
Current smoker | |
Unstable angina / ACS | 83% |
Multivessel coronary disease | 46.5% |
Blindness | double blind | Inclusion period | Mar 1993 - Jul 1994 |
Follow-up duration | hospital stay | Centers | 121 |
Lost to FU | geographical localisation | US | |
Primary endpoint | death, MI, abrupt clossure, rapide deterioration | Design | Parallel groups |
PeriodeInclusion | Mar 1993 - Jul 1994 | ||
Hypothese | Superiority | ||
Attempted lesions per patient (mean) | |||
Left main coronary arteryx-xbitm | |||
Left anterior descending coronary artery | |||
Left circumfl ex coronary artery | |||
Right coronary artery |
Although two parallel studies were specified to meet regulatory requirements, the protocol specified that scientific analysis and safety monitoring would involve the combined cohort of 4000 patients
Bittl JA, Feit F, A randomized comparison of bivalirudin and heparin in patients undergoing coronary angioplasty for postinfarction angina. Hirulog Angioplasty Study Investigators. Am J Cardiol 1998;82:43P-49P. [PMID: 9809891] link to pdf add to Mendeley
Shah PB, Ahmed WH, Ganz P, Bittl JA, Bivalirudin compared with heparin during coronary angioplasty for thrombus-containing lesions. J Am Coll Cardiol 1997;30:1264-9. [PMID: 9350925] link to pdf add to Mendeley
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. N Engl J Med 1995;333:764-9. [PMID: 7643883] link to pdf add to Mendeley
Bittl JA, Comparative safety profiles of hirulog and heparin in patients undergoing coronary angioplasty. The Hirulog Angioplasty Study Investigators. Am Heart J 1995;130:658-65. [PMID: 7668214] link to pdf add to Mendeley
Bittl JA, Chaitman BR, Feit F, Kimball W, Topol EJ Bivalirudin versus heparin during coronary angioplasty for unstable or postinfarction angina: Final report reanalysis of the Bivalirudin Angioplasty Study. Am Heart J 2001;142:952-9 [PMID: 11717596] link to pdf add to Mendeley
Comment: Bivalirudin Angioplasty Trial (BAT) is the post hoc reanalyzed of this trial using contemporary definitions of adjudicated end points
Appears in following systematic reviews: