BAT (Bittl), 1995 trial summary    PDF trial summary

A randomised clinical trial investigating the effect of bivalirudin versus UFH in patients undergoing urgent angioplasty for unstable or postinfarction angina

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Am Heart J 2001;142:952-9  



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 treatmentAspirin (300 to 325 mg),
Age (mean), years 62.5y
male (%) 67.5%



Patients patients undergoing urgent angioplasty for unstable or postinfarction angina
Group sizes2059 / 2039
Inclusion criteriapatients 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 criteriaserum creatinine concentrations exceeded 3.0 mg per deciliter (265┬Ámol 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
PeriodeInclusionMar 1993 - Jul 1994
HypotheseSuperiority
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



EndpointX1N1X0N0TE95% CI Ischaemic complication 235 2059 249 2039 0,93[0,77; 1,13] MI 65 2059 80 2039 0,80[0,58; 1,12] death, MI, revascularization - 2059 - 2039 no data Unplanned revascularisation for ischaemia 35 2059 35 2039 0,99[0,62; 1,59] death, MI, urgent TVR, in-hospital major bleeding - 2059 - 2039 no data All cause death 9 2059 4 2039 Out of scale2,23[0,69; 7,25] net benefit - 2059 - 2039 no data major bleeding 82 2059 210 2039 0,39[0,30; 0,50] safety criteria - 2059 - 2039 no data minor bleeding - 2059 - 2039 no data0,22,01,0

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  



Registering number (see trial on clinicaltrials.gov)
Code Name

Comment: Bivalirudin Angioplasty Trial (BAT) is the post hoc reanalyzed of this trial using contemporary definitions of adjudicated end points