Brachytherapy and bivalirudin evaluation study.
BACKGROUND
Bivalirudin is shown to be a competent substitute for heparin in percutaneous coronary intervention (PCI). The safety and efficacy of bivalirudin in patients undergoing PCI and vascular brachytherapy (VBT) are not known. This study aimed to assess the safety and efficacy of bivalirudin as a single antithrombotic agent in patients undergoing PCI and VBT.


METHODS
A total of 152 patients enrolled in the Brachytherapy and Bivalirudin Evaluation Study underwent PCI and VBT with either gamma (n = 8) or beta radiation (n = 144). The main outcome measures were in-hospital events and 30-day clinical outcomes. All patients were treated with bivalirudin (0.75 mg/kg bolus and 1.75 mg/kg per hour infusion for beta radiation, 1 mg/kg bolus and 2.5 mg/kg per hour infusion for gamma radiation) as a single antithrombotic agent during the entire procedure.


RESULTS
Baseline clinical and angiographic characteristics were similar between the 2 groups. More than 90% of the patients received beta radiation. In-hospital events showed a higher prevalence of acute procedural intracoronary thrombosis in patients treated with gamma- vs beta radiation (25% vs. 0.7%, P < .001). Thirty-day outcomes including death, Q-wave, and non-Q-wave myocardial infarctions, subacute stent thromboses, and repeat revascularizations were similar in both groups.


CONCLUSIONS
Bivalirudin, as a single antithrombotic agent during PCI and VBT with beta emitters, may be used safely, but its use in the setting of PCI and gamma radiation may not be acceptable due to an increased incidence of acute procedural intracoronary thrombosis.
Kuchulakanti
Pramod
P
Division of Cardiology, Department of Internal Medicine, Washington Hospital Center, Washington, DC 20010, USA.
Wolfram
Roswitha
R
Torguson
Rebecca
R
Rha
Seung-Woon
SW
Cheneau
Edouard
E
Pinnow
Ellen E
EE
Canos
Daniel
D
Satler
Lowell F
LF
Pichard
Augusto D
AD
Kent
Kenneth M
KM
Waksman
Ron
R
D015906:Angioplasty, Balloon, Coronary / Q000009:adverse effects; D000925:Anticoagulants / Q000627:therapeutic use*; D001918:Brachytherapy / Q000009:adverse effects*; D023921:Coronary Stenosis / Q000532:radiotherapy* / Q000628:therapy; D005260:Female; D006629:Hirudins; D006801:Humans; D008297:Male; D008875:Middle Aged; D010446:Peptide Fragments / Q000627:therapeutic use*; D011994:Recombinant Proteins / Q000627:therapeutic use; D013927:Thrombosis / Q000209:etiology / Q000517:prevention & control*
D000925:Anticoagulants; D006629:Hirudins; D010446:Peptide Fragments; D011994:Recombinant Proteins; C074619:bivalirudin