Safety and efficacy of bivalirudin for percutaneous coronary intervention with rotational atherectomy.
BACKGROUND
Although bivalirudin use in percutaneous coronary intervention (PCI) results in less bleeding compared to unfractionated heparin (UFH) use, its safety in patients undergoing rotational atherectomy (RA) is unknown.


METHODS
A cohort of 503 patients who underwent PCI with RA from 2000 to 2009 was studied. Patients receiving bivalirudin (n = 322) were compared to those (n = 181) treated with UFH +/- glycoprotein IIb/IIIa inhibitor (GPI) as PCI anticoagulation. Safety was assessed by the frequency of major bleeding (hematocrit drop > or =15%, intracerebral or gastro-intestinal bleeding) and need for transfusion. Efficacy was assessed by a composite end-point of in-hospital death, Q wave myocardial infarction (MI) or urgent coronary artery bypass graft (CABG).


RESULTS
Those in the bivalirudin group were older, more hypertensive, and had greater body mass index. The UFH group was more likely to have prior MI, prior CABG, and an acute coronary syndrome at baseline. GPI was used in 93 patients (52%) of the UFH group. No difference was found between groups for the composite of death/Q wave MI/urgent CABG (1.9% vs. 1.7%, respectively, in bivalirudin vs. UFH group; P = 0.2). The frequency of major bleeding (2.2% vs. 1.7%; P = 0.8) or transfusion (5.6% vs. 8.7%; P = 0.9) was also similar between groups. After adjustment, bivalirudin use was not associated with a reduction in death/Q wave MI/urgent CABG, major bleeding, or transfusion compared to UFH.


CONCLUSIONS
Bivalirudin use seems to be as safe and effective as UFH in patients undergoing RA.
Delhaye
Cedric
C
Department of Internal Medicine, Division of Cardiology, Washington Hospital Center, Washington, DC 20010, USA.
Wakabayashi
Kohei
K
Maluenda
Gabriel
G
Ben-Dor
Itsik
I
Torguson
Rebecca
R
Xue
Zhenyi
Z
Suddath
William O
WO
Satler
Lowell F
LF
Pichard
Augusto D
AD
Kent
Kenneth M
KM
Lindsay
Joseph
J
Waksman
Ron
R
D000368:Aged; D015906:Angioplasty, Balloon, Coronary; D000925:Anticoagulants / Q000009:adverse effects / Q000627:therapeutic use*; D017225:Atherectomy, Coronary / Q000009:adverse effects* / Q000706:statistics & numerical data; D015992:Body Mass Index; D015331:Cohort Studies; D016001:Confidence Intervals; D003324:Coronary Artery Disease / Q000188:drug therapy* / Q000628:therapy; D004219:District of Columbia; D005260:Female; D006471:Gastrointestinal Hemorrhage / Q000139:chemically induced; D006400:Hematocrit; D006493:Heparin / Q000627:therapeutic use; D006629:Hirudins / Q000009:adverse effects; D006801:Humans; D020300:Intracranial Hemorrhages / Q000139:chemically induced; D008297:Male; D015999:Multivariate Analysis; D016017:Odds Ratio; D010446:Peptide Fragments / Q000009:adverse effects / Q000627:therapeutic use*; D010975:Platelet Aggregation Inhibitors / Q000627:therapeutic use; D019039:Platelet Glycoprotein GPIIb-IIIa Complex / Q000037:antagonists & inhibitors*; D057216:Propensity Score; D011994:Recombinant Proteins / Q000009:adverse effects / Q000627:therapeutic use; D012042:Registries; D012189:Retrospective Studies; D012307:Risk Factors; D015607:Stents
D000925:Anticoagulants; D006629:Hirudins; D010446:Peptide Fragments; D010975:Platelet Aggregation Inhibitors; D019039:Platelet Glycoprotein GPIIb-IIIa Complex; D011994:Recombinant Proteins; D006493:Heparin; C074619:bivalirudin