PMID- 21972401 OWN - NLM STAT- MEDLINE DCOM- 20120208 LR - 20161125 IS - 1941-7632 (Electronic) IS - 1941-7640 (Linking) VI - 4 IP - 5 DP - 2011 Oct 1 TI - Bleeding risk comparing targeted low-dose heparin with bivalirudin in patients undergoing percutaneous coronary intervention: results from a propensity score-matched analysis of the Evaluation of Drug-Eluting Stents and Ischemic Events (EVENT) registry. PG - 463-73 LID - 10.1161/CIRCINTERVENTIONS.111.961912 [doi] AB - BACKGROUND: Prior randomized trials have shown reduced bleeding with bivalirudin compared with unfractionated heparin (UFH) in patients undergoing percutaneous coronary intervention (PCI). However, it is not known if this benefit is also present when UFH doses are more tightly controlled (as measured by activated clotting time, ACT). METHODS AND RESULTS: Patients enrolled in the EVENT (Evaluation of Drug-Eluting Stents and Ischemic Events) registry, were divided into 3 groups, based on the antithrombotic drug used during PCI (UFH monotherapy, UFH+glycoprotein IIb-IIIa receptor inhibitor [GPI], or bivalirudin alone). Propensity score matching was used to adjust for measured covariates (89 variables) and to compare bivalirudin versus UFH monotherapy and bivalirudin versus UFH+GPI groups. The UFH groups were stratified based on ACT achieved (optimal ACT defined as 250-300 for UFH monotherapy and 200-250 when GPI was also used). The primary bleeding outcome was in-hospital composite bleeding, defined as events of access site bleeding, Thrombolysis In Myocardial Infarction major/minor bleeding, or transfusion. Primary (in-hospital death/myocardial infarction) and secondary ischemic outcomes (death/MI/unplanned repeat revascularization at 12 months) were also evaluated. Propensity score matching yielded 3022 patients for the UFH monotherapy versus bivalirudin comparison and 3520 patients for the UFH+GPI versus bivalirudin comparison. Bivalirudin use was associated with numerically lower bleeding rates at all categories of achieved ACT when compared with UFH (low, optimal, high ACT: 2.5% versus 4.7%, 1.9% versus 6.0%, 3.1% versus 4.8%, respectively) or heparin+GPI groups (low, optimal, high ACT: 0.0% versus 2.7%, 2.7% versus 5.2%, 2.4% versus 6.1%, respectively) and was not associated with any statistically significant increase in either primary or secondary ischemic outcomes. CONCLUSIONS: Among unselected patients undergoing PCI, bivalirudin use during PCI was associated with a lower risk of bleeding at all comparator ACT levels without an increase in ischemic outcomes. FAU - Bangalore, Sripal AU - Bangalore S AD - Department of Medicine, Division of Cardiovascular Medicine, New York University School of Medicine, 530 First Avenue, New York, NY 10016, USA. sripalbangalore@gmail.com FAU - Cohen, David J AU - Cohen DJ FAU - Kleiman, Neal S AU - Kleiman NS FAU - Regev-Beinart, Tal AU - Regev-Beinart T FAU - Rao, Sunil V AU - Rao SV FAU - Pencina, Michael J AU - Pencina MJ FAU - Mauri, Laura AU - Mauri L CN - EVENT Registry Investigators, Boston, MA LA - eng PT - Clinical Trial PT - Comparative Study PT - Journal Article PT - Research Support, Non-U.S. Gov't DEP - 20111004 PL - United States TA - Circ Cardiovasc Interv JT - Circulation. Cardiovascular interventions JID - 101499602 RN - 0 (Fibrinolytic Agents) RN - 0 (Hirudins) RN - 0 (Peptide Fragments) RN - 0 (Platelet Glycoprotein GPIIb-IIIa Complex) RN - 0 (Recombinant Proteins) RN - 9005-49-6 (Heparin) RN - TN9BEX005G (bivalirudin) SB - IM MH - Acute Coronary Syndrome/diagnosis/mortality/physiopathology/*therapy MH - Aged MH - *Angioplasty, Balloon, Coronary MH - Drug Dosage Calculations MH - Female MH - *Fibrinolytic Agents/administration & dosage/adverse effects/pharmacology MH - Hemorrhage MH - *Heparin/administration & dosage/adverse effects MH - *Hirudins/administration & dosage/adverse effects MH - Humans MH - Male MH - Middle Aged MH - *Peptide Fragments/administration & dosage/adverse effects MH - Platelet Glycoprotein GPIIb-IIIa Complex/antagonists & inhibitors MH - Propensity Score MH - Recombinant Proteins/administration & dosage/adverse effects MH - Risk MH - Survival Analysis MH - Treatment Outcome MH - Whole Blood Coagulation Time EDAT- 2011/10/06 06:00 MHDA- 2012/02/09 06:00 CRDT- 2011/10/06 06:00 PHST- 2011/10/06 06:00 [entrez] PHST- 2011/10/06 06:00 [pubmed] PHST- 2012/02/09 06:00 [medline] AID - CIRCINTERVENTIONS.111.961912 [pii] AID - 10.1161/CIRCINTERVENTIONS.111.961912 [doi] PST - ppublish SO - Circ Cardiovasc Interv. 2011 Oct 1;4(5):463-73. doi: 10.1161/CIRCINTERVENTIONS.111.961912. Epub 2011 Oct 4.