Effectiveness of the concomitant use of bivalirudin and drug-eluting stents (from the prospective, multicenter BivAlirudin and Drug-Eluting STents [ADEST] study).
Sirolimus-eluting stents (SESs) reduce restenosis compared with bare metal stents. Safety issues with drug-eluting stents are particularly important given concerns of possible increased thrombogenicity. Compared with heparin plus glycoprotein IIb/IIIa inhibitors, the direct thrombin inhibitor bivalirudin has been shown to reduce the risk of hemorrhagic complications in patients receiving bare metal stents, with similar efficacy in preventing ischemic complications. The safety and efficacy of percutaneous coronary intervention (PCI) with SESs and bivalirudin anticoagulation have not been prospectively studied. This prospective study performed at 9 United States hospitals evaluated 1,182 patients referred for PCI with SESs in whom the procedural anticoagulant was bivalirudin. Clopidogrel was administered before PCI in 79% of patients, and only 5.3% received procedural glycoprotein IIb/IIIa inhibitors. At 30 days, major adverse cardiac events occurred in 7.1% of patients, including 0.3% mortality, 4.4% myocardial infarction (defined as creatine kinase-MB >3x normal), 1.7% target vessel revascularization, and 0.6% stent thrombosis. Major bleeding occurred in only 0.8% of patients. Thus, use of bivalirudin as the procedural anticoagulant to support SES implantation in a "real world" population of patients undergoing PCI results in low rates of major adverse cardiac events, stent thrombosis, and major bleeding.
Dangas
George
G
Columbia University Medical Center and Cardiovascular Research Foundation, New York, New York, USA. gdangas@crf.org
Lasic
Zoran
Z
Mehran
Roxana
R
Cox
David
D
Ghali
Magdi G H
MG
Henry
Timothy D
TD
Teirstein
Paul S
PS
Stella
Joseph F
JF
Browne
Kevin F
KF
Lewis
Stephen Alan
SA
Knopf
William
W
Leon
Martin B
MB
Moses
Jeffrey W
JW
Stone
Gregg W
GW
D015906:Angioplasty, Balloon, Coronary / Q000295:instrumentation* / Q000401:mortality; D000925:Anticoagulants / Q000627:therapeutic use*; D020099:Coated Materials, Biocompatible; D003327:Coronary Disease / Q000628:therapy*; D023903:Coronary Restenosis / Q000401:mortality / Q000517:prevention & control; D005500:Follow-Up Studies; D006629:Hirudins; D017052:Hospital Mortality; D006801:Humans; D007166:Immunosuppressive Agents / Q000627:therapeutic use; D008875:Middle Aged; D010446:Peptide Fragments / Q000627:therapeutic use*; D011446:Prospective Studies; D011994:Recombinant Proteins / Q000627:therapeutic use; D012307:Risk Factors; D012449:Safety; D020123:Sirolimus / Q000627:therapeutic use; D015607:Stents; D016896:Treatment Outcome; D014481:United States / Q000453:epidemiology
D000925:Anticoagulants; D020099:Coated Materials, Biocompatible; D006629:Hirudins; D007166:Immunosuppressive Agents; D010446:Peptide Fragments; D011994:Recombinant Proteins; C074619:bivalirudin; D020123:Sirolimus