• J Interv Cardiol · Oct 2009

    Randomized Controlled Trial Comparative Study

    Outcomes of patients with coronary artery perforation complicating percutaneous coronary intervention and correlations with the type of adjunctive antithrombotic therapy: pooled analysis from REPLACE-2, ACUITY, and HORIZONS-AMI trials.

    • Jacob A Doll, Eugenia Nikolsky, Gregg W Stone, Roxana Mehran, A Michael Lincoff, Adriano Caixeta, Brent McLaurin, Ecaterina Cristea, Martin Fahy, Vijaya Kesanakurthy, and Alexandra J Lansky.
    • Columbia University Medical Center and the Cardiovascular Research Foundation, New York, USA.
    • J Interv Cardiol. 2009 Oct 1; 22 (5): 453-9.

    BackgroundThe lack of a specific counteragent to bivalirudin may complicate the management of patients with coronary artery (CA) perforation during percutaneous coronary intervention (PCI).AimAssess outcomes of patients with CA perforation from three PCI trials comparing intravenous bivalirudin with provisional glycoprotein (GP) IIb/IIIa inhibition versus unfractionated heparin (UFH) plus GP IIb/IIIa.MethodsA pooled analysis of patients treated with PCI in three randomized trials including REPLACE-2, ACUITY, and HORIZONS-AMI.ResultsAmong a total of 12,921 patients, CA perforation occurred in 35 patients (0.27%). By multivariable analysis, baseline creatinine clearance was the only independent predictor of CA perforation (per 10 mL/min decrease, odds ratio [95% confidence interval]= 1.28 [1.11, 1.47], P = 0.0007). At 30 days, patients with versus without CA perforation had significantly (all P values < or =0.001) higher rates of 30-day mortality (11.4% vs. 1.0%), myocardial infarction (MI) [Q wave: 22.9% vs. 5.7%; non-Q wave: 17.1% vs. 4.9%], target vessel revascularization (TVR) [20.1% vs. 1.8%], and composite end-point of death/MI/TVR (31.4% vs. 7.8%). Patients assigned to bivalirudin versus UFH plus a GP IIb/IIIa inhibitor had nonsignificantly lower rates of death (0% vs. 18.8%, P = 0.08), similar rates of MI (26.7% vs. 25.0%, P = 0.92), significantly lower rates of TVR (6.7% vs. 37.5%, P = 0.04), and similar rates of the composite end-point of death/MI/TVR (35.5% vs. 26.7%, P = 0.54).ConclusionIn three PCI trials, treatment of patients experiencing CA perforation with adjunctive antithrombotic therapy of bivalirudin monotherapy was not associated with worse outcomes compared to treatment with UFH plus GP IIb/IIIa inhibitors.

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