The American journal of cardiology
-
Randomized Controlled Trial
Association of prerandomization anticoagulant switching with bleeding in the setting of percutaneous coronary intervention (A REPLACE-2 analysis).
The REPLACE-2 trial of patients who underwent urgent or elective percutaneous coronary intervention (PCI) demonstrated a significantly lower bleeding risk with bivalirudin plus provisional glycoprotein IIb/IIIa inhibitor compared with unfractionated heparin with planned glycoprotein IIb/IIIa inhibitor. The goal of this analysis was to evaluate whether a hazard existed when unfractionated heparin or low-molecular-weight heparin was administered before study medication in the REPLACE-2 trial. The REPLACE-2 trial randomized 6,010 patients undergoing PCI to receive bivalirudin plus provisional glycoprotein IIb/IIIa inhibitor or unfractionated heparin plus planned glycoprotein IIb/IIIa inhibitor. ⋯ However, in patients treated with unfractionated heparin plus planned glycoprotein IIb/IIIa inhibitor, there was a significant increase in the composite of protocol-defined major or minor bleeding and in noncoronary artery bypass graft blood transfusions (p<0.05 for 3-way comparison vs no unfractionated heparin and for 2-way comparisons of no unfractionated heparin vs unfractionated heparin or low-molecular-weight heparin). In conclusion, in patients treated with bivalirudin, pretreatment with antithrombin therapy was not associated with increased bleeding. In contrast, among patients randomized to receive unfractionated heparin and planned glycoprotein IIb/IIIa, pretreatment with antithrombin therapy was associated with increased protocol-defined composite major or minor bleeding and increased need for transfusion.
-
Randomized Controlled Trial Comparative Study
A comparative study of the efficacy and safety of procainamide versus propafenone versus amiodarone for the conversion of recent-onset atrial fibrillation.
The appropriate treatment for the restoration of sinus rhythm in patients with atrial fibrillation (AF) of recent onset is still the subject of controversy. In this prospective, randomized, single-blind, placebo-controlled clinical study, we investigated the effectiveness and safety of procainamide, propafenone, and amiodarone, administered intravenously, for the conversion of recent-onset AF. We enrolled 362 consecutive patients (183 men; age 34 to 86 years; mean 65+/-10) with AF duration of no >48 hours. ⋯ The treatment was successful in 61 of the 89 patients who received procainamide (68.53%; median time 3 hours), 73 of the 91 patients who received propafenone (80.21%; median time 1 hour), 82 of the 92 patients who received amiodarone (89.13%; median time 9 hours), and 55 of the 90 patients who received placebo (61.11%; median time 17 hours; p<0.05 for all medicated groups vs placebo; p<0.05 for amiodarone and propafenone vs procainamide). In conclusion, all 3 medications, when administered intravenously, are effective in the restoration of sinus rhythm in recent-onset AF. Amiodarone and propafenone are more effective whereas procainamide and propafenone are faster.