A randomized study of the safety and efficacy of fondaparinux versus placebo in the prevention of venous thromboembolism after coronary artery bypass graft surgery.

UNLABELLED: Venous thromboembolism (VTE) after coronary artery bypass graft (CABG) surgery may increase the postoperative morbidity and mortality. Therefore, we examined the current postoperative need for prophylactic antithrombotic therapy after CABG surgery. METHODS: This randomized, placebo-controlled, double-blind study was designed to compare the safety and efficacy of fondaparinux versus placebo in the prevention of VTE after CABG surgery. Between March 2010 and January 2013, 78 patients free from preoperative deep vein thrombosis (DVT) were enrolled, of whom 37 were randomly assigned to placebo and 41 to treatment with fondaparinux. The primary study end point was a composite, up to day 11, of (a) cumulative incidence of all VTE events, defined as symptomatic and asymptomatic DVT, and fatal and nonfatal pulmonary embolisms (efficacy end point), and (b) cumulative incidence of major hemorrhages (safety end point). RESULTS: A single asymptomatic DVT of a lower extremity was detected by duplex ultrasound at the time of discharge from the hospital in the placebo-treated group, and a single major postoperative hemorrhage occurred in the fondaparinux-treated group. CONCLUSIONS: The incidence of postprocedural asymptomatic DVT in this sample of patients undergoing CABG surgery was low. The overall incidence of DVT in the control and investigational treatment groups was similar. Our results showed no benefit of prophylactic postoperative fondaparinux in this population. These findings are congruent with other published studies and provide additional support for recent recommendations not to routinely use anticoagulant prophylaxis after cardiac surgery.

Long-term outcomes of drug-eluting stents versus bare-metal stents in saphenous vein graft disease: results from the Prairie "Real World" Stent Registry.

OBJECTIVES: This study was designed to compare long-term clinical outcomes of drug-eluting stents (DES) versus bare metal stents (BMS) in patients with saphenous vein graft (SVG) disease in the "real world." BACKGROUND: The safety and efficacy of DES versus BMS in SVG remains uncertain due to contradictory reports of either lower revascularization rates with DES; or clinical equivalence to BMS; or even an excess of clinical events associated with DES use. METHODS: We identified consecutive patients who underwent stent placement within a de novo SVG lesion between May 1, 2003 and July 31, 2007. Follow-up was obtained at regular intervals. The Kaplan-Meier method was used to produce actuarial survival estimates. Cox regression analysis was used to predict the risk associated with stent type, and propensity scores were generated to risk-adjust the results. RESULTS: The study group included 379 stent recipients (284 DES; 95 BMS) with 410 stented lesions. BMS were placed more frequently in current smokers, acute myocardial infarctions, larger vessels, and longer lesions. In-hospital mortality was higher in BMS recipients than in their DES counterparts (3.2% vs. 0, respectively; P = 0.015). At 3 years, there was no significant difference in clinical adverse event rates between DES and BMS recipients, even after risk adjustment. CONCLUSIONS: Three-year adverse event rates are similar among patients treated with DES or BMS in SVG lesions. Therefore, while DES are safe, they do not appear to offer an advantage in terms of long-term graft patency.