Cardio Trial Files Throwback Thursday: Sildenafil vs. Placebo in HF, PFO Closure vs. Medical Therapy in Cryptogenic Stroke, and Thrombolysis for PE
Effect of Phosphodiesterase-5 Inhibition on Exercise Capacity and Clinical Status in Heart Failure With Preserved Ejection Fraction
Redfield MM et al. JAMA (March 2013)
Bottom Line: This multicenter, double-blind, placebo-controlled, parallel-group, randomized clinical trial enrolled 216 stable outpatients with heart failure, ejection fraction ≥50%, elevated N-terminal brain-type natriuretic peptide or elevated invasively measured filling pressures, and reduced exercise capacity. Participants were randomized to receive sildenafil (n = 113) or placebo (n = 103) orally at 20 mg, 3 times daily for 12 weeks, followed by 60 mg, 3 times daily for 12 weeks. The primary end point was change in peak oxygen consumption after 24 weeks of therapy. Results showed no significant difference between the sildenafil and placebo groups in terms of peak oxygen consumption, 6-minute walk distance, or a hierarchical composite clinical status score. Adverse events and serious adverse events were similar between the two groups. Therefore, phosphodiesterase-5 inhibition with administration of sildenafil did not result in significant improvement in exercise capacity or clinical status in patients with heart failure and preserved ejection fraction.
Closure of Patent Foramen Ovale versus Medical Therapy after Cryptogenic Stroke
Carroll JD et al. NEJM (March 2013)
Bottom Line: This randomized, event-driven trial compared closure of a patent foramen ovale to medical therapy alone in 980 adults 18 to 60 years of age who had a cryptogenic ischemic stroke. The primary outcome was recurrent ischemic stroke or early death. In the intention-to-treat cohort, closure was not significantly beneficial, however, closure was indicated to be superior to medical therapy alone in the prespecified per-protocol and as-treated analyses. Serious adverse events occurred in 23.0% of the patients in the closure group and 21.6% in the medical-therapy group. Procedure-related or device-related serious adverse events occurred in 4.2% of the closure group, but the rate of atrial fibrillation or device thrombus was not increased.
Moderate Pulmonary Embolism Treated With Thrombolysis (MOPETT)
Sharifi M et al. The American Journal of Cardiology (January 2013)
Bottom Line: This prospective randomized trial studied the effects of a “safe dose” of thrombolysis plus anticoagulation compared to anticoagulation alone in 121 patients with moderate pulmonary embolism. The primary outcomes of pulmonary hypertension and the composite end point of pulmonary hypertension and recurrent PE at 28 months were significantly lower in the thrombolysis group (16%) compared to the control group (57%). Additionally, the duration of hospitalization was significantly shorter in the thrombolysis group (2.2 ± 0.5 days) compared to the control group (4.9 ± 0.8 days). No bleeding occurred in any group, and no difference was noted in the rate of individual outcomes of death and recurrent PE when assessed independently. The results of this study suggest that “safe dose” thrombolysis is safe and effective in the treatment of moderate PE, with a significant immediate reduction in the pulmonary artery pressure that was maintained at 28 months.
Cardio Trial Files Issue #CRD-2025-03
Want to view past issues? Visit our archive:
