Clinical trials in heart valve disease.

PURPOSE OF REVIEW: To summarize evidence from clinical trials of heart valve disease and identify areas where further trials are needed.

RECENT FINDINGS: Recent randomized studies suggest that statins do not influence progression of aortic stenosis. Other medical therapies with the potential to reduce progression of valve disease or decrease myocardial dysfunction include vasodilators in aortic regurgitation, angiotensin II receptor antagonists or beta-blockers in mitral regurgitation and angiotensin-converting enzyme inhibitors in aortic stenosis. However, these treatments have not been evaluated or have been evaluated only in small studies. Meta-analysis of randomized studies of antithrombotic strategies in patients with mechanical valves suggests overall risk is lower with the combination of warfarin with a lower target international normalized ratio and an antiplatelet drug. Novel anticoagulants have the potential to replace warfarin but have not yet been evaluated for this indication. Clinical trials are also needed to reliably evaluate different surgical strategies and novel percutaneous technology.

SUMMARY: Clinical trials in heart valve disease have important limitations, including the small number of trials undertaken and the small size of most studies. Many trials were undertaken more than 10-20 years ago in patients with earlier generation valve prostheses. To improve outcomes for patients with heart valve disease more clinical trials of contemporary approaches are needed.