How do doctors evaluate treatments for heart disease?

Studies of drugs, diets, and devices all come with their own unique set of challenges.

The best way to know if a new medical treatment truly works is with a randomized controlled trial — the “gold standard” of research studies, also known simply as a clinical trial. Volunteers are randomly assigned to receive either the new treatment or the comparison, which may be a placebo (an inactive therapy) or a treatment that’s already available.

As the nation’s top cause of death, cardiovascular disease has been at the leading edge of evidence generation, says Dr. Robert Yeh, director of the Smith Center for Outcomes Research in Cardiology at Harvard-affiliated Beth Israel Deaconess Medical Center. “We probably have more evidence for cardiovascular treatments than for any other field of medicine,” he says. Among the studies with the greatest impact were the clinical trials that heralded new therapies to treat heart attacks. These include clot-dissolving drugs in the 1980s, followed in the 1990s by artery-opening angioplasty procedures, which remain the standard of care today. Stents, the tiny mesh tubes used in these procedures, have also been extensively studied in clinical trials (see “Testing devices: Different dilemmas”).

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