Researchers used a new technique—known as fractional flow reserve—to decide if a patient should have a stent or not. The study authors suggested that FFR could help doctors figure out whether a patient's coronary blockage was going to put them at risk for a heart-related emergency, such as a heart attack or chest pain. The trial was stopped early because those who had not received stents experienced more heart attack symptoms and emergency hospitalizations than their stent counterparts.
St. Jude Medical acted after the Data Safety and Monitoring Board found "increased patient risk for major adverse cardiac events among patients randomized to optimal medical therapy alone compared with patients randomized to optimal medical therapy plus (fractional flow reserve) guided PCI. At the time the study was stopped, 12.7% of patients without stents had experienced one of these cardiac events while only 4.3% of people who received stents had.
In an understatement, the American College of Cardiology Foundation and SCAI issued a report this year on cath lab standards that notes stents have become a "particular hot button issue since the publication of certain politically provocative articles."
The report noted that stents have been overwhelmingly successful, citing, among other things, a Mayo Clinic report in 2009 that published 25-year trend data regarding the hospital's experience with angioplasty or PCI procedures. It found that despite an older and sicker population with more comorbid conditions, the success rate from PCI had improved from 78% to 94%, while hospital mortality had fallen from 3.0% to 1.8%.