PCI reduces need for additional drug even when blockages remain
DURHAM, N.C. -- Heart patients who had undergone an angioplasty procedure that opened only some blocked arteries tended to have a resolution of their chest pain, making it unnecessary to add another medication to treat the symptom, according to a study led by the Duke Clinical Research Institute.
In a finding presented Nov. 10, 2015, at the American Heart Association’s annual Scientific Sessions meeting, the researchers reported that patients randomly assigned to receive the drug ranolazine reported a similar quality of life related to angina as those taking a mock pill after undergoing angioplasty.
Angina is chest pain, and it’s a leading problem for heart patients, contributing to lower quality of life, less treatment satisfaction, and higher medical costs.
“This study does provide an important message for people who have residual disease following angioplasty,” said lead author Karen Alexander, M.D., professor of medicine at Duke and director of safety surveillance at the DCRI. “For patients who had angina prior to angioplasty, they were mostly asymptomatic following the angioplasty even though coronary blockages remained.”
Alexander and colleagues had set out to address whether the drug ranolazine, when added to standard medications in this population, would reduce symptoms along with hospitalizations and procedures over time. Ranolazine works at the heart muscle to lessen the effects of coronary blockages and to ease the pain of angina.
Patients with a history of chronic angina were enrolled in the RIVER-PCI study following percutaneous coronary intervention (PCI), which is also known as angioplasty, a common procedure used to unblock narrowed coronary arteries and improve blood flow to the heart.
Following angioplasty procedures, many patients still have residual disease in one or more of the coronary arteries, also referred to as incomplete revascularization. The patients were randomly assigned to receive either ranolazine or a placebo.
Patients were followed to determine whether they needed repeat cardiac procedures or hospitalizations. For most of the 2,389 patients who completed quality-of-life questionnaires at intervals throughout the first year of the study period, angina improved markedly. In both groups, the improvement was noted within the first month and was sustained up to a year following PCI.
Consistent with the neutral primary results of RIVER-PCI study, no differences were seen across treatment groups in angina or angina-related quality of life. Marginally greater reductions in angina with ranolazine were observed for patients with diabetes and those with frequent baseline angina.
“Our finding does not support prescribing ranolazine based upon coronary anatomy findings alone,” said senior author E. Magnus Ohman, DCRI senior investigator and the Kent and Siri Rawson Director of the Duke Program for Advanced Coronary Disease. “This piece of the study doesn’t negate the importance of ranolazine, it just says this group of patients with incomplete PCI didn’t have angina after the procedure.”
In addition to Alexander and Ohman, study authors at DCRI include Kristi Prather, Kevin J. Anstrom, Daniel Mark and Linda Davidson-Ray; along with Ori Ben-Yehuda and Gregg Stone of Cardiovascular Research Foundation; Giora Weisz of Shaare Zedek Medical Center; Ramin Farzaneh-Far, formerly of Gilead Sciences.
Gilead, which markets ranolazine in the United States, sponsored the trial along with the Menarini Group, which commercializes ranolazine outside the U.S.