In patients who received a stent to treat coronary artery blockage, those who experienced bleeding requiring hospitalization in the years after the procedure faced an increased risk of death that was similar to the risk faced by those who subsequently had heart attacks, according to a study of nearly 33,000 patients by UC San Francisco and Kaiser Permanente.
“Every year, 600,000 patients in the United States receive a coronary stent and are given drugs that prevent the formation of clots within the stent. These drugs prevent heart attacks but increase the risk of internal bleeding,” said lead author Dhruv Kazi, MD, MSc, MS, an assistant professor of medicine at UCSF. “These bleeds are often written off as a side effect, but it turns out that they may be just as bad for patients as the heart attacks we’re trying to avoid.”
The study in the April 14 issue of the Journal of the American College of Cardiology is the first to show that the two risks are of comparable magnitude.
Kazi said that the results underline the importance of treating cardiac patients based on personalized risk factors, instead of using what he called a “one-size-fits-all” approach based on population statistics. This study points toward the possibility of using other information about patients that may help identify the antiplatelet drug that is most likely to be the most safe and effective for individual patients in the long run.
The study authors analyzed the records of 32,906 patients in the Kaiser Permanente Northern California health care system who received stents between 1996 and 2008 and were followed for four years. They found that both post-procedure heart attack and episodes of bleeding requiring hospitalization were associated with a greater relative risk of death (91 percent and 61 percent, respectively) over the same time span. The risks in the two groups were not different statistically, so the researchers could not say the risk for one was greater than the other.
Senior author Alan S. Go, MD, of the Kaiser Permanente Division of Research, noted that the study results “highlight the need for and value of high-quality outcomes research using data from patients treated in the real world to inform patients and doctors about the consequences of treatments.”
Randomized trials, Go observed, “can tell us whether or not a drug, such as an antiplatelet medication, works. But patients enrolled in these trials are highly selected and may not really be like the patients we treat in the clinical practice and are usually followed for a short period of time.”
In contrast, Go said, when rigorously evaluated, data collected in everyday clinical practice can yield valuable insights about long-term effectiveness and safety that complement what is learned from randomized clinical trials.
“We’ve known for some time that bleeds that occur during the stent procedure are bad for the patient, so we increasingly take steps to reduce those bleeds, such as giving drugs with lower bleeding risk and using the radial artery to perform the procedure instead of the femoral artery,” Kazi said. “This is the first study to show that bleeds that occur in the months and years after discharge are also bad for the patient, emphasizing the need for long-term strategies that reduce a patient’s risk of bleeding.”
Other co-authors are Thomas K. Leong, MPH, and Matthew D. Solomon, MD, PhD, of Kaiser Permanente, and Tara I. Chang, MD, MS, and Mark A. Hlatky, MD, of Stanford University.
The study was supported by funds from the American Heart Association, Kaiser Permanente Northern California Division of Research, Stanford University and UCSF.
UCSF is the nation's leading university exclusively focused on health. Now celebrating the 150th anniversary of its founding as a medical college, UCSF is dedicated to transforming health worldwide through advanced biomedical research, graduate-level education in the life sciences and health professions, and excellence in patient care. It includes top-ranked graduate schools of dentistry, medicine, nursing and pharmacy; a graduate division with world-renowned programs in the biological sciences, a preeminent biomedical research enterprise and two top-tier hospitals, UCSF Medical Center and UCSF Benioff Children's Hospital San Francisco.
The Kaiser Permanente Division of Research conducts, publishes and disseminates epidemiologic and health services research to improve the health and medical care of Kaiser Permanente members and society at large. It seeks to understand the determinants of illness and well-being, and to improve the quality and cost-effectiveness of health care. Currently, DOR’s 550-plus staff is working on more than 250 epidemiological and health services research projects.
Kaiser Permanente is committed to helping shape the future of health care. We are recognized as one of America’s leading health care providers and not-for-profit health plans. Founded in 1945, Kaiser Permanente has a mission to provide high-quality, affordable health care services and to improve the health of our members and the communities we serve. We currently serve approximately 9.6 million members in eight states and the District of Columbia. Care for members and patients is focused on their total health and guided by their personal physicians, specialists and team of caregivers. Our expert and caring medical teams are empowered and supported by industry-leading technology advances and tools for health promotion, disease prevention, state-of-the-art care delivery and world-class chronic disease management. Kaiser Permanente is dedicated to care innovations, clinical research, health education and the support of community health.