Stockholm – A nurse-led secondary prevention program for patients after an acute coronary syndrome led to sustained, impressive improvement in cardiovascular risk factors, a multicenter, randomized, a Dutch clinical trial has shown.
The modest intervention employed in the RESPONSE (Randomized Evaluation of Secondary Prevention by Outpatient Nurse Specialists) trial consisted of four 30-minute individual outpatient sessions with a nurse during the first 6 months after a participant’s acute coronary syndrome (ACS), in addition to standard therapy.
Six months after the final session, and 1 full year post-ACS, patients in the intervention arm were 40% more likely to have good control of their cardiovascular risk factors than controls assigned to standard therapy, Dr. Ron J.G. Peters reported at the congress.
Moreover, the intervention group’s estimated 4.5% 10-year risk of mortality using the SCORE metric was 17% less than in controls. A similar significant advantage in projected 10-year survival favoring the intervention group was seen using the Framingham Risk Score more familiar to American physicians, said Dr. Peters of the Academic Medical Center in Amsterdam.
The RESPONSE trial included 754 patients discharged from 11 participating Dutch medical centers after an ACS. They were randomized in single-blind fashion to the four nurse visits or usual care within 8 weeks of their coronary event.
During the half-hour-long office visits, nurses assessed patients’ cardiovascular risk factor status and counseled them on the importance of adhering to the evidence-based, guideline-recommended preventive measures that are supposed to be part of standard care. Patients on-target for at least 7 of 9 cardiovascular risk factors 1-year post-ACS were categorized as having good control. These risk factors were dyslipidemia, systolic blood pressure, blood glucose, smoking, physical activity, waist circumference, body mass index, alcohol intake, and diet.
The intervention resulted in significantly higher on-target rates than in the control group for systolic blood pressure, LDL cholesterol, physical activity, and a healthy diet. The intervention had no impact on waist circumference, body mass index, smoking status, or identification and treatment of insulin resistance.
Dr. Peters noted, however, that the prevalence of smoking at 1 year of follow-up was cut in half, to about 24% in both study arms. This was probably the result of admonitions to quit smoking coupled with the life-altering nature of hospitalization for ACS, he added.
All nurses in the intervention arm received several hours of special training in cardiovascular risk factor reduction and motivational interviewing techniques. But they did not get any special training in smoking cessation, nor were they authorized to give medications to help patients stop smoking.
The intervention was popular with patients and was well attended. Indeed, 93% of patients went to all four sessions.
The RESPONSE trial was enthusiastically received.
"Although this is not a trial about a new drug or device, I consider this trial extremely important," declared session co-chair Dr. Ralph Brindis, president of the American College of Cardiology.
"We have to figure out a way of better integrating delivery of care in patients at discharge from the hospital. We don’t do this very well in the United States. We have evidence-based therapies that are not being done. And here we have a trial that shows an effective way of delivering care with things that we know work," said Brindis, an interventional cardiologist who is senior advisor for cardiovascular disease at Northern California Kaiser Permanente in Oakland, Calif.
Discussant M. Christie Deaton, Ph.D., agreed this is an intervention that ought to be widely implemented.
"I think if we had a drug therapy that had a 17% relative risk reduction in predicted 10-year mortality we would be very excited about that," observed Dr. Deaton, professor of nursing at the University of Manchester, UK.
"Nurses are well suited to coordinate or lead secondary prevention programs such as this," she added. "I’m not going to say that they’re the only ones who can do it, but by virtue of education, clinical background, and a focus on supporting, coaching, and educating patients, it does make them well suited to this."
The major remaining research questions involve how to optimize the intervention by fine tuning its duration, components, and intensity. For example, waist circumference and body mass index are cardiovascular risk factors that are notoriously difficult to improve. Since eating occurs in a family or social context, perhaps group classes or family-centered interventions are needed in order to see improvement in these domains, she said.
Dr. Peters and Dr. Deaton declared having no conflicts of interest.