Researchers find stents, surgery provide higher quality of life for those with chest pain.

Invasive procedures such as bypass surgery and stenting—commonly used to treat blocked arteries—are no better at reducing the risk for heart attack and death in patients with stable ischemic heart disease than medication and lifestyle changes alone.

However, such procedures offer better symptom relief and quality of life for some patients with chest pain, according to two new, milestone studies.

The studies, designed to settle a decades-old controversy in cardiology, appear online March 30 in the New England Journal of Medicine. While researchers released preliminary findings last November at the American Heart Association annual meeting, the papers published today report the official outcomes of the International Study of Comparative Health Effectiveness with Medical and Invasive Approaches (ISCHEMIA), the largest and one of the most consequential studies of its kind.

Funded by the National Heart, Lung, and Blood Institute (NHLBI), part of the National Institutes of Health, the trial followed more than 5,000 patients with stable heart disease and moderate to severe heart disease for a median of 3.2 years. It compared an initial conservative treatment strategy to an invasive treatment strategy. The conservative treatment strategy involved medications to control blood pressure, cholesterol, and angina (chest discomfort caused by inadequate blood to the heart), along with counseling about diet and exercise. The invasive treatment strategy involved medications and counseling, as well as coronary procedures performed soon after patients recorded an abnormal stress test. The trial allowed tests that assess coronary blood flow restriction, called ischemia, to determine who could participate in the study.

“Previous studies have reached similar conclusions as ISCHEMIA, but they were criticized for not including patients who had severe enough disease to benefit from the procedures. ISCHEMIA studied only patients with the most abnormal stress tests,” said Yves Rosenberg, M.D., study co-author and chief of NHLBI’s Atherothrombosis and Coronary Artery Disease Branch. “These findings should be applied in the context of careful attention to lifestyle behaviors and guideline-based adherence to medical therapy, and will likely change clinical guidelines and influence clinical practice.”

He cautioned patients in the meantime to confer with their doctors to determine what strategies are best for them.

Coronary artery disease, which is caused by narrowed arteries that reduce blood to the heart, is the most common type of heart disease. It affects about 18 million Americans and is the leading cause of death in the United States. Symptoms can vary, but some people do not have them at all and may not know they have heart disease until they experience chest pain, a heart attack, or sudden cardiac arrest.

To find out whether an invasive or conservative strategy would be more effective in reducing these kinds of events, researchers studied the impact of both on heart attack, hospitalization for unstable angina, heart failure, resuscitated cardiac arrest, and cardiovascular death. An additional key outcome of study was quality of life.

From August 2012 to January 2018, ISCHEMIA enrolled 5,179 patients who were an average of 64 years old, at 320 sites in 37 countries. Most participants had a history of chest pain, with 21% reporting daily or weekly chest pain. About 35% had no chest pain one month prior to enrollment.

The patients then were randomly assigned to receive either the conservative, medical therapy alone (unless their symptoms worsened), or medical therapy and an invasive intervention soon after having an abnormal stress test. Over the five years of the trial, 21% of patients in the conservative treatment group ended up having a stent implant or bypass surgery; the rest continued medication alone. Of those in the intervention group, revascularization was performed in 79%, three-quarters of them receiving stents and the others, bypass surgery.

By the end of the trial, the death rate between the two groups proved to be essentially the same: among the participants who had invasive procedures, 145 died, compared to 144 who received medication alone. The overall rate of disease-related events was similar among those who took medication alone: 352 experienced an event such as heart attack, compared to 318 who had invasive procedures.

Researchers noted one caveat; patients in the conservative strategy had fewer cardiovascular events during the first two years of the study. However, the invasive strategy patients had fewer events during the last two years, researchers noted, because of an uptick in heart attacks in that group in the first six months.

“We have known and confirmed in this study that stent and surgical procedures have a risk of some heart damage,” said Judith Hochman, M.D., study chair, co-lead author and Senior Associate Dean for Clinical Sciences NYU Grossman School of Medicine. “However, we saw that the heart damage related to a procedure was not as serious in terms of the risk of subsequent death compared to heart attacks that occurred spontaneously, unrelated to any procedure.”

The long-term follow-up of patients will be needed to better determine the true difference in prognosis between these two group.

For patients with angina, or chest pain, the comparative benefits of an invasive procedure over medical therapy alone were more consistent throughout the trial.

“ISCHEMIA showed an impressive, sustainable improvement in patients’ symptoms, function and quality of life with an invasive strategy for up to four years of follow-up,” said John Spertus, M.D., M.P.H., director of health outcomes research at Saint Luke’s Mid America Heart Institute in Kansas City, MO., and co-principal investigator for the ISCHEMIA quality of life analysis. “However, this benefit was only observed in roughly two-thirds of those who had angina at baseline and no benefit was seen in those who had no symptoms.”

“Taken together, the quality of life and clinical results suggest that there is no need for invasive procedures in patients without symptoms,” said David Maron, M.D., director of the Stanford Prevention Research Center at Stanford University and the study’s lead author and principal investigator. “For those with angina, our results show it is just as safe to begin treating with medication and lifestyle change, and then if symptoms persist, discuss invasive treatment options.”

Two other ISCHEMIA companion studies produced other key results. ISCHEMIA-Chronic Kidney Disease (CKD) and quality of life studies, also published in the New England Journal of Medicine, did not show a reduced risk for death and heart attack for participants who had advanced chronic kidney disease, stable coronary disease, as well as moderate or severe ischemia with the invasive treatment compared to the conservative treatment. There were no benefits in quality of life, even if participants had angina symptoms.

Finnish study lengthened lives by changing lifestyles

In the early 1970s, the Finnish province of North Karelia had one of the world’s highest death rates from heart disease.


Pekka Puska. Photo: Nilagia McCoy

Responding to an appeal from the community, local authorities partnered with the World Health Organization to launch the North Karelia Project, a community-wide effort to change the physical and social environment to promote healthier behaviors and save lives.

Project director Pekka Puska, a physician, researcher, and member of the Finnish parliament, recently spoke to a Harvard T.H. Chan School of Public Health audience about the project’s history and its implications for global cardiovascular disease prevention and policy.

Puska delivered the 14th Annual Stare-Hegsted Lecture on October 29 in Kresge G-2. The event, sponsored by the Department of Nutrition, honors two of the department’s founders, Fredrick Stare and D. Mark Hegsted.

The North Karelia Project was launched in 1972 and officially ended 25 years later. While its initial goal was to reduce smoking and saturated fat in the diet, it later added increasing consumption of fruits and vegetables. Behavioral change is complicated, Puska said. It requires more than simply giving people information about healthy behavior—you have to make the environment healthier.

During the project, researchers met with residents and enlisted the help of local groups like hunting clubs and church congregations. They made school lunch programs more nutritious and encouraged local sausage makers to reduce sodium and fat in their products. The helped get legislation passed in the province to ban tobacco advertising and cut dairy subsidies, and promoted local berry farming and cultivation of rapeseed for heart-healthy canola oil.

The project had marked success in reducing smoking and salt and butter consumption, and in getting residents to eat more fruits and vegetables. As a result, deaths from heart disease and other non-communicable diseases (NCDs) declined, and more residents reported on surveys that they felt healthy. Since the start of the project, the population of North Karelia has gained 10 more healthy years of life, Puska said.

The project demonstrates that population-based strategies to influence lifestyle risks are the most cost effective and sustainable way to prevent NCDs and promote healthy aging, Puska said. While personal responsibility is vital for good health, Puska said, public health can help by making it less of a burden to make a healthy choice.

Amy Roeder

Article published courtesy of Harvard T.H. Chan School of Public Health

Public-Private Partnerships Are Key To Addressing Childhood Obesity

The Mondelēz International Foundation on Monday announced the publication of a new study on the impact of Mondelēz International Foundation healthy lifestyles initiatives in the June edition of Food and Nutrition Bulletin.

Fundacion-Mondelez.jpgConducted by Dr. Rafael Pérez-Escamilla, Professor of Public Health & Director, Office of Public Health Practice at the Yale School of Public Health, and funded by the Foundation, the independent analysis titled “Innovative healthy lifestyles school-based public-private partnerships designed to Curb the Childhood Obesity Epidemic Globally: Lessons Learned from the Mondelēz International Foundation” identified key factors that have led to successful public-private partnerships across seven countries.

For more than nine years, the Mondelēz International Foundation has partnered with non-profit organizations across the world to support the delivery and evaluation of school-based healthy lifestyle programs. The findings published today provide learnings on how future public-private partnerships seeking to promote healthy lifestyles and help curb the risk of obesity can successfully be established.

“The Foundation and its partners around the world have created an effective framework for healthy lifestyle school-based public-private partnerships,” said Pérez-Escamilla. “As outlined in the paper, there is strong evidence that shows programs across all five continents are having a positive impact on nutrition and physical activity knowledge and practices.”

Qualitative data used to evaluate the Foundation’s partnerships was collected from two program evaluation workshops in 2013 and 2016, as well as from the Foundation’s annual country reports and project report, and interviews with key leaders from each program.

“Through effective partnerships with locally based organizations, we’ve transformed the lives of millions of children and families around the globe by improving nutrition knowledge, physical activity and access to fresh produce,” said Sarah Delea, President of the Mondelēz International Foundation. “We’re inspired by the change we’ve seen in those programs and hope that Dr. Pérez-Escamilla’s study in Food and Nutrition Bulletin will inspire others to make an impact through public-private partnerships.”

Supporting this review, data from program reports and surveys commissioned by partner organizations between 2014 through 2016 also indicated solid progress in both knowledge and behavior change. Specifically, across the Foundation programs, there was a twelve-percent increase in understanding what good nutrition is, including knowing the number of fruits and vegetables to eat daily; a six-percent increase in physical activity to at least 30 minutes daily; and an eleven-percent increase in eating more fruits, vegetables and other fresh foods, as part of the gardening programs.

The Foundation and its programs support Mondelēz International’s Impact For Growth platform, which is focused on four key areas where the company can make the greatest impact on people and planet: community, sustainability, well-being snacks and safety.

Mondelēz International, Inc. (NASDAQ:MDLZ) is building the best snacking company in the world, with 2017 net revenues of approximately $26 billion. Creating more moments of joy in approximately 160 countries, Mondelēz International is a world leader in biscuits, chocolate, gum, candy and powdered beverages, featuring global Power Brands such as Oreo and belVita biscuitsCadbury Dairy Milk and Milka chocolate; and Trident gum.  Mondelēz International is a proud member of the Standard and Poor’s 500, Nasdaq 100 and Dow Jones Sustainability Index.

The Mondelēz International Foundation is the international philanthropic arm of Mondelēz International. The Foundation is focused on three areas of action: investing in community programs that promote healthy lifestyles in at-risk communities around the world; providing humanitarian aid through cash and product when disaster strikes; and inspiring colleagues to contribute time and talent to help our local communities thrive. To learn more about our efforts,