Kristin Erbacher has dealt with rheumatoid arthritis, an autoimmune disorder that causes painful inflammation of joints, since 2005. Good days are smooth sailing. But bad days make simple tasks such as buttoning a shirt or picking up small objects a painful challenge.
To manage her arthritis, the 44-year-old Avon insurance broker watches what she eats, exercises five to six days a week and takes a biweekly injection of Humira, which helps prevent further damage to her bones and joints.
Like many people dealing with chronic pain, Erbacher also occasionally takes Celebrex, a prescription-strength nonsteroidal anti-inflammatory drug in a class of medicine that includes ibuprofen and naproxen.
It’s the medication that’s proved most effective.
“It works for me,” Erbacher says. “It helps with my pain. I’ve tried ibuprofen, and that upsets my stomach. I’ve tried naproxen. Celebrex has been the only one that’s really given me the relief that I need.”
Thankfully, Erbacher can take the drug on occasion without worrying about the impact it might have on her health.
Recent results from a 10-year clinical trial led by the Cleveland Clinic revealed that prescription-strength doses of celecoxib, the generic name for Celebrex, is no more likely to cause negative cardiovascular complications than ibuprofen and naproxen.
“That was a big deal,” says Dr. Elaine Husni, a Cleveland Clinic rheumatologist who was on the trial’s executive panel.
The study, which was funded by Celebrex’s maker Pfizer, is just one of many reasons why Northeast Ohio is a hot spot for fighting heart disease — the leading cause of death in both men and women in the U.S. The Clinic, ranked best in the country for cardiac care by U.S. News & World Report for 22 straight years, and other area hospitals are taking part in cutting-edge clinical trials and research studies, and implementing novel cardiovascular treatments that have helped advance medical techniques worldwide.
The trial started in 2006, two years after Vioxx, the common brand name for the nonsteroidal anti-inflammatory drug rofecoxib, was taken off the market due to concerns that chronic users were experiencing serious cardiovascular events such as heart attacks and strokes.
That troubled the Food and Drug Administration since Vioxx and Celebrex work in similar ways — by blocking the release of cyclooxygenase-2, an enzyme linked to inflammation. While these inhibitors proved gentler on patients’ digestive systems than prescription-strength ibuprofen or naproxen, did the decreased risks of stomach ulcers and bleeding outweigh any increased risk for cardiovascular damage?
So the FDA ordered Pfizer to launch a major trial while allowing it to continue selling Celebrex. “This was going to be the trial to help understand the cardiovascular safety of these pain relievers,” Husni says.
It enrolled 24,000 patients with osteoarthritis or rheumatoid arthritis who were high risk for cardiovascular disease. Each patient in the study randomly received daily, prescription-strength doses of ibuprofen, naproxen or celecoxib. Participants were studied for at least 18 months.
During the trial, 2.3 percent of celecoxib patients died or suffered a cardiovascular event, such as a heart attack or stroke, compared with 2.5 percent of naproxen patients and 2.7 percent of ibuprofen patients.
As expected since celecoxib was developed to be easier on the digestive system, it produced significantly lower incidents of gastrointestinal ulcers and bleeding than the others.
Husni stresses, however, that the study’s outcomes shouldn’t worry occasional over-the-counter anti-inflammatory users, folks who take an occasional Advil or Motrin for muscle aches and pain.
“This trial was done in people that took long-term, prescription-strength anti-Inflammatories,” she says. “These results are for people that need it on a daily basis for longer than a year. “
For doctors, however, the results are both a relief and illuminating.
“It’s going to allow us to be more individualized and more confident to use drugs when we use them, when we need them, in the safest way,” Husni says.
Grain Gain
Research touting the benefits of a diet rich in whole grains seems to be piling up like hay bales at harvest. In the past, major studies have found eating whole grains such as barley, oats, quinoa and wheat reduce the risks of stroke, heart disease and Type 2 diabetes.
Released in October, a study by the Clinic in collaboration with the Nestle Research Center found enormous cardiovascular benefits for obese or overweight adults under the age of 50, who eat roughly 93 grams of whole grains a day.
During the study, 33 obese or overweight people who were not physically active ate the same diet over two separate eight-week stretches with one difference: One featured foods with refined or milled grains while the other featured those same foods — except enriched with whole grains.
All of the meals, which included cereal, sandwiches and dinner entrees, were provided to the subjects.
Although people lost weight on both diets, the subjects eating whole grains significantly reduced their diastolic blood pressure, says Dr. John Kirwan, director of the Metabolic Translational Research Center and the study’s principal
investigator.
“What that tells us is that there’s something in this whole-grain diet that’s able to help us help them regulate their diastolic blood pressure better,” he says.
As to what that X factor is, Kirwan says, the study showed a significant correlation between change in blood pressure and the amount of adiponectin — a metabolism-regulating protein typically found in higher levels in healthier people — measured in patients. “There is a possibility that this protein is helping to regulate the blood pressure response,” he says.
In fact, the diastolic blood pressure for those on the whole-grain diet was an average of four points better.
This is important because it reflects the heart’s pressure while resting and is a very strong predictor of cardiovascular disease for people under the age of 50, Kirwan says.
“This has real implications in terms of something that you can actually do to control your risk for mortality,” he says.
Best of all, it’s an easy switch.
“This is not a magical diet,” he says. “This is something that you can obtain in your grocery store. And by simply eating a balanced diet enriched with whole grains, you can accrue some significant health benefits.”
Vanishing Act
As the most common type of heart disease in U.S., coronary artery disease kills more than 370,000 people every year, according to the Centers for Disease Control and Prevention.
Caused by a buildup of plaque along the walls of the arteries supplying blood to the heart, it can lead to heart attacks or strokes.
Traditionally, arterial blockages have been treated using balloons to break through the cholesterol deposits and permanent metal stents to keep the arteries open and supported while they heal.
In July, however, University Hospitals Case Medical Center became the first hospital in Ohio to offer patients a naturally dissolving stent.
Approved by the FDA that same month, the Absorb stent is made of a polymer that is gradually reabsorbed back into the body in the form of water and carbon dioxide.
“After a year, it starts losing integrity, but it’s still there,” says Dr. Hiram Bezerra, director of the Cardiac Catheterization Laboratory Imaging Core Laboratory at UH. “After three years, there is nothing left. You don’t find any residual
elements.”
Currently, the stent, a tiny metal mesh tube used to support the artery, remains in the body even though the damaged vessel may have healed as soon as six months after surgery.
While effective, Bezerra says, that’s unnecessary and potentially dangerous in the long term.
“The flexibility of the vessel changes,” he says. “There is metal stretching the vessel. We believe that, in part, is the mechanism of some very, very late stent failure.”
Because there’s nothing foreign left behind once the Absorb stent dissolves, the arteries are almost like new. “You almost reset the clock,” Bezerra says. “You are dealing with your native vessel, with your original vessel.”
That’s especially good news for patients who might require multiple stents over time. “At some point, you cannot keep piling up layers of metal,” Bezerra says. “There is no space in the vessel to do so.”
Still, he stresses, metallic stents are effective for improving blood flow to the heart and relieving chest pain. Currently, Absorb is suitable for only about two-thirds of coronary artery disease patients.
As a new technology, Absorb has a limited range of lengths and diameters available compared to metallic stents. And it’s crucial that those with an Absorb stent are on dual antiplatelet therapy, or blood thinners, which excludes patients with bleeding issues or scheduled for impending surgery, Bezerra says.
Still, he estimates that between 50 and 100 people have had an Absorb stent implanted at University Hospitals since July.
Stemming the Tide
Summa Health System’s Cardiovascular Institute in Akron continually works on research and clinical trials related to heart health with a focus in stem cells.
Currently, Summa is involved in a research study examining whether a molecule called SDF-1 could reduce damage incurred from heart attacks.
Discovered by the institute’s director of research Dr. Marc Penn, SDF-1 is produced by the heart when it’s injured, activating stem cells released from bone marrow that home in on the damaged areas and attempt to repair them.
However, these stem cells don’t reach the injured areas right away, says Dr. Kevin Silver, a Summa cardiologist who’s also a principal investigator for many of these trials.
So Summa is testing a new, potentially more direct and quicker, method of getting these stem cells to the right place.
When a heart attack patient ends up in the hospital, Silver uses a balloon and stent to open up the blood vessel, then injects stem cells through the side of the blood vessel to their heart muscle.
“We hope it will repair some of the damage that’s been done,” he says.
Flow Rider
While they sound similar, heart failure is not the same as a heart attack. In fact, as the leading cause of hospital admission in the U.S., heart failure develops gradually as a result of the heart’s inability to pump enough blood to meet the body’s needs.
While it may not be immediately life-threatening, it isn’t easily cured. With symptoms such as fatigue, shortness of breath and muscle weakness, sufferers are especially susceptible to multiple hospitalizations.
“Fiscally, it’s a huge load on the health care system,” says Dr. Robert Goldstein, a cardiac electrophysiologist at Lake Health.
But there is help. Approved by the FDA in 2014, the CardioMEMS HF System is the first and only such heart failure-monitoring device.
Implanted in the pulmonary artery during a short, hour-or-less procedure, the paper clip-sized sensor can detect changes in pulmonary artery pressure — one of the first indications of impending heart failure — months before patients even develop obvious physical symptoms.
“There’s nothing like it on the market,” Goldstein says. “This device allows us to intervene way, way before symptoms start to
manifest.”
Early intervention is important, he adds. Once a patient begins to exhibit symptoms such as shortness of breath with exertion and lower extremity swelling, the individual isn’t able to absorb medication as easily and hospitalization is likely.
Patients take their own daily pressure readings at home. The process, however, is simple: The sensor pairs wirelessly to a portable electronic unit embedded in a special pillow. The user simply lies on the pillow for 18 seconds to take a sensor reading and this data is wirelessly transmitted to their doctor.
Each person’s baseline pressure number is individual and subjective, Goldstein stresses. “We look at the trends more than the absolute number.”
The daily tracking allows even small anomalies to show up quickly. On Thanksgiving, for example, many patients’ numbers increased because of “dietary indiscretion” while celebrating the holiday, he says. “We intervened immediately and prevented hospitalizations really.”
Patients are given diuretics, causing the kidneys to remove sodium and water, which relaxes blood vessel walls.
Only patients with recurrent heart failure who have had at least one hospital admission within the past year are good candidates for the system. To date, however, Lake Health has implanted the system in 10 patients and has another 10 waiting to receive one.
“This is a device that has some costs, obviously,” Goldstein says, “but, in the long run, is a huge savings, both from patient morbidity and from an actual cost issue.”
Know the Score
To Dr. Bill Lewis, MetroHealth chief of cardiology, the best possible treatment begins with the best possible diagnosis.
Since April, MetroHealth has been assessing patients’ risk for coronary artery disease by offering cardiac calcium scoring. Using a CT scanner, doctors are able to measure the amount of calcium deposits in the coronary arteries.
“They are not technically blockages,” Lewis says, “but are an indicator that you have atherosclerosis of your coronary arteries.”
Doctors determine a score, ranging from 0 (no plaque) to more than 400 (severe plaque), based on the amount of buildup present in the arteries. A score above 100, for example, represents a moderate amount of plaque, with some potential blockage, and a moderate to high possibility of a heart attack.
“Anybody with a score over 100, we’re happy to see in our cardiology offices to counsel them, discuss the score and look at a plan for how we’re going to move forward with treatment,” Lewis says.
Because a coronary calcium scan measures the arterial buildup, it offers distinct advantages over a stress test and other common ways to identify heart disease.
“Bill Clinton had a stress test a month before his heart attack,” he says.
Similarly, 57 percent of people who have had a heart attack, stroke or cardiovascular event are not considered high risk based on factors such as age, blood pressure and smoking status, Lewis says.
By December, 185 patients received the five-minute scan at MetroHealth. The results are almost immediate and at $40, it’s remarkably cheap.
“We knew when we built this process, we had to make it easy, convenient and fast, from beginning to end,” Lewis says. “We want to be able to identify people who are at high-risk of coronary disease but don’t know it.”
