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FREEDOM Trial Finds That High-Dose Anticoagulation Can Improve Survival for Hospitalized COVID-19 Patients

Mar 7, 2023 | Cardiology, COVID-19, Featured, Research

The FREEDOM trial was initiated and led by Valentin Fuster, MD, PhD, President of Mount Sinai Heart and Physician-in-Chief of The Mount Sinai Hospital.

An international trial led by Mount Sinai found that high-dose anticoagulation can reduce deaths by 30 percent and intubations by 25 percent in hospitalized COVID-19 patients who are not critically ill, when compared to the standard treatment, which is low-dose anticoagulation. The innovative FREEDOM trial was initiated and led by Valentin Fuster, MD, PhD, President of Mount Sinai Heart and Physician-in-Chief of The Mount Sinai Hospital.

The study results were announced Monday, March 6, in a late-breaking clinical trial presentation at the scientific sessions of the American College of Cardiology Together With World Congress of Cardiology (ACC.23/WCC) in New Orleans and simultaneously published in the Journal of the American College of Cardiology.

“What we learned from this trial is that many patients hospitalized with COVID-19 with pulmonary involvement, but not yet in the intensive care unit (ICU), will benefit from high-dose subcutaneous enoxaparin or oral apixaban to inhibit thrombosis and the progression of the disease,” Dr. Fuster says. “This is the first study to show that high-dose anticoagulation may improve survival in this patient population—a major finding since COVID-19 deaths are still prevalent.”

Clinical Insights, Early in the Pandemic

This work was prompted by the discovery early in the pandemic that many patients hospitalized with COVID-19 developed high levels of life-threatening blood clots. In March 2020, during the early days of the pandemic, Dr. Fuster observed patients with blood clots in their legs who had been admitted with COVID-19. After hearing from colleagues abroad of other cases of small, pervasive, and unusual clotting that had triggered myocardial infarctions, strokes, and pulmonary embolisms, he initiated decisive action.

“We became one of the first medical centers in the world to treat all COVID-19 patients with anticoagulant medications,” says Dr. Fuster, a pioneer in the study of atherothrombotic disease. “It was a decision that we believe saved many lives.”

This early protocol led to groundbreaking research and insights by Mount Sinai into the role of anticoagulation in the management of COVID-19-infected patients. Mount Sinai research showed that treatment with prophylactic (low-dose) anticoagulation was associated with improved outcomes both in and out of the intensive care unit among hospitalized COVID-19 patients. Researchers further observed that therapeutic (high-dose) anticoagulation might lead to better results. Then, they designed the FREEDOM COVID Anticoagulation Strategy Randomized Trial to look further into the most effective regimen and dosage for improving outcomes of hospitalized COVID-19 patients who are not critically ill.

Researchers enrolled 3,398 hospitalized adult patients with confirmed COVID-19 (median age 53) from 76 urban and rural hospitals across 10 countries—including hospitals within the Mount Sinai Health System—between August 26, 2020, and September 19, 2022. Patients were not in the ICU or intubated, and about half of them had signs of COVID-19 impacting their lungs with acute respiratory distress syndrome (ARDS). Patients were randomized to receive doses of three different types of anticoagulants within 24 to 48 hours of being admitted to the hospital and followed for 30 days. Equal numbers of patients were treated with one of three different drug regimens: low-dose injections of enoxaparin, high-dose injections of enoxaparin, and high-dose, oral doses of apixaban. They compared the combined therapeutic groups to the prophylactic group.

Informing Future Care

The primary endpoint was a combination of death, requirement for ICU care, systemic thromboembolism (blood clots traveling through the arteries), or ischemic stroke at 30 days. This endpoint was not significantly reduced among the groups. However, 30-day mortality was lower for those treated with high-dose anticoagulation compared with those on the low-dose regimen. Seven percent of patients treated with the low-dose anticoagulation died within 30 days, compared with 4.9 percent of patients treated with high-dose anticoagulation—an overall reduction of 30 percent. The need for intubations was also reduced in the high-dose group: 6.4 percent of patients on the high-dose regimen were intubated within 30 days compared with 8.4 percent in the low-dose group—a 25 percent reduction. The study showed high-dose anticoagulation to be especially beneficial for patients with ARDS, a condition where COVID-19 damages the lungs. Among patients with ARDS at the time of hospital admission, 12.3 percent in the low-dose anticoagulation group died within 30 days, compared with 7.9 in the high-dose group.

All groups had low bleeding rates, and there were no differences between the two therapeutic blood thinners for safety and efficacy.

“This is an important study for patients with COVID-19 who are sick enough to require hospitalization but not so ill as to require ICU management. In this group of patients with radiologic evidence of ARDS, therapeutic dose anticoagulation prevents disease progression, especially the need for intubation, and saves lives,” says co-Principal Investigator Gregg W. Stone, MD, Professor of Medicine (Cardiology), and Population Health Science and Policy, at the Icahn School of Medicine at Mount Sinai. “This is especially important as COVID-19 is not going away. Even in the United States, the current number of daily deaths, although much lower than at the peak of the pandemic, is twice that compared with just one year ago. And in other countries COVID-19 is raging”

The FREEDOM trial was coordinated by the Mount Sinai Heart Health System. Dr. Fuster raised all funding for the trial.

Mount Sinai Experts Discuss the Future of Cancer Care and Research

Updated on Mar 7, 2023 | Featured, Research

More than 50 years after the United States formally declared war on cancer, what is the prognosis for innovative cancer research and care?

Two Mount Sinai leaders in cancer care and research, Ramon Parsons, MD, PhD, Director of The Tisch Cancer Institute at the Icahn School of Medicine at Mount Sinai, and Cardinale Smith, MD, PhD, Vice President, Cancer Clinical Services for the Mount Sinai Health System, offered their perspectives as part of a recent 92nd Street Y online event. You can watch the video here.

The two agreed on this overarching message: Tremendous progress has been made in unraveling the complex biology of cancer and targeting its many forms with advanced new medicines, particularly immunotherapies. But looming just as large are the challenges that remain in areas like overcoming resistance to these medicines, early detection of cancer through screening, and ensuring the equitable distribution of cancer care to diverse and disadvantaged populations.

Ramon Parsons, MD, PhD

“After 50 years we have a much more sophisticated understanding of how genes are altered in the cancer cell and how cancer cells reprogram the tumor microenvironment,” said Dr. Parsons, the Ward-Coleman Chair in Cancer Research. “And that has pushed the envelope in terms of our knowledge of the biology of cancer and, just as importantly, how we treat it. We’re seeing better outcomes for more and more of our patients and believe cancer rates will continue to come down because of treatments we didn’t have in the past, and more informed prevention.”

Dr. Smith, who is also Chief Medical Officer for the Tisch Cancer Hospital and a Professor of Medicine (Hematology and Medical Oncology), described the dramatic changes in cancer care and treatment, particularly in her specialized field of lung cancer.

“When I finished my fellowship training 12 years ago we had just two drugs for lung cancer, and now there are so many more,” she said. “Patients I treated as a fellow are still alive today thanks to clinical trials for new investigative drugs they were able to enroll in.”

Immunotherapies have carved out many of the greatest gains, while also raising some obstacles for the research community. Immunotherapy refers to treatments that use a person’s own immune system to fight cancer.

“The next frontier is determining which patients are going to have a long-term response to immunotherapy, and how do we overcome the resistance we so often see with these therapies,” said Dr. Parsons. “That’s the biology we still need to figure out, and to that end some of the research we’re most excited about is aimed at helping us better understand the switches in the immune system and how they can be regulated therapeutically.”

Two other areas of research where Dr. Parsons sees great promise are tumor suppressors, which are genes that regulate a cell during cell division, and liquid biopsies, which can detect through a simple blood test at the doctor’s office circulating tumor cells and tumor DNA.

With a strong background in tumor suppressors, he sees great advantage in being able to develop gene therapy or other innovative approaches to restore tumor suppressors, a natural part of the body’s defense mechanism that becomes altered or mutated in almost every type of cancer.

Liquid biopsies, still in early-stage development, could be another significant development. “This idea of being able to catch cancers before they are recognizable is going to ultimately move the needle in improving patient survival,” he said.

Cardinale Smith, MD, PhD

For Dr. Smith, early detection includes more aggressive screening by the health care providers.

“Uptake of lung cancer screening has been slow,” she said. “A lot of the work we’ve been doing at Mount Sinai is connecting with the community to understand what their needs are and how they prefer to partner with us. As a result, we’ve increased mammographies for women to detect breast cancer, and improved colorectal cancer screening for both men and women. Now we need to make the same kind of progress with lung cancer screening.”

She noted that as part of its outreach, Mount Sinai in April 2022 launched the Mount Sinai Robert F. Smith Mobile Prostate Cancer Screening Unit after noticing a high mortality rate for the disease in certain neighborhoods of New York City with a high Black male population. The purchase was funded by a $3.8 million donation from philanthropist Robert F. Smith. This successful effort between the Institute and the Department of Urology has been collecting blood samples to measure PSA levels and referring individuals for follow-up care when a problem is detected.

The nation’s war on cancer formally began with the National Cancer Act of 1971, which established the National Cancer Institute. As for the future of cancer care, Dr. Smith foresees patient care navigation and a palliative care workforce as movements with transformative potential.

Navigators with the ability to compassionately guide people through the often challenging cancer screening and treatment process would be an extremely beneficial allocation of resources, she maintains. So would development of specialized palliative care teams that could provide training and skills to oncologists and other clinicians, including nurses and advanced practice providers.

“We know that palliative care when combined with standard oncologic care can improve patients’ quality of life and mood by decreasing depression,” she said. “It also decreases unnecessary utilization of acute care, such as emergency room visits, hospitalizations, and readmission. Most importantly, it aligns cancer care with the goals and values of the patients, which all of us as clinicians need to hold as sacred in the years ahead.”

What Should I Do If My Child Has Norovirus?

Updated on Feb 24, 2023 | Adolescent Health, Featured, Pediatrics, Your Health

If your child has a stomach bug, it could be norovirus—a highly contagious stomach virus that causes diarrhea and vomiting. Cases of this virus are on the rise in New York City and much of the northeastern United States, according to the Centers for Disease Control and Prevention.

While typically mild in older children and adults, lasting usually only a few days, norovirus can cause severe dehydration in babies and kids with certain underlying conditions. Knowing how to care for them is crucial.

In this Q&A, Tessa Scripps, MD, a pediatrician at the Mount Sinai Kravis Children’s Hospital, and Assistant Professor of Pediatrics at the Icahn School of Medicine and Mount Sinai, answers your questions about the disease, including what to do if your child is sick.

What is norovirus, and what are norovirus symptoms?

Norovirus is a common contagious virus that inflames the intestines, causing nausea, diarrhea, and throwing up. Sometimes it can also cause fever. The disease is spread when particles from an infected person’s feces or vomit spreads to others, typically in bathrooms, but also by eating or drinking contaminated foods and beverages; using contaminated utensils; touching contaminated surfaces; or having any direct contact with someone who is infected. Norovirus is highly transmissible, and infected people can actually shed billions of norovirus particles at a time, but it can take fewer than 100 norovirus particles to make another person sick. People are most contagious when they actively have symptoms and in the few days after their symptoms have resolved.

Tessa Scripps, MD

How can I protect my child from catching norovirus?

The most common way norovirus is spread is through close contact with an infected person, so it’s a good idea to keep kids some distance from people who are sick, or who have recently recovered from being sick. Norovirus can infect an entire family at the same time, since even simple contact with others can lead to infection. So, the most important thing is for kids to wash hands frequently with soap and warm water, and for adults to do the same, especially if any of you have been in contact with a person who has symptoms. Alcohol-based sanitizers do not work as effectively against preventing transmission.

My child has norovirus. How does their age or health condition affect their risk for severe illness?

Newborn babies and children who have underlying chronic illnesses such as kidney disease and diabetes are at higher risk for becoming dehydrated and severely ill because excessive fluid losses can affect their kidney and their liver function. It’s important they get medical attention right away if symptoms last longer than three days or if they’re unable to keep hydrated.

What symptoms might indicate my child needs medical help?

Watch for symptoms of dehydration, such as decreased or less frequent urination and small volume- or very dark or strong-smelling urine. If it has been more than eight hours from when your child has had a wet diaper or used the toilet to pee, reach out to your doctor for advice. A rapid heart rate or a significant change in your child’s activity can also be a sign of dehydration. If you notice that your child seems very lethargic and listless, you should seek medical advice right away.

What can I do to help my child recover from norovirus?

Once the virus has passed and the vomiting and diarrhea have subsided, make sure they are well hydrated and rested. For newborns and infants, you can give them small amounts of breast milk or formula. Toddlers, older children, and adults should drink small volumes of fluids—about one to two ounces every one to two hours—to ensure fluids get absorbed and to prevent recurrent vomiting. Drinking water and electrolyte fluids like Pedialyte^®, Gatorade, or watered down apple juice can be very useful to maintain hydration, and can help prevent complications from norovirus. They can also have bland foods like rice, dry cereal, applesauce, bananas, and crackers.

Are there any medications I can give my child to ease their norovirus symptoms?

There are no over-the-counter anti-diarrheals or anti-nausea medicines that are recommended for children. In rare cases, pediatricians may prescribe Zofran, an anti-emetic, to help children stop vomiting so they can re-hydrate without the need for intravenous fluids.

How do I prevent norovirus from spreading to my other kids?

It is important that everyone in your house washes their hands regularly with warm water, and avoid sharing food and drinking cups with anyone who is sick. You should also wipe down any contaminated surfaces with a bleach-based disinfectant, especially toilets and sinks after an infected child has used them. And everyone should try to maintain some distance from infected household members while they’re actively sick.

Is there a test for norovirus I can give my child?

Testing is available. However, norovirus is similar to other types of stomach infections, such as rotavirus, and symptom management is the same, so testing isn’t useful. If there has been an outbreak at your child’s school and they are sick, there is a good chance they have norovirus.

The Doctor’s Doctor Will See You Now: Students Learn the Role of the Pathologist Is Much More Than What You See on TV

Updated on Feb 24, 2023 | Featured

More than 60 students representing the medical and graduate schools of Icahn Mount Sinai recently toured the New York City Office of Chief Medical Examiner to gain a better understanding of the role of pathologist, often called the doctor’s doctor. Photo credit: Office of the Chief Medical Examiner

You may think you know all about the work of a pathologist from all the television shows and films that focus on forensic pathology and solving crimes.

Barbara Sampson, MD, PhD, has a slightly different view. She refers to pathologists as the doctor’s doctor. That’s because these doctors are the experts upon whom other doctors routinely rely when trying to reach a diagnosis for their patient.

Before joining Mount Sinai’s Pathology Department in December of 2021, Dr. Sampson served as New York City’s Chief Medical Examiner, the largest medical examiner’s office in the United States, for almost a decade. Now she is working with medical students to help them gain a better understanding of the role of pathologist.

“My mission is to enlighten first-year and second-year students about the fascinating field of pathology before they differentiate into other areas of medicine,” says Dr. Sampson, Vice Chair for Strategic Laboratory Initiatives and Academic Affairs in the Department of Pathology, Molecular, and Cell Based Medicine at the Icahn School of Medicine at Mount Sinai.

So far, her efforts seem to be paying off. Dr. Sampson recently organized a field trip to the New York City Office of Chief Medical Examiner to give medical students a window into the cutting-edge science of pathology and forensic biology. The event was attended by more than 60 students representing the medical and graduate schools of Icahn Mount Sinai.

Students learned about DNA crime evidence analysis, the ongoing effort to identify victims of the 2001 World Trade Center attacks, and molecular autopsies that can identify genetic mutations responsible for sudden natural deaths and alert family members about inherited medical conditions. They also toured the Medical Examiner’s DNA training lab facilities and learned about its history of innovations to analyze the most challenging items of evidence.

“My mission is to enlighten first-year and second-year students about the fascinating field of pathology before they differentiate into other areas of medicine,” says Barbara Sampson, MD, PhD.

For second-year medical students Walter Jacob and Lucy Greenwald, who lead the Pathology Interest Group for students, the visit was an eye-opener.

“The thing that stood out the most for me was the emphasis on the World Trade Center disaster and learning that they are still working on identifying multiple hundreds of people who have yet to be identified. It was just amazing to think that this office is still working tirelessly,” he said.

She added, “When they started telling us about their WTC work, the mood was intense. We were listening intently, with awe. It was inspiring to hear the personal relationships they had developed with families over the years and how they meet with families annually, around the time of the anniversary, to provide an update and to let families know they are still searching for answers.”

Since taking over as leaders of the Pathology Interest Group, the two have organized several events to introduce students to pathology. They recently invited students to a tie-dye T-shirt workshop to celebrate the work of pathology, which uses a variety of stains to enhance the appearance of cells under a microscope.

“In a similar event, we set up shadowing for pathology specimens that come in mid surgery, allowing students to see up close how a pathologist plays a critical role during an oncological surgery. The pathologist makes the final call on whether the surgeon has successfully cut out the cancer with clean margins,” she said.

“Most specialties are patient-facing but, for the most part, pathology aids clinicians in the diagnosis of disease, like a doctor’s doctor.”

The Pathology Interest Group has organized several events to introduce students to pathology, including a tie-dye T-shirt workshop to celebrate the work of pathology, which uses a variety of stains to enhance the appearance of cells under a microscope.

Increased Privacy and Care Await Patients in New Cardiac Unit at Mount Sinai Morningside

Updated on Mar 29, 2023 | Featured

If you’ve ever been hospitalized due to a heart problem, you may know that a little privacy and extra care can make a big difference in your recovery.

In fact, research has found that patients can expect to have a better recovery if they have a room to themselves rather than sharing with another patient; stay in rooms close to a nurses’ station on their floor; and are in a location that affords a clear line of sight from the nurses’ station.

That’s why Mount Sinai Morningside has opened a new inpatient unit, 4 West, for patients undergoing cardiac surgery and other cardiac procedures, and those needing a more intense level of heart monitoring, such as those who have experienced heart failure. The unit has 14 private rooms with bathrooms, flat-screen TVs, digital message boards, and a central monitoring station located at the nurses’ station.

“This wonderful new unit has the look and feel of a five-star hotel,” said John D. Puskas, MD, Chair of the Department of Cardiac Surgery for Mount Sinai Morningside, Mount Sinai West, and Mount Sinai Beth Israel. “The real benefit though is that all the private rooms are clearly visible from, and located in relatively close proximity to, the nurses’ station.”

These rooms are designed to support patients’ rapid recovery. In addition, patients will be discharged directly from 4 West, so they don’t have to be transferred between hospital units.

“This unit ensures the environment the patients recover in matches the outstanding quality of care they receive from our surgeons, physicians, nurses, technicians, and more,” said Sean P. Pinney, MD, FACC, FAST, FHFSA, Chief of Cardiology, Mount Sinai Morningside. “Treating patients is both about care and comfort. We excel in providing the care, and with this unit, we give patients the privacy needed to fully recover.”

In addition, patients receive treatment from the unit’s highly skilled nurses. “They serve as advocates for their patients and work with the rest of the team to provide the best possible outcomes,” said Beth Oliver, DNP, RN, FAAN, Senior Vice President and Chief Nursing Executive, Mount Sinai Health System.

All rooms are modern with large windows that look across to the Columbia University campus, and are equipped with advanced medical technology. The unit also includes a family lounge, pantry, and a conference room for interdisciplinary consultation.

“Mount Sinai Morningside has become an important hub for cardiology and cardiac surgery, especially coronary bypass surgery,” said Arthur A. Gianelli, President, Mount Sinai Morningside. “The high level of care we are providing warranted this investment in our hospital and our community.”

Mount Sinai Heart at Mount Sinai Morningside offers a full range of cardiology services including cardiac surgery, cardiac catheterization, cardiac rehabilitation, catheter ablation, computed tomography angiography, electrophysiology, cardiac positron emission tomography/computed tomography, and other non-invasive diagnostics to treat coronary artery disease, atrial fibrillation and other abnormal heart rhythms; peripheral artery disease; and peripheral vascular disease.

Dubin Breast Center Annual Benefit Honors a Tennis Champion Who Is Also a Breast Cancer Survivor

Jan 25, 2023 | Featured, Patient Stories

Mary Joe Fernandez was one of the top professional tennis players in the United States during the 1990s in both singles and doubles. She won two Grand Slam doubles titles, first at the 1991 Australian Open and then at the 1996 French Open. She also won two Olympic Gold medals in doubles. After retiring in 2000, she became captain of the U.S. Fed Cup team and a television commentator for ESPN.

But after her annual mammogram in 2017, everything changed. She was diagnosed with breast cancer. Fortunately, a friend suggested she call the Dubin Breast Center. Once she arrived and met with the team, she knew she had found the right place for her treatment and recovery.

Mary Joe Fernandez and her husband, Anthony Godsick

“My journey with the Dubin Breast Center has been one of compassion and caring—and of confidence,” she says. “They really have mastered how to make a really difficult time in a woman’s life into something they can get through and have hope.”

Ms. Fernandez was one of two women honored at the Dubin Breast Center Annual Benefit, which celebrated its 12th anniversary. She recounted her story in an emotional video that was presented during the event.

The event was held Monday, December 12, at the Ziegfeld Ballroom in New York. More than 300 guests attended, and the event raised more than $3 million to support the Dubin Breast Center of The Tisch Cancer Institute at Mount Sinai Health System.

The second honoree was Hanna Yoko Irie, MD, PhD, Associate Professor of Medicine (Hematology and Medical Oncology, and Oncological Sciences) at the Icahn School of Medicine at Mount Sinai. She was honored for her contributions to the field of breast cancer research—most notably her work in triple-negative breast cancer, which is both more aggressive and harder to treat than other types—and for the care she provides to her patients at the Dubin Breast Center.

“We’ve been able to find new genes that promote or drive the growth of a subset of these triple-negative breast cancers,” Dr. Irie says, “targeting specific pathways but also understanding better how we can help boost the immune system.” Dr. Irie’s contributions to the Center as a physician-scientist were also described in this video.

The event was hosted by Mount Sinai Health System Trustee Eva Andersson-Dubin, MD, who founded the Center, and Elisa Port, MD, FACS, Chief of Breast Surgery and the Center’s Co-Director.

“The mission of the Dubin Breast Center has always been to deliver the most cutting-edge, groundbreaking research combined with the most compassionate care,” says Dr. Port. You can hear more from Dr. Port in a video that was also presented at the gala.

The Dubin Breast Center is also leading the way in early detection and was the first in New York City to offer 3D mammography. The Center performs more than 12,000 mammograms a year.

“Under the direction of Dr. Eva Andersson-Dubin and Dr. Elisa Port, the Dubin Breast Center will transform breast cancer research and care for decades to come,” says Kenneth L. Davis, MD, President of the Mount Sinai Health System.

See all the videos and read more about the Gala

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