Closing the gap: Reimagining care for cardiovascular diseases

Vascular and thromboembolic diseases rank among the leading causes of death and disability worldwide, affecting millions of patients and their families. Thrombosis, or the formation of blood clots in blood vessels or the cardiac chamber, can lead to frequent and serious cardiovascular events, including stroke and acute coronary syndrome (ACS). Thrombosis causes an obstruction of blood flow; when this blockage occurs in a brain vessel, it may result in a stroke, and when it affects a coronary artery, it can lead to a heart attack. Patients with Atrial fibrillation (AFib), or an irregular heartbeat, may develop a clot in a heart chamber that could break away and block a brain artery, resulting in a serious stroke.

While current medications like anticoagulants can help prevent the formation of these harmful blood clots, they may also increase the risk of bleeding, limiting their use in some patients. Despite advancements in treatment, a critical gap remains: a need for therapies that may effectively safeguard patients from serious cardiovascular events without increasing the risk of bleeding.

“Having been a heart disease patient, I knew that it takes a huge toll on you – financially, emotionally and physically,” said Mellanie True Hills, atrial fibrillation and heart disease survivor and founder and CEO of the American Foundation for Women’s Health and StopAfib.org.

Determined to address this unmet need, researchers at Bristol Myers Squibb and Johnson & Johnson have joined forces to advance beyond the standard of care for a wide range of patients with thromboembolic diseases. Our approach is deeply patient-centric, relying on the lived experiences of those navigating these conditions to guide drug development, clinical trials and research initiatives.

With perspectives from patient advocates like Mellanie, researchers can better understand the realities of the patient experience and the unmet need that patients face each day. These insights better equip our scientists to pinpoint meaningful solutions and explore new treatment options that intersect with the realities of patient lives, offering hope for a future where cardiovascular health can be protected without a lot of compromise.

The challenge: Bleeding risk can drive treatment decisions

Antithrombotic therapies, including antiplatelet therapies and anticoagulants, are used for the prevention of thromboembolic events. Anticoagulants, though effective, can also stop blood from clotting in the instance of everyday scrapes and bruises, which can cause unwanted bleeding to occur.

“So many patients on anticoagulants have had to cover up bruises and even make changes at home, such as not playing sports and not using kitchen knives or garden tools, because of the risk of bleeding. Their experiences with so-called ‘minor’ bleeding were anything but minor because of the impact it has on their daily lives.”

Because of concerns about bleeding risk, even with these advancements, many patients unfortunately still don’t receive adequate treatment to help lower their risk of heart attack and stroke because they may be at risk of bleeding, which can limit their treatment options.

While direct oral anticoagulants (DOACs) were revolutionary in reducing the risk for thromboembolic events, there are still millions of patients who are untreated or undertreated due to the potential risk of bleeding. These risks can limit the use of DOACs, particularly for combination therapy (such as anticoagulants with antiplatelet therapy) and long-term treatment. Consider this:

• Approximately 40 percent of people with AFib are often untreated or undertreated due to concerns about bleeding with current DOACs.
• Despite therapeutic advancements, the rate of stroke recurrence remains substantial, with 25% of stroke patients experiencing a second stroke within 5 years.
• Many people with ACS still face a significant risk of experiencing another heart attack, even three years later.

“There is still a significant gap in making sure patients get the right protection against thromboembolic events,” said Roland Chen, MD, senior vice president, drug development, Immunology and Cardiovascular Medicines, Bristol Myers Squibb. “In our research and development process, we’re committed to finding the ideal balance – ‘sweet spots’ – to optimize the benefit-risk profile of future therapeutic options.”

Finding new paths forward: Redefining care for thromboembolic diseases

There is hope on the horizon for making new advancements in the care for these conditions.

One innovative area of study is the inhibition of Factor XIa (FXIa), a clotting factor that plays a key role in the activation and amplification of the pathological coagulation cascade. Due to its location in the coagulation cascade, inhibiting FXIa is believed to help prevent thrombosis while preserving hemostasis, allowing blood clotting in the case of an injury. Hemostasis prevents blood loss in case of a break in the blood vessels, either by injury/trauma or spontaneously in some illnesses, a delicate process that traditional anticoagulants often disrupt.

“FXIa inhibition could potentially help prevent severe events like heart attack and stroke without increasing bleeding risk by preserving hemostasis,” said Roland. “This means that for patients at risk of bleeding, targeting FXIa could offer antithrombotic efficacy hand in hand with a safer bleeding profile.”  

Answering the patient community’s call

With decades of experience as global leaders in cardiovascular care, researchers at Bristol Myers Squibb and Johnson & Johnson are uniquely equipped to close this important gap in cardiovascular care. By combining a legacy in today’s leading anticoagulants with a long-standing relationship with patient advocates, they are well-positioned to progress the standard of care in these life-changing conditions.

With a 70-year legacy of discovering and developing paradigm-changing medicines for cardiovascular patients, Bristol Myers Squibb remains committed to pioneering life-changing cardiovascular therapies.