Colchicine also being evaluated as a treatment to prevent complications and death related to severe cases of COVID-19 by the Montreal Heart Institute

DATE OF RELEASE: Aug. 29, 2020

MONTREAL/PRNewswire/ — Data presented today at the virtual European Society of Cardiology (ESC) Congress late-breaking science session from the COLchicine Cardiovascular Outcomes Trial (COLCOT) shows that a daily dose of colchicine (0.5mg) on top of standard of care significantly reduces the risk of a first ischemic cardiovascular event by nearly half (48%) when given to patients within three days following a heart attack, also known as a myocardial infarction (MI)¹. These data have also been published simultaneously in the European Heart Journal¹.

The primary efficacy endpoint for COLCOT was a combination of cardiovascular death, resuscitated cardiac arrest, myocardial infarction, stroke, or urgent hospitalization for angina requiring coronary revascularization². After a median follow-up of almost two years, there was a significant reduction of 48% in the incidence of the primary endpoint for patients in whom colchicine was started 1. The beneficial effects of starting early colchicine treatment were also demonstrated for urgent hospitalization for angina requiring revascularization (HR=0.35), all coronary revascularization (HR=0.63) and the composite of cardiovascular death, resuscitated cardiac arrest, myocardial infarction or stroke (HR=0.55, all p<0.05), with reductions of 65%, 37% and 45% respectively ¹.

“Colchicine is a remarkably cost-effective and well-tolerated medication with anti-inflammatory and immunomodulatory properties,” said Dr. Jean-Claude Tardif, Director of the Research Center at the Montreal Heart Institute, Professor of Medicine at the University of Montreal, and COLCOT and COLCORONA primary investigator. “These new data not only support the benefits of colchicine in patients with coronary disease but strengthen our belief that the drug may also be a significant asset in the global fight against COVID-19 by reducing inflammatory storms in patients with the disease, preventing hospitalizations and even deaths.”

Additional pharmacogenetic data from COLCOT, also presented during the ESC virtual late-breaking session today, examined the role of genetic markers in identifying patients that may benefit from colchicine treatment following an MI³. Considering that patients receive long-term treatment with multiple drugs after a heart attack, prediction of those unlikely to benefit from a specific medication is necessary to decrease polypharmacy. These data show that there are credible genetic variants associated with cardiovascular endpoints and gastrointestinal disorder in patients treated with colchicine and that some patients might achieve a better response, with the potential for a more personalized approach to inflammation reduction for cardiovascular prevention³.

Colchicine, a potential drug to fight COVID-19

In addition to these meaningful results from COLCOT, colchicine is also being evaluated in the COLCORONA clinical trial. This multi-center, contact-less, at home study aims to determine the therapeutic benefit of colchicine as a treatment to prevent complications and death related to COVID-19. COLCORONA is one of the few current studies of COVID-19 infection in which non-hospitalized individuals can participate.

The significance of the COLCOT data and treatment with colchicine following a myocardial infarction has now been highlighted in four late-breaking science sessions at the AHA, ACC and ESC respectively over the last 10 months^1,2,3,4. These data show that not only is colchicine significantly effective in reducing the risk of first and total ischemic cardiovascular events by 23% and 34% respectively overall, but that adding colchicine 0.5mg daily to standard of care therapy following a myocardial infarction is economically dominant and may help generate significant cost-savings for healthcare systems^1,2,4.

About the COLchicine Cardiovascular Outcomes Trial (COLCOT)

Colchicine is an orally administered anti-inflammatory medication that is currently indicated for the management of pericarditis, gout, familial Mediterranean fever. COLCOT, published in the New England Journal of Medicine, was a randomized, double-blind, placebo-controlled, investigator-initiated trial comparing colchicine 0.5 mg once daily with placebo on top of standard of care in a 1:1 ratio across 167 sites in 12 countries².

About the COLCORONA Trial

COLCORONA is a randomized, double-blind, placebo-controlled clinical trial. It was initiated by Dr. Jean-Claude Tardif, Director of the MHI Research Center and Professor of Medicine at the University of Montreal and aims to determine if colchicine may prevent the phenomenon of major inflammatory storm observed in adults suffering from serious complications linked to COVID-19. The clinical trial requires the recruitment of 6000 patients who meet all the inclusion criteria and none of the exclusion criteria. Patients are randomly assigned to either colchicine or a placebo for 30 days. Evaluations by phone or videoconference then take place 15 and 30 days after the randomization. The study is monitored by a data monitoring committee (DMC) that includes experienced clinical researchers.

About the Montreal Heart Institute

Founded in 1954, the Montreal Heart Institute constantly aims for the highest standards of excellence in the cardiovascular field through its leadership in clinical and basic research, ultra-specialized care, professional training and prevention. It houses the largest research center in Canada, the largest cardiovascular prevention center in the country, and the largest cardiovascular genetics center in Canada. The Institute is affiliated with the University of Montreal and has more than 2,000 employees, including 245 doctors and more than 85 researchers.

About the Montreal Health Innovations Coordinating Center (MHICC)

The Montreal Health Innovations Coordinating Center (MHICC) is a leading academic clinical research organization and an integral part of the Montreal Heart Institute (MHI). The MHICC possesses an established network of collaborators in over 4,500 clinical sites in more than 30 countries. It has specific expertise in precision medicine, low-cost high-quality clinical trials and drug repurposing.

References:

1. Bouabdallaoui N, Tardif J-C, Walters D, et al. Time-to-treat initiation of colchicine and cardiovascular outcomes after myocardial infarction in the Colchicine Cardiovascular Outcomes Trial (COLCOT). Eur Heart J: Available at https://academic.oup.com/eurheartj/issue
2. Tardif J-C, Kouz S, Waters D, et al. Efficacy and safety of low-dose colchicine after myocardial infarction. N Engl J Med 2019; 381:2497-2505 DOI: 10.1056/NEJMoa1912388
3. Dube M-P, Legault M-A, Lemacon A, et al. Pharmacogenomics of the Efficacy and Safety of Colchicine in COLCOT. Presented by Dr. Dube at the virtual European Society of Cardiology Annual Scientific Sessions (ESC 2020), August 31, 2020.
4. Samuel M, Tardif J-C, Khairy P, et al. Cost-Effectiveness of Low-Dose Colchicine after Myocardial Infarction in the Colchicine Cardiovascular Outcomes Trial (COLCOT), Eur Heart J Qual Care Clin Outcomes. 2020 May 14;qcaa045. doi: 10.1093/ehjqcco/qcaa045.

Information about pharmaceutical products (including products currently in research) which is included in this press, release is not intended to constitute an advertisement or medical advice.

Contacts:

For COLCOT & Canadian/International media
Camille Turbide
Camille.turbide@gmail.com
+1 514 755 5354

For COLCORONA & U.S. media
Christy Maginn
Christina.Maginn@havas.com
+1 703 297-7194 

SOURCE Montreal Heart Institute

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• Myocardial infarction (MI)
• Acute myocardial infarction (AMI)
• Acute coronary syndrome
• Coronary thrombosis
• Coronary occlusion

A heart attack happens when the flow of oxygen-rich blood to a section of heart muscle suddenly becomes blocked and the heart can’t get oxygen. If blood flow isn’t restored quickly, the section of heart muscle begins to die.

Heart attack treatment works best when it’s given right after symptoms occur. If you think you or someone else is having a heart attack, even if you’re not sure, call 9–1–1 right away.

Heart attacks most often occur as a result of ischemic heart disease, also called coronary heart disease or coronary artery disease. Ischemic heart disease is a condition in which a waxy substance called plaque builds up inside the coronary arteries. These arteries supply oxygen-rich blood to your heart.

When plaque builds up in the arteries, the condition is called atherosclerosis. The buildup of plaque occurs over many years.

Eventually, an area of plaque can rupture (break open) inside of an artery. This causes a blood clot to form on the plaque’s surface. If the clot becomes large enough, it can mostly or completely block blood flow through a coronary artery.

If the blockage isn’t treated quickly, the portion of heart muscle fed by the artery begins to die. Healthy heart tissue is replaced with scar tissue. This heart damage may not be obvious, or it may cause severe or long-lasting problems.

Heart With Muscle Damage and a Blocked Artery

A less common cause of heart attack is a severe spasm (tightening) of a coronary artery. The spasm cuts off blood flow through the artery. Spasms can occur in coronary arteries that aren’t affected by atherosclerosis.

Heart attacks can be associated with or lead to severe health problems, such as heart failure and life-threatening arrhythmias.

Heart failure is a condition in which the heart can’t pump enough blood to meet the body’s needs. Arrhythmias are irregular heartbeats. Ventricular fibrillation is a life-threatening arrhythmia that can cause death if not treated right away.

Don’t Wait – Get Help Quickly

Acting fast at the first sign of heart attack symptoms can save your life and limit damage to your heart. Treatment works best when it’s given right after symptoms occur.

Many people aren’t sure what’s wrong when they are having symptoms of a heart attack. Some of the most common warning symptoms of a heart attack for both men and women are:

• Chest pain or discomfort. Most heart attacks involve discomfort in the center or left side of the chest. The discomfort usually lasts more than a few minutes or goes away and comes back. It can feel like pressure, squeezing, fullness, or pain. It also can feel like heartburn or indigestion.
• Upper body discomfort. You may feel pain or discomfort in one or both arms, the back, shoulders, neck, jaw, or upper part of the stomach (above the belly button).
• Shortness of breath. This may be your only symptom, or it may occur before or along with chest pain or discomfort. It can occur when you are resting or doing a little bit of physical activity.

Other possible symptoms of a heart attack include:

• Breaking out in a cold sweat
• Feeling unusually tired for no reason, sometimes for days (especially if you are a woman)
• Nausea (feeling sick to the stomach) and vomiting
• Light-headedness or sudden dizziness
• Any sudden, new symptom or a change in the pattern of symptoms you already have (for example, if your symptoms become stronger or last longer than usual)

Not all heart attacks begin with the sudden, crushing chest pain that often is shown on TV or in the movies, or other common symptoms such as chest discomfort. The symptoms of a heart attack can vary from person to person. Some people can have few symptoms and are surprised to learn they’ve had a heart attack. If you’ve already had a heart attack, your symptoms may not be the same for another one. 

Quick Action Can Save Your Life: Call 9–1–1

If you think you or someone else may be having heart attack symptoms or a heart attack, don’t ignore it or feel embarrassed to call for help. Call 9–1–1 for emergency medical care. Acting fast can save your life.

Do not drive to the hospital or let someone else drive you. Call an ambulance so that medical personnel can begin life-saving treatment on the way to the emergency room. Take a nitroglycerin pill if your doctor has prescribed this type of treatment.

What causes a Heart Attack

Coronary Heart Disease

A heart attack happens if the flow of oxygen-rich blood to a section of heart muscle suddenly becomes blocked and the heart can’t get oxygen. Most heart attacks occur as a result of ischemic heart disease.

Ischemic heart disease is a condition in which a waxy substance called plaque builds up inside of the coronary arteries. These arteries supply oxygen-rich blood to your heart.

When plaque builds up in the arteries, the condition is called atherosclerosis. The buildup of plaque occurs over many years.

Eventually, an area of plaque can rupture (break open) inside of an artery. This causes a blood clot to form on the plaque’s surface. If the clot becomes large enough, it can mostly or completely block blood flow through a coronary artery.

If the blockage isn’t treated quickly, the portion of heart muscle fed by the artery begins to die. Healthy heart tissue is replaced with scar tissue. This heart damage may not be obvious, or it may cause severe or long-lasting problems.

Coronary Artery Spasm

A less common cause of heart attack is a severe spasm (tightening) of a coronary artery. The spasm cuts off blood flow through the artery. Spasms can occur in coronary arteries that aren’t affected by atherosclerosis.

What causes a coronary artery to spasm isn’t always clear. A spasm may be related to:

• Taking certain drugs, such as cocaine
• Emotional stress or pain
• Exposure to extreme cold
• Cigarette smoking

Risk Factors

Certain risk factors make it more likely that you’ll develop ischemic heart disease and have a heart attack. You can control many of these risk factors.

Risk Factors You Can Control

The major risk factors for a heart attack that you can control include:

• Smoking
• High blood pressure
• High blood cholesterol
• Overweight and obesity
• An unhealthy diet (for example, a diet high in saturated fat, trans fat, cholesterol, and sodium)
• Lack of routine physical activity
• High blood sugar due to insulin resistance or diabetes

Some of these risk factors—such as obesity, high blood pressure, and high blood sugar—tend to occur together. When they do, it’s called metabolic syndrome.

In general, a person who has metabolic syndrome is twice as likely to develop heart disease and five times as likely to develop diabetes as someone who doesn’t have metabolic syndrome.

Risk Factors You Can’t Control

Risk factors that you can’t control include:

• Age. The risk of heart disease increases for men after age 45 and for women after age 55 (or after menopause).
• Family history of early heart disease. Your risk increases if your father or a brother was diagnosed with heart disease before 55 years of age, or if your mother or a sister was diagnosed with heart disease before 65 years of age.
• Preeclampsia (pre-e-KLAMP-se-ah). This condition can develop during pregnancy. The two main signs of preeclampsia are a rise in blood pressure and excess protein in the urine. Preeclampsia is linked to an increased lifetime risk of heart disease, including CHD, heart attack, heart failure, and high blood pressure.

Signs, Symptoms, and Complications

Not all heart attacks begin with the sudden, crushing chest pain that often is shown on TV or in the movies. In one study, for example, one-third of the patients who had heart attacks had no chest pain. These patients were more likely to be older, female, or diabetic.

The symptoms of a heart attack can vary from person to person. Some people can have few symptoms and are surprised to learn they’ve had a heart attack. If you’ve already had a heart attack, your symptoms may not be the same for another one. It is important for you to know the most common symptoms of a heart attack and also remember these facts:

• Heart attacks can start slowly and cause only mild pain or discomfort. Symptoms can be mild or more intense and sudden. Symptoms also may come and go over several hours.
• People who have high blood sugar (diabetes) may have no symptoms or very mild ones.
• The most common symptom, in both men and women, is chest pain or discomfort.
• Women are somewhat more likely to have shortness of breath, nausea and vomiting, unusual tiredness (sometimes for days), and pain in the back, shoulders, and jaw.

Some people don’t have symptoms at all. Heart attacks that occur without any symptoms or with very mild symptoms are called silent heart attacks.

Most Common Symptoms

The most common warning symptoms of a heart attack for both men and women are:

• Chest pain or discomfort. Most heart attacks involve discomfort in the center or left side of the chest. The discomfort usually lasts for more than a few minutes or goes away and comes back. It can feel like pressure, squeezing, fullness, or pain. It also can feel like heartburn or indigestion. The feeling can be mild or severe.
• Upper body discomfort. You may feel pain or discomfort in one or both arms, the back, shoulders, neck, jaw, or upper part of the stomach (above the belly button).
• Shortness of breath. This may be your only symptom, or it may occur before or along with chest pain or discomfort. It can occur when you are resting or doing a little bit of physical activity.

The symptoms of angina can be similar to the symptoms of a heart attack. Angina is chest pain that occurs in people who have ischemic heart disease, usually when they’re active. Angina pain usually lasts for only a few minutes and goes away with rest.

Chest pain or discomfort that doesn’t go away or changes from its usual pattern (for example, occurs more often or while you’re resting) can be a sign of a heart attack.

All chest pain should be checked by a doctor.

Other Common Signs and Symptoms

Pay attention to these other possible symptoms of a heart attack:

• Breaking out in a cold sweat
• Feeling unusually tired for no reason, sometimes for days (especially if you are a woman)
• Nausea (feeling sick to the stomach) and vomiting
• Light-headedness or sudden dizziness
• Any sudden, new symptoms or a change in the pattern of symptoms you already have (for example, if your symptoms become stronger or last longer than usual)

Not everyone having a heart attack has typical symptoms. If you’ve already had a heart attack, your symptoms may not be the same for another one. However, some people may have a pattern of symptoms that recur.

The more signs and symptoms you have, the more likely it is that you’re having a heart attack.

Quick Action Can Save Your Life: Call 9–1–1 

The signs and symptoms of a heart attack can develop suddenly. However, they also can develop slowly—sometimes within hours, days, or weeks of a heart attack.

Any time you think you might be having heart attack symptoms or a heart attack, don’t ignore it or feel embarrassed to call for help. Call 9–1–1 for emergency medical care, even if you are not sure whether you’re having a heart attack. Here’s why:

• Acting fast can save your life.
• An ambulance is the best and safest way to get to the hospital. Emergency medical services (EMS) personnel can check how you are doing and start life-saving medicines and other treatments right away. People who arrive by ambulance often receive faster treatment at the hospital. 
• The 9–1–1 operator or EMS technician can give you advice. You might be told to crush or chew an aspirin if you’re not allergic, unless there is a medical reason for you not to take one. Aspirin taken during a heart attack can limit the damage to your heart and save your life.

Diagnosing a Heart Attack

Your doctor will diagnose a heart attack based on your signs and symptoms, your medical and family histories, and test results.

Diagnostic Tests

EKG (Electrocardiogram)

An EKG is a simple, painless test that detects and records the heart’s electrical activity. The test shows how fast the heart is beating and its rhythm (steady or irregular). An EKG also records the strength and timing of electrical signals as they pass through each part of the heart.

An EKG can show signs of heart damage due to ischemic heart disease and signs of a previous or current heart attack.

Blood Tests

During a heart attack, heart muscle cells die and release proteins into the bloodstream. Blood tests can measure the amount of these proteins in the bloodstream. Higher than normal levels of these proteins suggest a heart attack.

Commonly used blood tests include troponin tests, CK or CK–MB tests, and serum myoglobin tests. Blood tests often are repeated to check for changes over time.

Coronary Angiography

Coronary angiography is a test that uses dye and special x rays to show the insides of your coronary arteries. This test often is done during a heart attack to help find blockages in the coronary arteries.

To get the dye into your coronary arteries, your doctor will use a procedure called cardiac catheterization.

A thin, flexible tube called a catheter is put into a blood vessel in your arm, groin (upper thigh), or neck. The tube is threaded into your coronary arteries, and the dye is released into your bloodstream.

Special x rays are taken while the dye is flowing through the coronary arteries. The dye lets your doctor study the flow of blood through the heart and blood vessels.

If your doctor finds a blockage, he or she may recommend a procedure called percutaneous coronary intervention (PCI), sometimes referred to as coronary angioplasty. This procedure can help restore blood flow through a blocked artery. Sometimes a small mesh tube called a stent is placed in the artery to help prevent blockages after the procedure.

Treatment

Early treatment for a heart attack can prevent or limit damage to the heart muscle. Acting fast, by calling 9–1–1 at the first symptoms of a heart attack, can save your life. Medical personnel can begin diagnosis and treatment even before you get to the hospital.

Immediate Treatment

Certain treatments usually are started right away if a heart attack is suspected, even before the diagnosis is confirmed. These include:

• Aspirin to prevent further blood clotting
• Nitroglycerin to reduce your heart’s workload and improve blood flow through the coronary arteries
• Oxygen therapy
• Treatment for chest pain

Once the diagnosis of a heart attack is confirmed or strongly suspected, doctors start treatments promptly to try to restore blood flow through the blood vessels supplying the heart. The two main treatments are clot-busting medicines and percutaneous coronary intervention, also known as coronary angioplasty, a procedure used to open blocked coronary arteries.

Clot-Busting Medicines

Thrombolytic medicines, also called clot busters, are used to dissolve blood clots that are blocking the coronary arteries. To work best, these medicines must be given within several hours of the start of heart attack symptoms. Ideally, the medicine should be given as soon as possible.

Percutaneous Coronary Intervention

Percutaneous coronary intervention is a nonsurgical procedure that opens blocked or narrowed coronary arteries. A thin, flexible tube (catheter) with a balloon or other device on the end is threaded through a blood vessel, usually in the groin (upper thigh), to the narrowed or blocked coronary artery. Once in place, the balloon located at the tip of the catheter is inflated to compress the plaque and related clot against the wall of the artery.

This restores blood flow through the artery. During the procedure, the doctor may put a small mesh tube called a stent in the artery. The stent helps to keep the blood vessel open to prevent blockages in the artery in the months or years after the procedure.

Other Treatments for Heart Attack

Other treatments for heart attack include:

• Medicines
• Medical procedures
• Heart-healthy lifestyle changes
• Cardiac rehabilitation

Medicines

Your doctor may prescribe one or more of the following medicines.

• ACE inhibitors. ACE inhibitors lower blood pressure and reduce strain on your heart. They also help slow down further weakening of the heart muscle.
• Anticlotting medicines. Anticlotting medicines stop platelets from clumping together and forming unwanted blood clots. Examples of anticlotting medicines include aspirin and clopidogrel.
• Anticoagulants. Anticoagulants, or blood thinners, prevent blood clots from forming in your arteries. These medicines also keep existing clots from getting larger.
• Beta blockers. Beta blockers decrease your heart’s workload. These medicines also are used to relieve chest pain and discomfort and to help prevent another heart attack. Beta blockers also are used to treat arrhythmias (irregular heartbeats).
• Statin medicines. Statins control or lower your blood cholesterol. By lowering your blood cholesterol level, you can decrease your chance of having another heart attack or stroke.

You also may be given medicines to relieve pain and anxiety, and treat arrhythmias. Take all medicines regularly, as your doctor prescribes. Don’t change the amount of your medicine or skip a dose unless your doctor tells you to. 

Medical Procedures

Coronary artery bypass grafting also may be used to treat a heart attack. During coronary artery bypass grafting, a surgeon removes a healthy artery or vein from your body. The artery or vein is then connected, or grafted, to bypass the blocked section of the coronary artery. The grafted artery or vein bypasses (that is, goes around) the blocked portion of the coronary artery. This provides a new route for blood to flow to the heart muscle.

Heart-Healthy Lifestyle Changes

Treatment for a heart attack usually includes making heart-healthy lifestyle changes. Your doctor also may recommend:

• Heart-healthy eating
• Aiming for healthy weight
• Managing stress
• Physical activity
• Quitting smoking

Taking these steps can lower your chances of having another heart attack.

Cardiac Rehabilitation

Your doctor may recommend cardiac rehabilitation (cardiac rehab) to help you recover from a heart attack and to help prevent another heart attack. Nearly everyone who has had a heart attack can benefit from rehab. Cardiac rehab is a medically supervised program that may help improve the health and well-being of people who have heart problems.

The cardiac rehab team may include doctors, nurses, exercise specialists, physical and occupational therapists, dietitians or nutritionists, and psychologists or other mental health specialists.

Rehab has two parts:

• Education, counseling, and training. This part of rehab helps you understand your heart condition and find ways to reduce your risk for future heart problems. The rehab team will help you learn how to cope with the stress of adjusting to a new lifestyle and how to deal with your fears about the future.
• Exercise training. This part helps you learn how to exercise safely, strengthen your muscles, and improve your stamina. Your exercise plan will be based on your personal abilities, needs, and interests.

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