• Health Conditions
  • XARELTO® for Chronic PAD
  • About PAD

About Peripheral Artery Disease (PAD)

 

What is PAD?

Peripheral artery disease, or PAD, is a progressive disease that is the result of plaque buildup in the arteries of the limbs—usually the legs. PAD also has similar risk factors and the same underlying cause as coronary artery disease, or CAD, which increases a person’s risk for a blood clot–related event like a heart attack or stroke. 

 

 

 

About 75% of adults age 50+ affected by PAD in the US are not aware of PAD

How common is PAD?

PAD affects up to 8.5 million people in the US alone. But studies showed only about 25% of adults age 50 and older have any awareness of PAD.*

*According to the Centers for Disease Control and Prevention (CDC).

PAD and atherosclerosis

PAD is the end result of atherosclerosis, or hardening of the arteries. This is the process by which the arteries become damaged and inflamed as a result of certain health conditions or risk factors, including:

Then, like sludge on the inside of pipes, cholesterol, white blood cells, and other substances build up inside the damaged walls, forming plaques. Plaques can start forming as early as childhood and build up slowly, over many years.

 

As the plaques grow larger, less blood can get through the artery to supply your muscles with the oxygen they need to function. This reduced blood flow may cause symptoms such as:

 

  • Pain or cramps in one or both hips, thighs, or calf muscles after walking or being physically active
  • Leg numbness or weakness
  • Lower leg or foot are cool to the touch, especially when compared to the other side
  • Sores that won’t heal on legs, feet, or toes
  • A change in the skin color on the legs
  • Hair loss or slower hair growth on feet or legs
  • Slower growth of toenails
  • Shiny skin on legs
  • No pulse or a weak pulse in legs or feet
  • Erectile dysfunction in men

 

blood clotting response

The risk with PAD is that some plaques can rupture. This triggers your body’s blood clotting response. A clot forms around the ruptured plaque, creating a blockage and cutting off blood flow to your legs which can cause pain. When your tissue doesn’t get enough oxygen, it can start to die. In the most serious cases, an amputation may be required.

 

PAD and coronary artery disease (CAD)

Another thing to be aware of is that because PAD and coronary artery disease, or CAD, share similar risk factors and are both caused by the buildup of plaque inside arteries, people with PAD also have a high chance of having CAD. CAD is the buildup of plaque inside the arteries that supply blood to the heart. A blood clot in these arteries is what can cause a heart attack or, if the blood clot travels to the brain, cause a stroke—both of which can be life-threatening.

PAD treatment options

Surgical and nonsurgical procedures may be performed to restore blood flow in a blocked artery. Examples include:

  • Angioplasty opens a blocked artery by inflating a tiny balloon inside the blockage
  • Stent implantation permanently props open a blocked artery with a tiny wire mesh tube that is placed during an angioplasty
  • Atherectomy uses a sharp blade and a catheter to collect and remove plaque from inside a blocked artery
  • Peripheral artery bypass graft surgery reroutes blood around a completely blocked artery using a man-made blood vessel or a blood vessel from another part of your body

While the above procedures may be life-saving, they do not fix you for good.

 

Prescription and nonprescription antiplatelet blood thinners may be prescribed immediately following diagnosis or an event to help prevent blood clots. Antiplatelets are one type of blood thinner that work by helping to keep platelets (which are pieces of blood cells) from sticking together. Examples include:

  • Dual antiplatelet therapy (DAPT): aspirin plus one other antiplatelet medicine, such as clopidogrel, are typically prescribed temporarily to help prevent blood clots after stent implantation, peripheral artery bypass graft surgery, or after a heart attack
  • Clopidogrel (Plavix®)
  • Aspirin

XARELTO® plus low-dose aspirin for chronic PAD

The medicines just discussed, including aspirin, have been recommended to reduce the risk of blood clots in people with chronic PAD. Now, a new medication is available for healthcare professionals to prescribe for people with chronic PAD. XARELTO® is an FDA-approved treatment that can be added to low-dose aspirin to help further reduce the risk of blood clots that may cause a serious cardiovascular event like a heart attack, stroke, or cardiovascular death.

Aspirin alone may not be enough

Aspirin alone may not be enough

Even when you’re following your healthcare professional’s instructions to take aspirin every day and to eat right and stay active, you may still have an underlying risk for blood clots that can cause another unexpected cardiovascular event like a severe blockage in your leg, a heart attack, or a stroke. 

While aspirin alone can help reduce your risk for these events, a large study of almost 40,000 people, including those with PAD or CAD, showed that even though more than half were taking aspirin, the number of heart attacks, strokes, and cardiovascular deaths more than doubled over a two-year period. 

Almost 96% of people with chronic PAD or CAD taking XARELTO® with low-dose aspirin didn’t have a cardiovascular event

Adding XARELTO® to your low-dose aspirin

XARELTO® 2.5 mg twice daily in combination with low-dose aspirin (75 mg–100 mg) once daily is proven to help further reduce the risk of heart attack, stroke, and cardiovascular death in people with chronic PAD versus aspirin alone.

In fact, in a clinical trial, almost 96% of people with chronic PAD or CAD taking XARELTO® 2.5 mg twice daily in combination with low-dose aspirin once daily did not have a heart attack, stroke, or die from a cardiovascular event.*

*Patients were followed for an average length of treatment of 23 months.

How XARELTO® works with aspirin

XARELTO® works together with aspirin to help protect you from blood clots that may cause a heart attack, a stroke, or cardiovascular death. Think of XARELTO® and aspirin like two members of the same team whose job it is to prevent serious blood clots from forming and growing. But they each play different positions—aspirin, an antiplatelet blood thinner, helps keep platelets (which are pieces of blood cells) from sticking together, and XARELTO®, an anticoagulant blood thinner, helps slow down the blood's clotting process.

Until recently, aspirin had to play defense on its own, but a study showed that adding XARELTO® to the team helps further reduce the risk of a heart attack, stroke, and cardiovascular death than aspirin alone.

 

Bleeding risk with XARELTO® plus low-dose aspirin

While all blood thinners come with a risk of bleeding, just under 3% of people taking XARELTO® 2.5 mg with their low-dose aspirin experienced a major bleed, such as bleeding into the brain. That represents an almost 1% increase in bleeding versus people taking only low-dose aspirin.

But remember, if you and your doctor chose to add XARELTO® to your low-dose aspirin, it’s likely because your doctor believes the benefit of helping to protect you from life-threatening blood clots outweighs your risk of bleeding.

 

Managing your overall health

It’s important to quit smoking, keep trying to eat right and stay active, and take any other medicines your doctor has prescribed, like medicines for high blood pressure or high cholesterol. Because while no drug or procedure can completely rid your arteries of plaques, managing your overall health can help slow the progression of your PAD.
 

Start the Conversation

If you have PAD and are taking aspirin, talk to your healthcare professional about your risk for blood clots that may cause a heart-related event such as a heart attack or a stroke and whether adding XARELTO® to your care plan may be right for you. 
 

IMPORTANT SAFETY INFORMATION

WHAT IS XARELTO®?

XARELTO® is a prescription medicine used to:

  • reduce the risk of stroke and blood clots in people who have a medical condition called atrial fibrillation that is not caused by a heart valve problem. With atrial fibrillation, part of the heart does not beat the way it should. This can lead to the formation of blood clots, which can travel to the brain, causing a stroke, or to other parts of the body
  • treat blood clots in the veins of your legs (deep vein thrombosis or DVT) or lungs (pulmonary embolism or PE)
  • reduce the risk of blood clots happening again in people who continue to be at risk for DVT or PE after receiving treatment for blood clots for at least 6 months
  • help prevent a blood clot in the legs and lungs of people who have just had hip or knee replacement surgery

XARELTO® is also used with low dose aspirin to:

  • reduce the risk of serious heart problems, heart attack and stroke in patients with coronary artery disease (a condition where the blood supply to the heart is reduced or blocked) or peripheral arterial disease (a condition where the blood flow to the legs is reduced)

It is not known if XARELTO® is safe and effective in children.

WHAT IS THE MOST IMPORTANT INFORMATION I SHOULD KNOW ABOUT XARELTO®?

XARELTO® may cause serious side effects, including:

  • Increased risk of blood clots if you stop taking XARELTO®.

    People with atrial fibrillation (an irregular heart beat) that is not caused by a heart valve problem (nonvalvular) are at an increased risk of forming a blood clot in the heart, which can travel to the brain, causing a stroke, or to other parts of the body. XARELTO® lowers your chance of having a stroke by helping to prevent clots from forming. If you stop taking XARELTO®, you may have increased risk of forming a clot in your blood. 

    Do not stop taking XARELTO® without talking to the doctor who prescribes it for you. Stopping XARELTO® increases your risk of having a stroke.

    If you have to stop taking XARELTO®, your doctor may prescribe another blood thinner medicine to prevent a blood clot from forming.

  • Increased risk of bleeding. XARELTO® can cause bleeding which can be serious, and may lead to death. This is because XARELTO® is a blood thinner medicine (anticoagulant) that lowers blood clotting. During treatment with XARELTO® you are likely to bruise more easily, and it may take longer for bleeding to stop.


    You may have a higher risk of bleeding if you take XARELTO® and take other medicines that increase your risk of bleeding, including:

    • Aspirin or aspirin-containing products
    • Long-term (chronic) use of non-steroidal anti-inflammatory drugs (NSAIDs)
    • Warfarin sodium (Coumadin®, Jantoven®)
    • Any medicine that contains heparin
    • Clopidogrel (Plavix®)
    • Selective serotonin reuptake inhibitors (SSRIs) or serotonin norepinephrine reuptake inhibitors (SNRIs)
    • Other medicines to prevent or treat blood clots
       

Tell your doctor if you take any of these medicines. Ask your doctor or pharmacist if you are not sure if your medicine is one listed above. ​

Call your doctor or get medical help right away if you develop any of these signs or symptoms of bleeding:

  • Unexpected bleeding or bleeding that lasts a long time, such as:

    • Nosebleeds that happen often
    • Unusual bleeding from gums
    • Menstrual bleeding that is heavier than normal, or vaginal bleeding
  • Bleeding that is severe or you cannot control
  • Red, pink, or brown urine
  • Bright red or black stools (looks like tar)
  • Cough up blood or blood clots
  • Vomit blood or your vomit looks like “coffee grounds”
  • Headaches, feeling dizzy or weak
  • Pain, swelling, or new drainage at wound sites
  • Spinal or epidural blood clots (hematoma). People who take a blood thinner medicine (anticoagulant) like XARELTO®, and have medicine injected into their spinal and epidural area, or have a spinal puncture, have a risk of forming a blood clot that can cause long-term or permanent loss of the ability to move (paralysis). Your risk of developing a spinal or epidural blood clot is higher if:

    • A thin tube called an epidural catheter is placed in your back to give you certain medicine
    • You take NSAIDs or a medicine to prevent blood from clotting
    • You have a history of difficult or repeated epidural or spinal punctures
    • You have a history of problems with your spine or have had surgery on your spine

If you take XARELTO® and receive spinal anesthesia or have a spinal puncture, your doctor should watch you closely for symptoms of spinal or epidural blood clots. Tell your doctor right away if you have back pain, tingling, numbness, muscle weakness (especially in your legs and feet), or loss of control of the bowels or bladder (incontinence).

  • XARELTO® is not for people with artificial heart valves.

​​Do not take XARELTO® if you:

  • Currently have certain types of abnormal bleeding. Talk to your doctor before taking XARELTO® if you currently have unusual bleeding.
  • Are allergic to rivaroxaban or any of the ingredients of XARELTO®.

Before taking XARELTO®, tell your doctor about all your medical conditions, including if you:

  • Have ever had bleeding problems
  • Have liver or kidney problems
  • Are pregnant or plan to become pregnant. It is not known if XARELTO® will harm your unborn baby.

    • Tell your doctor right away if you become pregnant during treatment with XARELTO®. Taking XARELTO® while you are pregnant may increase the risk of bleeding in you or in your unborn baby.
    • If you take XARELTO® during pregnancy, tell your doctor right away if you have any signs or symptoms of bleeding or blood loss. See “What is the most important information I should know about XARELTO®?” for signs and symptoms of bleeding.
  • Are breastfeeding or plan to breastfeed. XARELTO® may pass into your breast milk. You and your doctor should decide if you will take XARELTO® or breastfeed.

Tell all of your doctors and dentists that you are taking XARELTO®. They should talk to the doctor who prescribed XARELTO® for you before you have any surgery, medical or dental procedure.

Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Some of your other medicines may affect the way XARELTO® works, causing side effects. Certain medicines may increase your risk of bleeding. See “What is the most important information I should know about XARELTO®?”

HOW SHOULD I TAKE XARELTO®?

  • Take XARELTO® exactly as prescribed by your doctor.
  • Do not change your dose or stop taking XARELTO® unless your doctor tells you to.
  • Your doctor may change your dose if needed.
  • If you take XARELTO® for:​

    • Atrial Fibrillation that is not caused by a heart valve problem:

      • Take XARELTO® 1 time a day with your evening meal.
      • If you miss a dose of XARELTO®, take it as soon as you remember on the same day. Take your next dose at your regularly scheduled time.
    • Blood clots in the veins of your legs or lungs:

      • Take XARELTO® 1 or 2 times a day as prescribed by your doctor.
      • For the 15-mg and 20-mg doses, XARELTO® should be taken with food.
      • For the 10-mg dose, XARELTO® may be taken with or without food.
      • Take your XARELTO® doses at the same time each day.
      • If you miss a dose:

        • If you take the 15-mg dose of XARELTO® 2 times a day (a total of 30 mg of XARELTO® in 1 day)Take XARELTO® as soon as you remember on the same day. You may take 2 doses at the same time to make up for the missed dose. Take your next dose at your regularly scheduled time.
        • If you take XARELTO® 1 time a day: Take XARELTO® as soon as you remember on the same day. Take your next dose at your regularly scheduled time.​
    • Hip or knee replacement surgery:

      • Take XARELTO® 1 time a day with or without food.
      • If you miss a dose of XARELTO®, take it as soon as you remember on the same day. Take your next dose at your regularly scheduled time.
    • Reducing the risk of serious heart problems, heart attack and stroke in coronary artery disease or peripheral arterial disease:

      • Take XARELTO® 2 times a day with or without food.
      • If you miss a dose of XARELTO®, take your next dose at your regularly scheduled time.
  • If you have difficulty swallowing the XARELTO® tablet whole, talk to your doctor about other ways to take XARELTO®.
  • Your doctor will decide how long you should take XARELTO®.
  • XARELTO® may need to be stopped, if possible for one or more days before any surgery or medical/dental procedure. If you need to stop taking XARELTO® for any reason, talk to your doctor to find out when you should stop taking it. Do not stop taking XARELTO® without first talking to the doctor who prescribed it to you. Your doctor will tell you when to start taking XARELTO® again after your surgery or procedure.
  • Do not run out of XARELTO®. Refill your prescription for XARELTO® before you run out. When leaving the hospital following a hip or knee replacement, be sure that you have XARELTO® available to avoid missing any doses.
  • If you take too much XARELTO®, go to the nearest hospital emergency room or call your doctor right away.

WHAT ARE THE POSSIBLE SIDE EFFECTS OF XARELTO®?

  • The most common side effect of XARELTO® was bleeding.
  • See “What is the most important information I should know about XARELTO®?”

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects to Janssen Pharmaceuticals, Inc., at 1-800-JANSSEN (1-800-526-7736).

Please see full Prescribing Information, including Boxed Warnings, and Medication Guide.

Trademarks are those of their respective owners.

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