Tag Archives: stroke prevention

Blood Thinners (Oral Anticoagulants) For Atrial Fibrillation: Who Should Take Them and Which One To Take

The most serious  adverse consequence of having atrial fibrillation is stroke. Since we have safe and effective ways of preventing afib-related stroke with oral anticoagulant drugs (blood thinners), a major decision for the newly diagnosed patient with atrial fibrillation is “should I take a blood thinner?”

To answer this question the afibber should engage in a lengthy discussion with his/her health-care provider which results in a shared and informed  decision. Such discussion must cover your risk of stroke, the benefits of blood thinners in preventing stroke, the bleeding risks of blood thinners and the pros and cons of the five oral anticoagulants available to prevent stroke.

Estimating Your Risk of Stroke With Afib

The best way we have of estimating a patient’s risk of stroke if they have atrial fibrillation (AF) is by the CHA2DS2-VASc scale (which I like to call the Lip scale)

Stroke Risk EstimationThis scale take the factors we know that increase the risk of stroke and assigns 1 or 2 points. The acronym comes from the first letter of the factors that are known to increase risk as listed to the left.

Most of the factors get 1 point, but prior stroke (S) and age>75 (A) get 2 points.

We then add up your points and use another chart (or app) to calculate the risk of stroke per year.

CHA2 stroke riskYour risk of stroke is very low if you have zero risk factors; it gets progressively higher as you reach the maximum number of 9.

Treatment with an oral anticoagulant (OAC),  either warfarin, or one of the four novel anticoagulant agents (NOACS), is recommended when score is >/=2 corresponding to a  risk of stroke  above 1-2% per year.

These blood thinners have consistently been shown to lower your risk of stroke or systemic embolization (when a clot from the heart goes somewhere other than the brain) by almost 70%.

The higher the risk, the more the benefit of these blood thinners in preventing stroke.

Both European and American guidelines recommend using the CHA2DS2-VASc score for initial risk stratification. The European  guideline recommends OAC therapy for males with a CHA2DS2-VASc score ≥1 and for female patients with a score ≥2., whereas the American guideline recommends use of OAC if the CHA2DS2-VASc  score is ≥2 for men and women.

I’ve been using the CHA2DS2-VASc scale for several years in my afib patients. I try to review the patient’s risk of stroke and their risk of bleeding during every office visit, and decide whether they should be on or off an OAC.

Bleeding From Blood Thinners

All OACs cause increase bleeding. They don’t discriminate between bad clots that cause strokes and good clots that stop you from bleeding.

If you’re taking one you are more likely to have nose bleeds, bleeding into the intesitnal tract or urine and you will bleed longer when cut and more profusely if in an accident. In lower stroke risk patients, the bleeding risk of OAC of 1% per year may outweigh the benefits conferred by stroke reduction.

I wrote a post entitled “Why Does The TV Tell me Xarelto Is a Bad Drug” which points out that law suits against the makers of the newer OACs are frivolous and that these NOACs are likely more safe and effective than warfarin.

In recent years, four new drugs for reducing strokes in patients with atrial fibrillation which are much less influenced by diet and medications have gained approval from the FDA. These are generally referred to as “novel anticoagulants” reflecting their newness, different effects from warfarin or aspirin, and their blood thinning properties.  The first  (brand name Pradaxa) was released to much excitement and fanfare in October, 2010.  The press release for this approval read as follows:

PRADAXA, an oral direct thrombin inhibitor2 that was discovered and developed by Boehringer Ingelheim, is the first new oral anticoagulant approved in the U.S. in more than 50 years. As demonstrated in the RE-LY® trial, PRADAXA 150mg taken twice daily has been shown to significantly reduce stroke and systemic embolism by 35 percent beyond the reduction achieved with warfarin, the current standard of care for patients with non-valvular atrial fibrillation. PRADAXA 150mg taken twice daily significantly reduced both ischemic and hemorrhagic strokes compared to warfarin

What was very clear from the study with Pradaxa  and stated very clearly in all publications and patient and doctor  information sources was that just like warfarin, patients could have severe bleeding complications, sometimes fatal. Overall serious bleeding complications were about the same (the rate of major bleeding in patients Pradaxa  in the RE-LY trial was 3.1% versus 3.4% in the warfarin group) but Pradaxa had about 50% more bleeding from the gastrointestinal tract and warfarin about 50% more bleeding into the brain.

Another big difference between the novel anticoagulants and warfarin is that we have antidotes (Vitamin K, fresh frozen plasma) that can reverse the anticoagulation state rapidly for warfarin but until recently none for the newer drugs. (There is now available an antidote for Pradaxa).  This information also was made very clear to all doctors prescribing the medications in the package insert and educational talks. Despite this, in the major trials comparing these newer agents to warfarin, the newer agents were as safe or safer than warfarin.

The most feared bleeding complication on all OACs is bleeding into the head (intracranial hemorrhage). The risk of ICH is between 0.2 to 0.4 percent per year on warfarin. Studies show with the NOACs the risk is about half of the risk on warfarin.

Should You Take a NOAC or Warfarin?

Once the decision has been made to start a blood thinner, the next question is whether to take warfarin or a NOAC. Warfarin (brand name Coumadin) has been utilized since the 1950s  and prior to 2010 was  the only drug available for doctors to reduce clot formation in the heart and susbsequent strokes.. Warfarin is only effective and safe within a narrow window and its effects are strongly influenced by Vitamin K in the diet and most medications. Thus, frequent blood testing and adjustment in dosage is needed, and close monitoring of diet and changes in medications. Even with this close monitoring, serious and sometimes fatal bleeding occurs frequently with warfarin.

Here is a patient information sheet on warfarin which gives you an idea of issues you will need to be aware of when taking the drug. (WArfar patient handout)

If you do a Google search on warfarin you will quickly discover that it is used as a rat poison. Scientists isolate the chemical from  sweet clover that was causing cows to bleed and then developed a more potent form that they named warfarin in the 1940s. After developing blood tests that allowed the drug to be used safely  to dissolve clots it was approved for human use in the 1950s.

Warfarin or more potent variations on its chemical structure have been utilized as rat poison since the 1940s.

The rats are consuming much larger quantities of the blood thinner and are clearly not being monitored for blood thinness.

Some despicable sites peddling alternative or natural products such as this “Healthy Habits” site engage in fear-mongering over the warfarin/rat poison connection in order to promote totally unproven products. Healthy Habits indirectly suggests  that Nattokinase : is a safer, more effective natural alternative to warfarin” This remarkable enzyme has the ability to dissolve blood harmful clots involved in heart disease and strokes without upsetting normal healthy clotting.”

Such misinformation is dangerous and could lead to patients stopping a life-saving medication and suffering a stroke.

By the way, in this Xarelto (another NOAC competitor) ad, Screen Shot 2016-06-29 at 2.21.20 PMKevin Nealon says he chose Xarelto over warfarin because he wanted to eat salads. This is a common misconception and the makers of Xarelto should be ashamed for promulgating it.

I tell my patients it is fine to eat green, leafy vegetables while taking warfarin. The Vitamin K in the vegetables does influence the effectiveness of warfarin thinning blood but this is why we check the blood test to determine the appropriate dosage of warfarin for you and your personal dietary Vitamin K consumption , be it high or low.

Novel Oral Anticoagulant Drugs

The newer OACs, in contrast to warfarin do not require blood tests for monitoring of their efficacy because their levels are not significantly influenced by changes in diet or most medications.

In head to head studies versus warfarin four of these NOACs have demonstrated at least similar efficacy in preventing stroke and at most similar bleeding risk.

Due to their perceived advantages most new prescriptions for OACs are for NOACs. In contrast to 2014 American afib guidelines which don’t state a preference, the most recent European afib guidelines recommend choosing a NOAC over warfarin when initiating anticoagulant therapy in patients who are eligible for NOACs. (Ineligible patients include those with mitral stenosis, mechanical heart valves and end-stage renal disease.)

The ESC guidelines published in 2016, , make choosing a NOAC over warfarin a IA recommendation. This means there is a consensus that the treatment should be recommended (Class I recommendation) and that there is strong evidence from randomized controlled trials to support it (Level A.)

I have decided to primarily use Eliquis (apixaban) as my NOAC of choice based on my comparison of the different NOAC studies. If a patient’s insurance covers another NOAC better , making it cheaper then  I am happy to switch.

Because these four NOACs are new and brand name they are significantly more expensive than warfarin. Cost varies substantially based on type of insurance coverage and we can only determine how much a patient will pay for any given NOAC based on writing a prescription and having a pharmacy check out the cost.

I have found some patients paying nothing for their NOAC whereas some are paying several hundred dollars monthly. The more NOACs cost, the more likely the patient and I are to choose warfarin.

While waiting to determine if cost is going to be prohibitive I will typically provide the patient with samples of the NOAC chosen. The pharmaceutical companies making these NOACs are clearly making substantial profits off them and they are happy to provide lots of samples to doctors to influence the doctors to utilize their product.

NOACs are being extensively promoted both to physicians and directly to patients. Physicians have to be especially careful to make sure they are presenting a true summary of the relative risks and benefits of warfarin versus NOACs in light of these constant attempts to influence them.

Despite now having four NOACs with similar benefits and ease of use compared to warfarin, the cost of these agents doesn’t seem to have declined significantly from when the first NOAC came on the market. Personally, I would love to see Medicare step in and negotiate significantly lower costs for American senior citizens.

An abstract at the ACC meeting in March of 2017 suggested  a reduction in medical costs with NOACs despite their high costs. This was related to a lower rate of major bleeding complications: Xarelto cost $542 per patient compared with warfarin’s $500, or $42 more. Pradaxa, cost $367 to warfarin’s $452, saving $85.  Eliquis cost  $286 charge against warfarin’s $537 resulting in $251 in savings. Data were from from a study of U.S. Medicare patient records.

Aspirin May Not  Prevent Stroke In Afib

Many patients consider aspirin to be  a “blood thinner” that has some benefit in preventing clots and strokes in patients with afib. However,  aspirin is not considered a blood thinner or anticoagulant and is more properly  termed an anti-platelet agent.

I used to consider aspirin at doses of 120 to 200 mg daily provided some protection against stroke in afib and put afib patients on aspirin who were low risk for stroke or would not or could not take OACs.

More and more, however, experts are reaching the conclusion that the substantial bleeding complications from aspirin usage outweigh its very slight benefit in stroke prevention.

The most recent ESC guidelines, in fact, list aspirin therapy for stroke prevention in atrial fibrillation as IIIA. That means that overall it is felt to be harmful (III) with a high level of evidence (A.)

Bleeding risks for aspirin are similar to warfarin and Eliquis. Thus, patients should not consider aspirin as a safer alternative to prevent stroke in afib.

Finally, do not take any “natural” supplement that has been promoted as a blood thinner. These are neither safe nor effective. Remember that it took years of scientific investigation and careful testing in animals then humans before warfarin (the agent in sweet clover that caused cows to bleed ) was transformed into a safe and effective anticoagulant.

Antiemboligenically yours

-ACP

AliveCor Is Now Kardia and It Works Well At Identifying Atrial Fibrillation At Home And In Office

I’ve been using the AliveCor Mobile ECG App/Device to record my patients’ heart rhythm in my office for about 6 months now.

It has for the most part taken the place of the more elaborate, but cumbersome and time-consuming, 12-lead ECG in patients where heart rhythm is my only concern.

I’ve also convinced about a dozen of my patients who have intermitent atrial fibrillation to obtain the device and they are actively using it to monitor at home their heart rhythm. Through the AliveCor website, I can view their recordings and see what their heart rhythm is doing when they have symptoms.

Last week, a patient of mine (I’ll call her Suzy) who has had significant prolonged episodes of atrial fibrillation associated with heart failure (but cannot tell when she is in or out of rhythm) notified me that her device was interpreting her rhythm as atrial fibrillation. She had not had any symptoms, but was making  daily recordings for surveillance.

Suzy called our office and we brought her in the next day and confirmed with a 12-lead ECG that she was indeed in atrial fibrillation with a heart rate of 120 beats per minute.

It’s pretty amazing that this little, inexpensive device can now replace expensive and elaborate long term cardiac monitors for many of my patients.

AliveCor Rebrands Itself to Kardia


Screen Shot 2016-03-28 at 5.38.34 AM
I’ve noticed that AliveCor has rebranded itself as Kardia. If you go to http://www.alivecor.com now you see the fourth generation device along with promotion of a “Kardia band” which apparently works with an Apple Watch to record your ECG.

The Kardia band is not available for purchase at this time but if and when I can get one, it might motivate me to purchase an Apple watch.

When I purchased my AliveCor device in June, 2015 it cost $74.99 from Amazon.com. The newer version is priced at $99 at both AliveCor and Amazon websites. I’m told by Dr. David Albert of AliveCor that this “fourth generation” version is more accurate, so I have purchased it to see if it reduces the problem of occasional bad recordings.

Screen Shot 2016-03-28 at 5.38.10 AM

You can see in this picture from the website that the formerly flat metal electrodes now have bumps. Dr. Albert says these result in more surface area for better contact with skin. We will see.

The Value of Early Detection Of Atrial Fibrillation

Meanwhile, I will be doing an electrical cardioversion (shocking or resetting the heart) on Suzy to get her back to normal sinus rhythm.  If we had not detected the asymptomatic onset of her rapid atrial fibrillation using the AliveCor/Kardia device, chances are we wouldn’t have known about it until her heart muscle weakened again and she became short of breath from heart failure.

I have Suzy on blood thinners to lower her risk of stroke associated with her Afib but for my patients who are not on blood thinners, detection of silent or asymptomatic AFib is even more important.

-Affibly yours,

-ACP

p.s. The skeptician in me feels this post borders on infomercialese.

Let me make it clear that I have no connection with the company formerly known as AliveCor and have received nothing from them (not even free test devices or Apple Watch Kardia Bands!) but I’m just really excited about the device and how it can help my patients (oh, please excuse me, this really sounds like marketing) “empower” themselves to take control of their heart rhythm.

In the course of writing this, I’ve discovered an academic paper evaluating 13 ECG smart phone type ECG devices so there are other devices you could try. I haven’t had the time or resources to evaluate them.

AliveCor Smartphone App Detects Atrial fibrillation: Potential for Stroke Prevention

Atrial fibrillation (AF)  is a common abnormal rhythm of the heart which causes 1 in 4 strokes. Those afflicted with AF may lack any symptoms or only have a vague sense of irregularity of their heartbeat and thus the first symptom of AF can be stroke.

The gold standard for diagnosing AF has long been the electrocardiogram (ECG or EKG) and typically the ECG involves placing 12 electrodes on the chest/arm/legs and recording the electrical activity of the heart on an expensive device.

I’ve been checking out a device made by Alive Cor which works with your smart phone to record a single channel ECG and is capable of accurately diagnosing if you are in the normal (sinus) rhythm or in AF.
Screen Shot 2015-07-12 at 8.45.49 AMYou can purchase the third generation (significantly smaller then earlier versions) AliveCor Mobile ECG from Amazon or from AliveCor directly for 74.99$ and it works with an app with both iOS and Android devices.

I used mine with my iPhone 6. At first I carried it separately, fearing the added bulk when stuck on to my iPhone case but after a while I realized that it was never with me when I wanted to use it and that there was a huge risk of losing it and so I used the backing adhesive to attach it to my case.

After pairing the device with the app you put two fingers on each of the metal pads and the smartphone screen displays the recording. After 30 seconds of recording it then interprets the rhythm.

Screen Shot 2015-07-12 at 8.56.47 AM
Typical recording in normal sinus rhythm. The red arrow indicates the small p waves which are the electrical signal of the upper chambers (the atria) depolarizing , the blue arrow indicates the electrical depolarization of the ventricles (QRS). The orange arrow indicates that the time interval between the QRS complexes is the nearly the same for each beat, indicating the regularity that we expect when in NSR compared to AF.

Above is a typical recording I made in my office on a patient who had a history of AF. The quality is good and I can clearly see that he is in normal sinus rhythm. The app correctly made the diagnosis of NSR and calculated his heart rate at 68 beats per minute.

One day I had most of my patients record their ECG’s using AliveCor and compared it to the standard 12-lead ECG we normally record. The device correctly identified the two patients with AF out of this group and correctly identified the normals.

Screen Shot 2015-07-12 at 9.26.42 AM
AliveCor recording of patient with AF with heart rate of 70 beats per minute. Note the absence of p waves before the QRS complexes and note the beat to beat variation in the RR interval (orange arrow)

This recording is from a patient with persistent AF which had recurred two weeks earlier. The device correctly identified AF.

Studies have documented that AliveCor Mobile ECG can accurately diagnose AF in a screening setting and the FDA approved the device for AF screening in 2014.

Given the high prevalence of silent AF, the strong association of AF with stroke and the availability of anticoagulants which reduce AF associated stroke by 70%, screening for AF with devices like AliveCor holds the promise of preventing large numbers of stroke.

(For my comments on taking the pulse and stroke prevention see here and on the inadvisability of a routine 12-lead ECG see here)

AliveCor allows physicians utilizing the Mobile APP and ECG to have a “dashboard” into which their patients can transmit their AliveCor ECG recordings.

I will be discussing this remarkable new device with my AF patients  who are smartphone enabled. I think it will advance our ability to more efficiently and quickly diagnose AF in them.

My standard approach if a patient with AF calls and says that they feel like they are out of rhythm is to have them come into the office for a full 12-lead ECG. If they are AliveCor enabled, they could make their own recording, and we could review that remotely and make a diagnosis without the office visit.

Let me know your thoughts on smartphone ECGs.

fibrillatorily yours,

-ACP