Most Don't Need 'Bridging' When They Stop Warfarin Temporarily

 Heart patients on the clot-preventing drug warfarin usually have to stop the medication before having surgery. Now, a new study shows they can safely do that without taking another anti-clotting drug -- and they may even be better off.

The study, reported in the Aug. 27 New England Journal of Medicine, helps answer long-standing questions about how to manage patients taking warfarin (Coumadin) for an irregular heart rhythm known as atrial fibrillation.

Because warfarin is a powerful anticoagulant -- which means it prevents blood clots -- it can also raise the risk of internal bleeding. That's why people typically have to stop using warfarin in the days before and after an elective surgery.

But it hadn't been clear whether those patients need what doctors call "bridging anticoagulation." That means taking another type of anti-clotting medication that is short-acting -- usually heparin.

For years, it's been up to individual doctors and patients to decide, said Dr. Thomas Ortel, the senior researcher on the new study, and a professor of medicine at Duke University Medical Center, in Durham, N.C.

"We've had no clinical trial to tell us whether we need to be [bridging] at all," Ortel explained.

Now that clinical trial is done. And, it shows that for most atrial fibrillation patients, bridging with heparin is unnecessary, Ortel said.

In fact, the study found, bridging with heparin appears to raise the risk of major internal bleeding -- without any reduction in the risk of blood clots.

"For years, we've thought that bridging would be beneficial," said Dr. Alfonso Tafur, a vascular medicine specialist at NorthShore University Health System, in Chicago.

"But this study shows that for the majority of (atrial fibrillation) patients, bridging puts them at unnecessary risk," said Tafur, who was not involved in the research.

The study included nearly 1,900 patients who were having elective surgery or other invasive procedures and were taking warfarin to treat atrial fibrillation.

Atrial fibrillation is an irregular heart rhythm in which the heart's upper chambers quiver instead of efficiently pumping blood into the lower chambers, according to the American Heart Association. It's not immediately life-threatening, but it boosts the risk of blood clots forming in the heart. Those clots can then be pumped out of the heart and into an artery supplying the brain, causing a stroke. That's why these patients usually take an anti-clotting drug like warfarin to prevent these clots.

A problem with warfarin is that its effects take time to kick in, and time to wear off once a person stops using it. So when warfarin patients need surgery, they typically go off the drug about five days beforehand; once they restart, it takes another five to 10 days for the warfarin to be effective again, according to background information in the study.

In this study, Ortel's team randomly assigned patients to take either heparin or an inactive placebo during that time window.

In the end, heparin showed no effect on blood-clot risk. Just 0.3 percent of treated patients developed a clot within a month of their procedure, versus 0.4 percent of patients given the placebo, the study found.

On the other hand, heparin did boost the odds of serious bleeding. Just over 3 percent of patients developed "major" bleeding, compared with just over 1 percent of placebo patients, the study found.

The findings suggest that bridging is unnecessary for most atrial fibrillation patients, Ortel said, but there are some who still might benefit.

Tafur agreed. He said that patients who are at particularly high risk of a blood clot -- such as those who've had a stroke in the past -- might still need heparin when they go off warfarin.

For them, Tafur said, the increased bleeding risk may be offset by the anti-clotting benefit.

If your doctor does recommend bridging, Ortel said, feel free to ask why it's necessary.

There are times when warfarin patients may not have to stop the drug at all, Tafur pointed out. With relatively simple procedures, like tooth extractions and even catheter ablation -- which is sometimes used to treat atrial fibrillation -- a warfarin break may be unnecessary, he said.

And what about people who are on newer clot-preventing drugs, like dabigatran (Pradaxa), rivaroxaban (Xarelto) and apixaban (Eliquis)? Those medications act differently from warfarin, Ortel said, and bridging should be unnecessary in most cases.

Hemostasis and Tissue Sealing Agents Market to Experience Significant Growth Due to Aggressive Marketing Strategies

The global hemostasis and tissue sealing agents market signifies the market for sophisticated hemostat medical devices. These devices are utilized to control excessive bleeding in operations and surgeries and have significant roles in assisting healing processes in surgical procedures. 

Introduction of New Products Driving Hemostasis and Tissue Sealing Agents Market

The hemostasis and tissue sealing agents market is going through a steady growth phase. The major companies in the hemostasis and tissue sealing agents industry are adopting aggressive marketing strategies to increase their product penetration rate in the market. 

New and innovative hemostat products are being introduced on regular intervals, which serve diverse applications and are ready-to-use. Such dynamics of the market are resulting in a boost to the global hemostasis and tissue sealing agents industry. In addition to this, the rising base of geriatric population, more prone to diseases and more likely to require surgeries, is also considered an important factor that would drive the market growth further.

On the other hand, stern regulatory requirements, high cost, and increasing off-label use of hemostat products impacts the global market growth of hemostasis and tissue sealing agents in a negative manner.

Market Leaders - Hemostasis and Tissue Sealing Agents Industry

The topical hemostats market is the market leader in the global hemostasis and tissue sealing agents market. In the current scenario, it is expected to develop at a 6% CAGR from 2014 to 2020. This development is mainly credited to the increase in usage of topical hemostats for a broader array of surgical procedures such as cardiovascular, vascular, and others.

The topical hemostats market has three categories, flowable hemostats or combination topical hemostats, active hemostats or thrombin-based topical hemostats, and mechanical hemostats. Medical practitioners such as surgeons prefer active hemostat products due to their high efficiency in controlling excessive bleeding. This factor is supporting the active hemostat market in the hemostasis and tissue sealing agents industry to expand at the highest CAGR.

The adhesive and tissue sealing agents market has three segments, natural tissue sealants including fibrin sealants and other natural sealants such as tissue sealants based on collagen and albumin, synthetic tissue sealants including tissue adhesives based on cynoacrylate and other synthetic tissue sealants such as polyethylene glycol and others, and adhesion barrier products.

The market for adhesive and tissue sealing agents held over 40% of the total market share of the hemostasis and tissue sealing agents industry in 2013. Natural tissue sealants held the largest market share in the adhesive and tissue sealing agents segment due to commercial availability of natural tissue sealants in large amounts.

North America held the largest share of the global hemostasis and tissue sealing agents market in 2013. It accounted for around 36% of the total hemostasis and tissue sealing agents market. Rising number of inpatient surgical procedures added with an increase in the use of hemostat products by end users such as physicians and surgeons is driving the growth of the hemostasis and tissue sealing agents market in North America. 

Europe held the second largest hemostasis and tissue sealing agents market share in 2013 owing to continued growth in geriatric population. 

Asia Pacific is likely to experience the fastest growth rate from 2014 to 2020. This is due to liberal regulatory environment and increase in investment by major enterprises such as Pfizer, Inc., CryoLife, Inc., and others, in this region.

The major players in the hemostasis and tissue sealing agents market are CryoLife, Inc., Johnson & Johnson, Baxter, Advance Medical Solution Group plc, and Cohera Medical, Inc.

In 2014, Cohera Medical, Inc. launched Sylys Surgical Sealant, which can be utilized in gastrointestinal surgery to decrease anastomotic leak. In the same year, Baxter also gained the FDA permission for TISSEEL fibrin sealant, which is used in almost all types of surgical procedures. However, in the present scenario, investing in developing countries provides a good platform for the players in the hemostasis and tissue sealing agents market to register high revenue.

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