article on bridging

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halleyg

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When my INR was low a couple weeks ago, my coumadin mgr. told me about an article that said even if it was that low (1.4) for a few days, I could go 4-5 days w/out complication, or at least with slim chances of a complication (according to the article). Al had asked me for the article and I finally got a print-out from her.. you have to be a registered med. professional to go to the site and read it, so I thought I'd just paste it into my post if anyone is intersted in reading it. I'd love to hear any thoughts on it, too, as I've never had to bridge yet and am not sure what to think.

Safety of heparin "bridge" questioned when warfarin is stopped for minor procedures

January 16, 2008 Steve Stiles

Chicago, IL - Patients on chronic warfarin who go off the drug for up to five days while they undergo a minor invasive procedure appear to have a <1% risk of experiencing a thromboembolic event, suggests a prospective study that, moreover, pointed to a substantial risk of clinically important bleeding when some form of heparin is given as "bridge" therapy in warfarin's stead [1].

The findings speak to the dilemma providers face when taking patients off oral anticoagulation while they undergo a colonoscopy, dental procedures, or other such outpatient procedures, according to lead author Dr David A Garcia (University of New Mexico Health Sciences Center, Albuquerque). Many want to give short-acting parenteral anticoagulation during such procedures, accepting a potential for more bleeding complications in exchange for a reduced risk of potentially devastating thromboembolic events, he observed for heartwire. But prospective data for guiding such decisions have been in short supply.

We don't have good data about the benefit of perioperative heparin, whereas we are getting increasingly more evidence that perioperative heparin certainly comes with a risk.


"If there's an overriding message from our study, it's perhaps that the hemorrhagic risk associated with heparinlike perioperative anticoagulation is greater than previously appreciated and that it needs to be considered carefully in any risk/benefit analysis that one is doing around an interruption of warfarin for an elective procedure," Garcia said. "We don't have good data about the benefit of perioperative heparin, whereas we are getting increasingly more evidence that perioperative heparin certainly comes with a risk."

Anyway, he observed, the risk of thromboembolic complications during warfarin interruption appears to be quite low, at least in populations like the one his group studied: "outpatients undergoing elective, relatively minor invasive procedures, most of whom had their warfarin interrupted for only brief intervals, three to five days." Less than one-tenth of the study's >1000 patients had received bridge anticoagulation.

The group's findings, published in the January 14, 2008 issue of Archives of Internal Medicine, are consistent with those of other studies and with current guidelines "proposed by the American College of Chest Physicians, suggesting that low-risk patients may undergo four to five days of warfarin-therapy interruption without bridging therapy."

Their analysis covered 1293 instances of warfarin interruption in 1024 patients who underwent such outpatient procedures as colonoscopy, oral or dental surgery, or ophthalmic surgery. The patients averaged 72 years in age, and most had been on warfarin due to atrial fibrillation or mechanical heart valves or for management of venous thromboembolism. Only 8.3% of cases of warfarin interruption involved bridge anticoagulation therapy, which was nearly always with a low-molecular-weight heparin, according to the authors. Outcomes included the following:

There were only seven instances of thromboembolism (0.7%) within 30 days of the procedure. The rate was the same after exclusion of patients who received bridge therapy.
The rate of thromboembolism was 0.4% when the warfarin interruption lasted five days or less and 2.2% for those of seven or more days.
Six patients (0.6%), including four who had received bridge therapy, suffered a major bleeding complication, defined as hemorrhage that led to death or to hospitalization with a transfusion >2 U red packed cells or at a "critical" site (including, for example, intracranial or retroperitoneal bleeding).
Another 17 patients (1.7%), including 10 who had received bridge therapy, experienced "clinically significant, nonmajor bleeding."
Bleeding complication risk among patients who received or did not receive bridge anticoagulation therapy


Complication
Bridge anticoagulation (%)
No bridge anticoagulation (%)

Major hemorrhage
3.7 (Bridge)
0.2 (no bridge)

Significant nonmajor hemorrhage
9 (Bridge)
0.6 (no bridge)

To download table as a slide, click on slide logo below

"Although our paper doesn't provide any definitive answers, it questions whether the risk of bridging therapy, even in outpatients, can be justified by the potential benefit," Garcia said, cautioning that it doesn't apply to patients undergoing major surgery or who are hospitalized for an invasive procedure, whose thrombotic and bleeding risks would likely be higher. Randomized, placebo-controlled trials are now needed, he added, to settle the issue.


The study was funded by Bristol-Myers Squibb. Garcia reports receiving consulting honoraria and research support from Bristol-Myers Squibb, AstraZeneca, and Sanofi-Aventis. Coauthor Dr Elaine M Hylek (Boston University School of Medicine, MA) reports having served on advisory boards for Bristol-Myers Squibb and receiving research support from AstraZeneca and Bristol-Myers Squibb.
 
Nonetheless, does one want to have a stroke, which cannot be reversed or take the risk of bleeding, which can be reversed.
 
read between the lines

read between the lines

Here is the problem with the sudy:

This study like most that I have read deal with a combination of different indications for anticoagulation: AFIB, DVT, Heart Valve, etc. The problem with this is the fact that most of the studies don't break down rates of bleeding/thromboembolic complications between the various indications for anticoagulation. As in this study all of the complication rates are based on the group as a whole. The rate of stroke is much higher for mechanical mitral valves. If they gave a breakdown of the different patient groups you would find that the majority were in the afib group, then mech aortic valve, then mech mitral valve. Another interesting point is the fact that they state that only 8% of the total patient population were bridged. If they gave a breakdown on how many of the patients had mechanical mitral valves you would find that it would be about 8%-12% and those were most likey the patients that were bridged. According to the study none of the bridged patients suffered thromboembolic events. Another thing they don't tell you in the study is how many of the mechanical valve patients suffered a valve thrombus.

Keep in mind that the patients that had bleeding issues who were birdged probably would have had bleeding complications without bridge.

Halleyg: If your doctor isn't that concerned about an INR of 1.4 especially since you have a mech mitral valve, that in itself is a problem. If you were to have a problem resulting from a low INR then your chances of a complication are 100%.
 
No, no, my dr. was very concerned with my 1.4 INR, I had to go on lovenox shots for two days and double my coumadin until I was back up. It only took a couple of days. I just started to panic when I heard the 1.4 number, and my coumadin manager was trying to ease my mind, and she mentioned the article. Al had asked me to post it which is why I had her give me a copy.

The article is from the website www.theheart.org. The Source is Garcia DA, Regan S, Henault LE, et al. Risk of thrombeoembolism with short-term interruption of warfarin therapy. Arch Intern Med 2008; 168:63-69 (that is how it reads)
 
warrenr said:
Annualized Risk of Thrombotic Complications in the Absence of Anticoagulant Therapy for Selected Conditions from The Seventh ACCP Conference on Antithrombotic and Thrombolytic Therapy

http://www.chestjournal.org/cgi/content/full/126/3_suppl/204S/T7


Recommendations for Managing Anticoagulation Therapy in Patients Requiring Invasive Procedures from The Seventh ACCP Conference on Antithrombotic and Thrombolytic Therapy

http://www.chestjournal.org/cgi/content/full/126/3_suppl/204S/T8

Thanks for posting those links Warren.

I'd REALLY like to know more about the number quoted in the first reference for the Risk with Multiple Mechanical Valves, not to mention seeing a verification of it!

The Multiple Valve Risk number represents a significant Non-Linear increase over the Risks for a Single Mechanical Valve that is way beyond what one would expect from the combined risk for independent events.

I'm guessing that multiple valve risk is NOT a simple combination of independent events. Anybody have a more complete explanation? (Bradley White - here's your chance to 'shine' :)

'AL Capshaw'
 
return to article

return to article

Al,

If you go to the bottom of the links you will see a block that states "return to article" this will take you to the full article plus references. You should be able to find the info there.

Happy Reading
 
warrenr said:
Al,

If you go to the bottom of the links you will see a block that states "return to article" this will take you to the full article plus references. You should be able to find the info there.

Happy Reading

Thanks Warren.

The number for the "Annualized Risk of Thrombotic Complications (I'll take this as a 'medical euphimism' for STROKE) in the Absense of Anticoagulant Therapy" is a bit 'alarming' at first glance.

After thinking about that title a bit more, I *ASSUME* it means the Risk of 'the complication' IF the patient were to go ONE YEAR without anticoagulation.

I would like to see a graph of this risk with the increment in terms of 2 or 3 days out to several weeks. I think that would be more appropriate and meaningful to anticoagulated patients contemplating Major Surgery.

'AL Capshaw'
 
incremental graph

incremental graph

Al,

I wish there was an incremental graph that was based on pure numbers/fact, but as we both know the only way to see a factual numeric representation would be to do a real life Placebo test with mechanical heart valve patients and that would never be approved by any medical assoc/fda.
 

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