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What's New in Coagulation: APRIL 2009

What's New in Coagulation - April

Migraines Linked to Increased Risk for Stroke During Pregnancy
http://www.medscape.com/viewarticle/589640

Women who have migraines may be at increased risk for stroke during pregnancy as well as other vascular conditions, according to the results of a US population-based case-control study reported in the March 11 Online First issue of the BMJ. The goal of this study was to determine the association between migraine and cardiovascular diseases during pregnancy using a nationwide inpatient sample from the Healthcare Cost and Utilization Project of the Agency for Healthcare Research and Quality.From 2000 to 2003, there were 18,345,538 pregnancy-related hospital discharges recorded in this database. The primary endpoints were diagnosis of migraine, identified by International Classification of Diseases, Ninth Revision (ICD-9), codes 346.0 and 346.1, and of stroke and other vascular diseases, identified by use of standard ICD-9 codes.
Study Highlights
- Study data were drawn from the Healthcare Cost and Utilization Project of the Agency for Healthcare Research and Quality, which contains records from up to 8 million hospital stays in the United States.
- Researchers used ICD-9 codes to search for cases of migraine among pregnancy-related hospital discharge records from 2000 to 2003.
- The study team then cross-referenced this search with other diagnosis codes, particularly for vascular disease, diabetes, anemia, pneumonia, transfusion, postpartum hemorrhage and infection, and intrauterine fetal death.
- The main outcome of the study was the relationship between migraine headache and other outcomes during pregnancy. A logistic regression analysis was performed to reducing confounding factors.
- Of 18,345,538 total pregnancy-related hospital discharges, 33,956 included a diagnosis code for migraine. This yielded 185 cases of migraine per 100,000 deliveries.
- Most discharges with codes for migraine occurred at the time of delivery.
- The proportion of women diagnosed with migraine increased with increasing age. White women were more likely to have migraine vs other racial or ethnic groups.
- Migraine was associated with higher risks for multiple vascular outcomes, and the most prominent of these outcomes was stroke (adjusted OR, 15.05). The unadjusted OR for ischemic stroke associated with migraine diagnosis was 30.7. Migraine was not significantly associated with the risk for subarachnoid hemorrhage.
- Migraine was also associated with higher rates of myocardial infarction/heart disease (OR, 2.11) and pulmonary embolus/deep venous thrombosis (OR, 3.23).
- Women with migraine were more likely to have diagnoses of hypertension (OR, 8.61), diabetes (OR, 1.96), and cigarette smoking (OR, 2.85).
- Although migraine was associated with a higher rate of preeclampsia/gestational hypertension, it did not appear to promote gestational diabetes.
- Migraine did not significantly affect the risks for anemia, pneumonia, transfusion, postpartum hemorrhage and infection, and intrauterine fetal death.

Aspirin: More Evidence That Low Dose Is All That Is Needed

http://www.medscape.com/viewarticle/589895

Although cardiovascular disease is the underlying or contributing cause of death in the majority of adults in the United States, it affects women and men differently. Men have higher rates of coronary heart disease, and cardiac events occur at a younger mean age in men vs women. However, MI is more deadly in women overall. Similarly, rates of stroke are higher in men, but more women die of stroke. This is, in large part, because age is a significant risk factor for stroke, and women live longer than men.
Aspirin can be useful in the prevention of cardiovascular events among both men and women. The current recommendations from the USPSTF summarize the best practice for using aspirin as primary prevention against cardiovascular disease.
Study Highlights
- The decision whether to initiate aspirin therapy begins with a careful assessment of an individual patient's risk. A tool derived from the Framingham Heart Study uses sex, age, smoking status, diabetes, blood pressure, and cholesterol levels to determine the 10-year risk for coronary heart disease.
- Men derive benefit from aspirin in their risk for MI, whereas aspirin protects women against stroke. In the WHS, the relative risk for stroke in patients receiving aspirin vs placebo was 0.83. Aspirin reduced the risk for ischemic stroke by 24% but did not affect the risk for hemorrhagic stroke.
- In a meta-analysis, the use of aspirin was associated with an odds ratio of 0.68 for MI among men, but aspirin was not protective against stroke.
- There are limited data suggesting that aspirin can reduce the risk for overall mortality when used as primary cardiovascular prevention.
- The benefits of aspirin must be balanced against the risk for gastrointestinal tract bleeding. In the WHS, aspirin increased the relative risk for serious gastrointestinal tract bleeding events vs placebo by 1.40. In the larger meta-analysis, the odds ratio of major bleeding events associated with aspirin therapy was approximately 1.7 for both sexes.
- In low-risk adults younger than 60 years, the rate of serious gastrointestinal tract bleeding is 0.8 per 1000 person-years in men receiving aspirin and 0.4 per 1000 person-years in women receiving aspirin. However, older age, a history of upper gastrointestinal tract pain, and a history of gastrointestinal tract ulcer all significantly increase the risk of gastrointestinal tract bleeding with aspirin.
- The final recommendations suggest that aspirin should be considered to reduce the risk for MI in men between the ages of 45 and 79 years, and aspirin should be considered for reducing the risk for stroke in women between the ages of 55 and 79 years.
- Aspirin should be started only in patients for whom the potential benefit outweighs the potential risk. For men at the following age levels and the following 10-year risk levels for coronary heart disease, the cardiovascular benefit of aspirin closely resembles the risk for serious bleeding events:
o Ages 45 to 59 years: 10-year coronary heart disease risk, 4%
o Ages 60 to 69 years: 10-year coronary heart disease risk, 9%
o Ages 70 to 79 years: 10-year coronary heart disease risk, 12%
Similarly, the following data present the 10-year stroke risk in women at which benefits of aspirin are similar to the risk for serious bleeding events:
o Ages 55 to 59 years: 10-year stroke risk, 3%
o Ages 60 to 69 years: 10-year stroke risk, 8%
o Ages 70 to 79 years: 10-year stroke risk, 11%
- There is insufficient evidence to recommend for or against the use of aspirin to prevent cardiovascular disease in adults 80 years or older.
- The USPSTF recommends against the use of aspirin to prevent cardiovascular disease in women younger than 55 years and men younger than 45 years.





Frequency of Ischemic Stroke Climbs Steeply After the Age of 40 Years
http://www.medscape.com/viewarticle/590018

A new analysis from the Helsinki Young Stroke Registry finds the frequency of ischemic stroke rises sharply beginning at the age of 40 years. Traditional stroke risk factors started to accumulate around the age of 44 years, and subclinical infarcts were surprisingly common, researchers report. In this study, the researchers analyzed trends in the occurrence of, risk factors for, and etiology of first-ever ischemic stroke in a large cohort of 1008 consecutive stroke patients aged 15 to 49 years who were evaluated at Helsinki University Central Hospital between 1994 and 2007. All patients underwent neuroimaging at admission, allowing detailed analysis of these features in the patients.
They report that the estimated annual occurrence was 10.8 per 100,000, ranging from 8.4 to 13.0 per 100,000. Males predominated overall, accounting for 628 strokes, vs 380 females, for a ratio of 1.7:1. However, under 30 years of age, females predominated, as has been reported in other studies, the authors note; females accounted for 56% of strokes in that age group.Male dominance "rapidly increased around age 44," they note. For the 45-to-49-year-old age group, twice as many men as women had an ischemic stoke.
The most frequent risk factors were dyslipidemia (60%), smoking (44%), and hypertension (39%). Risk factors were more common among males and in those over 44 years of age. Males were more often heavy drinkers, while migraine as a risk factor for stroke was more common among females. Illicit drug use and migraine were more common among younger patients.
The most commonly identified stroke etiologies were cardioembolism in 19.6% and cervicocerebral artery dissection in 15.4%. The large proportion of dissections in this series, they note, mean that urgent vascular imaging should be a part of the workup for younger patients.
The proportion of strokes related to large-artery atherosclerosis (8%) and small-vessel disease (14%) began to increase after the age of 35 years, while the proportion with an undetermined etiology (33%) decreased with age. Posterior circulation infarcts were more common among patients under 45 years of age; left hemisphere infarcts were more common in general, they write.



STEMI Patients in TRITON-TIMI 38: Prasugrel Bests Clopidogrel Without Bleeding Risk
http://www.medscape.com/viewarticle/588869
In patients with ST-segment-elevation MI (STEMI) undergoing PCI, treatment with the new antiplatelet agent prasugrel (Lilly/Daiichi Sankyo) significantly reduced ischemic events compared with clopidogrel (Plavix, Bristol-Myers Squibb/Sanofi-Aventis), without a significant increase in bleeding risks . The results, from a prespecified analysis of the Trial to Assess Improvement in Therapeutic Outcomes by Optimizing Platelet Inhibition with Prasugrel (TRITON-TIMI 38), showed that treatment with prasugrel resulted in significant reductions in 30-day rates of cardiovascular death, nonfatal MI, or nonfatal stroke, a benefit that persisted out to 15 months. In addition, there were reductions in secondary end points, including a significant reduction in stent thrombosis rates, with prasugrel.
The TRITON Study
The TRITON trial included 13 608 moderate- to high-risk ACS patients scheduled for PCI and randomized to receive prasugrel (60-mg loading dose and then 10-mg daily maintenance dose) or clopidogrel (300-mg/75-mg) for six to 15 months. The results, which were presented at the American Heart Association 2007 Scientific Sessions and reported extensively by heartwire at that time, showed a significant reduction in the primary efficacy end point (cardiovascular death/MI/stroke), as well as in MI, urgent TVR, and stent thrombosis. But this was at the expense of a significant increase in major bleeding, life-threatening bleeding, and fatal bleeding.In this predefined analysis, Montalescot and colleagues report the results of the 3534 patients presenting with STEMI. At 30 days, treatment with prasugrel reduced the primary end point as well as reduced the risk of cardiovascular death, all-cause death, and stent thrombosis compared with clopidogrel. A secondary end point, a composite of cardiovascular death, MI, or TVR, was also reduced at 30 days.
Reductions in the primary end point, a composite of cardiovascular death, nonfatal MI, and nonfatal stroke, were maintained at 15 months, as were reductions in the secondary end point and other individual end points, including MI. Stent-thrombosis rates were also maintained with prasugrel at 15 months. All-cause and cardiovascular mortality rates, however, were similar between the two treatments at 15 months, despite statistically significant early benefits at 30 days.In contrast with the overall study, there was no increased bleeding in the STEMI patients treated with prasugrel compared with those randomized to clopidogrel.
Limitations of the Trial
In his editorial, Stone notes several limitations of the TRITON study, the first being the dose of the comparator drug. In the study, prasugrel was compared with a 300-mg loading dose of clopidogrel rather than the more potent 600-mg dose, the current standard of care for primary PCI. He also notes that STEMI patients enrolled in the study between 12 hours and 14 days after symptom onset, designated secondary PCI, likely did not receive the full benefit of clopidogrel because of inadequate preloading. Overall, 72% of patients in the clopidogrel arm received the study drug during PCI, whereas just 27% were preloaded within the allocated 24 hours prior to the procedure.


FDA MedWatch Safety Alert. Innohep (tinzaparin sodium injection).
http://www.fda.gov/medwatch/safety/2008/safety08.htm#Innohep
Celgene is alerting healthcare professionals of an increased mortality risk among certain elderly patients treated with Innohep (tinzaparin sodium injection). Innohep is a low-molecular weight heparin that is used along with warfarin to treat acute symptomatic deep vein thrombosis with or without pulmonary embolism.

Results of a controlled clinical study conducted in Europe suggest that elderly patients with kidney dysfunction may have a greater risk of death when treated with Innohep than comparable patients treated with unfractionated heparin. In a July 2008 letter, Celgene had highlighted this risk for patients who are 90 years and older, but the company has now changed the labeling to indicate that these risks apply to patients with kidney dysfunction who are 70 and older. The company says to consider alternatives to Innohep when treating these patients.
More Data Support Adverse Clopidogrel and Proton
http://www.medscape.com/viewarticle/589059
- Data for this study were part of the Cardiac Care Follow-Up Clinical Study, which used national data from the Veterans Health Administration external peer review program for quality monitoring of conditions that included MI and unstable angina.
- The records of all patients discharged from any Veterans Affairs hospital with MI or unstable angina were manually abstracted with use of standard reporting forms.
- 8790 patients with ACS who were prescribed clopidogrel and filled the prescription at discharge were included, beginning in 2003.
- Use of clopidogrel and PPI medications were based on pharmacy refill data, which record the date dispensed and number of pills.
- A 7-day gap was permitted between prescriptions before considering that the patient discontinued the medication in the primary analysis.
- The primary outcome was the combined endpoint of all-cause mortality and rehospitalization for ACS after the index admission.
- Secondary outcomes were rehospitalization, revascularization, and all-cause mortality after the index ACS hospitalization.
- The Veterans Affairs vital status file was used to assess mortality outcome.
- The ACS outcome was based on chart review.
- Vital status was obtained until 2006.
- Mean age was 66 years, 99% were men, 38% to 45% had diabetes, and one quarter had a history of MI.
- Of 8205 patients taking clopidogrel after discharge, 63.9% were prescribed a PPI and 36.1% were not.
- Those prescribed a PPI at any point were older with more comorbid conditions.
- Median follow-up after discharge was 521 days.
- Death or rehospitalization for ACS occurred in 20.8% of those not prescribed a PPI and 29.8% of those prescribed a PPI, with an increased risk for death or rehospitalization for ACS of 1.25 (95% confidence interval, 1.11 - 1.41).
- When a nested case-control design was used for analysis, the adjusted odds ratio (OR) remained elevated at 1.32.
- The risk for rehospitalization for ACS and revascularization procedures were higher in those prescribed a PPI, with an adjusted OR of 1.86 and 1.49, respectively.
- The risk for all-cause mortality was not increased for those prescribed a PPI vs those not prescribed a PPI.
- Periods of clopidogrel plus PPI use were associated with a higher risk for death or rehospitalization vs periods of clopidogrel use without PPIs.
- The risk associated with clopidogrel with PPI remained even after excluding patients with a history of gastrointestinal tract bleeding.
- In patients prescribed a PPI, 59.7% were prescribed omeprazole, 2.9% were prescribed rabeprazole, 0.4% were prescribed lansoprazole, and 36.7% were prescribed more than 1 type of PPI.
- There was no obvious dose-response relationship for the risk associated with PPIs.
- However, each 10% increase in duration taking clopidogrel with a PPI increased the risk for death or rehospitalization for ACS (OR, 1.07).
- There was a consistent association between use of omeprazole (OR, 1.24) and rabeprazole (OR, 2.83) and adverse outcomes.
- When patients were not taking clopidogrel, the use of a PPI was not associated with death or rehospitalization for ACS, supporting the hypothesis that the combination, rather than the PPI itself, was associated with adverse outcomes.
- The authors concluded that pending further confirmation of the findings, PPIs should only be prescribed concomitantly with clopidogrel in patients with ACS when a clear indication was present and should not be prescribed as prophylaxis.

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Thrombolysis May Benefit Some Patients Who Wake With Stroke
http://www.medscape.com/viewarticle/589161

Results of a retrospective case series suggest that certain patients who wake with stroke symptoms may still benefit from intervention using intravenous (IV) or intra-arterial (IA) thrombolysis. Researchers at the University of Texas-Houston report off-label use of thrombolysis in 46 patients with acute ischemic stroke appeared to be safe, with a rate of symptomatic intracerebral hemorrhage of 4.3%, and was associated with higher rates of excellent and favorable outcome, although mortality was also significantly higher than those who were not treated. In general, patients who wake with stroke symptoms are not considered candidates for thrombolytic therapy, because the time of stroke onset cannot be established reliably. Tissue plasminogen activator (tPA) is approved by the Food and Drug Administration (FDA) for use in patients who present within 3 hours of a known symptom onset. However, it is estimated that between 16% and 28% of patients who have a stroke each year wake up with their symptoms.
In some of these cases, when the computed tomography (CT) scan still shows radiologic features of a relatively recent ischemic event, their group has offered off-label, compassionate treatment with tPA, he said. In this study, they reviewed demographics, safety, and outcomes in these cases and compared them with wake-up stroke cases who did not receive thrombolysis, as well as outcomes in patients who met the 3-hour FDA-approved window for treatment.
Retrospective review of their database turned up 46 cases where thrombolysis was used in wake-up stroke patients; 28 (61%) of these received IV tPA, 14 (30%) were given only IA thrombolysis, and 4 (9%) received IV and IA tPA.
These were compared with 34 wake-up stroke patients who did not receive thrombolysis and 174 patients with an identifiable stroke onset who received thrombolysis within 3 hours of the start of symptoms.
After controlling for baseline National Institute of Health Stroke Scale (NIHSS) scores, they found that wake-up stroke patients who were treated had significantly higher rates of excellent and favorable outcomes on the modified Rankin Scale (mRS) but also had significantly higher mortality. There were 2 symptomatic intracranial hemorrhages in the treated group compared with none in untreated patients, but this difference did not reach statistical significance. Both of these had received IV tPA alone.
Compared with those patients who received tPA within the FDA-approved 3-hour window, they found no significant differences in the rates of excellent (P = .14) or favorable outcomes (P = .64) after controlling for higher median NIHSS scores in the wake-up stroke patients who received thrombolysis. Mortality in the standard-of-care patients was 10%, and symptomatic intracranial hemorrhage occurred in 2.9%.
Stroke 2009;40:827-832.
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An Appraisal of Dual Antiplatelet Therapy with Clopidogrel and Aspirin for Prevention of Cardiovascular Events


J Am Board Fam Med. 2009;22(1):51-56. ©2009 American Board of Family Medicine
Posted 03/10/2009
http://www.medscape.com/viewarticle/586949

Abstract and Introduction
Abstract
Combination antiplatelet therapy, typically with clopidogrel and aspirin, is commonly used for the prevention of cardiovascular events. When used for appropriate indications and duration, its benefits clearly outweigh its risks. However, it is not uncommon for the combination to be used outside of recommended indications or for longer than recommended durations. In these circumstances data are at best unclear and, at worst, indicative of harm. Furthermore, use for one of its indications-prevention of cardiac events after deployment of a coronary stent-is complicated by the type of stent used.
The primary determinant of using combination therapy is, of course, the indication. An overview of clinical trials investigating the efficacy of the combination of clopidogrel and aspirin has been provided. These trials have identified some conditions where combination therapy offers no benefits over monotherapy. Combination therapy has been shown to be no more effective than aspirin alone in primary prevention of coronary or cerebral events in patients at high risk.[3] Aspirin, at a dose of 75 to 162 mg daily, is the preferred treatment for primary prevention; clopidogrel alone is useful in patients with an aspirin allergy.[4] Likewise, combination therapy is inappropriate in patients with a recent stroke or transient ischemic attack because it increases the incidence of major and minor bleeds without offering any therapeutic benefit over clopidogrel alone.[5] The most appropriate indications for the use of combined clopidogrel and aspirin therapy are the treatment of acute coronary syndromes and the prevention of coronary events after placement of a stent.
Patients treated for acute coronary syndromes without the use of a stent should receive combination clopidogrel and aspirin for at least 1 month, and it is reasonable to lengthen that up to 1 year. Patients who receive stents, either electively or emergently, are not as clear-cut. Given the recent controversies, the use of bare metal stents may increase. This is probably appropriate but means that general assumptions as to the type of stent placed cannot be made. Although the primary care physician is not usually involved in choosing the type of stent to be placed, it is vital that the PCP find out this information. For patients receiving bare metal stents, combination therapy should be strongly recommended for the first month. Continued therapy out to 1 year may be helpful, but durations longer than that are not supported. For patients receiving drug-eluting stents, 1 year of combination therapy should be encouraged. However, longer term therapy from that point may best be reserved for those with a clear prothrombotic history (ie, previous myocardial infarction) and a relatively low risk of bleeding.

New Guidelines on Management of Aneurysmal Subarachnoid Hemorrhage
aSAH is a potentially devastating condition requiring prompt diagnosis and management. The prevalence of documented aSAH can vary between 2 and 23 cases per 100,000 persons, depending on the population studied. aSAH most commonly occurs between the ages of 40 and 60 years, and it is generally more prevalent in women vs men. In the United States, the risk for aSAH is higher in black adults vs white adults.
The American Heart Association last produced guidelines regarding the diagnosis and management of aSAH in 1994. The current guidelines update these previous recommendations with research published through 2006.
Study Highlights
- Prompt diagnosis of aSAH is critical. The severity of the initial bleed of aSAH and initial neurologic status are the most powerful indicators of prognosis. The risk of rebleeding for a ruptured aneurysm is at least 3% to 4% in the first 24 hours after rupture.
- CT scan is the cornerstone of diagnosis of SAH. CT has a sensitivity of 98% to 100% for the first 12 hours of aSAH, but this decreases to 93% after 24 hours. A lumbar puncture should be performed in suspected cases of aSAH when the CT scan result is negative.
- Catheter-based angiography remains the test of choice to identify and localize aneurysms in patients with SAH. CT angiography and magnetic resonance angiography should be reserved for cases in which conventional angiography cannot be performed in a timely fashion.
- Bed rest alone is insufficient to guard against the risk of rebleeding in patients with aSAH. These patients require active monitoring.
- Antifibrinolytic therapy may be considered to prevent rebleeding for patients at low risk for vasospasm and/or those who may benefit from a delay in definitive surgery.
- Both surgical clipping and endovascular coiling may be considered to reduce the risk of rebleeding after aSAH. The risk of rebleeding increases when definitive treatment of the aneurysm is delayed. Most patients should receive prompt definitive interventions.
- The experience of practitioners is important in outcomes of aSAH, and treatment at a center which offers both surgical clipping and endovascular coiling is preferred. Early referral to a center with experienced practitioners is reasonable.
- Avoiding hypovolemia after aSAH can prevent vasospasm, but the balance between benefit and harm of prophylactic hemodynamic therapy remains unclear.
- The use of volume expansion, induction of hypertension, and hemodilution may be considered to treat symptomatic cerebral vasospasm. Cerebral angioplasty and selective intraarterial vasodilator therapy are other treatment options.
- Among calcium channel antagonists, only oral nimodipine has proven to be effective in improving morbidity and functional outcomes in patients treated for aSAH.
- The administration of prophylactic anticonvulsants may be considered in the immediate posthemorrhagic period.
- In general, the routine use of long-term anticonvulsants is discouraged, but this treatment may be considered for patients with previous seizure, parenchymal hematoma, or middle cerebral artery aneurysm.
- Hyponatremia may occur in up to 30% of patients treated for aSAH. Hypertonic saline and fludrocortisone acetate may used to treat hyponatremia in this setting.


No Reduction in Bleeding With Vitamin K in High-INR Patients
http://www.medscape.com/viewarticle/589480
Patients receiving warfarin are frequently outside of the therapeutic window recommended for this medication, and excessive anticoagulation can increase the risk of bleeding. Garcia and colleagues quantified this risk in a study published in the February 21, 2006, issue of the Journal of the American College of Cardiology. They observed 1104 patients with an INR greater than 5 for 1 month, and the overall prevalence of major hemorrhage was 1.3%. Among the subgroup of patients with an INR between 5 and 9, the risk of major bleeding was 0.96%. Despite the risk of major bleeding, only 8.7% of patients in this study received oral vitamin K, which is known to reduce the INR in cases of excessive anticoagulation with warfarin.
The current study examines whether the use of low-dose vitamin K can reduce the risk of bleeding events in warfarin-treated patients who have a high INR.
Study Highlights
- Study participants were adults in outpatient anticoagulant therapy clinics with an INR between 4.5 and 10.0. Patients who were scheduled to completely discontinue warfarin therapy were excluded from study participation, as were those who required urgent correction of the INR.
- All study subjects were told to hold warfarin treatment for 1 day. Participants were randomly assigned to receive 1 capsule of vitamin K 1.25 mg or placebo on that day.
- Warfarin treatment was to be reinstituted once the INR had returned to therapeutic levels.
- The primary outcome of the study was the frequency of bleeding events during the 90 days after randomization. Researchers also followed rates of major bleeding, which was defined as the need to transfuse 2 or more units of packed red blood cells, bleeding resulting in a therapeutic intervention, or objectively confirmed bleeding into an enclosed space. Finally, participants were observed for rates of thromboembolism and death.
- 724 patients underwent randomization. Baseline characteristics were similar in the vitamin K and placebo groups. The mean age of participants was 69 years, and slightly more than half of the study cohort were men. Atrial fibrillation and the treatment of thromboembolism accounted for more than 80% of the indications for warfarin therapy.
- The rates of any bleeding event were similar in the vitamin K group (15.8%) and the placebo group (16.3%). The respective rates of major bleeding were also similar between groups (2.5% and 1.1%).
- Rates of bleeding events at study day 7 were also similar in comparing the vitamin K vs the placebo groups.
- The 90-day rates of thromboembolism in the vitamin K and placebo groups were 1.1% and 0.8%, respectively. This difference was not statistically significant.
- There was no significant difference in mortality rates between treatment groups.
- Vitamin K was more effective vs placebo in reducing INR. At 1 day after treatment, the mean reductions in INR in the vitamin K and placebo groups were 2.8 and 1.4, respectively.
- A subgroup analysis focused on older adults found the same outcomes as the overall study, although the overall risk of bleeding events was higher in this group.

Donna Castellone

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Donna Castellone,
MS, MT(ASCP)SH
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