Results of a significant Phase III EINSTEIN-DVT study, presented at the European Society of Cardiology (ESC), confirmed that, for the first time since the introduction of warfarin 55 years ago, we have taken a step towards being able to potentially offer an oral single-drug approach as an alternative to traditional standard treatment [a combination of low molecular weight heparin (LMWH) and warfarin] to patients with deep vein thrombosis (DVT).
Clopidogrel anticlotting prescription, in doubled dosages minimizes risk of cardiovascular deaths, heart attaches ad strokes by 14%. Intensified bleeding in patients did rise by 40%, but proved to show zero percent increase in coronary artery bypass graft surgery patients, intracranial bleeding or fatalities.
This trial included patients (n=18,624) with acute coronary syndrome randomly assigned ticagrelor 180-mg loading dose and 90-mg twice-daily maintenance dose vs. clopidogrel 300- to 600-mg loading dose and 75-mg maintenance dose for 6 to 12 months.
Two studies presented August 29, 2010, at the European Society of Cardiology (ESC) Congress demonstrated the effectiveness of the newer P2Y12 inhibitor drugs ticagrelor and prasugrel in overcoming high platelet reactivity compared with the standard antiplatelet agent clopidogrel.
The researchers found that the composite outcome of major or minor bleeding or major vascular access-site complications occurred in 4.7 percent of patients receiving a low dose of heparin, compared with 5.8 percent in the those receiving a standard dose (P = .27). Rates of major bleeding were similar between the two groups, though minor bleeding occurred in 0.7 percent in the low-dose group compared with 1.7 percent in standard-dose recipients (P = .04).
"The results of the EINSTEIN-DVT trial indicate that rivaroxaban is an effective and safe treatment for acute symptomatic DVT," said principal investigator, Professor Harry R. Büller, Academic Medical Center, Amsterdam, the Netherlands. "The single-drug approach with rivaroxaban will provide clinicians and patients with an attractive, simple, alternative regimen for the initial and long-term treatment of deep vein thrombosis."
The future of genetic testing to identify poor metabolizers of clopidogrel remains foggy after presentation of multiple substudies of randomized controlled trials here.
Late thrombosis of drug-eluting stents may be a greater risk for African Americans, according to a retrospective study. Black race emerged as the strongest independent predictor, conferring a 2.60-fold elevated risk of definite stent thrombosis beyond 30 days after implantation (P=0.0023) compared with all other ethnicities together, Ron Waksman, MD, of Washington Hospital Center in Washington, D.C., and colleagues found.
Results from the study showed that a high risk population was recruited, 18% of them elderly (over 75 years) and 5% in shock or cardiac arrest. Primary PCI was performed through a radial access in 68% of cases, with 75% of patients receiving GPIIb/IIIa inhibitors and two-thirds of patients receiving high dose clopidogrel.
At last year's ESC the RE-LY trial heightened interest in the prospect of dabigatran as a potential replacement for warfarin. Now the RE-LY investigators have analyzed the trial in an attempt to see whether the local standard of care has an impact on the beneficial effects of switching to dabigatran.
Our study showed that regular, moderate intensity physical exercise did not have any significant impact on the risk of venous thromboembolism in a general population. Future studies are required to assess the impact of regular physical on venous thromboembolism risk in different population subgroups.
New clopidogrel users on PPIs are at an increased risk of cardiovascular and GI complications compared with those who are not using a PPI. The inferior cardiovascular profile of clopidogrel users on PPIs and the occurrence of channeling bias may be important factors underlying this observation.
Seven of 213 patients in the Interstate Collaboration of the Enterprise Stent Coiling (ICES) Multicenter Registry experienced a thrombotic event 2-24 weeks after placement of the stent and stopping aspirin and clopidogrel, Dr. J. Mocco reported at the annual meeting of the Society of NeuroInterventional Surgery. Another two patients experienced acute cases of stent thrombosis.
Concomitant use of a proton pump inhibitor and clopidogrel significantly increased the risk of myocardial infarction but not death, a meta-analysis involving almost 160,000 patients found.
New P2Y12 inhibitors decrease mortality after PCI compared with clopidogrel. The risk/benefit ratio is particularly favorable in PCI for STEMI patients.
CT pulmonary angiography and perfusion scanning have equivalent clinical negative predictive value (99% for CT pulmonary angiography; 100% for perfusion scanning) and image quality in the care of pregnant patients. Therefore, the choice of study should be based on other considerations, such as radiation concern, radiographic results, alternative diagnosis, and equipment availability. Reducing the amount of radiation to the maternal breast favors use of perfusion scanning when the radiographic findings are normal and there is no clinical suspicion of an alternative diagnosis.
A diagnostic strategy combining clinical assessment, D-dimer, ultrasonography, and lung scan gave a non-invasive diagnosis in the vast majority of outpatients with suspected pulmonary embolism, and appeared to be safe.
Bivalirudin reduced 1-year mortality and recurrent MI vs. unfractionated heparin plus glycoprotein IIb/IIIa inhibitors in high-risk patients undergoing primary percutaneous coronary intervention for acute MI, study data indicated.
Ambulatory treatment with enoxaparin plus warfarin seems to be effective in symptomatic healing and in clinical improvement by reducing thrombus formation and organization at all levels of lower extremity venous system with DVT, without a significant major bleeding risk. Therefore, the results of our conventional conservative treatment are in line with 1A level evidence reported in the recent American College of Chest Physicians guideline.
Pericardial fat volume is highly associated with paroxysmal and persistent AF independent of traditional risk factors including left atrial enlargement. Whether pericardial fat plays a role in the pathogenesis of AF requires future investigation.
Statin use is associated with significantly reduced odds of developing VTE, DVT or PE by 32%, 41% and 30% respectively. Our meta-analysis included one RCT, JUPITER, which alone provided statistically significant reduction in the odds of developing VTE and DVT (43% and 55% respectively), and a nonsignificant reduction on PE. Conclusion: Currently available evidence suggests that statins can reduce patients' odds of developing VTE.
The use of bivalirudin should be considered a safe and effective anticoagulation regimen during CAS, using PEO as a distal protection device. Bivalirudin use is associated with a reduced incidence of bleedings.
Whilst DVT and PE are manifestations of the same disease, the phenotypic expression is predetermined. Patients presenting with PE are 3-times more likely to suffer recurrence as PE than patients presenting with DVT. Patients presenting with calf DVT are at low risk of recurrence and at low risk of recurrence as PE.
Our presentation is one of the very rare cases reported in literature regarding acute thrombosis of left main coronary artery related to cocaine use, in a patient with normal coronary arteries, successfully operated.
Overall, patients with previous ST had a reduced antiplatelet effect of aspirin, which might be explained by an increased platelet turnover.
Low platelet responsiveness to clopidogrel, a known predictor of thrombotic complications, does not have a significant impact on restenosis after DES.
This large study indicates that VTE outpatients seen by general practitioners in Italy have a high prevalence of the same medical diseases associated with VTE among patients treated in hospital.
Especially those with contraindications for oral anticoagulation are in a need of an alternative approach that is not associated with a long-term risk of hemorrhage and other attendant circumstances. The reasonable alternative may be the exclusion of the LAA cavity from circulation by either surgical or percutaneous catheter-based procedures.
Surveillance for and early recognition of thrombocytopenia, an appropriate differential diagnosis, and early institution of treatment are critically important in the management of patients with acute coronary syndromes.
Patients undergoing surgery receive anticoagulation for perioperative thromboprophylaxis or ischemic cardiovascular disease. Because anticoagulants may also potentiate bleeding, clinicians need to understand the implications of anticoagulation in perioperative and postoperative patient management. Many newer anticoagulants that are now available or are in clinical development do not require routine coagulation monitoring, have more predictable dose responses, and have fewer interactions with other drugs and food.
Pulmonary embolism (PE) is one of the major complications after percutaneous balloon angioplasty (PTBA) for Budd-Chiari's syndrome (BCS). The purpose of this study was to investigate the role of warfarin pre-treatment in the prevention of PE after PTBA in patients with large inferior vena cava (IVC) thrombus.
Although recombinant activated Factor VII reversed the effects of warfarin, it did not lead to improvements in bleeding model parameters, according to data from an exploratory phase 1 analysis published in Blood.
New Thrombosis publications available for July 2010.
Non-carriers of the CYP2C19*2 loss-of-function genetic polymorphism were able to overcome high on-treatment platelet reactivity with adjusted loading doses of clopidogrel, new study results indicated.
The authors found a high degree of consensus concerning a number of problems in the management of anticoagulation services. Consultant haematologists and chief pharmacists expressed concern about the level of competence of junior medical and nursing staff and the quality of patient discharge from general inpatient wards.
The simplified PESI has similar prognostic accuracy and clinical utility and greater ease of use compared with the original PESI.
In a safety alert, the FDA cautioned that it had received hundreds of reports of adverse events for retrievable inferior vena cava (IVC) filters since 2005 -- including device migration, perforation of the vena cava, filter embolization, and filter fracture. The agency expressed concern that physicians don't always remove the IVC filters -- intended only for short-term placement -- once a patient's risk for pulmonary embolism subsides. The FDA recommended that physicians consider removing the IVC filter as soon as the pulmonary embolism risk subsides -- since the risk of device migration and fracture appears related to the length of time the filter remains in the body.
"Although the primary efficacy endpoints were not met, the results of this study support the use of rheolytic thrombectomy before infarct artery stenting in patients with acute MI and evidence of coronary thrombus," the researchers wrote in the study. "However, the routine use of rheolytic thrombectomy in acute MI should be confirmed by future larger trials."
Based on our findings, majority of VTE in cancer patients occurred due to failure to offer prophylaxis, minority were due to prophylaxis failure. Meticulous quality improvement programs should be established to emphasize the importance of implementing more intensive prophylaxis among high-risk cancer patients.
VTE occurring in hospitalized patients carries a significantly higher risk for death of PE than in outpatients, underscoring the importance of VTE prevention strategies in the hospital setting.
Prescribed doses of low molecular weight heparins (LMWHs) for the treatment of a thromboembolic event are dependent on the weight of the patient and renal function. Underdosing has an increased risk of a further thromboembolic event, while overdosing can increase the risk of bleeding.
The incidence of venous thromboembolism (VTE) in the two calendar quarters following upper extremity arthroplasty was comparable to total hip arthroplasty. Specifically, the risk for pulmonary embolism (PE) was 6.7 per 1,000 patients for total shoulder arthroplasty compared to 8.7 per 1,000 patients in the hip.
NICE has provisionally recommended the wider use of clopidogrel in people who have previously had a stroke, or who have been diagnosed with peripheral arterial disease - putting them at high risk of stroke or heart attack.
Major orthopedic surgery (total hip replacement [THR], total knee replacement [TKR] or hip fracture surgery [HFS]) carries a high risk of venous thromboembolism (VTE). Pulmonary embolism (PE) following orthopedic surgery is reported to be rare. However, without prophylaxis, hospital-acquired deep venous thrombosis (DVT) has been estimated to occur in 40-60% of cases in the 7-14 days following surgery compared to 10-40% among medical or general surgical patients. A variety of strategies to prevent VTE are available and with routine use, the rate of symptomatic VTE in patients within 3 months of surgery is 1.3-10%.
Warfarin and other vitamin K antagonists are very effective for the treatment and prevention of both arterial and venous thromboembolism. Recombinant factor VIIa may not be as effective as previously thought for the urgent reversal of warfarin
Most surgeons believe that Asians have a low risk of developing venous thromboembolism (VTE) and routine thromboprophylaxis therapy is not required after major orthopaedic trauma. This study evaluates the postoperative risk of VTE in Indian patients sustaining pelvi-acetabular injury.
Non-fatal strokes increased mortality in ACTIVE-W, but non-disabling strokes did not. Among major bleeding events, only those also classified as severe increased mortality. Future research should emphasize the prevention of disabling strokes and severe bleeds and place less emphasis on non-disabling stroke or major bleeds that are not severe.
We demonstrated that protamine affects the propagation of thrombin generation, which is partially reversed by platelets or increased factor VIII/von Willebrand factor concentrations. The present data suggest that excess protamine might potentially increase bleeding in the case of severe thrombocytopenia or low factor VIII.
The combination of clopidogrel plus ASA did not improve limb or systemic outcomes in the overall population of PAD patients requiring below-knee bypass grafting. Subgroup analysis suggests that clopidogrel plus ASA confers benefit in patients receiving prosthetic grafts without significantly increasing major bleeding risk.
Bayer today announced that a novel, convenient single-drug treatment approach with oral rivaroxaban met the primary efficacy endpoint of non-inferiority in the EINSTEIN-DVT Phase III clinical trial and showed an overall relative risk reduction compared to the current standard therapy in the treatment of deep vein thrombosis (DVT) - initial enoxaparin treatment, followed by a vitamin K antagonist.
A total of 409 patients (39% with acute coronary syndrome) were randomized to receive a 600-mg clopidogrel loading dose 4 to 8 h before PCI (pre-load group, n = 204) or a 600-mg loading dose given in the catheterization lab after coronary angiography, but prior to PCI (in-lab group, n = 205). Primary end point was 30-day incidence of major adverse cardiac events: cardiac death, myocardial infarction (MI), or unplanned target vessel revascularization.
Endocrine alterations consequent to controlled ovarian hyperstimulation for IVF place patients at risk for thromboembolic events. Thromboembolic events may occur during an IVF cycle in the absence of overt ovarian hyperstimulation, an inherited thrombophilia, or pregnancy. Early diagnosis and treatment of superior mesenteric vein thrombosis can lead to a favorable outcome. Treatment guidelines for superior mesenteric vein thrombosis in setting of IVF are discussed.
Perfluorocarbon gas-containing BL with RGD peptide represent a novel echo contrast agent, which can markedly enhance ultrasonic thrombus imaging in vitro and in vivo, and may be useful for noninvasively diagnosing acute thrombotic vessel occlusion.
Spontaneous fibrinolysis of IVC thrombus occurs within 1 year in the majority of the patients treated with warfarin. Pre-treatment with warfarin prevents PE after PTBA in the patients with BCS with IVC membranous or segmental occlusion and large thrombus.
The total cost for warfarin-based anticoagulation amounted to at least 10 times the lowest cost for the drug. The costs provided should be useful for comparisons with newer drugs without requirement for routine laboratory monitoring and dose adjustments.
In patients aged at least 90 years presenting with acute pulmonary embolism, the incidence of fatal pulmonary embolism by far outweighs the incidence of fatal bleeding, and pulmonary embolism is the most common cause of death. Thus, there seems to be more reason to be concerned about fatal pulmonary embolism than about bleeding in elderly patients presenting with pulmonary embolism.
Clopidogrel is a prodrug that is converted via the hepatic cytochrome P450 system into its active thiol metabolite. Evidence is accumulating that proton pump inhibitors (PPIs) inhibit this enzymatic pathway and may therefore attenuate the antiplatelet effect of clopidogrel. The objective of this study was to investigate whether patients on clopidogrel therapy after drug-eluting stent (DES) placement who also receive a PPI are at higher risk of stent thrombosis (ST).
Study findings suggest that outpatient management of uncomplicated pulmonary embolism, in the absence of other indications for hospital admission, is effective and does not increase the risk for complications.
Restoration of myocardial perfusion is the goal of percutaneous coronary intervention (PCI) in patients with ST elevation myocardial infarction. A major predictor of no-reflow is the increasing time to treatment (TTT). Thrombus aspiration (TA) is reported to improve myocardial reperfusion as compared with standard PCI (SP).
This review examines the original studies, which suggested the adverse interaction, the subsequent and most recent studies, the pharmaco-dynamics of the two drugs and suggests an algorithm for the use of clopidogrel with proton pump inhibitors.
Some patients receiving oral anticoagulation therapy are more challenging to maintain within the therapeutic range than others. Our findings can be used to identify patients who require closer attention or innovative management strategies to maximize benefit and minimize harm from oral anticoagulation therapy.
DOCTORS are urging travellers not to take sleeping tablets during long-haul flights following the death of a healthy woman from blood clots. The 36-year-old woman, who was not identified due to patient confidentiality laws, had taken a single sleeping tablet and spent most of the flight asleep in one position, the New England Journal of Medicine reported last week.
The earlier a patient with ST-segment elevation myocardial infarction (STEMI) receives clopidogrel before primary coronary intervention (PCI), the better, according to a study in the July issue of the American Heart Journal. Earlier ìupstreamî pretreatment allows for optimal platelet inhibition and reduces ischemic complications such as reinfarction or stent thrombosis, without increased bleeding complications, the researchers say.
Iverson Genetic Diagnostics today announced the company has received approval from CMS to conduct a WARFARIN Clinical Study. The two-year (2) study will assess the impact of genetic information in calculating doses and the changes in the rate of adverse events when initiating Warfarin drug therapy. These changes will be compared against doses initiated without genetic data. The randomized and blinded, multi-center study will involve more than 7000 participants at over 50 sites nationwide.
Barbato and team studied 313 consecutive patients with STEMI who underwent primary PCI. Of these patients, 62% received thrombus aspiration before PCI, while the remainder were treated with conventional PCI alone. The decision to use thrombus aspiration or conventional PCI was left to the treating physician and patient characteristics were not significantly different between the two groups.
Surface induced thrombus generation is a major clinical concern associated with vascular medical devices and implants. Here, we show that high graft density hydrophilic non-charged poly (N,N-dimethylacrylamide) (PDMA) brushes prevent the initiation of blood coagulation on synthetic surfaces. Using a multi-faceted analysis approach, we have identified that PDMA brushes greater than 0.27 chains/nm2 graft density showed this highly desired property.
New Thrombosis publications available for June 2010.
In this article, we present a case of PE after silent (symptomless) DVT due to femoral catheterization. The patient had critical coronary artery disease and was a candidate of coronary artery bypass grafting. A inferior vena cava filter was implanted prior to cardiac surgery for prevention of a potential pulmonary embolus.
If untreated, the hospital mortality rate for major PE is 30%, whereas the mortality drops markedly in anticoagulated patients, emphasizing the need for rapid, accurate imaging for diagnosis and prognosis.
The FDA noted in its press release (see below) that the approval process for a "natural product" like enoxaparin is more complex than the process for small molecules. "Before approving generic enoxaparin sodium injection, we expected, among other things, a series of sophisticated analytical tests and a study in healthy volunteers to assure that the drug would be as safe and effective as the brand name product," said Keith Webber, Ph.D., deputy director of the FDA’s Office of Pharmaceutical Science, in an FDA press release.
69 out of 140 patients showed right heart dysfunction by echocardiography within 24 hours after diagnosis, 71 did not. Right ventricular dysfunction was significantly more frequent in patients with central clots on computed tomography (p=0.004), a history of syncope (p<0.001) and among women on oral contraceptives (p=0.003). In multiple regression analysis, only central thromboembolism (p<0.001) was identified as individual predictor of right ventricular dysfunction.
Rivaroxaban clearance is decreased with increasing renal impairment, leading to increased plasma exposure and pharmacodynamic effects - as expected for a partially renally excreted drug. However, the influence of renal function on rivaroxaban clearance was moderate, even in subjects with severe renal impairment.
Central and thoracic phlebectasia in patients with CLOVES syndrome is common and increases the risk of pulmonary embolism. Aggressive prophylactic measures should be considered before major interventions.
Cerebral venous sinus thrombosis (CVST) is one of the common causes of stroke in young people. Mortality in CVST, in addition to progressive thrombosis, is related to elevated intracranial pressure causing transtentorial herniation. The role of decompressive surgery in CVST is not well established.
This prospective study evaluated the risk of arterial thrombosis in 195 consecutive patients aged 18 to 65 years with newly diagnosed multiple myeloma (MM). All patients were treated with 3 cycles of VAD (vincristine, doxorubicin, and dexamethasone) or TAD (thalidomide-AD) or PAD (bortezomib-AD) in national trials, followed by high-dose melphalan and autologous stem cell transplantation.
There is a lack of information on clinical risk factors for venous thromboembolism (VTE) development following prolonged traveling. Clinical characteristics and additional risk factors for VTE in travelers were analyzed in RIETE, an ongoing registry of patients with symptomatic, confirmed acute VTE. Of 26,172 patients enrolled in RIETE as of May 2009, 2% developed VTE in association with recent traveling.
Renal cell carcinoma with intravenous tumor thrombus remains one of the most intriguing and challenging topics in urological oncology. With better understanding of the biology of intravascular tumor invasion and improvements in overall survival, the surgical and medical treatment of these patients is being completely redefined.
We used the International Study on Cerebral Vein and Dural sinus Thrombosis, which included 624 patients with CVT followed up for a median of 13.9 months. Outcome measures included all symptomatic VTEs and CVT recurrence. Potential predictors of recurrence, including demographic characteristics, imaging features, thrombophilic abnormalities, other risk factors for CVT, and anticoagulation, were analyzed by Cox survival analysis.
The purpose of this review was to analyse current knowledge and controversies associated with the diagnosis, treatment and prevention of recurrent venous thromboembolism (VTE).MEDLINE and manual searches were performed to select prospective papers on the diagnosis, treatment and prevention of recurrent VTE for their relevance and quality.The cumulative incidence of recurrent VTE increases from 11 per cent at 1 year to 40 per cent at 10 years.
The oral-direct thrombin inhibitor ximelagatran was withdrawn from the world market due to safety concerns. Newer anticoagulant drugs such as parenteral pentasaccharides (idraparinux, SSR126517E), novel oral-direct thrombin inhibitors (dabigatran), oral-direct factor Xa inhibitors (rivaroxaban, apixaban, YM-150, DU-176b), and tissue factor/factor VIIa complex inhibitors have been “tailor-made” to target specific procoagulant complexes and have the potential to greatly expand oral antithrombotic targets for both acute and long-term treatment of VTE, acute coronary syndromes, and for the prevention of stroke in atrial fibrillation patients.
There are several unanswered questions regarding clopidogrel loading prior to PCI. What is the optimal loading dose and timing of administration? Is non selective loading of all candidates of coronary angiography / possible PCI beneficial? What is the effect of adjunctive GPIIb/IlIa antagonists or bivalirudin treatment? Is a different policy necessary in ACS compared to stable coronary artery disease PCI? How we should act to overcome the increasingly recognized clopidogrel resistance? Recent experience suggests that there is no trend for less periprocedural events with delayed PCI following high dose clopidogrel loading compared to immediate PCI after loading. Several uncertain aspects are discussed.
The dramatic growth in the number of catheter ablations for atrial fibrillation and other left atrial arrhythmias has brought into sharp focus the incidence of thrombo-embolic complications, most frequently cerebrovascular in nature.
Outpatient management of uncomplicated pulmonary embolism seems safe and effective in the absence of other indications for hospital admission.
Pulmonary embolism (PE) is generally treated with blood thinners, but a more aggressive treatment may be required for massive PE in hemodynamically compromised patients, said Ali Amin, M.D., a vascular surgeon at The Read Hospital and Medical Center in Reading, Pa.
The incidence of venous thrombosis increases sharply with age: it is very rare in young individuals (<1 per 10 000 per year) but increases to ∼ 1% per year in very old age, which indicates that ageing is one of the strongest and most prevalent risk factor for venous thrombosis. The cause of this steep age-gradient is as yet, unexplained. The aim of this review was to provide an overview of studies on the effect of conventional risk factors as well as age-specific risk factors for thrombosis in the elderly.
We found as high a prevalence of VTE in stage IV melanoma as in lung and gastrointestinal cancers. All patients suffered thrombotic events when they were treated with chemotherapy and at home when they stopped heparin prophylaxis. Therefore, heparin prophylaxis should be maintained at home.
Half the standard dose of tissue plasminogen activator for pulmonary embolism exhibits similar efficacy and perhaps better safety in patients with acute pulmonary embolism.
New Thrombosis publications available for May 2010.
This systematic review demonstrates the underuse of oral anticoagulation therapy for real-world atrial fibrillation patients with an elevated risk of stroke, highlighting the need for improved therapies for stroke prevention in atrial fibrillation.
Our findings suggest that it is feasible to use the present simple citrate-enriched dialysate to dialyse patients safely and effectively. Furthermore, the approach is much simpler than a conventional, intermittent, saline-flushing method.
In the present population-based study, morbidity and mortality after outpatient PE were much higher than what was observed in clinical studies. Our findings raise questions about broad-based outpatient treatment of PE in the community setting. In our study, comorbid conditions and recent illness were important determinants of adverse outcomes, suggesting that these variables should be carefully considered before embarking on outpatient therapy of PE.
Use of extended-duration enoxaparin reduces VTE more than it increases major bleeding events in acutely ill medical patients with level 1 immobility, those older than 75 years, and women.
With several types of thromboprophylaxis indicated for primary total hip and knee arthroplasty — and only a few agreed-upon guidelines in place — the strategies that orthopaedic surgeons use for preventing venous thromboembolism in their patients vary greatly by geographic region, country, hospital and sometimes within departments. Yet common to them all is the goal of safely and effectively avoiding clinically significant deep vein thrombosis and pulmonary embolism events, while minimizing complications.
First-line therapies for HIT are argatroban or lepirudin. Patient-specific factors determine which drug should be used, and taking advantage of their differences allows effective anticoagulation with minimal risk of bleeding. Bivalirudin and fondaparinux require further study before they can be recommended. Once proven well tolerated and effective for treating thrombosis, these new oral anticoagulants should next be studied for treating HIT.
The new quality standards are a set of concise statements that show what high-quality care should look like for these conditions. The standards are sourced from the best available evidence such as NICE guidance, or evidence accredited by NHS Evidence.
A recent study published in The Lancet Oncology has found that men with prostate cancer are twice as likely as healthy men to suffer a blood clot, and those with the disease who undergo certain conventional treatments are at an even greater risk.
Use of extended-duration enoxaparin reduces VTE more than it increases major bleeding events in acutely ill medical patients with level 1 immobility, those older than 75 years, and women.
Patients taking warfarin, aspirin, or both up to the time of phacoemulsification had a significantly higher incidence of subconjunctival hemorrhage than those who discontinued therapy. There was no significant difference between the 2 groups in the incidence of intraoperative and postoperative complications or in visual improvement.
A higher incidence of catheter related infections was observed in patients with central venous catheters in contrast to patients with totally implanted access ports were venous thrombosis was more frequent.
The length of the hyperdense middle cerebral artery sign as detected on thin-slice NECT reconstructions in patients with acute ischemic stroke can be used to quantify thrombotic burden accurately. Thus, it might qualify as a new diagnostic parameter in acute stroke management that indicates and quantifies the extent of vascular obliteration.
Our findings demonstrate the effects of hypertension on the outcomes of warfarin therapy; further investigation is needed to clarify whether more aggressive antihypertensive therapy could result in better outcomes in hypertensive patients with non-valvular AF.
Depending on the estimated risk of an adverse outcome, admission to an intensive care unit and treatment with thrombolysis or catheter or surgical embolectomy may be required, but early hospital discharge or even home treatment may be considered. This review focuses on the optimal diagnostic strategy and management, according to the clinical presentation and estimated risk of an adverse outcome.
Even before prasugrel was approved by the US Food and Drug Administration (FDA) last year for use in patients with acute coronary syndromes (ACS) undergoing percutaneous coronary intervention (PCI), concerns were raised regarding a possible increased risk of cancer with the drug. Now, in a review of unpublished data that appears in the June 28, 2010, issue of Archives of Internal Medicine, clinicians and researchers bring this concern to the forefront again and suggest that the cancer risk is higher than initially thought.
This March, the Food and Drug Administration (FDA) revised the product label of clopidogrel, highlighting how genetic differences could affect response to the antiplatelet drug and listing options for patient management. To help physicians interpret the new FDA warning, the American College of Cardiology Foundation (ACCF) and American Heart Association (AHA) issued a joint clinical alert on June 28, 2010.
Clopidogrel-treated patients who carry a loss-of-function gene variant for the key enzyme needed to metabolize the drug and/or use a proton pump inhibitor (PPI) face an increased risk of cardiovascular events and death, according to a meta-analysis published in the July 5, 2010, issue of the Journal of the American College of Cardiology. However, the impact of PPIs appears to be limited to those at high baseline risk.
Because the study was not randomized, the treatment effect of various antithrombotic strategies was not assessed and the "results must be taken with caution," Dr. Lopes stressed. "We just looked at adjusted associations." That being said, Dr. Lopes characterized the lower mortality rate associated with bivalirudin as intriguing and noted it had not been shown in prior studies of NSTEMI patients. However, this finding was "likely confounded by other factors that can’t be assessed due to lack of randomization," he said. One such factor may have been the higher use of clopidogrel before PCI in these patients, which possibly contributed to better survival.
Risk factors for venous thromboembolism (VTE) are often modifiable and overlap with risk factors for coronary artery disease. Encouraging our patients to adopt a heart-healthy lifestyle by abstaining from cigarettes, maintaining lean weight, limiting red meat intake, and controlling hypertension might lower the risk of pulmonary embolism and deep vein thrombosis (DVT), although a cause-effect relationship has not been firmly established.
The strategy game Mah-Jong is one of the most popular leisure activities in many Chinese communities, especially in rural areas and the residential districts of cities. The activity involves sitting still for long periods and deep concentration. We report a case of deep-vein thrombosis (DVT) associated with Mah-Jong.
Findings from a real-world registry of patients with stent thrombosis after drug-eluting stent (DES) implantation suggest that presentation and outcomes vary depending on when the event occurs. The study was published online June 21, 2010, ahead of print in Circulation.
In patients with STEMI presenting for PCI, enoxaparin was associated with a reduction in all ischemic complications, more frequent therapeutic anticoagulation, and no increase in major bleeding when compared against unfractionated heparin.
High tea consumption is associated with a reduced risk of CHD mortality. Our results suggest a slight risk reduction for CHD mortality with moderate coffee consumption and strengthen the evidence on the lower risk of CHD with coffee and tea consumption.
Low response to clopidogrel as assessed by vasodilator-stimulated phosphoprotein (VASP) phosphorylation testing increases the risk of cardiovascular death as well as overall stent thrombosis in patients who undergo percutaneous coronary intervention (PCI), according to data from a prospective registry published in the June 2010 issue of JACC: Cardiovascular Interventions. The study identifies a threshold of residual platelet reactivity associated with increased adverse events.
In patients with prior DVT, perioperative symptomatic recurrence is common and is associated with high-risk procedures. A longer time interval between a DVT episode and subsequent surgery may decrease the risk of recurrence, but large clinical trials are needed to confirm this. Further prospective evaluations are needed to identify and treat patients at greatest risk for recurrence.
Risk factors for venous thromboembolism (VTE) are often modifiable and overlap with risk factors for coronary artery disease. Encouraging our patients to adopt a heart-healthy lifestyle by abstaining from cigarettes, maintaining lean weight, limiting red meat intake, and controlling hypertension might lower the risk of pulmonary embolism and deep vein thrombosis (DVT), although a cause-effect relationship has not been firmly established.
The acute exacerbation of COPD patients, who were immobilized for over 3 days, complicated by pneumonia and had respiratory failure type II, had a higher risk of DVT. In addition, DVT detection awareness should be increased in cases that had a lower extremity pain.
A new study of 1,960 White-Americans and 368 Black-Americans with objectively diagnosed venous thromboembolism (VTE) showed that, compared to Whites, Blacks had a significantly higher proportion with pulmonary embolism (PE), including idiopathic PE among Black women, and a significantly higher proportion of Blacks with VTE were women (71% vs 61% for Whites) The study is published today in the American Journal of Hematology.
This study has demonstrated that patients with a first episode of unprovoked isolated DVT are 2.1 times more likely to have a recurrent VTE episode than patients with a first episode of unprovoked isolated PE. These findings need to be considered when determining the optimal duration of anticoagulant therapy for patients with unprovoked VTE.
In patients with idiopathic VTE and a normal D-dimer at one month after anticoagulation suspension, females younger than 65 have a very low risk of recurrence.
Seniors who are traveling may be at risk for developing blood clots in the legs, particularly if they are sitting for long periods of time in one position. This medical condition can result in more serious complications if the clot begins to move and is known by several different names, including...
In this review, we summarise the advantages and disadvantages of three established anticoagulants (heparin, LMWH and warfarin) and the most promising new anticoagulants (fondaparinux, idraparinux, rivaroxaban, apixaban, dabigatran and ximelagatran) by discussing their pharmacodynamics and pharmacokinetics. We also discuss recent patents in the field of anticoagulation, which aim to improve the safety and effectiveness of antithrombotic agents currently in use or offer alternative ways for anticoagulation.
Results from two trials - ACTIVE-A and ACTIVE-W - were compared to determine the relative effects of aspirin; aspirin and clopidogrel (A+C); and warfarin on stroke rates and safety in patients with atrial fibrillation that had been determined to be both eligible and ineligible for warfarin treatment.
In patients with prior DVT, perioperative symptomatic recurrence is common and is associated with high-risk procedures. A longer time interval between a DVT episode and subsequent surgery may decrease the risk of recurrence, but large clinical trials are needed to confirm this. Further prospective evaluations are needed to identify and treat patients at greatest risk for recurrence.
Heparin-induced thrombocytopenia (HIT) is a life-threatening complication of heparin treatment; the prognosis depends on early and accurate diagnosis, and prompt start of alternative anticoagulants. Because of high sensitivity, the commercially available immunologic assays are widely used, though not suited to be run on single samples and with a turnaround time of 2-3 hours. We evaluated two new, rapid, automated, semi-quantitative chemiluminescent immunoassays in HIT suspected patients: HemosIL(R) AcuStar HIT-IgG(PF4-H) (specific for IgG anti-PF4/heparin antibodies) and HemosIL(R) AcuStar HIT-Ab(PF4-H) (detecting IgG, IgM and IgA anti-PF4/heparin antibodies) (both from Instrumentation Laboratory).
Venous thromboembolism(VTE) is a significant, common comorbidity of cancer patients associated with increased mortality. We evaluated the incidence and risk factors for developing a new VTE in ambulatory cancer patients while receiving therapy for advanced cancer. We also examined the affect of developing a new VTE on survival for patients with gastroesophageal malignancies.
EINSTEIN is a global clinical development program composed of three clinical studies in more than 8,000 patients. Two of these studies enrolled patients with acute, symptomatic deep vein thrombosis (EINSTEIN-DVT) or pulmonary embolism (EINSTEIN-PE). In these two trials, patients received oral rivaroxaban 15 mg twice-daily for the first three weeks, followed by oral rivaroxaban 20 mg once-daily, compared with initial enoxaparin treatment followed by a vitamin K antagonist.
Women with breast cancer assigned tamoxifen who experienced a thromboembolic event were five times more likely to carry the Factor V Leiden mutation when compared with matched controls taking tamoxifen who did not experience an event.
Patients with inflammatory bowel disease (IBD) are at increased risk of a first venous thromboembolism (VTE), yet their risk of recurrent VTE is unknown. We performed a cohort study to determine the risk for recurrent VTE among patients with IBD compared with subjects without IBD.
Recent advances in the pediatric heart surgery, especially the Fontan procedure, has necessitated an increased use of oral anticoagulants in pediatric cardiac patients. Warfarin is the standard agent used for most pediatric indications, though there are very few randomized control studies in children regarding its use. This review summarizes the current indications and evidence base regarding the use of oral anticoagulants in the pediatric age group.
This review article discusses the clinical evaluation and pharmacological properties of novel oral anticoagulants in late and earlier stages of clinical development, thereby providing a critical analysis and an outlook on the future of oral anticoagulation in cardiovascular disease.
To determine whether thromboembolic risk factor assessment could accurately indicate the pretest probability for pulmonary embolism (PE), and if so, computed tomographic (CT) angiography might be targeted more appropriately than in current usage, resulting in decreased costs and radiation exposure.
Statins decrease the incidence of VTE in cancer patients and may additionally provide a survival benefit. These results should be confirmed in large randomized prospective studies.
Multiple myeloma patients are at an increased risk of developing deep vein blood clots, and several myeloma treatments further increase the risk. However, blood clots can often be prevented with the use of blood thinners, according to Dr. Todd Zimmerman of the University of Chicago during a myeloma education session on June 7 at the annual American Society of Clinical Oncology (ASCO) meeting.
Venous thromboembolism (VTE), which includes both deep vein thrombosis (DVT) and pulmonary embolism (PE), affects 900,000 Americans annually and is a major cause of morbidity and mortality in hospitalized patients. In particular, a postoperative patient is at high risk for venous stasis, vascular endothelial injury, and a hypercoagulable state, each of which is predisposing to DVT. The most severe complication of DVT is PE, which occurs in 500,000 patients each year in the United States and is fatal in 300,000 patients annually.
No significant association was found between oestrogen exposure, either oral contraceptives or HRT, and a lower risk of recurrent VTE after adjustment for age, or analysis restricted to women in the same age range as oestrogen contraceptives and HRT users, respectively. The risk of recurrent VTE is low in women after a first otherwise unprovoked oestrogen-associated VTE. However, this risk is not significantly lower than in women whose VTE was not related to oestrogen use.
A body weight less than 50 kg and moderate renal failure increased drug exposure. Although the population pharmacokinetic model of fondaparinux was described, this one requires to be validated in everyday practice.
With their potentially consistent and predictable clinical profile, oral formulation, and decreased need for coagulation monitoring, these new agents will likely increase the use and duration of anticoagulation treatment in thromboembolic disorders and reduce the burden associated with long-term management.
Portal venous thrombosis (PVT) is a potentially fatal complication following splenectomy. Its mechanisms and risk factors are poorly understood, especially in patients with cirrhosis and portal hypertension. This study investigated risk factors for PVT following splenectomy in such patients.
The assessment of stroke risk in atrial fibrillation requires a comprehensive inclusion of risk factors – which can be expressed as the CHA2DS2-VASc score. It will allow identification of ‘truly low risk patients’ where no antithrombotic therapy is an option, whilst all other AF patients with one or more risk factors would be considered for oral anticoagulation, especially with the availability of new oral anticoagulants that overcome the disutility of warfarin.
Leading Republicans on the House Energy and Commerce Committee are asking the Food and Drug Administration (FDA) what the agency is doing to pursue credible leads in investigating Chinese firms implicated in supplying imported contaminated heparin that killed scores of people and sickened hundreds starting in 2008.
A therapeutic INR during RFCA of AF reduces the risk of cerebral thromboembolic complications without increasing the risk of cardiac tamponade or major bleeding complications.
Patients with acute pulmonary embolism (PE) were identified retrospectively from patients hospitalized during a 2-year period from 2005 to 2007. Among adult patients (≥20 years), the incidence of established acute PE was 88 (0.17%) of 50 882 in Dongsan Hospital. The incidence of acute PE at Dongsan Hospital was 26% lower than that at Henry Ford Hospital (P < .01).
When pulmonary embolism is suspected in the ED, use of an enzyme-linked immunosorbent assay D-dimer assay, often at cutoffs higher than those currently in use (for patients in whom deep venous thrombosis is not clinically suspected), followed by compression ultrasonography as appropriate, can reduce costs and improve outcomes.
Pharmacological reperfusion of an occluded coronary artery using a fibrinolytic agent is still the only treatment option for many patients presenting with acute ST-elevation myocardial infarction (STEMI) in many centres worldwide. To reduce the risk of early reocclusion, anticoagulants need to be given as an adjunct to lytic therapy.
The clinical guideline on the prevention of venous thromboembolism (VTE) applicable to all hospital patients was published by the National Institute for Health and Clinical Excellence (NICE) in January 2010 with considerable media attention. We believe that adherence to this guidance will save lives that might otherwise be lost due to preventable pulmonary embolism (PE).
In-hospital and 30-day mortality rates were 3.0% and 7.7%, respectively. Patients who received heparin in the ED had lower in-hospital (1.4% vs 6.7%; P = .009) and 30-day (4.4% vs 15.3%; P < .001) mortality rates as compared with patients given heparin after admission.
The Vienna prediction model has been developed to assess risk of recurrence in patients who have experienced an unprovoked venous thromboembolism (VTE). This new risk-scoring system is a simple nomogram that uses information about the patient's sex, location of VTE, and D-dimer levels to predict the likelihood that the patient will experience recurrent VTE.
The subspecialists leading the Internal Medicine 2010 precourse on cardiology were there to educate internists, but they were also looking for some help from the generalists. Specifically, they asked for assistance with the mutual goal of preventing cardiovascular events in high-risk patients. “Hospitalization is so short. There’s no time to discuss many of these important issues,” said David L. Fischman, FACP, associate professor of medicine at Thomas Jefferson University in Philadelphia. “The outpatient management is so crucial.” He offered a number of tips for treating patients who have been discharged from the hospital after an acute coronary event.
Stroke incidence increases with age. Atrial fibrillation (AF) is an important risk factor for ischemic stroke and its incidence also increases with age. However oral anticoagulant therapy (OAT) tends to be underused in the elderly population.
For the great majority of patients undergoing percutaneous coronary intervention (PCI), substituting bivalirudin for unfractionated heparin (UFH) alone is not cost-effective. Only when bivalirudin is targeted to those who are at high risk of major bleeding does the expected benefit justify the new drug’s considerably greater cost, according to an analysis published online May 20, 2010, ahead of print in Circulation: Cardiovascular Quality and Outcomes.
"Implantation of pacemakers and defibrillators in patients on continued warfarin therapy with therapeutic INR appears to be safe and cost effective compared to bridging therapy or temporarily withholding of anticoagulation," the researchers observed. "These findings need to be confirmed by multicenter, prospective, randomized, controlled studies."
Dual antiplatelet therapy with aspirin plus clopidogrel appears more effective than aspirin plus dipyridamole at reducing embolisation in patients with acute carotid stenosis, researchers said here at the 19th European Stroke Conference (ESC).
DVT had previously been thought to be a problem in surgery patients or the elderly. But the new figures, obtained by the thrombosis charity Lifeblood from the Office of National Statistics, reveal an alarming number of young people are killed by the condition. The charity found that between 2005 and 2008, some 1,075 people aged 40 or under died of a blood clot. Of these, 60 were children or teenagers.
Venous thromboembolism is a leading cause for maternal mortality. Because of the increase risk for thromboembolism in pregnancy and the postpartum period, the clinician must be on high alert for the signs and symptoms and use appropriate diagnostics in a timely manner so that prompt anticoagulation therapy can be initiated.
This guideline clearly sets out recommendations for reducing the risk of VTE for patients in hospital. It updates and expands the 2007 guideline from NICE on reducing the risk of VTE for surgical patients by using the latest clinical and economic data and including sections on prevention for medical patients.
The subjects of this prospective study were 269 patients (mean age 74 years) with AF who were anticoagulated with warfarin. The D-dimer level was measured upon entry into the study. The endpoints were thromboembolic events and combined cardiovascular events (thromboembolic events, cerebral hemorrhage, myocardial infarction, and cardiovascular deaths). The mean duration of follow-up was 25 months.
A total of 17,421 patients with ACS (including non–ST-segment elevation myocardial infarction [STEMI], STEMI, and biomarker-negative ACS) were studied in the ACUITY (Acute Catheterization and Urgent Intervention Triage strategY) and the HORIZONS-AMI (Harmonizing Outcomes with RevasculariZatiON and Stents in Acute Myocardial Infarction) trials. An integer risk score for major bleeding within 30 days was developed from a multivariable logistic regression model.
Routine use of long graduated compression stockings (GCS) provides no clinical benefit, while routine use of short GCS is associated with higher risks of proximal deep venous thrombosis (DVT) than long GCS, for immobile patients hospitalised for acute stroke.
Venous thromboembolism (VTE), a condition in which a blood clot forms in a vein, is seen as the biggest cause of preventable hospital deaths in the UK. Derriford staff are marking National Thrombosis Week with an information stand in the hospital's main concourse on Wednesday, June 2. The aim is to raise awareness of how dangerous VTE can be for hospital patients.
The following are 10 points to remember about antiplatelet treatment for acute coronary syndromes (ACS).
In patients who are carriers of the CYP2C19*2 loss of function allele, progressively increasing the clopidogrel loading dose may help overcome high platelet reactivity, according to clinical trial results presented Thursday, May 27 at EuroPCR 2010. CYP2C19 is one of several genotypes associated with enzyme activity in the P450 family that are responsible for converting clopidogrel to its active metabolite.
In patients undergoing percutaneous coronary intervention (PCI) who experience stent thrombosis, stent fracture and strut malapposition are common regardless of stent type, according to late-breaking findings presented Thursday, May 27 at EuroPCR 2010. However, in patients with very late stent thrombosis, the incidence of incomplete stent apposition is 3 times higher with drug-eluting stents (DES) than with bare-metal stents (BMS).
Hospital-wide education, risk-assessment tools, electronic alerts, computerized decision-support systems, together with audit and feedback mechanisms, are valuable tools that can be used to promote the use of performance measures to drive improvement of VTE prophylaxis and clinical outcomes.
In conclusion, antiplatelet therapy reduces the incidence of venous thrombosis in JAK2-positive ET patients and the rate of arterial thrombosis in patients with associated cardiovascular risk factors. In the remaining low-risk patients, this therapy is not effective as primary prophylaxis of thrombosis and observation may be an adequate option.
New data from a warfarin comparison study shows that the health characteristics of the patients enrolled on the ROCKET AF trial more closely reflect the typical AF patient population than four other recent major trials in this category. The baseline demographic data, from Bayer Schering Pharma's study, were presented today at the 19th European Stroke Conference, Barcelona; the study is designed to assess the safety and efficacy of once-daily oral rivaroxaban against warfarin in 14,269 AF patients.
Patients with inflammatory bowel disease (IBD) are at increased risk of a first venous thromboembolism (VTE), yet their risk of recurrent VTE is unknown. We performed a cohort study to determine the risk for recurrent VTE among patients with IBD compared with subjects without IBD.
We identified several PE- and non-PE related determinants of QoL in patients with a history of acute PE, which is impaired compared to sex and age adjusted population norms. QoL after acute PE should be studied more extensively and added as standard measure to outcome studies.
Meyer and colleagues highlight that pulmonary embolism is easily missed, but the number of unsuspected cases is increasing with improved detection methods such as computed tomography. How clinically important are these asymptomatic emboli?