On Oral Anticoagulation Research Articles

Comparison of health-related quality of life among patients using novel oral anticoagulants or warfarin for non-valvular atrial fibrillation.

Objective:The aim of this study was to compare health-related quality of life (HRQoL) measures between novel oral anticoagulants (NOACs) and warfarin-treated Turkish patients who had been started on oral anticoagulants (OACs) due to non-valvular atrial fibrillation (AF) and to determine the effects of OACs on patient’s emotional status, anxiety and depression.Methods:A total of 182 patients older than 18 years with non-valvular AF and being treated with OACs for at least 6 months according to current AF guidelines who were admitted to outpatient clinics between July 2014 and January 2015 were included in this cross-sectional study. The exclusion criteria were receiving OACs for conditions other than non-valvular AF and being unable to answer the questionnaire. A questionnaire was administered to all participants to evaluate HRQoL, depression and anxiety. The mean differences between the groups were compared using Student’s t-test; the Mann–Whitney U test was applied for comparisons of the medians.Results:The annual number of hospital admissions was significantly higher in the warfarin group (p<0.001), and all HRQoL scores were significantly lower and Hospital Anxiety and Depression Scale (HADS) score was higher in the warfarin group (p<0.001). History of any type of bleeding was significantly higher in the warfarin group (p<0.001). However, none of the patients had major bleeding. Among patients who experienced bleeding, all HRQoL scores were significantly lower and HADS score was significantly higher (p<0.001 and p=0.002, respectively).Conclusion:Warfarin-treated patients had higher levels of self-reported symptoms of depression and anxiety and compromised HRQoL when compared with NOAC-treated patients. The results may be explained by higher rates of bleeding episodes and higher number of hospital admissions, which may cause restrictions in life while on warfarin treatment.

Injuries and outcomes associated with traumatic falls in the elderly population on oral anticoagulant therapy

IntroductionFall risk for older adults is a multi-factorial public health problem as 90% of geriatric injuries are caused by traumatic falls. The CDC estimated 33% of adults >65 years incurred a fall in 2011, with 30% resulting in moderate injury. While much has been written about overall risk to trauma patients on oral anticoagulant (OAC) therapy, less has been reported on outcomes in the elderly trauma population. We used data from the National Trauma Data Bank (NTDB) to identify the types of injury and complications incurred, length of stay, and mortality associated with OACs in elderly patients sustaining a fall. MethodsUsing standard NTDB practices, data were collected on elderly patients (≥65 years) on OACs with diagnosis of fall as the primary mechanism of injury from 2007 to 2010. Univariate analysis was used to determine patient variables influencing risk of fall on OACs. Odds ratios were calculated for types of injury sustained and post-trauma complications. Logistic regression was used to determine mortality associated with type of injury incurred. ResultsOf 118,467 elderly patients sampled, OAC use was observed in 444. Predisposing risk factors for fall on OACs were >1 comorbidity (p<0.0001). Patients on OACs were 188% and 370% more likely to develop 2 and >3 complications (p<0.0001); the most significant being ARDS and ARF (p<0.0001). The mortality rate on OACs was 16%. Injuries to the GI tract, liver, spleen, and kidney (p<0.0002) were more likely to occur. However, if patients suffered a mortality, the most significant injuries were skull fractures and intracranial haemorrhage (p<0.0001). ConclusionsRisks of anticoagulation in elderly trauma patients are complex. While OAC use is a predictor of 30-day mortality after fall, the injuries sustained are markedly different between the elderly who die and those who do not. As a result there is a greater need for healthcare providers to identify preventable and non-preventable risks factors indicative of falls in the anti-coagulated elderly patient.

Ictus isquémico en pacientes en tratamiento anticoagulante por vía oral

IntroductionCardioembolic stroke is associated with poorer outcomes. Prevention is based on oral anticoagulant (OAC) therapy. Haemorrhage is the main complication of OACs, which are sometimes ineffective. Patients and methodsWe retrospectively reviewed 1014 consecutive patients who suffered an ischaemic stroke between 2011 and 2013, analysing those who were receiving OAC treatment at stroke onset (107 patients in total) with special attention to aetiology, outcomes, and INR value in the acute phase. ResultsThe mean age (SD) was 71.9 (10) years. Patients had been treated with OACs for 5.9 (5.5) years; 98.1% of them were being treated for heart disease. INR was <2 in 77 patients (72%), and 30 patients (28%) had an INR≥2. Nine patients (8.4%) had INR values within the therapeutic range. According to TOAST classification criteria, 88.8% of strokes were cardioembolic and 1.9% were atherothrombotic.Anticoagulation therapy was discontinued in 48 patients (44.9%) due to haemorrhagic transformation (24 patients), extensive infarction (23), or endarterectomy (1). Therapy was resumed in 24 patients (50%) after a mean lapse of 36 days. This was not possible in the remaining patients because of death or severe sequelae.New OACs (NOACs) were prescribed to 9 patients (18.7% of all potential candidates). At 3 months, patients with INR>1.7 in the acute phase exhibited better outcomes than patients with INR≤1.7 (mRS 0-2 in 62% vs 30.8%; death in 10% vs 38.4%; P=.0004). ConclusionsSome patients taking OACs suffer ischaemic strokes that are usually cardioembolic, especially if INR is below the therapeutic range. OACs can be resumed without complications, and NOACs are still underused. Despite cases in which treatment is ineffective, outcomes are better when INR is above 1.7 at stroke onset.

Dual antiplatelet therapy in the anticoagulated patient undergoing percutaneous coronary intervention risks, benefits, and unanswered questions.

A commonly encountered scenario is the patient with atrial fibrillation (AF) on oral anticoagulation (OAC) who either develops an acute coronary syndrome or has to undergo percutaneous coronary intervention with stent placement. In such patients, separate indications suggest combining OAC and dual antiplatelet therapy (DAPT). This approach, however, increases the risk of bleeding as well as thromboembolic risk if bleeding does not occur. For optimal clinical results, the risks and benefits of all possible treatment options should be determined based on the best available data. This review provides an overview of the most recent data regarding the optimal treatment of AF patients with an indication for combined treatment with OAC and DAPT.

Outcomes Associated With Prothrombin Complex Concentrate for International Normalized Ratio Reversal in Patients on Oral Anticoagulants With Acute Bleeding.

Management of bleeding in patients on oral anticoagulants (OACs) is crucial in optimizing outcomes. No large studies examine 3-factor prothrombin complex concentrate (PCC) for OAC reversal. To assess outcomes after administration of 3-factor PCC for reversal of international normalized ratio (INR). We conducted an institutional review board-approved retrospective cohort study in all patients admitted to our level II trauma center over a 5-year period from 2007 to 2012 who received PCC for INR reversal and bleeding management. The primary outcome was assessment of efficacy as measured by achievement of INR < 1.5. Secondary objectives were to evaluate: factors associated with achievement of target INR, cessation of bleeding, mortality, outcome differences with or without fresh frozen plasma (FFP) or protocol utilization, safety, and cost. A total of 403 patients were evaluated. Target INR was achieved in 88.8% of patients and was influenced by baseline INR. Associated factors were younger age (P = 0.02), utilization of the institution's protocol (P < 0.01), and concomitant administration of vitamin K (P < 0.01). Concomitant FFP did not affect achievement. Bleeding cessation occurred in 333 (82.6%) patients, and 68 (16.9%) patients died. Patients who achieved target INR were more likely to have bleeding cessation (P < 0.01). The odds of survival for those who reached target INR was 3.8 times greater (P < 0.01). The incidence of thromboembolism was 3.7%. Three-factor PCC administration with IV vitamin K was effective for INR reversal and bleeding cessation and should continue to be a mainstay of therapy pending head-to-head outcome and cost comparisons with 4-factor products.

Paroxysmal atrial fibrillation occurs often in cryptogenic ischaemic stroke. Final results from the SURPRISE study

Atrial fibrillation (AF) increases the risk of stroke fourfold and is associated with a poor clinical outcome. Despite work-up in compliance with guidelines, up to one-third of patients have cryptogenic stroke (CS). The prevalence of asymptomatic paroxysmal atrial fibrillation (PAF) in CS remains unknown. The SURPRISE project aimed at determining this rate using long-term cardiac monitoring. Patients with CS after protocolled work-up including electrocardiography (ECG) and telemetry were included after informed consent. An implantable loop recorder (ILR) was implanted subcutaneously. PAF was defined by events of atrial arrhythmia >2min with a correlating one-lead ECG confirming the diagnosis. Eighty-five patients were monitored for a mean of 569days (SD ±310). PAF was documented in 18 patients (20.7%) during the study period and detected by ILR in 14 patients (16.1%). In three patients PAF was detected by other methods before or after monitoring and was undiscovered due to device sensitivity in one case. The first event of PAF was documented at a mean of 109days (SD ±48) after stroke onset. PAF was asymptomatic in all cases and occurred in episodes lasting predominantly between 1 and 4h. Four recurrent strokes were observed, three in patients with PAF; all three patients were on oral anticoagulation (OAC). One in five patients with CS had PAF, which occurred at low burden and long after stroke. Future studies should determine the role of implantable cardiac monitors after stroke and determine the potential therapeutic benefit of OAC treatment of patients with PAF.

Mortality after ground-level fall in the elderly patient taking oral anticoagulation for atrial fibrillation/flutter

Elderly patients with atrial fibrillation or flutter who experience ground-level falls are at risk for lethal head injuries. Patients on oral anticoagulation (OAC) for thromboprophylaxis may be at higher risk for these head injuries. Trauma surgeons treating these patients face a difficult choice: (1) continue OAC to minimize stroke risk while increasing the risk of a lethal head injury or (2) discontinue OAC to avoid intracranial hemorrhage while increasing the risk of stroke. To inform this choice, we conducted a retrospective cohort study to assess long-term outcomes and risk factors for mortality after presentation with a ground-level fall among patients with and without OAC. Retrospective analysis of the longitudinal version of the California Office of Statewide Planning and Development database was performed for years 1995 to 2009. Elderly anticoagulated patients (age > 65 years) with known atrial fibrillation or flutter who fell were stratified by CHA2DS2-VASc score and compared with a nonanticoagulated control cohort. Multivariable logistic regression including patient demographics, stroke risk, injury severity, and hospital type identified risk factors for mortality. A total of 377,873 patient records met the inclusion criteria, 42,913 on OAC and 334,960 controls. The mean age was 82.4 and 80.6 years, respectively. Most were female, with CHA2DS2-VASc scores between 3 and 5. Mortality among OAC patients after a first fall was 6%, compared with 3.1% among non-OAC patients. Patients dying with a head injury constituted 31.6% of deaths within OAC patients compared with 23.8% among controls. Risk of eventual death with head injury exceeded annualized stroke risk for patients with CHA2DS2-VASc scores of 0 to 2. Predictors for mortality with head injury on the first admission included male sex, Asian ethnicity, a history of stroke, and trauma center admission. Elderly patients on OAC for atrial fibrillation and/or flutter who fall have a greater risk for mortality compared with controls. Patients with low CHA2DS2-VASc scores (0-3) at high risk for falls with identified risk factors should speak to their prescribing physicians regarding the risk/benefits of continued use of OAC. Epidemiologic/prognostic study, level III.

CP-151 Pharmacist plays an important role in managing anticoagulation therapy

BackgroundThe complexity of managing vitamin K antagonist therapy has led to the development in many countries of anticoagulant management services. In Belgium, a previous study in Erasme hospital showed that...

Abstract W P309: Hemorrhagic Risk Associated with Warfarin Initiation among Patients with Atrial Fibrillation: Assessment via a Large Insurance Database

Objective: Studies suggest that warfarin may increase the risk of stroke in the first month after initiation among atrial fibrillation (AF) patients. This study assess whether there is a similar occurrence with major bleeds. We compared rates of major bleeds (hospitalizations for bleeding) in the first 30 days and &gt;30 days after warfarin initiation between AF patients treated with warfarin and AF patients not on oral anticoagulants (OACs) in a large database. Methods: We identified adult AF patients via one inpatient or two outpatient AF diagnosis claims from the MarketScan insurance database with 95 million enrollees from 1/1/2008 to 3/31/2012. AF patients who started warfarin based on prescription claims, 1/1/2009-12/31/2010 and who didn’t use OACs 6-month prior were defined as warfarin initiators. Comparators were AF patients not on OACs from 7/1/2008-12/31/2010 and were 1:1 matched to warfarin initiators on age, sex and date of AF diagnosis. Patients were followed until major bleeding, discontinuation/switch of therapy, disenrollment, or end of study. We report crude rates of major bleeding and adjusted hazard ratios (HRs). Result: We studied 45,052 AF patients with an average follow-up of 1.9 years. Warfarin initiators and comparators were the same age (73.0) and sex (50% female) but had slightly lower CHADS2 scores (1.7 vs. 1.8) and ATRIA bleed scores (2.2 vs. 2.4). Compared to patients not on OACs, the rates of bleeding were higher among warfarin initiators during the first 30 days (adjusted HR=1.70) and after 30 days (adjusted HR=1.77) (Table) (p for interaction=0.86). The bleeding rate was higher in the first 30 days than after 30 days for the warfarin initiators, but this was also observed for the comparators (p=.02). Conclusion: Compared with AF patients not on OACs, warfarin appears to increase the risk of major bleeding similarly during the first 30 days and thereafter even though the rate was higher in the first 30 days for both warfarin initiators and comparators.

The optimal management of patients on oral anticoagulation undergoing coronary artery stenting. The 10th Anniversary Overview.

Even 10 years after the first appearance in the literature of articles reporting on the management of patients on oral anticoagulation (OAC) undergoing percutaneous coronary intervention with stent (PCI-S), this issue is still controversial. Nonetheless, some guidance for the everyday management of this patient subset, accounting for about 5-8 % of all patients referred for PCI-S, has been developed. In general, a period of triple therapy (TT) of OAC, with either vitamin K-antagonists (VKA) or non-vitamin K-antagonist oral anticoagulants (NOAC), aspirin, and clopidogrel is warranted, followed by the combination of OAC, and a single antiplatelet agent for up to 12 months, and then OAC alone. The duration of the initial period of TT is dependent on the individual risk of thromboembolism, and bleeding, as well as the clinical context in which PCI-S is performed (elective vs acute coronary syndrome), and the type of stent implanted (bare-metal vs drug-eluting). In this article, we aim to provide a comprehensive, at-a-glance, overview of the management strategies, which are currently suggested for the peri-procedural, medium-term, and long-term periods following PCI-S in OAC patients. While acknowledging that most of the evidence has been obtained from patients on OAC because of atrial fibrillation, and with warfarin being the most frequently used VKA, we refer in this overview to the whole population of OAC patients undergoing PCI-S. We refer to the whole population of patients on OAC undergoing PCI-S also when OAC is carried out with NOAC rather than VKA, pointing out, when appropriate, the particular management issues.

Atrial fibrillation and treatment changes in cryptogenic stroke patients with an implantable loop recorder for continuous cardiac rhythm monitoring

Introduction: This interim analysis evaluates the risk profile and incidence of atrial fibrillation (AF) in patients who underwent continuous monitoring with an implantable loop recorder (ILR) for cryptogenic (unexplained) stroke or transient ischemic attack (TIA). Methods: The observational INSIGHT XT study prospectively enrolled patients who received an ILR with dedicated diagnostics for atrial fibrillation, irrespective of the clinical indication. Of 1002 patients enrolled in the study between Aug 2008 and Jan 2012, 121 received the ILR to evaluate cryptogenic stroke or TIA. The definition of cryptogenic stroke/TIA was at the investigators' appraisal and no unified approach to patient work-up was required. This analysis includes 74 patients with cryptogenic stroke or TIA for whom at least one follow-up visit was available at the time of interim analysis. Results: The mean age was 63±12 (50% female). Stroke was the index event in 46 of 74 (62%) of patients. 61% had hypertension, 14% diabetes, and none had heart failure. The mean CHADS2 score was 3.0±0.8 and the mean CHA2DS2VASc score 4.0±1.2. Most patients (72%) had no prior symptoms or cardiac rhythm disturbances, whereas 18% had a history of prior palpitations. Sixty-seven patients were taking antiplatelet medication and four were on oral anticoagulation (OAC) at enrollment. During a median follow up of 12 months (IQR 7 to 18) AF was reported in 17 patients (23%) and two patients were started on OAC and 10 patients were converted from antiplatelets to OAC. Five patients experienced a stroke or TIA (median time to event 1.2 months), of which one patient died. Three of the patients with stroke or TIA had AF detected prior to the recurrent event. Conclusion: Continuous monitoring with an ILR in patients with cryptogenic stroke of TIA detects a high proportion of AF; this can be attributed to longer continuous monitoring in this study. These patients have high CHADS2/CHA2DS2VASc scores; documenting AF in these cases may therefore be clinically relevant in order to decide appropriate treatment.

Anticoagulation in “real world” patients with atrial fibrillation in Italy: Results from the ISPAF (Indagine Sicoa Paziente Con Fibrillazione Atriale) survey study

BackgroundAtrial fibrillation (AF) is associated with a high risk of stroke and other thrombo-embolic events and their prevention relies on antithrombotic therapy, at present mainly with vitamin K antagonists (VKA). The aim of this study was to provide an overall picture on the extent to which current recommendations on oral anticoagulation (OAC) therapy with VKA in AF correspond to actually prescribed OAC in an unselected, real world, population of consecutive patients with AF in Italy. Secondary objective was to assess the rate of “optimal” anticoagulation. MethodsSixty-three cardiology units located in different geographic areas of Italy enrolled a total of 2046 outpatients with nonvalvular AF (54% males and 46% females, age 73.3±10.2years). ResultsOAC with VKAs was prescribed in 1394 (68%) of patients and was progressively more frequent on going from paroxysmal (46%) to persistent (71%) and permanent AF (78%)(P<0.001). A high prescription rate (88%) occurred in patients with CHA2DS2-VASc >2. In patients with CHA2DS2-VASc=0 and HAS-BLED<3, still 59% were on OAC, whereas in 33% of patients with CHA2DS2-VASc ≥2 and HAS-BLED<3, OAC therapy was not prescribed. In patients with CHA2DS2-VASc ≥2 and HAS-BLED>3, the preference was towards OAC prescription. 66% of patients were at target for INR. ConclusionsThe ISPAF study shows that in an Italian population of real world patients with AF adherence to current guidelines on OAC therapy based on stroke-risk scoring system is rather high, although rate of prescription should be increased. However, contrary to recommendations, in a high proportion of low-risk patients OAC therapy is still prescribed, and this might expose patients to unjustified risks.

Vitamin K antagonists in patients with nonvalvular atrial fibrillation

Vitamin K antagonists (VKA) are highly recommended in patients with atrial fibrillation for their efficacy in preventing stroke. However, there is a lack of data on oral anticoagulation (OAC) with VKA overall treatment (i.e. from writing the prescription to time spent in therapeutic range) in patients discharged from hospital with a diagnosis of atrial fibrillation. The aim of this study was to assess the adherence to stroke prevention guidelines in a cohort of patients discharged with atrial fibrillation from the two hospitals of the Agency for Health Services no. 3 'Upper Friuli'. All patients discharged from the hospitals with a diagnosis of nonvalvular atrial fibrillation during the year 2009 were enrolled in this study. Record linkage for the previous 5 years and pharmaceutical data were used to assess comorbid conditions (ICD9-CM) and to calculate congestive heart failure, hypertension, age at least 75 years, diabetes and stroke (CHADS2) scores. Prescription orders were obtained from discharge letters. Patients' adherence to VKA prescription was assessed through pharmacy records, and prothrombin/international normalized ratios (INR) for a period of 180 days after discharge from the whole 'Upper Friuli' laboratories. A patient was considered to have purchased VKA if at least one drug purchase was found in the pharmacy records. Time in therapeutic range (TTR) was calculated in patients who had at least two INR measurements. In 2009, 509 patients (mean age 80 ± 8 years) were discharged with atrial fibrillation from 'Upper Friuli' hospitals (90% from internal medicine); of these, 284 patients (55.8%) had a CHADS2 score greater than 1 and no contraindications to VKA therapy at discharge. Within this subgroup, 112 patients (39.4%) received VKA prescription at discharge; of these, 84 (29.6%) purchased VKA and 58 patients had a TTR of at least 65% (20.4%). VKA prescription for atrial fibrillation patients is low and not explained by present or past comorbid condition. A second failure is represented by patients' low compliance. Overall, adherence to VKA guidelines in atrial fibrillation is scarce.

Long-term safety and efficacy of dual therapy with oral anticoagulation and clopidogrel in patients with atrial fibrillation treated with drug-eluting stents

The optimal antithrombotic treatment for patients on oral anticoagulants (OAC) undergoing percutaneous coronary intervention (PCI) is controversial. We analyzed the safety and efficacy of dual therapy with OAC plus clopidogrel in atrial fibrillation (AF) patients receiving drug-eluting stents (DES). In this retrospective analysis, all AF patients treated with dual therapy were retrospectively identified. Efficacy endpoints included cardiac death, myocardial infarction (MI), stent thrombosis (ST) and cerebrovascular stroke at follow-up, while safety was assessed by bleeding events defined by the Bleeding Academic Research Consortium (BARC). Between January 2008 and August 2010, 221 patients with high-risk AF received a DES and a dual therapy with OAC and clopidogrel. At a mean follow-up of 19 months, bleeding complications occurred in 22 patients (10 %), more than half of them (n = 12) were related to the index PCI. We observed 11 cardiac deaths (4.9 %), 9 MIs (4.1 %), 3 definite (1.4 %) and no probable ST at follow-up. All definite ST occurred after cessation of clopidogrel at 8, 22, and 30 months after PCI in patients not adequately anticoagulated. Eight patients (3.6 %) had an ischemic stroke, five of which after temporary or permanent cessation of OAC. The data generated from this large single-center experience in AF patients treated with DES revealed that dual therapy with OAC plus clopidogrel for 6-12 months followed by monotherapy with OAC appears both safe and effective at long-term follow-up. However, after clopidogrel cessation, maintaining therapeutic anticoagulation with an INR >2 is essential to prevent both thrombotic and embolic events.

Pulmonalarterielle Hypertonie bei angeborenen Herzfehlern: Problemstellung und Versorgungslage

Defects of the heart and associated large vessels (CHD) are among the most frequent congenital anomalies. Owing to improved interdisciplinary management, about 90% of CHD patients reach adulthood. Up to 10% maintain or newly develop pulmonary arterial hypertension (PAH) over time, which impairs exercise tolerance and prognosis. Data on the health care situation of patients with PAH-CHD are limited. The ongoing Prospective Registry of Newly Initiated Therapies for Pulmonary Hypertension (COMPERA, ClinTrials.gov Identifier NCT01347216) prospectively documents adult patients with all forms of pulmonary hypertension, if treated with PAH drugs (mean follow-up 40 months). As of 16 November 2012, 8% of the 3642 patients in the database had PAH-CHD. Of the latter, 104 were documented in great detail in specific CHD report forms. These patients were on average 39 years old, men in 39%, had a mean 6-minute walk distance of 370 ± 102 meters, and were in NYHA functional class I/II in 39%, III in 59%, und IV in 3%. Mean quality of life on the 100-point visual analogue scale (EQ-5 D) was 51. PAH-CHD patients received monotherapy in 80%, combination therapy in 9%, and no PAH drugs in 11%. Only 20% were on oral anticoagulation (OAC). Mean 4-year survival in incident patients (PAH-CHD diagnosis after start of the registry in 2007) was 79%, compared with 72% in patients with idiopathic PAH (IPAH). According to these registry data, patients with PAH-CHD have impaired exercise capacity, and substantially reduced quality of life. They receive combination therapy or OAC, respectively, less frequently than IPAH patients, however, their survival rate is higher.

Safety and effectiveness of Thulium VapoEnucleation of the prostate (ThuVEP) in patients on anticoagulant therapy

To evaluate the safety and efficacy of Thulium VapoEnucleation of the prostate (ThuVEP) for patients on oral anticoagulants (OA) with symptomatic benign prostatic obstruction (BPO). Fifty-six patients, undergoing ThuVEP at two institutions, were evaluated from May 2009 until June 2011. All patients were at high cardiopulmonary risk and presented with a median American Society of Anesthesiology score of 3 [interquartile range (IQR) 2-3]. Thirty-two patients were on aspirin, 8 were on clopidogrel or clopidogrel and aspirin, and 16 on phenprocoumon at the time of surgery. Patient demographic, perioperative, and follow-up data were analyzed. Median prostate volume was 50 (IQR 34-76) cc, and resected tissue weight was 32 (IQR 20-50) g. The median operative time was 61.5 (IQR 40-100.75) min, and the catheter time 2 (IQR 2-3) days. There were no perioperative thromboembolic events. Five patients (8.9%) required a second-look operation in the immediate postoperative course (hemorrhage n = 4, residual adenoma n = 1) and four (7.1%) blood transfusions. Complications within the first 30 days included urinary tract infections (1.7%), urinary retention (3.6%), and delayed bleeding (7.1%). These complications were managed conservatively. At 12-month follow-up, median QoL [5 (IQR 3.75-5) vs. 1 (IQR 1-2)], IPSS [21.5 (IQR 15.5-23.75) vs. 5 (IQR 3-8)], Qmax [7.7 (IQR 6.3-10) vs. 28.3 (IQR 21.25-39.2) ml/s], and postvoiding residual urine [100 (IQR 46-200) vs. 17.5 (IQR 0-36) ml] improved significantly (p < 0.002). Thulium VapoEnucleation of the prostate seems to be a safe and efficacious procedure for the treatment of symptomatic BPO in patients at high cardiopulmonary risk on OA.

Relation of psychological distress to the international normalized ratio in patients with venous thromboembolism with and without oral anticoagulant therapy

Psychological distress might affect the international normalized ratio (INR), but effects might vary depending on oral anticoagulant (OAC) therapy. To investigate the association of psychological distress with INR and clotting factors of the extrinsic pathway in patients with and without OAC therapy. We studied 190 patients with a previous venous thromboembolism (VTE); 148 had discontinued OAC therapy and 42 had ongoing OAC therapy. To assess psychological distress, all patients completed validated questionnaires to measure symptoms of depression, anxiety, worrying, anger and hostility. INR, fibrinogen, factor (F)II:C, FV:C, FVII:C and FX:C were measured as part of outpatient thrombophilia work-up. In VTE patients without OAC therapy, the odds of a reduced INR (< 1.00) were significantly increased from 1.5 to 1.8 times for an increase of 1 standard deviation (SD) in symptoms of depression, anxiety, worrying and anger, respectively, after adjusting for gender, age, body mass index, socioeconomic status, hematocrit and C-reactive protein. Worrying, anger and hostility also showed significant direct associations with FVII:C. In patients with OAC therapy, INR was unrelated to a negative affect; however, lower FVII:C related to anxiety and worrying as well as lower FX:C related to anger and hostility were observed in patients with OAC therapy compared with those without OAC therapy. Psychological distress was associated with a reduced INR in VTE patients without OAC therapy. The direction of the association between psychological distress and activity in some clotting factors of the extrinsic coagulation pathway might differ depending on whether VTE patients are under OAC therapy or not.

The Management of Patients on Oral Anticoagulation Undergoing Coronary Stent Implantation: A Survey among Interventional Cardiologists from Eight European Countries

To evaluate the current management, and adherence to recommendations, of patients on oral anticoagulation (OAC) undergoing coronary stent implantation (PCI-S). By means of a contact person who had been previously identified in 8 European countries, a questionnaire was electronically forwarded between April and July 2010 to the national institutions where PCI-S is performed. A total of 202 questionnaires (median response rate: 50%, range 33-78%) was received. The prevalence of OAC patients among those undergoing PCI-S is mostly reported 5-10% (97%). The peri-procedural pharmacological management mostly encompasses: preprocedural OAC interruption and bridging with low-molecular-weight heparin (59%), intraprocedural administration of an unfractionated heparin bolus (81%), and use of glycoprotein IIb/IIIa inhibitors on an individual basis (79%). The radial approach is reported as the preferred option (58%), as well as the implantation of bare metal stents (76%). Triple therapy (warfarin, aspirin, clopidogrel) is the most frequently prescribed (80%), generally for 1 month after bare metal stent (77%) and for at least 12 months after drug-eluting stent (60%). Throughout triple therapy, the International Normalized Ratio is mostly targeted to the lower end of the therapeutic range (77%), and gastric protection is routinely prescribed (69%), mostly by giving proton-pump inhibitors (70%). Among the 202 interventional cardiologists from the 8 European countries interviewed, the management of patients on OAC undergoing PCI-S appears variable and only partially adherent to currently available recommendations.

Standardization of lupus anticoagulant. Feasibility study of a calibration model to minimize between-method variability

Background Results for lupus anticoagulant (LA) are currently expressed as ratio of patient-to-normal clotting times (LA-ratio). Yet, numerical results do vary according to the method used for testing, thus making difficult the between-method comparison of results. We hypothesized that the standardization model currently used for the INR for patients on oral-anticoagulants (OAT) would be of value also for LA standardization. Patients and Methods To test this hypothesis we determined a sensitivity index valid for LA (called LASI) for six LA-detection methods against a common-standard using two sets of calibration-plasmas: (i)normal-plasmas spiked with IgG derived from patients strongly-positive for LA or (ii)plasmas from LA-positive patients. The LASI was then used to convert the LA-ratio into the standardized-LA-ratio (SLA-ratio) according to the equation: SLA-ratio = (LA-ratio) LASI. Results We demonstrate that (i)the model is feasible because calibration plots of log-transformed clotting times obtained for the LA-detection methods-vs.-the common-standard gave acceptable LASI values; (ii)the model is effective because between-method variability expressed as coefficient of variation, which was 42.8% with results expressed as LA-ratio, decreased to 7.8% with results expressed as SLA-ratio; (iii)the LASI value calculated with the LA-positive plasmas is more effective in minimizing between-method variability than the LASI value calculated with IgG-spiked plasmas. Conclusions A model of LA calibration similar to the INR for patients on OAT is feasible by using plasmas from LA-positive patients instead of patients on OAT. Potential application of the model are:(i)to compare the relative responsiveness of different LA-detection methods,(ii)to minimize differences between their results and (iii)to quantify LA potency.

Menstrual problems and contraception in women of reproductive age receiving oral anticoagulation

Background Oral anticoagulation is associated with increased bleeding complications. The aim of this study was to assess the changes in menstrual loss and pattern in women taking anticoagulant treatment. Study Design Women on oral anticoagulant (OA) treatment at the Royal Free Hospital were interviewed and completed a questionnaire about their menstrual cycle before and after commencing oral anticoagulation treatment. They were then asked to complete a pictorial bleeding assessment chart (PBAC) during their next menstrual bleeding episode. Results Fifty-three women between the ages of 20 and 50 years participated in the study. Of these, 47 women completed a PBAC. The mean duration of menstruation increased from 5 days before starting OA therapy to 7 days after the commencement of treatment. Thirty-one (66%) of the 47 women who completed the PBAC had a score that was greater than 100. The number of women who experienced flooding or clots during menstruation and intermenstrual or postcoital bleeding also increased. In total, 29 (54.7%) women changed their method of contraception during OA treatment. Seventeen women who did not want to become pregnant were not using contraception, including 10 women who were on hormonal contraception prior to starting anticoagulant therapy. Conclusion Women of reproductive age experience heavy and prolonged menstrual bleeding whilst on OA therapy. Women of reproductive age on OA therapy should be monitored for menstrual disorders to ensure that prompt and appropriate treatment is instituted. Advice about appropriate contraception should also be part of the medical care provided for these women. Barrier contraception, sterilization and progestin-only contraception are all suitable methods of contraception in this patient group.