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BACKGROUND AND AIMS Peripheral arterial disease (PAD) is one of the most prevalent cardiovascular diseases with more than 230 million people being affected worldwide. As highlighted by the recent European Society of Cardiology guidelines, data on the epidemiology of PAD is urgently needed. METHODS AND RESULTS We accessed the vital registration data of the Veneto region (Northern Italy, approximately five millions inhabitants) covering the period 2008-2019. We computed annual age-standardized rates for PAD reported as the underlying cause of death (UCOD) or as one of multiple causes of death (MCOD). Age-adjusted odds ratios (OR) served to study the association between PAD and cardiovascular comorbidities. The age-standardized mortality rate for PAD as MCOD slightly declined from 19.6 to 17.8 in men and from 10.8 to 9.1 deaths per 100,000 population-years in women. The age-standardized PAD-specific mortality rate (UCOD) remained stable: 3.1 to 3.7 per 100,000 person-years in women (Average Annual Percent Change 1.3, 95% CI -0.8; 3.4%) and 4.4 to 4.3 per 100,000 person-years (Average Annual Percent Change -0.2, 95% CI -3.6; 3.4%) in men. PAD contributed to 1.6% of all deaths recorded in the region. Ischemic heart disease, diabetes mellitus and neoplasms were the most prevalent UCOD among PAD patients. PAD was associated with diabetes mellitus (OR 3.79, 95%CI 3.55-4.06) and chronic kidney diseases (OR 2.73, 95%CI 2.51-2.97) in men, and with atrial fibrillation (OR 2.26, 95%CI 2.10-2.44) in women. CONCLUSION PAD remains a substantial cause of death in the general population of this high-income region of Western Europe with marked sex-specific differences.

Summary: Background: The global burden of peripheral arterial disease (PAD) is substantial. Reducing the major modifiable risk factors for noncommunicable disease, including dyslipidaemia, represents a public health priority. Aim is to evaluate the prevalent adequate use of lipid-lowering therapy (LLT) and low-density lipoprotein cholesterol (LDL-C) attainment among patients with PAD of the lower extremities undergoing percutaneous transluminal angioplasty. Patients and methods: We screened PAD patients treated at the University Hospital Zurich (January 2012–December 2018). We excluded patients

COVID-19 is a viral prothrombotic respiratory infection. Heparins exert antithrombotic and anti-inflammatory effects, and might have antiviral properties. We aimed to investigate whether thromboprophylaxis with enoxaparin would prevent untoward hospitalisation and death in symptomatic, but clinically stable outpatients with COVID-19.OVID was a randomised, open-label, parallel-group, investigator-initiated, phase 3 trial and was done at eight centres in Switzerland and Germany. Outpatients aged 50 years or older with acute COVID-19 were eligible if they presented with respiratory symptoms or body temperature higher than 37·5°C. Eligible participants underwent block-stratified randomisation (by age group 50-70 vs70 years and by study centre) in a 1:1 ratio to receive either subcutaneous enoxaparin 40 mg once daily for 14 days versus standard of care (no thromboprophylaxis). The primary outcome was a composite of any untoward hospitalisation and all-cause death within 30 days of randomisation. Analysis of the efficacy outcomes was done in the intention-to-treat population. The primary safety outcome was major bleeding. The study was registered in ClinicalTrials.gov (NCT04400799) and has been completed.At the predefined formal interim analysis for efficacy (50% of total study population), the independent Data Safety Monitoring Board recommended early termination of the trial on the basis of predefined statistical criteria having considered the very low probability of showing superiority of thromboprophylaxis with enoxaparin for the primary outcome under the initial study design assumptions. Between Aug 15, 2020, and Jan 14, 2022, from 3319 participants prescreened, 472 were included in the intention-to-treat population and randomly assigned to receive enoxaparin (n=234) or standard of care (n=238). The median age was 57 years (IQR 53-62) and 217 (46%) were women. The 30-day risk of the primary outcome was similar in participants allocated to receive enoxaparin and in controls (8 [3%] of 234 vs 8 [3%] of 238; adjusted relative risk 0·98; 95% CI 0·37-2·56; p=0·96). All hospitalisations were related to COVID-19. No deaths were reported during the study. No major bleeding events were recorded. Eight serious adverse events were recorded in the enoxaparin group versus nine in the control group.These findings suggest thromboprophylaxis with enoxaparin does not reduce early hospitalisations and deaths among outpatients with symptomatic COVID-19. Futility of the treatment under the initial study design assumptions could not be conclusively assessed owing to under-representation of older patients and consequent low event rates.SNSF (National Research Programme COVID-19 NRP78: 198352), University Hospital Zurich, University of Zurich, Dr-Ing Georg Pollert (Berlin), Johanna Dürmüller-Bol Foundation.

Aims We assessed morphological features of near-infrared spectroscopy (NIRS)-detected lipid-rich plaques (LRPs) by using optical coherence tomography (OCT) and intravascular ultrasound (IVUS). Methods and results IVUS-NIRS and OCT were performed in the two non-infarct-related arteries (non-IRAs) in patients undergoing percutaneous coronary intervention for treatment of an acute coronary syndrome. A lesion was defined as the 4 mm segment with the maximum amount of lipid core burden index (maxLCBI4mm) of each LRP detected by NIRS. We divided the lesions into three groups based on the maxLCBI4mm value: Conclusion LRPs with increasing maxLCBI4mm exhibit OCT and IVUS features of presumed plaque vulnerability including TCFA morphology, increased plaque burden, and positive remodelling.

BackgroundLow-density lipoprotein cholesterol (LDL-C) is a major risk factor for atherosclerotic cardiovascular disease (ASCVD). In confirmatory trials, proprotein convertase subtilisin/kexin type 9 inhibitor alirocumab substantially lowered LDL-C and reduced cardiovascular morbidity and mortality. However, the routine clinical use of alirocumab in Switzerland has not yet been studied.MethodsIn this prospective nation-wide cohort study, we aimed to investigate the patient profile and routine clinical efficacy and safety of alirocumab in 207 patients with ASCVD or heterozygous familial hypercholesterolemia and increased LDL-C despite maximally tolerated statin therapy. LDL-C was measured at baseline and after 3-months follow-up.ResultsOverall, mean age was 63 ± 11 years, 138 (67%) were men, and 168 (81%) had statin intolerance (SI). Patients with SI had a higher baseline LDL-C (4.3 ± 1.4 vs. 3.3 ± 1.4 mmol/l; p < 0.001) and less frequently ASCVD (71% vs. 95%; p = 0.002). After 3 months of treatment with alirocumab, LDL-C was reduced from 4.1 ± 1.5 to 2.0 ± 1.2 mmol/l (50.5%; p < 0.001). Mean absolute and relative reductions in LDL-C were similar in patients with vs. without SI (2.2 ± 1.2 vs. 1.9 ± 1.3 mmol/l; p = 0.24 and 49.0 vs. 56.6%; p = 0.11, respectively). In total, adverse events were recorded in 25 (12%) patients, with no new safety signals.ConclusionsIn routine clinical practice, alirocumab was predominantly used in patients with SI suggesting that the great majority of patients with insufficient LDL-C control who would be candidates for alirocumab are not receiving this therapeutic option in Switzerland. LDL-C lowering was potent and similar in patients with and without SI, replicating the favorable efficacy-safety profile of alirocumab from randomized trials.

BackgroundThe direct factor Xa inhibitor rivaroxaban is approved for the treatment of venous thromboembolism (VTE), based on the results of large phase III trials.ObjectivesTo confirm rivaroxaban's effectiveness and safety in routine clinical care of patients with VTE.MethodsData were obtained from prospective, noninterventional registries: the FIRST registry (United Kingdom), DRESDEN NOAC registry (Germany), and SWIVTER (Switzerland). Baseline characteristics of these registries and effectiveness and safety outcome rates for the FIRST and DRESDEN NOAC registries were compared.ResultsA total of 1841 rivaroxaban-treated patients with acute VTE (57.9% male, 76.6% deep vein thrombosis [DVT]; 23.4% pulmonary embolism ± DVT; median age, 61 years) were included: 1217 from the FIRST registry, 418 from the DRESDEN NOAC registry, and 206 from SWIVTER. Median time between VTE diagnosis and initiation of rivaroxaban was 1.4 ± 1.81 days (25th–75th percentile 1–1; range, 0–15 days). On-treatment outcome rates for the FIRST and DRESDEN NOAC registries were 0.74 per 100 patient-years (95% confidence interval [CI], 0.35–1.54) versus 0.96 per 100 patient-years (95% CI, 0.46–2.01) for VTE recurrence; 1.16 per 100 patient years (95% CI, 0.64–2.09) versus 2.51 per 100 patient-years (95% CI, 1.58–3.98) for ISTH major bleeding and 1.69 per 100 patient-years (95% CI, 1.21–2.35) versus 1.73 per 100 patient-years (95% CI, 1.27–2.36) for all-cause mortality (intention-to-treat analysis), respectively.ConclusionOverall treatment outcomes were consistent with the results of the phase III rivaroxaban trials in VTE treatment, indicating that the use of rivaroxaban offers acceptable treatment results also in routine care. However, we observed significant differences in patient characteristics and management patterns across Switzerland, the United Kingdom, and Germany, limiting direct comparisons of unadjusted outcome event rates between registries.

Introduction Pulmonary embolism (PE) and deep vein thrombosis (DVT), the two clinical manifestations of venous thromboembolism (VTE), constitute a major global burden of cardiovascular disease. They are often referred to as one disease but several patient characteristics, risk factors, real-world treatment, and clinical outcomes may differ substantially between PE and DVT alone. Materials and methods We conducted a narrative review of the state-of-the-art literature on the topic of PE and DVT alone using PubMed, Google scholar, and MEDLINE databases and the most established international consensus statement guidelines for the management of VTE, focusing on the recommendations for diagnosis and treatment but also including epidemiological and clinical characteristics of VTE, highlighting similarities and differences between PE and DVT alone. Results Several patient characteristics, risk factors, clinical manifestations, and outcomes differ substantially between PE versus DVT alone. Nevertheless, recommendations for both diagnosis and treatment are strikingly similar in the current guidelines for the management of DVT and PE, except for the indication for advanced reperfusion therapies. Conclusions The differences in risk factors, clinical manifestations, and clinical outcomes between patients with PE versus DVT alone are only marginally addressed in the current consensus guidelines. More data is needed allowing proposal of evidence-based adjustments in the diagnostic and therapeutic strategies for these two manifestations of VTE. Tailored risk stratification and individualized management strategies for patients with PE and DVT alone may lead to a better prognosis, less recurrence and complications, and possibly to a gain of quality-adjusted life years in patients with VTE.

Summary. Background: The optimal duration of anticoagulation therapy (AT) following catheter-based therapy of acute iliofemoral deep vein thrombosis (IFDVT) with stent placement is unknown. Theoretically, resolving the underlying obstructive iliac vein lesion by a stent may eliminate the main trigger for recurrence, the post-thrombotic syndrome (PTS), and the need for extended-duration AT. Patients and methods: From 113 patients with acute IFDVT who underwent endovascular thrombus removal and stent placement, we compared patency rates and clinical outcomes between 58 patients on limited-duration AT (3–12 month) and 55 patients on extended-duration AT (> 12 months). Results: Mean follow-up duration was 26 ± 18 (range 3–77) months; it was 24 ± 18 (range 3–69) months after cessation of AT in the limited-duration AT group. In comparison to patients with extended-duration AT, patients with limited-duration AT were younger (38 versus 54 years; p

Objective In patients with cancer-associated venous thromboembolism (VTE), the risk of recurrence is similar after incidental and symptomatic events. It is unknown whether the same applies to incidental VTE not associated with cancer. Methods and Results We compared baseline characteristics, anticoagulation therapy, all-cause mortality, and VTE recurrence rates at 90 days between patients with incidental (n = 131; 52% without cancer) and symptomatic (n = 1,931) VTE included in the SWIss Venous ThromboEmbolism Registry (SWIVTER). After incidental VTE, 114 (87%) patients received anticoagulation therapy for at least 3 months. The mortality rate was 9.2% after incidental and 8.4% after symptomatic VTE for hazard ratio (HR) 1.10 (95% confidence interval [CI] 0.49–2.50). After adjustment for competing risk of death, recurrence rate was 3.1 versus 2.8%, respectively, for sub-HR 1.07 (95% CI 0.39–2.93). These results were consistent among cancer (mortality: 15.9% vs. 12.6%; HR 1.32, 95% CI 0.67–2.59; recurrence: 4.8% vs. 4.7%; HR 1.02, 95% CI 0.30–3.42) and noncancer patients (mortality: 2.9% vs. 2.1%; HR 1.37, 95% CI 0.33–5.73; recurrence: 1.5% vs. 2.3%; HR 0.63, 95% CI 0.09–4.58). Patients with incidental VTE who received anticoagulation therapy for at least 3 months had lower mortality (4% vs. 41%) and recurrence rate (1% vs. 18%) compared with those who did not. Conclusion In SWIVTER, more than half of incidental VTE events occurred in noncancer patients who often received anticoagulation therapy. Among noncancer patients, early mortality and recurrence rates were similar after incidental versus symptomatic VTE. Our findings suggest that anticoagulation therapy for incidental VTE may be beneficial regardless of the presence of cancer.

Contains fulltext : 235282.pdf (Publisher’s version ) (Closed access) BACKGROUND: The risk for cardiovascular adverse events after acute myocardial infarction (AMI) remains high despite potent medical treatment including low-density lipoprotein cholesterol (LDL-C) lowering with statins. Proprotein convertase subtilisin/kexin type 9 (PCSK9) antibodies substantially reduce LDL-C when added to statin. Alirocumab, a monoclonal antibody to PCSK9, reduces major adverse cardiovascular events after AMI. The effects of alirocumab on coronary atherosclerosis including plaque burden, plaque composition and fibrous cap thickness in patients presenting with AMI remains unknown. AIMS: To determine the effect of LDL-C lowering with alirocumab on top of high-intensity statin therapy on intravascular ultrasound (IVUS)-derived percent atheroma volume (PAV), near-infrared spectroscopy (NIRS)-derived maximum lipid core burden index within 4 mm (maxLCBI(4 mm)) and optical coherence tomography (OCT)-derived fibrous cap thickness (FCT) in patients with AMI. METHODS: In this multicenter, double-blind, placebo-controlled trial, 300 patients with AMI (ST-elevation or non-ST-elevation myocardial infarction) were randomly assigned to receive either biweekly subcutaneous alirocumab (150 mg) or placebo beginning

Background: Angioplasty with stent placement is a therapeutic option for patients with acute thrombotic, postthrombotic, and nonthrombotic obstruction of the iliofemoral veins or inferior vena cava. Previous studies of steel-alloy stents described variable patency rate across indications. Methods: The prospective Swiss Venous Stent Registry includes patients treated with self-expandable nitinol stents for deep venous obstruction. Routine follow-up visits include serial duplex ultrasound for stent patency assessment. The primary outcome was primary stent patency. The secondary outcome was venous thromboembolisms. We studied the rate of stent occlusion and potentially contributing factors. Results: We included 379 patients: 160 with acute thrombotic, 193 with postthrombotic, and 26 with nonthrombotic deep vein obstruction. The mean age was 46±18 years; 55% were women. The cumulative 3-year primary patency rate was 80.5% (95% CI, 73.0%–88.0%) for acute thrombotic, 59.2% (95% CI, 50.4%–68.0%) for postthrombotic, and 100% for nonthrombotic obstruction (log-rank, P Conclusions: The rate of stent occlusion (patency loss) and venous thromboembolism varies substantially across indications, also with dedicated venous nitinol stents. Patients with postthrombotic femoral veins and those who received multiple stents were characterized by the highest risk. Registration: URL: https://clinicaltrials.gov . Unique identifier: NCT02433054.

Background/Aims: Despite availability of a broad spectrum of blood pressure (BP)-lowering drugs many hypertensive patients do not attain BP goals. We aimed to evaluate the influence of home blood pressure monitoring (HBPM) on patient’s awareness and attainment of BP goals under antihypertensive treatment with irbesartan alone or in combination with hydro-chlorothiazide. Methods: In total, 1,268 patients with arterial hypertension were enrolled in the Factors Influencing Results in anti-hypertenSive Treatment (FIRST) study by 348 general practitioners and internal medicine specialists across Switzerland. Patients selected for HBPM received detailed information and training on BP self-management. The study endpoints included patient’s awareness and attainment of BP goals, and the efficacy and tolerability of antihypertensive treatment at 3 months. Results: Overall, the mean age was 61±13 years and 616 (49%) were women. The mean systolic/diastolic BP was 161±17/96±11 mmHg, and 239 (19%) patients had diabetes mellitus. 758 (60%) patients were instructed to use HBPM. Both the proportion of patients aware of their BP goals (81% vs. 70%; p< 0.001) and the percentage of patients reaching their BP goal (64% vs. 57%; p=0.028) were higher in those with vs. without HBPM. The mean reduction in systolic/diastolic BP was 23.8/13.2 mmHg. Only 35 (3.0%) patients discontinued antihypertensive therapy. Conclusion: In a large Swiss cohort of patients with arterial hypertension, information and training on BP self-measurement and direct involvement of patients by using HBPM led to improvement in BP control. Treatment with irbesartan alone or in combination with hydrochlorothiazide was well tolerated and markedly reduced BP.

Background Improved thromboprophylaxis for acutely ill medical patients relies on valid predictions of thrombotic risks. Our aim was to compare the performance of the Improve and Geneva clinical risk assessment models (RAMs), and to simplify the current Geneva RAM. Methods Medical inpatients from eight Swiss hospitals were prospectively followed during 90 days, for symptomatic venous thromboembolism (VTE) or VTE-related death. We compared discriminative performance and calibration of the RAMs, using time-to-event methods with competing risk modelling of non-VTE death. Results In 1,478 patients, the 90-day VTE cumulative incidence was 1.6%. Discrimination of the Improve and Geneva RAM was similar, with a 30-day AUC (areas under the curve) of 0.78 (95% CI [confidence interval]: 0.65–0.92) and 0.81 (0.73–0.89), respectively. According to the Improve RAM, 68% of participants were at low risk (0.8% VTE at 90 days), and 32% were at high risk (4.7% VTE), with a sensitivity of 73%. According to the Geneva RAM, 35% were at low risk (0.6% VTE) and 65% were at high risk (2.8% VTE), with a sensitivity of 90%. Among patients without thromboprophylaxis, the sensitivity was numerically greater in the Geneva RAM (85%) than in the Improve RAM (54%). We derived a simplified Geneva RAM with comparable discrimination and calibration as the original Geneva RAM. Conclusions We found comparably good discrimination of the Improve and Geneva RAMs. The Improve RAM classified more patients as low risk, but with possibly lower sensitivity and greater VTE risks, suggesting that a lower threshold for low risk (

Essentials Venous thromboembolism (VTE) prophylaxis in hospitalized medical patients remains inconsistent. We implemented an electronic alert system featuring a validated risk assessment model for VTE. In this randomized controlled study, the e-alert system did not improve VTE prophylaxis. Many electronic alerts were ignored by ordering physicians. SUMMARY Background The use of thromboprophylaxis among acutely ill hospitalized medical patients remains inconsistent. Objective To improve thromboprophylaxis use by implementing a computer-based alert system combined with a Geneva Risk Score calculation tool in the electronic patient chart and order entry system. Patients/Methods Consecutive patients admitted to the general internal medicine wards of the University Hospital Bern, Switzerland were randomized to the alert group, in which an alert and the Geneva Risk Score calculation tool was issued in the electronic patient chart, or to the control group, in which no alert was issued. The primary endpoint was the rate of appropriate thromboprophylaxis during hospital stay. Results Overall, 1593 patients (alert group, 804; control group, 789) were eligible for analysis. The median age was 67 years (interquartile range, 53-79 years) and 47% were female. Appropriate thromboprophylaxis was administered to 536 (66.7%) patients from the alert group and to 526 (66.7%) patients from the control group. Among the 804 patients from the alert group, a total of 446 (55.5%) either had no score calculation by the physician in charge (n = 348) or had a calculated score result that was inconsistent with information from the patient chart (n = 98). Appropriate thromboprophylaxis was less often administered to patients with no score or an inconsistent score result than to 358 patients with a consistent score result (62.6% versus 71.8%). Conclusions The electronic alert (e-alert) system did not improve appropriate thromboprophylaxis, most likely because many e-alerts were ignored by ordering physicians. The use of appropriate thromboprophylaxis in the control group was higher than expected.

Essentials Acute iliofemoral deep vein thrombosis can be treated with catheter-directed thrombolysis (CDT). We performed a randomized trial comparing conventional CDT versus ultrasound-assisted CDT (USAT). Clinical and duplex sonographic outcomes at 12 months were similar in the CDT and USAT groups. In both groups, incidence of postthrombotic syndrome was very low with good quality of life.Background In patients with acute iliofemoral deep vein thrombosis (IFDVT), catheter-directed thrombolysis (CDT) aims to prevent the postthrombotic syndrome (PTS). Adding intravascular high-frequency, low-power ultrasound energy to CDT does not seem to improve the immediate thrombolysis results but its impact on clinical outcomes at 12 months is not known. Patients/Methods In this randomized-controlled trial, 48 patients (mean age 50 ± 21 years; 52% women) with acute IFDVT were randomized to conventional CDT (n = 24) or ultrasound-assisted CDT (USAT; n = 24). In both groups, a fixed-dose thrombolysis regimen (20 mg r-tPA over 15 h) was used, followed by routine stenting of residual venous obstruction. At 12 months, PTS and venous disease severity (Villalta score and revised Venous Clinical Severity Score [rVCSS]), disease-specific quality of live (QOL; CIVIQ-20) and duplex-sonographic outcomes were assessed. Results Among the 45 surviving patients, 40 (89%; 95% confidence interval [CI] 76-96%) patients were free from PTS (defined as Villalta score5 points; 83%, 95% CI 61-95% in the USAT and 96%, 95% CI 77-100% in the CDT group), with a similar mean total Villalta score of 2.3 ± 2.9 vs. 1.7 ± 1.6, and a mean total rVCSS of 3.0 ± 3.5 vs. 2.7 ± 2.9 in the USAT and the CDT groups, respectively. Both groups had good disease-specific QOL with a CIVIQ-20 score of 29.4 ± 11.8 vs. 26.1 ± 7.8, respectively. Primary (100% vs. 92%) and secondary (100% vs. 96%) iliofemoral patency rates and presence of femoro-popliteal venous reflux (39% vs. 33%) were similar in both groups. Conclusion The addition of intravascular ultrasound energy to conventional CDT for the treatment of acute IFDVT did not have any impact on relevant clinical or duplex sonographic outcomes, which were favorable in both study groups. Clinical Trial Registration URL: http://www.clinicaltrials.gov. Unique identifier:NCT01482273.

SummaryAlthough the use of thromboprophylaxis is recommended for acutely ill medical patients at increased risk of venous thromboembolism (VTE), it remains unclear which risk assessment model (RAM) should be routinely used to identify at-risk patients requiring thromboprophylaxis. We therefore aimed to describe existing RAMs, and to compare these tools in terms of validity and applicability for clinical decisionmaking. We performed a comprehensive systematic search in MEDLINE from the date of initiation until May 2016 for studies in acutely ill medical patients investigating validity of RAMs for VTE. Two reviewers independently screened the title, abstract, and full text, and evaluated the characteristics of studies, and the composition, evidence of validation, and results on validity of the RAMs. We included 11 studies assessing eight RAMs: 4-Element RAM, Caprini RAM, a full logistic model, Geneva risk score, IMPROVE-RAM, Kucher Model, a “Multivariable Model”, and Padua Prediction Score. The 4-Element RAM, IMPROVE-RAM, Multivariable Model, and full logistic model had derivation by identifying factors with predictive power. The other four RAMs were empirically generated based on consensus guidelines, published data, and clinical expertise. The Kucher Model, the Padua Prediction Score, the Geneva Risk Score and the IMPROVE-RAM underwent multicenter external validation. The Kucher Model, the Padua Prediction Score, and the Geneva Risk Score improved rates of thromboprophylaxis or clinical outcomes. In conclusion, existing RAMs to evaluate the need of thromboprophylaxis in acutely ill medical patients are difficult to compare and none fulfills the criteria of an ideal RAM. Nevertheless, the adequacy of thromboprophylaxis may be improved by implementing one of the validated RAMs.

Background Patients with postthrombotic syndrome (PTS) treated with stents are at risk of stent thrombosis (ST). The incidence of ST in the presence and absence of anticoagulation therapy (AT) is unknown. Risk factors are not well understood. Patients and Methods From the prospective Swiss Venous Stent registry, we conducted a subgroup analysis of 136 consecutive patients with PTS. Incidence of ST was estimated from duplex ultrasound or venography, and reported for the time on and off AT. Baseline, procedural, and follow-up data were evaluated to identify factors associated with ST. Results Median follow-up was 20 (interquartile range [IQR] 9–40) months. AT was stopped in 43 (32%) patients after 12 (IQR 6–14) months. Cumulative incidence of ST was 13.7% (95% confidence interval [CI] 7.8–19.6%) and 21.2% (95% CI 13.2–29.2%) during the first 6 and 36 months, respectively. The time-adjusted incidence rate was 11.2 (95% CI 7.7–16.2) events per 100 patient-years, 11.3 (95% CI 7.3–17.3) for the period on, and 11.2 (95% CI 5.3–23.6) for the period off AT. May–Thurner syndrome (MTS) was associated with decreased incidence of ST (hazard ratio [HR] 0.37, 95% CI 0.15–0.91), whereas age Conclusion The 6-month incidence of ST was considerably high. Beyond 6 months, consecutive annual incidence rates persisted at 4.1 and 3.4% per year thereafter. Patients with higher incidence of ST were younger, had stents below the common femoral vein, postthrombotic leg inflow veins, and less often MTS. Incidence rates for the period on and off AT must be interpreted with caution. Clinical Trial Registration The study is registered on the National Institutes of Health Web site (ClinicalTrials.gov; identifier NCT02433054).

Background The association between cancer and venous thromboembolism (VTE) in producing adverse clinical outcomes requires further investigation. Methods In the Swiss Venous ThromboEmbolism Registry (SWIVTER), we compared adverse clinical outcomes between 493 patients with cancer-associated VTE and 1,569 VTE patients without cancer, and identified independent predictors of 90-day mortality. Results Among cancer patients, 351 (71%) had active disease at the time of VTE diagnosis and 232 (47%) had metastatic disease. Cancer patients more frequently had asymptomatic VTE (13 vs. 4%; p

The modified Ottawa score (MOS) predicted venous thromboembolism (VTE) recurrence in a cohort of patients with cancer-associated thrombosis mainly managed on an outpatient basis. We aimed to assess the prognostic value of the MOS in hospitalized patients with cancer-associated thrombosis. In 383 hospitalized patients with cancer-associated VTE from the SWIss VTE Registry, 98 (25%) were classified as low risk, 175 (46%) as intermediate risk, and 110 (29%) as high risk for VTE recurrence based on the MOS. Clinical end points were recurrent VTE, fatal VTE, major bleeding, and overall mortality at 90 days. Overall, 179 (47%) patients were female, 172 (45%) had metastatic disease, and 72 (19%) prior VTE. The primary site of cancer was lung in 48 (13%) patients and breast in 43 (11%). According to the MOS, the rate of VTE recurrence was 4.1% for low, 6.3% intermediate, and 5.5% high risk (p = 0.75); the rate of fatal VTE was 0.8, 1.9, and 2.0% (p = 0.69); the rate of major bleeding was 3.1, 4.1, and 3.6% (p = 0.92); and the rate of death was 6.1, 12.0, and 28.2% (p

Background ― Appropriate antithrombotic therapy during percutaneous coronary intervention (PCI) reduces major cardiovascular events and bleeding complications.The objective of the present analysis of the multinational, prospective, observational Registry on IntraVenous anticoagulation In the Elective and primary Real world of Angioplasty (RIVIERA) was to prospectively evaluate in-hospital death, myocardial infarction (MI), major and minor bleeding, and angiographic complications of enoxaparin-guided primary or elective PCI. Methods ― In Switzerland, 255 consecutive patients from the Herz-Neuro-Zentrum Bodensee Kreuzlingen were enrolled in the RIVIERA study.The mean age of the patients was 64 years and 77% were men; 18% had primary PCI for acute STsegment elevation myocardial infarction.The mean dose of intravenous enoxaparin was 1mg/kg. Results ―The in-hospital mortality rate was 1.2%; MI occurred in 5.5% patients, and major and minor bleeding 0.8% and 2.7%, respectively.Angiographic complications occurred in 8.6% of patients, mainly coronary dissection (3.9%) and thrombus at the treated lesion site (1.6%). Conclusions ― In a real-world setting, the clinical efficacy and safety of intravenous enoxaparin during acute and elective PCI in a Swiss heart centre is comparable with the results of randomized controlled trials.

SummaryExtended pharmacological venous thromboembolism (VTE) prophylaxis beyond discharge is recommended for patients undergoing high-risk surgery. We prospectively investigated prophylaxis in 1,046 consecutive patients undergoing major orthopaedic (70%) or major cancer surgery (30%) in 14 Swiss hospitals. Appropriate in-hospital prophylaxis was used in 1,003 (96%) patients. At discharge, 638 (61%) patients received prescription for extended pharmacological prophylaxis: 564 (77%) after orthopaedic surgery, and 74 (23%) after cancer surgery (p

Background— For patients with acute iliofemoral deep vein thrombosis, it remains unclear whether the addition of intravascular high-frequency, low-power ultrasound energy facilitates the resolution of thrombosis during catheter-directed thrombolysis. Methods and Results— In a controlled clinical trial, 48 patients (mean age 50±21 years, 52% women) with acute iliofemoral deep vein thrombosis were randomized to receive ultrasound-assisted catheter-directed thrombolysis (N=24) or conventional catheter-directed thrombolysis (N=24). Thrombolysis regimen (20 mg r-tPA over 15 hours) was identical in all patients. The primary efficacy end point was the percentage of thrombus load reduction from baseline to 15 hours according to the length-adjusted thrombus score, obtained from standardized venograms and evaluated by a core laboratory blinded to group assignment. The percentage of thrombus load reduction was 55%±27% in the ultrasound-assisted catheter-directed thrombolysis group and 54%±27% in the conventional catheter-directed thrombolysis group ( P =0.91). Adjunctive angioplasty and stenting was performed in 19 (80%) patients and in 20 (83%) patients, respectively ( P >0.99). Treatment-related complications occurred in 3 (12%) and 2 (8%) patients, respectively ( P >0.99). At 3-month follow-up, primary venous patency was 100% in the ultrasound-assisted catheter-directed thrombolysis group and 96% in the conventional catheter-directed thrombolysis group ( P =0.33), and there was no difference in the severity of the post-thrombotic syndrome (mean Villalta score: 3.0±3.9 [range 0–15] versus 1.9±1.9 [range 0–7]; P =0.21), respectively. Conclusions— In this randomized controlled clinical trial of patients with acute iliofemoral deep vein thrombosis treated with a fixed-dose catheter thrombolysis regimen, the addition of intravascular ultrasound did not facilitate thrombus resolution. Clinical Trial Registration— URL: http://www.clinicaltrials.gov . Unique identifier: NCT01482273.

summaryBoth, underuse and overuse of thromboprophylaxis in hospitalised medical patients is common. We aimed to explore clinical factors associated with the use of pharmacological or mechanical thromboprophylaxis in acutely ill medical patients at high (Geneva Risk Score ≥ 3 points) vs low (Geneva Risk Score < 3 points) risk of venous thromboembolism. Overall, 1,478 hospitalised medical patients from eight large Swiss hospitals were enrolled in the prospective Explicit ASsessment of Thromboembolic RIsk and Prophylaxis for Medical PATients in SwitzErland (ESTIMATE) cohort study. The study is registered on ClinicalTrials. gov, number NCT01277536. Thromboprophylaxis increased stepwise with increasing Geneva Risk Score (p< 0.001). Among the 962 high-risk patients, 366 (38 %) received no thromboprophylaxis; cancer-associated thrombocytopenia (OR 4.78, 95 % CI 2.75–8.31, p< 0.001), active bleeding on admission (OR 2.88, 95 % CI 1.69–4.92, p< 0.001), and thrombocytopenia without cancer (OR 2.54, 95 % CI 1.31–4.95, p=0.006) were independently associated with the absence of prophylaxis. The use of thromboprophylaxis declined with increasing severity of thrombocytopenia (p=0.001). Among the 516 low-risk patients, 245 (48 %) received thromboprophylaxis; none of the investigated clinical factors predicted its use. In conclusion, in acutely ill medical patients, bleeding and thrombocytopenia were the most important factors for the absence of thromboprophylaxis among highrisk patients. The use of thromboprophylaxis among low-risk patients was inconsistent, without clearly identifiable predictors, and should be addressed in further research.

We investigated contemporary diabetes care, quality of glycaemic control, and progression of obesity in patients with diabetes mellitus in different cultural regions within Switzerland.Overall, 1121 patients treated for type 2 diabetes mellitus by 134 general practitioners were enrolled in this representative, national, cross-sectional survey and were followed retrospectively from the start of diabetes treatment. Patients were classified into four cultural regions; the German, French, Italian and Romansh speaking parts of Switzerland.During 5.5 ± 5.1 years of diabetes treatment (retrospective survey), mean HbA1c decreased from 8.28 ± 2.01% to 7.03 ± 1.24%, fasting glucose decreased from 9.97 ± 3.86 to 7.52 ± 2.23 mmol/l, and BMI decreased from 30.2 ± 5.5 to 29.8 ± 5.6 kg/m² (p0.001 for all parameters). Insulin therapy was associated with a larger improvement of mean HbA1c (-1.66 ± 2.33% vs. -1.15 ± 1.91%, p = 0.001) and an increase in BMI (+0.36 ± 2.92 vs. -0.63 ± 2.60 kg/m2, p0.001). At the time when the cross-sectional survey was conducted, the mean HbA1c and fasting glucose were higher in the Italian part compared to other regions (7.72 ± 1.60% and 9.03 ± 2.49 mmol/l, respectively, p0.001), and lower in the German part (6.89 ± 1.02% and 7.25 ± 2.02 mmol/l, respectively, p0.001). In comparison to other regions, biguanides were more often used in the French part (86.1% versus 75.7%), insulin secretagogues in the Italian part (69.9% versus 37.8%), thiazolidinediones in the Romansh part (34.1% versus 17.8%), and insulin was more often used in the German part of Switzerland (27.0% versus 17.1%) (p0.01 for all parameters).Efforts to identify regional-cultural differences and attempts to overcome associated potential barriers should be emphasised in any health care system when aiming for better diabetic patient care.

There is a gap between knowledge and recommendations regarding venous thromboembolism (VTE) on the one hand and daily practice on the other. This fact has prompted a Swiss multidisciplinary group consisting of angiologists, haematologists, internists, and emergency medicine and pharmaceutical medicine specialists interested in VTE, the SAMEX group, to set up a series of surveys and studies that give useful insight into the situation in our country. Their projects encompassed prophylactic and therapeutic aspects of VTE, and enrolled over 7000 patients from five academic and 45 non-academic acute care hospitals and fifty-three private practices in Switzerland. This comprehensive Swiss Clinical Study Programme forms the largest database surveying current clinical patterns of VTE management in a representative sample of the Swiss patient population. Overall the programme shows a lack of thromboprophylaxis use in hospitalised at-risk medical patients, particularly in those with cancer, acute heart or respiratory failure and the elderly, as well as under-prescription of extended prophylaxis beyond hospital discharge in patients undergoing major cancer surgery. In regard to VTE treatment, planning of anticoagulation duration, administration of LMWH for cancer-associated thrombosis, and the use of compression therapy for prevention of post-thrombotic syndrome in patients with symptomatic proximal DVT require improvement. In conclusion, this programme highlights insufficient awareness of venous thromboembolic disease in Switzerland, underestimation of its burden and inconsistent application of international consensus statement guidelines regarding prophylaxis and treatment adopted by the Swiss Expert Group.

SummaryA low simplified Pulmonary Embolism Severity Index (sPESI), defined as age ≤80 years and absence of systemic hypotension, tachycardia, hypoxia, cancer, heart failure, and lung disease, identifies low-risk patients with acute pulmonary embolism (PE). It is unknown whether cardiac troponin testing improves the prediction of clinical outcomes if the sPESI is not low. In the prospective Swiss Venous Thromboembolism Registry, 369 patients with acute PE and a troponin test (conventional troponin T or I, highly sensitive troponin T) were enrolled from 18 hospitals. A positive test result was defined as a troponin level above the manufacturers assay threshold. Among the 106 (29%) patients with low sPESI, the rate of mortality or PE recurrence at 30 days was 1.0%. Among the 263 (71%) patients with high sPESI, 177 (67%) were troponin-negative and 86 (33%) troponin-positive; the rate of mortality or PE recurrence at 30 days was 4.6% vs. 12.8% (p=0.015), respectively. Overall, risk assessment with a troponin test (hazard ratio [HR] 3.39, 95% confidence interval [CI] 1.38–8.37; p=0.008) maintained its prognostic value for mortality or PE recurrence when adjusted for sPESI (HR 5.80, 95%CI 0.76–44.10; p=0.09). The combination of sPESI with a troponin test resulted in a greater area under the receiver-operating characteristic curve (HR 0.72, 95% CI 0.63–0.81) than sPESI alone (HR 0.63, 95% CI 0.57–0.68) (p=0.023). In conclusion, although cardiac troponin testing may not be required in patients with a low sPESI, it adds prognostic value for early death and recurrence for patients with a high sPESI.

SummaryIn patients with acute cancer-associated thrombosis, current consensus guidelines recommend anticoagulation therapy for an indefinite duration or until the cancer is resolved. Among 1,247 patients with acute venous thromboembolism (VTE) enrolled in the prospective Swiss Venous Thromboembolism Registry (SWIVTER) II from 18 hospitals, 315 (25%) had cancer of whom 179 (57%) had metastatic disease, 159 (50%) ongoing or recent chemotherapy, 83 (26%) prior cancer surgery, and 63 (20%) recurrent VTE. Long-term anticoagulation treatment for >12 months was more often planned in patients with versus without cancer (47% vs. 19%; p12 months. In conclusion, long-term anticoagulation treatment for more than 12 months was planned in less than half of the cancer patients with acute VTE. The low rates of long-term anticoagulation in cancer patients with a first episode of VTE and in patients with non-metastatic cancer require particular attention.

We aimed to investigate clinical practice patterns for the outpatient management of acute deep vein thrombosis (DVT).In the prospective Outpatient Treatment of Deep Vein Thrombosis in Switzerland (OTIS-DVT) registry, 534 consecutive outpatients with acute DVT (49% proximal, 24% recurrent, and 12% cancer-associated) were enrolled: 41% patients were managed in private angiology practice, 34% in an outpatient hospital department, and 25% in private general or internal medicine practice.For diagnosis, ultrasound was used in 95% and D-dimer testing in 53%. Low-molecular-weight heparin (LMWH) was prescribed for a median (IQR) duration of 7 (5-12) days in 83% of patients, and vitamin K-antagonists for 163 (92-183) days in 81%. Mechanical measures to prevent post-thrombotic syndrome were prescribed in 83%; compression stockings or bandages for a median (IQR) duration of 364 (101-730) days from hospital physicians, and 92 (45-183) days from private practice physicians (p0.001). Among patients with symptomatic proximal DVT, mechanical measures were prescribed for at least 2 years in 24% patients; 55% in hospital, and 6% in private practice (p0.001). Among patients with cancer-associated DVT, the median (IQR) duration of LMWH therapy was 16 (8-45) days, and 35% received LMWH for less than 90 days.The OTIS-DVT registry provides representative information on clinical practice patterns for outpatients with acute DVT managed by hospital or private practice physicians. The use of mechanical measures in patients with symptomatic proximal DVT and the administration of LMWH for a long-term therapy of cancer-associated DVT require improvement to comply with current guidelines.

SummaryThree-month anticoagulation is recommended to treat provoked or first distal deep-vein thrombosis (DVT), and indefinite-duration anticoagulation should be considered for patients with unprovoked proximal, un-provoked recurrent, or cancer-associated DVT. In the prospective Out-patient Treatment of Deep Vein Thrombosis in Switzerland (OTIS-DVT) Registry of 502 patients with acute objectively confirmed lower extremity DVT (59% provoked or first distal DVT; 41% unprovoked proximal, unprovoked recurrent, or cancer-associated DVT) from 53 private practices and 11 hospitals, we investigated the planned duration of anticoagulation at the time of treatment initiation. The decision to administer limited-duration anticoagulation therapy was made in 343 (68%) patients with a median duration of 107 (interquartile range 91–182) days for provoked or first distal DVT, and 182 (interquartile range 111–184) days for unprovoked proximal, unprovoked recurrent, or cancer-associated DVT. Among patients with provoked or first distal DVT, anticoagulation was recommended for

BACKGROUND: The adequacy of thromboprophylaxis prescriptions in acutely ill hospitalized medical patients needs improvement. OBJECTIVE: To prospectively assess the efficacy of thromboprophylaxis adequacy of various clinical decision support systems (CDSS) with the aim of increasing the use of explicit criteria for thromboprophylaxis prescription in nine Swiss medical services. METHODS: We randomly assigned medical services to a pocket digital assistant program (PDA), pocket cards (PC) and no CDSS (controls). In centers using an electronic chart, an e-alert system (eAlerts) was developed. After 4 months, we compared post-CDSS with baseline thromboprophylaxis adequacy for the various CDSS and control groups. RESULTS: Overall, 1085 patients were included (395 controls, 196 PC, 168 PDA, 326 eAlerts), 651 pre- and 434 post-CDSS implementation: 472 (43.5%) presented a risk of VTE justifying thromboprophylaxis (31.8% pre, 61.1% post) and 556 (51.2%) received thromboprophylaxis (54.2% pre, 46.8% post). The overall adequacy (% patients with adequate prescription) of pre- and post-CDSS implementation was 56.2 and 50.7 for controls (P = 0.29), 67.3 and 45.3 for PC (P = 0.002), 66.0 and 64.9 for PDA (P = 0.99), 50.5 and 56.2 for eAlerts (P = 0.37), respectively, eAlerts limited overprescription (56% pre, 31% post, P = 0.01). CONCLUSION: While pocket cards and handhelds did not improve thromboprophylaxis adequacy, eAlerts had a modest effect, particularly on the reduction of overprescription. This effect only partially contributes to the improvement of patient safety and more work is needed towards institution-tailored tools.

BACKGROUND: The aim of the present analysis from the epidemiologic international day for the evaluation of patients at risk for venous thromboembolism (VTE) in the acute hospital care setting (ENDORSE) study was to evaluate the prevalence of VTE risk in acute care hospitals and the proportion of at-risk medical and surgical patients who receive recommended prophylaxis in Switzerland. METHODS: All patients (age ≥ 40 years) admitted to a medical ward or those (age ≥ 18 years) admitted to a surgical ward in ten randomly selected Swiss hospitals were assessed for risk of VTE. The 2004 American College of Chest Physicians (ACCP) evidence-based consensus guidelines were used to assess VTE risk and to determine whether patients were receiving recommended thromboprophylaxis. RESULTS: 2000 patients were eligible; of these 1153 (58%) were in surgical wards, and 847 (42%) in medical wards. According to the ACCP criteria, the proportion of surgical patients at VTE risk was similar in Switzerland (68%, between hospital range 48-86%) in comparison to the global ENDORSE study (64%) (p = 0.296). The rate of at-risk medical patients was lower in Switzerland (21%, range 3-44%) than in the global study (42%) (p

Background: Venous thromboembolism (VTE) prophylaxis among hospitalized patients remains underutilized. We investigated the use of appropriate prophylaxis and predictors for using prophylaxis prior to the onset of acute VTE. Methods: In 14 academic and non-academic Swiss hospitals, 567 consecutive patients (306 medical and 261 surgical patients) with objectively confirmed acute VTE and hospitalization within 30 days prior to the VTE event were enrolled. Data on acute and chronic comorbidities, VTE risk factors, and prophylaxis use prior to VTE were prospectively recorded. Results: Among the 567 patients (62±16 years), deep vein thrombosis (DVT) alone was diagnosed in 222 (39%), acute pulmonary embolism (PE) in 218 (38%), and PE plus DVT in 127 (22%). Overall, prophylaxis was used in 329 (58%) patients prior to the VTE event. Among the medical patients, 146 (48%) received prophylaxis, and among the surgical patients, 183 (70%) received prophylaxis (p 3 days (OR 2.12, 95% CI 1.45–3.09), obesity (OR 2.01, 95% CI 1.03–3.90), prior DVT (OR 1.71, 95% CI 1.31–2.24), and prior PE (OR 1.54, 95% CI 1.05–2.26) were independent predictors of prophylaxis. In contrast, cancer (OR 1.06, 95% CI 0.89–1.25), age (OR 0.99, 95% CI 0.98–1.01), acute heart failure (OR 1.13, 95% CI 0.79–1.63), and acute respiratory failure (OR 1.19, 95% CI 0.89–1.59) were not predictive of prophylaxis. Conclusions: Although an indication for prophylaxis was present in most patients who suffered acute VTE as a complication during or shortly after hospitalization, almost half did not receive any form of prophylaxis. Future effort should focus on the improvement of prophylaxis in hospitalized patients, particularly in patients with cancer, acute heart or respiratory failure, and in the elderly.

Abstract 1097 Background: In patients with cancer and acute venous thromboembolism (VTE), current consensus guidelines recommend anticoagulation therapy for an indefinite duration or until the cancer is resolved. Methods and results: Among 1’247 patients with acute VTE enrolled in the Swiss Venous Thromboembolism Registry (SWIVTER) from 18 hospitals, 315 (25%) had cancer of whom 179 (57%) had metastatic disease, 159 (50%) ongoing or recent chemotherapy, and 83 (26%) tumor surgery within 6 months. Patients with cancer were older (66±14 vs. 60±19 years, p3 days (25% vs. 16%, p Conclusions: Less than half of the cancer patients with acute VTE received a prescription for indefinite-duration anticoagulation treatment. Recurrent VTE, metastatic cancer, outpatient VTE diagnosis, and VTE requiring hospitalization were associated with an increased use of this strategy. Disclosures: Spirk: sanofi-aventis (suisse) sa: Employment.