Novel oral anticoagulant use in adults with congenital heart disease: a single-center experience report.

BACKGROUND: Adults with congenital heart disease (ACHD) are a group with an increased risk of thromboembolic complications and arrhythmias. Vitamin K antagonists are the most commonly used thromboprophylaxis therapy in this population. Studies on the efficacy and safety of novel oral anticoagulants (NOAC) are scare in ACHD. A retrospective study on ACHD patients on NOAC treatment registered in the National Quality Registry for Congenital Heart Disease, SWEDCON, and National Quality Registry for Atrial fibrillation and Anticoagulation, AuriculA, from Southern Sweden. RESULTS: Thirty patients who had been taking NOAC treatment for a minimum of 3 months were included. Their median age was 55 years (SD 17 years) and 57% were male. Median follow-up was 17 months (IQR: 10-41). Eliquis was the most used NOAC (47%). Median CHA2DS2-VASc score was 2 (IQR: 0-3) and HAS-BLED was 1 (IQR: 0-2). Complex ACHD was prevalent in 27% of the patients. No thromboembolic events were recorded; however, one major bleeding, unspecified, was reported during the total cumulative patient follow-up time of 64 years. CONCLUSIONS: The results of our study, although limited in size, suggest that NOAC appear safe and effective in ACHD patients. Further and larger studies on NOAC in ACHD patients are warranted.

Trends in Clinical Practice and Outcomes After Percutaneous Coronary Intervention of Unprotected Left Main Coronary Artery.

Background The use of percutaneous coronary intervention (PCI) to treat unprotected left main coronary artery disease has expanded rapidly in the past decade. We aimed to describe nationwide trends in clinical practice and outcomes after PCI for left main coronary artery disease. Methods and Results Patients (n=4085) enrolled in the SCAAR (Swedish Coronary Angiography and Angioplasty Registry) as undergoing PCI for left main coronary artery disease from 2005 to 2017 were included. A count regression model was used to analyze time-related differences in procedural characteristics. The 3-year major adverse cardiovascular and cerebrovascular event rate defined as death, myocardial infarction, stroke, and repeat revascularization was calculated with the Kaplan-Meier estimator and Cox proportional hazard model. The number of annual PCI procedures grew from 121 in 2005 to 589 in 2017 (389%). The increase was greater for men (479%) and individuals with diabetes (500%). Periprocedural complications occurred in 7.9%, decreasing from 10% to 6% during the study period. A major adverse cardiovascular and cerebrovascular event occurred in 35.7% of patients, falling from 45.6% to 23.9% (hazard ratio, 0.56; 95% CI, 0.41-0.78; P=0.001). Radial artery access rose from 21.5% to 74.2% and intracoronary diagnostic procedures from 14.0% to 53.3%. Use of bare-metal stents and first-generation drug-eluting stents fell from 19.0% and 71.9%, respectively, to 0, with use of new-generation drug-eluting stents increasing to 95.2%. Conclusions Recent changes in clinical practice relating to PCI for left main coronary artery disease are characterized by a 4-fold rise in procedures conducted, increased use of evidence-based adjunctive treatment strategies, intracoronary diagnostics, newer stents, and more favorable outcomes.

Safety of early hospital discharge following admission with ST-elevation myocardial infarction treated with percutaneous coronary intervention: a nationwide cohort study.

BACKGROUND: The Second Primary Angioplasty in Myocardial Infarction (PAMI-II) risk score is recommended by guidelines to identify low-risk patients with ST-elevation myocardial infarction (STEMI) for an early discharge strategy. AIMS: We aimed to assess the safety of early discharge (≤2 days) for low-risk STEMI patients treated with primary percutaneous coronary intervention (PCI). METHODS: Using nationwide data from the SWEDEHEART registry, we identified patients with STEMI treated with primary PCI during the period 2009-2017, of whom 8,092 (26.4%) were identified as low risk with the PAMI-II score. Low-risk patients were stratified according to their length of hospital stay (≤2 days vs >2 days). The primary endpoint was major adverse cardiovascular events (MACE, including death, reinfarction treated with PCI, stroke or heart failure hospitalisation) at one year, assessed using a Cox proportional hazards model with propensity score as well as an inverse probability weighting propensity score of average treatment effect to adjust for confounders. RESULTS: A total of 1,449 (17.9%) patients were discharged ≤2 days from admission. After adjustment, the one-year MACE rate was not higher for patients discharged at >2 days from admission than for patients discharged ≤2 days (4.3% vs 3.2%; adjusted HR 1.31, 95% confidence interval [CI]: 0.92-1.87, p=0.14), and no difference was observed regarding any of the individual components of the main outcome. Results were consistent across all subgroups with no difference in MACE between early and late discharge patients. CONCLUSIONS: Nationwide observational data suggest that early discharge of low-risk patients with STEMI treated with PCI is not associated with an increase in one-year MACE.

Bivalirudin Versus Heparin Monotherapy in Elderly Patients With Myocardial Infarction: A Prespecified Subgroup Analysis of the VALIDATE-SWEDEHEART Trial.

BACKGROUND: Elderly patients with acute myocardial infarction undergoing percutaneous coronary intervention are at increased risk of both ischemic and bleeding complications. The optimal anticoagulation strategy in these patients is uncertain. Therefore, we compared bivalirudin to heparin monotherapy in a contemporary cohort of such patients. METHODS: A prespecified subgroup analysis of elderly patients with myocardial infarction (≥75 years) from the VALIDATE-SWEDEHEART trial (Bivalirudin Versus Heparin in ST-Segment and Non-ST-Segment Elevation Myocardial Infarction in Patients on Modern Antiplatelet Therapy in the Swedish Web System for Enhancement and Development of Evidence-Based Care in Heart Disease Evaluated According to Recommended Therapies Registry Trial) was performed. In the trial, patients were randomized to either bivalirudin or heparin monotherapy during percutaneous coronary intervention, with mandatory potent P2Y12 inhibition, routine radial artery access, and only bail-out glycoprotein IIb/IIIa inhibition. Kaplan-Meier event rates were assessed for the primary end point, consisting of a composite of all-cause death, myocardial reinfarction, or major bleeding, within 180 days. RESULTS: The elderly (n=1592) had more than twice the risk of all events compared with younger patients (n=4406). Baseline and periprocedural characteristics were equal between bivalirudin (n=799) and heparin (n=793) treated patients ≥75 years. No differences were found in the elderly between bivalirudin and heparin monotherapy regarding the primary end point (180-day all-cause death, myocardial reinfarction, or major bleeding), the individual components of the primary end point, definite stent thrombosis, or stroke. CONCLUSIONS: In this prespecified subgroup analysis of the VALIDATE-SWEDEHEART trial, elderly patients with myocardial infarction had a highly increased risk of all events. However, no difference in outcomes could be observed with an anticoagulation strategy with either bivalirudin or heparin as monotherapy in this patient group.

Diagnostic accuracy of troponin T measured ≥6h after symptom onset for ruling out myocardial infarction.

Objectives: Guidelines recommend a single high-sensitivity cardiac troponin T (hs-cTnT) ≤14 ng/L measured ≥6 h after chest pain onset combined with a GRACE score <140 and the patient being pain-free for ruling out myocardial infarction (MI). There is however little data on the performance of this strategy. We therefore aimed to evaluate the diagnostic accuracy of a hs-cTnT ≤14 ng/L measured ≥6 h after chest pain onset when combined with GRACE score or other clinical risk stratification tools. Design: This was a secondary analysis of a prospective observational study, which enrolled emergency department (ED) chest pain patients. The hs-cTnT strategy was combined with HEART, TIMI, EDACS, GRACE score and ED physician's overall assessment of patient history and ECG. The primary outcome was MI, and the secondary outcome was 30-day major adverse cardiac events (MACE). Results: All tested diagnostic strategies were shown to have a negative predictive value (NPV) ≥99.5% for ruling out MI. Using HEART, TIMI, EDACS or ECG + patient history also resulted in a NPV ≥98% for ruling out 30-day MACE. An isolated hs-cTnT ≤14 ng/L measured ≥6 h after chest pain onset and the combination with GRACE score both had a NPV <98% for ruling out 30-day MACE. Conclusion: A single hs-cTnT ≤14 ng/L obtained ≥6 h from chest pain onset, with and without GRACE score, reliably ruled out MI but did not perform well for ruling out 30-day MACE. These results question current guideline recommendations, and indicate that HEART, EDACS, TIMI, or ECG + patient history strategies should be the preferred risk stratification tools.

Ischemic stroke rates decline in patients with atrial fibrillation as anticoagulants uptake improves: A Swedish cohort study.

INTRODUCTION: The impact of the increased anticoagulants uptake on incidence rate of ischemic stroke is largely unknown. We assessed time trends in rates of ischemic stroke in patients with incident atrial fibrillation (AF) diagnosed between 2011 and 2013. MATERIALS AND METHODS: Population-based retrospective registry study of all 11,500 adults diagnosed with incident non-valvular atrial fibrillation in 2011-2013 in primary and secondary care and receiving oral anticoagulants (n=4847), aspirin (n=2850) or no treatment (n=3766) in Skåne County, Sweden. The primary outcome was the rate of ischemic stroke within 365days after AF diagnosis. RESULTS AND CONCLUSION: Cumulative incidence of ischemic stroke decreased from 2.87% (95% confidence interval (CI) 2.37-3.45%) to 1.93% (95% CI 1.54-2.41%) while the uptake of oral anticoagulants increased from 36.6% to 48.4% between 2011 and 2013 (regression coefficient -0.08; 95% CI, -0.09 to -0.07, p<0.001). The increased uptake of oral anticoagulants in the community is associated with decreased incidence of ischemic stroke in AF patients.

Procoagulatory changes induced by head-up tilt test in patients with syncope: observational study.

BACKGROUND: Orthostatic hypercoagulability is proposed as a mechanism promoting cardiovascular and thromboembolic events after awakening and during prolonged orthostasis. We evaluated early changes in coagulation biomarkers induced by tilt testing among patients investigated for suspected syncope, aiming to test the hypothesis that orthostatic challenge evokes procoagulatory changes to a different degree according to diagnosis. METHODS: One-hundred-and-seventy-eight consecutive patients (age, 51 ± 21 years; 46% men) were analysed. Blood samples were collected during supine rest and after 3 min of 70° head-up tilt test (HUT) for determination of fibrinogen, von Willebrand factor antigen (VWF:Ag) and activity (VWF:GP1bA), factor VIII (FVIII:C), lupus anticoagulant (LA1), functional APC-resistance, and activated prothrombin time (APTT) with and without activated protein C (C+/-). Analyses were stratified according to age, sex and diagnosis. RESULTS: After 3 min in the upright position, VWF:Ag (1.28 ± 0.55 vs. 1.22 ± 0.54; p < 0.001) and fibrinogen (2.84 ± 0.60 vs. 2.75 ± 0.60, p < 0.001) increased, whereas APTT/C+/- (75.1 ± 18.8 vs. 84.3 ± 19.6 s; p < 0.001, and 30.8 ± 3.7 vs. 32.1 ± 3.8 s; p < 0.001, respectively) and APC-resistance (2.42 ± 0.43 vs. 2.60 ± 0.41, p < 0.001) decreased compared with supine values. Significant changes in fibrinogen were restricted to women (p < 0.001) who also had lower LA1 during HUT (p = 0.007), indicating increased coagulability. Diagnosis vasovagal syncope was associated with less increase in VWF:Ag during HUT compared to other diagnoses (0.01 ± 0.16 vs. 0.09 ± 0.17; p = 0.004). CONCLUSIONS: Procoagulatory changes in haemostatic plasma components are observed early during orthostasis in patients with history of syncope, irrespective of syncope aetiology. These findings may contribute to the understanding of orthostatic hypercoagulability and chronobiology of cardiovascular disease.

Higher levels of von Willebrand factor in patients with syncope due to orthostatic hypotension.

OBJECTIVES: Orthostatic hypotension has been linked with increased mortality and cardiovascular morbidity; however, the underlying mechanisms are still unknown. The aim of the study was to assess markers of coagulability in patients with and without orthostatic hypotension who suffered transient loss of consciousness. METHODS: A total of 233 consecutive patients more than 15 years old, with unexplained transient loss of consciousness, underwent head-up tilt test (HUT, Italian protocol). Blood samples were collected during supine rest before and at 3 min of 70° HUT for determination of fibrinogen, von Willebrand factor antigen (vWF:Ag) and activity (vWF:GP1bA), factor VIII (FVIII:C), lupus anticoagulant, and functional activated protein C-resistance. Orthostatic hypotension was defined as persistent decrease in SBP and/or DBP of more than 20/10 mmHg or SBP lower than 90 mmHg during passive HUT. RESULTS: One hundred and seventy-eight patients (81 men, 45.5%) not treated with vitamin-K antagonists were analyzed. Those with orthostatic hypotension (n = 49) were older [61 ±â€Š18 vs. 47 ±â€Š21 years (mean ±â€ŠSD), P < 0.001], had increased FVIII: C-supine (1.2 ±â€Š0.39 vs. 1.0 ±â€Š0.35, P = 0.001), FVIII:C-standing (1.2 ±â€Š0.36 vs. 1.0 ±â€Š0.34, P = 0.001), vWF:Ag-supine (1.5 ±â€Š0.66 vs. 1.1 ±â€Š0.44, P < 0.001), vWF:Ag-standing (1.5 ±â€Š0.67 vs. 1.1 ±â€Š0.46, P < 0.001), vWF:GP1bA-supine (1.5 ±â€Š0.73 vs. 1.1 ±â€Š0.42, P < 0.001), vWF:GP1bA-standing (1.5 ±â€Š0.75 vs. 1.1 ±â€Š0.42 P < 0.001), fibrinogen-standing (2.9 ±â€Š0.53 vs. 2.7 ±â€Š0.61, P = 0.03) but not fibrinogen-supine (2.8 ±â€Š0.54 vs. 2.7 ±â€Š0.61, P = 0.078) compared with patients without orthostatic hypotension. However, after adjustment for age, sex, and comorbidity, only vWF:Ag and vWF:GP1bA levels remained significantly increased in orthostatic hypotension patients. CONCLUSION: Concentration of vWF is elevated in patients with orthostatic hypotension who suffered a syncopal event. This observation may be helpful in understanding the increased risk of cardiovascular events in orthostatic hypotension.

Socioeconomic factors and concomitant diseases are related to the risk for venous thromboembolism during long time follow-up.

While the risk for arterial vascular disease has been shown to be influenced by socioeconomic status (SES), there is limited information whether SES also influences the risk for venous thromboembolism (VTE). To evaluate whether there is an association between SES and VTE incidence. In 1990, all 730,050 inhabitants (379,465 women and 350,585 men) above 25 years of age in the County of Skåne in Sweden were evaluated with regard to age, household income, marital status, country of birth, number of years of residence in Sweden, educational level, and concomitant diseases. The cohort was hereafter prospectively investigated regarding diagnosis of, or death from VTE (deep venous thrombosis or pulmonary embolism ), during 1991-2003. The association between socioeconomic data and concomitant diseases at the baseline investigation 1990 and incidence of VTE during follow-up was examined by Cox proportional hazard models. During the 13 years prospective follow-up, 10,212 women and 7,922 men were diagnosed with VTE. In both genders, age above 40 years at baseline, low income, single status, and a lower level of education were associated with an increased risk of VTE. However, both men and women born outside of Sweden have a lower risk for VTE during follow-up, however. Age above 40 years, low income, single marital status, and lower level of education were independently related to an increased risk of VTE diagnosis during 13 years of prospective follow-up.

Evaluation of recurrent venous thromboembolism in patients with Factor V Leiden mutation in heterozygous form.

INTRODUCTION: To evaluate the risk for recurrence after first venous thromboembolism (VTE) among patients with or without Factor V Leiden (FVL) mutation. MATERIALS AND METHODS: A prospective population based study of 1465 consecutive unselected VTE patients was performed at Skåne University Hospital 1998-2008. The VTE was objectively verified and the patients answered questionnaire and left blood samples for evaluation. RESULTS: Out of 1465 patients (721[49%] men and 744[51%] women) thrombophilia data were available for 1267, and FVL mutation was found in heterozygous form in 339 (27). The homozygous form and prothrombin mutation (PTM) were much less common. Patients were followed during 4.8 ± 2.3 years (total 6133 patient years) and recurrence after first VTE (evaluated in 1108 patients) occurred in 131 (12%, 95%CI 10-14%), where of 49(37%) had heterozygous FVL mutation and 57(44%) were without thrombophilia. The remaining 25(19%) patients had either PTM, FVL in homozygous form, compound PTM/FVL or unknown thrombophilia status. Having FVL mutation in heterozygous form significantly increased the risk for VTE recurrence (odds ratio 2.4 (95 %CI 1.6-3.6; p<0.01). In a Kaplan-Meier analysis the FVL group also differed significantly (p<0.01) from the other patients concerning time to recurrence (almost 25% vs. 10% after 8 years). CONCLUSIONS: FVL mutation in heterozygous form is common among VTE patients and significantly increases the risk for VTE recurrence.

Upper extremity deep venous thrombosis in the population-based Malmö thrombophilia study (MATS). Epidemiology, risk factors, recurrence risk, and mortality.

BACKGROUND: Deep venous thrombosis (DVT) is much less common in the upper than in the lower extremity. Furthermore, there is limited information on risk factors for and the prognosis of upper extremity (UE)DVT in the general population. AIMS: To estimate incidence, risk factors, and prognosis in UEDVT. MATERIAL AND METHODS: Among a total of 1203 patients with venous thromboembolism (VTE) diagnosed during 1998-2006 in the prospective population-based Malmö thrombophilia study, 63 (5%, 33 men [52%, age 54+/-17years], and 30 women [48%, age 55+/-22years]) had UEDVT and were evaluated concerning risk factors, treatment, recurrent VTE, and mortality. RESULTS: At diagnosis, 19(30%) patients had known malignancy and 6(10%) had VTE heredity. Among female UEDVT patients 4(13%) used hormone therapy, 1(3%) was pregnant, while none was in the postpartum period. Of all 63 UEDVT patients, 12(19%) were heterozygous, and 3(5%) homozygous for the Factor V Leiden (FVL)-mutation. Two (3%) patients were heterozygous for the prothrombin mutation, and 1 patient (1.6%) showed both heterozygous FVL-mutation and lupus anticoagulant antibodies. Phlebography had been used for diagnosis in 48(76%), ultrasonography in 16(25%), and computer tomography (CT) in 9(14%) patients. Twenty-two patients (35%) were treated in hospital, and the remaining 41(65%) as out-patients. Sixty-two (98%) was treated with low molecular weight heparin (LMH), 60(95%) with oral anticoagulants (OAC), 3(5%) with unfractionated heparin, and 3(5%) with thrombolysis. VTE recurrence rate during median 62 (range 31-117) month of follow-up was 8/63(13%). Fifteen (24%) UEDVT patients died during follow-up; 9(47%) of the 19 patients with known malignancy at diagnosis and 6(14%) of the other patients. Yearly incidence of UEDVT was 3.6/100.000 (95% confidence interval [CI], 3.3 - 4.03). CONCLUSION: Malignancies and the FVL mutation were common among patients with UEDVT. Mortality during follow-up vas high.

The effect of low molecular weight heparin (dalteparin) on duration and initiation of labour.

It has recently been reported that women treated with low molecular weight heparin (LMWH) during pregnancy had 3 h shorter duration of delivery. The aim of the present study was to evaluate whether LMWH (dalteparin) affects labour. From January 1996 to December 2005, 217 consecutive pregnancies, out of 34 216 newborn (prevalence 0.6%) that were given thromboprophylaxis with dalteparin (usually 5,000 IU once daily). These 217 consecutive pregnancies were compared to an unselected control group (n = 1,499) of gravidae. Main outcome was time in first and second stage of labour and gestational age at delivery. Among nulliparous women, there were significantly fewer women with prolonged first stage of labour as compared to controls (4.1% vs. 8.5%, P = 0.047). In addition, the duration of first stage of labour was 1 h shorter among those treated with LMWH (5.2 vs. 6.2 h, P = 0.06). There were no such differences among parous women. The risk of prematurity, profuse blood loss, and postpartum anaemia was almost doubled among those treated with LMWH (11.5% vs. 5.9%, P = 0.002, 10.6% vs. 5.9%, P < 0.001, and 12.9% vs. 8.7%, P = 0.048, respectively). Treatment with a prophylactic dose of LMWH (dalteparin) during pregnancy was related to fewer women with prolonged first stage of labour, but also to an increased risk of prematurity and blood loss complications.

Prospective analysis of risk factors and distribution of venous thromboembolism in the population-based Malmö Thrombophilia Study (MATS).

BACKGROUND: Despite venous thromboembolism (VTE) being a major cause of morbidity and mortality, there is still limited information on its prevalence and incidence in the general population. OBJECTIVE: To evaluate risk factors, distribution and epidemiology of VTE in the Malmö area with 280,000 inhabitants. METHODS: Patients diagnosed with VTE at Malmö University Hospital in 1998-2006 were invited to a prospective population-based study. Blood sampling and a questionnaire study could be performed in 70% of patients. Remaining 30% were excluded due to language problems, dementia, other severe disease, or unwillingness to participate. RESULTS: During 1998-2006 1140 VTE patients (559 men [49%, age 62+/-16 years] and 581 women [51%, age 61+/-20 years]) were included. Deep venous thrombosis (DVT) occurred in 882 (77%), pulmonary embolism (PE) in 330 (29%), and both DVT and PE in 72 (6%). The most common acquired risk factors among VTE patients were hormone therapy (24% of female DVT patients and 19% of female PE patients), immobilisation (17% of DVT patients and 18% of PE patients), previous surgery (13% of DVT patients and 19% of PE patients), and concomitant malignant disease (12% of DVT patients and 11% of PE patients). A positive family history for VTE was obtained from 25% of DVT patients and 22% of PE patients. Yearly incidences of VTE, DVT and PE in Malmö were 66, 51, and 19/100.000, respectively. CONCLUSION: Hormone therapy, immobilisation, previous surgery and concomitant malignancy were the most common acquired risk factors among VTE patients in this population-based study. The VTE-incidence was lower than in earlier epidemiological studies.

The Factor V Leiden mutation is associated with a higher blood haemoglobin concentration in women below 50 of the Malmö Thrombophilia Study (MATS).

The aim of this study was to investigate a relationship between FVL-mutation and levels of haemoglobin (Hb) in patients with venous thromboembolism (VTE). From March 1998 to December 2005, 927 consecutive patients with objectively diagnosed VTE were registered in the Malmö Thrombophilia Study (MATS). Female patients with FVL-mutation below 50 years of age had significantly higher median-Hb (133 vs. 126 g/l; P < 0.001) compared to female patients below the age of 50 years without FVL. No significant difference could be found for men or women above 50 years of age or men below 50 years of age. Female patients below the age of 50 years with FVL-mutation and VTE are associated with higher median Hb, and this finding is in accordance with earlier hypothesis that FVL-mutation may have constituted an evolutionary selection advantage.

Lipid-lowering therapy is related to inflammatory markers and 3-year mortality in patients with critical limb ischemia.

To evaluate relationships between lipid-lowering therapy, inflammation, and 3-year mortality in critical limb ischemia (CLI), 259 consecutive CLI patients underwent evaluation of medication, tumor necrosis factor-alpha, interleukin-6 (IL-6), neopterin, high-sensitivity C-reactive protein (hs-CRP), 8-epi-PGF(2 alpha), and endothelin-1. Mortality was assessed after 3 years. Sixty-one patients (24%) were on lipid-lowering therapy and 59 patients (97%) on statins. Patients on lipid-lowering therapy were younger and showed lower low-density lipoprotein cholesterol, hs-CRP, and IL-6 levels than patients without therapy. Three-year survival was higher among patients on lipid-lowering therapy. In logistic regression, the effect of lipid-lowering therapy on 3-year survival was significant with inflammatory markers entered into the model one by one but disappeared when all inflammatory markers were entered into the model together. In conclusion, hs-CRP and IL-6 levels were lower and 3-year survival was higher in CLI patients on lipid-lowering therapy.

Does supervised exercise after deep venous thrombosis improve recanalization of occluded vein segments? A randomized study.

OBJECTIVES: The aim of the present study was to evaluate weather early supervised exercise improves recanalization of acute deep vein thrombosis (DVT) and reduces symptoms. PATIENTS AND METHODS: From September 2001 to March 2004, of 381 patients, 72 eligible patients were included and with a mean age 54 +/- 14 years, 39 (52%) men with deep vein thrombosis (DVT) proven with phlebography were randomized to: an exercise group (n = 36) receiving routine anticoagulation, class II compression stockings and additionally supervised exercise and a control group (n = 36) receiving the same therapy but no exercise. Patients were followed-up during six months. Phlebography was scored initially and at six-months. RESULTS: There were at inclusion no differences between the two groups regarding age, body weight, body mass index (BMI), calf circumference of the affected leg, and overall quality of life estimated by visual analog scale (VAS)-scale. In both groups there were significant reductions regarding calf circumference in the affected leg compared to the inclusion time, both at one-month (P = 0.0012) and six month (P = 0.0002) follow-up. The degree of recanalization of the affected venous segments was high and did not differ between groups. There were no recurrent DVT or pulmonary emboli or other treatment complications in any individual during the six-month follow-up period. CONCLUSIONS: Early exercise did not acutely exacerbate the risk of complications in patients with DVT. No benefits of early exercise were seen regarding the degree of recanalization of the thrombi, or faster resolution of pain or swelling. Nevertheless, our study shows that early exercise/ambulation is safe in combination with anticoagulation and compression stockings for the majority of patients with DVT.