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• W2031127066 abstract "SummaryBackground: The influence of the duration of anticoagulant therapy after venous thromboembolism (VTE) on the long‐term morbidity and mortality is unclear. Aim: To investigate the long‐term sequelae of VTE in patients randomized to different duration of secondary prophylaxis. Methods: In a multicenter trial comparing secondary prophylaxis with vitamin K antagonists for 6 weeks or 6 months, we extended the originally planned 2 years follow‐up to 10 years. The patients had annual visits and at the last visit clinical assessment of the post‐thrombotic syndrome (PTS) was performed. Recurrent thromboembolism was adjudicated by a radiologist, blinded to treatment allocation. Causes of death were obtained from the Swedish Death Registry. Results: Of the 897 patients randomized, 545 could be evaluated at the 10 years follow‐up. The probability of developing severe PTS was 6% and any sign of PTS was seen in 56.3% of the evaluated patients. In multivariate analysis, old age and signs of impaired circulation at discharge from the hospital were independent risk factors at baseline for development of PTS after 10 years. Recurrent thromboembolism occurred in 29.1% of the patients with a higher rate among males, older patients, those with permanent triggering risk factor – especially with venous insufficiency at baseline – signs of impaired venous circulation at discharge, proximal deep vein thrombosis, or pulmonary embolism. Death occurred in 28.5%, which was a higher mortality than expected with a standardized incidence ratio (SIR) of 1.43 (95% CI 1.28–1.58), mainly because of a higher mortality than expected from cancer (SIR 1.83; 95% CI 1.44–2.23) or from myocardial infarction or stroke (SIR 1.28; 95% CI 1.00–1.56). The duration of anticoagulation did not have a statistically significant effect on any of the long‐term outcomes. Conclusion: The morbidity and mortality during 10 years after the first episode of VTE is high and not reduced by extension of secondary prophylaxis from 6 weeks to 6 months. A strategy to reduce recurrence of VTE as well as mortality from arterial disease is needed. Background: The influence of the duration of anticoagulant therapy after venous thromboembolism (VTE) on the long‐term morbidity and mortality is unclear. Aim: To investigate the long‐term sequelae of VTE in patients randomized to different duration of secondary prophylaxis. Methods: In a multicenter trial comparing secondary prophylaxis with vitamin K antagonists for 6 weeks or 6 months, we extended the originally planned 2 years follow‐up to 10 years. The patients had annual visits and at the last visit clinical assessment of the post‐thrombotic syndrome (PTS) was performed. Recurrent thromboembolism was adjudicated by a radiologist, blinded to treatment allocation. Causes of death were obtained from the Swedish Death Registry. Results: Of the 897 patients randomized, 545 could be evaluated at the 10 years follow‐up. The probability of developing severe PTS was 6% and any sign of PTS was seen in 56.3% of the evaluated patients. In multivariate analysis, old age and signs of impaired circulation at discharge from the hospital were independent risk factors at baseline for development of PTS after 10 years. Recurrent thromboembolism occurred in 29.1% of the patients with a higher rate among males, older patients, those with permanent triggering risk factor – especially with venous insufficiency at baseline – signs of impaired venous circulation at discharge, proximal deep vein thrombosis, or pulmonary embolism. Death occurred in 28.5%, which was a higher mortality than expected with a standardized incidence ratio (SIR) of 1.43 (95% CI 1.28–1.58), mainly because of a higher mortality than expected from cancer (SIR 1.83; 95% CI 1.44–2.23) or from myocardial infarction or stroke (SIR 1.28; 95% CI 1.00–1.56). The duration of anticoagulation did not have a statistically significant effect on any of the long‐term outcomes. Conclusion: The morbidity and mortality during 10 years after the first episode of VTE is high and not reduced by extension of secondary prophylaxis from 6 weeks to 6 months. A strategy to reduce recurrence of VTE as well as mortality from arterial disease is needed. Venous thromboembolism (VTE) is associated with acute morbidity, including pain and swelling of the leg and, in case of symptomatic pulmonary embolism (PE), respiratory symptoms, heart failure, and sometimes death. Long‐term sequels may also occur, such as the post‐thrombotic syndrome (PTS) with pain, swelling, pigmentation, eczema, and ulceration of the skin after deep vein thrombosis (DVT), chronic pulmonary hypertension after PE, and recurrent thromboembolic events. The incidence of the PTS varies in reports published during the past decade from 7% to 82%, depending on the characteristics of the population and the duration of follow‐up [1Prandoni P. Lensing A.W. Cogo A. Cuppini S. Villalta S. Carta M. Cattelan A.M. Polistena P. Bernardi E. Prins M.H. The long‐term clinical course of acute deep venous thrombosis.Ann Intern Med. 1996; 125: 1-7Crossref PubMed Scopus (1936) Google Scholar, 2Johnson B.F. Manzo R.A. Bergelin R.O. Strandness DE, J.r. The site of residual abnormalities of the leg veins in longterm follow‐up after deep vein thrombosis and their relationship to the development of the post‐thrombotic syndrome.Int Angiol. 1996; 15: 14-9PubMed Google Scholar, 3Brandjes D.P. Buller H.R. Heijboer H. Huisman M.V. De Rijk M. Jagt H. Ten Cate J.W. Randomised trial of effect of compression stockings in patients with symptomatic proximal‐vein thrombosis.Lancet. 1997; 349: 759-62Abstract Full Text Full Text PDF PubMed Scopus (839) Google Scholar, 4Mohr D.N. Silverstein M.D. Heit J.A. Petterson T.M. O'Fallon W.M. Melton L.J. The venous stasis syndrome after deep venous thrombosis or pulmonary embolism: a population‐based study.Mayo Clin Proc. 2000; 75: 1249-56Abstract Full Text Full Text PDF PubMed Scopus (176) Google Scholar, 5Ziegler S. Schillinger M. Maca T.H. Minar E. Post‐thrombotic syndrome after primary event of deep venous thrombosis 10 to 20 years ago.Thromb Res. 2001; 101: 23-33Abstract Full Text Full Text PDF PubMed Scopus (124) Google Scholar, 6Bank I. Mac Gillavry M.R. Brandjes D.P.M. Büller H.R. Does the location of deep venous thrombosis of the leg determine the risk of the post‐thrombotic syndrome.J Thromb Haemost. 2003; 1: 2058-9Abstract Full Text Full Text PDF PubMed Scopus (2) Google Scholar, 7Gabriel F. Labiós M. Portolés O. Guillén M. Corella D. Francés F. Martínes M. Gil J. Saiz C. Incidence of post‐thrombotic syndrome and its association with various risk factors in a cohort of Spanish patients after one year of follow‐up following acute deep venous thrombosis.Thromb Haemost. 2004; 92: 328-36Crossref PubMed Google Scholar, 8Prandoni P. Lensing A.W. Prins M.H. Frulla M. Marchiori A. Bernardi E. Tormene D. Mosena L. Pagnan A. Girolami A. Below‐knee elastic compression stockings to prevent the post‐thrombotic syndrome: a randomized, controlled trial.Ann Intern Med. 2004; 141: 249-56Crossref PubMed Scopus (590) Google Scholar]. The severe PTS was observed in 0.7–29%, mainly depending on the definition of the syndrome and the duration of follow‐up [1Prandoni P. Lensing A.W. Cogo A. Cuppini S. Villalta S. Carta M. Cattelan A.M. Polistena P. Bernardi E. Prins M.H. The long‐term clinical course of acute deep venous thrombosis.Ann Intern Med. 1996; 125: 1-7Crossref PubMed Scopus (1936) Google Scholar, 3Brandjes D.P. Buller H.R. Heijboer H. Huisman M.V. De Rijk M. Jagt H. Ten Cate J.W. Randomised trial of effect of compression stockings in patients with symptomatic proximal‐vein thrombosis.Lancet. 1997; 349: 759-62Abstract Full Text Full Text PDF PubMed Scopus (839) Google Scholar, 4Mohr D.N. Silverstein M.D. Heit J.A. Petterson T.M. O'Fallon W.M. Melton L.J. The venous stasis syndrome after deep venous thrombosis or pulmonary embolism: a population‐based study.Mayo Clin Proc. 2000; 75: 1249-56Abstract Full Text Full Text PDF PubMed Scopus (176) Google Scholar, 5Ziegler S. Schillinger M. Maca T.H. Minar E. Post‐thrombotic syndrome after primary event of deep venous thrombosis 10 to 20 years ago.Thromb Res. 2001; 101: 23-33Abstract Full Text Full Text PDF PubMed Scopus (124) Google Scholar, 8Prandoni P. Lensing A.W. Prins M.H. Frulla M. Marchiori A. Bernardi E. Tormene D. Mosena L. Pagnan A. Girolami A. Below‐knee elastic compression stockings to prevent the post‐thrombotic syndrome: a randomized, controlled trial.Ann Intern Med. 2004; 141: 249-56Crossref PubMed Scopus (590) Google Scholar, 9Janssen M.C.H. Haenen J.H. Van Asten W.N.J.C. Wollersheim H. Heijstraten F.M.J. De Rooij M.J.M. Thien T. Clinical and haemodynamic sequelae of deep venous thrombosis: retrospective evaluation after 7–13 years.Clin Sci. 1997; 93: 7-12Crossref PubMed Scopus (41) Google Scholar]. These studies were retrospective except for two trials, in which patients were randomized to use graded compression stockings for at least 2 years or no stockings [3Brandjes D.P. Buller H.R. Heijboer H. Huisman M.V. De Rijk M. Jagt H. Ten Cate J.W. Randomised trial of effect of compression stockings in patients with symptomatic proximal‐vein thrombosis.Lancet. 1997; 349: 759-62Abstract Full Text Full Text PDF PubMed Scopus (839) Google Scholar, 8Prandoni P. Lensing A.W. Prins M.H. Frulla M. Marchiori A. Bernardi E. Tormene D. Mosena L. Pagnan A. Girolami A. Below‐knee elastic compression stockings to prevent the post‐thrombotic syndrome: a randomized, controlled trial.Ann Intern Med. 2004; 141: 249-56Crossref PubMed Scopus (590) Google Scholar]. The use of compression therapy was associated with a reduction of the incidence of PTS. Ipsilateral recurrence of DVT was shown in another study to be strongly associated with the risk for the PTS with a hazard ratio of 6.4 [1Prandoni P. Lensing A.W. Cogo A. Cuppini S. Villalta S. Carta M. Cattelan A.M. Polistena P. Bernardi E. Prins M.H. The long‐term clinical course of acute deep venous thrombosis.Ann Intern Med. 1996; 125: 1-7Crossref PubMed Scopus (1936) Google Scholar]. It is not known whether the duration of secondary prophylaxis with vitamin K antagonists has any effect on the risk of developing the PTS. It could be hypothesized that with a too short duration of anticoagulation there are, in addition to the symptomatic and objectively verified recurrent events, also more asymptomatic recurrences, which may have an impact on the venous circulation. In the Duration of Anticoagulation (DURAC) I trial, patients with the first episode of VTE were randomized to secondary prophylaxis with vitamin K antagonists for 6 weeks or 6 months [10Schulman S. Rhedin A.S. Lindmarker P. Carlsson A. Larfars G. Nicol P. Loogna E. Svensson E. Ljungberg B. Walter H. A comparison of six weeks with six months of oral anticoagulant therapy after a first episode of venous thromboembolism. Duration of Anticoagulation Trial Study Group.N Engl J Med. 1995; 332: 1661-5Crossref PubMed Scopus (952) Google Scholar]. The longer duration was associated with a lower risk of recurrence after 2 years [10Schulman S. Rhedin A.S. Lindmarker P. Carlsson A. Larfars G. Nicol P. Loogna E. Svensson E. Ljungberg B. Walter H. A comparison of six weeks with six months of oral anticoagulant therapy after a first episode of venous thromboembolism. Duration of Anticoagulation Trial Study Group.N Engl J Med. 1995; 332: 1661-5Crossref PubMed Scopus (952) Google Scholar] and after 6 years of follow‐up [11Schulman S. The effect of the duration of anticoagulation and other risk factors on the recurrence of venous thromboembolisms. Duration of Anticoagulation Study Group.Wien Med Wochenschr. 1999; 149: 66-9PubMed Google Scholar] without a statistically significant increase of the risk of major hemorrhage. In a post hoc analysis, the longer treatment also appeared to be associated with a lower risk of developing cancer after at least 6 years of follow‐up [12Schulman S. Lindmarker P. Incidence of cancer after secondary prophylaxis against venous thromboembolism with warfarin.N Engl J Med. 2000; 342: 1953-8Crossref PubMed Scopus (319) Google Scholar]. The development of long‐term sequels at 10 years of follow‐up after the first episode of VTE, with emphasis on the PTS, is reported here. The design of the study has been reported previously [10Schulman S. Rhedin A.S. Lindmarker P. Carlsson A. Larfars G. Nicol P. Loogna E. Svensson E. Ljungberg B. Walter H. A comparison of six weeks with six months of oral anticoagulant therapy after a first episode of venous thromboembolism. Duration of Anticoagulation Trial Study Group.N Engl J Med. 1995; 332: 1661-5Crossref PubMed Scopus (952) Google Scholar]. Briefly, patients with the first episode of DVT of the lower limb (n = 790) or PE (n = 107), objectively verified with venography or perfusion–ventilation lung scanning, respectively, were included after informed consent. Major exclusion criteria were diagnosis of cancer at any time before randomization, previous venous ulcer, and reasons to suspect poor compliance with the study procedures. After initial treatment with unfractionated or low‐molecular‐weight heparin and, if indicated, thrombolytic therapy (only 22 cases), the patients were assigned by central telephone randomization according to computer‐generated lists at the time of discharge from the hospital to continue secondary prophylaxis with the vitamin K antagonists warfarin or dicoumarol for 6 weeks or 6 months. Patients and investigators were aware of the assignments. The treatment was targeted at an International Normalized Ratio (INR) of 2.0–2.85. The quality of anticoagulation was defined as ‘good’ if at least 75% of all INR results were at least 2.0. Patients with DVT were urged to use graduated and individually measured compression stockings for at least 1 year. The follow‐up was clinical with visits after 1.5, 3, 6, 9, and 12 months, and then annually. Signs or symptoms of recurrent VTE had to be verified objectively with the same methods as used for the initial diagnosis, as previously described [10Schulman S. Rhedin A.S. Lindmarker P. Carlsson A. Larfars G. Nicol P. Loogna E. Svensson E. Ljungberg B. Walter H. A comparison of six weeks with six months of oral anticoagulant therapy after a first episode of venous thromboembolism. Duration of Anticoagulation Trial Study Group.N Engl J Med. 1995; 332: 1661-5Crossref PubMed Scopus (952) Google Scholar]. All such events were adjudicated by an independent radiologist, who was blinded to the duration of treatment. For all patients included with DVT as the index event we collected information on chronic swelling or skin abnormalities to evaluate incidence of PTS prior to the inclusion. Ulcers were an exclusion criterion and would not be noted. Furthermore, at randomization, which occurred approximately 1 week after admission, the condition of the leg was graded according to a 5‐point scale. One point each was awarded for an increase by more than 1 cm of the circumference (a) at the ankle, (b) at maximum calf level, (c) at 10 cm above patella, (d) teleangiectasia or varicose veins, and (e) hyperpigmentation, and three points or more were defined as evidence of ‘impaired circulation’. At the follow‐up visits from 6 weeks to 2 years, an expanded 8‐point scale was used for the same purpose, with one additional point each for (f) a feeling of heaviness in the leg, (g) venous claudication, and (h) venous ulcer. The trial was designed to end after 2 years, but the protocol was later amended to allow for an extended 10‐year follow‐up to study the occurrence of the PTS, late recurrent thromboembolism, and mortality. At the concluding 10‐year visit, the clinical signs of the PTS were classified according to the updated standards of the International Consensus Committee on Chronic Venous Disease [13Porter J.M. Moneta G.L. An International Consensus Committee on Chronic Venous Disease.Reporting standards in venous disease: an update.J Vasc Surg. 1995; 21: 635-45Abstract Full Text Full Text PDF PubMed Scopus (1110) Google Scholar]. This places the patient into one of seven clinical classes, corresponding to: (C0) no signs of venous disease, (C1) teleangiectasia, reticular veins or malleolar flare, (C2) varicose veins, (C3) edema without skin changes, (C4) pigmentation, venous eczema or lipodermatosclerosis, (C5) skin changes as above with healed ulceration, and (C6) skin changes as above with active ulceration. The patients were also asked about symptoms associated with venous disease, such as pain, heaviness, or skin irritation. The 10‐year examination was performed by the investigators or by specially trained nurses, who had been provided with standardized color photographs representing the different classes. Patients with objectively verified ipsilateral recurrence of DVT were excluded from this assessment, because of the strong association with the PTS. Patients with other types of recurrent VTE, and who thereby had reached an endpoint according to the original protocol, were contacted again for continued follow‐up. Patients without telephone access and who did not respond to written invitations were checked against the Death Registry in Sweden. For suspected recurrences after 2 years of follow‐up, ultrasonography of the leg veins in case of thrombosis in previously unaffected venous segments or with computed tomography of the pulmonary arteries was added as possible alternatives to venography or ventilation–perfusion lung scanning, respectively, for objective verification of the diagnosis. Cause of death was verified for all deceased patients by reviewing medical records, autopsy protocols, and the Death Registry. For each year of follow‐up after inclusion, the expected numbers of deaths from myocardial infarction (MI) or ischemic stroke were calculated by multiplication of the number of patients observed with the appropriate nationwide sex‐ and age‐specific incidence rates in 5‐year age groups, provided by the National Board of Health and Welfare. Relative risk was expressed as standardized incidence ratio (SIR), which is the ratio of the observed numbers of incident deaths to those expected. Plasminogen activator inhibitor type 1 (PAI‐1) and cardiolipin antibodies of IgG‐type were determined at 6 months after the index event, as previously described [14Schulman S. Wiman B. The significance of hypofibrinolysis for the risk of recurrence of venous thromboembolism. Duration of Anticoagulation (DURAC) Trial Study Group.Thromb Haemost. 1996; 75: 607-11Crossref PubMed Scopus (77) Google Scholar, 15Schulman S. Svenungsson E. Granqvist S. Anticardiolipin antibodies predict early recurrence of thromboembolism and death among patients with venous thromboembolism following anticoagulant therapy. Duration of Anticoagulation Study Group.Am J Med. 1998; 104: 332-8Abstract Full Text Full Text PDF PubMed Scopus (461) Google Scholar]. Samples for analysis of the factor V G1691A mutation and the prothrombin G20210A polymorphism were obtained in all available patients of <70 years of age at 4–6 years after the index event, as previously reported [16Lindmarker P. Schulman S. Sten‐Linder M. Wiman B. Egberg N. Johnsson H. The risk of recurrent venous thromboembolism in carriers and non‐carriers of the G1691A allele in the coagulation factor V gene and the G20210A allele in the prothrombin gene. DURAC Trial Study Group. Duration of Anticoagulation.Thromb Haemost. 1999; 81: 684-9Crossref PubMed Scopus (223) Google Scholar]. On a subset of these patients, remaining plasma samples from 88 patients were subsequently used to measure the von Willebrand factor (VWF) antigen. The sample size calculation for this study had only been performed for the initial objective to determine the risk of recurrence during 2 years with 6 weeks or 6 months of secondary prophylaxis. Ninety‐five percent confidence intervals, using binomial distribution, were determined for all reported proportions. Univariate analysis of all proportions was performed with chi‐squared analysis, using Yate's correction. In the multivariate analysis, all variables that yielded a Pvalue of <0.1 in the univariate analysis were entered. The PoLytomous Universal Model (PLUM) was used in the multivariate analysis, which was performed with spss software from Technologies4Targeting Ltd (Peterborough, UK). The study was approved by the regional and local ethics committees and the amendment for extension of the trial was approved by the regional ethics committee of the Karolinska Institute." @default.
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• W2031127066 title "Post‐thrombotic syndrome, recurrence, and death 10 years after the first episode of venous thromboembolism treated with warfarin for 6 weeks or 6 months" @default.
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