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Practical issues in suspected venous thrombosis in general practice: A multicentre prospective cohort in primary care
Thrombosis Research 158 (2017) 19–21
Contents lists available at ScienceDirect
Thrombosis Research journal homepage: www.elsevier.com/locate/thromres
Letter to the Editors-in-Chief Practical issues in suspected venous thrombosis in general practice: A multicentre prospective cohort in primary care
Keywords: Venous thrombosis Anticoagulants General practice Referral and consultation Ultrasonography Diagnosis
1. Introduction Suspected deep vein thrombosis (DVT) is commonly encountered in primary care, whereas its diagnosis is confirmed in 10 to 20% of cases [1,2]. Only one guideline, from the American College of Chest Physicians (ACCP), details therapeutic management pending ultrasonography. A parenteral anticoagulant is recommended if the clinical probability is low and the delay before ultrasonography N24 h; if the clinical probability is intermediate and the delay before ultrasonography N4 h, and in all cases if the clinical probability is high [3]. The provision of medical transport to immobilise the patient awaiting ultrasonography is not addressed in guidelines. The ACCP guidelines note that they did not find any trial addressing therapeutic management pending ultrasonography and therefore assigned a grade 2C to these recommendations [3]. Initiating parenteral anticoagulation in primary care requires maintenance of a low molecular weight heparin supply with appropriate storage conditions and monitoring for expiration. Organising medical transport may further complicate patient management. These factors can explain variations observed in physician practice and divergence from the ACCP guidelines [4,5]. They can also cause misunderstandings between physicians when, for example, a patient presents to the Emergency Department on foot with suspected DVT and no previous anticoagulation. We wondered if current anticoagulation practices are related to patients' characteristics, physicians' characteristics and/or early thromboembolic complications. The objective of our study was to compare factors and outcomes depending on whether or not anticoagulation was administered before ultrasonography in patients with suspected DVT. 2. Materials and methods A multicentre prospective cohort study was conducted from 30 March to 12 July 2015, among patients referred by a general practitioner to a vascular physician for suspected lower-extremity DVT. We did not include patients with a clinical suspicion of pulmonary embolism (PE), patients already receiving long-term anticoagulant treatment and patients who could not be reached by telephone. Twenty-three vascular physicians enrolled consecutive, eligible patients during the study
http://dx.doi.org/10.1016/j.thromres.2017.08.002 0049-3848/© 2017 Elsevier Ltd. All rights reserved.
period. Fifteen days after enrolment, patients were contacted by telephone to collect their profile, their medical management, the result of ultrasonography, and occurrence of PE or bleeding. The patient's general practitioner was telephoned to complete data collection. In the event of discrepancy, the patient's answer was considered as the reference. In the event of a thrombotic or bleeding event, additional test records were collected. The provision of therapeutic anticoagulation was compared with the patient's personal history, general practitioner's characteristics, clinical probability of DVT, distance to the vascular physician, means of transport, delay before ultrasonography, result of ultrasonography, and occurrence of PE and/or bleeding within 15 days. Statistical analysis was performed with IBM SPSS statistics® software version 19. Frequencies were calculated for each outcome, with their corresponding 95% confidence interval (95% CI). Comparisons used chi-square and Fisher tests. The significance level has been set at p b 0.05, with bilateral setting. The protocol was approved by an independent Ethics Committee. All patients received written information on the study, emphasising their right to refuse participation or to withdraw at any time.
3. Results Of the 248 eligible patients, 25 refused to participate in the study. Of the 223 enrolled patients, one had incomplete data and 222 (99.6%) were included in the analysis. One hundred and forty-six general practitioners answered the 15 day questionnaire. There was no difference in follow-up data collected from patients and their general practitioners. The mean age was 59 years (standard deviation, 16) and there were 74 (33.3%) males. Ultrasonography was performed the same day for 119 patients (53.6%). DVT was confirmed in 43 patients (19.4%), and was proximal in 17 cases (39.5%).
3.1. Anticoagulation and transport modalities Forty-six patients (20.7%, 95% CI: 15.4–26.1%) received therapeutic doses of anticoagulation before ultrasonography (enoxaparin twice a day, tinzaparin once a day, fondaparinux once a day or rivaroxaban 15 mg twice a day). Among the 108 patients who had either a high clinical suspicion of DVT or a delay before ultrasonography of greater than one day, 34 (31.5%, 95% CI: 22.7–40.2%) received anticoagulation. Medical transport to the vascular physician's surgery had been arranged for 11 patients (5.0%, 95% CI: 2.1–7.8%).
3.2. Clinical outcomes after 15 days One distal DVT (0.5%), no PE and no bleeding events occurred within 15 days after enrolment. The patient with a new DVT had a negative initial ultrasonography, no initial anticoagulation and no medical transport.
20
Letter to the Editors-in-Chief
3.3. Factors and outcomes associated with anticoagulation In univariate analysis, anticoagulation was associated with a delay before ultrasonography of greater than one day, vascular physician location N 20 km away, a personal history of DVT and/or PE, a confirmed DVT diagnosis, and a general practice consultation occurring between 2 pm and 6 am (Table 1).
4. Discussion Pending ultrasonography, general practitioners prescribed anticoagulation to one patient in five. After 15 days of follow-up, one distal DVT, no PE and no bleeding events had been recorded. Empiric anticoagulant treatment was administered more often if there was a personal history of thromboembolism, if the consultation took place in the second half of the day or at night, and if the ultrasonography consultation was distant in time or place. Although associated with a positive DVT diagnosis, anticoagulation was not associated with the clinical probability as perceived by the general practitioner.
This study draws its strength from its multicenter design, with the participation of 23 vascular physicians and 146 general practitioners. Inclusion at the level of the vascular consultation rather than the general practice consultation limited a potential Hawthorne effect, by which the awareness of being observed may change practices. Crossed collection of data, from patients and from general practitioners, enhanced reliability. The retrospective and declarative collection of some data could have influenced answers. This could have occurred with the clinical probability as perceived by the general practitioner, but the main outcomes are all based on objective data. The power of our study does not allow multivariate analysis and definitive conclusions as to the possible impact of anticoagulation on the occurrence of thromboembolic events. The rate of anticoagulation before ultrasonography found in our study (20.7%) is located at a point between the only two data available in the literature. This rate was 39% in a French study with 125 patients [4] and 15.5% in a German study from the TULIPA register with 5421 patients [5]. These differences could reflect differences in study power or differences in national practices. The rate of confirmed DVT (19.4%) is similar to literature data, which mentions a percentage of diagnostic confirmation between 10 and 30% of cases [1,2].
Table 1 Anticoagulation management. Anticoagulation Age, N (%) 20–65 years N65 years Sex, N (%) Male Female Clinical circumstances Family history of DVT, N (%) No Yes Personal history of DVT, N (%) No Yes Thrombophilia No Yes Active cancer, N (%) No Yes Surgery ≤3 months, N (%) No Yes Cast immobilisation No Yes Travel N6 h in the last 3 weeks, N (%) No Yes Hormonal treatment No Yes General practice consultation hour, N (%) 6 h–14 h 14 h–6 h Clinical probability of DVT, N (%) Low Intermediate High Distance to the vascular physician, N (%) ≤20 km N20 km Delay before ultrasonography, N (%) Doppler on the same day Doppler the next day or after Ultrasonography result, N (%) Confirmed DVT Unconfirmed DVT DVT: deep vein thrombosis. a Fisher test.
No anticoagulation
OR
95% CI
p-Value
24 22
(18.0) (24.7)
109 67
(82.0) (75.3)
1.73
0.88–3.42
0.2292
18 28
(24.3) (18.9)
56 120
(75.6) (81.1)
0.95
0.48–1.86
0.3489
16 6
(12.3) (33.3)
68 12
(56.7) (66.7)
2.13
0.69–6.52
0.2104a
28 18
(15.9) (39.1)
148 28
(84.1) (60.9)
3.40
1.66–6.96
0.0005
44 2
(20.2) (50.0)
174 2
(79.8) (50.0)
3.95
0.54–28.86
0.1906a
45 1
(20.8) (16.7)
171 5
(79.2) (83.3)
0.76
0.09–6.67
1.0000a
40 6
(20.7) (20.7)
153 23
(79.3) (79.3)
1.00
0.38–2.62
0.9965
46 0
(20.9) (0.0)
174 2
(79.1) (100.0)
NA
NA
NA
42 4
(20.4) (25.0)
164 12
(79.6) (75.0)
1.30
0.40–4.24
0.7483a
46 0
(21.5) (0.0)
168 8
(78.5) (100.0)
NA
NA
NA
16 29
(13.8) (27.9)
100 75
(86.2) (72.1)
2.42
1.22–4.77
0.0097
10 19 9
(14.3) (24.4) (26.5)
60 59 25
(85.7) (75.6) (73.5)
1.93 2.16
0.83–4.50 0.78–5.96
34 12
(17.3) (46.2)
162 14
(82.7) (53.8)
4.08
1.74–9.60
0.0007
10 36
(8.4) (35.0)
109 67
(91.6) (65.0)
5.86
2.73–12.57
b0.0001
31 15
(17.3) (34.9)
148 28
(82.7) (65.1)
2.56
1.22–5.34
0.0107
0.2168
Letter to the Editors-in-Chief
With respect to ACCP guidelines, observed practices seemed to reflect inertia. The anticoagulation recommendation was met every third time [3]. Anticoagulation seems to be associated with the delay before ultrasonography rather than the level of clinical probability as perceived by the general practitioner. These results confirm those of a smaller (125 patients) French study published in 2006 [4]. The absence of bleeding events within 15 days corresponds with data from several articles in which anticoagulant administration before ultrasound was not associated with an increased risk of bleeding in patients [1,3,6]. Of the 46 patients who received anticoagulation, 1 received a direct oral anticoagulant. This practice could change in the coming years, with greater access to and use of the direct acting oral anticoagulants [7]. The medical transport prescriptions observed in our study were consistent with data from the 2006 French study [4] in which 6.0% of patients went to the vascular physician by ambulance (versus 5.0% by taxi or ambulance in our study). In conclusion, pending ultrasonography for suspected DVT of the lower limbs, general practitioners prescribe anticoagulation one out of 5 times. While we await more evidence on its impact on thromboembolic complications, the absence of bleeding outcomes, in addition to current guidelines, argue in favor of more frequent anticoagulant prescription pending ultrasonography. Funding None. Ethical approval The protocol had been approved by the Ethics Committee of CHU Saint-Etienne (IRB: IORG0007394) with the reference IRBN472015/ CHUSTE.
21
Laurent Bertoletti INSERM U1059, Sainbiose-Dysfonction Vasculaire et Hémostase, Saint-Etienne, France Department of Vascular and Therapeutic Medicine, University Hospital of Saint-Etienne, Saint-Etienne, France INSERM CIC1408, Saint-Etienne, France Patricia Fayard Vascular Medicine Practice, Rue de Jourcey, Veauche, France Emmanuel Chapelier Vascular Medicine Practice, Rue Bergson, Saint-Etienne, France Benjamin Seffert Department of Vascular and Therapeutic Medicine, University Hospital of Saint-Etienne, Saint-Etienne, France Béatrice Simon-Momège Vascular Medicine Practice, Rue Dugas-Montbel, Saint-Chamond, France Paul Frappé Department of General Practice, University of Saint-Etienne, Saint-Etienne, France INSERM U1059, Sainbiose-Dysfonction Vasculaire et Hémostase, Saint-Etienne, France INSERM CIC1408, Saint-Etienne, France the GUSTAVE investigators1 29 March 2017 Available online xxxx
Conflict of interest The authors declare they have no potential conflict of interest related to this research. References [1] P. Wells, D. Anderson, The diagnosis and treatment of venous thromboembolism, Hematology Am. Soc. Hematol. Educ. Program 2013 (1) (2013) 457–463. [2] H.R. Büller, A.J. Ten Cate-Hoek, A.W. Hoes, et al., Safely ruling out deep venous thrombosis in primary care, Ann. Intern. Med. 150 (4) (2009) 229–235. [3] C. Kearon, E.A. Akl, A.J. Comerota, et al., Antithrombotic therapy for VTE disease: antithrombotic therapy and prevention of thrombosis, 9th ed.: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines, Chest 141 (Suppl. 2) (2012) (e419S–94S). [4] G. Le Gal, P. Gagne, C. Leroyer, Prescribing attitude of general practitioners in front of patients with deep vein thrombosis suspicion, J. Thromb. Haemost. 4 (7) (2006) 1629–1631. [5] S.M. Schellong, H. Gerlach, V. Hach-Wunderle, et al., Diagnosis of deep-vein thrombosis: adherence to guidelines and outcomes in real-world health care, Thromb. Haemost. 102 (6) (2009) 1234–1240. [6] D. Imberti, W. Ageno, F. Dentali, et al., Management of primary care patients with suspected deep vein thrombosis: use of a therapeutic dose of low-molecular-weight heparin to avoid urgent ultrasonographic evaluation, J. Thromb. Haemost. 4 (5) (2006) 1037–1041. [7] S. Glund, J. Stangier, M. Schmohl, et al., Safety, tolerability, and efficacy of idarucizumab for the reversal of the anticoagulant effect of dabigatran in healthy male volunteers: a randomised, placebo-controlled, double-blind phase 1 trial, Lancet 386 (9994) (2015) 680–690.
Sébastien Bruel* Mouzayan Ginzarly Department of General Practice, University of Saint-Etienne, Saint-Etienne, France INSERM U1059, Sainbiose-Dysfonction Vasculaire et Hémostase, Saint-Etienne, France *Corresponding author at: Département de Médecine Générale, Faculté de Médecine Jacques Lisfranc, Campus Santé Innovations, 10, Rue de la Marandière, 42270 Saint-Priest-en-Jarez, France. E-mail address: [email protected] (S. Bruel).
1 Vascular physicians (n = 23): Magali Aurouet, Marjolaine Basset-Neel, Alexis Blanchard, Christian Boissier, Bénédicte Boucher-Hyp, Elisabeth Breysse, Valérie Chambefort, Emmanuel Chapelier, Serge Couzan, Asma El Jaouhari, Patricia Fayard, Séverine Féasson, Jean-Baptiste Gaultier, Cyrielle Gremillet, Pantea Guyomarc'h, Nelly Jagu, Nathalie Masson, Sylvie Perrot, Sandrine Rivière, Benjamin Seffert, Béatrice Simon-Momège, Catherine Talabard, Vanessa Thevenin. General practitioners (n = 146): Gérard Abrial, Pierre Algarra, Patricia Allemand, Gisèle Ancey, Philippe Andrieu, Serge Angenieux, Houria Argoubi Idrissi, Maud Badin, Jean-Noël Bally, Bruno Barbier, Christophe Barjat, Bastiani, Jean Baudry, Irène Bayard Antigone, Belonnas, Vincent Benvenuto, Christophe Berger, François Berger, Aurélie Bernard, Dominique Berthier, Isabelle Berthouze, Evelyne Bertin, Marc Blanc, André Bonnet, Astrid Bonnet, Mohamed Boukhadra, Nacer Eddine Boukhezra, Benjamin Bourlier, François Boyer, Nathalie BrosseGuillet, Sébastien Bruel, Nicole Brun, Jean-Michel Bruyas, Adrien Busseuil, Nadège Cahin Mercier, Nicolas Canivet, Sébastien Castelain, Jean-Louis Cayreyre, Justine Chabanel, Chabrier, Philippe Chaumier, Christelle Colas Fernandez, Pascal Corsini, Bérengère Crespel, Florent Crouzet, Serge Crouzet, Michèle Cusset-Poncet, Hubert De Jaureguiberry, Laurent De Matos, Jean-Luc Delorme, Delphine Duboeuf Richerol, Patrick Durand, Eric Faure, Elodie Fayolle, Nathalie Ferigo, Franck Fernandez-Hugon, Jean Feuillet, Patrice Freychet, Yannick Frezet, Daniel Gajovic, E Garcia, Garnier, Bruno Garnier, Jérôme Garnier, Mathilde Geissler, Jocelyne Ghuilhot, Audrey Gire, Romain Gire, Jean Girin, Antonio Gonzalez, Denis Grange, Jean-Paul Grégoire, Guy Grenier, Philippe Grenier, Maud Guillot, Jeanine Guyonnet, Nabil Hamdache, Bernadette Jacquet, Bruno Jeannin, Laurent Joubert, Roland Jourdy, Hélène Jury, Salah Kadoun, Bernard Karsenti, Abbas Khennouf, Pierre Lachal, Thibaud Lachmann, Maïté Lamarca Pitiot, Yves Lantner, Marie-Françoise Larue, Michel Laval, Huy Le Xuan, Fabien Lutz, Cyril Mallet, Marie-Laure Marchand, Alban Marcoux, Cécile Martinez, Nicole Mathevet-Perino, Pierre Metzdorff, Jean-François Meyer, François Meynier, Benoît Morel, Olivier Morisson, JeanMarc Mounier, Michel Mugnerot, Catherine Murat, Térésa Neto, Yves Partrat, Françoise Peillet-Gérard, Adrien Pereira, Yvan Perouse, Justine Perret, Dominique Pisanu Girard, Anne Plagnard Bouteille, Marie-Dominique Plagne, Jean-Luc Popin, Eric Poulteau, Frédéric Prudhomme Lacroix, Sylvie Ravel, Alain Roche, Denis Rollin, Béatrice Rossillol, Bénédicte Rouchouse Partrat, Rémi Rousseau, Chrystelle Sabourin-Chaumarat, Audrey Saby, Annie Scaion Lacour, Eugen Barzu Sorin, Michel Sorlin, Jérémy Suchet, Jean-François Teyssier, François Tezenas du Montcel, Gérard Thevenon, Laurianne Thollot, Martine Tholot, Tixier, Hubert Tronchon, Sébastien Usson, Aurélie Vanhille, Sandra Vannier, Estelle Viala, Charles Viceriat, Bernard Vincent, Marie-Paule Vincent, Frédéric Voirin.
Contents lists available at ScienceDirect
Thrombosis Research journal homepage: www.elsevier.com/locate/thromres
Letter to the Editors-in-Chief Practical issues in suspected venous thrombosis in general practice: A multicentre prospective cohort in primary care
Keywords: Venous thrombosis Anticoagulants General practice Referral and consultation Ultrasonography Diagnosis
1. Introduction Suspected deep vein thrombosis (DVT) is commonly encountered in primary care, whereas its diagnosis is confirmed in 10 to 20% of cases [1,2]. Only one guideline, from the American College of Chest Physicians (ACCP), details therapeutic management pending ultrasonography. A parenteral anticoagulant is recommended if the clinical probability is low and the delay before ultrasonography N24 h; if the clinical probability is intermediate and the delay before ultrasonography N4 h, and in all cases if the clinical probability is high [3]. The provision of medical transport to immobilise the patient awaiting ultrasonography is not addressed in guidelines. The ACCP guidelines note that they did not find any trial addressing therapeutic management pending ultrasonography and therefore assigned a grade 2C to these recommendations [3]. Initiating parenteral anticoagulation in primary care requires maintenance of a low molecular weight heparin supply with appropriate storage conditions and monitoring for expiration. Organising medical transport may further complicate patient management. These factors can explain variations observed in physician practice and divergence from the ACCP guidelines [4,5]. They can also cause misunderstandings between physicians when, for example, a patient presents to the Emergency Department on foot with suspected DVT and no previous anticoagulation. We wondered if current anticoagulation practices are related to patients' characteristics, physicians' characteristics and/or early thromboembolic complications. The objective of our study was to compare factors and outcomes depending on whether or not anticoagulation was administered before ultrasonography in patients with suspected DVT. 2. Materials and methods A multicentre prospective cohort study was conducted from 30 March to 12 July 2015, among patients referred by a general practitioner to a vascular physician for suspected lower-extremity DVT. We did not include patients with a clinical suspicion of pulmonary embolism (PE), patients already receiving long-term anticoagulant treatment and patients who could not be reached by telephone. Twenty-three vascular physicians enrolled consecutive, eligible patients during the study
http://dx.doi.org/10.1016/j.thromres.2017.08.002 0049-3848/© 2017 Elsevier Ltd. All rights reserved.
period. Fifteen days after enrolment, patients were contacted by telephone to collect their profile, their medical management, the result of ultrasonography, and occurrence of PE or bleeding. The patient's general practitioner was telephoned to complete data collection. In the event of discrepancy, the patient's answer was considered as the reference. In the event of a thrombotic or bleeding event, additional test records were collected. The provision of therapeutic anticoagulation was compared with the patient's personal history, general practitioner's characteristics, clinical probability of DVT, distance to the vascular physician, means of transport, delay before ultrasonography, result of ultrasonography, and occurrence of PE and/or bleeding within 15 days. Statistical analysis was performed with IBM SPSS statistics® software version 19. Frequencies were calculated for each outcome, with their corresponding 95% confidence interval (95% CI). Comparisons used chi-square and Fisher tests. The significance level has been set at p b 0.05, with bilateral setting. The protocol was approved by an independent Ethics Committee. All patients received written information on the study, emphasising their right to refuse participation or to withdraw at any time.
3. Results Of the 248 eligible patients, 25 refused to participate in the study. Of the 223 enrolled patients, one had incomplete data and 222 (99.6%) were included in the analysis. One hundred and forty-six general practitioners answered the 15 day questionnaire. There was no difference in follow-up data collected from patients and their general practitioners. The mean age was 59 years (standard deviation, 16) and there were 74 (33.3%) males. Ultrasonography was performed the same day for 119 patients (53.6%). DVT was confirmed in 43 patients (19.4%), and was proximal in 17 cases (39.5%).
3.1. Anticoagulation and transport modalities Forty-six patients (20.7%, 95% CI: 15.4–26.1%) received therapeutic doses of anticoagulation before ultrasonography (enoxaparin twice a day, tinzaparin once a day, fondaparinux once a day or rivaroxaban 15 mg twice a day). Among the 108 patients who had either a high clinical suspicion of DVT or a delay before ultrasonography of greater than one day, 34 (31.5%, 95% CI: 22.7–40.2%) received anticoagulation. Medical transport to the vascular physician's surgery had been arranged for 11 patients (5.0%, 95% CI: 2.1–7.8%).
3.2. Clinical outcomes after 15 days One distal DVT (0.5%), no PE and no bleeding events occurred within 15 days after enrolment. The patient with a new DVT had a negative initial ultrasonography, no initial anticoagulation and no medical transport.
20
Letter to the Editors-in-Chief
3.3. Factors and outcomes associated with anticoagulation In univariate analysis, anticoagulation was associated with a delay before ultrasonography of greater than one day, vascular physician location N 20 km away, a personal history of DVT and/or PE, a confirmed DVT diagnosis, and a general practice consultation occurring between 2 pm and 6 am (Table 1).
4. Discussion Pending ultrasonography, general practitioners prescribed anticoagulation to one patient in five. After 15 days of follow-up, one distal DVT, no PE and no bleeding events had been recorded. Empiric anticoagulant treatment was administered more often if there was a personal history of thromboembolism, if the consultation took place in the second half of the day or at night, and if the ultrasonography consultation was distant in time or place. Although associated with a positive DVT diagnosis, anticoagulation was not associated with the clinical probability as perceived by the general practitioner.
This study draws its strength from its multicenter design, with the participation of 23 vascular physicians and 146 general practitioners. Inclusion at the level of the vascular consultation rather than the general practice consultation limited a potential Hawthorne effect, by which the awareness of being observed may change practices. Crossed collection of data, from patients and from general practitioners, enhanced reliability. The retrospective and declarative collection of some data could have influenced answers. This could have occurred with the clinical probability as perceived by the general practitioner, but the main outcomes are all based on objective data. The power of our study does not allow multivariate analysis and definitive conclusions as to the possible impact of anticoagulation on the occurrence of thromboembolic events. The rate of anticoagulation before ultrasonography found in our study (20.7%) is located at a point between the only two data available in the literature. This rate was 39% in a French study with 125 patients [4] and 15.5% in a German study from the TULIPA register with 5421 patients [5]. These differences could reflect differences in study power or differences in national practices. The rate of confirmed DVT (19.4%) is similar to literature data, which mentions a percentage of diagnostic confirmation between 10 and 30% of cases [1,2].
Table 1 Anticoagulation management. Anticoagulation Age, N (%) 20–65 years N65 years Sex, N (%) Male Female Clinical circumstances Family history of DVT, N (%) No Yes Personal history of DVT, N (%) No Yes Thrombophilia No Yes Active cancer, N (%) No Yes Surgery ≤3 months, N (%) No Yes Cast immobilisation No Yes Travel N6 h in the last 3 weeks, N (%) No Yes Hormonal treatment No Yes General practice consultation hour, N (%) 6 h–14 h 14 h–6 h Clinical probability of DVT, N (%) Low Intermediate High Distance to the vascular physician, N (%) ≤20 km N20 km Delay before ultrasonography, N (%) Doppler on the same day Doppler the next day or after Ultrasonography result, N (%) Confirmed DVT Unconfirmed DVT DVT: deep vein thrombosis. a Fisher test.
No anticoagulation
OR
95% CI
p-Value
24 22
(18.0) (24.7)
109 67
(82.0) (75.3)
1.73
0.88–3.42
0.2292
18 28
(24.3) (18.9)
56 120
(75.6) (81.1)
0.95
0.48–1.86
0.3489
16 6
(12.3) (33.3)
68 12
(56.7) (66.7)
2.13
0.69–6.52
0.2104a
28 18
(15.9) (39.1)
148 28
(84.1) (60.9)
3.40
1.66–6.96
0.0005
44 2
(20.2) (50.0)
174 2
(79.8) (50.0)
3.95
0.54–28.86
0.1906a
45 1
(20.8) (16.7)
171 5
(79.2) (83.3)
0.76
0.09–6.67
1.0000a
40 6
(20.7) (20.7)
153 23
(79.3) (79.3)
1.00
0.38–2.62
0.9965
46 0
(20.9) (0.0)
174 2
(79.1) (100.0)
NA
NA
NA
42 4
(20.4) (25.0)
164 12
(79.6) (75.0)
1.30
0.40–4.24
0.7483a
46 0
(21.5) (0.0)
168 8
(78.5) (100.0)
NA
NA
NA
16 29
(13.8) (27.9)
100 75
(86.2) (72.1)
2.42
1.22–4.77
0.0097
10 19 9
(14.3) (24.4) (26.5)
60 59 25
(85.7) (75.6) (73.5)
1.93 2.16
0.83–4.50 0.78–5.96
34 12
(17.3) (46.2)
162 14
(82.7) (53.8)
4.08
1.74–9.60
0.0007
10 36
(8.4) (35.0)
109 67
(91.6) (65.0)
5.86
2.73–12.57
b0.0001
31 15
(17.3) (34.9)
148 28
(82.7) (65.1)
2.56
1.22–5.34
0.0107
0.2168
Letter to the Editors-in-Chief
With respect to ACCP guidelines, observed practices seemed to reflect inertia. The anticoagulation recommendation was met every third time [3]. Anticoagulation seems to be associated with the delay before ultrasonography rather than the level of clinical probability as perceived by the general practitioner. These results confirm those of a smaller (125 patients) French study published in 2006 [4]. The absence of bleeding events within 15 days corresponds with data from several articles in which anticoagulant administration before ultrasound was not associated with an increased risk of bleeding in patients [1,3,6]. Of the 46 patients who received anticoagulation, 1 received a direct oral anticoagulant. This practice could change in the coming years, with greater access to and use of the direct acting oral anticoagulants [7]. The medical transport prescriptions observed in our study were consistent with data from the 2006 French study [4] in which 6.0% of patients went to the vascular physician by ambulance (versus 5.0% by taxi or ambulance in our study). In conclusion, pending ultrasonography for suspected DVT of the lower limbs, general practitioners prescribe anticoagulation one out of 5 times. While we await more evidence on its impact on thromboembolic complications, the absence of bleeding outcomes, in addition to current guidelines, argue in favor of more frequent anticoagulant prescription pending ultrasonography. Funding None. Ethical approval The protocol had been approved by the Ethics Committee of CHU Saint-Etienne (IRB: IORG0007394) with the reference IRBN472015/ CHUSTE.
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Laurent Bertoletti INSERM U1059, Sainbiose-Dysfonction Vasculaire et Hémostase, Saint-Etienne, France Department of Vascular and Therapeutic Medicine, University Hospital of Saint-Etienne, Saint-Etienne, France INSERM CIC1408, Saint-Etienne, France Patricia Fayard Vascular Medicine Practice, Rue de Jourcey, Veauche, France Emmanuel Chapelier Vascular Medicine Practice, Rue Bergson, Saint-Etienne, France Benjamin Seffert Department of Vascular and Therapeutic Medicine, University Hospital of Saint-Etienne, Saint-Etienne, France Béatrice Simon-Momège Vascular Medicine Practice, Rue Dugas-Montbel, Saint-Chamond, France Paul Frappé Department of General Practice, University of Saint-Etienne, Saint-Etienne, France INSERM U1059, Sainbiose-Dysfonction Vasculaire et Hémostase, Saint-Etienne, France INSERM CIC1408, Saint-Etienne, France the GUSTAVE investigators1 29 March 2017 Available online xxxx
Conflict of interest The authors declare they have no potential conflict of interest related to this research. References [1] P. Wells, D. Anderson, The diagnosis and treatment of venous thromboembolism, Hematology Am. Soc. Hematol. Educ. Program 2013 (1) (2013) 457–463. [2] H.R. Büller, A.J. Ten Cate-Hoek, A.W. Hoes, et al., Safely ruling out deep venous thrombosis in primary care, Ann. Intern. Med. 150 (4) (2009) 229–235. [3] C. Kearon, E.A. Akl, A.J. Comerota, et al., Antithrombotic therapy for VTE disease: antithrombotic therapy and prevention of thrombosis, 9th ed.: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines, Chest 141 (Suppl. 2) (2012) (e419S–94S). [4] G. Le Gal, P. Gagne, C. Leroyer, Prescribing attitude of general practitioners in front of patients with deep vein thrombosis suspicion, J. Thromb. Haemost. 4 (7) (2006) 1629–1631. [5] S.M. Schellong, H. Gerlach, V. Hach-Wunderle, et al., Diagnosis of deep-vein thrombosis: adherence to guidelines and outcomes in real-world health care, Thromb. Haemost. 102 (6) (2009) 1234–1240. [6] D. Imberti, W. Ageno, F. Dentali, et al., Management of primary care patients with suspected deep vein thrombosis: use of a therapeutic dose of low-molecular-weight heparin to avoid urgent ultrasonographic evaluation, J. Thromb. Haemost. 4 (5) (2006) 1037–1041. [7] S. Glund, J. Stangier, M. Schmohl, et al., Safety, tolerability, and efficacy of idarucizumab for the reversal of the anticoagulant effect of dabigatran in healthy male volunteers: a randomised, placebo-controlled, double-blind phase 1 trial, Lancet 386 (9994) (2015) 680–690.
Sébastien Bruel* Mouzayan Ginzarly Department of General Practice, University of Saint-Etienne, Saint-Etienne, France INSERM U1059, Sainbiose-Dysfonction Vasculaire et Hémostase, Saint-Etienne, France *Corresponding author at: Département de Médecine Générale, Faculté de Médecine Jacques Lisfranc, Campus Santé Innovations, 10, Rue de la Marandière, 42270 Saint-Priest-en-Jarez, France. E-mail address: [email protected] (S. Bruel).
1 Vascular physicians (n = 23): Magali Aurouet, Marjolaine Basset-Neel, Alexis Blanchard, Christian Boissier, Bénédicte Boucher-Hyp, Elisabeth Breysse, Valérie Chambefort, Emmanuel Chapelier, Serge Couzan, Asma El Jaouhari, Patricia Fayard, Séverine Féasson, Jean-Baptiste Gaultier, Cyrielle Gremillet, Pantea Guyomarc'h, Nelly Jagu, Nathalie Masson, Sylvie Perrot, Sandrine Rivière, Benjamin Seffert, Béatrice Simon-Momège, Catherine Talabard, Vanessa Thevenin. General practitioners (n = 146): Gérard Abrial, Pierre Algarra, Patricia Allemand, Gisèle Ancey, Philippe Andrieu, Serge Angenieux, Houria Argoubi Idrissi, Maud Badin, Jean-Noël Bally, Bruno Barbier, Christophe Barjat, Bastiani, Jean Baudry, Irène Bayard Antigone, Belonnas, Vincent Benvenuto, Christophe Berger, François Berger, Aurélie Bernard, Dominique Berthier, Isabelle Berthouze, Evelyne Bertin, Marc Blanc, André Bonnet, Astrid Bonnet, Mohamed Boukhadra, Nacer Eddine Boukhezra, Benjamin Bourlier, François Boyer, Nathalie BrosseGuillet, Sébastien Bruel, Nicole Brun, Jean-Michel Bruyas, Adrien Busseuil, Nadège Cahin Mercier, Nicolas Canivet, Sébastien Castelain, Jean-Louis Cayreyre, Justine Chabanel, Chabrier, Philippe Chaumier, Christelle Colas Fernandez, Pascal Corsini, Bérengère Crespel, Florent Crouzet, Serge Crouzet, Michèle Cusset-Poncet, Hubert De Jaureguiberry, Laurent De Matos, Jean-Luc Delorme, Delphine Duboeuf Richerol, Patrick Durand, Eric Faure, Elodie Fayolle, Nathalie Ferigo, Franck Fernandez-Hugon, Jean Feuillet, Patrice Freychet, Yannick Frezet, Daniel Gajovic, E Garcia, Garnier, Bruno Garnier, Jérôme Garnier, Mathilde Geissler, Jocelyne Ghuilhot, Audrey Gire, Romain Gire, Jean Girin, Antonio Gonzalez, Denis Grange, Jean-Paul Grégoire, Guy Grenier, Philippe Grenier, Maud Guillot, Jeanine Guyonnet, Nabil Hamdache, Bernadette Jacquet, Bruno Jeannin, Laurent Joubert, Roland Jourdy, Hélène Jury, Salah Kadoun, Bernard Karsenti, Abbas Khennouf, Pierre Lachal, Thibaud Lachmann, Maïté Lamarca Pitiot, Yves Lantner, Marie-Françoise Larue, Michel Laval, Huy Le Xuan, Fabien Lutz, Cyril Mallet, Marie-Laure Marchand, Alban Marcoux, Cécile Martinez, Nicole Mathevet-Perino, Pierre Metzdorff, Jean-François Meyer, François Meynier, Benoît Morel, Olivier Morisson, JeanMarc Mounier, Michel Mugnerot, Catherine Murat, Térésa Neto, Yves Partrat, Françoise Peillet-Gérard, Adrien Pereira, Yvan Perouse, Justine Perret, Dominique Pisanu Girard, Anne Plagnard Bouteille, Marie-Dominique Plagne, Jean-Luc Popin, Eric Poulteau, Frédéric Prudhomme Lacroix, Sylvie Ravel, Alain Roche, Denis Rollin, Béatrice Rossillol, Bénédicte Rouchouse Partrat, Rémi Rousseau, Chrystelle Sabourin-Chaumarat, Audrey Saby, Annie Scaion Lacour, Eugen Barzu Sorin, Michel Sorlin, Jérémy Suchet, Jean-François Teyssier, François Tezenas du Montcel, Gérard Thevenon, Laurianne Thollot, Martine Tholot, Tixier, Hubert Tronchon, Sébastien Usson, Aurélie Vanhille, Sandra Vannier, Estelle Viala, Charles Viceriat, Bernard Vincent, Marie-Paule Vincent, Frédéric Voirin.