How the Results of a Randomized Trial of Catheter-Directed Thrombolysis versus Anticoagulation Alone for Submassive Pulmonary Embolism Would Affect Patient and Physician Decision Making: Report of an Online Survey
Abstract
:1. Introduction
2. Materials and Methods
3. Results
4. Discussion
5. Conclusions
Author Contributions
Conflicts of Interest
References
- Sista, A.K.; Horowitz, J.M.; Goldhaber, S.Z. Four key questions surrounding thrombolytic therapy for submassive pulmonary embolism. Vasc. Med. 2016, 21, 47–52. [Google Scholar] [CrossRef] [PubMed]
- Sista, A.K.; Goldhaber, S.Z.; Vedantham, S.; Kline, J.A.; Kuo, W.T.; Kahn, S.R.; Kabrhel, C.; McLaughlin, V.V.; White, S.B.; Kim, N.H.; et al. Research priorities in submassive pulmonary embolism: Proceedings from a multidisciplinary research consensus panel. J. Vasc. Interv. Radiol. 2016, 27, 787–794. [Google Scholar] [CrossRef] [PubMed]
- Klok, F.A.; Tijmensen, J.E.; Haeck, M.L.; van Kralingen, K.W.; Huisman, M.V. Persistent dyspnea complaints at long-term follow-up after an episode of acute pulmonary embolism: Results of a questionnaire. Eur. J. Intern. Med. 2008, 19, 625–629. [Google Scholar] [CrossRef] [PubMed]
- Meyer, G.; Vicaut, E.; Danays, T.; Agnelli, G.; Becattini, C.; Beyer-Westendorf, J.; Bluhmki, E.; Bouvaist, H.; Brenner, B.; Couturaud, F.; et al. Fibrinolysis for patients with intermediate-risk pulmonary embolism. N. Engl. J. Med. 2014, 370, 1402–1411. [Google Scholar] [CrossRef] [PubMed]
- Sista, A.K.; Klok, F.A. Late outcomes of pulmonary embolism. The post-PE syndrome. Thromb. Res. 2017, 164, 157–162. [Google Scholar] [CrossRef] [PubMed]
- Klok, F.A.; van der Hulle, T.; den Exter, P.L.; Lankeit, M.; Huisman, M.V.; Konstantinides, S. The post-PE syndrome: A new concept for chronic complications of pulmonary embolism. Blood Rev. 2014, 28, 221–226. [Google Scholar] [CrossRef] [PubMed]
- Chatterjee, S.; Chakraborty, A.; Weinberg, I.; Kadakia, M.; Wilensky, R.L.; Sardar, P.; Kumbhani, D.J.; Mukherjee, D.; Jaff, M.R.; Giri, J. Thrombolysis for pulmonary embolism and risk of all-cause mortality, major bleeding, and intracranial hemorrhage: A meta-analysis. JAMA 2014, 311, 2414–2421. [Google Scholar] [CrossRef] [PubMed]
- Kuo, W.T. Endovascular therapy for acute pulmonary embolism. J. Vasc. Interv. Radiol. 2012, 23, 167–179. [Google Scholar] [CrossRef]
- Banovac, F.; Buckley, D.C.; Kuo, W.T.; Lough, D.M.; Martin, L.G.; Millward, S.F.; Clark, T.W.; Kundu, S.; Rajan, D.K.; Sacks, D.; Cardella, J.F. Reporting standards for endovascular treatment of pulmonary embolism. J. Vasc. Interv. Radiol. 2010, 21, 44–53. [Google Scholar] [CrossRef]
- Kearon, C.; Akl, E.A.; Comerota, A.J.; Prandoni, P.; Bounameaux, H.; Goldhaber, S.Z.; Nelson, M.E.; Wells, P.S.; Gould, M.K.; Dentali, F.; 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 2012, 141, e419S–e496S. [Google Scholar]
- Kearon, C.; Akl, E.A.; Ornelas, J.; Blaivas, A.; Jimenez, D.; Bounameaux, H.; Huisman, M.; King, C.S.; Morris, T.A.; Sood, N.; et al. Antithrombotic therapy for VTE disease: CHEST guideline and expert panel report. Chest 2016, 149, 315–352. [Google Scholar] [CrossRef] [PubMed]
- Kucher, N.; Boekstegers, P.; Muller, O.J.; Kupatt, C.; Beyer-Westendorf, J.; Heitzer, T.; Tebbe, U.; Horstkotte, J.; Muller, R.; Blessing, E.; et al. Randomized, controlled trial of ultrasound-assisted catheter-directed thrombolysis for acute intermediate-risk pulmonary embolism. Circulation 2014, 129, 479–486. [Google Scholar] [CrossRef] [PubMed]
- Kuo, W.T.; Banerjee, A.; Kim, P.S.; DeMarco, F.J.; Levy, J.R., Jr.; Facchini, F.R.; Unver, K.; Bertini, M.J.; Sista, A.K.; Hall, M.J.; et al. Pulmonary embolism response to fragmentation, embolectomy, and catheter thrombolysis (PERFECT): Initial results from a prospective multicenter registry. Chest 2015, 148, 667–673. [Google Scholar] [CrossRef] [PubMed]
- Piazza, G.; Hohlfelder, B.; Jaff, M.R.; Ouriel, K.; Engelhardt, T.C.; Sterling, K.M.; Jones, N.J.; Gurley, J.C.; Bhatheja, R.; Kennedy, R.J.; et al. A prospective, single-arm, multicenter trial of ultrasound-facilitated, catheter-directed, low-dose fibrinolysis for acute massive and submassive pulmonary embolism: The SEATTLE II study. JACC Cardiovasc. Interv. 2015, 8, 1382–1392. [Google Scholar] [CrossRef]
- Hennemeyer, C.; Khan, A.; McGregor, H.; Moffett, C.; Woodhead, G. Outcomes of catheter-directed therapy plus anticoagulation versus anticoagulation alone for submassive and massive pulmonary embolism. Am. J. Med. 2019, 132, 240–246. [Google Scholar] [CrossRef] [PubMed]
- Taslakian, B.; Chawala, D.; Sista, A.K. A survey of submassive pulmonary embolism treatment preferences among medical and endovascular physicians. J. Vasc. Interv. Radiol. 2017, 28, 1693–1699. [Google Scholar] [CrossRef] [PubMed]
- Sullivan, G.M.; Artino, A.R., Jr. Analyzing and interpreting data from likert-type scales. J. Grad Med. Educ. 2013, 5, 541–542. [Google Scholar] [CrossRef]
- Jamieson, S. Likert scales: How to (ab)use them. Med. Educ. 2004, 38, 1217–1218. [Google Scholar] [CrossRef]
- Frank, L.; Basch, E.; Selby, J.V. The PCORI perspective on patient-centered outcomes research. Jama 2014, 312, 1513–1514. [Google Scholar] [CrossRef]
- Hess, E.P.; Hollander, J.E.; Schaffer, J.T.; Kline, J.A.; Torres, C.A.; Diercks, D.B.; Jones, R.; Owen, K.P.; Meisel, Z.F.; Demers, M.; et al. Shared decision making in patients with low risk chest pain: Prospective randomized pragmatic trial. BMJ 2016, 355, i6165. [Google Scholar] [CrossRef]
- Chen, R.C.; Basak, R.; Meyer, A.M.; Kuo, T.M.; Carpenter, W.R.; Agans, R.P.; Broughman, J.R.; Reeve, B.B.; Nielsen, M.E.; Usinger, D.S.; et al. Association between choice of radical prostatectomy, external beam radiotherapy, brachytherapy, or active surveillance and patient-reported quality of life among men with localized prostate cancer. Jama 2017, 317, 1141–1150. [Google Scholar] [CrossRef] [PubMed]
- Stein, P.D.; Matta, F. Thrombolytic therapy in unstable patients with acute pulmonary embolism: Saves lives but underused. Am. J. Med. 2012, 125, 465–470. [Google Scholar] [CrossRef] [PubMed]
- Kahn, S.R.; Hirsch, A.M.; Akaberi, A.; Hernandez, P.; Anderson, D.R.; Wells, P.S.; Rodger, M.A.; Solymoss, S.; Kovacs, M.J.; Rudski, L.; et al. Functional and exercise limitations after a first episode of pulmonary embolism: Results of the ELOPE Prospective Cohort Study. Chest 2017, 151, 1058–1068. [Google Scholar] [CrossRef] [PubMed]
- Devereaux, P.J.; Anderson, D.R.; Gardner, M.J.; Putnam, W.; Flowerdew, G.J.; Brownell, B.F.; Nagpal, S.; Cox, J.L. Differences between perspectives of physicians and patients on anticoagulation in patients with atrial fibrillation. observational study. BMJ 2001, 323, 1218–1222. [Google Scholar] [CrossRef] [PubMed]
- Protheroe, J.; Fahey, T.; Montgomery, A.A.; Peters, T.J. The impact of patients’ preferences on the treatment of atrial fibrillation. observational study of patient based decision analysis. BMJ 2000, 320, 1380–1384. [Google Scholar] [CrossRef] [PubMed]
- Thomson, R.; Parkin, D.; Eccles, M.; Sudlow, M.; Robinson, A. Decision analysis and guidelines for anticoagulant therapy to prevent stroke in patients with atrial fibrillation. Lancet 2000, 355, 956–962. [Google Scholar] [CrossRef]
- Wilke, T.; Bauer, S.; Mueller, S.; Kohlmann, T.; Bauersachs, R. Patient preferences for oral anticoagulation therapy in atrial fibrillation. A systematic literature review. Patient 2017, 10, 17–37. [Google Scholar] [CrossRef]
- Barnes, G.D.; Kabrhel, C.; Courtney, D.M.; Naydenov, S.; Wood, T.; Rosovsky, R.; Rosenfield, K.; Giri, J. Diversity in the pulmonary embolism response team model. An organizational survey of the National PERT Consortium members. Chest 2016, 150, 1414–1417. [Google Scholar] [CrossRef]
- Robert-Ebadi, H.; Le Gal, G.; Carrier, M.; Couturaud, F.; Perrier, A.; Bounameaux, H.; Righini, M. Differences in clinical presentation of pulmonary embolism in women and men. J. Thromb. Haemost. 2010, 8, 693–698. [Google Scholar] [CrossRef]
- Marshall, A.L.; Bartley, A.C.; Ashrani, A.A.; Pruthi, R.K.; Durani, U.; Gonsalves, W.I.; Kapoor, P.; Hashmi, S.K.; Siddiqui, M.A.; Go, R.S. Sex-based disparities in venous thromboembolism outcomes: A National Inpatient Sample (NIS)-based analysis. Vasc. Med. 2017, 22, 121–127. [Google Scholar] [CrossRef]
Scenario | Scenario Presented to Physicians | Scenario Presented to Patients | Summary |
---|---|---|---|
S1 |
|
| No difference in bleeding or clinical deterioration |
S2 |
|
| The risk of major bleeding is doubled with CDT; no difference in clinical deterioration |
S3 |
|
| The risk of major bleeding is doubled with CDT; clinical deterioration is lower in the CDT group |
S4 |
|
| The risk of major bleeding is quadrupled with CDT; no difference in clinical deterioration. |
S5 |
|
| The risk of major bleeding is quadrupled with CDT; clinical deterioration is lower in the CDT group |
Scenario | No Prior PE (n = 14) | Prior PE (n = 16) | p Value | ||||||
---|---|---|---|---|---|---|---|---|---|
Mean | SD | Median | IQR | Mean | SD | Median | IQR | ||
1 | 4.50 | 0.76 | 5.00 | 1.00 | 4.25 | 0.77 | 4.00 | 1.00 | 0.389 |
2 | 3.93 | 0.83 | 4.00 | 0.50 | 3.75 | 0.93 | 4.00 | 0.75 | 0.664 |
3 | 4.36 | 0.84 | 5.00 | 1.25 | 4.38 | 0.50 | 4.00 | 1.00 | 0.764 |
4 | 2.79 | 0.80 | 3.00 | 1.00 | 2.50 | 0.97 | 2.00 | 1.00 | 0.333 |
5 | 3.29 | 0.99 | 3.00 | 1.00 | 3.13 | 0.96 | 3.00 | 1.75 | 0.741 |
© 2019 by the authors. Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license (http://creativecommons.org/licenses/by/4.0/).
Share and Cite
Taslakian, B.; Li, C.; Goldhaber, S.Z.; Mikkelsen, K.Z.; Horowitz, J.M.; Kabrhel, C.; Barnes, G.D.; Sista, A.K. How the Results of a Randomized Trial of Catheter-Directed Thrombolysis versus Anticoagulation Alone for Submassive Pulmonary Embolism Would Affect Patient and Physician Decision Making: Report of an Online Survey. J. Clin. Med. 2019, 8, 215. https://doi.org/10.3390/jcm8020215
Taslakian B, Li C, Goldhaber SZ, Mikkelsen KZ, Horowitz JM, Kabrhel C, Barnes GD, Sista AK. How the Results of a Randomized Trial of Catheter-Directed Thrombolysis versus Anticoagulation Alone for Submassive Pulmonary Embolism Would Affect Patient and Physician Decision Making: Report of an Online Survey. Journal of Clinical Medicine. 2019; 8(2):215. https://doi.org/10.3390/jcm8020215
Chicago/Turabian StyleTaslakian, Bedros, Clayton Li, Samuel Z. Goldhaber, Kathryn Z. Mikkelsen, James M. Horowitz, Christopher Kabrhel, Geoffrey D. Barnes, and Akhilesh K. Sista. 2019. "How the Results of a Randomized Trial of Catheter-Directed Thrombolysis versus Anticoagulation Alone for Submassive Pulmonary Embolism Would Affect Patient and Physician Decision Making: Report of an Online Survey" Journal of Clinical Medicine 8, no. 2: 215. https://doi.org/10.3390/jcm8020215
APA StyleTaslakian, B., Li, C., Goldhaber, S. Z., Mikkelsen, K. Z., Horowitz, J. M., Kabrhel, C., Barnes, G. D., & Sista, A. K. (2019). How the Results of a Randomized Trial of Catheter-Directed Thrombolysis versus Anticoagulation Alone for Submassive Pulmonary Embolism Would Affect Patient and Physician Decision Making: Report of an Online Survey. Journal of Clinical Medicine, 8(2), 215. https://doi.org/10.3390/jcm8020215