Effect of Aspirin vs Enoxaparin on Symptomatic Venous Thromboembolism in Patients Undergoing Hip or Knee Arthroplasty: The CRISTAL Randomized Trial

doi:10.1001/jama.2022.13416

Randomized Controlled Trial

. 2022 Aug 23;328(8):719-727.

doi: 10.1001/jama.2022.13416.

Effect of Aspirin vs Enoxaparin on Symptomatic Venous Thromboembolism in Patients Undergoing Hip or Knee Arthroplasty: The CRISTAL Randomized Trial

CRISTAL Study Group; Verinder S Sidhu^{1

2}, Thu-Lan Kelly³, Nicole Pratt³, Stephen E Graves⁴, Rachelle Buchbinder^{5

6}, Sam Adie⁷, Kara Cashman⁸, Ilana Ackerman^{5

6}, Durga Bastiras⁴, Roger Brighton^{9

10}, Alexander W R Burns¹¹, Beng Hock Chong^{12

13}, Ornella Clavisi¹⁴, Maggie Cripps^{1

2}, Mark Dekkers¹⁵, Richard de Steiger¹⁶, Michael Dixon¹⁷, Andrew Ellis^{18

19}, Elizabeth C Griffith⁸, David Hale²⁰, Amber Hansen^{1

2}, Anthony Harris²¹, Raphael Hau^{16

22}, Mark Horsley²³, Dugal James²⁴, Omar Khorshid²⁵, Leonard Kuo²⁶, Peter Lewis²⁷, David Lieu²⁸, Michelle Lorimer⁸, Samuel MacDessi^{7

29}, Peter McCombe³⁰, Catherine McDougall³¹, Jonathan Mulford³², Justine Maree Naylor^{1

2}, Richard S Page³³, John Radovanovic³⁴, Michael Solomon³⁵, Rami Sorial³⁶, Peter Summersell³⁷, Phong Tran³⁸, William L Walter^{18

19

39}, Steve Webb⁵, Chris Wilson^{40

41}, David Wysocki⁴², Ian A Harris^{1

2

43}

Affiliations

¹ School of Clinical Medicine, UNSW Medicine and Health, UNSW Sydney, Sydney, New South Wales, Australia.
² Whitlam Orthopaedic Research Centre, Ingham Institute for Applied Medical Research, Liverpool, New South Wales, Australia.
³ Clinical and Health Sciences, Quality Use of Medicines Pharmacy Research Centre, University of South Australia, Adelaide, South Australia, Australia.
⁴ Australian Orthopaedic Association National Joint Replacement Registry, Adelaide, South Australia, Australia.
⁵ Department of Epidemiology and Preventive Medicine, School of Public Health and Preventive Medicine, Monash University, Melbourne, Victoria, Australia.
⁶ Monash-Cabrini Department of Musculoskeletal Health and Clinical Epidemiology, Cabrini Health, Melbourne, Victoria, Australia.
⁷ School of Clinical Medicine, UNSW Medicine and Health, St George and Sutherland Clinical Campuses, Faculty of Medicine and Health, UNSW Sydney, New South Wales, Australia.
⁸ South Australian Health and Medical Research Institute, Adelaide, South Australia, Australia.
⁹ Orthopaedic Department, Westmead Private Hospital, Westmead, Sydney, New South Wales, Australia.
¹⁰ Orthopaedic Department, Lakeview Private Hospital, Baulkham Hills, Sydney, New South Wales, Australia.
¹¹ Orthopaedic Department, Calvary John James Hospital, Deakin, Canberra, Australian Capital Territory, Australia.
¹² Department of Medicine, Faculty of Medicine, University of New South Wales, Sydney, New South Wales, Australia.
¹³ Department of Hematology, New South Wales Pathology, Kogarah Campus, Sydney, New South Wales, Australia.
¹⁴ Musculoskeletal Australia, Melbourne, Victoria, Australia.
¹⁵ Orthopaedic Department, Greenslopes Private Hospital, Greenslopes, Brisbane, Queensland, Australia.
¹⁶ Department of Surgery, Epworth Healthcare, University of Melbourne, Melbourne, Victoria, Australia.
¹⁷ Orthopaedic Department, Kareena Private Hospital, Sutherland, Sydney, New South Wales, Australia.
¹⁸ Orthopaedic Department, Royal North Shore Hospital, St Leonard's, Sydney, New South Wales, Australia.
¹⁹ Sydney Musculoskeletal Health Flagship Centre of the University of Sydney and Royal North Shore Hospital, St Leonard's, Sydney, New South Wales, Australia.
²⁰ Orthopaedic Department, Hornsby and Kuringai Hospital, Hornsby, Sydney, New South Wales, Australia.
²¹ Centre for Health Economics, Monash Business School, Monash University, Melbourne, Victoria, Australia.
²² Eastern Health Clinical School, Monash University, Box Hill, Victoria, Australia.
²³ Orthopaedic Department, Royal Prince Alfred Hospital, Camperdown, Sydney, New South Wales, Australia.
²⁴ Bendigo Healthcare Group, Bendigo Hospital, Bendigo, Victoria, Australia.
²⁵ Orthopaedic Department, Fremantle Hospital, Fremantle, Western Australia, Australia.
²⁶ Orthopaedic Department, Canterbury Hospital, Canterbury, Sydney, New South Wales, Australia.
²⁷ Orthopaedic Department, Calvary Hospital, Adelaide, South Australia, Australia.
²⁸ Orthopaedic Department, Fairfield Hospital, Fairfield, Sydney, New South Wales, Australia.
²⁹ Orthopaedic Department, St George Private Hospital, Kogarah, Sydney, New South Wales, Australia.
³⁰ Orthopaedic Department, Frankston Hospital, Frankston, Melbourne, Victoria, Australia.
³¹ Orthopaedic Department, The Prince Charles Hospital, Chermside, Brisbane, Queensland, Australia.
³² Orthopaedic Department, Launceston General Hospital, Launceston, Tasmania, Australia.
³³ School of Medicine, St John of God Hospital and Barwon Health, Deakin University, Geelong, Victoria, Australia.
³⁴ Orthopaedic Department, Mater Hospital, Raymond Terrace, Brisbane, Queensland, Australia.
³⁵ Orthopaedic Department, Prince of Wales Hospital, Randwick, Sydney, New South Wales, Australia.
³⁶ Orthopaedic Department, Nepean Hospital, Nepean, Sydney, New South Wales, Australia.
³⁷ Orthopaedic Department, Coffs Harbour Base Hospital, Coffs Harbour, New South Wales, Australia.
³⁸ Orthopaedic Department, Western Health, Melbourne, Victoria, Australia.
³⁹ The Kolling Institute, Faculty of Medicine and Health, The University of Sydney and the Northern Sydney Local Health District, Sydney, New South Wales, Australia.
⁴⁰ Orthopaedic Department, Flinders Medical Centre, Bedford Park, Adelaide, South Australia, Australia.
⁴¹ Department of Medicine and Public Health, Flinders University, Adelaide, South Australia, Australia.
⁴² Orthopaedic Department, Sir Charles Gardiner Hospital, Perth, Western Australia, Australia.
⁴³ Institute of Musculoskeletal Health, School of Public Health, The University of Sydney, Sydney, New South Wales, Australia.

PMID: 35997730
PMCID: PMC9399863
DOI: 10.1001/jama.2022.13416

Randomized Controlled Trial

Effect of Aspirin vs Enoxaparin on Symptomatic Venous Thromboembolism in Patients Undergoing Hip or Knee Arthroplasty: The CRISTAL Randomized Trial

CRISTAL Study Group et al. JAMA. 2022.

. 2022 Aug 23;328(8):719-727.

doi: 10.1001/jama.2022.13416.

Authors

Affiliations

¹ School of Clinical Medicine, UNSW Medicine and Health, UNSW Sydney, Sydney, New South Wales, Australia.
² Whitlam Orthopaedic Research Centre, Ingham Institute for Applied Medical Research, Liverpool, New South Wales, Australia.
³ Clinical and Health Sciences, Quality Use of Medicines Pharmacy Research Centre, University of South Australia, Adelaide, South Australia, Australia.
⁴ Australian Orthopaedic Association National Joint Replacement Registry, Adelaide, South Australia, Australia.
⁵ Department of Epidemiology and Preventive Medicine, School of Public Health and Preventive Medicine, Monash University, Melbourne, Victoria, Australia.
⁶ Monash-Cabrini Department of Musculoskeletal Health and Clinical Epidemiology, Cabrini Health, Melbourne, Victoria, Australia.
⁷ School of Clinical Medicine, UNSW Medicine and Health, St George and Sutherland Clinical Campuses, Faculty of Medicine and Health, UNSW Sydney, New South Wales, Australia.
⁸ South Australian Health and Medical Research Institute, Adelaide, South Australia, Australia.
⁹ Orthopaedic Department, Westmead Private Hospital, Westmead, Sydney, New South Wales, Australia.
¹⁰ Orthopaedic Department, Lakeview Private Hospital, Baulkham Hills, Sydney, New South Wales, Australia.
¹¹ Orthopaedic Department, Calvary John James Hospital, Deakin, Canberra, Australian Capital Territory, Australia.
¹² Department of Medicine, Faculty of Medicine, University of New South Wales, Sydney, New South Wales, Australia.
¹³ Department of Hematology, New South Wales Pathology, Kogarah Campus, Sydney, New South Wales, Australia.
¹⁴ Musculoskeletal Australia, Melbourne, Victoria, Australia.
¹⁵ Orthopaedic Department, Greenslopes Private Hospital, Greenslopes, Brisbane, Queensland, Australia.
¹⁶ Department of Surgery, Epworth Healthcare, University of Melbourne, Melbourne, Victoria, Australia.
¹⁷ Orthopaedic Department, Kareena Private Hospital, Sutherland, Sydney, New South Wales, Australia.
¹⁸ Orthopaedic Department, Royal North Shore Hospital, St Leonard's, Sydney, New South Wales, Australia.
¹⁹ Sydney Musculoskeletal Health Flagship Centre of the University of Sydney and Royal North Shore Hospital, St Leonard's, Sydney, New South Wales, Australia.
²⁰ Orthopaedic Department, Hornsby and Kuringai Hospital, Hornsby, Sydney, New South Wales, Australia.
²¹ Centre for Health Economics, Monash Business School, Monash University, Melbourne, Victoria, Australia.
²² Eastern Health Clinical School, Monash University, Box Hill, Victoria, Australia.
²³ Orthopaedic Department, Royal Prince Alfred Hospital, Camperdown, Sydney, New South Wales, Australia.
²⁴ Bendigo Healthcare Group, Bendigo Hospital, Bendigo, Victoria, Australia.
²⁵ Orthopaedic Department, Fremantle Hospital, Fremantle, Western Australia, Australia.
²⁶ Orthopaedic Department, Canterbury Hospital, Canterbury, Sydney, New South Wales, Australia.
²⁷ Orthopaedic Department, Calvary Hospital, Adelaide, South Australia, Australia.
²⁸ Orthopaedic Department, Fairfield Hospital, Fairfield, Sydney, New South Wales, Australia.
²⁹ Orthopaedic Department, St George Private Hospital, Kogarah, Sydney, New South Wales, Australia.
³⁰ Orthopaedic Department, Frankston Hospital, Frankston, Melbourne, Victoria, Australia.
³¹ Orthopaedic Department, The Prince Charles Hospital, Chermside, Brisbane, Queensland, Australia.
³² Orthopaedic Department, Launceston General Hospital, Launceston, Tasmania, Australia.
³³ School of Medicine, St John of God Hospital and Barwon Health, Deakin University, Geelong, Victoria, Australia.
³⁴ Orthopaedic Department, Mater Hospital, Raymond Terrace, Brisbane, Queensland, Australia.
³⁵ Orthopaedic Department, Prince of Wales Hospital, Randwick, Sydney, New South Wales, Australia.
³⁶ Orthopaedic Department, Nepean Hospital, Nepean, Sydney, New South Wales, Australia.
³⁷ Orthopaedic Department, Coffs Harbour Base Hospital, Coffs Harbour, New South Wales, Australia.
³⁸ Orthopaedic Department, Western Health, Melbourne, Victoria, Australia.
³⁹ The Kolling Institute, Faculty of Medicine and Health, The University of Sydney and the Northern Sydney Local Health District, Sydney, New South Wales, Australia.
⁴⁰ Orthopaedic Department, Flinders Medical Centre, Bedford Park, Adelaide, South Australia, Australia.
⁴¹ Department of Medicine and Public Health, Flinders University, Adelaide, South Australia, Australia.
⁴² Orthopaedic Department, Sir Charles Gardiner Hospital, Perth, Western Australia, Australia.
⁴³ Institute of Musculoskeletal Health, School of Public Health, The University of Sydney, Sydney, New South Wales, Australia.

PMID: 35997730
PMCID: PMC9399863
DOI: 10.1001/jama.2022.13416

Abstract

Importance: There remains a lack of randomized trials investigating aspirin monotherapy for symptomatic venous thromboembolism (VTE) prophylaxis following total hip arthroplasty (THA) or total knee arthroplasty (TKA).

Objective: To determine whether aspirin was noninferior to enoxaparin in preventing symptomatic VTE after THA or TKA.

Design, setting, and participants: Cluster-randomized, crossover, registry-nested trial across 31 hospitals in Australia. Clusters were hospitals performing greater than 250 THA or TKA procedures annually. Patients (aged ≥18 years) undergoing hip or knee arthroplasty procedures were enrolled at each hospital. Patients receiving preoperative anticoagulation or who had a medical contraindication to either study drug were excluded. A total of 9711 eligible patients were enrolled (5675 in the aspirin group and 4036 in the enoxaparin group) between April 20, 2019, and December 18, 2020. Final follow-up occurred on August 14, 2021.

Interventions: Hospitals were randomized to administer aspirin (100 mg/d) or enoxaparin (40 mg/d) for 35 days after THA and for 14 days after TKA. Crossover occurred after the patient enrollment target had been met for the first group. All 31 hospitals were initially randomized and 16 crossed over prior to trial cessation.

Main outcomes and measures: The primary outcome was symptomatic VTE within 90 days, including pulmonary embolism and deep venous thrombosis (DVT) (above or below the knee). The noninferiority margin was 1%. Six secondary outcomes are reported, including death and major bleeding within 90 days. Analyses were performed by randomization group.

Results: Enrollment was stopped after an interim analysis determined the stopping rule was met, with 9711 patients (median age, 68 years; 56.8% female) of the prespecified 15 562 enrolled (62%). Of these, 9203 (95%) completed the trial. Within 90 days of surgery, symptomatic VTE occurred in 256 patients, including pulmonary embolism (79 cases), above-knee DVT (18 cases), and below-knee DVT (174 cases). The symptomatic VTE rate in the aspirin group was 3.45% and in the enoxaparin group was 1.82% (estimated difference, 1.97%; 95% CI, 0.54%-3.41%). This failed to meet the criterion for noninferiority for aspirin and was significantly superior for enoxaparin (P = .007). Of 6 secondary outcomes, none were significantly better in the enoxaparin group compared with the aspirin group.

Conclusions and relevance: Among patients undergoing hip or knee arthroplasty for osteoarthritis, aspirin compared with enoxaparin resulted in a significantly higher rate of symptomatic VTE within 90 days, defined as below- or above-knee DVT or pulmonary embolism. These findings may be informed by a cost-effectiveness analysis.

Trial registration: ANZCTR Identifier: ACTRN12618001879257.

PubMed Disclaimer

Conflict of interest statement

Conflict of Interest Disclosures: Drs de Steiger and Lewis reported being deputy directors of the AOANJRR, under whose registry nested clinical trials platform this study was performed. Dr McDougall reported consulting for Johnson & Johnson in the field of orthopedic instruments and giving paid teaching presentations for Stryker on total knee replacement. Dr Page reported receipt of institutional education and research support from DePuy Synthes. Dr Walter reported receipt of research support grants and personal consulting fees from DePuy Synthes, receipt of royalties from and holding shares in MatOrtho, holding shares in Navbit, receipt of personal consulting fees from Smith + Nephew, receipt of personal consulting fees from MicroPort, and receipt of research support from Think Surgical; in addition, Dr Walter had a patent issued with Navbit not related to anticoagulation. Dr Wilson reported receipt of personal fees from DePuy Australia. No other disclosures were reported.

Figures

**Figure 1.. Participant Flow in a Trial of Anticoagulation After Hip or Knee Arthroplasty**
^aA total of 1333 patients declined to have their data collected after enrollment; therefore, group allocation was not recorded. These patients were not included in any analysis and are not included in the tallies represented here. ^bPatients taking dabigatran, rivaroxaban, apixaban, edoxaban, betrixaban, warfarin, or dual antiplatelet therapy preoperatively were excluded from the primary analysis. ^cPatients who opted out chose to withdraw after initially consenting and prior to 90-day follow-up. ^dOne additional patient who died recorded a venous thromboembolic event prior to death and therefore was not considered to be missing an outcome.

**Figure 2.. Subgroup Analyses of the Primary Outcome of Symptomatic Venous Thromboembolism (Deep Venous Thrombosis or Pulmonary Embolism) Within 90 Days**

**Figure 3.. Kaplan-Meier Analysis of Time to Venous Thromboembolism (Deep Venous Thrombosis or Pulmonary Embolism) Occurrence by Randomized Group**
Shaded areas indicate 95% confidence intervals. Median time to venous thromboembolism in the aspirin group was 7.5 days (IQR, 5-9 days); median time to venous thromboembolism in the enoxaparin group was 12 days (IQR, 7-25 days). ^aThree patients in the aspirin group who experienced a venous thromboembolism did not have a date of event recorded and are excluded from this analysis.

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Comment in

Thromboprophylaxis After Hip or Knee Arthroplasty.
Chan NC, Bhandari M. Chan NC, et al. JAMA. 2022 Aug 23;328(8):712-713. doi: 10.1001/jama.2022.11249. JAMA. 2022. PMID: 35997752 No abstract available.
Review of Article: CRISTAL Study Group. Effect of aspirin vs. enoxaparin on symptomatic venous thromboembolism in patients undergoing hip or knee arthroplasty: The CRISTAL randomized trial. JAMA. 2022;328(8):719-727.
Whipple MO. Whipple MO. J Vasc Nurs. 2022 Sep;40(3):155-156. doi: 10.1016/j.jvn.2022.10.001. J Vasc Nurs. 2022. PMID: 36414372 Clinical Trial. No abstract available.
In THA or TKA, risk for symptomatic VTE was higher with aspirin vs. enoxaparin at 90 d.
Garcia D. Garcia D. Ann Intern Med. 2022 Dec;175(12):JC141. doi: 10.7326/J22-0096. Epub 2022 Dec 6. Ann Intern Med. 2022. PMID: 36469926
Low-Molecular-Weight Heparin Is Superior to Aspirin in the Prevention of Thromboembolic Disease: Or Is It?
Parvizi J, DeMik DE, Dunbar M, Hozack WJ, Mont MA, Lachiewicz PF. Parvizi J, et al. J Bone Joint Surg Am. 2022 Dec 7;104(23):2045-2046. doi: 10.2106/JBJS.22.01024. Epub 2022 Nov 4. J Bone Joint Surg Am. 2022. PMID: 36476736 No abstract available.
Aspirin vs Enoxaparin and Symptomatic Venous Thromboembolism in Hip or Knee Arthroplasty.
Hsu CH, Chen CH, Hsu NC. Hsu CH, et al. JAMA. 2023 Jan 10;329(2):176-177. doi: 10.1001/jama.2022.20751. JAMA. 2023. PMID: 36625814 No abstract available.
Aspirin vs Enoxaparin and Symptomatic Venous Thromboembolism in Hip or Knee Arthroplasty.
Hsu CC, Hsu CJ, Wei JC. Hsu CC, et al. JAMA. 2023 Jan 10;329(2):176. doi: 10.1001/jama.2022.20748. JAMA. 2023. PMID: 36625815 No abstract available.
Aspirin vs Enoxaparin and Symptomatic Venous Thromboembolism in Hip or Knee Arthroplasty.
DeMik DE, Mont MA, Dunbar M. DeMik DE, et al. JAMA. 2023 Jan 10;329(2):177. doi: 10.1001/jama.2022.20745. JAMA. 2023. PMID: 36625816 No abstract available.

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References

1. Sloan M, Premkumar A, Sheth NP. Projected volume of primary total joint arthroplasty in the US, 2014 to 2030. J Bone Joint Surg Am. 2018;100(17):1455-1460. doi:10.2106/JBJS.17.01617 - DOI - PubMed
1. Kurtz S, Ong K, Lau E, Mowat F, Halpern M. Projections of primary and revision hip and knee arthroplasty in the United States from 2005 to 2030. J Bone Joint Surg Am. 2007;89(4):780-785. doi:10.2106/00004623-200704000-00012 - DOI - PubMed
1. An VV, Phan K, Levy YD, Bruce WJ. Aspirin as thromboprophylaxis in hip and knee arthroplasty: a systematic review and meta-analysis. J Arthroplasty. 2016;31(11):2608-2616. doi:10.1016/j.arth.2016.04.004 - DOI - PubMed
1. Anderson DR, Dunbar M, Murnaghan J, et al. . Aspirin or rivaroxaban for VTE prophylaxis after hip or knee arthroplasty. N Engl J Med. 2018;378(8):699-707. doi:10.1056/NEJMoa1712746 - DOI - PubMed
1. Abdel MP, Meneghini RM, Berry DJ. Current practice trends in primary hip and knee arthroplasties among members of the American Association of Hip and Knee Surgeons: an update during the COVID-19 pandemic. J Arthroplasty. 2021;36(7S):S40-S44. doi:10.1016/j.arth.2021.01.080 - DOI - PubMed

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[1] Sloan M, Premkumar A, Sheth NP. Projected volume of primary total joint arthroplasty in the US, 2014 to 2030. J Bone Joint Surg Am. 2018;100(17):1455-1460. doi:10.2106/JBJS.17.01617 - DOI - PubMed

[2] Sloan M, Premkumar A, Sheth NP. Projected volume of primary total joint arthroplasty in the US, 2014 to 2030. J Bone Joint Surg Am. 2018;100(17):1455-1460. doi:10.2106/JBJS.17.01617 - DOI - PubMed

[3] Kurtz S, Ong K, Lau E, Mowat F, Halpern M. Projections of primary and revision hip and knee arthroplasty in the United States from 2005 to 2030. J Bone Joint Surg Am. 2007;89(4):780-785. doi:10.2106/00004623-200704000-00012 - DOI - PubMed

[4] Kurtz S, Ong K, Lau E, Mowat F, Halpern M. Projections of primary and revision hip and knee arthroplasty in the United States from 2005 to 2030. J Bone Joint Surg Am. 2007;89(4):780-785. doi:10.2106/00004623-200704000-00012 - DOI - PubMed

[5] An VV, Phan K, Levy YD, Bruce WJ. Aspirin as thromboprophylaxis in hip and knee arthroplasty: a systematic review and meta-analysis. J Arthroplasty. 2016;31(11):2608-2616. doi:10.1016/j.arth.2016.04.004 - DOI - PubMed

[6] An VV, Phan K, Levy YD, Bruce WJ. Aspirin as thromboprophylaxis in hip and knee arthroplasty: a systematic review and meta-analysis. J Arthroplasty. 2016;31(11):2608-2616. doi:10.1016/j.arth.2016.04.004 - DOI - PubMed

[7] Anderson DR, Dunbar M, Murnaghan J, et al. . Aspirin or rivaroxaban for VTE prophylaxis after hip or knee arthroplasty. N Engl J Med. 2018;378(8):699-707. doi:10.1056/NEJMoa1712746 - DOI - PubMed

[8] Anderson DR, Dunbar M, Murnaghan J, et al. . Aspirin or rivaroxaban for VTE prophylaxis after hip or knee arthroplasty. N Engl J Med. 2018;378(8):699-707. doi:10.1056/NEJMoa1712746 - DOI - PubMed

[9] Abdel MP, Meneghini RM, Berry DJ. Current practice trends in primary hip and knee arthroplasties among members of the American Association of Hip and Knee Surgeons: an update during the COVID-19 pandemic. J Arthroplasty. 2021;36(7S):S40-S44. doi:10.1016/j.arth.2021.01.080 - DOI - PubMed

[10] Abdel MP, Meneghini RM, Berry DJ. Current practice trends in primary hip and knee arthroplasties among members of the American Association of Hip and Knee Surgeons: an update during the COVID-19 pandemic. J Arthroplasty. 2021;36(7S):S40-S44. doi:10.1016/j.arth.2021.01.080 - DOI - PubMed

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Effect of Aspirin vs Enoxaparin on Symptomatic Venous Thromboembolism in Patients Undergoing Hip or Knee Arthroplasty: The CRISTAL Randomized Trial

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Effect of Aspirin vs Enoxaparin on Symptomatic Venous Thromboembolism in Patients Undergoing Hip or Knee Arthroplasty: The CRISTAL Randomized Trial

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