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Open Access 01-12-2021 | Stroke | Systematic review update

Carotid endarterectomy with patch angioplasty versus primary closure in patients with symptomatic and significant stenosis: a systematic review with meta-analyses and trial sequential analysis of randomized clinical trials

Authors: Martijn S. Marsman, Jørn Wetterslev, Abdelkarime Kh. Jahrome, Christian Gluud, Frans L. Moll, Frederik Keus, Giel G. Koning

Published in: Systematic Reviews | Issue 1/2021

Abstract

Background

Patch angioplasty in conventional carotid endarterectomy is suggested to reduce the risk of restenosis and recurrent ipsilateral stroke compared with primary closure. A systematic review of randomized clinical trials is needed to compare outcomes (benefits and harms) of both techniques.

Methods

Searches (CENTRAL, PubMed/MEDLINE, EMBASE, and other databases) were last updated 3rd of January 2021. We included randomized clinical trials comparing carotid endarterectomy with patch angioplasty versus primary closure of the arterial wall in patients with a symptomatic and significant (> 50%) carotid stenosis. Primary outcomes are defined as all-cause mortality and serious adverse events.

Results

We included 12 randomized clinical trials including 2187 participants who underwent 2335 operations for carotid stenosis comparing carotid endarterectomy with patch closure (1280 operations) versus carotid endarterectomy with primary closure (1055 operations). Meta-analysis comparing carotid endarterectomy with patch angioplasty versus carotid endarterectomy with primary closure may potentially decrease the number of patients with all-cause mortality (RR 0.53; 95% CI 0.26 to 1.08; p = 0.08, best-case scenario for patch), serious adverse events (RR 0.73; 95% CI 0.56 to 0.96; p = 0.02, best-case scenario for patch), and the number of restenosis (RR 0.41; 95% CI 0.23 to 0.71; p < 0.01). Trial sequential analysis demonstrated that the required information sizes were far from being reached for these patient-important outcomes. All the patient-relevant outcomes were at low certainty of evidence according to The Grading of Recommendations Assessment, Development, and Evaluation.

Conclusions

This systematic review showed no conclusive evidence of a difference between carotid endarterectomy with patch angioplasty versus primary closure of the arterial wall on all-cause mortality, < 30 days mortality, < 30 days stroke, or any other serious adverse events. These conclusions are based on data from 15 to 35 years ago, obtained in trials with very low certainty according to GRADE, and should be interpreted cautiously. Therefore, we suggest conducting new randomized clinical trials patch angioplasty versus primary closure in carotid endarterectomy in symptomatic patients with an internal carotid artery stenosis of 50% or more. Such trials ought to be designed according to the Standard Protocol Items: Recommendations for Interventional Trials statement (Chan et al., Ann Intern Med 1:200–7, 2013) and reported according to the Consolidated Standards of Reporting Trials statement (Schulz et al., 7, 2010). Until conclusive evidence is obtained, the standard of care according to guidelines should not be abandoned.

Systematic review registration

PROSPERO CRD42014013416. Review protocol publication 2019 DOI: https://doi.org/10.1136/bmjopen-2018-026419.

Available only for authorised users

Fisher M. Occlusion of the internal carotid artery. AMA Arch Neurol Psychiatry. 1951;65(3):346–77. https://doi.org/10.1001/archneurpsyc.1951.02320030083009.CrossRefPubMed

Raman G, Moorthy D, Hadar N, Dahabreh IJ, O’Donnell TF. Management strategies for asymptomatic carotid stenosis: a systematic review and meta-analysis. Ann Intern Med. 2013;158(9):676–85. https://doi.org/10.7326/0003-4819-158-9-201305070-00007.CrossRefPubMed

Abbott AL. Medical (nonsurgical) intervention alone is now best for prevention of stroke associated with asymptomatic severe carotid stenosis: results of a systematic review and analysis. Stroke. 2009;40(10):573–84. https://doi.org/10.1161/STROKEAHA.109.556068.CrossRef

Constantinou J, Jayia P, Hamilton G. Best evidence for medical therapy for carotid artery stenosis. J Vasc Surg. 2013;58(4):1129–39. https://doi.org/10.1016/j.jvs.2013.06.085.CrossRefPubMed

Cina CS, Clase CM, Haynes RB, Orrapin S, Rerkasem K. Carotid endarterectomy for symptomatic carotid stenosis. Cochrane Database Syst Rev. 2017;(2):CD001081. https://doi.org/10.1002/14651858.CD001081.

Warlow C. MRC European Carotid Surgery Trial: interim results for symptomatic patients with severe (70-99%) or with mild (0-29%) carotid stenosis. Lancet. 1991;337(8752):1235–43. https://doi.org/10.1016/0140-6736(91)92916-P.CrossRef

Collaborators NASCET. Beneficial effect of carotid endarterectomy in symptomatic patients with high-grade carotid stenosis. N Engl J Med. 1991;325(7):445–53.CrossRef

Naylor A. Management of atherosclerotic carotid and vertebral artery disease: 2017 clinical practice guidelines of the European Society for Vascular Surgery (ESVS). Eur J Vasc Endovasc Surg. 2017;55(1):1–79. https://doi.org/10.1016/j.ejvs.2017.06.021.CrossRef

Bernstein EF, Torem S, Dilley RB. Does carotid restenosis predict an increased risk of late symptoms, stroke, or death? Ann Surg. 1990;212(5):629–36. https://doi.org/10.1097/00000658-199011000-00011.CrossRefPubMedPubMedCentral

10.

Knudsen L, Sillesen H, Schroeder T, Buchardt Hansen HJ. Eight to ten years follow-up after carotid endarterectomy: clinical evaluation and Doppler examination of patients operated on between 1978 and 1980. Eur J Vasc Surg. 1990;4(3):259–64. https://doi.org/10.1016/S0950-821X(05)80204-X.CrossRefPubMed

11.

Ouriel K, Green RM. Clinical and technical factors influencing recurrent carotid stenosis and occlusion after endarterectomy. J Vasc Surg. 1987;5(5):702–6. https://doi.org/10.1016/0741-5214(87)90157-1.CrossRefPubMed

12.

Volteas N, Labropulos N, Leon M, Kalodiki E, Chan PNA. Risk factors associated with recurrent carotid stenosis. Int Angiol. 1994;13(2):143–7.PubMed

13.

Zierler RE, Bandyk DF, Thiele BL, Strandness DE. Carotid artery stenosis following endarterectomy. Arch Surg. 1982;117(11):1408–15. https://doi.org/10.1001/archsurg.1982.01380350016003.CrossRefPubMed

14.

De Bakey ME, Crawford ES, Cooley DA, Morris GC Jr. Surgical considerations of occlusive disease of innominate, carotid, subclavian, and vertebral arteries. Ann Surg. 1959;149(5):690–710 Available from: http://www.ncbi.nlm.nih.gov/pubmed/13637687%5Cnhttp://www.pubmedcentral.nih.gov/articlerender.fcgi?artid=PMC1451085.CrossRef

15.

Rerkasem K, Rothwell PM. Systematic review of randomized controlled trials of patch angioplasty versus primary closure and different types of patch materials during carotid endarterectomy. Asian J Surg. 2011;34(1):32–40. https://doi.org/10.1016/S1015-9584(11)60016-X.CrossRefPubMed

16.

Liapis CD, Bell SPRF, Mikhailidis D, Sivenius J, Nicolaides A, Fernandes e Fernandes J, et al. ESVS Guidelines. Invasive treatment for carotid stenosis: indications, techniques. Eur J Vasc Endovasc Surg. 2009;37(4 SUPPL):1–19. https://doi.org/10.1016/j.ejvs.2008.11.006.CrossRefPubMed

17.

Nederlandse Vereniging voor Neurologie en het Kwaliteitsinstituut voor de Gezondheidszorg CBO. Diagnostiek, behandeling en zorg voor patiënten met een beroerte. Richtlijn Diagnostiek, behandeling en zorg voor patiënten met een beroerte. 2008. Available from: http://med-info.nl/Richtlijnen/Geriatrie/Beroerte.pdf. Cited 2017 Dec 2.

18.

Bass A, Krupski WC, Schneider PA, Otis SM, Dilley RB, Bernstein EF. Intraoperative transcranial Doppler: limitations of the method. J Vasc Surg. 1989;10(5):549–53. https://doi.org/10.1016/0741-5214(89)90137-7.CrossRefPubMed

19.

Gnanadev DA, Wang N, Comunale FL, Reile DA. Carotid artery stump pressure: how reliable is it in predicting the need for a shunt? Ann Vasc Surg. 1989;3(4):313–7. https://doi.org/10.1016/S0890-5096(06)60152-0.CrossRefPubMed

20.

Kresowik T, Worsey M, Khoury M, Krain L. Limitations of electroencephalography for cerebral ischemia during carotid endarterectomy. J Vasc Surg. 1991;13(3):439–43. https://doi.org/10.1067/mva.1991.26500.CrossRefPubMed

21.

Kearse LA, Brown EN, McPeck K. Somatosensory evoked potentials sensitivity relative to electroencephalography for cerebral ischemia during carotid endarterectomy. Stroke. 1992;23(4):498–505. https://doi.org/10.1161/01.STR.23.4.498.CrossRefPubMed

22.

Benjamin ME, Silva MB Jr, Watt C, McCaffrey MT, Burford-Froggs A, Flinn WR. Awake patient monitoring to determine the need for shunting during carotid endarterectomy. Surgery. 1993;114(4):673–9 discussion 679-681.PubMed

23.

Rerkasem K, Bond R, Pm R. Local versus general anaesthesia for carotid endarterectomy (Review). Cochrane Collab. 2005;(2). https://doi.org/10.1002/14651858.CD000126.pub2.

24.

Rerkasem K, Rothwell PM. Routine or selective carotid artery shunting for carotid endarterectomy (and different methods of monitoring in selective shunting). Cochrane Database Syst Rev. 2009;(4):CD000190. https://doi.org/10.1002/14651858.CD000190.pub2.

25.

Rerkasem K, Rothwell PM. Patches of different types for carotid patch angioplasty. Cochrane Database Syst Rev. 2010;(3):CD000071. https://doi.org/10.1002/14651858.CD000071.pub3.

26.

Chung B, Heo S, Park Y, Kim Y, Woo S, Kim D, et al. Comparative analysis using propensity score matching analysis: primary closure versus patch angioplasty during carotid endarterectomy. Ann Vasc Surg. 2019:1–7. https://doi.org/10.1016/j.avsg.2018.11.011.

27.

Huizing E, Vos CG, Hulsebos RG, Van Den Akker PJ, De Borst GJ. Patch angioplasty or primary closure following carotid endarterectomy for symptomatic carotid artery stenosis. Surg J. 2018;1(212):96–101.

28.

Edenfield L, Blazick E, Healey C, Hawkins R, Bloch P, Eldrup-jorgensen J, et al. Long-term impact of the Vascular Study Group of New England carotid patch quality initiative. J Vasc Surg. 2019;69(6):1801–6. https://doi.org/10.1016/j.jvs.2018.07.078.CrossRefPubMed

29.

Liu D, Li Z-L, Wang M, Wu R-D, Wang J-S, Wang S-M, et al. Comparative analysis of patch angioplasty versus selective primary closure during carotid endarterectomy performed at a single vascular center in China. Ann Vasc Surg. 2020; in press.

30.

Higgins J, Green S. Cochrane handbook for systematic review of intervention version 5.1.0: The Cochrane Collaboration; 2011. Available from: www.Cochrane-handbook.org

31.

Keus F, Wetterslev J, Gluud C, van Laarhoven CJHM. Evidence at a glance: error matrix approach for overviewing available evidence. BMC Med Res Methodol. 2010;10:90. https://doi.org/10.1186/1471-2288-10-90.CrossRefPubMedPubMedCentral

32.

Marsman MS, Wetterslev J, Jahrome AK, Gluud C, Moll FL, Karimi A, et al. Carotid endarterectomy with primary closure versus patch angioplasty in patients with symptomatic and significant stenosis: protocol for a systematic review with meta-analyses and trial sequential analysis of randomized clinical trials. BMJ Open. 2019;9(1–7):e026419. https://doi.org/10.1136/bmjopen-2018-026419.CrossRefPubMedPubMedCentral

33.

Huizing E, Vos CG, Van Den Akker PJ, Schreve MA. A systematic review of patch angioplasty versus primary closure for carotid endarterectomy. J Vasc Surg. 2019;69(6):1962–74. https://doi.org/10.1016/j.jvs.2018.10.096.CrossRefPubMed

34.

Rerkasem K, Rothwell PM. Patch angioplasty versus primary closure for carotid endarterectomy. Cochrane Database Syst Rev. 2009;(4):CD000160. https://doi.org/10.1002/14651858.CD000160.pub3.

35.

Moher D, Liberati A, Tetzlaff J, Altman DG, PRISMA Group. Preferred reporting items for systematic reviews and meta-analyses: the PRISMA statement. PLoS Med. 2009;6(7). https://doi.org/10.1371/journal.pmed.1000097.

36.

Cao P, De Rango P, Zannetti S. Eversion vs conventional carotid endarterectomy: a systematic review. Eur J Vasc Endovasc Surg. 2002;23(3):195–201. https://doi.org/10.1053/ejvs.2001.1560.CrossRefPubMed

37.

Guyatt GH, Oxman AD, Kunz R, Vist GE, Falck-Ytter Y, Schünemann HJ, et al. What is “‘quality of evidence’” and why is it important to clinicians? BMJ. 2008;336(7651):995–8. https://doi.org/10.1136/bmj.39490.551019.BE.CrossRefPubMedPubMedCentral

38.

International Conference on Harmonisation Expert Working Group. International conference on harmonization of technical requirements for registration of pharmaceuticals for human use. ICH harmonised tripartite guideline. Guideline for good clinical practice. Guidel Good Clin Pract CFR ICH Guidel. 1997;1:1–66. https://database.ich.org/sites/default/files/E6_R2_Addendum.pdf.

39.

Sterne JAC, Savović J, Page MJ, Elbers RG, Blencowe NS, Boutron I, et al. RoB 2: a revised tool for assessing risk of bias in randomised trials as an essential component of a. BMJ. 2019;366(14898):1–8. https://doi.org/10.1136/bmj.l4898.CrossRef

40.

Review Manager (RevMan). Copenhagen: The Nordic Cochrane Centre, The Cochrane Collaboration; 2014. Available from: https://community.cochrane.org/help/tools-and-software/revman-5. Accessed 2 Oct 2017.

41.

Jakobsen JC, Wetterslev J, Lange T, Gluud C. Editorial - viewpoint: taking into account risks of random errors when analysing multiple outcomes in systematic reviews: Cochrane Library; 2016. p. 2–7. https://doi.org/10.1002/14651858.ED000111.CrossRef

42.

Jakobsen JC, Wetterslev J, Winkel P, Lange T, Gluud C. Thresholds for statistical and clinical significance in systematic reviews with meta-analytic methods. BMC Med Res Methodol. 2014;14(1):1–13. https://doi.org/10.1186/1471-2288-14-120.CrossRef

43.

Wetterslev J, Thorlund K, Brok J, Gluud C. Trial sequential analysis may establish when firm evidence is reached in cumulative meta-analysis. J Clin Epidemiol. 2008;61(1):64–75. https://doi.org/10.1016/j.jclinepi.2007.03.013.CrossRefPubMed

44.

Brok J, Thorlund K, Wetterslev J, Gluud C. Apparently conclusive meta-analyses may be inconclusive - trial sequential analysis adjustment of random error risk due to repetitive testing of accumulating data in apparently conclusive neonatal meta-analyses. Int J Epidemiol. 2009;38(1):287–98. https://doi.org/10.1093/ije/dyn188.CrossRefPubMed

45.

Turner RM, Bird SM, Higgins JPT. The impact of study size on meta-analyses: examination of underpowered studies in Cochrane reviews. PLoS One. 2013;8(3):1–8.

46.

Guyatt GH, Oxman AD, Kunz R, Brozek J, Alonso-Coello P, Rind D, et al. GRADE guidelines 6. Rating the quality of evidence - Imprecision. J Clin Epidemiol. 2011;64(12):1283–93. https://doi.org/10.1016/j.jclinepi.2011.01.012.CrossRefPubMed

47.

Savović J, Jones HE, Altman DG, Harris RJ, Juni P, Pildal J, et al. Influence of reported study design characteristics on intervention effect estimates from randomised controlled trials: combined analysis of meta-epidemiological studies. Health Technol Assess (Rockv). 2012;16(35):1–81. https://doi.org/10.3310/hta16350.CrossRef

48.

Savovic J, Jones HE, Altman DG, Harris RJ, Pildal J, Als-nielsen B, et al. Research and reporting methods influence of reported study design characteristics on intervention. Ann Intern Med. 2012;157(6):429–38. https://doi.org/10.7326/0003-4819-157-6-201209180-00537.CrossRefPubMed

49.

Castellini G, Bruschettini M, Gianola S, Gluud C, Moja L. Assessing imprecision in Cochrane systematic reviews: a comparison of GRADE and trial sequential analysis. Syst Rev. 2018;7(1):1–10. https://doi.org/10.1186/s13643-018-0770-1.CrossRef

50.

De Vleeschauwer P, Wirthle W, Holler L, Krause E, Horsch S. Is venous patch grafting after carotid endarterectomy able to reduce the rate of restenosis? Prospective randomized pilot study with stratification. Acta Chir Belg. 1987;87(4):242–6.PubMed

51.

Lord RSA, Raj TB, Stary DL, Nash PA, Graham AR, Goh KH. Comparison of saphenous vein patch, polytetrafluoroethylene patch , and direct arteriotomy closure after carotid endarterectomy. Part I. Perioperative results. J Vasc Surg. 1989;9(4):521–9. https://doi.org/10.1016/0741-5214(89)90467-9.CrossRefPubMed

52.

Katz D, Snyder SO, Gandhi RH, Wheeler JR, Gregory RT, Gayle RG, et al. Long-term follow-up for recurrent stenosis: a prospective randomized study of expanded polytetrafluoroethylene patch angioplasty versus primary closure after carotid endarterectomy. J Vasc Surg. 1994;19(2):198–205. https://doi.org/10.1016/S0741-5214(94)70095-8.CrossRefPubMed

53.

Myers SI, Valentine RJ, Chervu A, Bowers BL, Clagett GP, Texas D. Saphenous vein patch versus primary closure for carotid endarterectomy: long-term assessment of a randomized prospective study. J Vasc Surg. 1994;19(1):15–22. https://doi.org/10.1016/S0741-5214(94)70116-4.CrossRefPubMed

54.

Mannheim D, Weller B, Vahadim E, Karmeli R. Carotid endarterectomy with a polyurethane patch versus primary closure: a prospective randomized study. J Vasc Surg. 2002;41:403–7.CrossRef

55.

Clagett GP, Patterson CB, Fisher DF, Fry RE, Eidt JF, Humble TH, et al. Vein patch versus primary closure for carotid endarterectomy. J Vasc Surg. 1989;9(2):213–23. https://doi.org/10.1016/0741-5214(89)90040-2.CrossRefPubMed

56.

Aburahma AF, Robinson PA, Mullins DA, Holt SM, Herzog TA, Mowery NT. Frequency of postoperative carotid duplex surveillance and type of closure: results from a randomized trial. J Vasc Surg. 2000;32(6):1043–51. https://doi.org/10.1067/mva.2000.111281.CrossRefPubMed

57.

Aburahma AF, Robinson P, Holt SM, Herzog TA, Mowery NT. Perioperative and late stroke rates of carotid endarterectomy contralateral to carotid artery occlusion results from a randomized trial. Stroke. 2000;31(7):1566–71. https://doi.org/10.1161/01.STR.31.7.1566.CrossRefPubMed

58.

Aburahma AF, Robinson PA, Richmond BK. Reanalysis of factors predicting recurrent stenosis in a prospective randomized trial of carotid endarterectomy comparing primary closure and patch closure. Vasc Surg. 2000;34(4):319–29. https://doi.org/10.1177/153857440003400406.CrossRef

59.

Ranaboldo CJ, Barros D’Sa AA, Bell PRF, Chant ADB, Perry PM. Randomized controlled trial of patch angioplasty for carotid endarterectomy. Br J Surg. 1993;80(12):1528–30. https://doi.org/10.1002/bjs.1800801211.CrossRefPubMed

60.

Aburahma AF, Robinson PA, Saiedy S, Khan JH, Boland JP. Prospective randomized trial of carotid endarterectomy with primary closure and patch angioplasty with saphenous vein , jugular vein , and polytetrafluoroethylene. J Vasc Surg. 1998;27:222–34.CrossRef

61.

Al-Rawi PG, Turner CL, Waran V, Ng I, Kirkpatrick PJ. A randomized trial of synthetic patch versus direct primary closure in carotid endarterectomy. Neurosurgery. 2006;59(4):822–9. https://doi.org/10.1227/01.NEU.0000232640.11438.C0.CrossRefPubMed

62.

AbuRahma AF, Khan JH, Robinson PA, Saiedy S, Short YS, Boland JP, et al. Prospective randomized trial of carotid endarterectomy with primary closure and patch angioplasty with saphenous vein , jugular vein , and polytetrafluoroethylene: perioperative ( 30-day ) results. J Vasc Surg. 1996;24(6):998–1007. https://doi.org/10.1016/S0741-5214(96)70045-9.CrossRefPubMed

63.

Pratesi C, Frullini A, Rega L, Fonda C, Matticari S, Alessi Innocenti A, et al. The follow-up after carotid TEA. In: Trends and controversies. Munich: W Zuckschwerdt; 1986. p. 313–5.

64.

Eikelboom BC, Ackerstaff RGA, Ludwig JW, Teeuwen C, Vermeulen FEE, Welten RJT. Benefits of carotid patching: a randomized study. J Vasc Surg. 1988;7(2):240–7. https://doi.org/10.1016/0741-5214(88)90142-5.CrossRefPubMed

65.

Letter JAM De, Moll FL, Welten RJT. Benefits of carotid patching: a prospective randomized study with. Ann Vasc Surg. 1993;8(1):54–8.

66.

Savovic J, Turner RM, Mawdsley D, Jones HE, Beynon R. Systematic reviews and meta- and pooled analyses association between risk-of-bias assessments and results of randomized trials in Cochrane reviews: the ROBES meta-epidemiologic study. Am J Epidemol 2018;187(5):1113–22. https://doi.org/10.1093/aje/kwx344.

67.

Brott TG, Ii RWH, Howard G, Roubin GS, Ph D, Clark WM, et al. Stenting versus endarterectomy for treatment of carotid-artery stenosis. N Engl J Med. 2010;363(1):11–23. https://doi.org/10.1056/NEJMoa0912321.CrossRefPubMedPubMedCentral

68.

Murphy SJX, Naylor AR, Ricco J, Sillesen H, Kakkos S, Halliday A. Optimal antiplatelet therapy in moderate to severe asymptomatic and symptomatic carotid stenosis: a comprehensive review of the literature. Eur J Vasc Endovasc Surg. 2018:1–16. https://doi.org/10.1016/j.ejvs.2018.09.018.

69.

Diener H, Sacco RL, Yusuf S, Cotton D, Ôunpuu S, Lawton WA, et al. Effects of aspirin plus extended-release dipyridamole versus clopidogrel and telmisartan on disability and cognitive function after recurrent stroke in patients with ischaemic stroke in the prevention regimen for effectively avoiding second strokes (PRoFESS) trial: a double-blind, active and placebo-controlled study. Lancet Neurol. 2008;7(10):875–84. https://doi.org/10.1016/S1474-4422(08)70198-4.CrossRefPubMedPubMedCentral

70.

Tse D, Hill MD, Coutts SB, Tse D, Hill MD. Early secondary prevention in transient ischemic attack (TIA) and minor stroke. Curr Neurol Neurosci Rep. 2019;19(34):1–7. https://doi.org/10.1007/s11910-019-0950-y.CrossRef

71.

Marsman MS, Özdemir-van Brunschot DM, Jahrome AK, Veeger NJGM, Schuiling WJ, Van Rooij FG, et al. Case series about the changed antiplatelet protocol for carotid endarterectomy in a teaching hospital: more patients with complications? Surg J. 2018;5(4):220–5. https://doi.org/10.1055/s-0038-1675566.CrossRef

72.

Wood L, Egger M, Gluud LL, Schulz KF, Altman DG, Ju P, et al. Empirical evidence of bias in treatment effect estimates in. Br Med J. 2008;336(7644):601–5. https://doi.org/10.1136/bmj.39465.451748.AD.CrossRef

73.

Skoog M, Saarimäki J, Gluud C, Sheinin M, Erlendsson K, Aamdal S, et al. Transparency and registration in clinical research in the Nordic countries. Nordforsk. 2015:1–108. https://nta.nordforsk.org/projects/nta_transparency_report.pdf

74.

Claire R, Gluud C, Berlin I, Coleman T, Leonardi-bee J. Using trial sequential analysis for estimating the sample sizes of further trials: example using smoking cessation intervention. BMC Med Res Methodol. 2020;20(284):1–10.

75.

Chan A, Tetzlaff JM, Altman DG, Laupacis A, Gøtzsche PC, Hro A, et al. SPIRIT 2013 Statement: defining standard protocol items for clinical trials. Ann Intern Med. 2013;1(158):200–7.CrossRef

76.

Schulz KF, Altman DG, Moher D. CONSORT 2010 Statement: updated guidelines for reporting parallel group randomised trials. BMJ. 2010;7(3):c332–c332. https://doi.org/10.1136/bmj.c332.

Title: Carotid endarterectomy with patch angioplasty versus primary closure in patients with symptomatic and significant stenosis: a systematic review with meta-analyses and trial sequential analysis of randomized clinical trials
Authors: Martijn S. Marsman
Jørn Wetterslev
Abdelkarime Kh. Jahrome
Christian Gluud
Frans L. Moll
Frederik Keus
Giel G. Koning
Publication date: 01-12-2021
Publisher: BioMed Central
Keywords: Stroke
Carotid Stenosis
Carotid Endarterectomy
Carotid Stenosis
Published in: Systematic Reviews / Issue 1/2021
Electronic ISSN: 2046-4053
DOI: https://doi.org/10.1186/s13643-021-01692-8

Keynote webinar | Spotlight on medication adherence

Springer Medicine

Carotid endarterectomy with patch angioplasty versus primary closure in patients with symptomatic and significant stenosis: a systematic review with meta-analyses and trial sequential analysis of randomized clinical trials

Abstract

Background

Methods

Results

Conclusions

Systematic review registration

Keynote webinar | Spotlight on medication adherence

Springer Medicine

Abstract

Background

Methods

Results

Conclusions

Systematic review registration

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