Skip to main content
Top
Published in: Neurosurgical Review 1/2019

01-03-2019 | Original Article

Impact of randomized controlled trials on neurosurgical practice in decompressive craniectomy for ischemic stroke

Authors: Thomas Beez, Hans-Jakob Steiger

Published in: Neurosurgical Review | Issue 1/2019

Login to get access

Abstract

Randomized controlled trials (RCTs) are gold standard for comparing treatment modalities. Recently, RCTs transformed ischemic stroke care by first proving benefit of decompressive craniectomy (DC) and later of interventional mechanical thrombectomy. Aim of this study was to explore the impact of RCTs on neurosurgical practice. RCTs investigating DC and thrombectomy were identified. Annual numbers of DCs for ischemic stroke between 2000 and 2017 were determined and correlated with publication dates of RCTs. The initial RCTs demonstrating efficacy of DC were published in 2007, followed by an increase in DC numbers between 2008 and 2009. The first RCTs on mechanical thrombectomy were published in 2014 and 2015, with a decline in DCs observed between 2015 and 2016. There is a close temporal relationship between publication of these RCTs and changes in neurosurgical practice. Dynamics of annual DCs appear to correlate with the publication of RCTs. Significantly positive results of surgical and interventional RCTs were translated into clinical practice with a latency of 1 year, as reflected by shifts in annual DC numbers.
Literature
2.
go back to reference Berkhemer OA, Fransen PSS, Beumer D, van den Berg LA, Lingsma HF, Yoo AJ, Schonewille WJ, Vos JA, Nederkoorn PJ, Wermer MJH, van Walderveen MAA, Staals J, Hofmeijer J, van Oostayen JA, Lycklama à Nijeholt GJ, Boiten J, Brouwer PA, Emmer BJ, de Bruijn SF, van Dijk LC, Kappelle LJ, Lo RH, van Dijk EJ, de Vries J, de Kort PLM, van Rooij WJJ, van den Berg JSP, van Hasselt BAAM, Aerden LAM, Dallinga RJ, Visser MC, Bot JCJ, Vroomen PC, Eshghi O, Schreuder THCML, Heijboer RJJ, Keizer K, Tielbeek AV, den Hertog HM, Gerrits DG, van den Berg-Vos RM, Karas GB, Steyerberg EW, Flach HZ, Marquering HA, MES S, SFM J, LFM B, van den Berg R, Koudstaal PJ, van Zwam WH, YBWEM R, van der Lugt A, van Oostenbrugge RJ, CBLM M, DWJ D, MR CLEAN Investigators (2015) A randomized trial of intraarterial treatment for acute ischemic stroke. N Engl J Med 372:11–20. https://doi.org/10.1056/NEJMoa1411587 CrossRefPubMed Berkhemer OA, Fransen PSS, Beumer D, van den Berg LA, Lingsma HF, Yoo AJ, Schonewille WJ, Vos JA, Nederkoorn PJ, Wermer MJH, van Walderveen MAA, Staals J, Hofmeijer J, van Oostayen JA, Lycklama à Nijeholt GJ, Boiten J, Brouwer PA, Emmer BJ, de Bruijn SF, van Dijk LC, Kappelle LJ, Lo RH, van Dijk EJ, de Vries J, de Kort PLM, van Rooij WJJ, van den Berg JSP, van Hasselt BAAM, Aerden LAM, Dallinga RJ, Visser MC, Bot JCJ, Vroomen PC, Eshghi O, Schreuder THCML, Heijboer RJJ, Keizer K, Tielbeek AV, den Hertog HM, Gerrits DG, van den Berg-Vos RM, Karas GB, Steyerberg EW, Flach HZ, Marquering HA, MES S, SFM J, LFM B, van den Berg R, Koudstaal PJ, van Zwam WH, YBWEM R, van der Lugt A, van Oostenbrugge RJ, CBLM M, DWJ D, MR CLEAN Investigators (2015) A randomized trial of intraarterial treatment for acute ischemic stroke. N Engl J Med 372:11–20. https://​doi.​org/​10.​1056/​NEJMoa1411587 CrossRefPubMed
7.
go back to reference Goyal M, Demchuk AM, Menon BK, Eesa M, Rempel JL, Thornton J, Roy D, Jovin TG, Willinsky RA, Sapkota BL, Dowlatshahi D, Frei DF, Kamal NR, Montanera WJ, Poppe AY, Ryckborst KJ, Silver FL, Shuaib A, Tampieri D, Williams D, Bang OY, Baxter BW, Burns PA, Choe H, Heo J-H, Holmstedt CA, Jankowitz B, Kelly M, Linares G, Mandzia JL, Shankar J, Sohn S-I, Swartz RH, Barber PA, Coutts SB, Smith EE, Morrish WF, Weill A, Subramaniam S, Mitha AP, Wong JH, Lowerison MW, Sajobi TT, Hill MD, Trial Investigators ESCAPE (2015) Randomized assessment of rapid endovascular treatment of ischemic stroke. N Engl J Med 372:1019–1030. https://doi.org/10.1056/NEJMoa1414905 CrossRefPubMed Goyal M, Demchuk AM, Menon BK, Eesa M, Rempel JL, Thornton J, Roy D, Jovin TG, Willinsky RA, Sapkota BL, Dowlatshahi D, Frei DF, Kamal NR, Montanera WJ, Poppe AY, Ryckborst KJ, Silver FL, Shuaib A, Tampieri D, Williams D, Bang OY, Baxter BW, Burns PA, Choe H, Heo J-H, Holmstedt CA, Jankowitz B, Kelly M, Linares G, Mandzia JL, Shankar J, Sohn S-I, Swartz RH, Barber PA, Coutts SB, Smith EE, Morrish WF, Weill A, Subramaniam S, Mitha AP, Wong JH, Lowerison MW, Sajobi TT, Hill MD, Trial Investigators ESCAPE (2015) Randomized assessment of rapid endovascular treatment of ischemic stroke. N Engl J Med 372:1019–1030. https://​doi.​org/​10.​1056/​NEJMoa1414905 CrossRefPubMed
8.
go back to reference Goyal M, Menon BK, van Zwam WH, Dippel DWJ, Mitchell PJ, Demchuk AM, Dávalos A, Majoie CBLM, van der Lugt A, de Miquel MA, Donnan GA, Roos YBWEM, Bonafe A, Jahan R, Diener H-C, van den Berg LA, Levy EI, Berkhemer OA, Pereira VM, Rempel J, Millán M, Davis SM, Roy D, Thornton J, Román LS, Ribó M, Beumer D, Stouch B, Brown S, Campbell BCV, van Oostenbrugge RJ, Saver JL, Hill MD, Jovin TG, collaborators HERMES (2016) Endovascular thrombectomy after large-vessel ischaemic stroke: a meta-analysis of individual patient data from five randomised trials. Lancet (London, England) 387:1723–1731. https://doi.org/10.1016/S0140-6736(16)00163-X CrossRef Goyal M, Menon BK, van Zwam WH, Dippel DWJ, Mitchell PJ, Demchuk AM, Dávalos A, Majoie CBLM, van der Lugt A, de Miquel MA, Donnan GA, Roos YBWEM, Bonafe A, Jahan R, Diener H-C, van den Berg LA, Levy EI, Berkhemer OA, Pereira VM, Rempel J, Millán M, Davis SM, Roy D, Thornton J, Román LS, Ribó M, Beumer D, Stouch B, Brown S, Campbell BCV, van Oostenbrugge RJ, Saver JL, Hill MD, Jovin TG, collaborators HERMES (2016) Endovascular thrombectomy after large-vessel ischaemic stroke: a meta-analysis of individual patient data from five randomised trials. Lancet (London, England) 387:1723–1731. https://​doi.​org/​10.​1016/​S0140-6736(16)00163-X CrossRef
9.
go back to reference Higgins J, Green S (2011) Cochrane Handbook for Systematic Reviews of Interventions Version 5.1.0 [updated March 2011]. In: Cochrane Collab. www.cochrane-handbook.org (accessed September 2014) Higgins J, Green S (2011) Cochrane Handbook for Systematic Reviews of Interventions Version 5.1.0 [updated March 2011]. In: Cochrane Collab. www.​cochrane-handbook.​org (accessed September 2014)
10.
go back to reference Hofmeijer J, Kappelle LJ, Algra A, Amelink GJ, van Gijn J, van der Worp HB, HAMLET investigators (2009) Surgical decompression for space-occupying cerebral infarction (the hemicraniectomy after middle cerebral artery infarction with life-threatening edema trial [HAMLET]): a multicentre, open, randomised trial. Lancet Neurol 8:326–333. https://doi.org/10.1016/S1474-4422(09)70047-X CrossRefPubMed Hofmeijer J, Kappelle LJ, Algra A, Amelink GJ, van Gijn J, van der Worp HB, HAMLET investigators (2009) Surgical decompression for space-occupying cerebral infarction (the hemicraniectomy after middle cerebral artery infarction with life-threatening edema trial [HAMLET]): a multicentre, open, randomised trial. Lancet Neurol 8:326–333. https://​doi.​org/​10.​1016/​S1474-4422(09)70047-X CrossRefPubMed
14.
go back to reference Jovin TG, Chamorro A, Cobo E, de Miquel MA, Molina CA, Rovira A, San Román L, Serena J, Abilleira S, Ribó M, Millán M, Urra X, Cardona P, López-Cancio E, Tomasello A, Castaño C, Blasco J, Aja L, Dorado L, Quesada H, Rubiera M, Hernandez-Pérez M, Goyal M, Demchuk AM, von Kummer R, Gallofré M, Dávalos A, REVASCAT Trial Investigators (2015) Thrombectomy within 8 hours after symptom onset in ischemic stroke. N Engl J Med 372:2296–2306. https://doi.org/10.1056/NEJMoa1503780 CrossRefPubMed Jovin TG, Chamorro A, Cobo E, de Miquel MA, Molina CA, Rovira A, San Román L, Serena J, Abilleira S, Ribó M, Millán M, Urra X, Cardona P, López-Cancio E, Tomasello A, Castaño C, Blasco J, Aja L, Dorado L, Quesada H, Rubiera M, Hernandez-Pérez M, Goyal M, Demchuk AM, von Kummer R, Gallofré M, Dávalos A, REVASCAT Trial Investigators (2015) Thrombectomy within 8 hours after symptom onset in ischemic stroke. N Engl J Med 372:2296–2306. https://​doi.​org/​10.​1056/​NEJMoa1503780 CrossRefPubMed
16.
go back to reference Kennedy HL (1999) The importance of randomized clinical trials and evidence-based medicine: a clinician’s perspective. Clin Cardiol 22:6–12CrossRefPubMed Kennedy HL (1999) The importance of randomized clinical trials and evidence-based medicine: a clinician’s perspective. Clin Cardiol 22:6–12CrossRefPubMed
17.
go back to reference Ketley D, Woods KL (1993) Impact of clinical trials on clinical practice: example of thrombolysis for acute myocardial infarction. Lancet (London, England) 342:891–894CrossRef Ketley D, Woods KL (1993) Impact of clinical trials on clinical practice: example of thrombolysis for acute myocardial infarction. Lancet (London, England) 342:891–894CrossRef
18.
go back to reference Khoury NN, Darsaut TE, Ghostine J, Deschaintre Y, Daneault N, Durocher A, Lanthier S, Pope AY, Odier C, Lebrun L-H, Guilbert F, Gentric J-C, Batista A, Weill A, Roy D, Bracard S, Raymond J, trial collaborators EASI (2017) Endovascular thrombectomy and medical therapy versus medical therapy alone in acute stroke: a randomized care trial. J Neuroradiol 44:198–202. https://doi.org/10.1016/j.neurad.2017.01.126 CrossRefPubMed Khoury NN, Darsaut TE, Ghostine J, Deschaintre Y, Daneault N, Durocher A, Lanthier S, Pope AY, Odier C, Lebrun L-H, Guilbert F, Gentric J-C, Batista A, Weill A, Roy D, Bracard S, Raymond J, trial collaborators EASI (2017) Endovascular thrombectomy and medical therapy versus medical therapy alone in acute stroke: a randomized care trial. J Neuroradiol 44:198–202. https://​doi.​org/​10.​1016/​j.​neurad.​2017.​01.​126 CrossRefPubMed
19.
go back to reference Krogias C, Bartig D, Kitzrow M, Brassel F, Busch EW, Nolden-Koch M, Reimann G, Weimar C, Weber R, Eyding J (2017) [Availability of mechanical thrombectomy for acute stroke : analysis of the health care reality in Germany]. Nervenarzt. https://doi.org/10.1007/s00115-017-0324-0 Krogias C, Bartig D, Kitzrow M, Brassel F, Busch EW, Nolden-Koch M, Reimann G, Weimar C, Weber R, Eyding J (2017) [Availability of mechanical thrombectomy for acute stroke : analysis of the health care reality in Germany]. Nervenarzt. https://​doi.​org/​10.​1007/​s00115-017-0324-0
24.
go back to reference Mocco J, Zaidat OO, von Kummer R, Yoo AJ, Gupta R, Lopes D, Frei D, Shownkeen H, Budzik R, Ajani ZA, Grossman A, Altschul D, McDougall C, Blake L, Fitzsimmons B-F, Yavagal D, Terry J, Farkas J, Lee SK, Baxter B, Wiesmann M, Knauth M, Heck D, Hussain S, Chiu D, Alexander MJ, Malisch T, Kirmani J, Miskolczi L, Khatri P, Trial Investigators* THERAPY (2016) Aspiration thrombectomy after intravenous alteplase versus intravenous alteplase alone. Stroke 47:2331–2338. https://doi.org/10.1161/STROKEAHA.116.013372 CrossRefPubMed Mocco J, Zaidat OO, von Kummer R, Yoo AJ, Gupta R, Lopes D, Frei D, Shownkeen H, Budzik R, Ajani ZA, Grossman A, Altschul D, McDougall C, Blake L, Fitzsimmons B-F, Yavagal D, Terry J, Farkas J, Lee SK, Baxter B, Wiesmann M, Knauth M, Heck D, Hussain S, Chiu D, Alexander MJ, Malisch T, Kirmani J, Miskolczi L, Khatri P, Trial Investigators* THERAPY (2016) Aspiration thrombectomy after intravenous alteplase versus intravenous alteplase alone. Stroke 47:2331–2338. https://​doi.​org/​10.​1161/​STROKEAHA.​116.​013372 CrossRefPubMed
25.
go back to reference Muir KW, Ford GA, Messow C-M, Ford I, Murray A, Clifton A, Brown MM, Madigan J, Lenthall R, Robertson F, Dixit A, Cloud GC, Wardlaw J, Freeman J, White P, PISTE Investigators (2017) Endovascular therapy for acute ischaemic stroke: the pragmatic ischaemic stroke thrombectomy evaluation (PISTE) randomised, controlled trial. J Neurol Neurosurg Psychiatry 88:38–44. https://doi.org/10.1136/jnnp-2016-314117 CrossRefPubMed Muir KW, Ford GA, Messow C-M, Ford I, Murray A, Clifton A, Brown MM, Madigan J, Lenthall R, Robertson F, Dixit A, Cloud GC, Wardlaw J, Freeman J, White P, PISTE Investigators (2017) Endovascular therapy for acute ischaemic stroke: the pragmatic ischaemic stroke thrombectomy evaluation (PISTE) randomised, controlled trial. J Neurol Neurosurg Psychiatry 88:38–44. https://​doi.​org/​10.​1136/​jnnp-2016-314117 CrossRefPubMed
27.
go back to reference Saver JL, Goyal M, Bonafe A, Diener H-C, Levy EI, Pereira VM, Albers GW, Cognard C, Cohen DJ, Hacke W, Jansen O, Jovin TG, Mattle HP, Nogueira RG, Siddiqui AH, Yavagal DR, Baxter BW, Devlin TG, Lopes DK, Reddy VK, du Mesnil de Rochemont R, Singer OC, Jahan R, SWIFT PRIME Investigators (2015) Stent-retriever thrombectomy after intravenous t-PA vs. t-PA alone in stroke. N Engl J Med 372:2285–2295. https://doi.org/10.1056/NEJMoa1415061 CrossRefPubMed Saver JL, Goyal M, Bonafe A, Diener H-C, Levy EI, Pereira VM, Albers GW, Cognard C, Cohen DJ, Hacke W, Jansen O, Jovin TG, Mattle HP, Nogueira RG, Siddiqui AH, Yavagal DR, Baxter BW, Devlin TG, Lopes DK, Reddy VK, du Mesnil de Rochemont R, Singer OC, Jahan R, SWIFT PRIME Investigators (2015) Stent-retriever thrombectomy after intravenous t-PA vs. t-PA alone in stroke. N Engl J Med 372:2285–2295. https://​doi.​org/​10.​1056/​NEJMoa1415061 CrossRefPubMed
30.
go back to reference Vahedi K, Hofmeijer J, Juettler E, Vicaut E, George B, Algra A, Amelink GJ, Schmiedeck P, Schwab S, Rothwell PM, Bousser M-G, van der Worp HB, Hacke W, DECIMAL, DESTINY and H investigators (2007) Early decompressive surgery in malignant infarction of the middle cerebral artery: a pooled analysis of three randomised controlled trials. Lancet Neurol 6:215–222. https://doi.org/10.1016/S1474-4422(07)70036-4 CrossRefPubMed Vahedi K, Hofmeijer J, Juettler E, Vicaut E, George B, Algra A, Amelink GJ, Schmiedeck P, Schwab S, Rothwell PM, Bousser M-G, van der Worp HB, Hacke W, DECIMAL, DESTINY and H investigators (2007) Early decompressive surgery in malignant infarction of the middle cerebral artery: a pooled analysis of three randomised controlled trials. Lancet Neurol 6:215–222. https://​doi.​org/​10.​1016/​S1474-4422(07)70036-4 CrossRefPubMed
31.
go back to reference Vahedi K, Vicaut E, Mateo J, Kurtz A, Orabi M, Guichard J-P, Boutron C, Couvreur G, Rouanet F, Touzé E, Guillon B, Carpentier A, Yelnik A, George B, Payen D, Bousser M-G, DECIMAL Investigators (2007) Sequential-design, multicenter, randomized, controlled trial of early decompressive craniectomy in malignant middle cerebral artery infarction (DECIMAL trial). Stroke 38:2506–2517. https://doi.org/10.1161/STROKEAHA.107.485235 CrossRefPubMed Vahedi K, Vicaut E, Mateo J, Kurtz A, Orabi M, Guichard J-P, Boutron C, Couvreur G, Rouanet F, Touzé E, Guillon B, Carpentier A, Yelnik A, George B, Payen D, Bousser M-G, DECIMAL Investigators (2007) Sequential-design, multicenter, randomized, controlled trial of early decompressive craniectomy in malignant middle cerebral artery infarction (DECIMAL trial). Stroke 38:2506–2517. https://​doi.​org/​10.​1161/​STROKEAHA.​107.​485235 CrossRefPubMed
Metadata
Title
Impact of randomized controlled trials on neurosurgical practice in decompressive craniectomy for ischemic stroke
Authors
Thomas Beez
Hans-Jakob Steiger
Publication date
01-03-2019
Publisher
Springer Berlin Heidelberg
Published in
Neurosurgical Review / Issue 1/2019
Print ISSN: 0344-5607
Electronic ISSN: 1437-2320
DOI
https://doi.org/10.1007/s10143-018-0967-8

Other articles of this Issue 1/2019

Neurosurgical Review 1/2019 Go to the issue