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19.03.2018 | Original Article

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

verfasst von: Thomas Beez, Hans-Jakob Steiger

Erschienen in: Neurosurgical Review | Ausgabe 1/2019

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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.
Literatur
2.
Zurück zum Zitat 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.
Zurück zum Zitat 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.
Zurück zum Zitat 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.
Zurück zum Zitat 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.
Zurück zum Zitat 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.
Zurück zum Zitat 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.
Zurück zum Zitat 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.
Zurück zum Zitat 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.
Zurück zum Zitat 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.
Zurück zum Zitat 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.
Zurück zum Zitat 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.
Zurück zum Zitat 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.
Zurück zum Zitat 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.
Zurück zum Zitat 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.
Zurück zum Zitat 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
Metadaten
Titel
Impact of randomized controlled trials on neurosurgical practice in decompressive craniectomy for ischemic stroke
verfasst von
Thomas Beez
Hans-Jakob Steiger
Publikationsdatum
19.03.2018
Verlag
Springer Berlin Heidelberg
Erschienen in
Neurosurgical Review / Ausgabe 1/2019
Print ISSN: 0344-5607
Elektronische ISSN: 1437-2320
DOI
https://doi.org/10.1007/s10143-018-0967-8

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