RECO Flow Restoration Device Versus Solitaire FR With the Intention for Thrombectomy Study (REDIRECT): a prospective randomized controlled trial

View More View Less
  • 1 Department of Neurosurgery, The First People’s Hospital of Changzhou/The Third Affiliated Hospital of Soochow University, Changzhou;
  • 2 Department of Neurology, Fuzhou General Hospital of Nanjing Military Command, Fuzhou;
  • 3 Department of Neurology, The Affiliated Hospital of Nantong University, Nantong;
  • 4 Department of Neurology, The Affiliated Hospital of Qingdao University, Qingdao;
  • 5 Department of Neurology, Zhongshan Hospital of Xiamen University, Xiamen;
  • 6 Department of Imaging, Yangzhou No. 1 People’s Hospital, Yangzhou; and
  • 7 Department of CCU, Daping Hospital, Chongqing, People’s Republic of China
Restricted access

Purchase Now

USD  $45.00

JNS + Pediatrics - 1 year subscription bundle (Individuals Only)

USD  $505.00

JNS + Pediatrics + Spine - 1 year subscription bundle (Individuals Only)

USD  $600.00
Print or Print + Online

OBJECTIVE

The RECO flow restoration (FR) device is a new stent retriever designed for rapid flow restoration in acute ischemic stroke (AIS) caused by large vessel occlusion (LVO). Here, the authors compared the efficacy and safety of the RECO device with the predicate Solitaire FR stent retriever.

METHODS

The RECO Flow Restoration Device Versus Solitaire FR With the Intention for Thrombectomy Study (REDIRECT) was a multicenter, prospective, open randomized controlled trial. Patients with acute LVO at 7 Chinese stroke centers participated in the study. The primary efficacy endpoint was defined as a modified thrombolysis in cerebral infarction (mTICI) reperfusion grade ≥ 2 within three passes. The primary safety endpoint comprised any serious adverse device effect, symptomatic intracerebral hemorrhage (sICH), and any serious adverse event (SAE; defined as cerebral palsy or death) within 24 hours after the procedure. The secondary efficacy endpoints consisted of functional independence (modified Rankin Scale score 0–2), procedure duration, and 90-day all-cause mortality.

RESULTS

Between January 2014 and August 2016, 67 patients were randomly allocated to the RECO group and 69 patients to the Solitaire FR group. The primary efficacy endpoint (mTICI grade ≥ 2 within three passes) was similar in the two treatment groups (91% vs 87%, respectively, p = 0.5861), and the rate of reperfusion with an mTICI grade 2b/3 was 87% versus 75% (p = 0.1272). There were no serious adverse device effects in any patient. The rates of sICH (1.5% vs 7.2%, p = 0.1027) and SAEs (6.0% vs 1.4%, p = 0.2050) within 24 hours after the procedure were similar in the two treatment groups. There was no significant difference in the rate of functional independence (63% vs 46%, p = 0.0609) or 90-day all-cause mortality (13% vs 23%, p = 0.1848) or in procedure duration (85.39 ± 47.01 vs 89.94 ± 53.34 minutes, p = 0.5986) between the two groups.

CONCLUSIONS

The RECO stent retriever is effective and safe as a mechanical thrombectomy device for AIS due to LVO.

Clinical trial registration no.: NCT01983644 (clinicaltrials.gov)

ABBREVIATIONS AIS = acute ischemic stroke; FR = flow restoration; LVO = large vessel occlusion; mRS = modified Rankin Scale; MT = mechanical thrombectomy; mTICI = modified thrombolysis in cerebral infarction; NIHSS = National Institutes of Health Stroke Scale; RCT = randomized controlled trial; rt-PA = recombinant tissue plasminogen activator; SAE = serious adverse event; sICH = symptomatic intracerebral hemorrhage.

JNS + Pediatrics - 1 year subscription bundle (Individuals Only)

USD  $505.00

JNS + Pediatrics + Spine - 1 year subscription bundle (Individuals Only)

USD  $600.00

Contributor Notes

Correspondence Ya Peng: The First People’s Hospital of Changzhou/The Third Affiliated Hospital of Soochow University, Changzhou, Jiangsu Province, China. neuropengya@sina.com.

INCLUDE WHEN CITING Published online June 5, 2020; DOI: 10.3171/2020.3.JNS193356.

Disclosures The study was funded by Minitech Medical.

  • 1

    Berkhemer OA, Fransen PS, Beumer D, A randomized trial of intraarterial treatment for acute ischemic stroke. N Engl J Med. 2015;372(1):1120.

    • Search Google Scholar
    • Export Citation
  • 2

    Jovin TG, Chamorro A, Cobo E, Thrombectomy within 8 hours after symptom onset in ischemic stroke. N Engl J Med. 2015;372(24):22962306.

    • Search Google Scholar
    • Export Citation
  • 3

    Puñal-Riobóo J, Atienza G, Blanco M. Safety and efficacy of mechanical thrombectomy using stent retrievers in the endovascular treatment of acute ischaemic stroke: a systematic review. Intervent Neurol. 2015;3(3-4):149164.

    • Search Google Scholar
    • Export Citation
  • 4

    Campbell BC, Mitchell PJ, Kleinig TJ, Endovascular therapy for ischemic stroke with perfusion-imaging selection. N Engl J Med. 2015;372(11):10091018.

    • Search Google Scholar
    • Export Citation
  • 5

    Saver JL, Goyal M, Bonafe A, Stent-retriever thrombectomy after intravenous t-PA vs. t-PA alone in stroke. N Engl J Med. 2015;372(24):22852295.

    • Search Google Scholar
    • Export Citation
  • 6

    Khatri P, Yeatts SD, Mazighi M, Time to angiographic reperfusion and clinical outcome after acute ischaemic stroke: an analysis of data from the Interventional Management of Stroke (IMS III) phase 3 trial. Lancet Neurol. 2014;13(6):567574.

    • Search Google Scholar
    • Export Citation
  • 7

    Yi HJ, Lee DH, Kim SU. Effectiveness of Trevo stent retriever in acute ischemic stroke: comparison with Solitaire stent. Medicine (Baltimore). 2018;97(20):e10747.

    • Search Google Scholar
    • Export Citation
  • 8

    Bourcier R, Abed D, Piotin M, Multicenter initial experience with the EmboTrap device in acute anterior ischemic stroke. J Neuroradiol. 2018;45(4):230235.

    • Search Google Scholar
    • Export Citation
  • 9

    Zaidat OO, Bozorgchami H, Ribó M, Primary results of the multicenter ARISE II study (Analysis of Revascularization in Ischemic Stroke With EmboTrap). Stroke. 2018;49(5):11071115.

    • Search Google Scholar
    • Export Citation
  • 10

    Saver JL, Jahan R, Levy EI, Solitaire flow restoration device versus the Merci Retriever in patients with acute ischaemic stroke (SWIFT): a randomised, parallel-group, non-inferiority trial. Lancet. 2012;380(9849):12411249.

    • Search Google Scholar
    • Export Citation
  • 11

    Nogueira RG, Lutsep HL, Gupta R, Trevo versus Merci retrievers for thrombectomy revascularisation of large vessel occlusions in acute ischaemic stroke (TREVO 2): a randomised trial. Lancet. 2012;380(9849):12311240.

    • Search Google Scholar
    • Export Citation
  • 12

    Walcott BP, Boehm KM, Stapleton CJ, Retrievable stent thrombectomy in the treatment of acute ischemic stroke: analysis of a revolutionizing treatment technique. J Clin Neurosci. 2013;20(10):13461349.

    • Search Google Scholar
    • Export Citation
  • 13

    Saber H, Rajah GB, Kherallah RY, Comparison of the efficacy and safety of thrombectomy devices in acute stroke: a network meta-analysis of randomized trials. J Neurointerv Surg. 2018;10(8):729734.

    • Search Google Scholar
    • Export Citation
  • 14

    Blackwelder WC. “Proving the null hypothesis” in clinical trials. Control Clin Trials. 1982;3(4):345353.

  • 15

    Saver JL, Goyal M, van der Lugt A, Time to treatment with endovascular thrombectomy and outcomes from ischemic stroke: a meta-analysis. JAMA. 2016;316(12):12791288.

    • Search Google Scholar
    • Export Citation
  • 16

    Prothmann S, Schwaiger BJ, Gersing AS, Acute Recanalization of Thrombo-Embolic Ischemic Stroke with pREset (ARTESp): the impact of occlusion time on clinical outcome of directly admitted and transferred patients. J Neurointerv Surg. 2017;9(9):817822.

    • Search Google Scholar
    • Export Citation
  • 17

    Kabra R, Phillips TJ, Saw JL, Mechanical thrombectomy for anterior circulation stroke: 5-year experience in a statewide service with differences in pretreatment time metrics across two hospitals sites. J Neurointerv Surg. 2017;9(6):535540.

    • Search Google Scholar
    • Export Citation
  • 18

    Minnerup J, Wersching H, Teuber A, Outcome after thrombectomy and intravenous thrombolysis in patients with acute ischemic stroke: a prospective observational study. Stroke. 2016;47(6):15841592.

    • Search Google Scholar
    • Export Citation
  • 19

    Raoult H, Redjem H, Bourcier R, Mechanical thrombectomy with the ERIC retrieval device: initial experience. J Neurointerv Surg. 2017;9(6):574577.

    • Search Google Scholar
    • Export Citation
  • 20

    Hopf-Jensen S, Preiß M, Marques L, Impact and effectiveness of dual aspiration technique in stent-assisted mechanical thrombectomy: recent improvements in acute stroke management. Cardiovasc Intervent Radiol. 2016;39(11):16201628.

    • Search Google Scholar
    • Export Citation
  • 21

    Goyal M, Menon BK, van Zwam WH, Endovascular thrombectomy after large-vessel ischaemic stroke: a meta-analysis of individual patient data from five randomised trials. Lancet. 2016;387(10029):17231731.

    • Search Google Scholar
    • Export Citation
  • 22

    Marder VJ, Chute DJ, Starkman S, Analysis of thrombi retrieved from cerebral arteries of patients with acute ischemic stroke. Stroke. 2006;37(8):20862093.

    • Search Google Scholar
    • Export Citation
  • 23

    Costalat V, Lobotesis K, Machi P, Prognostic factors related to clinical outcome following thrombectomy in ischemic stroke (RECOST study). 50 patients prospective study. Eur J Radiol. 2012;81(12):40754082.

    • Search Google Scholar
    • Export Citation
  • 24

    Bourcier R, Brecheteau N, Costalat V, MRI quantitative T2* mapping on thrombus to predict recanalization after endovascular treatment for acute anterior ischemic stroke. J Neuroradiol. 2017;44(4):241246.

    • Search Google Scholar
    • Export Citation

Metrics

All Time Past Year Past 30 Days
Abstract Views 389 389 389
Full Text Views 36 36 36
PDF Downloads 29 29 29
EPUB Downloads 0 0 0