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Five-year results of randomized bioactive versus bare metal coils in the treatment of intracranial aneurysms: the Matrix and Platinum Science (MAPS) Trial
  1. Cameron G McDougall1,
  2. S Claiborne Johnston2,
  3. Steven W Hetts3,
  4. Anil Gholkar4,
  5. Stanley L Barnwell5,
  6. Juan Carlos Vazquez Suarez6,
  7. Javier Massó Romero7,
  8. John C Chaloupka8,
  9. Alain Bonafe9,
  10. Ajay K Wakhloo10,
  11. Donatella Tampieri11,
  12. Christopher F Dowd12,
  13. Allan J Fox13,
  14. Aquilla S Turk14
  15. for the MAPS Investigators
  1. 1Neurosurgery, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA
  2. 2Dean's Office, University of Texas at Austin Dell Seton Medical Center, Austin, Texas, USA
  3. 3Interventional Neuroradiology, University of California San Francisco, San Francisco, California, USA
  4. 4Neuroradiology, Newcastle upon Tyne Hospitals, Newcastle upon Tyne, UK
  5. 5Neurological Surgery and Diagnostic Radiology, Oregon Health & Science University, Portland, Oregon, USA
  6. 6Interventional Neuroradiology, Erasme University Hospital, Brussels, Belgium
  7. 7Interventional Neuroradiology, Hospital Universitario de Donostia, San Sebastian, Spain
  8. 8Neurosurgery and Radiology, Mount Sinai Medical Center, Miami Beach, Florida, USA
  9. 9Neuroradiology, Hopital Gui de Chauliac, Montpellier, France
  10. 10Neurointerventional Radiology, Lahey Hospital and Medical Center, Burlington, Massachusetts, USA
  11. 11Radiology, Queen's University, Kingston, Queensland, Canada
  12. 12Radiology and Biomedical Imaging, University of California, San Francisco (UCSF), San Francisco, California, USA
  13. 13Neuroradiology, Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada
  14. 14Neurointerventional Surgery, Radiology, and Neurosurgery, Medical University of South Carolina, Charleston, South Carolina, USA
  1. Correspondence to Dr Steven W Hetts, Radiology, University of California San Francisco, San Francisco, CA 94143, USA; steven.hetts{at}ucsf.edu

Abstract

Background No randomized trial of intracranial aneurysm coiling has compared long-term efficacy of polymer-modified coils to bare metal coils (BMCs). We report 5-year results comparing Matrix2 coils to BMCs. The primary objective was to compare the rates of target aneurysm recurrence (TAR) at 12 months. Secondary objectives included angiographic outcomes at TAR or 12 months and TAR at 5 years.

Methods A total of 626 patients were randomized to BMCs or Matrix2 coils. Detailed methods and 1-year results have been published previously.

Results Of 580 patients eligible for 5-year follow-up, 431 (74.3%) completed follow-up or reached TAR. Matrix2 coils were non-inferior to BMCs (P=0.8) but did not confer any benefit. Core lab reported post-treatment residual aneurysm filling (Raymond III) correlated with TAR (P<0.0001) and with aneurysm hemorrhage after treatment (P<0.008). Repeat aneurysmal hemorrhage after treatment, but before hospital discharge, occurred in three patients treated for acutely ruptured aneurysms. Additionally, two patients treated for unruptured aneurysms experienced a first hemorrhage during follow-up. All five hemorrhages resulted from aneurysms with Raymond III residual aneurysm filling persisting after initial treatment. After 5 years follow-up, 2/626 (0.3%) patients are known to have had target aneurysm rupture following hospital discharge. The annualized rate of delayed hemorrhage after coiling was 2/398/5=0.001 (0.1%) per year for unruptured aneurysms and 0 for ruptured aneurysms.

Conclusions After 5 years Matrix2 coils were non-inferior to BMCs but no benefit was demonstrated. Post-treatment residual angiographic aneurysm filling (Raymond III) is strongly associated with TAR (P<0.0001) and post-treatment aneurysmal hemorrhage (P=0.008).

  • aneurysm
  • bioactive
  • coil
  • device
  • subarachnoid
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Footnotes

  • Twitter @StanleyBarnwe

  • Contributors CGM: planning, conduct, conception and design, acquisition of data, analysis, writing of final manuscript, editing of final manuscript. SCJ: planning, conduct, conception and design, acquisition of data, analysis, editing of final manuscript. SWH: planning, conduct, conception and design, acquisition of data, analysis, writing of final manuscript, editing of final manuscript, correspondence. AG: conduct, acquisition of data, analysis, editing of final manuscript. SLB: conduct, acquisition of data, analysis, editing of final manuscript. JCVS: conduct, acquisition of data, analysis, editing of final manuscript. JMR: conduct, acquisition of data, analysis, editing of final manuscript. JCC: conduct, acquisition of data, analysis, editing of final manuscript. AB: conduct, acquisition of data, analysis, editing of final manuscript. AKW: conduct, acquisition of data, analysis, editing of final manuscript. DT: conduct, acquisition of data, analysis, editing of final manuscript. CFD: conduct, acquisition of data, analysis, editing of final manuscript. AJF: conduct, acquisition of data, analysis, editing of final manuscript. AST: planning, conduct, conception and design, acquisition of data, analysis, editing of final manuscript.

  • Funding This study was funded by Stryker (MAPS Trial).

  • Competing interests SWH: core lab services for Stryker and MicroVention Terumo (money paid to UCSF, over $5K); consulting for Microvention Terumo (money paid to Dr Hetts, under $5K). CGM: consultant for Medtronic and Microvention. JCC: consultant for Stryker. AB: consultant for Stryker, Microvention, Balt, and Phenox. AKW: research grant from Philips Medical; serves as a consultant for Stryker and Phenox; is a stockholder of InNeuroCo, EpiEP, Neural Analytics, Rist, Analytics 4 Life, and ThrombX; and is on the Speakers’ Bureau for SCENT trial (Surpass Intracranial Aneurysm Embolization System Pivotal Trial to Treat Large or Giant Wide Neck Aneurysms) presentations. AG: consultant for Microvention and emeritus consultant at Newcastle upon Tyne Hospitals NHS Trust. CFD: chief adjudicator, Stryker EVOLVE Trial Core Angiography Lab (salary support to department).

  • Patient consent for publication Not required.

  • Provenance and peer review Not commissioned; externally peer reviewed.

  • Data availability statement Data are available upon reasonable request. All datasets are available upon reasonable request. These data are maintained by Stryker Neurovascular. Patricia Morgan, BSN, RN, Medical Science Liaison, can be contacted at patricia.morgan@stryker.com regarding such inquiries.

  • Supplemental material This content has been supplied by the author(s). It has not been vetted by BMJ Publishing Group Limited (BMJ) and may not have been peer-reviewed. Any opinions or recommendations discussed are solely those of the author(s) and are not endorsed by BMJ. BMJ disclaims all liability and responsibility arising from any reliance placed on the content. Where the content includes any translated material, BMJ does not warrant the accuracy and reliability of the translations (including but not limited to local regulations, clinical guidelines, terminology, drug names and drug dosages), and is not responsible for any error and/or omissions arising from translation and adaptation or otherwise.

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