Article Figures & Data
Figures
- Fig 1.
Patient flow for MAPS stent substudy. FU indicates follow-up; UIA, unruptured intracranial aneurysm; SAC, stent-assisted coiling; CA, coiling alone; WNA, wide-neck aneurysm.
- Fig 2.
Stent use by enrolling site. SAC indicates stent-assisted coiling, CA, coiling alone, NF, Neuroform stent.
Tables
All Unruptured Aneurysms Wide-Neck Aneurysms Stent-Coil (n = 137) Coil Alone (n = 224) P Value Stent-Coil (n = 85) Coil Alone (n = 73) P Value North American 88.3% 65.6% .0001 89.4% 61.6% <.0001 Age, y 56.5 56.7 .90 58.4 57.7 .68 Female 76.6 76.8 .98 72.9 79.5 .34 Coronary artery disease 19.0% 13.1% .14 22.4% 5.6% .003 ≥2 Cerebrovascular risk factorsa 32.1% 25.9% .20 34.1% 26.0% .27 Prior CVA 16.9% 14.5% .54 17.9% 8.3% .08 Preprocedure mRS 0 80.3% 84.4% >.99 80.0% 90.4% NA 1 15.3% 11.6% 14.1% 9.6% 2 4.4% 3.6% 5.9% 0.0% 3 0.0% 0.4% >.99 0.0% 0.0% NA Note:—CVA indicates cerebrovascular accident; NA, not applicable.
↵a Cerebrovascular risk factors include hypertension, hyperlipidemia, coronary artery disease, and diabetes mellitus.
All Unruptured Aneurysms Wide-Neck Aneurysms Stent-Coil (n = 137) Coil Alone (n = 224) P Value Stent-Coil (n = 85) Coil Alone (n = 73) P Value Maximum dimension 7.6 7.8 .46 8.9 10.1 .007 Height is max 43.8% 54.9% .04 42.4% 50.7% .30 Width is max 29.9% 21.4% .07 30.6% 23.3% .30 Depth is max 26.3% 23.7% .58 27.1% 26.0% .88 Max dimension >10 mm 19.7% 21.0% .77 30.6% 47.9% .03 Neck ≥4 mm 62.0% 32.6% <.0001 100% 100% NA Average neck 4.7 3.5 <.0001 5.6 5.0 .004 Dome/neck radio 1.3 1.8 <.0001 1.2 1.6 <.0001 Dome/parent artery ratio 2.0 2.1 .33 2.2 2.6 .01 Circle of Willis location 44.5% 64.7% .0002 48.2% 72.6% .002 Note:—Max indicates maximum.
All Unruptured Aneurysms Wide-Neck Aneurysms Stent-Coil (n = 137) Coil Alone (n = 224) P Value Stent-Coil (n = 85) Coil Alone (n = 73) P Value Aspirin alone 8.0% 23.2% .0002 4.7% 28.8% <.0001 Clopidogrel alone 5.1% 4.5% .78 3.5% 1.4% 0.62 Aspirin + clopidogrel 78.1% 37.1% <.0001 82.4% 37.0% <.0001 Antiplatelet use not recordeda 8.8% 35.3% <.0001 9.4% 32.9% .0003 Procedure time, min 134.2 117.8 .02 147.5 135.2 .30 No. of coils 6.9 7.1 .70 8.5 10.1 .07 Bare metal coils 49.6% 50.9% .82 48.2% 53.4% .52 Matrix coils 50.4% 49.1% .82 51.8% 46.6% .52 Packing density 26.2% 24.0% .07 26.4% 21.1% .002 Technical success 97.8% 100% .054 97.6% 100% .50 Occlusion assessment Raymond 1 21.1% 33.9% .02b 18.6% 27.1% .25c Raymond 2 25.4% 25.6% .98b 27.1% 30.5% .67c Raymond 3 53.5% 40.6% .03b 54.3% 42.4% .18c ↵a No antiplatelet use recorded in these subjects: for an individual subject, this could mean no aspirin or clopidogrel was used or that data are missing.
↵b Core lab occlusion assessment for the 81% of patients who had assessable angiograms after the procedure.
↵c Core lab occlusion assessment for the 82% of patients who had assessable angiograms after the procedure.
All Unruptured Aneurysms Wide-Neck Aneurysms Stent-Coil (n = 137) Coil Alone (n = 224) P Value Stent-Coil (n = 85) Coil Alone (n = 73) P Value Periprocedural significant adverse event rate 6.6% 4.5% .39 3.7% 0.89% .11 1-Year hemorrhagic stroke rate 2.9% 0.4% .07 2.4% 0.0% .50 1-Year ischemic stroke rate 8.8% 2.2% .005 11.8% 4.1% .08 if problem site is excludeda 1-Year ischemic stroke rate 6.2% 2.2% .11 8.8% 4.1% .31 ↵a One enrolling site accounted for 5 of 12 subjects with ischemic stroke in the unruptured aneurysm group. All ischemic strokes at that site occurred ≥7 days after the procedure.
12-Month mRSa All Unruptured Aneurysms Wide-Neck Aneurysms Stent-Coil Coil Alone Stent-Coil Coil Alone Base (n = 137) 1 Year (n = 128) Base (n = 224) 1 Year (n = 202) P Value Base (n = 85) 1 Year (n = 81) Base (n = 73) 1 Year (n = 66) P Value 0 80.3% 80.5% 84.4% 87.6% 80.0% 80.2% 90.4% 92.4% 1 15.3% 14.1% 11.6% 6.9% 14.1% 12.3% 9.6% 6.1% 2 4.4% 1.6% 3.6% 1.0% 5.9% 2.5% 0.0% 0.0% 3 0.0% 1.6% 0.4% 2.5% 0.0% 2.5% 0.0% 1.5% 6 0.0% 2.3% 0.0% 2.0% 0.0% 2.5% 0.0% 0.0% mRS worse than base 12.5% 8.4% .23 13.6% 4.5% .06 ↵a Twelve-month mRS scores were available for 128, 202, 81, and 66 patients, respectively, across all subsets.
All Unruptured Aneurysms Wide-Neck Aneurysms Stent-Coil (n = 137) Coil Alone (n = 224) P Value Stent-Coil (n = 85) Coil Alone (n = 73) P Value TAR 8.8% 8.5% .93 14.1% 13.7% .94 Delayed bleed 0.0% 0.4% <.99 0.0% 1.4% .46 Retreatment 8.8% 8.5% .93 14.1% 13.7% .94 All Unruptured Aneurysms Wide-Neck Aneurysms Stent-Coil (n = 114) Coil Alone (n = 180) P Value Stent-Coil (n = 70) Coil Alone (n = 59) P Value Occlusion assessment Raymond 1 51.8% 44.4% .22 45.7% 27.1% .03 Raymond 2 21.1% 23.9% .57 17.1% 30.5% .07 Raymond 3 27.2% 31.7% .41 37.1% 42.4% .55 Change assessment Better 51.8% 31.1% .0004 45.7% 20.3% .003 Same 31.6% 35.6% .48 32.9% 28.8% .62 Worse 16.7% 33.3% .002 21.4% 50.8% .0005 Note:—81% of subjects in the “all unruptured aneurysms” group and 82% of subjects in the “wide-neck aneurysms” subgroup had angiograms assessable by the core lab at 1-year follow-up.
Parameter 1-Year OR (95% CI) 1-Year P Value 2-Year OR (95% CI) 2-Year P Value Prior cerebrovascular accident 3.84 (1.29–11.4) .0159 4.71 (1.47–15.0) .0089 Aneurysm neck size ≥4 mm 3.70 (1.09–12.5) .0359 4.51 (1.27–16.0) .0196 Stent used 1.85 (0.61–5.59) .2732 1.05 (0.34–3.27) .9351 Note:—Complete data on ischemic stroke rates were included in predictor analysis, including data from all enrolling centers.
Parameter 1-Year OR (95% CI) 1-Year P Value 2-Year OR (95% CI) 2-Year P Value Aneurysm dome size ≥10 mm 10.1 (4.06–24.9) <.0001 9.94 (4.12–24.0) <.0001 Aneurysm neck size ≥4 mm 2.34 (0.94–5.81) .0664 2.17 (0.93–5.06) .0729 Stent used 0.89 (0.38–2.10) .7855 0.83 (0.36–1.88) .6505 Note:—Complete data on target aneurysm recurrence rates were included in predictor analysis, including data from all enrolling centers.
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