Article Figures & Data
Figures
- Fig 1.
Subject flow through 455 days.
- Fig 2.
Kaplan-Meier curve showing freedom from TAR to 455 days in the intent-to-treat population (n = 626).
Tables
Variable BMC (n = 315) Matrix2 (n = 311) Male 104 (33.0%) 82 (26.4%) Age (yr) 54.4 ± 13.2 55.7 ± 11.6 Ethnicity and race Caucasian/white 259 (82.2%) 249 (80.1%) Black or African American 13 (4.1%) 12 (3.9%) Asian 11 (3.5%) 13 (4.2%) Hispanic or Latino 13 (4.1%) 16 (5.1%) Other 19 (6.0%) 21 (6.8%) Current use of illicit drugs and/or alcohol abuse 25 (8.4%) 25 (8.6%) Hypertension 143 (45.5%) 153 (49.5%) Coronary disease 29 (9.4%) 44 (14.5%) Hyperlipidemia/hypercholesterolemia 70 (22.5%) 85 (28.0%) Intracranial atherosclerosis 7 (2.3%) 4 (1.3%) Current smoking 124 (42.6%) 117 (41.6%) Diabetes 19 (6.1%) 33 (10.7%) Prior stroke or TIA 35 (11.2%) 31 (10.2%) ↵a Values are presented as mean ± SD for continuous variables and No. (%) for categoric variables. The denominator used for rates (%) can be smaller than the number of subjects in each group due to missing values.
Subjects BMC (No.) (%) Matrix2 (No.) (%) All Subjects (No.) (%) Overall 315 311 626 Subjects who met primary end point 35 (11.1) 34 (10.9) 69 (11.0) Re-intervention only 33 (10.5) 31 (10.0) 64 (10.2) Ruptures or reruptures 2 (0.6) 2 (0.6) 4 (0.6)a Unknown causes of death 0 1 (0.3) 1 (0.2) Symptomatic TAR 3 (1.0) 4 (1.3) 7 (1.1) Symptomatic retreatment 2 (0.6) 2 (0.6) 4 (0.6) Unruptured 196 202 398 Subjects who met primary end point 18 (9.2) 19 (9.4) 37 (9.3) Re-intervention only 18 (9.2) 18 (8.9) 36 (9.0) Ruptures or reruptures 0 1 (0.5) 1 (0.3)b Unknown causes of death 0 0 0 Symptomatic TAR 1 (0.5) 2 (1.0) 3 (0.8) Symptomatic retreatment 1 (0.5) 2 (1.0) 3 (0.8) Ruptured 119 109 228 Subjects who met primary end point 17 (14.3) 15 (13.8) 32 (14.0) Re-intervention only 15 (12.6) 13 (11.9) 28 (12.3) Ruptures or reruptures 2 (1.7) 1 (0.9) 3 (1.3)c Unknown causes of death 0 1 (0.9) 1 (0.4) Symptomatic TAR 2 (1.7) 2 (1.8) 4 (1.8) Symptomatic retreatment 1 (0.8) 0 1 (0.4) Assessment BMC (n = 315) Matrix2 (n = 311) Relative Risk (95% CI) Difference (95% CI) P Value Angiographic assessment by core laboratory Modified Raymond Scale after procedure 1) Complete obliteration 89 (35.6%) 87 (36.6%) 0.97 (0.77–1.23) −1.0% (−9.5–7.6) .9894 2) Residual neck/dog ear 68 (27.2%) 60 (25.2%) 1.08 (0.80–1.45) 2.0% (−5.8–9.8) 3) Residual aneurysm 93 (37.2%) 91 (38.2%) 0.97 (0.77–1.22) −1.0% (−9.6–7.6) Modified Raymond Scale at 455-day FU or re-intervention 1) Complete obliteration 99 (39.9%) 105 (44.3%) 0.90 (0.73–1.11) −4.4% (−13.2–4.4) .8297 2) Residual neck/dog ear 69 (27.8%) 48 (20.3%) 1.37 (1.00–1.90) 7.6% (0.0–15.1) 3) Residual aneurysm 80 (32.3%) 84 (35.4%) 0.91 (0.71–1.17) −3.2% (−11.6–5.2) Aneurysm change Better 81 (32.7%) 60 (25.4%) 1.28 (0.97–1.70) 7.2% (−0.8–15.3) .1225 Same 82 (33.1%) 85 (36.0%) 0.92 (0.72–1.17) −3.0% (−11.4–5.5) Worse 85 (34.3%) 91 (38.6%) 0.89 (0.70–1.13) −4.3% (−12.9–4.3) Neurologic assessment Worseb mRS score At post-index procedure 25 (8.5%) 30 (10.5%) 0.81 (0.49–1.35) −2.0% (−6.7–2.8) .4220 At 455 days follow-upc 33 (11.7%) 28 (9.9%) 1.19 (0.74–1.92) 1.9% (−3.2–7.0) .4705 Technical success Technical procedure successd 307 (97.5%) 301 (96.8%) 1.01 (0.98–1.03) 0.7% (−1.9–3.3) .6130 Note:—FU indicates follow-up.
↵a Values are presented as mean ± SD for continuous variables and No. (%) for categoric variables. The denominator used for rates (%) can be smaller than the number of subjects in each group due to missing values.
↵b Compared with the pre-index procedure.
↵c All causes of deaths within 455 days were incorporated as a follow-up mRS score of 6.
↵d Technical success evaluated at the patient level.
Modified Raymond Scale BMC Matrix2 Relative Risk (95% CI) Difference (95% CI) P Value 1) Complete obliteration 7.9% (7/89) 3.4% (3/87) 2.28 (0.61–8.54) 4.4% (−2.4–11.2) .3297 2) Residual neck/dog ear 11.8% (8/68) 1.7% (1/60) 7.06 (0.91–54.81) 10.1% (1.8–18.4) .0358 3) Residual aneurysm 16.1% (15/93) 24.2% (22/91) 0.67 (0.37–1.20) −8.0% (−19.6–3.5) .1733 ↵a Values are presented as % (x/N).
Variable Coefficient Standard Error OR (95% CI) P Value Rupture status (ruptured vs unruptured) 1.4 0.3 4.0 (2.1–7.9) <.0001 Core lab postproc Raymond Scale (2 vs 1) 0.3 0.5 1.4 (0.5–3.7) .4917 Core lab postproc Raymond Scale (3 vs 1) 1.6 0.4 5.0 (2.2–11.0) <.0001 Dome sizea (≥10 vs <10 mm) 1.6 0.4 5.0 (2.2–11.5) .0001 Neck size (≥4 vs <4 mm) 0.8 0.3 2.3 (1.2–4.4) .0140 Note:—postproc indicates postprocedural; AP, anteroposterior.
↵a Dome size is calculated as a minimum of the 2 widths (AP plane, lateral plane).
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