Table 2:
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) |
Three patients (2 BMC, 1 Matrix2) with a rupture/rerupture also had a subsequent re-intervention.
One patient (Matrix2) with a rupture also had a subsequent re-intervention.
Two patients (BMC) with a rerupture also had a subsequent re-intervention.