Table 3.
Angiographic and IVUS/IVUS-VH outcomes of ABSORB II trial
| Bioresorbable scaffold group (n=335) | Metallic stent group (n=166) | Difference (95 % CI) | p | |
|---|---|---|---|---|
| Angiographic analysis | ||||
| Lesion length obstruction (mm) | 13.8 (6.5) | 13.8 (6.6) | 0.00 (−1.18, 1.18) | 1.00 |
| Total scaffolded/stented length (mm) | 21.1 (8.8) | 20.9 (7.4) | 0.24 (−1.17, 1.65) | 0.74 |
| Reference vessel diameter | ||||
| Pre-procedure diameter (mm) | 2.59 (0.38) | 2.63 (0.40) | −0.03 (−0.10, 0.04) | 0.36 |
| Postprocedure diameter (mm) | 2.64 (0.36) | 2.80 (0.34) | −0.16 (−0.22, −0.09) | <0.001 |
| Minimum lumen diameter | ||||
| Pre-procedure diameter (mm) | 1.07 (0.32) | 1.05 (0.32) | 0.02 (−0.03, 0.08) | 0.44 |
| Post-procedure in-stent or in-scaff old diameter (mm) | 2.22 (0.33) | 2.50 (0.33) | −0.28 (−0.34, −0.22) | <0.001 |
| In-stent/in-scaff old acute gain (mm) | 1.15±0.38 | 1.46±0.38 | −0.30 (−0.37, −0.24) | <0.001 |
| Diameter stenosis | ||||
| Pre-procedure percent diameter stenosis (%) | 59±11 % | 60±12 % | −1.07 (−3.11, 0.97) | 0.30 |
| Post-procedure in-stent/in-scaffold diameter stenosis (%) | 16±7 % | 10±5 % | 5.37 (4.38, 6.36) | <0.001 |
| Pre-procedural fibrotic tissue (%) | 31.47±11.39 | 30.62±11.42 | 0.85 (−1.33, 3.04) | 0.44 |
| Pre-procedural fibrofatty tissue (%) | 47.43±16.91 | 48.55±16.86 | −1.12 (−4.35, 2.11) | 0.50 |
| Pre-procedural necrotic core (%) | 16.20±6.86 | 16.15±6.90 | 0.05 (−1.27, 1.37) | 0.94 |
| Pre-procedural dense calcium (%) | 4.90±4.73 | 4.68±4.10 | 0.22 (−0.61, 1.05) | 0.60 |
| Vessel area | ||||
| Pre-procedure area (mm2) | 11.51±3.40 | 12.34±3.42 | −0.83 (−1.47, −0.19) | 0.02 |
| Post-procedure area (mm2) | 13.17±3.55 | 14.28±3.59 | −1.11 (−1.78, −0.44) | 0.001 |
| Plaque area | ||||
| Pre-procedure plaque area (mm2) | 6.67±2.52 | 7.30±2.68 | 0.6 (−1.12, 0.13) | 0.01 |
| Post-procedure plaque area (mm2) | 7.11±2.46 | 7.43±2.44 | −0.32 (−0.78, 0.14) | 0.18 |
| Mean lumen area | ||||
| Pre-procedure mean lumen area (mm2) | 4.84±1.39 | 5.02±1.47 | −0.19 (−0.47, 0.08) | 0.16 |
| Post-procedure mean lumen area (mm2) | 6.06±1.44 | 6.85±1.60 | −0.80 (−1.09, −0.50) | <0.001 |
| Minimal lumen area | ||||
| Pre-procedure minimal lumen area (mm2) | 2.04±0.72 | 2.13±0.83 | −0.10 (−0.25, 0.05) | 0.20 |
| Post-procedure minimal lumen area (mm2) | 4.89±1.38 | 5.73±1.51 | −0.84 (−1.12, −0.57) | <0.001 |
| Acute gain in minimal lumen area (mm2) | 2.85±1.25 | 3.60±1.34 | −0.75 (−0.99, −0.50) | <0.001 |