Introduction
Methods
Search strategy and study selection
Risk of bias assessment and data extraction
Study outcomes
Statistical analysis
Results
Patient and lesion characteristics
ABSORB II (2011) | EVERBIO II (2012) | ABSORB China (2013) | ABSORB Japan (2013) | AIDA (2013) | ABSORB III (2013) | TROFI II (2014) | |
---|---|---|---|---|---|---|---|
Patient characteristics
| |||||||
Randomised, n
| 501 | 240 | 480 | 400 | 1854 | 2008 | 191 |
Included, n
| 501 | 158 | 475 | 400 | 1845 | 2008 | 191 |
Age (years) | 61 ± 10 | 65 ± 11 | 57 ± 11 | 67±9 | 64 ± 11 | 64 ± 11 | 59 ± 10 |
Men | 385 (77) | 125 (79) | 343 (72) | 309 (77) | 1370 (74) | 1415 (70) | 157 (82) |
Diabetes | 120 (24) | 30 (19) | 115 (24) | 144 (36) | 324 (18) | 640 (32) | 32 (17) |
– Insulin dependent | 36 (7) | 5 (3) | 41 (9) | 35 (9) | 110 (6) | 215 (11) | 8 (4) |
Dyslipidaemia | 385 (77) | 94 (5) | 192 (40) | 328 (82) | 694 (38) | 1732 (86) | 115 (6) |
ACS at admission | 105 (21) | 55 (35) | 306 (64) | 48 (12) | 1029 (56) | 523 (26) | 191 (100) |
– STEMI | 0 | 15 (9) | 0 | 0 | 465 (25) | 0 | 191 (100) |
– NSTEMI | 0 | 29 (18) | 0 | 0 | 377 (20) | 0 | 0 |
– UAP | 105 (21) | 11 (7) | 306 (64) | 48 (12) | 157 (9) | 523 (26) | 0 |
DAPTa
| 472 (94) | 158 (100) | 468 (99) | 400 (100) | 1845 (100) | 1987 (99) | 191 (100) |
– Clopidogrel or Ticlopidine | 427 (90) | NA | 465 (99) | 400 (100) | 645 (35) | 1268 (64) | 65 (34) |
– Prasugrel or Ticagrelor | 45 (20) | NA | 3 (1) | 0 | 1198 (65) | 719 (36) | 127 (66) |
Lesion characteristics
| |||||||
Randomised, n
| 546 | 208 | 503 | 412 | 2446 | 2098 | 193 |
Diameter stenosis (%) | 59.0 ± 11.3 | 80.5 ± 15.7 | 64.9 ± 0.82 | 64.6 ± 11.1 | NA | 65.5 ± 12.2 | 89.7 ± 15.3 |
RVD (mm) | 2.60 ± 0.39 | 2.57 ± 0.65 | 2.81 ± 0.03 | 2.74 ± 0.45 | 3.05 ± 0.42 | 2.66 ± 0.45 | 2.81 ± 0.50 |
Length (mm) | 13.8 ± 11.4 | NA | 14.0 ± 0.31 | 13.4 ± 5.36 | 19.0 ± 9.25 | 12.8 ± 5.5 | 13.1 ± 7.2 |
Type B2/C | 254 (47) | 67 (32) | 369 (74) | 313 (76) | 1288 (53) | 1462 (70) | NA |
ABSORB II (2011) | EVERBIO II (2012) | ABSORB China (2013) | ABSORB Japan (2013) | AIDA (2013) | ABSORB III (2013) | TROFI II (2014) | ||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Absorb | Xience | Absorb | Xience | Absorb | Xience | Absorb | Xience | Absorb | Xience | Absorb | Xience | Absorb | Xience | |
Pre-dilatation | 364 (100) | 180 (99) | 93 (97)a
| 96 (86) | 250 (99.6) | 247 (98.0) | 275 (100) | 137 (100) | 1199a,c (97) | 1103c (91) | NA | NA | 53 (55.8) | 50 (51.0) |
Pre-dilatation balloon size | NA | NA | NA | NA | 2.8 ± 0.4 | 2.7 ± 0.4 | 2.80 ± 0.37 | 2.86 ± 0.36 | 2.71 ± 0.38a
| 2.64 ± 0.38 | NA | NA | NA | NA |
Pre-dilatation maximum pressure | NA | NA | NA | NA | 12.4 ± 3.3a
| 11.8 ± 3.3 | 11.6 ± 3.8 | 11.9 ± 3.7 | 11.8 ± 3.0a
| 11.3 ± 3.0 | NA | NA | NA | NA |
Nominal size scaffold/stent | 3.01 ± 0.31 | 3.05 ± 0.28 | 3.1 ± 0.4 | 3.0 ± 1.0 | 3.1 ± 0.4 | 3.1 ± 0.4 | 3.09 ± 0.37 | 3.13 ± 0.38 | 3.07 ± 0.37 | 3.05 ± 0.40 | 3.18 ± 0.43a
| 3.12 ± 0.45 | 3.25 ± 0.30a
| 3.12 ± 0.37 |
Implantation maximum balloon pressure | 14.23 ± 3.43b
| 15.03 ± 3.33b
| 13.6 ± 2.8a
| 14.6 ± 2.9 | 12.8 ± 2.4 | 12.8 ± 2.8 | 10.4 ± 3.0a
| 11.2 ± 2.7 | 13.0 ± 2.7a
| 13.5 ± 2.7 | 15.4 ± 3.0 | 15.4 ± 3.2 | 14.1 ± 3.8 | 13.3 ± 3.0 |
Post-dilatation | 221 (61) | 107 (59) | 33 (34) | 35 (31) | 162a,c (63) | 141c (54.4) | 226c (82.2) | 106c (77.4) | 915c (74)a
| 594c (49) | 866a (65.5) | 351 (51.2) | 48a (50.5) | 25 (25.5) |
Post-dilatation balloon size | 3.08 ± 0.34b
| 3.16 ± 0.36b
| NA | NA | 3.3 ± 0.4 | 3.2 ± 0.4 | 3.18 ± 0.44a
| 3.29 ± 0.51 | 3.28 ± 0.44 | 3.29 ± 0.49 | NA | NA | 3.51 ± 0.34 | 3.29 ± 0.62 |
Post-dilatation with non-compliant balloon | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | 43a (89.6) | 13 (52.0) |
Post-dilatation maximum balloon pressure |
b
|
b
| NA | NA | 16.8 ± 3.8 | 16.9 ± 3.4 | 15.5 ± 4.2 | 16.0 ± 3.9 | 15.4 ± 3.8 | 15.6 ± 3.5 | NA | NA | 15.8 ± 3.4a
| 18.6 ± 3.9 |
Post-dilatation balloon >0.5 mm |
b
|
b
| NA | NA | NA | NA | 9c
(4.0) | NA | 18/912 (2) | 14/593 (2) | NA | NA | NA | NA |
Device success | 99% | 100% | NA | NA | 98% | 99.6% | 98.9% | 99.3% | 92%a
| 98% | 94.3%a
| 99.3% | 95.8% | 100% |
Primary and secondary endpoints
ABSORB II (2011) | EVERBIO II (2012) | ABSORB China (2013) | ABSORB Japan (2013) | AIDA (2013) | ABSORB III (2013) | TROFI II (2014) | ||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Absorb (335) | Xience (166) | Absorb (78) | Xience (80) | Absorb (238) | Xience (237) | Absorb (266) | Xience (133) | Absorb (924) | Xience (921) | Absorb (1322) | Xience (686) | Absorb (95) | Xience (96) | |
Early ST (0–30 days) | 2 | 0 | 0 | 0 | 1 | 0 | 3 | 1 | 13 | 5 | 14 | 5 | 1 | 0 |
Late ST (31 days–1 year) | 1 | 0 | 1 | 0 | 0 | 0 | 1 | 1 | 8 | 1 | 6 | 0 | 0 | 0 |
Very late ST (>1 year) | 6 | 0 | 0 | 0 | 1 | 0 | 4 | 0 | 10 | 2 | 4 | 0 | 1 | 1 |