Table 1. Major Characteristics of the 4 Randomized ABSORB Trials.
| Characteristic | ABSORB II | ABSORB | ABSORB III | |
|---|---|---|---|---|
| Japan | China | |||
| ClinicalTrials.gov identifier | NCT01425281 | NCT01844284 | NCT01923740 | NCT01751906 |
| Masking | Single blind | Single blind | Open label | Single blind |
| No. of centers | 46 | 38 | 24 | 193 |
| No. of randomized patients | 501 | 400 | 480a | 2008 |
| Assigned to BVS | 335 | 266 | 241 | 1322 |
| Assigned to EES | 166 | 134 | 239 | 686 |
| No. of study lesions allowed | 2 | 2 | 2 | 2 |
| No. of study vessels allowedb | 2 | 2 | 2 | 2 |
| Target lesion reference vessel diameter | Maximum lumen diameter 2.25 to 3.8 mm by online QCA | ≥2.5 to ≤3.75 mm by online QCA or visual assessment | ≥2.5 to ≤3.75 mm by online QCA or visual assessment | ≥2.5 to ≤3.75 mm by visual assessment (QCA or imaging allowed) |
| Target lesion length, mm | ≤48 | ≤24 | ≤24 | ≤24 |
| Device overlap allowed | Yes | For bailout only | For bailout only | For bailout only |
| Routine angiographic follow-up | At 3 y | At 13 mo | At 1 y | No |
| Primary end point | Angiographic vasomotion at 3 y | TLF at 1 y | Angiographic in-segment late loss at 1 y | TLF at 1 y |
| Clinical follow-up complete, No. (%)c | ||||
| 3 y | 481 (96.0) | 383 (95.8) | 471 (99.2) | 1879 (93.6) |
| 5 y | 401 (80.0) | 375 (93.8) | 458 (96.4) | 1742 (86.7) |
| Total duration of follow-up, y | 5 | 5 | 5 | 5 |
Abbreviations: BVS, bioresorbable vascular scaffolds; EES, everolimus-eluting stents; QCA, quantitative coronary angiography; TLF, target lesion failure.
a
A total of 5 patients (3 randomized to BVS and 2 randomized to EES) withdrew consent immediately after enrollment and were deregistered. These patients are not included in the study population.
b
Maximum 1 lesion per vessel.
c
Follow-up is defined as complete for that time if there is follow-up data within 28 days or a prior TLF event or death. Modified from Stone et al.26