Table 2.
Clinical trials with Absorb BVS.
|
Study (Identifiers) |
Aim | Start date |
Follow-up (BVS, n) |
Death (%) | Cardiac death (%) | MI (%) |
ID-TLR (%) |
TLF (%) |
D/P ST (%) |
|---|---|---|---|---|---|---|---|---|---|
| ABSORB cohort A (NCT00300131) |
The First in Man clinical study to evaluate the feasibility and safety of Absorb BVS in patients with single de novo native coronary artery lesions | Mar 2006 | 5 years (29) |
6.9 | 0 | 3.4 | 0 | 3.4 | 0 |
| ABSORB Cohort B (NCT00856856) |
To evaluate the safety and performance of the Absorb BVS in patients with a maximum of two de novo native coronary artery lesions located in two different major epicardial vessels. | Mar 2009 | 5 year s (100) |
3.0 | 0 | 3.0 | 8.0 | 14.0 | 0 |
| ABSORB extend (NCT01023789) |
To evaluate performance of the Absorb BVS in a lesion subset representative of daily clinical practice, including calcified lesions, total occlusions, long lesions, and small vessels. | Jan 2010 | 3 years (812) |
N/A | 2.1 | 4.0 | 3.1 | 9.2 | 2.2 |
| ABSORB II (NCT01425281) |
To compare the safety, efficacy and performance of Absorb BVS Against XIENCE EES in patients with de novo native coronary artery lesions | Nov 2011 | 3 years (335) | 2.5 | 0.9 | 8.3 | 6.2 | 10.5 | 2.8 |
| ASSURE (NCT01583608) | To evaluate the safety, performance and efficacy of the Absorb BVS in patients with de novo native coronary artery lesions in a real-world setting. | Apr 2012 | 1 year (183) | 1.1 | 0.5 | 1.7 | N/A | 5.0 | 0 |
| EVERBIO II (NCT01711931) |
To compare the efficacy and safety of everolimus- and biolimus-bluting stents with Absorb BVS. | Oct 2012 | 2 years (78) |
2.6 | 1.3 | 5.1 | 14.1 | 20.5 | 1.2 |
| ABSORB III (NCT01751906) |
To evaluate the safety and effectiveness of the Absorb BVS System compared to the XIENCE EES | Dec 2012 | 5 years (1,322) |
7.0 | 2.7 | 12.7 | 9.5 | 17.5 | 2.5 |
| PRAGUE-19 (ISRCTN43696201) |
To evaluate the safety and effectiveness of the Absorb BVS in patients with STEMI. | Dec 2012 | 5 years (79) |
6.3 | 3.8 | 2.5 | 3.8 | 12.6 | 2.5 |
| ABSORB Japan (NCT01844284) |
To evaluate the safety and effectiveness of Absorb BVS in Japanese population with de novo native coronary artery lesions compared with XIENCE EES | Apr 2013 | 5 years (254) | 11.8 | 7.9 | 7.5 | 8.3 | 11.0 | 3.8 |
| ABSORB China (NCT01923740) |
To evaluate the safety and efficacy of the Absorb BVS compared to the XIENCE EES in patients with up to two de novo native coronary artery lesions in separate epicardial vessels. | Jul 2013 | 3 years (236) |
0.8 | 0.4 | 3.4 | 4.2 | 6.8 | 0.9 |
| AIDA (NCT01858077) |
To evaluate the efficacy and performance of Absorb BVS versus XIENCE EES in an all-comers contemporary population with coronary lesions. | Aug 2013 | 2 years (924) | 3.5 | 2.0 | 7.1 | 3.0 | 10.3 | 3.5 |
| ISAR- ABSORB MI (NCT01942070) |
To evaluate the clinical performance of Absorb BVS versus EES in patients undergoing PCI in the setting of acute MI. | Sep 2013 | 1 years (173) | 3.5 | 2.3 | 1.8 | 4.8 | 7.0 | 1.8 |
| GABI-R (NCT02066623) |
To evaluate the safety and performance of the ABSORB BVS in patients with coronary artery stenosis | Nov 2013 | 2 years (2,709) |
2.9 | 0.8 | 5.0 | N/A | 6.7 | 2.8 |
| TROFI II (NCT01986803) |
To assess the neointimal healing score of Absorb BVS versus XIENCE EES in patients with STEMI. | Jan 2014 | 3 years (95) |
2.1 | 2.1 | 3.2 | 3.2 | 5.3 | 2.1 |
| ABSORB IV (NCT02173379) |
To continue evaluate the safety and effectiveness as well as the potential short and long-term benefits of Absorb BVS compared to XIENCE EES | July 2014 | 1 year (1,296) |
1.2 | 0.8 | 6.2 | 2.9 | 7.6 | 0.7 |
BVS, bioresorbable vascular scaffold; D/P ST, definite or probable stent thrombosis; EES, everolimus eluting coronary stent; ID-TLR, ischemia driven-target-lesion revascularization; MI, myocardial infarction; N/A, not available; STEMI, ST-elevation myocardial infarction; TLF, target lesion failure.