Table 1. Studies assessing the BVS performance in patients with acute coronary syndrome.
| Study title/author | Study design | Patients, n | ACS (% of patient) | Post-dilation rate | Follow-up duration | Outcomes | DAPT, %, (Clopidogrel, Ticagrelor, Prasugrel) | Reference number |
|---|---|---|---|---|---|---|---|---|
| Gori et al. | Single center, single arm study | 133 | 100% (20% UA, 43%, NSTEMI, 38% STEMI) | 11% | 12 months | Death 3%, ScT 3% | 22%, 33%, 45% | (25) |
| Expand Registry | Prospective, single-center, single-arm study | 249 | 59.1% (16.1% UA, 43% NSTEMI) | 53.3% | 622 (IQR: 376–734) days | MACE: 6.8%; definite ScT: 1.9% | NA | (26) |
| POLAR ACS | Prospective, multicenter, single-arm, observational registry | 100 | 100 (46% UA, 38% NSTEMI, 16% STEMI) | 40% | 12 months | MACE: 3%, ScT: 1% | 98%, 1%, 1% | (27) |
| ASSURE Registry | Prospective, multicenter, single-arm, observational registry | 183 | 21.3% UA | 25% | 12 months | MACE: 5% | 100%, 0%, 0% | (28) |
| RAI Registry | Prospective, multicenter, single-arm, observational registry | 1,505 | 59% (14% UA, 24% NSTEMI, 21% STEMI) | 96.8% | 30 days | TLR: 0.6%; ScT: 0.8%. | 51%, 33.4%, 14.7% | (29) |
| ISAR-ABSORB | Single center, retrospective, single-arm, observational registry | 419 | 39% (11.5%, 19.1%, 8.4%) | 71.5% | 12 months | TLR:13.1%, ScT.2.6% | NA | (30) |
| GHOST-EU | Retrospective, multicenter, single-arm, observational registry | 1,477 | 47.1% (13.2%UA, 18% NSTEMI, 16.1 STEMI) | 46.2% in ACS vs. 59.1% in SCAD | 12 months | DOCE: 6.4% in ACS vs. 4.2 in SCAD (P=0.052), ScT: 2.8% in ACS vs. 0.8% in SCAD (P=0.006) | in ACS patients 64.7%; 32%; 3.2% | (31) |
| BVS Expand and BVS STEMI first | Prospective, single-center, single-arm studies | 351 | 72.6% (15.6% UA, 37.3% NSTEMI, 46.9% STEMI) | 41.3% in ACS vs. 62.2% in SCAD | 12 months | MACE 5.5% in ACS vs. 5.3% in SCAD (P=0.90), ScT: 2.0% in ACS vs. 2.1% in SCAD (P=0.94) | in ACS patients 23.5%; 64.3%; 11.8% | (32) |
| PRAGUE 19 | Prospective, two-center, open-label study | 117 | 100% STEMI | NA | 730±275 days | Combined clinical endpoint (death, re-infarction or target vessel revascularization): 11.5%, ScT: 1.7% | NA | (35) |
| MAINZ ACS | Single center, prospective study comparing BVS vs. DES cohort | BVS =150 vs. EES =103 | 100% (16%, 40%, 44%) | 14% | 6 months | MACE (non-fatal MI, death, any PCI) BVS: 10.7%, DES 15.5%, P>0.8; ScT: 2.0% BVS, 1.9% DES, P=1. | 18%, 33%, 49% | (36) |
| Cortese et al. | Multicenter, prospective registry comparing BVS vs. EES in primary PCI | BVS =122 vs. EES =441 | 100% STEMI | 94.1% | 220 (IQR: 178–369) days | POCE: BVS =4.9% vs. EES =7.0%, P=0.4; ScT BVS 2.5% vs. EES =1.4%, P=0.4 | 51%, 33.4%, 14.7% | (37) |
| BVS EXAMINATION | Multicenter, propensity match analysis comparing BVS vs. EES vs. BMS in STEMI | 290 | 100% STEMI | 36.3% | 2-years | DOCE: BVS =6.2%, EES =4.8%, P=0.678, ScT: BVS =3.3% vs. EES =1.0%; P=0.081 | 33.3%, 32.9%, 33.8% | (38,39) |
| BVS STEMI first | Single center, propensity match analysis comparing BVS vs. EES in STEMI | 151 | 100% STEMI | 39.7% | 18 months | MACE BVS =9.8% vs. EES =3.6%, P=0.02. ScT BVS =4.3% vs. EES =1.3%; P=0.15 | NA | (40) |
| Imori et al. | Multicenter, propensity match analysis comparing BVS vs. EES in ACS | BVS =303 vs. EES =748 | 100% (41.9% STEMI) | 49.2% | 24 months | MACE lower in BVS with post-dilation but comparable to EES. ScT higher in BVS with or without post-dilation compared to EES (2.0% vs. 2.6% vs. 1.2%; P=0.09) | NA | (41) |
| EVERBIO II | Single-center, assessor-blinded randomized trial comparing EES vs. BES vs. BVS | 240 | 37% (8% UA, 17% NSTEMI, 12% STEMI) | 34% | 9 months | DOCE d 12% in BVS and 9% in the EES/BES group (P=0.6). ScT 1% in BVS and 0% in the EES/BES group (P= 0.33) | NA | (42) |
| TROFI II | Multicenter, single-blind, non-inferiority, randomized controlled trial comparing BVS vs. EES in STEMI | 191 | 100% STEMI | 50.5% | 6 months | Lower healing score in BVS compared to EES (1.74±2.39 vs. 2.80±4.44; P non-inferiority =0.001). DOCE 1.1% in BVS vs. 0% in EES. ScT 1.1% in BVS vs. 0% in EES, P= ns. | 37.9%; 44.2%, 18.9% | (18) |
| AIDA | Single-blind, multicenter, investigator initiated non-inferiority, randomized, clinical trial comparing BVS vs. EES in routine PCI | BVS =924 vs. EES =921 | 54% (7% UA, 10% NSTEMI, 26% STEMI) | 74% | 2 years | TLF comparable between BVS and EES (11.7% vs. 10.7%, HR 1.12, 95% CI, 0.85–1.48). ScT higher in BVS vs. EES (3.5% vs. 0.9%, HR 3.87; 95% CI, 1.78–8.42) | NA | (12) |
ACS, acute coronary syndrome; DAPT, dual antiplatelet therapy; UA, unstable angina; NSTEMI, non ST-segment elevation myocardial infarction; MACE, major adverse cardiovascular events; ScT, scaffold thrombosis; TLR, target lesion revascularization; SCAD, stable coronary artery disease; DOCE, device oriented composite endpoint; POCE, patients oriented composite endpoint; MI, myocardial infarction; DES, drug-eluting stent; EES, everolimus-eluting stent; BVS, bioresorbable vascular scaffold; BES, biolimus eluting stent; TLF, target lesion failure.