Abstract
Objectives: Based on outcomes of the BIOSOLVE-II study, a novel second generation drug-eluting absorbable metal scaffold gained CE-mark in 2016. The BIOSOLVE-III study aimed to confirm these outcomes and to obtain additional 12-month angiographic data.
Background: Bioresorbable scaffolds are intended to overcome possible long-term effects of permanent stents such as chronic vessel wall inflammation, stent crushing, and fractures. Methods: The prospective, multicenter BIOSOLVE-II and BIOSOLVE-III studies enrolled 184 patients with 189 lesions (123 patients in BIOSOLVE-II and 61 patients in BIOSOLVE-III). Primary endpoints were in-segment late lumen loss at 6 months (BIOSOLVE-II) and procedural success (BIOSOLVE-III).
Results: Mean patient age was 65.5 ± 10.8 years and mean lesion reference diameter was 2.70 ± 0.43 mm. In BIOSOLVE-III, there were significantly more type B2/C lesions than in BIOSOLVE-II (80.3% versus 43.4%, P < 0.0001) and significantly more moderate-to-severe calcifications (24.2% versus 10.7%, P = 0.014). At 12 months, there was no difference in late lumen loss between the two studies; in the overall population, it was 0.25 ± 0.31 mm in-segment and 0.39 ± 0.34 mm in-scaffold. Target lesion failure occurred in six patients (3.3%) and included two cardiac deaths, one target-vessel myocardial infarction, and three clinically driven target lesion revascularizations. No definite or probable scaffold thrombosis was observed.
Conclusion: The pooled outcomes of BIOSOLVE-II and BIOSOLVE-III provide further evidence on the safety and performance of a novel drug-eluting absorbable metal scaffold with constant clinical and angiographic performance parameters at 12 months and no definite or probable scaffold thrombosis.
| Original language | English |
|---|---|
| Pages (from-to) | E502-E511 |
| Journal | Catheterization and cardiovascular interventions |
| Volume | 92 |
| Issue number | 7 |
| DOIs | |
| Publication status | E-pub ahead of print/First online - 5 Aug 2018 |
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Keywords
- UT-Hybrid-D
- Coronary artery disease
- Percutaneous coronary intervention (PCI)
- Stent bioabsorbable
- Stent restenosis
- Thrombosis
- Clinical trials
Cite this
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Safety and clinical performance of a drug eluting absorbable metal scaffold in the treatment of subjects with de novo lesions in native coronary arteries : Pooled 12-month outcomes of BIOSOLVE-II and BIOSOLVE-III. / Haude, Michael (Corresponding Author); Ince, Hüseyin; Kische, Stephan; Abizaid, Alexandre; Tölg, Ralph; Alves Lemos, Pedro; Van Mieghem, Nicolas M.; Verheye, Stefan; von Birgelen, Clemens; Christiansen, Evald Høj; Barbato, Emanuele; Garcia-Garcia, Hector M.; Waksman, Ron.
In: Catheterization and cardiovascular interventions, Vol. 92, No. 7, 05.08.2018, p. E502-E511.Research output: Contribution to journal › Article › Academic › peer-review
TY - JOUR
T1 - Safety and clinical performance of a drug eluting absorbable metal scaffold in the treatment of subjects with de novo lesions in native coronary arteries
T2 - Pooled 12-month outcomes of BIOSOLVE-II and BIOSOLVE-III
AU - Haude, Michael
AU - Ince, Hüseyin
AU - Kische, Stephan
AU - Abizaid, Alexandre
AU - Tölg, Ralph
AU - Alves Lemos, Pedro
AU - Van Mieghem, Nicolas M.
AU - Verheye, Stefan
AU - von Birgelen, Clemens
AU - Christiansen, Evald Høj
AU - Barbato, Emanuele
AU - Garcia-Garcia, Hector M.
AU - Waksman, Ron
N1 - Wiley deal
PY - 2018/8/5
Y1 - 2018/8/5
N2 - Objectives: Based on outcomes of the BIOSOLVE-II study, a novel second generation drug-eluting absorbable metal scaffold gained CE-mark in 2016. The BIOSOLVE-III study aimed to confirm these outcomes and to obtain additional 12-month angiographic data.Background: Bioresorbable scaffolds are intended to overcome possible long-term effects of permanent stents such as chronic vessel wall inflammation, stent crushing, and fractures. Methods: The prospective, multicenter BIOSOLVE-II and BIOSOLVE-III studies enrolled 184 patients with 189 lesions (123 patients in BIOSOLVE-II and 61 patients in BIOSOLVE-III). Primary endpoints were in-segment late lumen loss at 6 months (BIOSOLVE-II) and procedural success (BIOSOLVE-III).Results: Mean patient age was 65.5 ± 10.8 years and mean lesion reference diameter was 2.70 ± 0.43 mm. In BIOSOLVE-III, there were significantly more type B2/C lesions than in BIOSOLVE-II (80.3% versus 43.4%, P < 0.0001) and significantly more moderate-to-severe calcifications (24.2% versus 10.7%, P = 0.014). At 12 months, there was no difference in late lumen loss between the two studies; in the overall population, it was 0.25 ± 0.31 mm in-segment and 0.39 ± 0.34 mm in-scaffold. Target lesion failure occurred in six patients (3.3%) and included two cardiac deaths, one target-vessel myocardial infarction, and three clinically driven target lesion revascularizations. No definite or probable scaffold thrombosis was observed.Conclusion: The pooled outcomes of BIOSOLVE-II and BIOSOLVE-III provide further evidence on the safety and performance of a novel drug-eluting absorbable metal scaffold with constant clinical and angiographic performance parameters at 12 months and no definite or probable scaffold thrombosis.
AB - Objectives: Based on outcomes of the BIOSOLVE-II study, a novel second generation drug-eluting absorbable metal scaffold gained CE-mark in 2016. The BIOSOLVE-III study aimed to confirm these outcomes and to obtain additional 12-month angiographic data.Background: Bioresorbable scaffolds are intended to overcome possible long-term effects of permanent stents such as chronic vessel wall inflammation, stent crushing, and fractures. Methods: The prospective, multicenter BIOSOLVE-II and BIOSOLVE-III studies enrolled 184 patients with 189 lesions (123 patients in BIOSOLVE-II and 61 patients in BIOSOLVE-III). Primary endpoints were in-segment late lumen loss at 6 months (BIOSOLVE-II) and procedural success (BIOSOLVE-III).Results: Mean patient age was 65.5 ± 10.8 years and mean lesion reference diameter was 2.70 ± 0.43 mm. In BIOSOLVE-III, there were significantly more type B2/C lesions than in BIOSOLVE-II (80.3% versus 43.4%, P < 0.0001) and significantly more moderate-to-severe calcifications (24.2% versus 10.7%, P = 0.014). At 12 months, there was no difference in late lumen loss between the two studies; in the overall population, it was 0.25 ± 0.31 mm in-segment and 0.39 ± 0.34 mm in-scaffold. Target lesion failure occurred in six patients (3.3%) and included two cardiac deaths, one target-vessel myocardial infarction, and three clinically driven target lesion revascularizations. No definite or probable scaffold thrombosis was observed.Conclusion: The pooled outcomes of BIOSOLVE-II and BIOSOLVE-III provide further evidence on the safety and performance of a novel drug-eluting absorbable metal scaffold with constant clinical and angiographic performance parameters at 12 months and no definite or probable scaffold thrombosis.
KW - UT-Hybrid-D
KW - Coronary artery disease
KW - Percutaneous coronary intervention (PCI)
KW - Stent bioabsorbable
KW - Stent restenosis
KW - Thrombosis
KW - Clinical trials
UR - http://www.scopus.com/inward/record.url?scp=85053218689&partnerID=8YFLogxK
U2 - 10.1002/ccd.27680
DO - 10.1002/ccd.27680
M3 - Article
AN - SCOPUS:85053218689
VL - 92
SP - E502-E511
JO - Catheterization and cardiovascular interventions
JF - Catheterization and cardiovascular interventions
SN - 1522-1946
IS - 7
ER -