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

Michael Haude* (Corresponding Author), Hüseyin Ince, Stephan Kische, Alexandre Abizaid, Ralph Tölg, Pedro Alves Lemos, Nicolas M. Van Mieghem, Stefan Verheye, Clemens von Birgelen, Evald Høj Christiansen, Emanuele Barbato, Hector M. Garcia-Garcia, Ron Waksman

*Corresponding author for this work

Research output: Contribution to journalArticleAcademicpeer-review

9 Citations (Scopus)
27 Downloads (Pure)

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 languageEnglish
Pages (from-to)E502-E511
JournalCatheterization and cardiovascular interventions
Volume92
Issue number7
DOIs
Publication statusE-pub ahead of print/First online - 5 Aug 2018

Fingerprint

Coronary Vessels
Metals
Safety
Pharmaceutical Preparations
Stents
Thrombosis
Therapeutics
Myocardial Infarction
Inflammation
Population

Keywords

  • UT-Hybrid-D
  • Coronary artery disease
  • Percutaneous coronary intervention (PCI)
  • Stent bioabsorbable
  • Stent restenosis
  • Thrombosis
  • Clinical trials

Cite this

Haude, Michael ; 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. / 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. In: Catheterization and cardiovascular interventions. 2018 ; Vol. 92, No. 7. pp. E502-E511.
@article{ee13ce4c8c3742ad9069212434e07850,
title = "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",
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.",
keywords = "UT-Hybrid-D, Coronary artery disease, Percutaneous coronary intervention (PCI), Stent bioabsorbable, Stent restenosis, Thrombosis, Clinical trials",
author = "Michael Haude and H{\"u}seyin Ince and Stephan Kische and Alexandre Abizaid and Ralph T{\"o}lg and {Alves Lemos}, Pedro and {Van Mieghem}, {Nicolas M.} and Stefan Verheye and {von Birgelen}, Clemens and Christiansen, {Evald H{\o}j} and Emanuele Barbato and Garcia-Garcia, {Hector M.} and Ron Waksman",
note = "Wiley deal",
year = "2018",
month = "8",
day = "5",
doi = "10.1002/ccd.27680",
language = "English",
volume = "92",
pages = "E502--E511",
journal = "Catheterization and cardiovascular interventions",
issn = "1522-1946",
publisher = "Wiley-Liss Inc.",
number = "7",

}

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 journalArticleAcademicpeer-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 -