TY - JOUR
T1 - Sustained safety and clinical performance of a drug-eluting absorbable metal scaffold up to 24 months
T2 - Pooled outcomes of BIOSOLVE-II and BIOSOLVE-III
AU - Haude, Michael
AU - Ince, Hüseyin
AU - Kische, Stephan
AU - Abizaid, Alexandre
AU - Tölg, Ralph
AU - Lemos, Pedro Alves
AU - Van Mieghem, Nicolas M.
AU - Verheye, Stefan
AU - von Birgelen, Clemens
AU - Christiansen, Evald Høj
AU - Wijns, William
AU - Garcia-Garcia, Hector M.
AU - Waksman, Ron
PY - 2017/7/20
Y1 - 2017/7/20
N2 - Aims: We aimed to assess the safety and performance of the DREAMS 2G scaffold up to 24 months post implant.Methods and results: The present study population comprises a total of 184 patients with 189 lesions who were enrolled in the prospective, multicentre BIOSOLVE-II and BIOSOLVE-III trials. Clinical followup was scheduled at one, six, 12, 24 and 36 months. The present report includes pooled follow-up data at six months and BIOSOLVE-II data at 24 months. Patients were 65.5±10.8 years old, and lesions were 12.5±5.1 mm long with reference diameters of 2.7±0.4 mm. Procedural success was obtained in 97.8%. At six months, the composite clinical endpoint target lesion failure was 3.3% (95% CI: 1.2-7.1), based on two cardiac deaths (1.1%, one unknown and one not device-related), one target vessel myocardial infarction (0.6%), and three clinically driven target lesion revascularisations (1.7%). For BIOSOLVE-II at 24 months, the target lesion failure rate was 5.9% (95% CI: 2.4-11.8), based on two cardiac deaths (1.7%), one target vessel myocardial infarction (0.9%) and four target lesion revascularisations (3.4%). There was no definite or probable scaffold thrombosis.Conclusions: The present analysis provides additional evidence on the safety of a drug-eluting absorbable metal scaffold with promising clinical outcomes up to 24 months and absence of definite or probable scaffold thrombosis.
AB - Aims: We aimed to assess the safety and performance of the DREAMS 2G scaffold up to 24 months post implant.Methods and results: The present study population comprises a total of 184 patients with 189 lesions who were enrolled in the prospective, multicentre BIOSOLVE-II and BIOSOLVE-III trials. Clinical followup was scheduled at one, six, 12, 24 and 36 months. The present report includes pooled follow-up data at six months and BIOSOLVE-II data at 24 months. Patients were 65.5±10.8 years old, and lesions were 12.5±5.1 mm long with reference diameters of 2.7±0.4 mm. Procedural success was obtained in 97.8%. At six months, the composite clinical endpoint target lesion failure was 3.3% (95% CI: 1.2-7.1), based on two cardiac deaths (1.1%, one unknown and one not device-related), one target vessel myocardial infarction (0.6%), and three clinically driven target lesion revascularisations (1.7%). For BIOSOLVE-II at 24 months, the target lesion failure rate was 5.9% (95% CI: 2.4-11.8), based on two cardiac deaths (1.7%), one target vessel myocardial infarction (0.9%) and four target lesion revascularisations (3.4%). There was no definite or probable scaffold thrombosis.Conclusions: The present analysis provides additional evidence on the safety of a drug-eluting absorbable metal scaffold with promising clinical outcomes up to 24 months and absence of definite or probable scaffold thrombosis.
KW - Bioresorbable scaffolds
KW - Myocardial infarction
KW - Stable angina
KW - Stent thrombosis
UR - http://www.scopus.com/inward/record.url?scp=85026527197&partnerID=8YFLogxK
U2 - 10.4244/EIJ-D-17-00254
DO - 10.4244/EIJ-D-17-00254
M3 - Article
C2 - 28504239
AN - SCOPUS:85026527197
VL - 13
SP - 432
EP - 439
JO - EuroIntervention
JF - EuroIntervention
SN - 1774-024X
IS - 4
ER -