Safety and performance of the second-generation drug-eluting absorbable metal scaffold in patients with de-novo coronary artery lesions (BIOSOLVE-II): 6 month results of a prospective, multicentre, non-randomised, first-in-man trial.
Safety and performance of the second-generation drug-eluting absorbable metal scaffold in patients with de-novo coronary artery lesions (BIOSOLVE-II): 6 month results of a prospective, multicentre, non-randomised, first-in-man trial.
- 2016
Available online from MWHC library: 1995 - present, Available in print through MWHC library: 1983 - 2007
BACKGROUND: Absorbable scaffolds were designed to overcome the limitations of conventional, non-absorbable metal-based drug-eluting stents. So far, only polymeric absorbable scaffolds are commercially available. We aimed to assess the safety and performance of a novel second-generation drug-eluting absorbable metal scaffold (DREAMS 2G) in patients with de-novo coronary artery lesions. FINDINGS: Between Oct 8, 2013, and May 22, 2015, we enrolled 123 patients with 123 coronary target lesions. At 6 months, mean in-segment late lumen loss was 0.27 mm (SD 0.37), and angiographically discernable vasomotion was documented in 20 (80%) of 25 patients. Intravascular ultrasound assessments showed a preservation of the scaffold area (mean 6.24 mm(2) [SD 1.15] post-procedure vs 6.21 mm(2) [1.22] at 6 months) with a low mean neointimal area (0.08 mm(2) [0.09]), and optical coherence tomography did not detect any intraluminal mass. Target lesion failure occurred in four (3%) patients: one (<1%) patient died from cardiac death, one (<1%) patient had periprocedural myocardial infarction, and two (2%) patients needed clinically driven target lesion revascularisation. No definite or probable scaffold thrombosis was observed. FUNDING: Biotronik AG.Copyright © 2016 Elsevier Ltd. All rights reserved. INTERPRETATION: Our findings show that implantation of the DREAMS 2G device in de-novo coronary lesions is feasible, with favourable safety and performance outcomes at 6 months. This novel absorbable metal scaffold could be an alternative to absorbable polymeric scaffolds for treatment of obstructive coronary disease. METHODS: We did this prospective, multicentre, non-randomised, first-in-man trial at 13 percutaneous coronary intervention centres in Belgium, Brazil, Denmark, Germany, Singapore, Spain, Switzerland, and the Netherlands. Eligible patients had stable or unstable angina or documented silent ischaemia, and a maximum of two de-novo lesions with a reference vessel diameter between 2.2 mm and 3.7 mm. Clinical follow-up was scheduled at months 1, 6, 12, 24, and 36. Patients were scheduled for angiographic follow-up at 6 months, and a subgroup of patients was scheduled for intravascular ultrasound, optical coherence tomography, and vasomotion assessment. All patients were recommended to take dual antiplatelet treatment for at least 6 months. The primary endpoint was in-segment late lumen loss at 6 months. We did analysis by intention to treat. This trial is registered with ClinicalTrials.gov, number NCT01960504.
English
0140-6736
*Absorbable Implants
*Antibiotics, Antineoplastic/tu [Therapeutic Use]
*Coronary Restenosis/pa [Pathology]
*Coronary Stenosis/th [Therapy]
*Drug-Eluting Stents
*Sirolimus/tu [Therapeutic Use]
*Tissue Scaffolds
Aged
Alloys
Cohort Studies
Coronary Restenosis/us [Ultrasonography]
Endosonography
Female
Humans
Magnesium
Male
Middle Aged
Percutaneous Coronary Intervention
Prospective Studies
Tomography, Optical Coherence
Treatment Outcome
MedStar Heart & Vascular Institute
Clinical Study
Journal Article
Multicenter Study
Research Support, Non-U.S. Gov't
Available online from MWHC library: 1995 - present, Available in print through MWHC library: 1983 - 2007
BACKGROUND: Absorbable scaffolds were designed to overcome the limitations of conventional, non-absorbable metal-based drug-eluting stents. So far, only polymeric absorbable scaffolds are commercially available. We aimed to assess the safety and performance of a novel second-generation drug-eluting absorbable metal scaffold (DREAMS 2G) in patients with de-novo coronary artery lesions. FINDINGS: Between Oct 8, 2013, and May 22, 2015, we enrolled 123 patients with 123 coronary target lesions. At 6 months, mean in-segment late lumen loss was 0.27 mm (SD 0.37), and angiographically discernable vasomotion was documented in 20 (80%) of 25 patients. Intravascular ultrasound assessments showed a preservation of the scaffold area (mean 6.24 mm(2) [SD 1.15] post-procedure vs 6.21 mm(2) [1.22] at 6 months) with a low mean neointimal area (0.08 mm(2) [0.09]), and optical coherence tomography did not detect any intraluminal mass. Target lesion failure occurred in four (3%) patients: one (<1%) patient died from cardiac death, one (<1%) patient had periprocedural myocardial infarction, and two (2%) patients needed clinically driven target lesion revascularisation. No definite or probable scaffold thrombosis was observed. FUNDING: Biotronik AG.Copyright © 2016 Elsevier Ltd. All rights reserved. INTERPRETATION: Our findings show that implantation of the DREAMS 2G device in de-novo coronary lesions is feasible, with favourable safety and performance outcomes at 6 months. This novel absorbable metal scaffold could be an alternative to absorbable polymeric scaffolds for treatment of obstructive coronary disease. METHODS: We did this prospective, multicentre, non-randomised, first-in-man trial at 13 percutaneous coronary intervention centres in Belgium, Brazil, Denmark, Germany, Singapore, Spain, Switzerland, and the Netherlands. Eligible patients had stable or unstable angina or documented silent ischaemia, and a maximum of two de-novo lesions with a reference vessel diameter between 2.2 mm and 3.7 mm. Clinical follow-up was scheduled at months 1, 6, 12, 24, and 36. Patients were scheduled for angiographic follow-up at 6 months, and a subgroup of patients was scheduled for intravascular ultrasound, optical coherence tomography, and vasomotion assessment. All patients were recommended to take dual antiplatelet treatment for at least 6 months. The primary endpoint was in-segment late lumen loss at 6 months. We did analysis by intention to treat. This trial is registered with ClinicalTrials.gov, number NCT01960504.
English
0140-6736
*Absorbable Implants
*Antibiotics, Antineoplastic/tu [Therapeutic Use]
*Coronary Restenosis/pa [Pathology]
*Coronary Stenosis/th [Therapy]
*Drug-Eluting Stents
*Sirolimus/tu [Therapeutic Use]
*Tissue Scaffolds
Aged
Alloys
Cohort Studies
Coronary Restenosis/us [Ultrasonography]
Endosonography
Female
Humans
Magnesium
Male
Middle Aged
Percutaneous Coronary Intervention
Prospective Studies
Tomography, Optical Coherence
Treatment Outcome
MedStar Heart & Vascular Institute
Clinical Study
Journal Article
Multicenter Study
Research Support, Non-U.S. Gov't