Author + information
- Michael Haude1,
- Hüseyin Ince2,
- Alexandre Abizaid3,
- Ralph Toelg4,
- Pedro A. Lemos5,
- Clemens von Birgelen6,
- Evald Christiansen7,
- William Wijns8,
- Franz-Josef Neumann9,
- Eric Eeckhout10,
- Javier Escaned11,
- Ron Waksman12 and
- Hector Garcia-Garcia13
- 1Lukaskrankenhaus Neuss, Neuss, Germany
- 2Vivantes Klinikum im Friedrichshain and Am Urban snd Department of Cardiology University of Rostock, Berlin, Germany
- 3Instituto Dante Pazzanese de Cardiologia, São Paulo, São Paulo, Brazil
- 4Herzzentrum Segeberger Kliniken GmbH, Bad Segeberg, Germany
- 5Heart Institute-InCor, University of São Paulo, São Paulo, São Paulo, Brazil
- 6Thoraxcentrum Twente, Enschede, Netherlands
- 7Aarhus University Hospital, Aarhus, Denmark
- 8The Lambe Institute for Translational Medicine and Curam, and Saolta University Healthcare Group, Galway, Galway, Ireland
- 9Universitäts-Herzzentrum Freiburg-Bad Krozingen, Bad Krozingen, Germany
- 10Lausanne University Hospital, 1011 Lausanne, Switzerland
- 11Hospital Clínico San Carlos, Madrid, Spain
- 12Medstar Washington Hospital Center, Washington, District of Columbia, United States
- 13MedStar Washington Hospital Center, Washington, District of Columbia, United States
In order to assess the intermediate term safety, clinical performance and the bioabsorption process of the Sirolimus-Eluting Bioabsorbable Magnesium Scaffold (DREAMS 2G) 2-year clinical data and multi-modality imaging outcomes up to 1 year follow-up are reported.
One hundred twenty three (123) subjects with 123 lesions have been enrolled in BIOSOLVE-II Study. Clinical follow-ups are scheduled at 1, 6, 12, 24 and 36-months. Angiographic follow-up are planned at 6-month and voluntarily at 12-month and 36 month. A subgroup of 30 subjects undergoes additional IVUS and OCT assessment at 6-month and voluntarily at 12-month and 36 month. Vasomotion testing is performed with acetylcholine, followed by nitroglycerine at 6-month and 12-month and 36 month, if subjects consent. Dual antiplatelet therapy was recommended for 6 months. Primary endpoint is in-segment late lumen loss (LLL) at 6-month follow-up.
Previously published study results showed that the late lumen loss results remained stable from 6 to 12 months: in-segment late lumen loss 0.20±0.21 mm versus 0.25±0.22 mm, p=0.117 and in-scaffold late lumen loss 0.37±0.25 versus 0.39±0.27 mm, p=0.446, respectively. TLF rate at 24-month was 5.9% including 4 TLRs, 1 peri-procedural MI and 2 death of unknown cause. No definite or probable scaffold thrombosis was observed up to 24-month. All clinical events have been adjudicated by an independent CEC. Multi-modality imaging data demonstrate vasomotion of ≥ 3% change in mean lumen diameter after administration of acetylcholine or nitroglycerine for 80% (20/25) of the subjects at 6-month, demonstrating the uncaging aspect of the absorption process with no further change at the 12-month follow-up. Six-month virtual histology (VH) data showed a significant decrease in the dense calcium by 14% (p<0.0001) remaining stable from 6- to 12-month follow-up. This decrease is interpreted as a surrogate assessment for the bioabsorption process of the scaffold material.
The 24-months safety results of the DREAMS 2G are encouraging with a TLF rate comparable to existing bioabsorbable scaffolds and no definite or probable scaffold thrombosis.
CORONARY: Bioresorbable Vascular Scaffolds