In vivo serial invasive imaging of the second-generation drug-eluting absorbable metal scaffold (Magmaris — DREAMS 2G) in de novo coronary lesions: Insights from the BIOSOLVE-II First-In-Man Trial
Introduction
Bioresorbable scaffolds (BRS) are newly approved devices in Europe for treating stable patients with obstructive coronary lesions. Since these devices are fully resorbable, they might overcome some of the problems related to the everlasting presence of metallic stents in coronary arteries. While it is expected that BRS may confer clinical benefit in long-term studies, early mechanistic studies using intravascular imaging have provided insightful information about the immediate and mid-term local serial effects of BRS on the coronary vessel wall [1].
The BIOSOLVE-II study assessed a newly redesigned second-generation drug-eluting absorbable metal scaffold (Magmaris — DREAMS 2G). The magnesium backbone of DREAMS 2G has been improved and it has a drug-polymer combination composed of sirolimus/poly-l-lactide (Biotronik AG, Buelach, Switzerland) [2], [3]. The clinical reports showed a continuous favorable safety profile and stable performance outcomes up to 12 months [4]; however, the mechanistic explanation of these optimal results is uncertain.
We therefore assessed, the baseline, 6-month and 12-month imaging performance of DREAMS 2G with regard to the serial geometrical changes in angiographic curvature, angulation and vasomotion, as well as to the temporal changes in bioresorption process as assessed by optical coherence tomography (OCT) attenuation and backscattering analyses, and intravascular ultrasound (IVUS) derived-radiofrequency (RF) data analysis and -echogenicity.
Section snippets
Study design and population
BIOSOLVE-II is a prospective, multi-center, first-in-man study which evaluates the safety and performance of DREAMS 2G (drug-eluting absorbable metal scaffold system — Biotronik AG, Buelach, Switzerland) in 123 patients (Fig. 1 supplement online). Key inclusion criteria: patients with stable or unstable angina or documented silent ischemia, a maximum of 2 single de novo lesions (length of ≤ 21 mm) in 2 separate coronary arteries (with a reference vessel diameter between 2.2 and 3.7 mm). Exclusion
Results
Between October 2013 and May 2015, 123 subjects were enrolled. Baseline parameters are listed in Table 1 supplement online. In 2 lesions, DREAMS 2G could not be implanted due to insufficient pre-dilatation; follow-up of these 2 subjects was consequently not included in this analysis. Most patients were male and had stable angina (71.5%) at baseline. At 12-months follow-up, 100 (86.2%) patients were symptom-free. Detailed 12-month clinical follow-up has been previously reported [4].
Discussion
The main findings of our study are: 1) restoration of the vessel geometry was observed between baseline and 6 and 12 months; 2) vasomotion signs were observed at follow-up and there was a relationship with underlying IVUS-derived radiofrequency data plaque composition; 3) many objective signs of bioresorption were documented by means of optical coherence tomography derived attenuation and backscattered measurements and with the use of serial assessments of IVUS-derived radiofrequency data and
Conclusion
Serial imaging of DREAMS 2G was associated with restoration of the anatomy of the treated segment and significant bioresorption of the scaffold by 6 and 12 months after its implantation in diseased human coronary arteries. This enables the vessel to react to vasoactive agents in relation with composition of the underlying vessel wall without the interference of the device since it has been bioreabsorbed. The coronary lumen is being preserved from 6 to 12 months, which speaks to the halting of the
Funding
This work was supported by Biotronik (https://clinicaltrials.gov/ct2/show/NCT01960504) AG, Buelach, Switzerland.
Conflict of interest
H.M.G, K.K., A.H., P.A.L., A.A., J.E. and J.D. declare no conflict of interest.
M.H. reports study grants and lecture fees from Biotronik, Abbott Vascular, Cardiac Dimensions, Medtronic, Volcano, and Lilly.
R.T. reports personal fees from Biotronik and Abbott Vascular.
C.v.B. has been an unpaid consultant to Biotronik and other device-manufacturing companies and reports institutional research grants from Biotronik, Medtronic, Boston Scientific, and AstraZeneca.
W.W. reports grants from Abbott
Acknowledgement
Sameer Desale performed the statistical analysis for this report.
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