Effect of non‐compliant balloon postdilatation on magnesium‐based bioresorbable vascular scaffolds

Blachutzik, Florian; Achenbach, Stephan; Tröbs, Monique; Marwan, Mohamed; Weissner, Melissa; Nef, Holger; Schlundt, Christian

doi:10.1002/ccd.27794

Cited by 6 publications

(4 citation statements)

References 27 publications

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“…In ex vivo porcine carotid jugular arteriovenous shunt models, magnesium-based scaffolds have shown reduced thrombogenicity compared to the Absorb scaffold and to a stainless steel stent, suggesting that the magnesium-based metal scaffold may have inherent properties that reduce thrombogenicity 4,5 . No scaffold thrombosis has been reported for the second-generation drug-eluting absorbable magnesium scaffold (DREAMS 2G, commercial name Magmaris ® ; Biotronik AG, Bülach, Switzerland) in 184 patients studied up to 24 months, which is beyond its degradation time of approximately 12 months [6][7][8] . We now report three-year outcomes of BIOSOLVE-II (BIOTRONIK -Safety and Clinical PerFormance of the Drug Eluting Absorbable Metal Scaffold in the Treatment of Subjects with de NOvo Lesions in NatiVE Coronary Arteries) to assess vessel response up to two years post resorption.…”

Section: Introductionmentioning

confidence: 99%

Safety and performance of the second-generation drug-eluting absorbable metal scaffold (DREAMS 2G) in patients with de novo coronary lesions: three-year clinical results and angiographic findings of the BIOSOLVE-II first-in-man trial

Haude

Ince²,

Lemos

et al. 2020

EuroIntervention

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Aims:We aimed to evaluate the safety and performance of a magnesium-based sirolimus-eluting metal scaffold at three-year follow-up to assess vessel response two years beyond scaffold resorption.Methods and results: BIOSOLVE-II is an international, multicentre first-in-man study, including 123 patients with de novo lesions. Predilatation was mandatory and post-dilatation was left to the discretion of the investigators. Dual antiplatelet therapy was recommended for six months. At three years, 91.1% of patients were angina-free and 8.0% were on dual antiplatelet therapy. The target lesion failure rate was 6.8% (n=8: two cardiac deaths, one target vessel myocardial infarction and five target lesion revascularisations). No probable or definite scaffold thrombosis was observed. Imaging follow-up was voluntary and serial angiographic assessment at 6, 12, and 36 months was available in 25 patients. In these, a slight increase in insegment and in-scaffold late lumen loss and diameter stenosis was observed between 12 and 36 months (by 0.11±0.28 mm and 0.13±0.30 mm for late lumen loss, and by 3.8±10.1% and 4.1±10.2% for diameter stenosis).Conclusions: Two years beyond the resorption period of a sirolimus-eluting bioresorbable metal scaffold built from a proprietary magnesium alloy, complication rates remained low. In the patients with serial angiographic assessment, late lumen loss and diameter stenosis did not increase substantially beyond the resorption period.

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Section: Introductionmentioning

confidence: 99%

Safety and performance of the second-generation drug-eluting absorbable metal scaffold (DREAMS 2G) in patients with de novo coronary lesions: three-year clinical results and angiographic findings of the BIOSOLVE-II first-in-man trial

Haude

Ince²,

Lemos

et al. 2020

EuroIntervention

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“…The mean post-dilation balloon diameter was 3.4 ± 0.3 mm, inflated at a mean pressure of 18.5 ± 2.4 atm. This reflected the adherence of the operators to the predefined Mg-BVS implantation technique recommendations [ 27 , 28 ].…”

Section: Resultsmentioning

confidence: 99%

Bioresorbable Magnesium-Based Stent: Real-World Clinical Experience and Feasibility of Follow-Up by Coronary Computed Tomography: A New Window to Look at New Scaffolds

et al. 2023

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(1) Background: The diagnostic accuracy of coronary computed tomography angiography (CCTA) for coronary artery disease (CAD) has greatly improved so CCTA represents a transition in the care of patients suffering from CAD. Magnesium-based bioresorbable stents (Mg-BRS) secure acute percutaneous coronary intervention (PCI) results without leaving, in the long term, a metallic caging effect. The purpose of this real-world study was to assess clinical and CCTA medium- and long-term follow-up of all our patients with implanted Mg-BRS. (2) Methods: The patency of 52 Mg-BRS implanted in 44 patients with de novo lesions (24 of which had acute coronary syndrome (ACS)) was evaluated by CCTA and compared to quantitative coronary angiography (QCA) post-implantation. (3) Results: ten events including four deaths occurred during a median follow-up of 48 months. CCTA was interpretable and in-stent measurements were successful at follow-up without being hindered by the stent strut’s “blooming effect”. Minimal in-stent diameters on CCTA were found to be 1.03 ± 0.60 mm smaller than the expected diameter after post-dilation on implantation (p < 0.05), a difference not found in comparing CCTA and QCA. (4) Conclusions: CCTA follow-up of implanted Mg-BRS is fully interpretable and we confirm the long-term Mg-BRS safety profile.

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“…The POSTDIL-STEM trial also found that post-dilatation during primary PCI for ST-elevation MI enhanced the stent expansion, apposition, and post-PCI fractional flow reserve without having a significant impact on the coronary microcirculation [ 19 ]. Furthermore, post-dilatation with an NC balloon is necessary to achieve optimal expansion while effectively minimizing malposition [ 20 ].…”

Section: Discussionmentioning

confidence: 99%

Clinical Outcomes of a Non-Compliant Balloon Dilatation Catheter: MOZEC™ NC Study

Pradhan

Vishwakarma

Bhandari

et al. 2022

IJERPH

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The present study sought to assess the clinical outcomes of the Mozec™ Non-compliant (NC) Rx PTCA balloon dilatation catheter (BDC) (Meril Life Sciences Pvt. Ltd., Vapi, India) for dilatation of coronary lesions. This was a post-marketing, single-centre, single-arm, retrospective study. In total, 57 patients who had undergone post-dilatation with the Mozec™ NC Rx PTCA balloon dilatation catheter were evaluated. The primary endpoint was procedural success defined as (i) successful delivery of the investigational device to and across the target lesion; (ii) successful inflation, deflation, and withdrawal of the investigational device; (iii) absence of vessel perforation, flow-limiting vessel dissection, increase in thrombolysis in myocardial infarction (TIMI) flow from baseline, clinically significant arrhythmia requiring medical treatment; and (iv) achievement of final TIMI flow grade 3 after percutaneous coronary intervention of the target lesion after single or multiple attempts to cross the target lesion. Procedural success was achieved in 57 (100%) patients. There were no incidences of major adverse cardiac events (MACE)/target lesion failure (TLF). Mozec™ NC Rx PTCA balloon dilatation catheter has demonstrated favourable outcomes for the dilatation of routine and complex coronary lesions in a small cohort, as evidenced by its 100% procedural success rate and absence of MACE.

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Effect of non‐compliant balloon postdilatation on magnesium‐based bioresorbable vascular scaffolds

Abstract: NC balloon postdilatation of Magmaris® BRS is required to achieve optimal expansion. It significantly reduces malapposition and can safely be performed without relevant rates of strut fracture.

Cited by 6 publications

References 27 publications

Safety and performance of the second-generation drug-eluting absorbable metal scaffold (DREAMS 2G) in patients with de novo coronary lesions: three-year clinical results and angiographic findings of the BIOSOLVE-II first-in-man trial

Safety and performance of the second-generation drug-eluting absorbable metal scaffold (DREAMS 2G) in patients with de novo coronary lesions: three-year clinical results and angiographic findings of the BIOSOLVE-II first-in-man trial

Bioresorbable Magnesium-Based Stent: Real-World Clinical Experience and Feasibility of Follow-Up by Coronary Computed Tomography: A New Window to Look at New Scaffolds

Clinical Outcomes of a Non-Compliant Balloon Dilatation Catheter: MOZEC™ NC Study

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