Trial reportCatheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions2018
Safety and clinical performance of a drug eluting absorbable metal scaffold in the treatment of subjects with de novo lesions in native coronary arteries: Pooled 12-month outcomes of BIOSOLVE-II and BIOSOLVE-III.
Trial report in Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 30 papers.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
30 citing papers in PubMed, 61 citations in OpenAlex.
- Optimal Predilatation Treatment Before Implantation of a Magmaris Bioresorbable Scaffold in Coronary Artery Stenosis: The OPTIMIS Trial.Circulation. Cardiovascular interventions · 2025Trial
- A new resorbable magnesium scaffold for de novo coronary lesions (DREAMS 3): one-year results of the BIOMAG-I first-in-human study.EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology · 2023Trial
- Safety and clinical performance of a drug eluting absorbable metal scaffold in the treatment of subjects with de novo lesions in native coronary arteries: Pooled 12-month outcomes of BIOSOLVE-II and BIOSOLVE-III.Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions · 2018Trial
- Cardiovascular stent technologies for coronary and valvular heart disease: the potential of 3D printing for stent fabrication.Nature reviews. Cardiology · 2026Review
- A Comparison of Performance of the Different Generations of Magnesium-Based Bioresorbable Coronary Stents.Journal of clinical medicine · 2026Review
- Stent Thrombosis: A Narrative Review From Pathophysiology to Therapy.Clinical cardiology · 2026Review
- One-year outcomes of bioresorbable magnesium scaffold implantation in complex coronary lesions.Frontiers in cardiovascular medicine · 2026Article
- Preclinical research models for evaluating the biocompatibility of bioresorbable metallic cardiovascular stents: A comparative review.Bioactive materials · 2025Review
- The Impact of Underlying Plaque Characteristics Following the Third-Generation Resorbable Magnesium Scaffold Implantation: An Intravascular OCT Assessment up to 12-Months.Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions · 2025Article
- The Safety and Efficacy Profile of Magnesium-Based Bioresorbable Coronary Stents as Compared to Poly-L-Lactic Acid-Based Bioresorbable and Contemporary Drug-Eluting Coronary Stents-A Systematic Review.Cardiology research and practice · 2025Review
- Optimal lesion preparation before implantation of a Magmaris bioresorbable scaffold in patients with coronary artery stenosis: Rationale, design and methodology of the OPTIMIS study.Contemporary clinical trials communications · 2024Article
- Development and Future Trends of Protective Strategies for Magnesium Alloy Vascular Stents.Materials (Basel, Switzerland) · 2023Review
- One- and two-year clinical outcomes of treatment with resorbable magnesium scaffolds for coronary artery disease: the prospective, international, multicentre BIOSOLVE-IV registry.EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology · 2023Article
- Article
- 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.Biomedicines · 2023Article
- Application of Biodegradable Magnesium Membrane Shield Technique for Immediate Dentoalveolar Bone Regeneration.Biomedicines · 2023Article
- Mid-term safe and effective profile of the Magmaris scaffold in percutaneous coronary intervention: a prospective, single-center study.Frontiers in cardiovascular medicine · 2023Article
- Advances in the development of biodegradable coronary stents: A translational perspective.Materials today. Bio · 2022Review
- Long-Term Performance of the Magmaris Drug-Eluting Bioresorbable Metallic Scaffold in All-Comers Patients' Population.Journal of clinical medicine · 2022Article
- Outcomes of the two generations of bioresorbable scaffolds (Magmaris vs. Absorb) in acute coronary syndrome in routine clinical practice.Cardiology journal · 2022Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
14 authors at 12 institutions in 7 countries.
Funding
Abstract
objectivesBased on outcomes of the BIOSOLVE-II study, a novel second generation drug-eluting absorbable metal scaffold gained CE-mark in 2016. The BIOSOLVE-III study aimed to confirm these outcomes and to obtain additional 12-month angiographic data.
backgroundBioresorbable scaffolds are intended to overcome possible long-term effects of permanent stents such as chronic vessel wall inflammation, stent crushing, and fractures.
methodsThe prospective, multicenter BIOSOLVE-II and BIOSOLVE-III studies enrolled 184 patients with 189 lesions (123 patients in BIOSOLVE-II and 61 patients in BIOSOLVE-III). Primary endpoints were in-segment late lumen loss at 6 months (BIOSOLVE-II) and procedural success (BIOSOLVE-III).
resultsMean patient age was 65.5 ± 10.8 years and mean lesion reference diameter was 2.70 ± 0.43 mm. In BIOSOLVE-III, there were significantly more type B2/C lesions than in BIOSOLVE-II (80.3% versus 43.4%, P < 0.0001) and significantly more moderate-to-severe calcifications (24.2% versus 10.7%, P = 0.014). At 12 months, there was no difference in late lumen loss between the two studies; in the overall population, it was 0.25 ± 0.31 mm in-segment and 0.39 ± 0.34 mm in-scaffold. Target lesion failure occurred in six patients (3.3%) and included two cardiac deaths, one target-vessel myocardial infarction, and three clinically driven target lesion revascularizations. No definite or probable scaffold thrombosis was observed.
conclusionThe pooled outcomes of BIOSOLVE-II and BIOSOLVE-III provide further evidence on the safety and performance of a novel drug-eluting absorbable metal scaffold with constant clinical and angiographic performance parameters at 12 months and no definite or probable scaffold thrombosis.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.