A First-in-Human Study of the Bioheart Sirolimus-Eluting Bioresorbable Vascular Scaffold in Patients with Coronary Artery Disease: Two-Year Clinical and Imaging Outcomes

Ferdous, Md Misbahul; Zhao, Jie; Gao, Lijian; Qiao, Shubin; Li, Haibo; Guan, Changdong; Hu, Fenghuan; Kottu, Lakshme; Qian, Jie; Yan, Hong‐Bin; Luo, Tong; Yang, Wenrui; Qiu, Hong; Mao, Yi; Sun, Zhongwei; Yu, Mengyue; Cui, Jingang; Xu, Bo; Wu, Yongjian

doi:10.1007/s12325-022-02154-w

Cited by 4 publications

(2 citation statements)

References 22 publications

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“…Short-term data focused on the diabetes population are available only to magnesium BRS and seem to be favorable 21 also comparing the Magmaris to the second generation of metallic DES. 44,22 Data regarding the relationship between DM t2 and other novel BRS are partial and incomplete [45][46][47] making it difficult to analyze and discuss. Observed in our study cohort favorable clinical outcomes (no significant differences in terms of Primary outcome, principally secondary outcome, TLF, with additional lack of stent thrombosis in the study population) after Magmaris implantation in diabetic ACS-NSTE population seems to support data obtained in all-comers Magmaris registries.…”

Section: Discussionmentioning

confidence: 99%

Mid-term safety and efficacy of magnesium bioresorbable vascular scaffolds – magmaris in diabetic population. 2-Years outcome in acute coronary syndrome cohort

Włodarczak

Rola

Barycki

et al. 2023

Diabetes and Vascular Disease Research

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Background Diabetes type 2 is one of the strongest risk factors affecting coronary artery disease (CAD) and is also a marker of poor short and long-term prognosis in subjects with acute coronary syndrome (ACS) treated with percutaneous coronary intervention (PCI) with subsequent drug-eluting stent (DES) implantation. Chronic local vascular inflammation along with endothelial dysfunction is postulated to be the pathophysiological background of unfavorable results. The second generation of metallic magnesium BRS –Magmaris (Biotronik, Berlin, Germany) had been introduced to clinical practice to overcome these limitations. Methods We evaluated 2-years clinical outcomes after Magmaris BRS implantation in NSTE-ACS diabetic ( n-72) and non-diabetic ( n-121) cohorts. Results No significant differences between diabetic and non-diabetes cohorts were noticed in terms of Primary Outcome (cardiac death, myocardial infarction, stent thrombosis) (8.1% vs 3.3% p = 0.182) and Principal secondary outcome – TLF- target lesion failure (9.5% vs 3.3% p = 0.106) at 2-years follow-up. Conclusions 2-years outcome suggests good safety and efficacy of the magnesium BRS (Magmaris) in NSTE- ACS and concomitant DM. Nevertheless, there is a strong need for large multicenter, randomized, prospective studies for a full assessment of this novel device in diabetic patients with ACS.

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Section: Discussionmentioning

confidence: 99%

Mid-term safety and efficacy of magnesium bioresorbable vascular scaffolds – magmaris in diabetic population. 2-Years outcome in acute coronary syndrome cohort

Włodarczak

Rola

Barycki

et al. 2023

Diabetes and Vascular Disease Research

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“…TARGET STEMI OCT China trial compared the vascular healing of a biodegradable polymer sirolimus-eluting stent (Firehawk) versus a durable polymer everolimus-eluting stent (Xience) after PCI within 12 h of ST-EMI onset. [45] The results showed that the Firehawk stent was non-inferior to the Xience stent in terms of the neointimal thickness [73.03 ± 33.30 μm vs. 78.96 ± 33.29 μm; absolute difference: -5.94 (one-sided 95% CI: -23.09); P < 0.001 for non-inferiority] at 6 months. No significant difference was observed between the Firehawk and Xience regarding the strut coverage, neointimal formation, and strut malapposition.…”

Section: New Developments In Instruments and Techniquesmentioning

confidence: 95%

Epidemiology and current management of cardiovascular disease in China

2024

Journal of Geriatric Cardiology

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The Annual Report on Cardiovascular Health and Diseases in China (2022) intricate landscape of cardiovascular health in China. This is the fourth section of the report with a specific focus on epidemiology and current management of cardiovascular disease (CVD) in China. This section of the report highlights the epidemiological trends of CVD in China. It reveal a concerning rise in prevalence, with approximately 330 million affected individuals, including significant numbers with stroke, coronary artery disease (CAD), heart failure, and other conditions. CVD stands as the primary cause of mortality among both urban and rural populations, accounting for nearly half of all deaths in 2020. Mortality rates are notably higher in rural areas compared to urban centers since 2009. While age-standardized mortality rates have decreased, the absolute number of CVD deaths has increased, primarily due to population aging. Ischemic heart disease, hemorrhagic and ischemic strokes are the leading causes of CVD-related deaths. Notably, the burden of atherosclerotic cardiovascular disease has risen substantially, with atherosclerotic cardiovascular disease-related deaths increasing from 1990 to 2016. The incidence of ischemic stroke and ischemic heart disease has shown similar increasing trends over the past three decades. CAD mortality, particularly acute myocardial infarction, has been on the rise, with higher mortality rates observed in rural areas since 2016. The prevalence of CAD has increased significantly, with over 11 million patients identified in 2013. Studies assessing hospital performance in managing acute coronary syndrome reveal gaps in adherence to guideline-recommended strategies, with disparities in care quality across hospitals. However, initiatives like the China Patient-centered Evaluative Assessment of Cardiac Events (PEACE)-Retrospective AMI Study and the Improving Care for Cardiovascular Disease in China-Acute Coronary Syndrome (CCC-ACS) project aim to improve patient outcomes through enhanced care protocols. Moreover, advancements in medical technology, such as quantitative flow ratio-guided lesion selection during percutaneous coronary intervention, show promise in improving clinical outcomes for patients undergoing intervention.

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New insights and perspectives into biodegradable metals in cardiovascular stents: A mini review

Wang,

Song,

Peng

2024

Journal of Alloys and Compounds

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A First-in-Human Study of the Bioheart Sirolimus-Eluting Bioresorbable Vascular Scaffold in Patients with Coronary Artery Disease: Two-Year Clinical and Imaging Outcomes

Cited by 4 publications

References 22 publications

Mid-term safety and efficacy of magnesium bioresorbable vascular scaffolds – magmaris in diabetic population. 2-Years outcome in acute coronary syndrome cohort

Mid-term safety and efficacy of magnesium bioresorbable vascular scaffolds – magmaris in diabetic population. 2-Years outcome in acute coronary syndrome cohort

Epidemiology and current management of cardiovascular disease in China

New insights and perspectives into biodegradable metals in cardiovascular stents: A mini review

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