Long-term clinical follow-up of the resorbable magnesium scaffolds in acute coronary syndrome patients

Włodarczak, Adrian; Łanocha, Magdalena; Lesiak, Maciej; Benett, Johan; Szudrowicz, Marek; Jastrzębski, Artur; Pęcherzewski, Maciej; Kulczycki, Jan Jakub; Furtan, Łukasz; Turkiewicz, Karol; Korda, Andrzej

doi:10.33963/kp.a2021.0035

Cited by 8 publications

(8 citation statements)

References 20 publications

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“…In the contrast, the data on implantation of Magmaris in ACS conditions are more comprehensive and reliable. Several observational registries confirmed favorable short-term and long-term outcomes [ 6 , 29 ] Furthermore, recently published data from the largest all-comers Magmaris registry [ 30 ] which included 2054 subjects showed that the one-year TLF rate was 4.3% with only one subacute in-stent thrombosis event. The results obtained are far more favorable than the first generation of BRS and comparable to the newest DES.…”

Section: Discussionmentioning

confidence: 99%

Biodegradable Polymer DES (Ultimaster) vs. Magnesium Bioresorbable Scaffold (BRS Magmaris) in Diabetic Population with NSTE-ACS: A One-Year Clinical Outcome of Two Sirolimus-Eluting Stents

Rola

Włodarczak²,

Barycki

et al. 2021

Journal of Diabetes Research

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Background. Cardiovascular disease (CVD) with significant involvement of coronary artery disease (CAD) remains a major cause of death and disability among the diabetic population. Although percutaneous coronary intervention (PCI) continues to evolve, type 2 diabetes mellitus (T2DM) is a well-established marker of poor clinical prognosis after PCI, which is mainly attributed to the rapid progression of atherosclerosis requiring recurrent revascularizations. Hence, the use of bioresorbable materials could provide some solution to this problem. Material and Methods. The study was divided into two arms. For the first one, we qualified 169 patients with NSTE-ACS treated with PCI who received the drug-eluting stent (DES) coated with a biodegradable polymer Ultimaster (Terumo, Tokyo, Japan). The second arm was composed of 193 patients with ACS who underwent PCI with a magnesium bioresorbable scaffold Magmaris (Biotronik, Berlin, Germany). Both arms were divided into two subsequent groups: the T2DM (59 and 72) and the non-DM (110 and 121, respectively). The primary outcomes were cardiovascular death, myocardial infarction, and in-stent thrombosis. The main secondary outcomes included target lesion failure (TLF) and were recorded at a 1-year-follow-up. Results. There were no significant differences between the diabetic and nondiabetic populations in primary endpoints or main secondary endpoints (TLF, scaffold restenosis, death from any reason, and other cardiovascular events) either in the Ultimaster or Magmaris group. At a 1-year-follow-up, the primary endpoint in the DM t.2 population was recorded in 2.7% Ultimaster vs. 5.1% Magmaris, respectively. At the same time, the TLF occurred in the diabetic group in 4.1% Magmaris and 3.3% in the Ultimaster arm, respectively. Conclusion. Both, Ultimaster and Magmaris revealed relative safety and efficiency at a one-year follow-up in the diabetic population in ACS settings. The observed rates of TLF were low, which combined with a lack of in-stent thrombosis suggests that both investigated devices might be an interesting therapeutic option for diabetics with ACS. Nevertheless, further large randomized clinical trials are needed to confirm fully our results.

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Section: Discussionmentioning

confidence: 99%

Biodegradable Polymer DES (Ultimaster) vs. Magnesium Bioresorbable Scaffold (BRS Magmaris) in Diabetic Population with NSTE-ACS: A One-Year Clinical Outcome of Two Sirolimus-Eluting Stents

Rola

Włodarczak²,

Barycki

et al. 2021

Journal of Diabetes Research

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“…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. [48][49][50][51] Despite no statistically significant difference in terms of study endpoints occur noticeable unfavorable trend in restenosis ratio in DM t.2 subpopulations occurred (8.1% vs 3.3%; p = 0.182). Additionally taking into consideration unfavorable long-term outcomes of first-generation BRS (Absorb) 41,52 future long-term high-number studies are required for a proper evaluation of Magmaris performance in the diabetic population.…”

Section: Discussionmentioning

confidence: 86%

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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“…This trend, was remarked upon in a study comparing Magmaris to Orsiro (second generation of DES) [ 34 ], was statistically irrelevant. Furthermore, a recently published study suggests favorable safety features and long-term prognosis of patients treated with Magmaris scaffold implanted in terms of ACS [ 35 , 36 ]. Such a good clinical performance of the magnesium BRS was achieved by overcoming the scaffold thrombosis issues.…”

Section: Discussionmentioning

confidence: 99%

Outcomes of the two generations of bioresorbable scaffolds (Magmaris vs. Absorb) in acute coronary syndrome in routine clinical practice

Rola¹,

Włodarczak²,

Łanocha³

et al. 2022

Cardiol J.

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Background Acute coronary syndrome (ACS) as a clinical manifestation of coronary artery disease (CAD) remains a significant cause of mortality and morbidity, as reported worldwide annually. The second generation of drug-eluting stents (DES) is a gold standard in percutaneous interventions in ACS patients however, permanent caging of the vessel with metallic DES has some drawbacks. Bioresorbable vascular scaffolds (BRS) were designed as a temporal vessel-supporting technology allowing for anatomical and functional restoration. Nevertheless, following the initial encouraging reports, numerous concerns about the safety of BRS occurred. Methods In this study, a 1-year performance of 193 patients with magnesium BRS — Magmaris (Biotronik, Berlin, Germany) was evaluated in comparison to 160 patients with polymer BRS — Absorb (Abbott-Vascular, Chicago, USA) in the non-ST-segment elevation-ACS setting. Results The Magmaris, when compared to Absorb showed a significantly lower rate of primary endpoint (death from cardiac causes, myocardial infarction, stent thrombosis) as well as target lesion failure in 30-day and 1 year follow-up. In the Absorb group, a significantly higher rate of stent thrombosis was observed. Conclusions Data from the present study suggests encouraging safety a profile and more favorable clinical outcomes of magnesium BRS in comparison to the polymer Absorb — BRS.

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Long-term clinical follow-up of the resorbable magnesium scaffolds in acute coronary syndrome patients

Cited by 8 publications

References 20 publications

Biodegradable Polymer DES (Ultimaster) vs. Magnesium Bioresorbable Scaffold (BRS Magmaris) in Diabetic Population with NSTE-ACS: A One-Year Clinical Outcome of Two Sirolimus-Eluting Stents

Biodegradable Polymer DES (Ultimaster) vs. Magnesium Bioresorbable Scaffold (BRS Magmaris) in Diabetic Population with NSTE-ACS: A One-Year Clinical Outcome of Two Sirolimus-Eluting Stents

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

Outcomes of the two generations of bioresorbable scaffolds (Magmaris vs. Absorb) in acute coronary syndrome in routine clinical practice

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