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Multicenter Study
. 2021 Jul 1;98(1):E1-E8.
doi: 10.1002/ccd.29260. Epub 2020 Sep 3.

BIOSOLVE-IV-registry: Safety and performance of the Magmaris scaffold: 12-month outcomes of the first cohort of 1,075 patients

Stefan Verheye  1 , Adrian Wlodarczak  2 , Piero Montorsi  3 , Jan Torzewski  4 , Johan Bennett  5 , Michael Haude  6 , Gregory Starmer  7 , Thomas Buck  8 , Marcus Wiemer  9 , Amin A B Nuruddin  10 , Bryan P-Y Yan  11 , Michael K-Y Lee  12
Affiliations
Multicenter Study

BIOSOLVE-IV-registry: Safety and performance of the Magmaris scaffold: 12-month outcomes of the first cohort of 1,075 patients

Stefan Verheye et al. Catheter Cardiovasc Interv. .

Abstract

Objectives: We aimed to assess the safety and performance of the Magmaris sirolimus-eluting bioresorbable magnesium scaffold in a large patient population.

Background: Magmaris has shown good outcomes in small-sized controlled trials, but further data are needed to confirm its usability, safety, and performance.

Methods: BIOSOLVE-IV is an international, single arm, multicenter registry including patients with a maximum of two single de novo lesions. Follow-up is scheduled up to 5 years; the primary outcome is target lesion failure (TLF) at 12 months.

Results: A total of 1,075 patients with 1,121 lesions were enrolled. Mean patient age was 61.3 ± 10.5 years and 19.2% (n = 206) presented with non-ST-elevation myocardial infarction (NSTEMI). Lesions were 3.2 ± 0.3 mm in diameter and 14.9 ± 4.2 mm long; 5.1% (n = 57) were bifurcation lesions. Device success was 97.3% (n = 1,129) and procedure success 98.9% (n = 1,063). The Kaplan-Meier estimate of TLF at 12 months was 4.3% [95% confidence interval, CI: 3.2, 5.7] consisting of 3.9% target lesion revascularizations, 0.2% cardiac death, and 1.1% target-vessel myocardial infarction. Definite/probable scaffold thrombosis occurred in five patients (0.5% [95% CI: 0.2, 1.1]), thereof four after early discontinuation of antiplatelet/anticoagulation therapy.

Conclusion: BIOSOLVE-IV confirms the safety and performance of the Magmaris scaffold in a large population with excellent device and procedure success and a very good safety profile up to 12 months in a low-risk population.

Keywords: NSTEMI; bioresorbable scaffolds; coronary artery disease; magnesium; sirolimus.

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Conflict of interest statement

S.V. reports speaking fees from Biotronik, Elixir Medical, and Neovasc; M.H. reports study grants and personal fees from Biotronik, Abbott Vascular, Cardiac dimensions, and Philips, A.A.B.N. reports grants from Biotronik. J.B. has received research grants and speaking fees from Abbott Vascular and Biotronik AG. All other authors reported no conflict of interest.

Figures

FIGURE 1
FIGURE 1
Magmaris resorption process. m, month; Mg, magnesium
FIGURE 2
FIGURE 2
Subject disposition
FIGURE 3
FIGURE 3
Ischemic status at baseline and follow‐up. Data were available for all patients at baseline, for 1,054 patients at 6 months, and for 1,041 patients at 12 months. NSTEMI, non‐ST‐elevation myocardial infarction
FIGURE 4
FIGURE 4
Estimates of events. CD‐TLR, clinically driven target lesion revascularization; Ext.Hist.Def, Extended historical definitions; SCAI, Society for Cardiovascular Angiography and Interventions; TLF, target lesion failure; TV‐MI, target‐vessel myocardial infarction
See this image and copyright information in PMC

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