MAGnesium-based Bioresorbable Scaffold in ST Segment Elevation Myocardial Infarction (MAGSTEMI)

• ClinicalTrials.gov Identifier: NCT03234348
• Recruitment Status: Completed
• First Posted: July 31, 2017
• Last Update Posted: April 17, 2020
• Sponsor: Hospital Clinic of Barcelona
• Collaborator: Spanish Society of Cardiology
• Information provided by (Responsible Party): Manel Sabate, MD, Hospital Clinic of Barcelona

Study Description

Brief Summary:

This is a prospective, randomized, active control, single-blind, non-inferiority, multicenter clinical trial. 148 subjects will be registered at up to 10 Spanish sites. Subjects will be followed for 5 years.

All eligible patients (STEMI < 12 hours from onset of chest pain) will be randomized to

• Biotronik MAGMARISTM Sirolimus Eluting Bioresorbable Vascular Scaffold System (M-BRS) or
• Biotronik ORSIRO Sirolimus Eluting Coronary Stent System

Endothelium-independent vasomotor response (NTG injection) will be analyzed at 12 months angiographic follow-up (Primary endpoint).

In a subgroup of 40 patients Optical Coherence Tomography will be performed after the procedure and at 12 months follow-up.

Angiographic (QCA pre- and post-procedure and at 12 months follow-up), OCT data (at 12 months follow-up) will be analyzed off-line by an independent core lab.

Condition or disease	Intervention/treatment	Phase
Acute Coronary Syndrome; ST Segment Elevation Myocardial Infarction; Stent	Device: Percutaneous coronary intervention	Phase 3

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 151 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment

Intervention Model Description

Patients will be randomised to one of two groups:

MAGMARIS stent arm or ORSIRO stent arm in the ratio of 1:1

• Masking: Double (Participant, Outcomes Assessor)
• Masking Description: Neither the participant ot the outcomes assessor will be aware of the treatment received. The patient will be blinded until the primary endpoint is reached (1 year follow-up).
• Primary Purpose: Treatment
• Official Title: MAGnesium-based Bioresorbable Scaffold and Vasomotor Function in Patients With Acute ST Segment Elevation Myocardial Infarction
• Actual Study Start Date: July 1, 2017
• Actual Primary Completion Date: June 30, 2019
• Actual Study Completion Date: October 31, 2019

Arms and Interventions

Arm	Intervention/treatment
Experimental: Magmaris; Percutaneous coronary intervention by means of Magnesium-based sirolimus-eluting bioresorbable scaffold implantation after proper lesion preparation by balloon predilatation and/or manual thrombectomy.	Device: Percutaneous coronary intervention; PCI + stent implantation; Other Name: stent implantation
Placebo Comparator: Orsiro; Percutaneous coronary intervention by means of Biodegradable polymer sirolimus-eluting stent implantation after proper lesion preparation by balloon predilatation and/or manual thrombectomy.	Device: Percutaneous coronary intervention; PCI + stent implantation; Other Name: stent implantation

Outcome Measures

Primary Outcome Measures :

1. In-stent/scaffold vasodilatory endothelium independent response [ Time Frame: 12 months follow-up ]
   in-stent/scaffold vasodilatory response ≥3% (delta in mean lumen diameter) after nitroglycerin injection

Secondary Outcome Measures :

1. Device success [ Time Frame: Immediate after the procedure ]
   implantation of the intended device with attainment of <30% residual stenosis of the target lesion and TIMI ≥2
2. Procedure success [ Time Frame: Up to 7 days ]
   device success and no in-hospital cardiac events: death, repeat MI, TVR or stent/scaffold thrombosis
3. Device-oriented Composite Endpoint (DOCE) [ Time Frame: 1, 6 months, 1,2,3,4,5 years ]
   Combined of cardiac death, Target vessel MI, or clinically-indicated target lesion revascularization
4. Cardiac death [ Time Frame: 1, 6 months, 1,2,3,4,5 years ]
   ARC definition
5. Target vessel MI [ Time Frame: 1, 6 months, 1,2,3,4,5 years ]
   ARC definition
6. Clinically driven target lesion revascularization [ Time Frame: 1, 6 months, 1,2,3,4,5 years ]
   ARC definition-Ischemia driven revascularization
7. Stent/scaffold thrombosis [ Time Frame: 1, 6 months, 1,2,3,4,5 years ]
   ARC definition: definite, probable, possible, acute, subacute, late and very late
8. Patient oriented endpoint (POCE) [ Time Frame: 1, 6 months, 1,2,3,4,5 years ]
   Combined of all-cause death, any repeat myocardial infarction and any revascularization
9. All-cause death [ Time Frame: 1, 6 months, 1,2,3,4,5 years ]
   All-cause death rate
10. Any repeat myocardial infarction [ Time Frame: 1, 6 months, 1,2,3,4,5 years ]
    According to WHO extended definition
11. Any revascularization [ Time Frame: 1, 6 months, 1,2,3,4,5 years ]
    Any repeat intervention in the patient
12. Target lesion revascularization [ Time Frame: 1, 6 months, 1,2,3,4,5 years ]
    ARC definition
13. Target vessel revascularization [ Time Frame: 1, 6 months, 1,2,3,4,5 years ]
    ARC definition
14. MLD [ Time Frame: Baseline and 1 year follow-up ]
    Minimal lumen diameter by QCA
15. %DS [ Time Frame: Baseline and 1 year follow-up ]
    percentage diameter stenosis by QCA
16. Acute gain [ Time Frame: Baseline ]
    MLD post - MLD pre by QCA
17. Late loss [ Time Frame: 1 year ]
    MLD post - MLD at 1 year follow-up by QCA
18. Binary restenosis [ Time Frame: 1 year ]
    % of patients with >50% DS at 1 year follow-up by QCA
19. Lumen area [ Time Frame: 1 year follow-up ]
    Mean and minimum lumen area of the stented/scaffolded segment by OCT
20. Mean lumen volume [ Time Frame: 1 year follow-up ]
    mean lumen volume of the stented/scaffolded segment by OCT
21. % strut malapposition [ Time Frame: 1 year follow-up ]
    mean area of strut malapposition by OCT
22. Tissue Prolapse [ Time Frame: 1 year follow-up ]
    presence and % of lumen area occupied by tissue prolapse by OCT
23. Neointimal hyperplasia [ Time Frame: 1 year follow-up ]
    mean intra-stent/scaffold area occupied by neointimal hyperplasia by OCT
24. Healing index [ Time Frame: 1 year follow-up ]
    Index obtained by a combination of % malapposition, % coverage, % tissue prolapse by OCT
25. Strut coverage [ Time Frame: 1 year follow-up ]
    Presence and amount of tissue covering the strut of the stent/scaffold by OCT
26. RUTTS [ Time Frame: 1 year follow-up ]
    Ratio of Uncovered to Total Stent/scaffold Struts Per Cross Section (RUTTS) score of ≤30% of the target stent/scaffold as determined by OCT pullback
27. in-stent/in-scaffold endothelium-dependent vasomotion [ Time Frame: at 12 months ]
    % change in mean luminal dimeter on the treated segment after acetylcholine infusion

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 90 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

Clinical:

1. At least 18 years of age.
2. ST-segment elevation Myocardial Infarction documented in an ambulance or in a Cathlab, with ≥2 mm ST segment elevation in at least two contiguous leads, presenting in the Cathlab <12 hours after the onset of symptoms lasting ≥20 min requiring primary PCI.
3. Target lesion must be a de-novo lesion located in a native vessel.
4. The patient accepts Informed Consent

5. The patient understands and accepts clinical follow-up and angiographic control.

   Angiographic:

6. Vessel size should match available M-BRS scaffold sizes (≥2.75 mm, and ≤3.7 mm by visual assessment).
7. Lesion preparation by either manual thrombectomy or pre-dilatation has been successful, with opening of the vessel and TIMI ≥2 and residual stenosis <20%.

Exclusion Criteria:

1. Pregnancy.
2. Known intolerance to aspirin, heparin, stainless steel, sirolimus, and contrast material.
3. Distal vessel occlusion after recanalization
4. STEMI due to stent/scaffold thrombosis
5. Severe tortuous, calcified or angulated coronary anatomy of the study vessel that in the opinion of the investigator would result in sub-optimal m-BRS placement.
6. Fibrinolysis prior to PCI
7. Known thrombocytopenia (PLT< 100,000/mm3)
8. Active bleeding or coagulopathy or patients at chronic anticoagulation therapy
9. Cardiogenic Shock
10. Significant comorbidities precluding clinical/angiographic FU (as judged by investigators)
11. Major planned surgery that requires discontinuation of dual antiplatelet therapy.
12. Diffuse coronary artery disease that will require CABG
13. Chronic kidney disease with GFR<30 ml/min

Contacts and Locations

Locations

Spain

Hospital General de Alicante

Alicante, Spain

Hospital Clínic

Barcelona, Spain, 08036

Hospital Sant Pau

Barcelona, Spain

Hospital Universitari Bellvitge

Barcelona, Spain

Hospital Vall d'Hebron

Barcelona, Spain

Hospital San Pedro de Alcántara

Cáceres, Spain

Hospital Clínico San Carlos

Madrid, Spain

Hospital La Princesa

Madrid, Spain

Hospital Puerta de Hierro Majadahonda

Madrid, Spain

Hospital Ramon y Cajal

Madrid, Spain

Hospital Alvaro Cunqueiro

Vigo, Spain

Sponsors and Collaborators

Hospital Clinic of Barcelona

Spanish Society of Cardiology

Investigators

• Principal Investigator: Manel Sabaté, MD; Hospital Clinic of Barcelona

More Information

Publications of Results:

Sabate M, Alfonso F, Cequier A, Romani S, Bordes P, Serra A, Iniguez A, Salinas P, Garcia Del Blanco B, Goicolea J, Hernandez-Antolin R, Cuesta J, Gomez-Hospital JA, Ortega-Paz L, Gomez-Lara J, Brugaletta S. Magnesium-Based Resorbable Scaffold Versus Permanent Metallic Sirolimus-Eluting Stent in Patients With ST-Segment Elevation Myocardial Infarction: The MAGSTEMI Randomized Clinical Trial. Circulation. 2019 Dec 3;140(23):1904-1916. doi: 10.1161/CIRCULATIONAHA.119.043467. Epub 2019 Sep 25.

Other Publications:

Brugaletta S, Cequier A, Alfonso F, Iniguez A, Romani S, Serra A, Salinas P, Goicolea J, Bordes P, Del Blanco BG, Hernandez-Antolin R, Pernigotti A, Gomez-Lara J, Sabate M. MAGnesium-based bioresorbable scaffold and vasomotor function in patients with acute ST segment elevation myocardial infarction: The MAGSTEMI trial: Rationale and design. Catheter Cardiovasc Interv. 2019 Jan 1;93(1):64-70. doi: 10.1002/ccd.27825. Epub 2018 Sep 9.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Gomez-Lara J, Ortega-Paz L, Brugaletta S, Cuesta J, Romani S, Serra A, Salinas P, Garcia Del Blanco B, Goicolea J, Hernandez-Antolin R, Antuna P, Romaguera R, Regueiro A, Rivero F, Cequier A, Alfonso F, Gomez-Hospital JA, Sabate M; Collaborators. Bioresorbable scaffolds versus permanent sirolimus-eluting stents in patients with ST-segment elevation myocardial infarction: vascular healing outcomes from the MAGSTEMI trial. EuroIntervention. 2020 Dec 4;16(11):e913-e921. doi: 10.4244/EIJ-D-20-00198.

• Responsible Party: Manel Sabate, MD, MD, PhD, Hospital Clinic of Barcelona
• ClinicalTrials.gov Identifier: NCT03234348
• Other Study ID Numbers: MAG-01
• First Posted: July 31, 2017
• Last Update Posted: April 17, 2020
• Last Verified: April 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• Plan Description: Data on primary/secondary outcomes on individual basis may be shared with other researchers once main report as been published and review and approval of the research proposal by the steering committee of the Magstemi Trial
• Supporting Materials: Study Protocol; Statistical Analysis Plan (SAP); Clinical Study Report (CSR)
• Time Frame: Data on primary/secondary outcomes on individual basis may be shared with other researchers once main report as been published and review and approval of the research proposal by the steering committee of the Magstemi Trial

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Manel Sabate, MD, Hospital Clinic of Barcelona:

biodegradable stent; STEMI; Magnesium bioresorbable; Vasomotion

Additional relevant MeSH terms:

Myocardial Infarction; Acute Coronary Syndrome; ST Elevation Myocardial Infarction; Infarction; Ischemia; Pathologic Processes; Necrosis; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases