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

MAGnesium-based Bioresorbable Scaffold and Vasomotor Function in Patients With Acute ST Segment Elevation Myocardial Infarction

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.

Study Overview

• Status: Completed
• Conditions: Acute Coronary Syndrome; ST Segment Elevation Myocardial Infarction; Stent
• Intervention / Treatment: Device: Percutaneous coronary intervention

• Study Type: Interventional
• Enrollment (Actual): 151
• Phase: Phase 3

Contacts and Locations

Study Locations

• Spain
  • Alicante, Spain
    • Hospital General de Alicante
  • Barcelona, Spain, 08036
    • Hospital Clinic
  • Barcelona, Spain
    • Hospital Vall d'Hebron
  • Barcelona, Spain
    • Hospital Sant Pau
  • Barcelona, Spain
    • Hospital Universitari Bellvitge
  • Cáceres, Spain
    • Hospital San Pedro de Alcantara
  • Madrid, Spain
    • Hospital Ramón y Cajal
  • Madrid, Spain
    • Hospital Clinico San Carlos
  • Madrid, Spain
    • Hospital La Princesa
  • Madrid, Spain
    • Hospital Puerta de Hierro Majadahonda
  • Vigo, Spain
    • Hospital Álvaro Cunqueiro

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: 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 Names: stent implantation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
In-stent/scaffold vasodilatory endothelium independent response	in-stent/scaffold vasodilatory response ≥3% (delta in mean lumen diameter) after nitroglycerin injection	12 months follow-up

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Hospital Clinic of Barcelona
• Collaborators: Spanish Society of Cardiology
• Investigators: Principal Investigator: Manel Sabaté, MD, Hospital Clinic of Barcelona

Publications and helpful links

General 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 1, 2017
• Primary Completion (ACTUAL): June 30, 2019
• Study Completion (ACTUAL): October 31, 2019

Study Registration Dates

• First Submitted: July 24, 2017
• First Submitted That Met QC Criteria: July 26, 2017
• First Posted (ACTUAL): July 31, 2017

Study Record Updates

• Last Update Posted (ACTUAL): April 17, 2020
• Last Update Submitted That Met QC Criteria: April 15, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Keywords: STEMI; biodegradable stent; Magnesium bioresorbable; Vasomotion
• Additional Relevant MeSH Terms: Ischemia; Pathologic Processes; Necrosis; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Myocardial Infarction; Infarction; ST Elevation Myocardial Infarction; Acute Coronary Syndrome
• Other Study ID Numbers: MAG-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD 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
• IPD Sharing 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
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No