Clinical trial NCT03234348: MAGnesium-based Bioresorbable Scaffold in ST Segment Elevation Myocardial Infarction
Official title: MAGnesium-based Bioresorbable Scaffold and Vasomotor Function in Patients With Acute ST Segment Elevation Myocardial Infarction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Acute Coronary Syndrome
ST Segment Elevation Myocardial Infarction
Stent
Keywords: biodegradable stent
STEMI
Magnesium bioresorbable
Vasomotion
Lead sponsor: Hospital Clinic of Barcelona
Sponsor class: OTHER
Collaborators: name: Spanish Society of Cardiology
First posted: 2017-07-31
Enrollment: 151
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: In-stent/scaffold vasodilatory endothelium independent response
timeFrame: 12 months follow-up
Secondary outcomes:
measure: Device success
timeFrame: Immediate after the procedure
measure: Procedure success
timeFrame: Up to 7 days
measure: Device-oriented Composite Endpoint (DOCE)
timeFrame: 1, 6 months, 1,2,3,4,5 years
measure: Cardiac death
timeFrame: 1, 6 months, 1,2,3,4,5 years
measure: Target vessel MI
timeFrame: 1, 6 months, 1,2,3,4,5 years
measure: Clinically driven target lesion revascularization
timeFrame: 1, 6 months, 1,2,3,4,5 years
measure: Stent/scaffold thrombosis
timeFrame: 1, 6 months, 1,2,3,4,5 years
measure: Patient oriented endpoint (POCE)
timeFrame: 1, 6 months, 1,2,3,4,5 years
measure: All-cause death
timeFrame: 1, 6 months, 1,2,3,4,5 years
measure: Any repeat myocardial infarction
timeFrame: 1, 6 months, 1,2,3,4,5 years
measure: Any revascularization
timeFrame: 1, 6 months, 1,2,3,4,5 years
measure: Target lesion revascularization
timeFrame: 1, 6 months, 1,2,3,4,5 years
measure: Target vessel revascularization
timeFrame: 1, 6 months, 1,2,3,4,5 years
measure: MLD
timeFrame: Baseline and 1 year follow-up
measure: %DS
timeFrame: Baseline and 1 year follow-up
measure: Acute gain
timeFrame: Baseline
measure: Late loss
timeFrame: 1 year
measure: Binary restenosis
timeFrame: 1 year
measure: Lumen area
timeFrame: 1 year follow-up
measure: Mean lumen volume
timeFrame: 1 year follow-up
measure: % strut malapposition
timeFrame: 1 year follow-up
measure: Tissue Prolapse
timeFrame: 1 year follow-up
measure: Neointimal hyperplasia
timeFrame: 1 year follow-up
measure: Healing index
timeFrame: 1 year follow-up
measure: Strut coverage
timeFrame: 1 year follow-up
measure: RUTTS
timeFrame: 1 year follow-up
measure: in-stent/in-scaffold endothelium-dependent vasomotion
timeFrame: at 12 months
Other outcomes:
Locations:
city: Alicante
country: Spain
facility: Hospital General de Alicante
city: Barcelona
country: Spain
facility: Hospital Clínic
city: Barcelona
country: Spain
facility: Hospital Sant Pau
city: Barcelona
country: Spain
facility: Hospital Universitari Bellvitge
city: Barcelona
country: Spain
facility: Hospital Vall d'Hebron
city: Cáceres
country: Spain
facility: Hospital San Pedro de Alcántara
city: Madrid
country: Spain
facility: Hospital Clínico San Carlos
city: Madrid
country: Spain
facility: Hospital La Princesa
city: Madrid
country: Spain
facility: Hospital Puerta de Hierro Majadahonda
city: Madrid
country: Spain
facility: Hospital Ramon y Cajal
city: Vigo
country: Spain
facility: Hospital Alvaro Cunqueiro
Study officials:
affiliation: Hospital Clinic of Barcelona
name: Manel Sabaté, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.