Acute Coronary Syndrome, Stent, ST Segment Elevation Myocardial Infarction
Conditions
Keywords
biodegradable stent, STEMI, Magnesium bioresorbable, Vasomotion
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.
Interventions
DEVICEPercutaneous coronary intervention
PCI + stent implantation
Sponsors
Spanish Society of Cardiology
Hospital Clinic of Barcelona
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, 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).
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
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| In-stent/scaffold vasodilatory endothelium independent response | 12 months follow-up | in-stent/scaffold vasodilatory response ≥3% (delta in mean lumen diameter) after nitroglycerin injection |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Procedure success | Up to 7 days | device success and no in-hospital cardiac events: death, repeat MI, TVR or stent/scaffold thrombosis |
| Device-oriented Composite Endpoint (DOCE) | 1, 6 months, 1,2,3,4,5 years | Combined of cardiac death, Target vessel MI, or clinically-indicated target lesion revascularization |
| Cardiac death | 1, 6 months, 1,2,3,4,5 years | ARC definition |
| Target vessel MI | 1, 6 months, 1,2,3,4,5 years | ARC definition |
| Clinically driven target lesion revascularization | 1, 6 months, 1,2,3,4,5 years | ARC definition-Ischemia driven revascularization |
| Stent/scaffold thrombosis | 1, 6 months, 1,2,3,4,5 years | ARC definition: definite, probable, possible, acute, subacute, late and very late |
| Patient oriented endpoint (POCE) | 1, 6 months, 1,2,3,4,5 years | Combined of all-cause death, any repeat myocardial infarction and any revascularization |
| All-cause death | 1, 6 months, 1,2,3,4,5 years | All-cause death rate |
| Any repeat myocardial infarction | 1, 6 months, 1,2,3,4,5 years | According to WHO extended definition |
| Any revascularization | 1, 6 months, 1,2,3,4,5 years | Any repeat intervention in the patient |
| Target lesion revascularization | 1, 6 months, 1,2,3,4,5 years | ARC definition |
| Target vessel revascularization | 1, 6 months, 1,2,3,4,5 years | ARC definition |
| MLD | Baseline and 1 year follow-up | Minimal lumen diameter by QCA |
| Device success | Immediate after the procedure | implantation of the intended device with attainment of \<30% residual stenosis of the target lesion and TIMI ≥2 |
| Acute gain | Baseline | MLD post - MLD pre by QCA |
| Late loss | 1 year | MLD post - MLD at 1 year follow-up by QCA |
| Binary restenosis | 1 year | % of patients with \>50% DS at 1 year follow-up by QCA |
| Lumen area | 1 year follow-up | Mean and minimum lumen area of the stented/scaffolded segment by OCT |
| Mean lumen volume | 1 year follow-up | mean lumen volume of the stented/scaffolded segment by OCT |
| % strut malapposition | 1 year follow-up | mean area of strut malapposition by OCT |
| Tissue Prolapse | 1 year follow-up | presence and % of lumen area occupied by tissue prolapse by OCT |
| Neointimal hyperplasia | 1 year follow-up | mean intra-stent/scaffold area occupied by neointimal hyperplasia by OCT |
| Healing index | 1 year follow-up | Index obtained by a combination of % malapposition, % coverage, % tissue prolapse by OCT |
| Strut coverage | 1 year follow-up | Presence and amount of tissue covering the strut of the stent/scaffold by OCT |
| RUTTS | 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 |
| in-stent/in-scaffold endothelium-dependent vasomotion | at 12 months | % change in mean luminal dimeter on the treated segment after acetylcholine infusion |
| %DS | Baseline and 1 year follow-up | percentage diameter stenosis by QCA |
Countries
Spain
Outcome results
None listed