Clinical trial NCT01986803: ABSORB STEMI: the TROFI II Study
Official title: Comparison of the ABSORBTM Everolimus Eluting Bioresorbable Vascular Scaffold System With a Drug- Eluting Metal Stent (XienceTM) in Acute ST-Elevation Myocardial Infarction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute ST Segment Elevation Myocardial Infarction
Keywords: ST-elevation Myocardial Infarction (STEMI)
Primary Percutaneous Coronary Intervention within 24 hrs
Healing score
OFDI
Lead sponsor: ECRI bv
Sponsor class: INDUSTRY
Collaborators: name: Abbott Medical Devices
name: Terumo Europe N.V.
First posted: 2013-11-19
Enrollment: 191
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a Prospective, randomized (1:1), active control, single-blind, non-inferiority, European multicenter clinical trial.

The primary objective of this study is to assess the neointimal healing score (as evaluated by intra-coronary OFDI) in patients with ST-elevation Myocardial Infarction (STEMI) and treated with Abbott Vascular ABSORB everolimus eluting bioresorbable vascular scaffold (BVS) at 6 months follow-up by comparing with a metallic drug eluting stent (XIENCE). Furthermore, the safety and feasibility of implanting ABSORB BVS in patients with STEMI is assessed.

It is hypothesized that acutely and at 6 months follow-up implantation of the ABSORB fully bioresorbable everolimus-eluting scaffold is at least as safe as implantation of metallic drug-eluting stent, and that at late follow-up the ABSORB scaffold could improve the arterial healing process and potentially reduce late stent thrombosis in patients presenting with STEMI.

This is a preparatory trial in anticipation of a major outcome study.

Detailed description: A total of 190 patients will be included in this trial, at 8-10 European sites.

The primary endpoint is arterial healing at 6 month follow up. To assess the arterial healing, at 6 months follow-up all patients will undergo angiographic follow-up with OFDI investigation. To score the arterial healing, a Healing Score is used.

Eligibility criteria: Inclusion Criteria:

1. Subject must be at least 18 years of age;
2. Primary PCI within 24 hours of symptom onset;
3. ST-segment elevation of \> 1mm in \> 2 contiguous leads, or (presumably new) left bundle branch block, or true posterior MI with ST depression of \>1mm in \>2 contiguous anterior leads;
4. Presence of at least one acute infarct artery target vessel with one or more coronary artery stenoses in a native coronary artery within planned device deployment segment (Dmax) by visual estimation of ≥ 2.5 mm and ≤ 3.8 mm;
5. Subject agrees to not participate in any other investigational or invasive clinical study for a period of 6 months following the index procedure.

Exclusion Criteria:

1. Inability to provide informed consent;
2. Known pregnancy at time of randomization. Female who is breastfeeding at time of randomization;
3. Known intolerance to aspirin, heparin, PLLA (poly(L-lactic acid), everolimus, contrast material;
4. Cardiogenic Shock;
5. Unprotected left main coronary artery stenosis;
6. Distal occlusion of target vessel;
7. Acute myocardial infarction secondary to stent thrombosis;
8. Mechanical complications of acute myocardial infarction;
9. Severe tortuous, calcified or angulated coronary anatomy of the study vessel that in the opinion of the investigator would result in sub-optimal imaging or excessive risk of complication from placement of an OFDI catheter;
10. Fibrinolysis prior to PCI;
11. Active bleeding or coagulopathy or patients at chronic anticoagulation therapy;
12. Subject is currently participating in another clinical trial that has not yet completed its primary endpoint.

Primary outcomes:
measure: Healing Score
timeFrame: 6 months follow-up
Secondary outcomes:
measure: Procedure success
timeFrame: Study patients will be followed for the duration of hospital stay (e.g. until hospital discharge), an expected average of 2 days.
measure: Device-Oriented Composite Endpoint
timeFrame: Up to 3 years
measure: Cardiac Death
timeFrame: Up to 6 months
measure: Cardiac Death
timeFrame: Up to 3 years
measure: MI not clearly attributable to a non-intervention vessel
timeFrame: Up to 6 months
measure: MI not clearly attributable to a non-intervention vessel
timeFrame: Up to 3 years
measure: Clinically-indicated target lesion revascularization
timeFrame: Up to 6 months
measure: Clinically-indicated target lesion revascularization
timeFrame: Up to 3 years
measure: All-cause death at all timepoints
timeFrame: Up to 6 months
measure: All-cause death at all timepoints
timeFrame: Up to 3 years
measure: Any Myocardial Infarction at all timepoints
timeFrame: Up to 6 months
measure: Any Myocardial Infarction at all timepoints
timeFrame: Up to 3 years
measure: Non Ischemia-driven target lesion revascularization (TLR) at all timepoints
timeFrame: Up to 6 months
measure: Non Ischemia-driven target lesion revascularization (TLR) at all timepoints
timeFrame: Up to 3 years
measure: Ischemia-driven and non ischemia-driven target vessel revascularization (TVR) at all timepoints
timeFrame: Up to 6 months
measure: Ischemia-driven and non ischemia-driven target vessel revascularization (TVR) at all timepoints
timeFrame: Up to 3 years
measure: Scaffold/Stent thrombosis according to ARC definitions at all timepoints
timeFrame: Up to 6 months
measure: Scaffold/Stent thrombosis according to ARC definitions at all timepoints
timeFrame: Up to 3 years
measure: Angina Class at all timepoints
timeFrame: Up to 6 months
measure: Angina Class at all timepoints
timeFrame: Up to 3 years
measure: Other Serious Adverse Events at all timepoints
timeFrame: Up to 6 months
measure: Other Serious Adverse Events at all timepoints
timeFrame: Up to 3 years
measure: Device-Oriented Composite Endpoint
timeFrame: Up to 6 months
measure: Percent diameter stenosis (%DS)
timeFrame: Up to 6-months
measure: Minimal Lumen Diameter(MLD)
timeFrame: Up to 6-months
measure: Late loss of the target lesion
timeFrame: Up to 6-months
measure: Angiographic binary restenosis (ABR)
timeFrame: Up to 6-months
measure: Presence of filling defect (%ILD)
timeFrame: 6-months
measure: Presence of both malapposed and uncovered struts (%MN)
timeFrame: 6-months
measure: Presence of uncovered struts alone(%N)
timeFrame: 6-months
measure: Presence of malapposed struts alone(%M)
timeFrame: 6-months
measure: Mean/minimal scaffold/stent diameter/area/volume
timeFrame: 6-months
measure: Mean/minimal lumen diameter/area/volume
timeFrame: 6-months
measure: Incomplete strut apposition (ISA) area/volume
timeFrame: 6-months
measure: Percentage of covered struts
timeFrame: 6-months
measure: Mean/maximal thickness of the struts coverage
timeFrame: 6-months
measure: Neointimal hyperplasia area/volume
timeFrame: 6-months
measure: Mean Flow area/volume
timeFrame: 6-months
measure: Intraluminal defect area/volume
timeFrame: 6-months
measure: Thickness of neointimal tissue developed over lipid rich plaque
timeFrame: 6-months
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Research centre Aarhus, DK003
city: Odense
country: Denmark
facility: Research centre Odense, DK002
city: Leeuwarden
country: Netherlands
facility: Research centre Leeuwarden, NL002
city: Nieuwegein
country: Netherlands
facility: Research centre Nieuwegein, NL014
city: Barcelona
country: Spain
facility: Research centre Barcelona, ES001
city: Barcelona
country: Spain
facility: Research centre Barcelona, ES003
city: Vigo
country: Spain
facility: Research centre Vigo, ES004
city: Bern
country: Switzerland
facility: Research centre Bern, CH006
Study officials:
affiliation: Erasmus Medical Centre Rotterdam, the Netherlands
name: P. Serruys, Prof.
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Barcelona, Spain
name: M. Sabaté, Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Bern University Hospital, Bern, Switzerland
name: S. Windecker, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Cassese S, Katagiri Y, Byrne RA, Brugaletta S, Alfonso F, Raber L, Maeng M, Iniguez A, Kretov E, Onuma Y, Joner M, Sabate M, Laugwitz KL, Windecker S, Kastrati A, Serruys PW. Angiographic and clinical outcomes of STEMI patients treated with bioresorbable or metallic everolimus-eluting stents: a pooled analysis of individual patient data. EuroIntervention. 2020 Mar 20;15(16):1451-1457. doi: 10.4244/EIJ-D-18-01080.
citation: Yamaji K, Brugaletta S, Sabate M, Iniguez A, Jensen LO, Cequier A, Hofma SH, Christiansen EH, Suttorp M, van Es GA, Sotomi Y, Onuma Y, Serruys PW, Windecker S, Raber L. Effect of Post-Dilatation Following Primary PCI With Everolimus-Eluting Bioresorbable Scaffold Versus Everolimus-Eluting Metallic Stent Implantation: An Angiographic and Optical Coherence Tomography TROFI II Substudy. JACC Cardiovasc Interv. 2017 Sep 25;10(18):1867-1877. doi: 10.1016/j.jcin.2017.07.035.