ABSORB STEMI: the TROFI II Study

Comparison of the ABSORBTM Everolimus Eluting Bioresorbable Vascular Scaffold System With a Drug- Eluting Metal Stent (XienceTM) in Acute ST-Elevation Myocardial Infarction

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.

Study Overview

• Status: Completed
• Conditions: Acute ST Segment Elevation Myocardial Infarction
• Intervention / Treatment: Device: Percutaneous Coronary Intervention

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.

• Study Type: Interventional
• Enrollment (Actual): 191
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Aarhus, Denmark
    • Research centre Aarhus, DK003
  • Odense, Denmark
    • Research centre Odense, DK002
• Netherlands
  • Leeuwarden, Netherlands
    • Research centre Leeuwarden, NL002
  • Nieuwegein, Netherlands
    • Research centre Nieuwegein, NL014
• Spain
  • Barcelona, Spain
    • Research centre Barcelona, ES001
  • Barcelona, Spain
    • Research centre Barcelona, ES003
  • Vigo, Spain
    • Research centre Vigo, ES004
• Switzerland
  • Bern, Switzerland
    • Research centre Bern, CH006

Participation Criteria

Eligibility Criteria

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

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: PCI with ABSORBTM bioresorbable vascular scaffold system (BVS); All patients assigned to the experimental arm will be treated with a primary Percutaneous Coronary Intervention using the Abbott Vascular ABSORB TM everolimus eluting bioresorbable vascular scaffold system (BVS)	Device: Percutaneous Coronary Intervention; Implanting a device ("Xience Xpedition" stent or "Abbott Vascular ABSORBTM everolimus eluting bioresorbable vascular scaffold system (BVS)" to open a diseased coronary artery by going to the coronary artery subcutaneously through the arteries from the radial or femoral artery access point.
ACTIVE_COMPARATOR: PCI with XIENCE Xpedition stent; All patients assigned to the experimental arm will be treated with a primary Percutaneous Coronary Intervention using the XIENCE Everolimus Eluting Coronary Stent System (XIENCE Xpedition) (commercial product)	Device: Percutaneous Coronary Intervention; Implanting a device ("Xience Xpedition" stent or "Abbott Vascular ABSORBTM everolimus eluting bioresorbable vascular scaffold system (BVS)" to open a diseased coronary artery by going to the coronary artery subcutaneously through the arteries from the radial or femoral artery access point.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Healing Score	The primary endpoint is: Healing Score at 6 months follow-up. This is measured with OFDI imaging. This Healing Score is a weighted index that combines the following parameters: Presence of filling defect (%ILD) is assigned weight of "4",; Presence of both malapposed and uncovered struts (%MN) is assigned a weight of "3",; Presence of uncovered struts alone (%N) is assigned a weight of "2" and finally,; Presence of malapposition alone (%M) is assigned a weight of "1".	6 months follow-up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Procedure success	Clinical Endpoint. Procedure success is no in-hospital Device Oriented Composite Endpoint, which is defined as cardiac death, MI not clearly attributable to a non-intervention vessel, and clinically-indicated target lesion revascularization.	Study patients will be followed for the duration of hospital stay (e.g. until hospital discharge), an expected average of 2 days.
Device-Oriented Composite Endpoint	Clinical Endpoint. Device-oriented Composite Endpoint (DoCE) is defined as cardiac death, MI not clearly attributable to a non-intervention vessel, and clinically-indicated target lesion revascularization.	Up to 3 years
Cardiac Death	Clinical Endpoint. One of the individual components of the Device Oriented Composite Endpoints, which is a secondary endpoint on itself.	Up to 6 months
Cardiac Death	Clinical Endpoint. One of the individual components of the Device Oriented Composite Endpoints, which is a secondary endpoint on itself.	Up to 3 years
MI not clearly attributable to a non-intervention vessel	Clinical Endpoint. One of the individual components of the Device Oriented Composite Endpoints, which is a secondary endpoint on itself.	Up to 6 months
MI not clearly attributable to a non-intervention vessel	Clinical Endpoint. One of the individual components of the Device Oriented Composite Endpoints, which is a secondary endpoint on itself.	Up to 3 years
Clinically-indicated target lesion revascularization	Clinical Endpoint. One of the individual components of the Device Oriented Composite Endpoints, which is a secondary endpoint on itself.	Up to 6 months
Clinically-indicated target lesion revascularization	Clinical Endpoint. One of the individual components of the Device Oriented Composite Endpoints, which is a secondary endpoint on itself.	Up to 3 years
All-cause death at all timepoints	Clinical Endpoint.	Up to 6 months
All-cause death at all timepoints	Clinical Endpoint.	Up to 3 years
Any Myocardial Infarction at all timepoints	Clinical Endpoint.	Up to 6 months
Any Myocardial Infarction at all timepoints	Clinical Endpoint.	Up to 3 years
Non Ischemia-driven target lesion revascularization (TLR) at all timepoints	Clinical Endpoint.	Up to 6 months
Non Ischemia-driven target lesion revascularization (TLR) at all timepoints	Clinical Endpoint.	Up to 3 years
Ischemia-driven and non ischemia-driven target vessel revascularization (TVR) at all timepoints	Clinical Endpoint.	Up to 6 months
Ischemia-driven and non ischemia-driven target vessel revascularization (TVR) at all timepoints	Clinical Endpoint.	Up to 3 years
Scaffold/Stent thrombosis according to ARC definitions at all timepoints	Clinical Endpoint. ARC = academic research consortium	Up to 6 months
Scaffold/Stent thrombosis according to ARC definitions at all timepoints	Clinical Endpoint. ARC = academic research consortium	Up to 3 years
Angina Class at all timepoints	Clinical Endpoint. Angina Pectoris	Up to 6 months
Angina Class at all timepoints	Clinical Endpoint. Angina Pectoris	Up to 3 years
Other Serious Adverse Events at all timepoints	Clinical Endpoint.	Up to 6 months
Other Serious Adverse Events at all timepoints	Clinical Endpoint.	Up to 3 years
Device-Oriented Composite Endpoint	Clinical Endpoint. Device-oriented Composite Endpoint (DoCE) is defined as cardiac death, MI not clearly attributable to a non-intervention vessel, and clinically-indicated target lesion revascularization.	Up to 6 months
Percent diameter stenosis (%DS)	Angiographic endpoint. Percent diameter stenosis (%DS)at in in-segment (target lesion), in-device, proximal and distal	Up to 6-months
Minimal Lumen Diameter(MLD)	Angiographic endpoint. Minimal Lumen Diameter(MLD)at in in-segment (target lesion), in-device, proximal and distal	Up to 6-months
Late loss of the target lesion	Angiographic endpoint. Late loss (LL), which is decrease in blood vessel lumen diameter, at in in-segment (target lesion), in-device, proximal and distal	Up to 6-months
Angiographic binary restenosis (ABR)	Angiographic endpoint. Angiographic binary restenosis (ABR)at in in-segment (target lesion), in-device, proximal and distal	Up to 6-months
Presence of filling defect (%ILD)	OFDI endpoint. Presence of filling defect (%ILD), which is an individual component of the primary endpoint "Healing Score".	6-months
Presence of both malapposed and uncovered struts (%MN)	OFDI endpoint. Presence of both malapposed and uncovered struts (%MN)of the index stent, which is an individual component of the primary endpoint "Healing Score".	6-months
Presence of uncovered struts alone(%N)	OFDI endpoint. Presence of both uncovered struts of the index stent, which is an individual component of the primary endpoint "Healing Score".	6-months
Presence of malapposed struts alone(%M)	OFDI endpoint. Presence of both malapposed struts of the index stent, which is an individual component of the primary endpoint "Healing Score".	6-months
Mean/minimal scaffold/stent diameter/area/volume	OFDI endpoint. Mean/minimal scaffold/stent diameter/area/volume at 6-months follow-up.	6-months
Mean/minimal lumen diameter/area/volume	OFDI endpoint. Mean/minimal lumen diameter/area/volume at 6-months follow-up.	6-months
Incomplete strut apposition (ISA) area/volume	OFDI endpoint. Incomplete strut apposition (ISA) area/volume at 6-months follow-up.	6-months
Percentage of covered struts	OFDI endpoint. Percentage of covered struts at 6-months follow-up.	6-months
Mean/maximal thickness of the struts coverage	OFDI endpoint. Mean/maximal thickness of the struts coverage at 6-months follow-up.	6-months
Neointimal hyperplasia area/volume	OFDI endpoint. Neointimal hyperplasia area/volume at 6-months follow-up.	6-months
Mean Flow area/volume	OFDI endpoint. Mean Flow area/volume at 6-months follow-up.	6-months
Intraluminal defect area/volume	OFDI endpoint. Intraluminal defect area/volume at 6-months follow-up.	6-months
Thickness of neointimal tissue developed over lipid rich plaque	OFDI endpoint. Thickness of neointimal tissue developed over lipid rich plaque at 6-months follow-up.	6-months

Collaborators and Investigators

• Sponsor: ECRI bv
• Collaborators: Terumo Europe N.V.; Abbott Medical Devices
• Investigators: Principal Investigator: P. Serruys, Prof., Erasmus Medical Centre Rotterdam, the Netherlands; Principal Investigator: M. Sabaté, Dr., University of Barcelona, Spain; Principal Investigator: S. Windecker, Dr., Bern University Hospital, Bern, Switzerland

Publications and helpful links

General Publications

• 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.
• 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.

Helpful Links

• Primary endpoint manuscript (PUBMED ID: 26405232)

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 6, 2014
• Primary Completion (ACTUAL): April 13, 2015
• Study Completion (ACTUAL): September 21, 2017

Study Registration Dates

• First Submitted: August 29, 2013
• First Submitted That Met QC Criteria: November 16, 2013
• First Posted (ESTIMATE): November 19, 2013

Study Record Updates

• Last Update Posted (ACTUAL): July 24, 2018
• Last Update Submitted That Met QC Criteria: July 23, 2018
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Keywords: OFDI; ST-elevation Myocardial Infarction (STEMI); Primary Percutaneous Coronary Intervention within 24 hrs; Healing score
• Additional Relevant MeSH Terms: Ischemia; Pathologic Processes; Necrosis; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Myocardial Infarction; Infarction; ST Elevation Myocardial Infarction
• Other Study ID Numbers: ECRI-003