Drug-coated Balloon Versus Drug-eluting Stent in Acute Myocardial Infarction (REVELATION)

August 15, 2014 updated by: J.P.R. Herrman, Onze Lieve Vrouwe Gasthuis

Revascularization With Paclitaxel-coated Balloon Angioplasty Versus Drug-eluting Stenting in Acute Myocardial Infarction - a Randomized Controlled Trial.

Rationale: Compared with balloon angioplasty, implantation of bare metal stents (BMS) and drug eluting stents (DES) have shown to reduce repeat target lesion revascularization in primary percutaneous coronary intervention (PPCI). However, this did not result in a reduction of mortality or recurrent myocardial infarction. Furthermore, there are concerns of the occurrence of stent thrombosis. The PAPPA-pilot study, evaluating safety and feasibility of using a drug-coated balloon (DCB) only strategy in PPCI, showed good short- and long-term clinical results, with sustained safety and efficacy at 12 months follow-up. To date little is known about the long-term effects of this treatment modality in STEMI. Besides, angiographic follow-up is of great clinical importance by giving insight on the treated infarct lesion and to assess the functional angioplasty result.

Objective: This randomized controlled, non-inferiority trial is mainly designed to prospectively assess the safety and efficacy of a CE-marked paclitaxel-eluting balloon only strategy vs. third generation DES in the setting of a ST-elevation myocardial infarction (STEMI).

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Rationale: Compared with balloon angioplasty, implantation of bare metal stents (BMS) and drug eluting stents (DES) have shown to reduce repeat target lesion revascularization in primary percutaneous coronary intervention (PPCI). However, this did not result in a reduction of mortality or recurrent myocardial infarction. Furthermore, there are concerns of the occurrence of stent thrombosis. The PAPPA-pilot study, evaluating safety and feasibility of using a drug-coated balloon (DCB) only strategy in PPCI, showed good short- and long-term clinical results, with sustained safety and efficacy at 12 months follow-up. To date little is known about the long-term effects of this treatment modality in STEMI. Besides, angiographic follow-up is of great clinical importance by giving insight on the treated infarct lesion and to assess the functional angioplasty result.

Objective: This randomized controlled, non-inferiority trial is mainly designed to prospectively assess the safety and efficacy of a CE-marked paclitaxel-eluting balloon only strategy vs. third generation DES in the setting of a ST-elevation myocardial infarction (STEMI).

Study design: This is a prospective, single center, non-inferiority, randomized controlled trial.

Study population: All patients presenting with STEMI and suitable for PPCI.

Intervention: PPCI will be performed according to current guidelines. After thrombus aspiration and pre-dilatation, randomization between a DCB only strategy (with bail-out stenting if indicated) and DES will be done by 1:1 ratio. Concomitant medication will be administered according current standards. Control coronary angiography, including measurement of the fractional flow reserve (FFR) of the treated lesion(s), will be performed after 9 months.

Main study parameters/endpoints: The main study parameter is the fractional flow reserve at 9 months follow-up. Secondary study parameters include cardiac death, recurrent myocardial infarction in the target vessel area and ischemia driven target lesion revascularisation at 9 months.

Study Type

Interventional

Enrollment (Anticipated)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Netherlands
      • Amsterdam, Netherlands, 1091 AC
        • Onze Lieve Vrouwe Gasthuis
        • Principal Investigator:
          • R. J. van der Schaaf, MD, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Acute myocardial infarction eligible for primary PCI:
  • > 20 min of chest-pain and at least 1 mm ST-elevation in at least two contiguous leads, a new left bundle branch block or a true posterior myocardial infarction (confirmed by ECG or echocardiography)
  • Reperfusion is expected to be feasible within 12 hours after onset of complaints
  • Infarct related artery eligible for PPCI and:
  • De novo lesion in a native coronary artery
  • Reference-vessel diameter ≥ 2.5mm and ≤ 4mm
  • Without severe calcification
  • Without diameter stenosis of >50% (by visual assessment) after thrombus aspiration and pre-dilatation.

The protocol requires visualization, thrombus aspiration and pre-dilatation of the culprit lesion before inclusion.

Exclusion Criteria:

  • Age < 18 years and > 75 years
  • History of myocardial infarction
  • Known contraindication/resistance for bivalirudin, fondaparinux, heparin, aspirin, prasugrel and/or ticagrelor.
  • Participation in another clinical study, interfering with this protocol
  • Uncertain neurological outcome e.g. resuscitation
  • Intubation/ventilation
  • Cardiogenic shock prior to randomization
  • Known intracranial disease (mass, aneurysm, AVM, hemorrhagic CVA, ischemic CVA/TIA < 6 months prior to inclusion or ischemic CVA with permanent neurological deficit)
  • Gastro-intestinal / urinary tract bleeding < 2 months prior to inclusion
  • Refusal to receive blood transfusion
  • Planned major surgery within 6 weeks
  • Stent implantation < 1 month prior to inclusion
  • Expected mortality from any cause within the next 12 months

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Drug-eluting stent
Treatment of infarct related laesion with a drug-eluting stent
Procedure: Treatment according arm
Experimental: Drug-coated balloon
After treatment of the infarct related artery with a drug-coated ballon, an additional BMS is advised to be used in case of residual stenosis > 50% or coronary artery dissection type > B.
Procedure: Treatment according arm

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fractional flow reserve (FFR)
Time Frame: At 9 months follow-up
Fractional flow reserve is the ratio of mean coronary pressure distal of the treated lesion to mean aortic pressure during maximum hyperemia.
At 9 months follow-up

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Major adverse cardiac event (MACE)
Time Frame: In-hospital, at 1 and 9 months follow-up and at 2, 3, 4 and 5 year follow-up.
  1. Cardiac death (ARC); defined as any death in which a cardiac cause cannot be excluded.
  2. Recurrent MI in the target vessel area.
  3. Ischemia driven target lesion revascularization (PCI within 5 mm of the treated segment in case of balloon, or stent area borders in case of stent, or CABG of the target vessel).
In-hospital, at 1 and 9 months follow-up and at 2, 3, 4 and 5 year follow-up.
Angiographic endpoint: iFR
Time Frame: At 9 months follow-up.
At 9 months follow-up.
ST-segment resolution
Time Frame: 90 minutes after initial procedure
ST-segment resolution post-initial procedure at 90 minutes, defined as the ST-segment deviation resolution in only the single lead showing maximum deviation.
90 minutes after initial procedure
Non-coronary artery bypass grafting major bleeding
Time Frame: At 1 month follow-up
  • Intracranial, intraocular, intra-articular or retroperitoneal bleeding
  • Access site bleed requiring intervention/surgery
  • Hematoma ≥ 5 cm
  • Hemoglobin (Hgb) ≥4 g/dL without an overt source
  • Hgb ≥3 g/dL with an overt source
  • Operation for bleeding
  • Any blood transfusions
At 1 month follow-up
Stent thrombosis
Time Frame: During follow-up
  • Definite or confirmed stent thrombosis: Angiographic confirmation of vessel occlusion or thrombus formation within, or adjacent to, the stented segment or proven stent thrombosis at autopsy.
  • Probable stent thrombosis: Unexplained death within 30 days or target vessel recurrent MI without angiographic confirmation.
  • Possible stent thrombosis: Unexplained death after 30 days.
During follow-up
Angiographic endpoint: TIMI flow
Time Frame: At 9 months follow-up
At 9 months follow-up
Angiographic endpoint: late lumen loss
Time Frame: At 9 months follow-up
At 9 months follow-up
Angiographic endpoint: minimal lumen diameter
Time Frame: At 9 months follow-up
At 9 months follow-up
Angiographic endpoint: diameter stenosis
Time Frame: At 9 months follow-up
At 9 months follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Onze Lieve Vrouwe Gasthuis

Collaborators

Biotronik SE & Co. KG
Volcano Corporation

Investigators

  • Principal Investigator: R. J. van der Schaaf, MD, PhD, OLVG

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2014

Primary Completion (Anticipated)

December 1, 2016

Study Registration Dates

First Submitted

June 30, 2014

First Submitted That Met QC Criteria

August 15, 2014

First Posted (Estimate)

August 19, 2014

Study Record Updates

Last Update Posted (Estimate)

August 19, 2014

Last Update Submitted That Met QC Criteria

August 15, 2014

Last Verified

August 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NL48495.100.14

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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