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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified August 2014 by Onze Lieve Vrouwe Gasthuis
Sponsor:
Collaborators:
Biotronik SE & Co. KG
Volcano Corporation
Information provided by (Responsible Party):
J.P.R. Herrman, Onze Lieve Vrouwe Gasthuis
ClinicalTrials.gov Identifier:
NCT02219802
First received: June 30, 2014
Last updated: August 15, 2014
Last verified: August 2014
  Purpose

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).


Condition Intervention
Coronary Artery Disease
Acute Myocardial Infarction
Procedure: Treatment according arm

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Revascularization With Paclitaxel-coated Balloon Angioplasty Versus Drug-eluting Stenting in Acute Myocardial Infarction - a Randomized Controlled Trial.

Resource links provided by NLM:


Further study details as provided by Onze Lieve Vrouwe Gasthuis:

Primary Outcome Measures:
  • Fractional flow reserve (FFR) [ Time Frame: At 9 months follow-up ] [ Designated as safety issue: No ]
    Fractional flow reserve is the ratio of mean coronary pressure distal of the treated lesion to mean aortic pressure during maximum hyperemia.


Secondary Outcome Measures:
  • 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. ] [ Designated as safety issue: Yes ]
    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).

  • Angiographic endpoint: iFR [ Time Frame: At 9 months follow-up. ] [ Designated as safety issue: No ]
  • ST-segment resolution [ Time Frame: 90 minutes after initial procedure ] [ Designated as safety issue: No ]
    ST-segment resolution post-initial procedure at 90 minutes, defined as the ST-segment deviation resolution in only the single lead showing maximum deviation.

  • Non-coronary artery bypass grafting major bleeding [ Time Frame: At 1 month follow-up ] [ Designated as safety issue: Yes ]
    • 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

  • Stent thrombosis [ Time Frame: During follow-up ] [ Designated as safety issue: Yes ]
    • 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.

  • Angiographic endpoint: TIMI flow [ Time Frame: At 9 months follow-up ] [ Designated as safety issue: No ]
  • Angiographic endpoint: late lumen loss [ Time Frame: At 9 months follow-up ] [ Designated as safety issue: No ]
  • Angiographic endpoint: minimal lumen diameter [ Time Frame: At 9 months follow-up ] [ Designated as safety issue: No ]
  • Angiographic endpoint: diameter stenosis [ Time Frame: At 9 months follow-up ] [ Designated as safety issue: No ]

Estimated Enrollment: 120
Study Start Date: August 2014
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02219802

Contacts
Contact: R. J. van der Schaaf, MD, PhD +31-20-5992387 r.j.vanderschaaf@olvg.nl
Contact: N. S. Vos, MD +13-20-5992387 n.s.vos@olvg.nl

Locations
Netherlands
Onze Lieve Vrouwe Gasthuis Not yet recruiting
Amsterdam, Netherlands, 1091 AC
Principal Investigator: R. J. van der Schaaf, MD, PhD         
Sponsors and Collaborators
Onze Lieve Vrouwe Gasthuis
Biotronik SE & Co. KG
Volcano Corporation
Investigators
Principal Investigator: R. J. van der Schaaf, MD, PhD OLVG
  More Information

Publications:

Responsible Party: J.P.R. Herrman, J.P.R.Herrman, MD, PhD, Onze Lieve Vrouwe Gasthuis
ClinicalTrials.gov Identifier: NCT02219802     History of Changes
Other Study ID Numbers: NL48495.100.14
Study First Received: June 30, 2014
Last Updated: August 15, 2014
Health Authority: The Netherlands: Onze Lieve Vrouwe Gasthuis

Keywords provided by Onze Lieve Vrouwe Gasthuis:
Coronary artery disease
Acute myocardial infarction
Drug-coated balloon
Drug-eluting stent

Additional relevant MeSH terms:
Myocardial Infarction
Infarction
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Ischemia
Pathologic Processes
Necrosis
Arteriosclerosis
Arterial Occlusive Diseases

ClinicalTrials.gov processed this record on October 19, 2014