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

Onze Lieve Vrouwe Gasthuis

Status: Unknown

Conditions: Coronary Artery Disease; Acute Myocardial Infarction

Treatments: Procedure: Treatment according arm

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02219802

NL48495.100.14

Details and patient eligibility

About

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).

Full 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.

Enrollment: 120 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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120 participants in 2 patient groups

Drug-eluting stent

Active Comparator group

Description:

Treatment of infarct related laesion with a drug-eluting stent

Treatment:

Procedure: Treatment according arm

Drug-coated balloon

Experimental group

Description:

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.

Treatment:

Procedure: Treatment according arm