Clinical trial NCT02219802: Drug-coated Balloon Versus Drug-eluting Stent in Acute Myocardial Infarction
Official title: Revascularization With Paclitaxel-coated Balloon Angioplasty Versus Drug-eluting Stenting in Acute Myocardial Infarction - a Randomized Controlled Trial.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Coronary Artery Disease
Acute Myocardial Infarction
Keywords: Coronary artery disease
Acute myocardial infarction
Drug-coated balloon
Drug-eluting stent
Lead sponsor: Onze Lieve Vrouwe Gasthuis
Sponsor class: OTHER
Collaborators: name: Biotronik SE & Co. KG
name: Volcano Corporation
First posted: 2014-08-19
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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).

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 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

Primary outcomes:
measure: Fractional flow reserve (FFR)
timeFrame: At 9 months follow-up
Secondary outcomes:
measure: Major adverse cardiac event (MACE)
timeFrame: In-hospital, at 1 and 9 months follow-up and at 2, 3, 4 and 5 year follow-up.
measure: Angiographic endpoint: iFR
timeFrame: At 9 months follow-up.
measure: ST-segment resolution
timeFrame: 90 minutes after initial procedure
measure: Non-coronary artery bypass grafting major bleeding
timeFrame: At 1 month follow-up
measure: Stent thrombosis
timeFrame: During follow-up
measure: Angiographic endpoint: TIMI flow
timeFrame: At 9 months follow-up
measure: Angiographic endpoint: late lumen loss
timeFrame: At 9 months follow-up
measure: Angiographic endpoint: minimal lumen diameter
timeFrame: At 9 months follow-up
measure: Angiographic endpoint: diameter stenosis
timeFrame: At 9 months follow-up
Other outcomes:
Locations:
city: Amsterdam
country: Netherlands
facility: Onze Lieve Vrouwe Gasthuis
Study officials:
affiliation: OLVG
name: R. J. van der Schaaf, MD, PhD
role: PRINCIPAL_INVESTIGATOR
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