Clinical trial NCT01274728: PAclitaxel-eluting Balloon in Primary PCI in Amsterdam; Pilot Study
Official title: Pilot Study on PAclitaxel-eluting Balloon in Primary PCI in Amsterdam. A Clinical Evaluation, to Study the Feasibility and Safety of a Paclitaxel-eluting Balloon in Primary Percutaneous Coronary Intervention for Acute ST-elevation Myocardial Infarction.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Acute Myocardial Infarction
Keywords: Acute myocardial infarction
Primary percutaneous coronary intervention
Drug-eluting balloon
Bivalirudin
Lead sponsor: Onze Lieve Vrouwe Gasthuis
Sponsor class: OTHER
First posted: 2011-01-11
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients who are presented at the emergency room or in ambulance with STEMI

Brief summary: This clinical evaluation will study the feasibility and safety of a CE-marked paclitaxel-eluting balloon in primary PCI in patients with a STEMI. Drug eluting balloons provide the potential advantage of delivering a anti-proliferative drug, without the disadvantage of leaving a coronary stent, in STEMI patients treated with primary PCI.

Detailed description: Multiple randomized clinical trials and pooled analyses have shown improved clinical outcomes of primary PCI when compared with fibrinolytic therapy. Primary PCI for STEMI results in greater patency of the infarct-related artery (IRA) and lower rates of death, re-infarction, and stroke when compared with fibrinolysis. The use of coronary stents has reduced the need for repeat revascularization in patients treated with primary PCI. However, in the setting of STEMI this reduction in target lesion revascularization (TLR) did not reduce re-infarction rates or both short term and long-term mortality rates. This was confirmed by a large meta-analysis by De Luca et al, using 13 randomized trials and involving 6922 patients. In studies evaluating DES versus BMS in STEMI mortality rates are similar in patients treated with BMS or DES. Although TLR rates are reduced with the use of DES, there have been concerns about long-term delay of arterial healing produced by both the Cypher DES and Taxus DES and the associated risk of late stent thrombosis. Anti-proliferative drugs in DES used to prevent neointimal hyperplasia also prevent the formation of an epithelial surface at the inner side of stents causing possible stent malapposition and potentionally late stent thrombosis. A new approach in treatment of STEMI is now available by the development of a drug eluting balloon. These DEB can be used with or without additional stent placement. Potential advantages compared to DES are a more homogeneous drug distribution, short lasting exposure and a higher local drug dose. Moreover, when no additional stent is needed, it might reduce the need for long term aggressive anti-platelet therapy in order to prevent acute, late or very late stent thrombosis. In short, DEB provides the potential advantage of delivering a anti-proliferative drug, without the disadvantage of leaving a coronary stent, in STEMI patients treated with primary PCI. The use of DEB is already tested for treatment of de novo coronary lesions and in-stent restenosis and has been shown to be a feasible and safe.In this clinical evaluation the use of the CE-marked Paclitaxel-eluting balloon with provisional stenting for STEMI will be evaluated on top of current highest standard therapy.

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
  * reperfusion is expected to be feasible within 12 hours after onset of complaints
* Infarct related artery eligible for PPCI including stent implantation. Diameter of IRA ≥ 2.5 mm, ≤ 4 mm.
* Infarction is caused by a de novo lesion in a native coronary artery

Exclusion Criteria:

* Age \< 18
* Reperfusion not feasible within 12 hours after onset of complaints
* Failed thrombolysis
* Infarct related artery unsuitable for PCI
* Sub-acute stent thrombosis
* STEMI caused by in-stent re-stenosis
* Infarct related vessel / target vessel SVG or LIMA
* Contraindication or resistance for bivalirudin, fondaparinux ,aspirin, clopidogrel and/or prasugrel.
* Participation in another clinical study, interfering with this protocol
* Cardiogenic shock prior to inclusion
* Uncertain neurological outcome e.g. resuscitation
* Intubation/ventilation
* 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
* Platelet number \< 100.000 x 10\^9/L
* 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: Major acute coronary event
timeFrame: 1 month
Secondary outcomes:
measure: Cross-over to bail-out stenting
timeFrame: 1, 6 and 12 months
measure: Death from any cause
timeFrame: 1, 6 and 12 months
measure: Major acute coronary event
timeFrame: 6 and 12 months
measure: In-hospital major acute coronary event
timeFrame: index hospitalisation
measure: Recurrent MI non-target vessel related
timeFrame: 1, 6 and 12 months
measure: Target vessel revascularisation
timeFrame: 1, 6 and 12 months
measure: Stroke
timeFrame: 1, 6 and 12 months
measure: Stent thrombosis
timeFrame: index hospitalisation, 1, 6 and 12 months
measure: NON-CABG major bleeding
timeFrame: 1 month
measure: Hemorrhagic events
timeFrame: 1 month
Other outcomes:
Locations:
city: Amsterdam
country: Netherlands
facility: Onze Lieve Vrouwe Gasthuis
Study officials:
affiliation: Onze Lieve Vrouwe Gasthuis Amsterdam
name: R.J. van der Schaaf, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Onze Lieve Vrouwe Gasthuis Amsterdam
name: M.T. Dirksen, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Onze Lieve Vrouwe Gasthuis Amsterdam
name: N.S. Vos, MD
role: STUDY_CHAIR
affiliation: Onze Lieve Vrouwe Gasthuis
name: J.P.H. Herrman, MD, PhD
role: STUDY_DIRECTOR
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