Clinical trial NCT03610347: Paclitaxel Eluting Balloon After Bare Metal Stent Implantation vs. Drug-Eluting Stent in St Elevation Myocardial Infarction
Official title: Study to Evaluate the Efficacy and Safety of Paclitaxel Eluting Balloon After Bare Metal Stent Implantation Versus Drug-eluting Stent in St Elevation Myocardial Infarction
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Acute Myocardial Infarction
Lead sponsor: Fundacion Investigacion Interhospitalaria Cardiovascular
Sponsor class: OTHER
Collaborators: name: Effice Servicios Para la Investigacion S.L.
First posted: 2018-08-01
Enrollment: 199
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Study objective is the evaluation of safety and efficacy at 12 months of the combination treatment of bare metal Stent plus Paclitaxel Eluting Balloon vs drug eluting stent in patients with ST-elevation myocardial infarction with less than 12 hours of evolution.

Detailed description: This is a multicenter, prospective, randomized, open study

After the permeabilization of the clinical event responsible artery patients will be randomized in a 1:1 ratio to one of the following treatment groups:

Group 1: insertion of a bare metal stent with post-dilatation with a paclitaxel eluting balloon (Pantera Lux ®)

Group 2: insertion of a drug elution stent

Patients (or their legal representative) must sign the consent before randomization.

Patients will be monitored 30 days after surgery, at 6 and 12 months.

The primary efficacy endpoint is Target Vessel Failure (TVF) at 12 months

This study will involve patients over 18 years old with STEMI, or new left bundle branch block or posterior AMI (ECG) that occur within 12 hours of onset of symptoms.

A total of 516 patients will be included.

Eligibility criteria: Inclusion Criteria:

* Patients aged equal or older than 18 years.
* Acute myocardial infarction (AMI) within 12 hours of evolution (from the onset of symptoms) systolic time elevation of at least 1 mm (recorded in two or more contiguous leads), new left bundle branch block, or true posterior infarction.
* Patients candidates for primary angioplasty as medical criteria
* Written informed consent according to International Conference on Harmonization / Guide Clinical Practice and local legislation, obtained before any study procedure.
* Diameter vascular coronary artery to treat between 2 mm and 4 mm.
* Patients with 85-100% stenosis and TIMI Score (Thrombolysis In Myocardial Infarction) of 0-I.

Exclusion Criteria:

* Patients who refuse to participate in the study
* Cardiogenic shock (defined as systolic blood pressure less than 80 mm Hg for more than 30 minutes or need for vasopressors or intra-aortic balloon counterpulsation)
* Concomitant diseases associated with a life expectancy of less than one year
* Angiographic variables:

  * Trunk unprotected
  * Branching (side branch greater than 2.5 mm)
  * Sinus tachycardia segment elevation myocardial infarction thrombosis secondary to stent
  * If more than one stent to treat a single segment (overlapping stents)
  * Patient candidate for surgical revascularization within 30 days
  * Stenosis of greater than 30 mm in length (corresponding with the ball longer available)
  * More severe stenosis in the same artery in which is expected to be addressed in the next 9 months
* Women at childbearing age, where there is the possibility of pregnancy during the first year of follow-up, or nursing.
* Any clinical condition, which in the opinion of the investigator, is considered clinically significant as to participate in the study.
* Subjects who are participating in any study drug or medical.
* Individuals who show inability to follow instructions or help during the course of the study.
* Bleeding diathesis or other disorders such as gastrointestinal ulceration or cerebral circulatory disorders, restricting the use of treatments platelet aggregation inhibitors and anticoagulants.
* Patients with an ejection fraction \<30% (if known).
* Allergy or hypersensitivity to paclitaxel intolerance, or compounds structurally related to the Butyryl tri-n-hexyl citrate (BTHC) matrix of administration.
* Severe allergy to contrast media.
* Coronary artery spasm in the absence of significant stenosis.

Primary outcomes:
measure: Target Vessel Failure (TVF)
timeFrame: 1 year
Secondary outcomes:
measure: Target Lesion Revascularization (TLR)
timeFrame: 1 year
measure: Major Adverse Cardiac Events (MACE)
timeFrame: 1 year
Other outcomes:
measure: Angiographic Substudy
timeFrame: 9 months
measure: Optical Coherence Tomography (OCT) Substudy
timeFrame: 3 and 6 months
Locations:
city: Palma De Mallorca
country: Spain
facility: H. U. Son Espases
state: Baleares
city: Puerto Real
country: Spain
facility: H. U. Puerto Real
state: Cádiz
city: L'Hospitalet De Llobregat
country: Spain
facility: H. U. de Bellvitge
state: H. U. De Bellvitge
city: Albacete
country: Spain
facility: Complejo Hospitalario U. de Albacete
city: Barcelona
country: Spain
facility: H. del Mar
city: Barcelona
country: Spain
facility: H. U. Vall D'Hebron
city: Barcelona
country: Spain
facility: H. Clínic
city: Ciudad Real
country: Spain
facility: H. General U. de Ciudad Real
city: Granada
country: Spain
facility: H. U. Virgen de las Nieves
city: Madrid
country: Spain
facility: H. U. de La Princesa
city: Madrid
country: Spain
facility: H. Clínico San Carlos
city: Madrid
country: Spain
facility: H. U. 12 de Octubre
city: Madrid
country: Spain
facility: H. U. Puerta de Hierro Majadahonda
city: Málaga
country: Spain
facility: H. Regional U. de Málaga
city: Valencia
country: Spain
facility: H. U. i Politècnic La Fe de Valencia
city: Valladolid
country: Spain
facility: H. Clínico U. de Valladolid
Study officials:
References:
citation: Garcia-Touchard A, Gonzalo N, Goicolea J, Gomez-Lara J, Martin-Yuste V, Peral V, Martinez-Romero P, Vaquerizo B, Sanchez-Recalde A, Sarnago F, Oteo JF, Alfonso F. Early coronary healing in ST segment elevation myocardial infarction: sirolimus-eluting stents vs. drug-coated balloons after bare-metal stents. The PEBSI-2 optical coherence tomography randomized study. Coron Artery Dis. 2021 Dec 1;32(8):673-680. doi: 10.1097/MCA.0000000000001038.