Minimal Invasive Procedure for Myocardial Infarction

NCT ID: NCT01360242

Last Updated: 2015-03-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 160 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-06-30
• Study Completion Date: 2013-06-30

Brief Summary

In the setting of primary Percutaneous Coronary Intervention (PCI), the investigators hypothesize that a 24-48 hour delay strategy of stenting after successful thrombus aspiration and establishment of Thrombolysis In Myocardial Infarction (TIMI)-3 flow with optimal antithrombotic therapy may decrease the risk of MicroVascular Obstruction (MVO) as assessed by Cardiac Magnetic Resonance Imaging (CMRI).

Detailed Description

Primary PCI is the reperfusion therapy of choice in patients with acute ST-elevation myocardial infarction (STEMI) [Van de Werf et al. 2008; Kushner et al. 2009]. The first objective in primary PCI is to restore TIMI-3 flow. However, despite restoration of TIMI-3 flow, myocardial reperfusion remains suboptimal in a significant proportion of patients, predominantly as a consequence of the so called "myocardial non-reperfusion phenomenon", "low/no-reflow phenomenon" or MVO. This, in turn, is associated with significant morbidity and mortality [Brodie et al. 2005; Bruder et al. 2008; Hombach et al. 2005; Nijveldt et al. 2008; Thiele et al. 2008; Wu et al. 1998]. Although TIMI flow is well assessed by angiography, contrast-enhanced CMRI remains the gold standard in the assessment of MVO. Indeed, the presence and extent of hypoenhanced areas have been shown to be associated with a poor outcome [Bruder et al. 2008; Hombach et al. 2005; Nijveldt et al. 2008; Wu et al. 1998].

There is now a large body of evidence to suggest that even in patients with TIMI-3 flow on angiography, as many as 60% of these patients will subsequently exhibit MVO with CMRI [Brodie et al. 2005; Bruder et al. 2008; Hombach et al. 2005; Nijveldt et al. 2008; Thiele et al. 2008; Wu et al. 1998]. Our knowledge of the mechanisms of MVO occurrence as well as measures to reduce MVO has been considerably enhanced by recent publications. For instance, Sianos et al. [2007] demonstrated that the thrombus burden at the time of angiography is an independent predictor of MVO extension and 2-year mortality. Furthermore, Isaaz et al. [2006] recommended a two-step strategy as a means of minimising the risk of MVO, with the first step consisting of TIMI-3 flow restoration, followed 2-6 days later by further angiography to determine the therapeutic strategy of choice (PCI, cardiac surgery, or medical treatment: 67%, 25%, and 8% respectively). Meneveau et al. [2009] also adopted a two-step strategy in a small cohort of STEMI patients with TIMI-3 flow and ST-segment regression at the time of the procedure. They demonstrated that a 24-hour delay in stent implantation led to a higher rate of procedural success than immediate stenting. Isaaz et al. [2006] and Meneveau et al. [2009] also reported a decreased thrombus burden and no culprit-artery re-occlusion between the first and the second procedure.

Both the Thrombus Aspiration during Percutaneous coronary intervention in Acute myocardial infarction Study (TAPAS) [Svilaas et al. 2008] and the thrombectomy with EXPort catheter in Infarct-Related Artery during primary percutaneous coronary intervention (EXPIRA) [Sardella et al. 2009] studies demonstrated the benefits of thrombus aspiration as the first step in primary PCI prior to either ballooning or direct stenting. However, as the effects of stenting upon MVO in the setting of acute STEMI remain poorly understood, we propose a randomized study to evaluate the benefits of a 24-48-hour delay in stent implantation compared to immediate stenting in patients presenting with acute STEMI who will undergo primary PCI.

Conditions

ST Elevation Myocardial Infarction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

MIMI procedure (two-step strategy)

Thrombus aspiration is performed to achieve TIMI-3 flow. Once TIMI-3 flow is restored and sustained for \> 10 minutes, the initial procedure is stopped regardless of the presence of any residual stenosis. A second coronary angiogram is performed 24-48 hours later and the physician is free to decide on the best treatment, i.e. surgery, medical treatment, or stent implantation (drug-eluting stent if indicated for on-label patients). If stenting is required and the thrombus is still too large (greater than twice the artery width), the physician could postpone stent implantation for days or weeks.

Group Type: ACTIVE_COMPARATOR

MIMI procedure (two-step strategy)

Intervention Type: PROCEDURE

A second coronary angiogram is performed 24-48 hours later and the physician is free to decide on the best treatment, i.e. surgery, medical treatment, or stent implantation (drug-eluting stent if indicated for on-label patients). If stenting is required and the thrombus is still too large (greater than twice the artery width), the physician could postpone stent implantation for days or weeks.

Immediate Stenting (one-step strategy)

The physician is encouraged to implant a stent after the thrombus aspiration (drug-eluting stent if indicated for on-label patients).

Group Type: SHAM_COMPARATOR

Immediate Stenting (one-step strategy)

Intervention Type: PROCEDURE

The physician is encouraged to implant a stent after the thrombus aspiration (drug-eluting stent if indicated for on-label patients).

Interventions

MIMI procedure (two-step strategy)

A second coronary angiogram is performed 24-48 hours later and the physician is free to decide on the best treatment, i.e. surgery, medical treatment, or stent implantation (drug-eluting stent if indicated for on-label patients). If stenting is required and the thrombus is still too large (greater than twice the artery width), the physician could postpone stent implantation for days or weeks.

Intervention Type: PROCEDURE

Immediate Stenting (one-step strategy)

The physician is encouraged to implant a stent after the thrombus aspiration (drug-eluting stent if indicated for on-label patients).

Intervention Type: PROCEDURE

Other Intervention Names

Delayed angioplasty; Two-step strategy; Immediate Angioplasty

Eligibility Criteria

Inclusion Criteria

• Patients with acute STEMI presenting within 12 hours of symptom onset, requiring a primary percutaneous coronary intervention; and written informed consent.
• Patients will be randomized during the angiography if the initial TIMI flow is 0 or 1 in a major artery and if TIMI-3 flow can be restored after thrombus aspiration and sustained for 10 minutes.
• Acute STEMI is defined as typical chest pain with 30 minutes of sustained ST-segment elevation >1 mm in two or more consecutive limb leads or >2 mm in two or more precordial leads in the ECG. Major artery is defined as the proximal or mid segment of the left descending artery, the proximal segment of the circumflex artery (before the first marginal), or the right coronary artery before the posterior descendant artery.

Exclusion Criteria

• Patients less than 18 years' old
• Pregnant and breast feeding women
• Patients with a pacemaker, automated implantable cardioverter-defibrillator (AICD), or left bundle branch block
• Contraindication to abciximab, prasugrel, or clopidogrel
• Cardiac arrest as initial presentation
• Current medical condition with a life expectancy of < 6 months
• Patients not living in France
• Patients in cardiogenic shock
• Culprit artery <2.5 mm
• Absence of informed consent
• Patients with initial TIMI 2 or 3 flow or no TIMI-3 flow restored after thrombus aspiration
• Rescue PCI after fibrinolysis
• Known creatinine clearance < 30 ml/min.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Grenoble

OTHER

Sponsor Role: collaborator

Centre Hospitalier Annecy Genevois

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Loic BELLE, MD

Role: PRINCIPAL_INVESTIGATOR

Centre Hospitalier Annecy Genevois

Locations

CHRA

Annecy, , France

Hopital Privé

Antony, , France

Ch Bastia

Bastia, , France

Clinique Convert

Bourg-en-Bresse, , France

CH

Cannes, , France

CH

Chambéry, , France

CHU

Clermont-Ferrand, , France

CHU

Dijon, , France

CHU Nord

Grenoble, , France

Clinique Mutualiste

Grenoble, , France

CHU

Lille, , France

CH St Luc St Joseph

Lyon, , France

CHU Croix Rousse

Lyon, , France

Clinique du Tonkin

Lyon, , France

CHU Nord

Marseille, , France

CHI

Montfermeil, , France

Clinique Marie Lannelongue

Paris, , France

CH

Pontoise, , France

Clinique de Courlancy

Reims, , France

Clinique St Hilaire

Rouen, , France

CHU

Saint-Etienne, , France

Clinique St Gatien

Tours, , France

CH

Valence, , France

CH

Vichy, , France

Countries

France

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Other Identifiers

2010-A01345-34

Identifier Type: -

Identifier Source: org_study_id