Thromboaspiration in Patients With High Thrombotic Burden Undergoing Primary Percutaneous Coronary Intervention (PCI)

Efficacy of Thromboaspiration in Patients With High Thrombotic Burden Undergoing Primary Percutaneous Coronary Intervention

200 consecutive patients presenting with STEMI within 12 hours from the onset of symptoms and having a high thrombotic burden at coronary angiography, defined as the presence of a thrombus size ≥ 2 times the diameter of the vessel, according to a visual estimate. The main objective of the study is to evaluate the effectiveness of thrombectomy (either rheolytic or manual aspiration) as an adjunct to primary or rescue angioplasty, in patients with angiographic evidence high thrombotic burden in the culprit artery. Primary end points: (1) rate of complete ST-segment elevation resolution at 60 minutes after the end of the procedure; (2) infarct size as assessed by delayed-enhancement cardiac magnetic resonance imaging (DE-MRI) at 3 months after the index procedure.

Secondary endpoints: post-procedural TIMI flow grade; post-procedural MBG; infarct transmurality at 3 months; MVO at 3 months; 1-year actuarial freedom from MACEs.

Study Overview

• Status: Completed
• Conditions: Primary PCI for STEMI
• Intervention / Treatment: Device: standard primary PCI (with stenting, as required); Device: coronary thrombectomy

• Study Type: Interventional
• Enrollment (Actual): 208
• Phase: Phase 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 88 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Prolonged, continuous signs and symptoms of ischemia lasting more than 20 min, starting within 12 hours prior to randomization, and ST elevation ≥ 2mm in ≥2 contiguous ECG leads, or new left bundle branch block (LBBB)
2. Presence of high thrombotic burden in the culprit lesion at diagnostic angiography (defined as the presence of a thrombus size ≥ 2 times the diameter of the vessel, according to a visual estimate, or abrupt cut-off occlusion of a coronary artery ≥3 mm in reference vessel diameter)
3. Written informed consent

Exclusion Criteria:

• Low-risk (ST elevation in ≤2 leads) inferior AMI
• Previous infarction in the same area (assessed by ECG)
• PCI in the 2 weeks prior to AMI
• Active internal bleeding
• History of cerebrovascular accident in the previous 2 years or cerebrovascular accident with a significant residual neurological deficit
• Head or spine surgery or trauma in the previous 2 months
• Recent (within six weeks) gastrointestinal (GI) or genitourinary (GU) bleeding of clinical significance
• Administration of oral anticoagulants within seven days unless prothrombin time is <1.2 times control
• Bleeding diathesis or severe uncontrolled arterial hypertension
• Thrombocytopenia (<100 000 cells/mL)
• Recent (within six weeks) major surgery or trauma
• Intracranial neoplasm, arteriovenous malformation, or aneurysm
• Severe renal or liver failure
• Allergy to aspirin
• Contraindication to MRI examination
• Pregnancy and lactation

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: standard primary coronary intervention	Device: standard primary PCI (with stenting, as required); standard primary PCI (usually with stenting) for STEMI, without use of thrombectomy or distal protection devices
Experimental: coronary thrombectomy	Device: coronary thrombectomy; coronary thrombectomy with either Angiojet device (rhelytic thrombectomy) or Export device (manual aspiration)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Rate of Complete ST-segment Elevation Resolution at 60 Minutes After the End of the Procedure	60 minutes after the end of the procedure
Infarct Size as Assessed by Delayed-enhancement Cardiac Magnetic Resonance Imaging (DE-MRI)	3 months after the index procedure

Collaborators and Investigators

• Sponsor: University of Pisa

Publications and helpful links

General Publications

• De Carlo M, Aquaro GD, Palmieri C, Guerra E, Misuraca L, Giannini C, Lombardi M, Berti S, Petronio AS. A prospective randomized trial of thrombectomy versus no thrombectomy in patients with ST-segment elevation myocardial infarction and thrombus-rich lesions: MUSTELA (MUltidevice Thrombectomy in Acute ST-Segment ELevation Acute Myocardial Infarction) trial. JACC Cardiovasc Interv. 2012 Dec;5(12):1223-30. doi: 10.1016/j.jcin.2012.08.013.

Study record dates

Study Major Dates

• Study Start: February 1, 2009
• Primary Completion (Actual): September 1, 2011
• Study Completion (Actual): March 1, 2012

Study Registration Dates

• First Submitted: November 13, 2011
• First Submitted That Met QC Criteria: November 15, 2011
• First Posted (Estimate): November 16, 2011

Study Record Updates

• Last Update Posted (Actual): February 12, 2019
• Last Update Submitted That Met QC Criteria: January 21, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: UP-DCT-201001