Primary PCI for STEMI
Conditions
Brief summary
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.
Interventions
DEVICEcoronary thrombectomy
coronary thrombectomy with either Angiojet device (rhelytic thrombectomy) or Export device (manual aspiration)
DEVICEstandard primary PCI (with stenting, as required)
standard primary PCI (usually with stenting) for STEMI, without use of thrombectomy or distal protection devices
Sponsors
University of Pisa
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
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
Design outcomes
Primary
| 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 |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Standard Primary Coronary Intervention standard primary PCI (with stenting, as required): standard primary PCI (usually with stenting) for STEMI, without use of thrombectomy or distal protection devices | 104 |
| Coronary Thrombectomy coronary thrombectomy: coronary thrombectomy with either Angiojet device (rhelytic thrombectomy) or Export device (manual aspiration) | 104 |
| Total | 208 |
Baseline characteristics
| Characteristic | Standard Primary Coronary Intervention | Coronary Thrombectomy | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 44 Participants | 46 Participants | 90 Participants |
| Age, Categorical Between 18 and 65 years | 60 Participants | 58 Participants | 118 Participants |
| Age, Continuous | 62 years | 63 years | 62 years |
| coronary TIMI frame count | 86 frames STANDARD_DEVIATION 28 | 95 frames STANDARD_DEVIATION 17 | 91 frames STANDARD_DEVIATION 25 |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Region of Enrollment Italy | 104 participants | 104 participants | 208 participants |
| Sex: Female, Male Female | 25 Participants | 16 Participants | 41 Participants |
| Sex: Female, Male Male | 79 Participants | 88 Participants | 167 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 2 / 104 | 2 / 104 |
| other Total, other adverse events | 0 / 104 | 0 / 104 |
| serious Total, serious adverse events | 0 / 104 | 0 / 104 |
Outcome results
Primary
Infarct Size as Assessed by Delayed-enhancement Cardiac Magnetic Resonance Imaging (DE-MRI)
Time frame: 3 months after the index procedure
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard Primary Coronary Intervention | Infarct Size as Assessed by Delayed-enhancement Cardiac Magnetic Resonance Imaging (DE-MRI) | 19.3 % of LV mass | Standard Deviation 10.6 |
| Coronary Thrombectomy | Infarct Size as Assessed by Delayed-enhancement Cardiac Magnetic Resonance Imaging (DE-MRI) | 20.4 % of LV mass | Standard Deviation 10.5 |
Primary
Rate of Complete ST-segment Elevation Resolution at 60 Minutes After the End of the Procedure
Time frame: 60 minutes after the end of the procedure
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Standard Primary Coronary Intervention | Rate of Complete ST-segment Elevation Resolution at 60 Minutes After the End of the Procedure | 38 Participants |
| Coronary Thrombectomy | Rate of Complete ST-segment Elevation Resolution at 60 Minutes After the End of the Procedure | 58 Participants |