Clinical trial NCT01281033: CompariSon of Manual Aspiration With Rheolytic Thrombectomy in Patients Undergoing Primary PCI. The SMART-PCI Trial
Official title: CompariSon of Manual Aspiration With Rheolytic Thrombectomy in Patients Undergoing Primary PCI. The SMART-PCI Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: ST-segment Elevation Myocardial Infarction
Thrombus
Keywords: primary PCI
ST-segment elevation myocardial infarction
thrombus aspiration
Lead sponsor: Careggi Hospital
Sponsor class: OTHER
Collaborators: name: Cardiovascular Research Foundation, New York
First posted: 2011-01-21
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To compare rheolytic thrombectomy (RT) with manual thrombus aspiration (MTA) in patients with acute ST-segment elevation myocardial infarction (STEMI) undergoing primary PCI.

Occlusive thrombosis triggered by a disrupted or eroded atherosclerotic plaque is the anatomic substrate of ST-segment elevation myocardial infarction (STEMI). Due to this substrate, macro- and microembolization during percutaneous coronary intervention (PCI) in AMI is frequent and may result in obstruction of the microvessel network, and decreased efficacy of reperfusion and myocardial salvage. Direct stenting without predilation or postdilation is the most simplistic approach to the problem of embolization, and may decrease embolization and the incidence of the no-reflow phenomenon. Other approaches to the problem of microvessel embolization include thrombectomy before stent implantation, and the use of antiembolic devices (filters and occlusive devices with retrieval of thromboembolic material after stent implantation). Most concluded studies on removing of thrombus before stenting used manual aspiration catheters and meta-analyses derived from these studies support the use of manual thrombus aspiration (MTA) catheters in the setting of primary PCI. MTA is currently recommended in the setting of primary PCI as a Class II b recommendation; level of evidence B. Rheolytic thrombectomy (RT) using multiple jets of saline solution and aspiration based on the Bernoulli effect has been proven to be effective in decreasing major adverse events during PCI in saphenous vein grafts or native coronary arteries with angiographic evidence of thrombus, and 2 out of 3 concluded studies have shown a better reperfusion and clinical outcome in patients randomized to RT as compared to control.

Detailed description: The SMART Study is an on-label, randomized, 2-arms, prospective study in patients with STEMI undergoing primary PCI. Diagnosis of STEMI is based on ECG evidence of ischemic ST changes, clinical symptoms, and elevated CK and CK-MB cardiac enzymes. Patients who are eligible for the Study and who provide written informed consent will be included in the study.

Inclusion Criteria:

* Patient is \> 18 years of age.
* Patient has ST-segment elevation of at least 0.1 mV in 2 or more contiguous leads or presumably new LBBB for all types of infarcts.
* Patient's AMI presentation is greater than 30 minutes but less than 6 hours after symptom onset.
* Patient provides written informed consent.
* Patient has no childbearing potential or is not pregnant.
* Target artery has a reference vessel diameter of at least 2.5 mm on visual assessment at baseline angiography.

Exclusion Criteria:

* Known prior history of renal insufficiency (serum creatinine 2.0 mg/dL).
* Cardiogenic shock.
* Prior administration of thrombolysis for the current infarction.
* Participation in another study.
* Major surgery within past 6 weeks.
* History of stroke within 30 days, or any history of hemorrhagic stroke.
* Severe hypertension (systolic BP \> 200 mm Hg or diastolic BP \> 110 mm Hg) not controlled on antihypertensive therapy.
* Known neutropenia ( \<1000 neutrophils per mm3) or known severe thrombocytopenia (\< 50,000 platelets per mm3).
* Patient unwilling to receive blood products.
* Previously stented IRA (stent thrombosis).
* Inability to identify the IRA.
* Severe vessel tortuosity that enables OCT assessment.

Eligibility criteria: Inclusion Criteria:

Clinical inclusion criteria:

* Patient is \> 18 years of age.
* Patient has ST-segment elevation of at least 0.1 mV in 2 or more contiguous leads or presumably new LBBB for all types of infarcts.
* Patient's AMI presentation is greater than 30 minutes but less than 6 hours after symptom onset.
* Patient provides written informed consent. Patient has no childbearing potential or is not pregnant

Angiographic inclusion criteria:

* All patients with or without evidence of thrombus are eligible.
* Target artery has a reference vessel diameter 2.5 mm on visual assessment at baseline angiography.

Exclusion Criteria:

Clinical exclusion criteria:

* Known prior history of renal insufficiency (serum creatinine 2.0 mg/dL).
* Cardiogenic shock.
* Prior administration of thrombolysis for the current infarction.
* Participation in another study.
* Major surgery within past 6 weeks.
* History of stroke within 30 days, or any history of hemorrhagic stroke.
* Severe hypertension (systolic BP \> 200 mm Hg or diastolic BP \> 110 mm Hg) not controlled on antihypertensive therapy.
* Known neutropenia ( \<1000 neutrophils per mm3) or known severe thrombocytopenia (\< 50,000 platelets per mm3).
* Patient unwilling to receive blood products

Angiographic exclusion criteria:

* Previously stented IRA (stent thrombosis).
* Inability to identify the IRA.
* Severe vessel tortuosity that enables OCT assessment.

Primary outcomes:
measure: Post-thrombectomy thrombus burden as assessed by coronary OCT
timeFrame: baseline
Secondary outcomes:
measure: Angiographic thrombus grade after thrombectomy
timeFrame: baseline
measure: ST-segment resolution at 30 minutes post-PCI, assessed by 12-lead ECG
timeFrame: 30 minutes
measure: Angiographic markers of reperfusion:TIMI flow grade, TIMI myocardial blush.
timeFrame: baseline
measure: Procedural angiographic complications : distal embolization, no-reflow, perforation, dissection.
timeFrame: baseline
measure: Infarct size and microvascular obstruction measured by MRI at 3-7 days
timeFrame: 3-7 days
measure: Six-month MACE (death, reinfarction, TVR, stroke)
timeFrame: six months
measure: Six-month binary angiographic restenosis (> 50%)
timeFrame: six months
measure: Percent of malapposed struts at 6-month OCT follow-up
timeFrame: six months
measure: Six-month left ventricular remodelling by 2D ECHO
timeFrame: six months
measure: Twelve-month MACE or hospital admission for heart failure
timeFrame: 12 months
Other outcomes:
Locations:
city: Florence
country: Italy
facility: Careggi Hospital
Study officials:
affiliation: Careggi Hospital, Division of Invasive Cardiology
name: David Antoniucci, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Parodi G, Valenti R, Migliorini A, Maehara A, Vergara R, Carrabba N, Mintz GS, Antoniucci D. Comparison of manual thrombus aspiration with rheolytic thrombectomy in acute myocardial infarction. Circ Cardiovasc Interv. 2013 Jun;6(3):224-30. doi: 10.1161/CIRCINTERVENTIONS.112.000172. Epub 2013 Jun 4.