Laser Atherectomy for ST Elevation Myocardial Infarction

Study Overview
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Brief Summary
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The objectives of this study are to observe and examine prospectively whether excimer laser coronary angioplasty (ELCA) and percutaneous coronary intervention with biodegradable-polymer platinum chromium everolimus-eluting stent may improve the myocardial salvage in the patients with anterior ST elevation myocardial infarction (STEMI) using the myocardial scintigram (acute-phase I123-BMIPP and chronic-phase 99mTc-tetrofosmin), and to clarify the myocardial protective effect of excimer laser in the patients with anterior STEMI.

Detailed Description
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The clinical result of catheter treatment in the patients with acute myocardial infarction in these several decades improved because of progress of early reperfusion therapy and stent treatment technique. However, the no-reflow phenomenon is still remaining as a problem, which is involved in a decrease in left ventricular function and worsening of prognosis. It is considered that the no-reflow phenomenon is induced by atherosclerotic and thrombotic emboli, endothelial dysfunction of capillary vessels, free radicals and cytokine. The treatment combining the peripheral protection and thrombus aspiration aiming at prevention of no-reflow is expected to reduce no-reflow and the infarct size and has been conducted on the patients with acute myocardial infarction. However, a lot of randomized studies have been conducted, so far, which do not lead to reduction of infarct size and improvement of survival rate, and the efficacy has not been demonstrated. Some explanations have been suggested for this phenomenon: The operation method of device is complicated, and it is difficult to acquire the treatment technique. Giant thrombus and solid lesion could not be aspirated effectively. A lot of randomized studies have not focused on the patients with anterior descending lesion of thrombolysis in myocardial infarction (TIMI) grade 0/1, of which the time from onset to treatment is within 6 hours, considered to have the largest benefit of prevention of no-reflow. In recent years in Japan, excimer laser coronary angioplasty (ELCA) has been used in the patients with acute coronary syndrome (ACS), and not only debulking of arteriosclerotic lesion but also thrombolytic effect have been reported. In the Camel trial and Utility of Laser for Transcatheter Atherectomy Multicenter Analysis around Naniwa (ULTRAMAN) registry, the efficacy and safety in ACS have been reported, but the infarct size has not been evaluated. This time in this study, it is considered that verification whether or not ELCA is able to improve the myocardial salvage in anterior ST elevation myocardial infarction (STEMI) using myocardial scintigram (acute-phase BMIPP and chronic-phase TF) will provide the useful information helpful for selection of treatment to medical care staffs and patients for future patients suffering from ACS and will be able to contribute to further improvement of medical science and medical practice. MRI will be performed twice at 5-9 days and at 6 months post index ST elevation myocardial infarction to assess myocardial damage and functional variables, which details will be described in the following outcome measurement section.

Official Title
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Evaluation of Myocardial Salvage by Scintigraphy After Excimer Laser Coronary Angioplasty and Percutaneous Coronary Intervention With Biodegradable-polymer Platinum Chromium Everolimus-eluting Stent in the Patients With Anterior ST Elevation Myocardial Infarction

Conditions
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STEMI - ST Elevation Myocardial Infarction

Intervention / Treatment
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* Device: Excimer laser catheter


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients to whom PCI treatment for anterior STEMI is indicated [Main selection criteria] First-episode anterior STEMI patients within 6 hours of onset that satisfy electrocardiogram criteria Patients who are 21 years of age or older at the time of consent acquisition Patient who the patient himself agreed in writing Exclusion Criteria: Patients presenting cardiac shock at the time of visit Patients whose target lesions are left main trunk, circumflex, right coronary artery, distal anterior descending branch Patients who have TIMI 2, 3 at the initial imaging Patients with a reference vessel diameter of 2.5 mm or less Patients determined to lack consent ability for mental or other reasons Patient who is judged inappropriate by research researcher or research sharing doctor The inclusion and exclusion criteria for the MRI will follow the main study, but in addition, will exclude following conditions. Atrial fibrillation subject at the timing of MRI scan Internally implanted devices such as pacemakers or ICDs Subject that is allergic to Gadolinium, Subject with claustrophobia Pregnancy

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ELCA<br>On the antegrade delivery of the laser catheter after wiring, we used safe laser techniques and injected saline before and during the laser procedure at a 0.5 mm/sec catheter advancement rate. Whether to perform a retrograde laser method depended on each operator. After ablation by ELCA, patients undergo balloon dilation via standard techniques, and as appropriate, receive drug-eluting stent deployment. | Device: Excimer laser catheter<br>* The excimer laser catheter is equipped with multiple optical fibers on the periphery of the guide wire lumen corresponding to 0.014 inch, which is used for the purpose of reperfusion of barrier site of coronary artery. The connector on the front side is connected with the CVX-300 laser generator, and the tip at the top contact directly with the lesion. The laser catheter consisting of multiple optical fibers transmits the energy in the ultraviolet region from the CVX300 laser generator to the blockage in the blood vessel. The ultraviolet energy is transmitted from the tip of laser catheter, transpires the fibrous, calcified and arteriosclerotic lesion by light, and enables reperfusion in the lesion. The laser catheter has appropriate hydrophilic coating and easily follows the inside of coronary artery.<br>|
| No Intervention: non ELCA<br>In non ELCA group, the conventional PCI procedure, including thrombus aspiration, POBA, and stent implantation was performed. The indication for aspiration was at the discretion of the physician based on angiographic, intravascular ultrasound, or optical coherence tomography/Optical Frequency-Domain Imaging. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| myocardial salvage (17 segment model) by SPECT | Calculation of score using software in the Core Lab (Tokai University, Department of Radiology). Scoring should be conducted in 17 segments and at 5 grades from 0 to 4 in each segment on the polar map images. The Myocardial salvage (17-segment) was calculated by subtracting the total sum of the 123I-BMIPP and 99mTc-tetrofosmin defect scores in each segment ( ∑123I-BMIPP defect score minus 99mTc-∑tetrofosmin defect score). | 3 day to 6 month | 
| Myocardial Salvage index (17 segment model) by SPECT | Salvage index was calculated as follows: Myocardial Salvage index =∑123I-BMIPP defect score minus ∑99mTc-tetrofosmin defect score/ ∑123I-BMIPP defect score × 100 (%). | 3 day to 6 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Myocardial scar amount assessment by MRI | All the outcome values will be derived by MRI image assessment. Each variables values will be derived as follows: Myocardial scar amount assessed on Late Short Axis LGE image | 5-9 days and 6 month | 
| Microvascular obstruction assessment by MRI | All the outcome values will be derived by MRI image assessment. Each variables values will be derived as follows: Microvascular obstruction on perfusion image and Early Short Axis LGE image | 5-9 days and 6 month | 
| Myocardial salvage assessment by MRI | All the outcome values will be derived by MRI image assessment. Each variables values will be derived as follows: Myocardial salvage derived from T2WBB and Late Short Axis LGE images | 5-9 days and 6 month | 
| Ejection fraction assessment by MRI | All the outcome values will be derived by MRI image assessment. Each variables values will be derived as follows: Ejection Fraction derived from Cine images | 5-9 days and 6 month | 
| Gray zone assessment by MRI | All the outcome values will be derived by MRI image assessment. Each variables values will be derived as follows: Gray zone derived from Late Short Axis LGE images. | 5-9 days and 6 month | 
| Left ventricular ejection fraction by TF scintigraphy at 6 months | 99mTc-tetrofosmin (TF) scintigraphy was performed 6 months after the PCI procedure. For the scanning procedure, the 740 MBq of 99mTc-tetrofosmin injected with patient while at rest. ejection fraction (%) based on 99mTc-tetrofosmin QGS data. | 5-7 month | 
| Left ventricular volume (ml) by TF scintigraphy at 6 months | 99mTc-tetrofosmin (TF) scintigraphy was performed 6 months after the PCI procedure. For the scanning procedure, the 740 MBq of 99mTc-tetrofosmin injected with patient while at rest. Left ventricular volume (ml) based on 99mTc-tetrofosmin QGS data. | 5-7 month | 
| Left ventricular end-diastolic volume (ml) by TF scintigraphy at 6 months | 99mTc-tetrofosmin (TF) scintigraphy was performed 6 months after the PCI procedure. For the scanning procedure, the 740 MBq of 99mTc-tetrofosmin injected with patient while at rest. Left ventricular end-diastolic volume (ml) based on 99mTc-tetrofosmin QGS data. | 5-7 month | 
| Left ventricular end-systolic volume (ml) by TF scintigraphy at 6 months | 99mTc-tetrofosmin (TF) scintigraphy was performed 6 months after the PCI procedure. For the scanning procedure, the 740 MBq of 99mTc-tetrofosmin injected with patient while at rest. Left ventricular end-systolic volume (ml) on 99mTc-tetrofosmin QGS data. | 5-7 month | 
| Intra-stent tissue volume by OCT | OCT analysis should be conducted by an independent core lab (Kobe University Hospital) before and after stenting at Primary PCI and 1 year after PCI in selected patients. Should be conducted preoperatively, postoperatively and 1 year after operation. For analysis, the required matters (catheter size and target lesion) should be entered into the technician worksheet. The size and length of the stent used should be entered, in particular. In conducting OCI imaging in each medical institution, attention should be paid to the following points, and the requirements should be entered in the given section of technician worksheet: Analysis should be conducted based on the stent length described in the technician worksheet. In the qualitative analysis, the inside of stent and 5 mm to proximal and distal ends of stent should be evaluated at the interval of 0.2 mm. In the quantitative analysis, the inside of stent should be evaluated at the interval of 1.0 mm. | at the end of procedure and 1-year | 
| Myocardial salvage [total perfusion defect (TPD) model] by SPECT | Myocardial salvage [total perfusion defect model (TPD)] = (Risk at area: TPD measured by BMIPP 3-9 days after p-PCI) minus (Infarct size: TPD measured by Tc99m-tetrofosmin at 6 months after p-PCI) | 3 day to 6 month | 
| Myocardial salvage index (%) [total perfusion defect (TPD) model] by SPECT | Myocardial salvage index (%) [total perfusion defect model (TPD)] = myocardial salvage / Risk at area: TPD measured by BMIPP 3-9 days after p-PCI x 100 | 3 day to 6 month | 
| Major adverse cardiovascular events (MACE) at 12 months | Major adverse cardiovascular events (MACE) MACE were defined as all-cause death, myocardial infarction (MI), or target lesion revascularization (TLR). | 12 months | 
| Major adverse cardiovascular events (MACE) at 36 months | Major adverse cardiovascular events (MACE) MACE were defined as all-cause death, myocardial infarction (MI), or target lesion revascularization (TLR). | 36 months | 
| Major adverse cardiovascular events (MACE) at 60 months | Major adverse cardiovascular events (MACE) MACE were defined as all-cause death, myocardial infarction (MI), or target lesion revascularization (TLR). | 60 months | 
| Cardiac death at 12 months | Death was considered to be of cardiac origin unless obvious noncardiac causes could be identified. | 12 months | 
| Cardiac death at 36 months | Death was considered to be of cardiac origin unless obvious noncardiac causes could be identified. | 36 months | 
| Cardiac death at 60 months | Death was considered to be of cardiac origin unless obvious noncardiac causes could be identified. | 60 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ELCA, STEMI, Myocardial Salvage