Thrombus Aspiration during Percutaneous coronary intervention in Acute myocardial infarction Study (TAPAS) - Study design
ABSTRACT Embolization of atherothrombotic material is common during percutaneous coronary intervention (PCI) in acute myocardial infarction (MI). This may lead to distal vessel occlusion resulting in impaired myocardial perfusion, which is associated with larger infarct size and increased mortality. Adjunctive devices for PCI to protect the microcirculation have been developed. We intend to determine whether aspiration of thrombotic material before stent implantation of the infarct-related coronary artery results in improved myocardial perfusion compared with conventional primary PCI.
TAPAS is a single-center, prospective, randomized trial with a planned inclusion of 1080 patients with ST-elevation MI. Patients are assigned to treatment with thrombus aspiration with the 6F Export Aspiration Catheter (Medtronic Corporation, Santa Rosa, Calif) or to balloon angioplasty before stent implantation in the infarct-related artery. All patients will be treated medically according to current international guidelines including glycoprotein IIb/IIIa inhibitors before PCI. Randomization will be performed before coronary angiography. The primary end point is angiographic myocardial blush grade of <2. Secondary end points are enzymatic infarct size, ST-segment elevation resolution and persistent ST-segment elevation, postprocedural distal embolization, and Major Adverse Cardiac Events at 30 days and 1 year.
If thrombus aspiration significantly improves myocardial perfusion, it will lend support to the use of this treatment as part of the standard approach in patients with acute MI.
SourceAvailable from: Jawaid Sial[Show abstract] [Hide abstract]
ABSTRACT: To determine the safety and efficacy of selective thrombus aspiration during Primary Percutaneous Coronary Intervention (PCI).
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ABSTRACT: Objective: To determine the safety and efficacy of selective thrombus aspiration during Primary Percutaneous Coronary Intervention (PCI). Methods: This observational prospective study was conducted in the catheterization laboratory of a tertiary care cardiovascular centre. A total of 150 consecutive patients who underwent primary PCI were enrolled. Aspiration was done only when thrombus burden was considered significant. After completion of procedure angiographic and electrocardiographic signs were recorded and clinical follow up was documented up to 1 year. Results: No significant difference among the groups was found in age, height, weight and other risk factors like Hypertension, Diabetes Mellitus and Smoking. In general, left anterior descending artery was culprit in ~ 65 % of patients and more than 90 % of culprit vessels had visible thrombus. Multivessel disease was present in 38 % of patients and 22.7% had past history of myocardial infarction. Out of 150 patients 117 (78%) underwent thrombus aspiration. No significant difference was found in ST resolution within 60 minutes (72.6 vs 81.8 %; P<0.285) and myocardial blush grade II & III (41.9 vs 27.3 %; P<0.128). No difference in event free survival was observed among the two groups (80.3 vs 84.8 %; P<0.708) at one year. Conclusion: Selective thrombus aspiration in definite thrombus laden arteries and no aspiration in low or negligible thrombus burden vessels may be a safe and effective strategy in patients undergoing primary PCI. Overall poor risk profile of our patients as compared to western population necessitates further evaluation of this matter in randomized studies. Keywords: Acute ST elevation myocardial infarction, Priamry percutaneous coronary intervention, Aspiration thrombectomy. (JPMA 64: 653; 2014).Journal of the Pakistan Medical Association 06/2014; 64(6):653-9. · 0.40 Impact Factor
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ABSTRACT: Objective: This study was a pilot trial to determine safety and feasibility of intracoronary infusion of mononuclear bone marrow cells (MBMC) in patients with acute myocardial infarction (MI). Background: Studies reporting the effect of MBMC therapy on improvement of left ventricular (LV) function have shown variable results. The HEBE trial is a large multicenter, randomized trial that currently enrolls patients. Prior to this trial we performed a pilot study. Methods: Twenty-six patients with a first acute MI were prospectively enrolled in eight centers. Bone marrow aspiration was performed at a median of 6 days after primary PCI (interquartile range, 5–7 days). MBMC were isolated by gradient centrifugation and were infused intracoronary the same day. All patients underwent magnetic resonance imaging before cell infusion and after 4 months. Clinical events were assessed up to 12 months. Results: Within 10 hr after bone marrow aspiration, 246 ± 133 × 106 MBMC were infused, of which 3.9 ± 2.3 × 106 cells were CD34+. In one patient, this procedure was complicated by local dissection. LV ejection fraction significantly increased from 45.0 ± 6.3% to 47.2 ± 6.5% (P = 0.03). Systolic wall thickening in dysfunctional segments at baseline improved with 0.9 ± 0.7 mm (P < 0.001). Infarct size decreased 37% from 17.8 ± 8.2 to 11.2 ± 4.2 gram (P < 0.001). During 12-month follow-up, 3 additional revascularizations were performed and an ICD was implanted in one patient, 3 weeks after PCI. Conclusion: In patients with acute MI, intracoronary infusion of MBMC is safe in a multicenter setting. At 4-month follow-up, a modest increase in global and regional LV function was observed, with a concomitant decrease in infarct size. © 2008 Wiley-Liss, Inc.Catheterization and Cardiovascular Interventions 02/2008; 71(3):273 - 281. DOI:10.1002/ccd.21337 · 2.40 Impact Factor