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.
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ABSTRACT: Significant microvascular obstruction (MVO) during primary percutaneous coronary intervention (PCI) may suggest severe myocardial damage. The predictive value of N-terminal pro-B-type natriuretic peptide levels (NT-proBNP) for MVO has not been previously evaluated. The purpose of the study was to determine whether NT-proBNP levels measured upon hospital admission of ST-segment elevation myocardial infarction (STEMI) patients receiving primary PCI have predictive value for MVO. NT-proBNP levels were obtained upon admission to the emergency department, for 41 acute STEMI patients. Cardiac contrast-enhanced magnetic resonance imaging (CE-MRI) was performed within 4 days after PCI. The optimal cut-off value to predict grade 3 MVO was determined using a receiver operating characteristic (ROC) curve. Multivariate regression analysis was performed to determine predictors for grade 3 MVO. MVO grade correlated with left ventricular ejection fraction (LVEF; r =-0.383, P = 0.013), peak serum creatine kinase MB iso-enzyme (CK-MB; r = 0.470, P = 0.002), and NT-proBNP levels (r = 0.357, P = 0.022). The optimal cut-off value to predict grade 3 MVO was an NT-proBNP level of ≥80 pg/mL. Multivariate regression analysis, including LVEF, peak CK-MB, and an NT-proBNP ≥80 pg/mL revealed that only an NT-proBNP ≥80 pg/mL was an independent factor related to grade 3 MVO. NT-proBNP levels upon hospital admission have a predictive value for MVOs. Further study is needed to determine if protective treatment strategies are warranted in STEMI patients with high NT-proBNP levels at presentation.Journal of Interventional Cardiology 02/2011; 24(1):34-41. · 1.50 Impact Factor
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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. · 0.41 Impact Factor
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ABSTRACT: We aimed to assess the safety and feasibility of thrombectomy with the Export Aspiration Catheter (EAC) before angioplasty, and its ability to improve angiographic results in patients with ST-segment elevation myocardial infarction (STEMI). Distal embolization of atherothrombotic material often occurs during angioplasty in STEMI, compromising optimal myocardial reperfusion. We performed a thrombus-aspiration with EAC prior to angioplasty in 64 consecutive patients with STEMI. Successful thrombectomy was defined as an improvement of TIMI flow grade >or=1. Successful thrombectomy (increase of TIMI flow >or=1) was achieved in 40 patients (62.5%). Mean TIMI flow grade increased from 0.7 +/- 1 to 1.9 +/- 1.2 (p < 0.0001) after thrombectomy. TIMI flow grade 3 was observed more frequently after EAC compared with guidewire alone (51.5% vs. 9%, p = 0.0062). Direct stenting was performed in most of the patients (n = 41, 64%). Distal embolization and no reflow/slow flow phenomenon occurred in 8 patients (12.5%). No vessel injury after EAC thrombectomy was reported. After treatment with balloon angioplasty and/or stenting, final TIMI flow grade 3 was achieved in 54 patients (84.5%). By multivariate analysis, ischemic time < 6 hours was a significant independent predictor of successful thrombectomy (p = 0.0437). Our series suggests that EAC thrombectomy prior to angioplasty in the setting of STEMI is safe and feasible. It might reduce the culprit coronary lesion's thrombus burden, leading to improved flow restoration and myocardial reperfusion. Further large randomized studies are warranted to confirm these preliminary results and to assess the impact of thrombus-aspiration on infarct size as well as on clinical outcomes.Journal of Interventional Cardiology 04/2007; 20(2):136-42. · 1.50 Impact Factor