Effect of thrombus aspiration on infarct size and left ventricular function in high-risk patients with acute myocardial infarction treated by percutaneous coronary intervention. Results of a prospective controlled pilot study. Am Heart J 157:583.e1-583.e7
Department of Cardiology, G. Montpied University Hospital, Clermont-Ferrand, France. American heart journal
(Impact Factor: 4.46).
04/2009; 157(3):583.e1-7. DOI: 10.1016/j.ahj.2008.11.017
Thrombus aspiration devices have been shown to improve reperfusion criteria and to reduce distal embolization in patients treated by percutaneous coronary interventions (PCI) in the acute phase of ST-elevation myocardial infarction (STEMI). There are, however, little data about their efficacy in the reduction of infarct size.
We sought to assess in a prospective randomized trial the impact of thrombus aspiration on infarct size and severity and on left ventricular function in high-risk patients with a first STEMI. The primary end point was scintigraphic infarct size, and secondary end points were infarct severity and regional and global left ventricular function. Forty-four patients with completely occluded (Thrombolysis in Myocardial Infarction flow 0-1) proximal segments of infarct-related artery were randomly assigned to thrombus aspiration group with the Export catheter (n = 20) (Medtronic, Inc, Minneapolis, MN) or PCI-only group. A rest Tc-99-mibi gated single-photon emission computed tomographic and contrast-enhanced magnetic resonance imaging were performed 6 +/- 2 days later.
Infarct size was comparable in patients in the thrombus aspiration group and PCI-only group (30.6% +/- 15.8% vs 28.5% +/- 17.9% of the left ventricle, P = .7) as was infarct severity in infarct-related artery territory (55% +/- 12% vs 55% +/- 14%, P = .9). Transmurality score as assessed by magnetic resonance imaging was similar in both groups (2.03 +/- 1.05 vs 2.16 +/- 1.21, P = .7). There was no impact of thrombus aspiration on other secondary end points.
In our study, thrombus aspiration with the Export catheter performed as adjunctive therapy in high-risk patients with total occlusion of the proximal part of major coronary arteries does not decrease infarct size or severity and has no effect on left ventricular regional and global function.
Available from: Tobias Geisler
- "The pivotal TAPAS (Thrombus Aspiration during Percutaneous coronary intervention in Acute myocardial infarction Study) trial of patients with STEMI, which compared a strategy with thrombectomy with a strategy without thrombectomy, showed a reduction in cardiac mortality at 1 year . By contrast, other randomized, controlled studies did not observe superiority of thrombectomy over standard PCI with respect to surrogate endpoints of reperfusion success [33,34]. However, meta-analyses in patients with STEMI showed a mortality-related benefit after thrombectomy compared with PCI alone [2,3]. "
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Current guidelines recommend thrombus aspiration in patients with ST-elevation myocardial infarction (STEMI); however, there are insufficient data to unequivocally support thrombectomy in patients with non-STEMI (NSTEMI).
The TATORT-NSTEMI (Thrombus Aspiration in ThrOmbus containing culpRiT lesions in Non-ST-Elevation Myocardial Infarction) trial is a prospective, controlled, multicenter, randomized, open-label trial enrolling 460 patients. The hypothesis is that, against a background of early revascularization, adjunctive thrombectomy leads to less microvascular obstruction (MO) compared with conventional percutaneous coronary intervention (PCI) alone, as assessed by cardiac magnetic resonance imaging (CMR) in patients with NSTEMI. Patients will be randomized in a 1:1 fashion to one of the two treatment arms. The primary endpoint is the extent of late MO assessed by CMR. Secondary endpoints include early MO, infarct size, and myocardial salvage assessed by CMR as well as enzymatic infarct size and angiographic parameters, such as thrombolysis in myocardial infarction flow post-PCI and myocardial blush grade. Furthermore, clinical endpoints including death, myocardial re-infarction, target vessel revascularization, and new congestive heart failure will be recorded at 6 and 12 months. Safety will be assessed by the incidence of bleeding and stroke.
The TATORT-NSTEMI trial has been designed to test the hypothesis that thrombectomy will improve myocardial perfusion in patients with NSTEMI and relevant thrombus burden in the culprit vessel reperfused by early PCI.
The trial is registered under http://www.clinicaltrials.gov: NCT01612312.
Trials 04/2013; 14(1):110. DOI:10.1186/1745-6215-14-110 · 1.73 Impact Factor
Available from: med.mcgill.ca
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ABSTRACT: In available trials and meta-analyses, adjunctive thrombectomy in acute myocardial infarction (MI) improves markers of myocardial reperfusion but has limited effects on clinical outcomes. Thrombectomy devices simply aspirate thrombus or mechanically fragment it before aspiration. Simple aspiration thrombectomy may offer a distinct advantage.
We identified 21 eligible trials (16 that used a simple aspiration thrombectomy device) involving 4299 patients with ST-segment elevation MI randomized to reperfusion therapy by primary percutaneous coronary intervention with or without thrombectomy. By using Bayesian meta-analysis methods, we found that thrombectomy yielded substantially less no-reflow (odds ratio [OR], 0.39; 95% credible interval [CrI], 0.18 to 0.69), more ST-segment resolution > or =50% (OR, 2.22; 95% CrI, 1.60 to 3.23), and more thrombolysis in myocardial infarction/myocardial perfusion grade 3 (OR, 2.50; 95% CrI, 1.48 to 4.41). There was no evidence for a decrease in death (OR, 0.94; 95% CrI, 0.47 to 1.80), death, recurrent MI, or stroke (OR, 1.07; 95% CrI, 0.63 to 1.92) with thrombectomy. Restriction of the analysis to trials that used simple aspiration thrombectomy devices did not yield substantially different results, except for a positive effect on postprocedure thrombolysis in myocardial infarction grade 3 flow (OR, 1.49; 95% CrI, 1.14 to 1.99).
In this Bayesian meta-analysis, adjunctive thrombectomy improves early markers of reperfusion but does not substantially effect 30-day post-MI mortality, reinfarction, and stroke. The use of aspiration thrombectomy devices is not associated with a reduction in post-MI clinical outcomes. Thrombectomy is one of the rare effective preventive measures against no-reflow.
Circulation Cardiovascular Interventions 02/2010; 3(1):6-16. DOI:10.1161/CIRCINTERVENTIONS.109.904037 · 6.22 Impact Factor
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ABSTRACT: In ST-elevation myocardial infarction (STEMI), distal embolization of thrombus material often precludes restoration of normal coronary artery flow. Small-scaled studies have demonstrated that intracoronary thrombus aspiration improves flow and myocardial perfusion, but only one larger randomized single-center study has suggested a survival benefit. Thrombus aspiration is widely used in clinical practice and is recommended by international guidelines despite limited evidence.
The Thrombus Aspiration in ST-Elevation myocardial infarction in Scandinavia is a multicenter, prospective, randomized, controlled, clinical open-label trial based on the Swedish angiography and angioplasty registry (SCAAR) platform with blinded evaluation of end points. A total of 5,000 patients with STEMI undergoing primary percutaneous coronary intervention (PCI) will randomly be assigned either to conventional PCI or to thrombus aspiration followed by PCI. SCAAR will be used as the platform for randomization, allowing a broad population of all-comers in the registry network to be enrolled. All follow-up will also be done in SCAAR and other national registries. The primary end point is time to all-cause death at 30 days.
The Thrombus Aspiration in ST-Elevation myocardial infarction in Scandinavia trial is the largest trial to date to evaluate the effect of thrombus aspiration on death following PCI in patients with STEMI. We propose the term randomized clinical registry trial to describe the novel entity of using an online national registry as platform for case records, randomization, and follow-up.
American heart journal 12/2010; 160(6):1042-8. DOI:10.1016/j.ahj.2010.08.040 · 4.46 Impact Factor
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