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: Thrombectomy in patients with ST-elevation myocardial infarction (STEMI) undergoing percutaneous coronary intervention (PCI) is associated to better myocardial reperfusion. However, no single trial was adequately powered to asses the impact of thrombectomy on long-term clinical outcome and to identify patients at higher benefit. Thus, we sought to assess these issues in a collaborative individual patient-data pooled analysis of randomized studies (study acronym: ATTEMPT, number of registration: NCT00766740). Individual data of 2686 patients enrolled in 11 trials entered the pooled analysis. Primary endpoint of the study was all-cause mortality. Major adverse cardiac events (MACE) were considered as the occurrence of all-cause death and/or target lesion/vessel revascularization and/or myocardial infarction (MI). Subgroups analysis was planned according to type of thrombectomy device (manual or non-manual), diabetic status, IIb/IIIa-inhibitor therapy, ischaemic time, infarct-related artery, pre-PCI TIMI flow. Clinical follow-up was available in 2674 (99.6%) patients at a median of 365 days. Kaplan-Meier analysis showed that allocation to thrombectomy was associated with significantly lower all-cause mortality (P = 0.049). Thrombectomy was also associated with significantly reduced MACE (P = 0.011) and death + MI rate during the follow-up (P = 0.015). Subgroups analysis showed that thrombectomy is associated to improved survival in patients treated with IIb/IIIa-inhibitors (P = 0.045) and that the survival benefit is confined to patients treated in manual thrombectomy trials (P = 0.011). The present large pooled analysis of randomized trials suggests that thrombectomy (in particular manual thrombectomy) significantly improves the clinical outcome in patients with STEMI undergoing mechanical reperfusion and that its effect may be additional to that of IIb/IIIa-inhibitors.European Heart Journal 10/2009; 30(18):2193-203. · 14.10 Impact Factor
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ABSTRACT: The data used for the present study were obtained as part of a clinical trial evaluating the effect of thrombus aspiration after primary percutaneous coronary intervention (PCI). The study was conducted at a tertiary referral facility for primary PCI at a University Medical Center Groningen in The Netherlands. Prognosis after ST elevation myocardial infarction (STEMI) is strongly related to infarct size. As part of a randomized clinical trial, the first electrocardiogram (ECG) after primary PCI for STEMI was analyzed for the incidence of Q waves (>0.1 mV) on the 12-lead ECG. Infarct size was measured as area under curve (AUC) of creatine kinase (CK) and CK-myocardial band (CK-MB). Nine hundred thirty-three patients were included, the median number of Q waves on the postprocedural ECG was 3 (interquartile range, 1-4). The number of Q waves on the postprocedural ECG was an independent predictor of infarct size measured either as AUC of CK (P < .001) or AUC of CK-MB (P < .001) and was a significant predictor of mortality during follow-up of 14 months. In conclusion, the number of Q waves on the postprocedural 12-lead ECG after primary PCI for STEMI is a strong predictor of infarct size and long-term mortality.Journal of electrocardiology 04/2009; 42(4):310-8. · 1.08 Impact Factor
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ABSTRACT: Reinfarction and stent thrombosis are major complications after primary percutaneous coronary intervention (PCI) for ST-elevation myocardial infarction (STEMI). We sought to investigate the incidence, predictors, and outcome of reinfarction and stent thrombosis in a contemporary cohort of STEMI patients. Reinfarction and stent thrombosis within 1 year after primary PCI for STEMI were analyzed in the Thrombus Aspiration during Percutaneous coronary intervention in Acute myocardial infarction Study (TAPAS). Reinfarction was observed in 3.4% (34/995) of patients within 1 year after primary PCI. Angiographic evidence of stent thrombosis was observed in 15/34 (44.1%). During the index primary PCI, intra-aortic balloon counterpulsation was used in 10/32 (31.3%) patients with and 47/900 (5.2%) without reinfarction (P < 0.001). After the index primary PCI, thrombus was visible in 6/34 (17.7%) with reinfarction when compared with that in 25/952 (2.6%) without reinfarction (P < 0.001), and complete ST-segment resolution in 8/33 (24.2%) compared with that in 462/892 (51.8%, P = 0.002). Mortality at 1 year after the index PCI was higher after reinfarction: 6/34 (17.7%) compared with 53/961 (5.5%, P = 0.003). Patients with stent thrombosis showed myocardial blush grade 0-1 in 11/15 (73.3%) cases, distal embolization in 8/15 (53.3%), and a mortality at 1 year of 4/15 (26.7%). In contemporary practice with primary PCI and triple antiplatelet therapy for STEMI, the incidence of reinfarction is low. Outcome characteristics after the index PCI were important determinants of reinfarction. However, reinfarction was associated with poor prognosis, and in particular patients with stent thrombosis had poor outcome.Catheterization and Cardiovascular Interventions 05/2009; 73(5):627-34. · 2.51 Impact Factor