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OUR MISSION: TO REDUCE THE BURDEN OF CARDIOVASCULAR DISEASE
Prof. Raffaele De Caterina,
Prof. Ole Frobert
Presenter abstract | Discussant | All the Scientific resources on ESC Congress 365
By Ole FröbertOther authors: Bo Lagerqvist, MD, PhD, Sweden, Göran K. Olivecrona, MD, PhD, Sweden, Elmir Omerovic, MD, PhD, Sweden, Thórarinn Gudnason, MD, PhD, FESC, Iceland, Michael Maeng, MD, PhD, Denmark, Ulf Jensen, MD, PhD, Sweden, Ollie Östlund, MSc, Sweden, Johan Nilsson, MD, PhD, Sweden, Oskar Angerås, MD, Sweden, Jan Harnek, MD, PhD, Sweden, Fredrik Calais, MD, Sweden, Amra Kåregren, MD, Sweden, Mikael Danielewicz, MD, Sweden, Lennart Sandhall, MD., Sweden, Lars Hellsten MD. Sweden, David Erlinge, MD, PhD.,Sweden, Mikael Aasa, MD, PhD., Sweden, Agneta C. Johansson, MD., Sweden, Lotta Robertson, MD., Sweden, Iwar Sjögren, MD., Sweden, Stefan K. James, MD. PhD, Sweden.Background:Reperfusion failure following primary percutaneous coronary intervention (PCI) in ST-segment elevation myocardial infarction (STEMI) is associated with unfavourable outcome. Intracoronary thrombus aspiration reduces distal embolization of thrombus and plaque material, improves reperfusion and has a class IIa, level of evidence B recommendation in the 2012 ESC STEMI guidelines. We aimed to evaluate if thrombus aspiration reduces mortality.Methods:The Thrombus Aspiration in ST-Elevation myocardial infarction in Scandinavia (TASTE trial) is a multicenter, prospective, randomised, controlled open-label clinical trial. The national, all-encompassing Swedish Coronary Angiography and Angioplasty Registry (SCAAR) served as on-line platform for randomization, case record forms and follow-up. Blinded evaluation of hard endpoints was done through national registries. The primary endpoint was time to all-cause death at 30 days. The trial was powered to detect a hazard ratio (HR) of 0.67 in the primary endpoint in patients with STEMI randomized to manual thrombus aspiration followed by PCI as compared with PCI alone.Results:Patients were enrolled in all of the 29 Swedish, 1 Danish and 1 Icelandic PCI center. A total of 7244 patients with STEMI undergoing PCI were randomised, representing 60% of all patients with this diagnosis during the study period. Inclusion in the TASTE trial was terminated March 25, 2013. At the ESC Congress 2013 we will present the main 30-day results on death as well as the composite endpoint of death and myocardial infarction.Conclusion:The TASTE trial will provide evidence on whether thrombus aspiration during primary PCI reduces mortality and improves outcome in patients with STEMI. (ClinicalTrials.gov number, NCT01093404).
Raffaele De Caterina, MD, PhD, FESCPrimary percutaneous coronary intervention (PCI) is effective in opening the infarct-related artery and provides the best current approach to reduce infarct size and mortality in patients with ST-segment elevation myocardial infarction (STEMI). Microvascular obstruction with diminished myocardial perfusion occurs in a large proportion of patients with a reopened epicardial vessel after primary PCI, and this event, which is at least partially due to distal embolization of thrombus and plaque material, is associated with increased infarct size, reduced recovery of ventricular function, and increased mortality.In a previous single-center trial (TAPAS)(1) including 1,071 STEMI patients, manual aspiration thrombectomy had been shown effective in reducing not only myocardial blush (primary end point of the study) and ST-segment resolution (both indices of microcirculatory perfusion), but also cardiac death and reinfarction, with incidence of these latter related to the former. A pooled-analysis (2) published in 2009 and compiling 11 trials, of which TAPAS was by far the largest, had similarly concluded that there was a significantly favorable effect on hard outcomes with manual thrombectomy, but conclusions were not the same in two subsequent meta-analyses (3, 4), that included 174 and 21 trials(3), respectively.TASTE was a prospective multicenter controlled trial randomly allocating 7244 patients to either PCI, or PCI preceded by manual thrombectomy performed with the use of three different aspiration devices(5). The sample size was therefore >7 times higher than TAPAS and the power to detect differences in hard end points much higher. The study, performed with contemporary techniques and medications, did not show any significant difference in the primary outcome of all-cause mortality, and non-significant trends towards less MI and stent thrombosis at 30 days. Although findings apparently leave little role for manual thrombus aspiration as a routine adjunct to PCI in STEMI, the door to thrombus aspiration is probably not yet totally closed. A few open questions remain, such as:(a) will the trend towards less reinfarction and stent thrombosis at 30 days translate into later survival benefits? Odds are against this if one consider the wide separation of mortality curves already occurring at 30 days in TAPAS, contrary to TASTE, but the trend for MI and stent thrombosis in TASTE can also be seen as encouraging;(b) The concept of thrombus aspiration is still logical, feasible, and will continue to be attractive for many. Will the use of other methods of thrombus removal, such as rheolytic thrombectomy(6) lead to better outcomes than conventional stent-PCI?1 - Svilaas T, Vlaar PJ, van der Horst IC, Diercks GF, de Smet BJ, van den Heuvel AF, Anthonio RL, Jessurun GA, Tan ES, Suurmeijer AJ, Zijlstra F. Thrombus aspiration during primary percutaneous coronary intervention. N Engl J Med 2008;358:557-67.2 - Burzotta F, De Vita M, Gu YL, Isshiki T, Lefevre T, Kaltoft A, Dudek D, Sardella G, Orrego PS, Antoniucci D, De Luca L, Biondi-Zoccai GG, Crea F, Zijlstra F. Clinical impact of thrombectomy in acute ST-elevation myocardial infarction: an individual patient-data pooled analysis of 11 trials. Eur Heart J 2009;30:2193-203.3 - Mongeon FP, Belisle P, Joseph L, Eisenberg MJ, Rinfret S. Adjunctive thrombectomy for acute myocardial infarction: A bayesian meta-analysis. Circ Cardiovasc Interv 2010;3:6-16.4 - Tamhane UU, Chetcuti S, Hameed I, Grossman PM, Moscucci M, Gurm HS. Safety and efficacy of thrombectomy in patients undergoing primary percutaneous coronary intervention for acute ST elevation MI: a meta-analysis of randomized controlled trials. BMC Cardiovasc Disord 2010;10:10.5 - Fröbert O, Lagerqvist B, Olivecrona GK, Omerovic E, Gudnason T, Maeng M, Aasa M, Angerås O, Calais F, Danielewicz M, Erlinge D, Hellste L, Jensen U, Johansson AC, Kåregren A, Nilsson J, Robertson L, Sandhall L, Sjögren I, Östlund O, Harnek J, James SK. Thrombus aspiration during ST- elevation myocardial infarction. A multicenter, prospective, registry-based randomized clinical trial. N Engl J Med 2013; in press.6 - Parodi G, Valenti R, Migliorini A, Maehara A, Vergara R, Carrabba N, Mintz GS, Antoniucci D. Comparison of manual thrombus aspiration with rheolytic thrombectomy in acute myocardial infarction. Circ Cardiovasc Interv 2013;6:224-30.
TASTE: Thrombus aspiration during ST-segment elevation myocardial infarction. A multicenter, prospective, registry based randomized clinical trial
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