Sanjit S Jolly1, Stefan James2, Vladimír Džavík2, John A Cairns2, Karim D Mahmoud2, Felix Zijlstra2, Salim Yusuf2, Goran K Olivecrona2, Henrik Renlund2, Peggy Gao2, Bo Lagerqvist2, Ashraf Alazzoni2, Sasko Kedev2, Goran Stankovic2, Brandi Meeks2, Ole Frøbert2. 1. From McMaster University and the Population Health Research Institute, Hamilton Health Sciences, Hamilton, ON, Canada (S.S.J., S.Y., P.G., A.A., B.M.); Department of Medical Science, Uppsala University and Uppsala Clinical Research Centre, Uppsala, Sweden (S.J., H.R., B.L.); Peter Munk Cardiac Centre, University Health Network, Toronto, ON, Canada (V.D.); University of British Columbia, Vancouver, BC, Canada (J.A.C.); Department of Cardiology, Thorax Center, Erasmus Medical Centre, Rotterdam, the Netherlands (K.D.M., F.Z.); Skåne University Hospital-Lund/Lund University, Lund, Sweden (G.K.O.); University Clinic of Cardiology, Sts. Cyril and Methodius University, Skopje, Macedonia (S.K.); Clinical Center of Serbia and Department of Cardiology, Medical Faculty, University of Belgrade, Belgrade, Serbia (G.S.); and Örebro University, Faculty of Health, Department of Cardiology, Södra Grev Rosengatan, Örebro, Sweden (O.F.). sanjit.jolly@phri.ca. 2. From McMaster University and the Population Health Research Institute, Hamilton Health Sciences, Hamilton, ON, Canada (S.S.J., S.Y., P.G., A.A., B.M.); Department of Medical Science, Uppsala University and Uppsala Clinical Research Centre, Uppsala, Sweden (S.J., H.R., B.L.); Peter Munk Cardiac Centre, University Health Network, Toronto, ON, Canada (V.D.); University of British Columbia, Vancouver, BC, Canada (J.A.C.); Department of Cardiology, Thorax Center, Erasmus Medical Centre, Rotterdam, the Netherlands (K.D.M., F.Z.); Skåne University Hospital-Lund/Lund University, Lund, Sweden (G.K.O.); University Clinic of Cardiology, Sts. Cyril and Methodius University, Skopje, Macedonia (S.K.); Clinical Center of Serbia and Department of Cardiology, Medical Faculty, University of Belgrade, Belgrade, Serbia (G.S.); and Örebro University, Faculty of Health, Department of Cardiology, Södra Grev Rosengatan, Örebro, Sweden (O.F.).
Abstract
BACKGROUND: Thrombus aspiration during percutaneous coronary intervention (PCI) for the treatment of ST-segment-elevation myocardial infarction (STEMI) has been widely used; however, recent trials have questioned its value and safety. In this meta-analysis, we, the trial investigators, aimed to pool the individual patient data from these trials to determine the benefits and risks of thrombus aspiration during PCI in patients with ST-segment-elevation myocardial infarction. METHODS: Included were large (n≥1000), randomized, controlled trials comparing manual thrombectomy and PCI alone in patients with ST-segment-elevation myocardial infarction. Individual patient data were provided by the leadership of each trial. The prespecified primary efficacy outcome was cardiovascular mortality within 30 days, and the primary safety outcome was stroke or transient ischemic attack within 30 days. RESULTS: The 3 eligible randomized trials (TAPAS [Thrombus Aspiration During Percutaneous Coronary Intervention in Acute Myocardial Infarction], TASTE [Thrombus Aspiration in ST-Elevation Myocardial Infarction in Scandinavia], and TOTAL [Trial of Routine Aspiration Thrombectomy With PCI Versus PCI Alone in Patients With STEMI]) enrolled 19 047 patients, of whom 18 306 underwent PCI and were included in the primary analysis. Cardiovascular death at 30 days occurred in 221 of 9155 patients (2.4%) randomized to thrombus aspiration and 262 of 9151 (2.9%) randomized to PCI alone (hazard ratio, 0.84; 95% confidence interval, 0.70-1.01; P=0.06). Stroke or transient ischemic attack occurred in 66 (0.8%) randomized to thrombus aspiration and 46 (0.5%) randomized to PCI alone (odds ratio, 1.43; 95% confidence interval, 0.98-2.10; P=0.06). There were no significant differences in recurrent myocardial infarction, stent thrombosis, heart failure, or target vessel revascularization. In the subgroup with high thrombus burden (TIMI [Thrombolysis in Myocardial Infarction] thrombus grade ≥3), thrombus aspiration was associated with fewer cardiovascular deaths (170 [2.5%] versus 205 [3.1%]; hazard ratio, 0.80; 95% confidence interval, 0.65-0.98; P=0.03) and with more strokes or transient ischemic attacks (55 [0.9%] versus 34 [0.5%]; odds ratio, 1.56; 95% confidence interval, 1.02-2.42, P=0.04). However, the interaction P values were 0.32 and 0.34, respectively. CONCLUSIONS: Routine thrombus aspiration during PCI for ST-segment-elevation myocardial infarction did not improve clinical outcomes. In the high thrombus burden group, the trends toward reduced cardiovascular death and increased stroke or transient ischemic attack provide a rationale for future trials of improved thrombus aspiration technologies in this high-risk subgroup. CLINICAL TRIAL REGISTRATION: URLs: http://www.ClinicalTrials.gov http://www.crd.york.ac.uk/prospero/. Unique identifiers: NCT02552407 and CRD42015025936.
BACKGROUND:Thrombus aspiration during percutaneous coronary intervention (PCI) for the treatment of ST-segment-elevation myocardial infarction (STEMI) has been widely used; however, recent trials have questioned its value and safety. In this meta-analysis, we, the trial investigators, aimed to pool the individual patient data from these trials to determine the benefits and risks of thrombus aspiration during PCI in patients with ST-segment-elevation myocardial infarction. METHODS: Included were large (n≥1000), randomized, controlled trials comparing manual thrombectomy and PCI alone in patients with ST-segment-elevation myocardial infarction. Individual patient data were provided by the leadership of each trial. The prespecified primary efficacy outcome was cardiovascular mortality within 30 days, and the primary safety outcome was stroke or transient ischemic attack within 30 days. RESULTS: The 3 eligible randomized trials (TAPAS [Thrombus Aspiration During Percutaneous Coronary Intervention in Acute Myocardial Infarction], TASTE [Thrombus Aspiration in ST-Elevation Myocardial Infarction in Scandinavia], and TOTAL [Trial of Routine Aspiration Thrombectomy With PCI Versus PCI Alone in Patients With STEMI]) enrolled 19 047 patients, of whom 18 306 underwent PCI and were included in the primary analysis. Cardiovascular death at 30 days occurred in 221 of 9155 patients (2.4%) randomized to thrombus aspiration and 262 of 9151 (2.9%) randomized to PCI alone (hazard ratio, 0.84; 95% confidence interval, 0.70-1.01; P=0.06). Stroke or transient ischemic attack occurred in 66 (0.8%) randomized to thrombus aspiration and 46 (0.5%) randomized to PCI alone (odds ratio, 1.43; 95% confidence interval, 0.98-2.10; P=0.06). There were no significant differences in recurrent myocardial infarction, stent thrombosis, heart failure, or target vessel revascularization. In the subgroup with high thrombus burden (TIMI [Thrombolysis in Myocardial Infarction] thrombus grade ≥3), thrombus aspiration was associated with fewer cardiovascular deaths (170 [2.5%] versus 205 [3.1%]; hazard ratio, 0.80; 95% confidence interval, 0.65-0.98; P=0.03) and with more strokes or transient ischemic attacks (55 [0.9%] versus 34 [0.5%]; odds ratio, 1.56; 95% confidence interval, 1.02-2.42, P=0.04). However, the interaction P values were 0.32 and 0.34, respectively. CONCLUSIONS: Routine thrombus aspiration during PCI for ST-segment-elevation myocardial infarction did not improve clinical outcomes. In the high thrombus burden group, the trends toward reduced cardiovascular death and increased stroke or transient ischemic attack provide a rationale for future trials of improved thrombus aspiration technologies in this high-risk subgroup. CLINICAL TRIAL REGISTRATION: URLs: http://www.ClinicalTrials.gov http://www.crd.york.ac.uk/prospero/. Unique identifiers: NCT02552407 and CRD42015025936.
Authors: Dhanuka Perera; Krishnaraj S Rathod; Oliver Guttmann; Anne-Marie Beirne; Constantinos O'Mahony; Roshan Weerackody; Andreas Baumbach; Anthony Mathur; Andrew Wragg; Daniel A Jones Journal: Am J Cardiovasc Dis Date: 2020-12-15
Authors: Johannes Blumenstein; Steffen Daniel Kriechbaum; Jürgen Leick; Alexander Meyer; Won-Keun Kim; Jan Sebastian Wolter; Maisun Abu-Samra; Kay Weipert; Matthias Bayer; Oliver Dörr; Claudia Walther; Christian W Hamm; Holger Nef; Christoph Liebetrau; Helge Möllmann Journal: J Thromb Thrombolysis Date: 2018-02 Impact factor: 2.300
Authors: H M H Spronk; T Padro; J E Siland; J H Prochaska; J Winters; A C van der Wal; J J Posthuma; G Lowe; E d'Alessandro; P Wenzel; D M Coenen; P H Reitsma; W Ruf; R H van Gorp; R R Koenen; T Vajen; N A Alshaikh; A S Wolberg; F L Macrae; N Asquith; J Heemskerk; A Heinzmann; M Moorlag; N Mackman; P van der Meijden; J C M Meijers; M Heestermans; T Renné; S Dólleman; W Chayouâ; R A S Ariëns; C C Baaten; M Nagy; A Kuliopulos; J J Posma; P Harrison; M J Vries; H J G M Crijns; E A M P Dudink; H R Buller; Y M C Henskens; A Själander; S Zwaveling; O Erküner; J W Eikelboom; A Gulpen; F E C M Peeters; J Douxfils; R H Olie; T Baglin; A Leader; U Schotten; B Scaf; H M M van Beusekom; L O Mosnier; L van der Vorm; P Declerck; M Visser; D W J Dippel; V J Strijbis; K Pertiwi; A J Ten Cate-Hoek; H Ten Cate Journal: Thromb Haemost Date: 2018-01-29 Impact factor: 5.249