PMID- 21095287 OWN - NLM STAT- MEDLINE DCOM- 20110118 LR - 20101124 IS - 1097-6744 (Electronic) IS - 0002-8703 (Linking) VI - 160 IP - 5 DP - 2010 Nov TI - Thrombus aspiration followed by direct stenting: a novel strategy of primary percutaneous coronary intervention in ST-segment elevation myocardial infarction. Results of the Polish-Italian-Hungarian RAndomized ThrombEctomy Trial (PIHRATE Trial). PG - 966-72 LID - 10.1016/j.ahj.2010.07.024 [doi] AB - BACKGROUND: Previous studies with thrombectomy showed different results, mainly due to use of thrombectomy as an additional device not instead of balloon predilatation. The aim of the present study was to assess impact of aspiration thrombectomy followed by direct stenting. METHODS: Patients with ST elevation myocardial infarction (STEMI) <6 hours from pain onset and occluded infarct-related artery in baseline angiography were randomized into aspiration thrombectomy followed by direct stenting (TS, n = 100) or standard balloon predilatation followed by stent implantation (n = 96). The primary end point of the study was the electrocardiographic ST-segment elevation resolution >70% (STR > 70%) 60 minutes after primary angioplasty (percutaneous coronary intervention [PCI]). Secondary end points included angiographic myocardial blush grade (MBG) after PCI, combination of STR > 70% immediately after PCI and MBG grade 3 (optimal myocardial reperfusion), Thrombolysis In Myocardial Infarction flow after PCI, angiographic complications, and in-hospital major adverse cardiac events. RESULTS: Aspiration thrombectomy success rate was 91% (crossing of the lesion with thrombus reduction and flow restoration). There was no significant difference in STR >/= 70% after 60 minutes (53.7% vs 35.1%, P = .29). STR > 70% immediately after PCI (41% vs 26%, P < .05), MBG grade 3 (76% vs 58%, P < .03), and optimal myocardial reperfusion (35.1% vs 11.8%, P < .001) were more frequent in TS. There was no difference in between the groups in 6-month mortality (4% vs 3.1%, P = .74) and reinfarction rate (1% vs 3.1%, P = .29). CONCLUSIONS: Aspiration thrombectomy and direct stenting is safe and effective in STEMI patients with early presentation (<6 hours). The angiographic parameters of microcirculation reperfusion and ECG ST-segment resolution directly after PCI were significantly better in thrombectomy group despite the lack of the difference in ST-segment resolution 60 minutes after PCI. CI - Copyright (c) 2010 Mosby, Inc. All rights reserved. FAU - Dudek, Dariusz AU - Dudek D AD - Department of Interventional Cardiology Jagiellonian University Medical College, Krakow, Poland. mcdudek@cyf-kr.edu.pl FAU - Mielecki, Waldemar AU - Mielecki W FAU - Burzotta, Francesco AU - Burzotta F FAU - Gasior, Mariusz AU - Gasior M FAU - Witkowski, Adam AU - Witkowski A FAU - Horvath, Ivan G AU - Horvath IG FAU - Legutko, Jacek AU - Legutko J FAU - Ochala, Andrzej AU - Ochala A FAU - Rubartelli, Paolo AU - Rubartelli P FAU - Wojdyla, Roman M AU - Wojdyla RM FAU - Siudak, Zbigniew AU - Siudak Z FAU - Buchta, Piotr AU - Buchta P FAU - Pregowski, Jerzy AU - Pregowski J FAU - Aradi, Daniel AU - Aradi D FAU - Machnik, Andrzej AU - Machnik A FAU - Hawranek, Michal AU - Hawranek M FAU - Rakowski, Tomasz AU - Rakowski T FAU - Dziewierz, Artur AU - Dziewierz A FAU - Zmudka, Krzysztof AU - Zmudka K LA - eng SI - ClinicalTrials.gov/NCT00377650 PT - Comparative Study PT - Journal Article PT - Multicenter Study PT - Randomized Controlled Trial PL - United States TA - Am Heart J JT - American heart journal JID - 0370465 SB - IM MH - Angioplasty, Balloon, Coronary/*methods MH - Coronary Angiography MH - Coronary Thrombosis/complications/*surgery MH - *Electrocardiography MH - Female MH - Follow-Up Studies MH - Humans MH - Hungary MH - Italy MH - Male MH - Middle Aged MH - Myocardial Infarction/etiology/physiopathology/*therapy MH - Poland MH - Retrospective Studies MH - *Stents MH - Suction/*methods MH - Thrombectomy/*methods MH - Time Factors MH - Treatment Outcome EDAT- 2010/11/26 06:00 MHDA- 2011/01/19 06:00 CRDT- 2010/11/25 06:00 PHST- 2010/04/12 00:00 [received] PHST- 2010/07/25 00:00 [accepted] PHST- 2010/11/25 06:00 [entrez] PHST- 2010/11/26 06:00 [pubmed] PHST- 2011/01/19 06:00 [medline] AID - S0002-8703(10)00667-8 [pii] AID - 10.1016/j.ahj.2010.07.024 [doi] PST - ppublish SO - Am Heart J. 2010 Nov;160(5):966-72. doi: 10.1016/j.ahj.2010.07.024.