title: 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).
abstract: 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.
authors.affiliation: Department of Interventional Cardiology Jagiellonian University Medical College, Krakow, Poland. mcdudek@cyf-kr.edu.pl
authors.forename: Dariusz
authors.initials: D
authors.lastname: Dudek
authors.forename: Waldemar
authors.initials: W
authors.lastname: Mielecki
authors.forename: Francesco
authors.initials: F
authors.lastname: Burzotta
authors.forename: Mariusz
authors.initials: M
authors.lastname: Gasior
authors.forename: Adam
authors.initials: A
authors.lastname: Witkowski
authors.forename: Ivan G
authors.initials: IG
authors.lastname: Horvath
authors.forename: Jacek
authors.initials: J
authors.lastname: Legutko
authors.forename: Andrzej
authors.initials: A
authors.lastname: Ochala
authors.forename: Paolo
authors.initials: P
authors.lastname: Rubartelli
authors.forename: Roman M
authors.initials: RM
authors.lastname: Wojdyla
authors.forename: Zbigniew
authors.initials: Z
authors.lastname: Siudak
authors.forename: Piotr
authors.initials: P
authors.lastname: Buchta
authors.forename: Jerzy
authors.initials: J
authors.lastname: Pregowski
authors.forename: Daniel
authors.initials: D
authors.lastname: Aradi
authors.forename: Andrzej
authors.initials: A
authors.lastname: Machnik
authors.forename: Michal
authors.initials: M
authors.lastname: Hawranek
authors.forename: Tomasz
authors.initials: T
authors.lastname: Rakowski
authors.forename: Artur
authors.initials: A
authors.lastname: Dziewierz
authors.forename: Krzysztof
authors.initials: K
authors.lastname: Zmudka
mesh_terms: D015906:Angioplasty, Balloon, Coronary / Q000379:methods*; D017023:Coronary Angiography; D003328:Coronary Thrombosis / Q000150:complications / Q000601:surgery*; D004562:Electrocardiography; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D006814:Hungary; D007558:Italy; D008297:Male; D008875:Middle Aged; D009203:Myocardial Infarction / Q000209:etiology / Q000503:physiopathology / Q000628:therapy*; D011044:Poland; D012189:Retrospective Studies; D015607:Stents; D013396:Suction / Q000379:methods*; D017131:Thrombectomy / Q000379:methods*; D013997:Time Factors; D016896:Treatment Outcome