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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) - 05/08/11

Doi : 10.1016/j.ahj.2010.07.024 
Dariusz Dudek, MD, PhD a, , Waldemar Mielecki, MD b, Francesco Burzotta, MD, PhD c, Mariusz Gasior, MD, PhD d, Adam Witkowski, MD, PhD e, Ivan G. Horvath, MD, PhD f, Jacek Legutko, MD, PhD a, Andrzej Ochala, MD, PhD g, Paolo Rubartelli, MD h, Roman M. Wojdyla, MD b, Zbigniew Siudak, MD, PhD b, Piotr Buchta, MD d, Jerzy Pregowski, MD e, Daniel Aradi, MD f, Andrzej Machnik, MD a, Michal Hawranek, MD d, Tomasz Rakowski, MD, PhD b, Artur Dziewierz, MD, PhD b, Krzysztof Zmudka, MD, PhD a
a Department of Interventional Cardiology Jagiellonian University Medical College, Krakow, Poland 
b 2nd Department of Cardiology, University Hospital, Krakow, Poland 
c Institute of Cardiology, Catholic University of the Sacred Heart, Rome, Italy 
d Silesian Center of Cardiology, Zabrze, Poland 
e Institute of Cardiology, Warsaw, Poland 
f Heart Institute, Medical School of University Pecs, Pecs, Hungary 
g 3rd Division of Cardiology, Silesian School of Medicine, Katowice, Poland 
h Cardiology Department Hospital Villascassi, Genova, Italy 

Reprint requests: Dariusz Dudek, MD, PhD, Department of Interventional Cardiology, Jagiellonian University Medical College, Kopernika 17 St., 31-501 Krakow, Poland.

Riassunto

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.

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 RCT reg #NCT00377650.


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Vol 160 - N° 5

P. 966-972 - Novembre 2010 Ritorno al numero
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