Clinical InvestigationInterventional CardiologyThrombus 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)
Section snippets
Background
It has been demonstrated that primary percutaneous coronary intervention (PPCI) is the best treatment strategy for ST-segment elevation myocardial infarction (STEMI).1 PPCI is a highly effective method of epicardial flow restoration. Normal epicardial flow in the infarct-related artery is not equal to the restoration of myocardial perfusion at the microcirculation level. After conventional PPCI with stent implantation and glycoprotein (GP) IIb/IIIa inhibitors use, optimal myocardial perfusion
Patient's population
The study was approved by the local Ethical Review Board at the Jagiellonian University in Krakow, Poland. Study was also registered at ClinicalTrials.gov (NCT 00377650). All patients provided informed consent, and the study conformed to applicable institutional and national guidelines for research on human subjects, as well as to the Declaration of Helsinki with later amendments. Between August 2005 and July 2007, a total of 196 patients with STEMI, who were referred to catheterization
Results
Baseline clinical and angiographic groups' characteristics are reported in Table I. The groups did not show any significant differences, except more frequent prior angina occurrence in the thrombectomy group. Aspiration thrombectomy success rate was 91% (passing of the lesion with thrombus reduction and flow restoration). Technical success of thrombectomy and direct stenting was achieved in 75% of cases. In 7 cases, there was no thrombus removal due to lack of lesion crossing possibility and in
Discussion
PPCI significantly improves outcome of STEMI patients. However, despite very high efficacy in achieving TIMI grade 3 flow in infarct-related artery, impaired myocardial perfusion is very frequent and influences clinical outcome.2 Several studies showed better myocardial perfusion after thrombectomy in comparison to standard PPCI.8, 9, 10, 11 Balloon predilatation before stenting may lead to thrombus material mobilization and displacement that triggers distal embolization. Distal embolization
Conclusions
Aspiration thrombectomy and direct stenting are 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 the thrombectomy group despite the lack of the difference in ST-segment resolution 60 minutes after PCI.
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2016, American Journal of CardiologyCitation Excerpt :After the removal of duplicates, the titles and abstracts of 553 publications were screened. Of these, 49 full-text studies were retrieved and screened for eligibility, with 17 studies (containing data from 14 RCTs) meeting inclusion criteria (n = 20,285).4–8,13–24 The 12-month data of one of these RCTs were recently published25 and have also been included, bringing the number of studies meeting inclusion criteria up to 18.
RCT reg #NCT00377650.