Elsevier

American Heart Journal

Volume 160, Issue 5, November 2010, Pages 966-972
American Heart Journal

Clinical Investigation
Interventional Cardiology
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)

https://doi.org/10.1016/j.ahj.2010.07.024Get rights and content

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.

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.

References (23)

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