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Polish-Italian-Hungarian Randomized Thrombectomy Trial - PIHRATE
Description:
The goal of the trial was to evaluate treatment with aspiration thrombectomy compared with primary percutaneous coronary intervention (PCI) in patients with ST-elevation myocardial infarction (STEMI).
Hypothesis:
Aspiration thrombectomy will be more effective at improving myocardial reperfusion.
Study Design
Patients Enrolled: 196
Mean Follow Up: 6 months
Mean Patient Age: 60 years
Female: 20
Patient Populations:
Patients with STEMI within 6 hours of symptom onset
Primary Endpoints:
70% ST-segment resolution 60 minutes after PCI
Secondary Endpoints:
Myocardial blush grade, death, and MI
Drug/Procedures Used:
Patients with STEMI were randomized to aspiration thrombectomy (n = 102) or primary PCI (n = 94).
Concomitant Medications:
The use of abciximab was 62% in the thrombectomy group and 63% in the primary PCI group.
Principal Findings:
At baseline, Killip class I was present in 83% of the thrombectomy group versus 91% of the primary PCI group. Direct stenting was employed in 75% versus 5% (p < 0.0001), respectively. The primary outcome, ST-resolution at 60 minutes, occurred in 50% of the thrombectomy group and 41% of the primary PCI group (p = 0.28). Final TIMI 3 flow was similar (88% vs. 82%) and myocardial blush grade of 3 was improved with thrombectomy (76% vs. 59%, p = 0.023). Periprocedural complications occurred with similar frequency in both groups (15.7% vs. 22.6%, p = 0.22). At 6 months, death (4.0 % vs. 3.1%, p = 0.74) and MI (p = 1.0% vs. 3.1%, p = 0.29) were similar for thrombectomy versus control, respectively.
Interpretation:
Among STEMI patients who presented within 6 hours of symptom onset, a strategy of aspiration thrombectomy compared with primary PCI failed to reduce ST-resolution 60 minutes after PCI, although it did improve myocardial blush grade of 3. There was no obvious benefit with clinical endpoints at 6 months of follow-up. This small single-center study needs to be considered in the context of the larger TAPAS trial that demonstrated superior myocardial reperfusion from thrombectomy, which translated into improved clinical outcomes including death at 1 year of follow-up.
References:
Dudek D, Mielecki W, Burzotta F, et al. 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). Am Heart J. 2010 Nov;160(5):966-72.
Polish-Italian-Hungarian Randomized Thrombectomy Trial (PIHRATE Trial). Presented by Dr. Dariusz Dudek at the European Society of Cardiology Congress, Munich, Germany, August/September 2008.
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