Aspiration Thrombectomy and Direct Stenting Appear Safe, Effective in Patients With ST Segment Elevation Myocardial Infarction: Presented at ESC

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Title: Aspiration Thrombectomy and Direct Stenting Appear Safe, Effective in Patients With ST Segment Elevation Myocardial Infarction: Presented at ESC
URL: http://www.pslgroup.com/dg/22A6A2.htm
Doctor's Guide
September 2, 2008

By Chris Berrie

MUNICH, Germany -- September 1, 2008 -- Simple manual aspiration thrombectomy and direct stenting in patients with ST segment elevation myocardial infarction (STEMI) with an occluded infarct-related artery are safe and easy to perform, according to results of a multicentre, prospective, nonblinded, randomised study.

In addition, the study found that the percutaneous coronary intervention (PCI) procedure provides better myocardial reperfusion than standard balloon predilatation followed by stent implantation, the researchers reported on August 31 here at the European Society of Cardiology 2008 Congress (ESC).

However, they noted, there are no significant benefits on ST resolution or cardiac death and repeat myocardial infarction at 6 months.

This study results were presented on behalf of the Polish-Italian-Hungarian Randomised Thrombectomy Trial (PIHRATE) investigators by Dariusz Dudek, MD, PhD, Department of Interventional Cardiology, Jagiellonian University College of Medicine and Institute of Cardiology, University Hospital, Krakow, Poland.

"Distal embolism is a problem for everyday practice for international cardiologists during primary PCI, with it affecting about 15% of patients after PCI," Dr. Dudek said. His team therefore conducted the study to determine the primary PCI efficacy improvements under thrombus reduction.

They enrolled patients who had undergone PCI within 6 hours of STEMI, who showed increased ST segment of >3 minutes in a minimum of 1 electrocardiogram lead. They also needed to have thrombolysis in myocardial infarction (TIMI) grade 0 or 1 at baseline.

The primary endpoint was ST resolution >70% at 60 minutes after PCI, with a range of secondary endpoints, including potential improvements in TIMI grade, myocardial blush grade (MBG), and major adverse cardiac events (MACE).

Patients were randomised to receive thrombectomy (n = 100; mean age, 61 years; male, 79%) or dilatation (n = 96; mean age, 58; male, 81%) prior to either direct stenting or stent implantation, respectively. Patients' baseline characteristics, including those for angiography, were similar in the 2 treatment groups.

For the technical aspects, Dr. Dudek said, stent implantation was done successfully in 99% versus 97% of patients, respectively. The stent characteristics and maximum pressure were also the same across treatment groups, while the thrombectomy group had significantly more direct stenting than the predilatation group (75% vs 5%, respectively; P < .0001).

For the primary endpoint of ST segment resolution at 6 months, there was no significant difference between the thrombectomy and predilatation groups (50% vs 41%, respectively; P = .28). Similarly, there were no significant differences for MACE, both in hospital and after 6 months of follow-up.

However, a range of secondary endpoints was significantly improved in the thrombectomy group compared with the dilatation group. These included (respectively): immediate effects on ST segment resolution >=70 (41% vs 27%; P = .037), MBG 3 (76% vs 59%; P = .023), MBG 3 plus TIMI stage 3 (73% vs 56%; P = .02), MBG 3 plus ST segment resolution >=70% (35% vs 12%; P = .0001), and the combination of MBG 3, TIMI stage 3, and ST segment resolution >=70% (35% vs 12%; P = .0001).

These results indicate the improvements to myocardial perfusion obtained, Dr. Dudek said, and noted that "aspiration thrombectomy and direct stenting is easy, safe and effective in STEMI patients with early presentation."

[Study title: Polish-Italian-Hungarian Randomised Thrombectomy Trial (PIHRATE trial) Clinical Trial Update I. Abstract 979]

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