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March 16, 2010
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JETSTENT: Improved results linked with rheolytic thrombectomy after MI

American College of Cardiology 59th Annual Scientific Session

ATLANTA – Rheolytic thrombectomy before direct infarct-related artery stenting produced improved clinical outcomes in patients with acute STEMI compared with stenting alone in the recent JETSTENT trial.

“These study results support the routine use of thrombectomy in patients with acute ST-segment elevation MI and evidence of thrombus,”David Antoniucci, MD, head of cardiology at Careggi Hospital in Florence, Italy, said in a press release.

Researchers randomly assigned 501 patients across eight sites to receive either stenting alone or stenting plus rheolytic thrombectomy. Primary endpoints included ST-segment resolution at 30 to 45 minutes post-procedure and final infarct size at 30 days. Clinical endpoints were a composite of death, MI, target vessel revascularization and stroke at one, six and 12 months, as well as a composite of death and readmission for congestive HF at 12 months.

Patients treated with rheolytic thrombectomy plus direct stenting had significantly improved resolution of their ST-segment elevation vs. those receiving stenting alone (85.8% vs. 78.8%; P= 0.043). While there were no significant differences in infarct size, which was evaluated using one-month scintigraphy, the thrombectomy cohort had a lower infarct size vs. those receiving stenting alone (11.8% vs. 12.7%).

At six months, researchers reported a decrease in adverse CV events in patients receiving rheolytic thrombectomy (death, 3%; major adverse cardiac and cerebrovascular events, 12%) as compared with patients in the direct stenting alone group (death, 4.9%; adverse cardiac and cerebrovascular events, 20.7%; P=0.012).

There were no significant differences between the study’s other endpoints.

Originally designed to address questions raised by similar studies, the JETSTENT data are at odds with the outcomes reported in the AiMI trial.

Researchers said reasons for the disparities may include: only enrolling patients with angiographically-visible thrombi; the use of a single-pass antegrade method; and greater sensitivity due to the narrow temporal definition of ST-segment elevation resolution (>50% resolution within 30 to 45 minutes of the procedure), as opposed to the 90-minute time frame used in the AiMI study. – by Matthew Brannon

PERSPECTIVE

For 25 years, we have known that thrombus and thrombus burden were bad this setting, and we have never had good conclusive trials. My overall thought is that this is a positive study and there are some benefits, and it really refocuses us on the problem with thrombus burden and how to effectively treat it in the acute MI setting.

I liked the primary endpoint of ST-segment resolution, which has been previously demonstrated to be an important predictor of one-year survival. The second endpoint I would have predicted (without even knowing the trial) would have been negative because 60% of your patients were non-anterior. The final infarct size was approximately 10% above the mass standard deviation, which was really broad and went from 2% to 23%. Most of the other trials we have been doing have shown that there is little incremental benefit for infarct size reduction in non-anterior acute MI.

You have major adverse cardiac events at six months, and they are lower. Now they have something that goes along with the TRAPIST trial, which also demonstrated there was some value and survival at one year. It is an excellent, thorough, well-conducted, well-monitored trial with a clear result.

– William W. O'Neill, MD

Professor and Executive Dean for Clinical Affairs,

Division of Cardiology, University of Miami Miller School of Medicine

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