TASTE: Thrombus aspiration before primary PCI not beneficial to 30-day mortality

AMSTERDAM — Results of the TASTE trial have shown that routine intracoronary thrombus aspiration before primary PCI does not benefit mortality out to 30 days when compared with primary PCI alone.

Without clear evidence as to the clinical effect of routine thrombus aspiration before primary PCI in patients with STEMI, researchers for TASTE undertook the largest clinical trial to date on thrombus aspiration, according to Ole Fröbert, MD, PhD, trial investigator with the department of cardiology, Örebro University Hospital, Sweden, who presented the trial at ESC Congress 2013. The multicenter, prospective, open-label, randomized, controlled trial evaluated thrombus aspiration in 7,244 patients with STEMI from the Swedish Coronary Angiography and Angioplasty Registry (SCAAR), including 29 hospitals from Sweden, one from Denmark and one from Iceland. The study featured a novel registry-based randomized clinical trial concept, Fröbert said, in which national heart registries served as platforms for randomization, case reports and follow-up.

Patients were randomly assigned to manual thrombus aspiration followed by PCI (n=3,621) or to PCI alone (n=3,623).

The primary endpoint, all-cause mortality at 30 days, was 2.8% in the thrombus-aspiration group compared with 3% in the PCI-only group (HR=0.94; P=.63). In the per-protocol analysis, 30-day mortality was 2.6% with thrombus aspiration vs. 2.9% with PCI only (HR=0.88; P=.38).

Ole Frobert, MD, PhD 

Ole Fröbert

There were trends favoring thrombus aspiration in rehospitalizaton due to reinfarction (0.5% vs. 0.9%; P=.09) and stent thrombosis (0.2% vs. 0.5%; P=.06), although these did not reach statistical significance. Similarly, differences in the rates of stroke or neurologic complications, perforation or tamponade, HF or left ventricular dysfunction at the time of discharge, and length of stay in the hospital did not reach statistical significance.

The results were consistent across all major prespecified subgroups, including those defined by thrombus burden and coronary flow before PCI.

“Our results do not support the role of thrombus aspiration as a routine future treatment,” Fröbert said. “These results will likely have an impact on guidelines.”

Further, Fröbert added that the study’s unique registry-based randomized clinical trial concept represents a new, efficient and inexpensive way to assess treatments in large patient populations.

Results from the TASTE trial were simultaneously published in The New England Journal of Medicine.by Brian Ellis

For more information:

Fröbert O. Hot Line I: Late breaking trials on thrombosis. Presented at: the European Society of Cardiology Congress; Aug. 31-Sept. 4, 2013; Amsterdam.

Fröbert O. N Eng J Med. 2013;doi:10.1056/nejmoa1308789.

Disclosure: Fröbert reports receiving grants from the Swedish Heart-Lung Foundation. The study was supported by unrestricted grants from Medtronic, the Swedish Research Council, the Swedish Association of Local Authorities and Regions, Terumo and Vascular Solutions.

Perspective

Theodore A. Bass

  • Trials assessing the value of adjunctive aspiration thrombectomy before TASTE were much smaller, a little inconsistent and had more focal endpoints, such as myocardial blush. TASTE instead looked at a hard clinical endpoint of 30-day all-cause mortality. The endpoint wasn’t reached in TASTE, indicating that there was no clinical benefit in performing aspiration thrombectomy. With the TAPAS trial, at 1 year they did show a mortality benefit, so the question is why TASTE did not. Although I can’t definitively answer that question, I can say that this only looked at 1 month data, and perhaps positive effects will manifest at 1 year. 

    • Theodore A. Bass, MD
    • Professor of Medicine, University of Florida, Jacksonville
      President, Society for Cardiovascular Angiography and Interventions
  • Disclosures: Bass reports no relevant financial disclosures.
Perspective
  • What we know from previous clinical trials is that thrombus aspiration tends to reduce distal embolization of thrombus and prevents low reflow. And clinically, we find that as an interventionalist, it’s quite useful in patients with heavy thrombus, for example. And we know from data from the American College of Cardiology – National Cardiovascular Data Registry that in about 20% of STEMIs, interventionalists use thrombus aspiration.

    The TASTE trial has a very ambitious design, in that it’s the first trial probably in the last 5 to 10 years to use all-cause mortality as a primary outcome. And the reason why that’s unique is because mortality rates in STEMI are so low that [sponsors of] most trials, particularly [those funded by] pharmaceutical and device companies, have decided that it simply isn’t economically feasible to do a trial for all-cause mortality. When I first heard about this design, I was very happy that they were trying to go for such an ambitious outcome, but I was also concerned when I read the design paper that they initially planned for 10% control-rate mortality, because 10% mortality in a randomized clinical trial, even in an all-comers registry-based trial, is pretty unlikely. And they had data that they presented at various meetings on the mortality rates that they were observing, and they were somewhere between 2% to 3%. So you realize all of the sudden, if a trial was powered for 10% mortality, then going from 5% to 7% is not going to do the job in terms of accounting for that reduction in control event rates.

    • Sanjit S. Jolly, MD
    • Interventional Cardiologist, Associate Professor
      Hamilton Health Sciences, McMaster University, Ontario, Canada
  • Disclosures: Jolly has received grant support from Medtronic.

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