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).
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.