AMSTERDAM, THE NETHERLANDS — Thrombus aspiration performed before PCI in patients with ST-segment-elevation MI (STEMI) failed to significantly reduce the risk of death at 30 days, according to the results of a new study presented here today at the European Society of Cardiology (ESC) 2013 Congress .
Overall, death from any cause at 30 days occurred in 2.8% of patients in the thrombus-aspiration group and 3.0% of patients who received PCI without thrombus aspiration, a nonsignificant difference. There were trends toward reductions in the risk of hospitalization for recurrent MI at 30 days and the risk of stent thrombosis with thrombus aspiration, but these differences also failed to achieve statistical significance.
"The neutral outcome was consistent in all patient subgroups, regardless of baseline clinical or angiographic characteristics," report the investigators. "Furthermore, there was no significant effect of thrombus aspiration on any of the prespecified secondary end points."
The registry-based Thrombus Aspiration in ST-Elevation Myocardial Infarction in Scandinavia (TASTE) trial, led by Dr Ole Fröbert (Örebro University Hospital, Sweden), is published simultaneously in the New England Journal of Medicine to coincide with the ESC hot-line session.
Still Might Be Some Proponents Out There
The study was designed as a multicenter, prospective, randomized, open-label trial enrolling patients from the Swedish Coronary Angiography and Angioplasty Registry (SCAAR). (A second presentation on TASTE, describing the unique registry-randomization design, is being presented later at the ESC meeting.) As a result, all clinical end points were evaluated through the national registries. In total, 7244 patients with STEMI were randomized, with 3623 randomized to PCI only and 3621 randomized to the thrombus-aspiration arm.
Given the negative results, Drs Robert Byrne and Adnan Kastrati (Deutsches Herzzentrum, Munich, Germany), who wrote an accompanying editorial , said the key question in interpreting TASTE is making sure that no clinically meaningful effect is overlooked. For example, the benefits of thrombus aspiration, which include improved myocardial salvage and favorable remodeling, might not be evident at 30 days. In addition, while the TASTE study was pragmatic in its design and clear in its research question, the clinical end points were not centrally adjudicated.
As a result, there might be some proponents of thrombus aspiration who continue to perform the procedure given the lack of safety concerns. These proponents might also be bolstered by the trend toward a reduction in hospitalizations for recurrent MI and the reduction in stent thrombosis.
"For the moment, however, the data presented by Fröbert and colleagues suggest that the mortality benefit with thrombus aspiration that was observed in earlier clinical trials may have been a chance finding," write Byrne and Kastrati. "An updated analysis of outcomes at 12 months of follow-up is imperative."
An additional thrombus aspiration study, known as a Trial of Routine Aspiration Thrombectomy With Percutaneous Coronary Intervention versus PCI Alone in Patients With STEMI Undergoing Primary PCI (TOTAL), is ongoing.
heartwire will update this story following the TASTE presentation at the ESC 2013 Congress.
Heartwire from Medscape © 2013 Medscape, LLC
Cite this: Not a TASTE, Not a Nibble: Thrombectomy a Letdown for PCI-Treated STEMI Patients - Medscape - Sep 01, 2013.