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TASTE: Thrombus aspiration before PCI failed to reduce mortality at 1 year
BARCELONA, Spain — Among patients with STEMI, routine thrombus aspiration before PCI did not affect all-cause mortality at 1 year when compared with PCI alone, according to data presented here.
Thirty-day results from the TASTE trial were initially presented at ESC Congress 2013 and showed that the primary endpoint of all-cause mortality did not differ for patients treated with routine thrombus aspiration followed by PCI vs. PCI alone.
Recently, the European Society of Cardiology changed its recommendation for thrombus aspiration from a class IIa recommendation to a class IIb recommendation, according to Bo Lagerqvist, MD, PhD.
“This means that selected patients [with MI] could be considered for the treatment,” Lagerqvist, with Uppsala Clinical Research Center, Uppsala, Sweden, said during a press conference. “The evidence grade is also upgraded from ‘B’ to ‘A.’ Most of this [decision-making was] based on the TASTE 30-day results.”
In the analysis presented here at ESC Congress, Lagerqvist and fellow TASTE investigators looked at the impact of both strategies on 1-year all-cause mortality, the prespecified secondary endpoint.
The registry-based trial included 7,244 patients with STEMI who were randomly assigned to manual thrombus aspiration and PCI (n=3,621) or PCI alone (n=3,623).
At 1 year, all-cause mortality was reported in 5.3% of patients assigned thrombus aspiration vs. 5.6% of patients assigned PCI only, a difference that did not reach statistical significance (HR=0.94; 95% CI, 0.78-1.15; P=.57). When Lagerqvist and colleagues examined the composite of death from any cause, rehospitalization from MI or stent thrombosis, they also found no significant differences between groups (thrombus aspiration, 8% vs. PCI only, 8.5%; HR=0.94; 95% CI, 0.8-1.11; P=.48).
In addition, rates of rehospitalization for MI (2.7% for both; HR=0.97; 95% CI, 0.73-1.28; P=.81) and stent thrombosis (thrombus aspiration, 0.7% vs. PCI only, 0.9%; HR=0.84; 95% CI, 0.5-1.4; P=.51) were also comparable between the strategies.
According to Lagerqvist, the findings were consistent across all major subgroups, including grade of thrombus burden and coronary flow before PCI.
As a result of these data, Lagerqvist said, “Our recommendation was routine thrombus aspiration should not be recommended for PCI in STEMI for European guidelines.” – by Brian Ellis
For more information:
Lagerqvist B. Hot Line IV. Myocardial Infarction. Presented at: the European Society of Cardiology Congress; Aug. 30-Sept. 3, 2014; Barcelona, Spain.
Lagerqvist B. N Engl J Med. 2014;doi:10.1056/nejmoa1405707.
Disclosure: Lagerqvist reports no relevant financial disclosures.
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The TASTE trial represents a new way of doing research that is completely different than what we’ve done in the past. The ability to glean data from a registry and have a randomized trial that is done, in a way, retrospectively and prospectively at the same time is fantastic and represents a big change in our capabilities.
This trial also helps inform us of something we probably shouldn’t be doing: routine thrombus aspiration. Going forward, we need to look at the issues of how thrombus aspiration is done and what the timing of it is, and find out whether there is a way to perform the procedure that is less traumatic to the vasculature. However, it may be that the most important thing to do, instead, is focus on making sure patients are receiving proper antiplatelet and anticoagulant therapy.
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The TASTE trial showed that at 1 year, there was no difference in mortality between thrombectomy and no thrombectomy in this registry-based randomized trial. I think people were expecting that there would be a difference at 1 year despite no difference at 30 days, and that the benefit of thrombectomy would increase over time. Unlike a drug therapy that’s ongoing, for example ticagrelor (Brilinta, AstraZeneca), thrombectomy is a one-time intervention. The major challenge with TASTE is that it had much fewer events than planned, and was really only powered for a 50% reduction in mortality. Going out to 1 year doesn’t fix that, necessarily. The earlier events are likely to be the most responsive to the intervention of thrombectomy. At late events, between 6 months and 1 year, people die for all sorts of reasons.
It certainly confirms that there is not an effect size of a 50% reduction in mortality with thrombectomy. What we don’t know is whether there are more modest reductions, like 20%. We hope that the TOTAL trial, a large, randomized study that recently completed recruitment of nearly 11,000 patients, will help answer that.
I don’t think the 1-year results are going to have any more impact on clinical practice than the initial 30-day results did. Clinicians have become less dogmatic about the use of thrombectomy, and are now using it selectively in patients with large thrombus to optimize their angiographic results.