麻豆果冻传媒影音

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For patients with ST-segment elevation MI (STEMI), routine removal of the thrombus before percutaneous coronary intervention (PCI) did not improve outcomes, in a registry-based randomized trial.

The rate of all-cause death at 30 days was 2.8% among patients who underwent thrombus aspiration and 3% among those who underwent PCI without thrombus removal, a nonsignificant difference (HR 0.94, 95% CI 0.72-1.22), according to Ole Fröbert, MD, PhD, of Örebro University Hospital in Sweden, and colleagues.

And there were no differences on any of the secondary endpoints either, they reported online in the .

The findings -- which were presented simultaneously at the European Society of Cardiology meeting in Amsterdam -- "suggest that the mortality benefit with thrombus aspiration that was observed in earlier clinical trials may have been a chance finding," Robert Byrne, MBBCh, PhD, of Technische Universität in Munich, and Adnan Kastrati, MD, of Deutsches Zentrum für Herz-Kreislauf-Forschung in Munich, wrote in an editorial in NEJM.

Freek Verheugt, MD, a professor of cardiology at the University of Nijmegen and a spokesperson for the ESC, told MedPage Today that the trial result "is so convincing that it will change the guidelines," which say that thrombus aspiration should be considered.

Previous studies have yielded mixed results regarding the potential benefit of routine thrombus aspiration before PCI in patients with STEMI, with most studies underpowered for hard clinical endpoints.

The 1,071-patient TAPAS trial showed a reduction in mortality at 1 year with thrombus aspiration, but the trial was not powered to assess differences in that secondary endpoint.

To further explore the issue, Fröbert and colleagues initiated the TASTE study, a randomized trial that enrolled patients through the Swedish Coronary Angiography and Angioplasty Registry (SCAAR) and collected endpoint data from national registries. The novel approach was used "to make this investigator-initiated undertaking economically and administratively feasible," according to the researchers.

The trial included 7,244 patients with STEMI who underwent PCI at 29 centers in Sweden and one center each in Iceland and Denmark, making it larger than all previous trials of thrombus aspiration combined, Fröbert said at a press briefing.

Thrombus aspiration was achieved by placing a guidewire through the thrombus and then sucking it out with a manual aspiration catheter. The protocol recommended three catheters -- Terumo's Eliminate, Medtronic's Export Aspiration Catheter, or Vascular Solutions' Pronto extraction catheter -- but others could be used.

Through 30 days, there were no significant differences between the aspiration and control groups for all-cause mortality or several secondary endpoints, including hospitalization for recurrent MI, stent thrombosis, target-lesion revascularization, target-vessel revascularization, stroke or neurological complications, perforation or tamponade, heart failure, length of stay, or left ventricular function.

Similar results were seen across subgroups, including those defined by thrombus burden and coronary flow before PCI, and devices.

In their editorial, Byrne and Kastrati said, "The key limitations were that in designing a pragmatic registry-based trial, the investigators dispensed with standard measures to protect against the risk of ascertainment bias inherent in an open-label study, using neither dedicated data monitoring nor central adjudication of events. This means that interpretation of endpoints other than all-cause mortality requires extreme caution."

In addition, they wrote, the researchers did not collect information on variables that could potentially explain why thrombus aspiration did not work, including ST-segment resolution and infarct size.

They indicated that some clinicians may not see the TASTE results as ruling out a benefit for thrombus aspiration.

"Many interventional cardiologists will continue to perform thrombus aspiration for now, contending that the results of the TASTE trial do not entirely exclude the possibility of a potential benefit of the procedure," Byrne and Kastrati wrote. "Indeed, proponents of thrombus aspiration may well find some support for their position in the results of the trial: there was no evidence of safety concerns, and the rates of stent thrombosis and rehospitalization for myocardial infarction were each reduced by approximately 50% [although not significantly]."

Also, the benefits of thrombus aspiration may become evident with longer follow-up, as was the case in the TAPAS trial.

Some clinicians, too, may await the results of another large trial of thrombus aspiration in STEMI -- -- before drawing any conclusions.

But Verheugt said that he doesn't expect positive results from that trial either. After those results are announced, he said, "I think this intuitively beautiful treatment will be dead."

From the American Heart Association: