Another Strike Against Thrombectomy in 1-Year TASTE Results

BARCELONA, Spain—Routine intracoronary thrombus aspiration before primary percutaneous coronary intervention (PCI) does not improve outcomes through 1 year in patients with ST-segment elevation myocardial infarction (STEMI), confirming the lack of benefit seen at 30 days, according to an update of the TASTE trial presented on September 2, 2014, at the European Society of Cardiology (ESC) Congress and simultaneously published online in the New England Journal of Medicine.  

“Routine thrombus aspiration should not be recommended for PCI in STEMI,” presenter Bo Lagerqvist, MD, PhD, of Uppsala University Hospital (Uppsala, Sweden), said. He noted that an update to the revascularization guidelines from the ESC and the European Association for Cardio-Thoracic Surgery (EACTS) released earlier in the meeting included a downgraded recommendation for the technique.

Methods
TASTE was a randomized trial based in the Swedish Coronary Angiography and Angioplasty Registry (SCAAR). It included 7,244 STEMI patients randomized at all 29 Swedish PCI centers, the lone PCI center in Iceland, and one center in Denmark to PCI plus manual thrombus aspiration or PCI alone. The investigators endorsed 3 aspiration catheters: Eliminate (Terumo; Tokyo, Japan), Export (Medtronic; Minneapolis, MN), and Pronto (Vascular Solutions; Minneapolis, MN). 

No Clinical Benefit from Aspiration

Thirty-day results—reported last year at the ESC Congress—showed that the rate of all-cause mortality (primary endpoint) was not different between the groups (P = .63), although there were trends toward lower rates of stent thrombosis and rehospitalization due to MI among the patients who received thrombus aspiration.

The new 1-year results affirmed the lack of a mortality difference and removed any hint of benefit for other clinical outcomes (table 1).

Table 1. Clinical Outcomes at 1 Year

 

PCI + Aspiration 

(n = 3621)

PCI Alone 

(n = 3623)

HR (95% CI)

All-Cause Death

5.3%

5.6%

0.94 (0.78-1.15)

Readmission for MI

2.7%

2.7%

0.97 (0.73-1.28)

Stent Thrombosis

0.7%

0.9%

0.84 (0.50-1.40)

TVR

4.4%

4.9%

0.90 (0.72-1.10)

TLR

3.2%

3.5%

0.91 (0.71-1.17)

 

Subgroup analyses did not reveal any patient populations—including those with high thrombotic risk—that might benefit from thrombus aspiration.

TASTE Disputes TAPAS

The findings conflict with those from the single-center TAPAS trial, which was not powered for clinical endpoints but showed a trend toward mortality reduction at 1 month (P = .07) and a significant benefit at 1 year (P = .04).

Dr. Lagerqvist and colleagues point out in their paper that the TAPAS result “was based on a total of 66 events. Furthermore, the reduction in mortality occurred immediately after randomization, with a nonsignificant 48% reduction in the rate of death from any cause at 30 days and with no further separation of the event curves up to 1 year.”

TASTE, on the other hand, was powered to detect a mortality difference at 30 days and had a much larger number of deaths at 1 year (393). Also, there was a lower crossover rate in TASTE vs TAPAS because randomization occurred after angiography. The researchers acknowledge, however, that a major limitation of TASTE is the fact that clinical events were collected as part of the registry and were not systematically adjudicated.

Another trial of thrombus aspiration that has a target enrollment of 10,700 STEMI patients—TOTAL—is ongoing, they note.

Aspiration in Limbo

That trial might help clarify a role for thrombus aspiration, which was recently downgraded in the ESC/EACTS revascularization guidelines from a class IIa level of evidence B recommendation (“should be considered”) to a class IIb level of evidence A recommendation (“could be considered”). US STEMI guidelines give manual thrombus aspiration a class IIa level of evidence B recommendation (“is reasonable”) for patients undergoing primary PCI.

Dr. Lagerqvist said that he agrees with the ESC/EACTS recommendation because it maintains the flexibility to use the technique—which has proven safe—in specific cases. He added, however, that it should not be used routinely.

Discussant Gilles Montalescot, MD, PhD, of Centre Hospitalier Pitié-Salpêtrière (Paris, France), outlined the arguments both for and against abandoning thrombus aspiration following the TASTE results, but said it would be premature to stop doing the procedure altogether before seeing what comes from TOTAL.

In the meantime, he said, operators should probably be more selective when deciding on whether to employ the technique, using it in early presenters and those with a large thrombus burden or TIMI 0 flow, for example. In addition, Dr. Montalescot said, aspiration possibly should be used in combination with glycoprotein IIb/IIIa inhibitors, especially in patients who have a large thrombus.



Sources: 
Lagerqvist B, Fröbert O, Olivecrona G, et al. Outcomes 1 year after thrombus aspiration for myocardial infarction. N Engl J Med. 2014;Epub ahead of print. 

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Disclosures
  • TASTE was supported by unrestricted research grants from Medtronic, the Swedish Association of Local Authorities and Regions, the Swedish Research Council, Terumo Medical, and Vascular Solutions; by grants from the Swedish Heart-Lung Foundation; and by the Landspitali University Hospital Research Fund.
  • Dr. Lagerqvist reports no relevant conflicts of interest.

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