No Benefit for Thrombus Aspiration in STEMI Patients: TOTAL at 1 Year

October 13, 2015

SAN FRANCISCO, CA — Two studies, one large and one small, presented today at TCT 2015 find no support for the routine use of manual thrombectomy in ST-segment-elevation MI (STEMI) patients undergoing primary PCI[2].

In the large TOTAL trial, which included 10,732 patients with STEMI presenting to the hospital within 12 hours of symptom onset, routine thrombus aspiration during PCI did not reduce clinical events at 1 year. In contrast, the use of thrombectomy was associated with a significantly increased risk of stroke.

Overall, the primary end point—a composite of cardiovascular death, MI, cardiogenic shock, or heart failure—occurred in 8% of the 5035 patients randomized to thrombectomy and 8% of the 5029 patients randomized to PCI alone. The rate of stroke was 1.2% in the thrombectomy arm vs 0.7% in the PCI-alone arm, a difference that was statistically significant (hazard ratio 1.66; 95% CI 1.10–2.51).

"It's been a very attractive story," said Dr Sanjit Jolly (McMaster University, Hamilton, ON), lead investigator of TOTAL, in reference to the use of manual thrombectomy prior to primary PCI. "We've really wanted to see if the TAPAS trial results were true. It doesn't appear to be that's the case."

The 1-year TOTAL results, which were presented today and published simultaneously in the Lancet, also include an updated meta-analysis of 20 randomized trials with 21,173 patients. In that analysis, the rate of all-cause mortality in the thrombectomy arm was 4% vs 5% in the PCI-alone arm, a difference that was not statistically significant (odds ratio [OR] 0.90; 95% CI 0.79–1.02). Stroke occurred in 0.9% of patients in the thrombectomy arm and 0.6% of patients treated with PCI alone. This difference was statistically significant (OR 1.43; 95% CI 1.03–1.99).

Dr Sanjit Jolly

To heartwire from Medscape, Jolly said the data show a real risk of stroke with thrombus aspiration, and unless this finding is confirmed or disproven in a study with 20,000 or 30,000 patients, the best available evidence suggests the routine use of thrombus aspiration can cause harm. In a landmark analysis, there was no increased risk of stroke observed between the two treatments beyond 180 days.

"Based on these data, manual thrombectomy can no longer be recommended as a routine strategy during primary PCI for STEMI," Jolly concluded.

Another Study Shows No Benefit

In the second study, which is published simultaneously in JACC: Cardiovascular Interventions to coincide with the TCT 2015 first-reports presentation, investigators also failed to show a benefit of thrombus aspiration in STEMI patients[2].

The difference between TOTAL and this other trial, which was led by Dr Steffen Desch (University Heart Center, Lübeck, Germany), is that STEMI patients presented to the hospital between 12 and 48 hours after symptom onset. On average, patients presented to the hospital 28 hours after their first symptoms. In total, 152 patients were randomized to primary PCI with or without thrombus aspiration, and all patients underwent cardiac magnetic resonance (CMR) imaging 1 to 4 days after randomization.

Overall, the extent of microvascular obstruction as assessed as the percentage of ventricular mass was not significantly different between patients randomized to thrombectomy and those undergoing PCI alone. In addition, the researchers saw no difference in infarct size, myocardial salvage, left ventricular ejection fraction, or angiographic/clinical end points between the two groups.

To heartwire , Desch said the up-front use of routine thrombectomy in primary PCI likely is "dead" but might be a viable option as a bailout therapy. This might include cases where reperfusion has not been achieved following PCI, such as slow-flow or no-flow patients.

"Manual thrombus aspiration used to be a very nice idea," said Desch. "You aspirate and at times you really have a beautiful thrombus—it's like the old gold diggers from the Klondike—and sometimes it's really a large thrombus. It really made people happy, they believed they had done something good. But then in the next patient, you don't aspirate anything and might have shifted something downstream."

Desch said that despite ongoing accumulation of data, there are physicians continuing perform manual thrombectomy.

"Anyone arguing in favor of routine thrombus aspiration really has to consider these stroke data," said Desch. "Before the stroke results, you could say, 'OK, it might be neutral, it really doesn't hurt.' But now we have the stroke data, and this is something we have to worry about."

Also commenting on the continued use of manual thrombectomy, Jolly said it often takes time for study evidence to filter into clinical practice, although he has seen a decline in the number of colleagues using thrombus aspiration during PCI. "Also, as interventional cardiologists, we're very visually driven," said Jolly. "When we see something, we want to take it out."

Jolly has received grants from Medtronic during the conduct of the study; disclosures for the coauthors are listed in the paper. The study by Desch et al is supported by Medtronic with an unrestricted grant.

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