Randomized Trial of Primary PCI with or without Routine Manual Thrombectomy (TOTAL Trial)

Hoa Tang, Mercer University College of Pharmacy 2015

The purpose of adjunctive thrombectomy during percutanenous coronary intervention (PCI) is to reduce the thrombus burden and to decrease distal embolization.1 According to 2013 American College of Cardiology/American Heart Association guidelines for the management of patients with ST-elevation myocardial infarction (STEMI), manual aspiration thrombectomy is reasonable for patients undergoing primary PCI. This recommendation is supported by the results of a few clinical studies which demonstrate the use of manual aspiration thrombectomy during primary PCI to improve microvascular reperfusion and to decrease deaths and adverse cardiac events.2 However, the TASTE trial suggested that upfront routine thrombus aspiration during PCI did not reduce 30-day mortality among patients with STEMI.3

A recently published study compared the outcomes of primary PCI with or without routine manual thrombectomy in patients with STEMI (TOTAL trial).4

Title: Randomized Trial of Primary PCI with or without Routine Manual Thrombectomy
Design International, investigator-initiated, multicenter, prospective, randomized, open trial with blinded adjudication of outcomes; 10,732 patients
Objective Compare the outcomes in patients with STEMI who have undergone thrombectomy followed by PCI with the outcomes in those who have undergone PCI-alone
Study Groups Thrombectomy group (n=5,033) vs. PCI-alone group (n=5,030)
Methods Patients in the thrombectomy group received thrombectomy plus the PCI, which was performed after thrombus aspiration was completed.

Patients in the PIC-alone group underwent the PCI procedure without thrombectomy. Bailout thrombectomy was allowed if there was failure of the initial PIC-alone strategy.

Duration From August 2010 through July 2014
Primary Outcome Measure A composite of death from cardiovascular causes, recurrent myocardial infarction (MI), cardiogenic shock, or new or worsening New York Heart Association (NYHA) class IV heart failure within 180 days

The safety outcome was stroke within 30 days.

Baseline Characteristics Thrombectomy group- mean age 61, male 76.8%, previous MI 9.2%, previous PCI 8.3%, current smoker 44.6%, the interval from symptom onset to hospital arrival 128 minutes

PCI group- age 61, male 78.2%, previous MI 8.9%, previous PCI 8.4%, current smoker 46.8%, the interval from symptom onset to hospital arrival 120 minutes

Results The primary outcome in patients who underwent PCI for index STEMI was 6.9% in the thrombectomy group versus 7.0% in the PCI-alone group (hazard ratio, 0.99; 95% confidence interval [Cl], 0.85 to 1.15; p=0.86).

Stroke within 30 days occurred 0.7% of the patients in thrombectomy group and 0.3% of those in PCI group (hazard ratio, 2.08; 95% confidence interval [Cl], 1.13 to 3.75; p=0.34).

Adverse Events Common Adverse Events: not reported
Serious Adverse Events:

Thrombectomy group- cardiovascular death 3.1%, major bleeding 1.6%, stroke within 30 days 0.7%

PCI-alone group- cardiovascular death 3.5%, major bleeding 1.5%, stroke within 30 days 0.3%

Percentage that discontinued due to Adverse Events: not reported
Study Author Conclusions In patients with STEMI who were undergoing PCI, a strategy of routine manual thrombectomy did not reduce the risk of cardiovascular death, recurrent MI, cardiogenic shock, or class IV heart failure within 180 days, as compared with a strategy of PCI-alone with only bailout thrombectomy. Routine thrombectomy was associated with an increased rate of stroke within 30 days.

Results from this study showed that routine manual thrombectomy followed by PCI in patients with STEMI was not lower the rate of cardiovascular events within 180 days as compared to those who received PCI-alone. However, the rate of stroke was higher in the thrombectomy group than the PCI-alone group. The outcomes in this study were measured regardless of initial thrombus burden.4 Since the available information regarding benefits of routine manual thrombectomy during PCI is uncertain, the recommendation for routine manual thrombectomy during PCI in patients with STEMI of different thrombus burden levels should be further evaluated.

References:

  1. Srinivasan M, Rihal C, Holmes DR, Prasad A. Adjunctive thrombectomy and distal protection in primary percutaneous coronary intervention: impact on microvascular perfusion and outcomes. Circulation. 2009;119(9):1311-9. http://circ.ahajournals.org/content/119/9/1311.full.pdf+html. Accessed March 28, 2015.
  2. O’Gara PT, Kushner FG, Ascheim DD, et al. 2013 ACCF/AHA Guideline for the Management of ST-Elevation Myocardial Infarction: A Report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines. J Am Coll Cardiol. 2013;61(4):e78-e140. doi:10.1016/j.jacc.2012.11.019. Accessed March 28, 2015.
  3. Fröbert O, Lagerqvist B, Olivecrona GK, et al. Thrombus aspiration during ST-segment elevation myocardial infarction. N Engl J Med. 2013;369(17):1587-97. http://www.nejm.org/doi/pdf/10.1056/NEJMoa1308789. Accessed March 29, 2015.
  4. Jolly SS, Cairns JA, Yusuf S, et al. Randomized Trial of Primary PCI with or without Routine Manual Thrombectomy. N Engl J Med. 2015; Accessed March 24, 2015.
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