Trial of Routine Aspiration Thrombectomy With PCI vs. PCI Alone in Patients With STEMI - TOTAL

Jul 20, 2016
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Presenter/Author:
Sanjit S. Jolly, MD
Author/Summarized by Author:
Dharam J. Kumbhani, MD, SM, FACC
Summary Reviewer:
Deepak L. Bhatt, MD, MPH, MBA, FACC
Trial Sponsor:
Canadian Institutes of Health Research, Canadian Network and Centre for Trials Internationally, and Medtronic Inc.
Date Presented:
10/13/2015
Date Published:
04/28/2016
Date Updated:
07/20/2016
Original Posted Date:
03/16/2015
References

Description:

The goal of the trial was to compare outcomes after routine adjunctive aspiration thrombectomy versus conventional percutaneous coronary intervention (PCI) in patients with ST-segment elevation myocardial infarction (STEMI) undergoing primary PCI.

Contribution to the Literature: The TOTAL study suggests that routine aspiration thrombectomy is not superior to conventional PCI in patients with STEMI undergoing primary PCI.

Study Design

Patients were randomized in a 1:1 fashion to either aspiration thrombectomy followed by PCI (n = 5,033) or conventional PCI alone (n = 5,030). Aspiration was performed with the Export catheter. Crossover rate from thrombectomy to PCI alone was 4.6%, and from PCI to thrombectomy was 1.4%. An additional 7.1% in PCI alone group needed bailout thrombectomy.

Patient population:

  • Total number of enrollees: 10,063
  • Duration of follow-up: 1 year
  • Mean patient age: 61 years
  • Percentage female: 22%
  • Percentage diabetics: 18%

Other salient features/characteristics:

  • Killip class ≥2: 4.3%
  • Location of myocardial infarction (MI): anterior, 40%; inferior, 55%
  • Radial access: 68.2%
  • Time from symptom onset to hospital arrival: 128 vs. 120 minutes (p < 0.05)
  • Unfractionated heparin: 81%
  • Upfront glycoprotein IIb/IIIa inhibitor use: 22.7% vs. 25.3% (p = 0.001)
  • TIMI 0 flow before PCI: 67%
  • Direct stenting: 38.3% vs. 21.3%
  • Bare-metal stent use: 52%

Inclusion criteria:

  • Patients with STEMI referred for primary PCI within 12 hours

Exclusion criteria:

  • Prior coronary artery bypass grafting
  • Fibrinolytic therapy

Principal Findings:

The primary composite outcome, cardiovascular death, MI, cardiogenic shock, or New York Heart Association class IV chronic heart failure at 180 days was 6.9% vs. 7.0% (p = 0.86). Cardiovascular death: 3.1% vs. 3.5% (p = 0.34); recurrent MI: 2.0% vs. 1.8% (p = 0.62); cardiogenic shock: 1.8% vs. 2.0% (p = 0.56).

Secondary outcomes:

  • Periprocedural: incomplete ST-segment resolution: 27% vs. 30.2% (p < 0.001); distal embolization: 1.6% vs. 3.0% (p < 0.001)
  • 180 days: stent thrombosis: 1.5% vs. 1.7% (p = 0.42); target lesion revascularization: 4.5% vs. 4.3% (p = 0.77)
  • 30-day strokes: 0.7% vs. 0.3% (p = 0.02)

One-year outcomes: Primary composite outcome: 7.8% vs. 7.8%, p = 0.99; all-cause mortality: 4.3% vs. 4.5%, p = 0.6; CV death: 3.6% vs. 3.8%, p = 0.93; recurrent MI: 2.5% vs. 2.3%, p=0.68; stroke: 1.2% vs. 0.7%, p = 0.015; stent thrombosis: 1.7% vs. 2.1%, p = 0.18; TLR: 5.5% vs. 5.1%, p = 0.48.

Angiographic substudy (n = 1,610): Final myocardial blush grade 0/1 for thrombectomy vs. primary PCI alone: 28% vs. 30%, p = 0.38; TIMI 3 flow: 90% vs. 89.5%, p = 0.73; distal embolization: 7.1% vs. 10.7%, p = 0.01.

Interpretation:

The results of this trial indicate that, among patients with STEMI undergoing primary PCI, routine aspiration thrombectomy does not improve clinical outcomes at 1 year compared with conventional PCI alone (with use of bailout thrombectomy as needed), despite an improvement in periprocedural reperfusion markers. Immediate reperfusion markers did not improve with thrombectomy in an angiographic subset (~15% of the randomized population), although thrombectomy reduced distal embolization. Thirty-day stroke risk was higher with aspiration thrombectomy. This is the largest clinical trial on this topic.

The utility of routine aspiration thrombectomy in primary PCI has been unclear. The TAPAS trial demonstrated a significant benefit, with a reduction in cardiovascular death on long-term follow-up. Subsequently, INFUSE-AMI, TASTE, and now TOTAL, however, did not observe a benefit in clinical outcomes with aspiration thrombectomy compared with conventional PCI. Although current STEMI guidelines provide a Class IIa recommendation for aspiration thrombectomy use, it is likely that this will be downgraded in future iterations based on these trials. Some of the benefit with aspiration thrombectomy in earlier trials was observed only on long-term follow-up, and thus, longer-term follow-up of the current trial is awaited.

References:

Sharma V, Jolly SS, Hamid T, et al. Myocardial blush and microvascular reperfusion following manual thrombectomy during percutaneous coronary intervention for ST elevation myocardial infarction: insights from the TOTAL trial. Eur Heart J 2016;37:1891-8.

Jolly SS, Cairns JA, Yusuf S, et al., on behalf of the TOTAL Investigators. Outcomes after thrombus aspiration for ST elevation myocardial infarction: 1-year follow-up of the prospective randomised TOTAL trial. Lancet 2016;387:127-35.

Presented by Dr. Sanjit S. Jolly at the Transcatheter Cardiovascular Therapeutics meeting (TCT 2015), San Francisco, CA, October 13, 2015.

Jolly SS, Cairns JA, Yusuf S, et al., on behalf of the TOTAL Investigators. Randomized trial of primary PCI with or without routine manual thrombectomy. N Engl J Med 2015;372:1389-98.

Presented by Dr. Sanjit Jolly at ACC.15, San Diego, CA, March 16, 2015.

Keywords: ACC Annual Scientific Session, Percutaneous Coronary Intervention, Heart Failure, Thrombectomy, Myocardial Infarction, Stents, Stroke, Shock, Cardiogenic, Thrombosis, Transcatheter Cardiovascular Therapeutics


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