The routine use of thrombectomy with manual aspiration in patients undergoing primary percutaneous coronary intervention (PCI) did not improve outcomes in the TOTAL trial, according to Sanjit S. Jolly, MD, MSc, McMaster University and Hamilton Health Sciences, Hamilton, Ontario, Canada [Jolly SS et al. N Engl J Med. 2015].

The data supporting the routine use of thrombectomy in patients undergoing PCI for STEMI have differed in prior studies. The single-center TAPAS trial, conducted in The Netherlands, showed that thrombectomy plus PCI reduced cardiac death at 12 months when compared with PCI only for STEMI [Viaar PJ et al. Lancet. 2008]. However, the TASTE trial—a large multicenter randomized trial conducted in Sweden—did not find any benefit with thrombectomy [Fröbert O et al. N Engl J Med. 2013]. The TOTAL trial is the largest primary PCI trial to date evaluating the benefit of routine thrombectomy in patients with STEMI undergoing PCI.

In the international multicenter TOTAL trial, 10 732 patients were randomized within 12 hours after onset of STEMI symptoms to receive thrombectomy with manual aspiration followed by PCI (n = 5033) or PCI alone (n = 5030). In patients randomized to PCI only, thrombectomy was allowed when PCI alone failed to clear occluded vessels (7% of cases). The baseline characteristics of the patients and the procedural characteristics were similar between the 2 groups.

The primary outcome was the composite of cardiovascular (CV) death, recurrent myocardial infarction (MI), cardiogenic shock, and NYHA class IV heart failure within 180 days. The primary safety outcome was stroke within 30 days.

There were no significant differences between the thrombectomy and PCI-only groups for the primary composite outcome (6.9% vs 7.0%; HR, 0.99; 95% CI, 0.85 to 1.15; P = .86) or its individual components (CV death, 3.1% vs 3.5%, P = .34; recurrent MI, 2.0% vs 1.8%, P = .62; cardiogenic shock, 1.8% vs 2.0%, P = .56; class IV heart failure, 1.9% vs 1.8%, P = .57). In addition, there were no significant differences in stent thrombosis (HR, 0.85; 95% CI, 0.60 to 1.21; P = .370) or target vessel revascularization (HR, 0.95; 95% CI, 0.75 to 1.22; P = .692) at 30 days. There were no difference in outcomes for any of the prespecified subgroups (ie, timing of symptom onset, TIMI grade, initial TIMI flow, MI type, or age), said Dr Jolly.

However, patients randomized to routine thrombectomy did have an increased risk of stroke (Table 1).

Further study is needed of the higher risk of stroke, and a detailed case review is underway to better understand how this might be related to the procedure, said Dr Jolly.