Original title: Randomized Trial of Primary PCI with or without Routine Manual Thrombectomy. Reference: S.S. Jolly et al. for the TOTAL Investigators. N Engl J Med. 2015 Apr 9;372(15):1389-98.
Manual thrombectomy is a routine procedure with ST elevation AMI patients. This common practice proved to reduce mortality in the TAPAS study. However, the TASTE study did not observe this benefit, but an increased risk of stroke. This divergent evidence inspired a comparative larger study comparing PCI vs. PCI + manual thrombectomy in STEMI patients.
The TOTAL trial is an international, multicenter, prospective and randomized study. 10063 patients were analyzed: 5033received manual thrombectomy followed by PCI and 5030 received PCI only. Primary end point was cardiovascular death, recurrent myocardial infarction, cardiogenic shock, new cardiac failure or worsening to CF IV within 180 days. Secondary end point was in-stent thrombosis or new revascularization in addition to primary end point variables. Safety end point was stroke within 30 days.
There were no differences in primary or secondary end points (6.9% vs. 7%, p = 0.86 and 9.9% vs. 9.8%, p = 0.95, respectively).Differences were observed in safety end point, where the thrombectomy group showed a higher incidence of stroke (0.7% vs. 0.3%, p=0.02).
In STEMI patients, routine manual thrombectomy + PCI, compared to PCI alone, did not reduce the risk of cardiovascular death, recurrent myocardial infarction, cardiogenic shock, or NYHA class IV heart failure within 180 days. The routine manual thrombectomy strategy was associated with an increased rate of stroke within 30 days, compared to PCI alone.
Until now, the benefit of manual thrombectomy in reducing mortality with STEMI patients is not conclusive. This study, the most important work in this matter so far, shows that routine manual thrombectomy is not associated to reduced mortality, but to an increased incidence of stroke, which differs with previous studies showing this tendency.
Two factors are worth noting: firstly, patients in the PCI group received more GP IIB/IIIA inhibitors, which may be affecting the final outcome. Secondly, the study compared routine manual thrombectomy despite thrombus load, which could also affect outcome, since manual thrombectomy in patients with low thrombus load would not benefit as much.
The present evidence does not support manual thrombectomy as a routine strategy. However, this strategy should not be discarded and should be considered for patients with post PCI high thrombus load.
Courtesy of Drs. Juan Pablo Bachini and Ariel Durán. Montevideo, Uruguay.
Dres. Juan Pablo Bachini y Ariel Durán