Randomized Trial of Primary PCI with or without Routine Manual Thrombectomy

Abstract

BACKGROUND-During primary percutaneous coronary intervention (PCI), manual thrombectomy may reduce distal embolization and thus improve microvascular perfusion. Small trials have suggested that thrombectomy improves surrogate and clinical outcomes, but a larger trial has reported conflicting results.

Outcomes after thrombus aspiration for ST elevation myocardial infarction: 1-year follow-up of the prospective randomised TOTAL trial

“…Thrombus aspiration in the TOTAL trial improved ST segment resolution and reduced the occurrence of angiographic distal embolisation. 9 In the TOTAL angiographic substudy, distal embolisation and not blush grade was independently associated with worse prognosis. 24 However, distal embolisation occurred in only 10% of patients in the PCI alone group and this surrogate endpoint was only reduced by a third with thrombus aspiration compared with PCI alone.…”

“…These results have been published previously. 9 For the 1-year follow-up, we report the following prespecified outcomes: the primary outcome; components of the primary outcome (including cardiovascular death); the key net benefit outcome (cardiovascular death, recurrent myocardial infarction, cardiogenic shock, class IV heart failure, or stroke); and other outcomes including target vessel revascularisation, stent thrombosis, stroke, and transient ischaemic attack. All outcomes were analysed by modified intention to treat.…”

“…9,27 A previously published detailed analysis of the strokes in the TOTAL trial showed a significant increase in strokes-mainly ischaemic-in the first 48 h. 27 A potential mechanism of stroke related to thrombectomy is embolisation of thrombus to systemic circulation during removal of the thrombectomy catheter. A landmark analysis showed no difference in late strokes beyond 180 days.…”

“…The trial of routine aspiration ThrOmbecTomy with PCI versus PCI ALone in Patients with STEMI (TOTAL) 9 showed no difference at 180 days in the primary outcome of cardiovascular death, myocardial infarction, cardiogenic shock, or class IV heart failure between patients who had received thrombectomy with PCI versus those who had PCI alone. Notably, the trial showed significant improvements in surrogate outcomes of distal embolisation and ST segment resolution in patients who received thrombectomy.…”

Pathophysiological aspects and management workflow of coronary microvascular obstruction in ST-segment elevation myocardial infarction

“…67,68 Eventually, the TOTAL trial has recently clarified as, in patients with STEMI undergoing primary PCI, routine manual thrombectomy as compared to PCI alone did not reduce the risk of cardiovascular death, recurrent MI, cardiogenic shock, or New York Heart Association (NYHA) class IV heart failure within 180 days but was associated with an increased rate of stroke within 30 days. 69 The Angiojet mechanical thrombectomy device in the JETSTENT study showed an improvement in STR and a lower 1-year MACEs rate in the treatment group, compared to the direct stenting group. 70 Other approaches including stent with trapping capabilities 71 and local delivery of abciximab at culprit lesion level through special porous balloon 72 failed to improve clinical outcome.…”