Browsing by Author "Rokoss, Michael J. (8895026900)"

Aims Thrombectomy during primary percutaneous coronary intervention (PPCI) for ST elevation myocardial infarction (STEMI) has been thought to be an effective therapy to prevent distal embolization and improve microvascular perfusion. The TOTAL trial (N = 10 732), a randomized trial of routine manual thrombectomy vs. PCI alone in STEMI, showed no difference in the primary efficacy outcome. This angiographic sub-study was performed to determine if thrombectomy improved microvascular perfusion as measured by myocardial blush grade (MBG). Methods and results Of the 10 732 patients randomized, 1610 randomly selected angiograms were analysable by the angiographic core laboratory. Primary outcomes included MBG and post-PCI thrombolysis in myocardial infarction (TIMI) flow grade. Secondary outcomes included distal embolization, PPCI complications, and each component of the complications. The primary end point of final myocardial blush (221 [28%] 0/1 for thrombectomy vs. 246 {30%} 0/1 for PCI alone group, P = 0.38) and TIMI flow (712 [90%] TIMI 3 for thrombectomy vs. 733 [89.5%] TIMI 3 for PCI alone arm, P = 0.73) was similar in the two groups. Thrombectomy was associated with a significantly reduced incidence of distal embolization compared with PCI alone (56 [7.1%] vs. 87 [10.7%], P = 0.01). In multivariable analysis, distal embolization was an independent predictor of mortality (HR 3.00, 95% CI 1.19-7.58) while MBG was not (HR 2.73, 95% CI 0.94-5.3). Conclusions Routine thrombectomy during PPCI did not result in improved MBG or post-PCI TIMI flow grade but did reduce distal embolization compared with PCI alone. Distal embolization and not blush grade is independently associated with mortality. © The Author 2016.

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. Methods: We randomly assigned 10,732 patients with ST-segment elevation myocardial infarction (STEMI) undergoing primary PCI to a strategy of routine upfront manual thrombectomy versus PCI alone. The primary outcome was a composite of death from cardiovascular causes, recurrent myocardial infarction, cardiogenic shock, or New York Heart Association (NYHA) class IV heart failure within 180 days. The key safety outcome was stroke within 30 days. Results: The primary outcome occurred in 347 of 5033 patients (6.9%) in the thrombectomy group versus 351 of 5030 patients (7.0%) in the PCI-alone group (hazard ratio in the thrombectomy group, 0.99; 95% confidence interval [CI], 0.85 to 1.15; P = 0.86). The rates of cardiovascular death (3.1% with thrombectomy vs. 3.5% with PCI alone; hazard ratio, 0.90; 95% CI, 0.73 to 1.12; P = 0.34) and the primary outcome plus stent thrombosis or target-vessel revascularization (9.9% vs. 9.8%; hazard ratio, 1.00; 95% CI, 0.89 to 1.14; P = 0.95) were also similar. Stroke within 30 days occurred in 33 patients (0.7%) in the thrombectomy group versus 16 patients (0.3%) in the PCI-alone group (hazard ratio, 2.06; 95% CI, 1.13 to 3.75; P = 0.02). Conclusions: In patients with STEMI who were undergoing primary PCI, routine manual thrombectomy, as compared with PCI alone, did not reduce the risk of cardiovascular death, recurrent myocardial infarction, cardiogenic shock, or NYHA class IV heart failure within 180 days but was associated with an increased rate of stroke within 30 days. Copyright © 2015 Massachusetts Medical Society.