Myocardial blush and microvascular reperfusion following manual thrombectomy during percutaneous coronary intervention for ST elevation myocardial infarction: insights from the TOTAL trial.

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.

Stroke in the TOTAL trial: a randomized trial of routine thrombectomy vs. percutaneous coronary intervention alone in ST elevation myocardial infarction.

AIMS: TOTAL (N = 10 732), a randomized trial of routine manual thrombectomy vs. percutaneous coronary intervention alone in ST elevation myocardial infarction, showed no difference in the primary efficacy outcome but a significant increase in stroke. We sought to understand these findings. METHODS AND RESULTS: A detailed analysis of stroke timing, stroke severity, and stroke subtype was performed. Strokes were adjudicated by neurologists blinded to treatment assignment. Stroke within 30 days, the primary safety outcome, was increased [33 (0.7%) vs. 16 (0.3%), hazard ratio (HR) 2.06; 95% confidence interval (CI) 1.13-3.75]. The difference in stroke was apparent within 48 h [15 (0.3%) vs. 5 (0.1%), HR 3.00; 95% CI 1.09-8.25]. There was an increase in strokes within 180 days with minor or no disability (Rankin 0-2) [18 (0.4%) vs. 13 (0.3%) HR 1.38; 95% CI 0.68-2.82] and in strokes with major disability or fatal (Rankin 3-6) [35 (0.7%) vs. 13 (0.3%), HR 2.69; 95% CI 1.42-5.08]. Most of the absolute difference was due to an increase in ischaemic strokes within 180 days [37 (0.7%) vs. 21 (0.4%), HR 1.71; 95% CI 1.03-3.00], but there was also an increase in haemorrhagic strokes [10 (0.2%) vs. 2 (0.04%), HR 4.98; 95% CI 1.09-22.7]. Patients that had a stroke had a mortality of 30.8% within 180 days vs. 3.4% without a stroke (P < 0.001). A meta-analysis of randomized trials (N = 21 173) showed an increase in risk of stroke (odds ratio 1.59; 95% CI 1.11-2.27) but a trend towards reduction in mortality odds ratio (odds ratio 0.87; 95% CI 0.76-1.00). CONCLUSION: Thrombectomy was associated with a significant increase in stroke. Based on these findings, future trials must carefully collect stroke to determine safety in addition to efficacy.