Manual thrombectomy did not significantly reduce pre-stent thrombus burden at the culprit lesion compared with PCI-alone in patients with STEMI (2.36% vs. 2.88%, P=0.373).
RCT (n=214)
Core laboratory blinded
Randomized
Yes
Does manual thrombectomy reduce pre-stent thrombus burden in STEMI patients treated with primary PCI?
Manual thrombectomy does not significantly reduce pre-stent thrombus burden compared to PCI-alone in STEMI patients, as assessed by OCT.
Absolute Event Rate: 2.36% vs 2.88%
p-value: p=0.373
AIMS: Manual thrombectomy has been proposed as a strategy to reduce thrombus burden during primary percutaneous coronary intervention (PCI) in patients with ST-segment elevation myocardial infarction (STEMI). However, the effectiveness of manual thrombectomy in reducing thrombus burden is uncertain. In this substudy of the TOTAL (ThrOmbecTomy versus PCI ALone) trial, we compared the thrombus burden at the culprit lesion using optical coherence tomography (OCT) in patients treated with thrombectomy vs. PCI-alone. METHODS AND RESULTS: The TOTAL trial (N = 10 732) was an international, multicentre, randomized trial of thrombectomy (using the Export catheter, Medtronic Cardiovascular, Santa Rosa, CA, USA) in STEMI patients treated with primary PCI. The OCT substudy prospectively enrolled 214 patients from 13 sites in 5 countries. Optical coherence tomography was performed immediately after thrombectomy or PCI-alone and then repeated after stent deployment. Thrombus quantification was performed by an independent core laboratory blinded to treatment assignment. The primary outcome of pre-stent thrombus burden as a percentage of segment analysed was 2.36% (95% CI: 1.73-3.22) in the thrombectomy group and 2.88% (95% CI: 2.12-3.90) in the PCI-alone group (P = 0.373). Absolute pre-stent thrombus volume was not different (2.99 vs. 3.74 mm(3), P = 0.329). Other secondary outcomes of pre-stent quadrants of thrombus, post-stent atherothrombotic burden, and post-stent atherothrombotic volume were not different between groups. CONCLUSION: Manual thrombectomy did not reduce pre-stent thrombus burden at the culprit lesion compared with PCI-alone. Both strategies were associated with low thrombus burden at the lesion site after the initial intervention to restore flow.
“The message from this study is that thrombectomy should not be used as a routine strategy. This is still an important therapy, but given the downsides we observed in our trial, its use should be quite selective and as a measure when an initial balloon angioplasty attempt fails to open up the artery, rather than as a routine strategy.”
Bhindi et al. (2015) conducted an RCT in ST-segment elevation myocardial infarction (STEMI) (n=214). Manual thrombectomy vs. PCI-alone was evaluated on Pre-stent thrombus burden as a percentage of segment analysed (p=0.373). Manual thrombectomy did not significantly reduce pre-stent thrombus burden at the culprit lesion compared with PCI-alone in patients with STEMI (2.36% vs. 2.88%, P=0.373).