Culprit lesion thrombus burden after manual thrombectomy or percutaneous coronary intervention-alone in ST-segment elevation myocardial infarction: the optical coherence tomography sub-study of the TOTAL (ThrOmbecTomy versus PCI ALone) trial
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Key result
Manual thrombectomy fails to reduce pre-stent thrombus burden vs PCI alone in STEMI.
- P=0.373
- n=214
Why the study?
Manual thrombectomy was proposed to reduce thrombus burden during primary PCI in STEMI, but its effectiveness remained uncertain.
Does manual thrombectomy reduce pre-stent thrombus burden in STEMI patients treated with primary PCI?
Key Points
- To determine whether routine manual thrombectomy reduces culprit lesion thrombus burden compared with PCI-alone assessed by optical coherence tomography in patients with ST-segment elevation myocardial infarction.
- Prospective substudy of the international, multicentre, randomized TOTAL trial enrolling 214 STEMI patients (104 randomized to thrombectomy and 110 to PCI-alone) across 13 sites in 5 countries.
- Optical coherence tomography imaging was performed immediately following thrombectomy or initial PCI-alone and repeated following coronary stent deployment.
- Thrombus quantification was conducted by an independent core laboratory blinded to treatment allocation.
- Primary outcome pre-stent thrombus burden as a percentage of segment analysed was 2.36% (95% CI: 1.73-3.22) in the thrombectomy group versus 2.88% (95% CI: 2.12-3.90) in the PCI-alone group (P = 0.373).
- Absolute pre-stent thrombus volume was 2.99 mm(3) in the thrombectomy group versus 3.74 mm(3) in the PCI-alone group (P = 0.329).
- Post-stent atherothrombotic burden was 6.23% (95% CI 5.74–6.76) with thrombectomy versus 5.71% (95% CI 5.27–6.18) with PCI-alone (P = 0.136).
Study Design
Type
RCT (n=214)
Blinding
Core laboratory blinded
Randomization
Randomized
Multicenter
Yes
Structured PICO
Does manual thrombectomy reduce pre-stent thrombus burden in STEMI patients treated with primary PCI?
P
Population
214 STEMI patients treated with primary PCI, multinational (13 sites in 5 countries)
I
Intervention
Manual thrombectomy (using the Export catheter) during primary PCI
C
Comparator
Primary PCI alone
O
Outcome
Pre-stent thrombus burden as a percentage of segment analysed, measured by optical coherence tomography (OCT)surrogate
Main Result
Absolute Event Rate: 2.36% vs 2.88%
p-value: p=0.373
Manual thrombectomy does not significantly reduce pre-stent thrombus burden compared to PCI-alone in STEMI patients, as assessed by OCT.
Limitations
- Observed mean pre-stent thrombus burden was lower than anticipated, potentially underpowering the study
- Inability to image patients with high residual thrombus burden due to vessel re-occlusion or inability to clear blood
- Passage of catheters may have displaced thrombus prior to imaging
- Potential exclusion of patients with more extreme thrombus burden due to operator discretion
Key expert perspectives
Captured external expert commentary on this paper, strongest first. Original sources are linked where available.
“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.”
SKStefan K. JamesCardiologist, Uppsala Clinical Research Center
“It's OK to still use thrombectomy.”
IMIrene Marthe LangProfessor of Internal Medicine, Medical University of Vienna
“Large, dedicated trials (eg, TASTE, TOTAL) have shown little to no benefit of thrombus aspiration. Based on predominantly negative study evidence, routine thrombus aspiration during primary PCI is not recommended by guidelines, and this is related to a lack of effectiveness at the price of potential harm.”
Implication
Does not support routine thrombectomy in STEMI PCI; confirms neutral effect and reinforces PCI alone as standard.
Abstract
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.
Discussion
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Cite This Study
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).
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