Aspiration Thrombectomy With Primary PCI for STEMI: Review of the Data and Current Guidelines
Primary percutaneous coronary intervention (PCI) has greatly improved outcomes in patients with ST-elevation myocardial infarction (STEMI) and has become the preferred reperfusion strategy in patients with STEMI.
The presence of visible coronary thrombus at the time of primary PCI creates special challenges for the interventional cardiologist. Large thrombus burden is associated with an increased incidence of distal embolization and no-reflow and may limit reperfusion at the microvascular level as measured by myocardial blush and ST-segment resolution (STR). Large thrombus burden is associated with a greater frequency of major adverse cardiac events (MACE) and is a strong independent predictor of late mortality.1
There are many ways to deal with coronary thrombus at the time of primary PCI: pharmacologic strategies (typically glycoprotein IIb/IIIa platelet inhibitors), embolic protection devices (filters and distal balloon occlusion with aspiration), mechanical thrombectomy (AngioJet Rheolytic Thrombectomy, Medrad Interventional/Possis, Minneapolis, Minnesota), and manual or aspiration thrombectomy devices (Figure 1). This paper reviews the role of manual thrombectomy in patients with STEMI.
Major Randomized Trials
The TAPAS (Thrombus Aspiration during Percutaneous coronary intervention in Acute myocardial infarction) Trial was a landmark study that brought manual thrombectomy into the mainstream as adjuctive therapy with primary PCI for STEMI.2 This trial randomized 1,071 patients with STEMI of less than 12 hours duration to primary PCI with manual thrombectomy with the Export catheter versus primary PCI alone. Aspiration was able to be performed in 90% of patients and retrieved visible thrombus or atheromatous material in 72% of patients. Aspiration resulted in significant improvement in the primary endpoint of frequency of myocardial blush grade 3 (MBG 3) (46% versus 32%, p70%) (57% versus 44%, p
Meta-analyses
In addition to the two trials described above, there have been numerous small randomized trials evaluating manual thrombectomy, mechanical thrombectomy, and distal protection devices in patients undergoing primary PCI for STEMI. None of these trials has been adequately powered to evaluate clinical events. For this reason, a number of meta-analyses have been performed to help evaluate the role of manual thrombectomy (and other devices) as adjunctive therapy with primary PCI for STEMI. Bavry and Bhatt analyzed 13 trials with manual thrombectomy, 5 trials with mechanical thrombectomy (AngioJet, Medrad Interventional/Possis, Minneapolis, Minnesota, and X-sizer, EV3, Plymouth, Minnesota), and 9 trials with distal protection devices (Percusurge GuardWire, Medtronic; FilterWire, Boston Scientific, SpideRx, ev3; Angioguard, Cordis).5 Manual thrombectomy resulted in better myocardial blush scores and better STR; distal protection resulted in better myocardial blush but no improvement in STR; and mechanical thrombectomy resulted in no improvement in either myocardial blush or STR.



Limitations of Current Evidence
The evidence supporting the benefit of aspiration thrombectomy on surrogate outcomes (TIMI flow, MBG, and STR) and angiographic outcomes (distal emboli and no-reflow) is strong and convincing. The evidence supporting the benefit in mortality reduction is not as strong and has limitations. The TAPAS Trial, which showed a significant mortality reduction at 1 year with aspiration thrombectomy, was a single center study and was not powered to evaluate mortality.2 The 46% reduction in mortality was certainly not expected and may have occurred by chance.3 Some of the benefit of aspiration may be from direct stenting, which was performed in 59% of aspiration patients, although this would not diminish the benefit of this overall approach. Meta-analyses certainly have limitations, one of which is selection bias for publication of positive trials. Negative trials are often not submitted for publication and when submitted may be less likely to be accepted for publication. There are certainly examples of treatments that were thought to be effective based on meta-analyses, but which were proven to be of no benefit when evaluated by a properly powered clinical trial. A prominent example is the use of magnesium for treatment of acute myocardial infarction. Magnesium was thought to reduce mortality with acute myocardial infarction based on a large meta-analysis but was found not to be effective in the large ISIS-4 trial.11,12Current Guidelines
Based on the TAPAS Trial and the above meta-analyses, the ACC/AHA Guidelines have given aspiration thrombectomy a Class IIa (Level of Evidence B) indication with primary PCI for STEMI, and the ESC Guidelines recently upgraded to Level of Evidence A.13,14 This opinion states that “aspiration thrombectomy is reasonable for patients with STEMI undergoing primary PCI.” The committee did not feel the evidence for benefit on clinical outcomes was strong enough to warrant a Class I indication.Unanswered Questions
All randomized trials with aspiration thrombectomy have been performed in “all comers” with STEMI, and it is not clear which subgroups may benefit most and which subgroups may not benefit at all. There are little data to help answer this question. Sianos and colleagues have shown that both angiographic outcomes and clinical outcomes are worse in patients with large thrombus burden.1 Napodano and colleagues found that patients with RCA infarcts, long lesions and high thrombus score had the highest frequency of distal embolization.15 We might expect these subgroups to benefit most from thrombectomy, but data from the TAPAS trial do not support this.2 Improvement in MBG with aspiration was no better in patients with RCA infarcts versus non-RCA infarcts and was no better in patients with visible thrombus compared with patients without visible thrombus. There was a trend for more benefit in patients with reperfusion time of less than 3 hours, but there were no differential benefits in patients stratified by pre-PCI TIMI flow. Overall, there are little current data to support selective use of aspiration thrombectomy in any subgroup of STEMI patients treated with primary PCI. Aspiration thrombectomy has limited ability to remove large thrombus burden and sometimes may be associated with incomplete thrombus removal, no-reflow, and/or distal emboli. There is previous and very recent evidence that mechanical thrombectomy may effectively improve outcomes in patients with large thrombus burden,1,16 and whether mechanical thrombectomy is preferable to aspiration thrombectomy in patients with large thrombus burden remains an unanswered question.References
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