Consistent with previous data with a shorter follow-up period, the Impact of Thrombectomy With Export Catheter in Infarct-Related Artery During Primary Percutaneous Coronary Intervention (EXPIRA) trial investigators recently reported in The American Journal of Cardiology that pretreatment with manual thrombectomy results in a lower incidence of cardiac mortality and fewer major adverse cardiac events at 2-year follow-up compared with “standard” percutaneous coronary intervention (PCI; direct stenting or stenting after predilation) in patients with ST-segment elevation myocardial infarction (STEMI).

In this regard, we would like to point out some aspects. First, patients who were candidates for rescue PCI or who had cardiogenic shock on admission were excluded, so the whole spectrum of patients with STEMI was not fully investigated. Second, predilation, which is known to accentuate embolization, was performed in virtually all cases in the control arm, as shown by the small “direct stenting” percentage. Third, the very high symptom-to-balloon time achieved by Sardella et al would be responsible for the very low myocardial blush grade ≥2, as well as poor ST-segment resolution >70% reported in their study population (especially in the control arm).

We previously demonstrated, in a multicenter registry, safety and feasibility at 30-day follow-up of the “standard” MGuard stent (InspireMD, Tel Aviv, Israel) in 100 patients with STEMI with high baseline thrombus burdens. Patients requiring rescue PCI, as well as those with cardiogenic shock presentation, were included, with short times to treatment (104.48 ± 48.51 and 122.20 ± 77.14 minutes for rescue and primary PCI, respectively). The MGuard is a new bare-metal stent with an ultrathin flexible polyethylene terephthalate mesh sleeve anchored to the external surface of the struts, aiming to minimize distal embolization during PCI.

Two-year follow-up, completed in all patients, showed a cumulative incidence of major adverse cardiac events (cardiac death, myocardial infarction, and target vessel revascularization, defined as any revascularization involving the treated vessel) of 13%; cardiac death was reported in 6%, myocardial infarction in 9%, and target vessel revascularization in 6% of patients. Overall stent thrombosis incidence was 4% (definite or probable stent thrombosis according to Academic Research Consortium criteria).

Cox regression analysis showed that shock presentation (hazard ratio 14.2, 95% confidence interval 3.5 to 56.8, p <0.0001) and chronic kidney disease (hazard ratio 12.9, 95% confidence interval 1.1 to 147.1, p = 0.04) were the only independent predictors of major adverse cardiac events at 2-year follow-up. In patients without shock (n = 84), a lower overall incidence of major adverse cardiac event at 2-year follow-up was reported (7.4%): cardiac death occurred in 2%, myocardial infarction in 5.2%, and target vessel revascularization in 3.2% of patients. Overall definite or probable stent thrombosis incidence was 2%.

The major drawbacks of our study were its nonrandomized design and the absence of a control group (i.e., bare-metal stenting plus thrombectomy). We have started a randomized, multicenter, noninferiority, open-label study, MGuard Stent in ST-Elevation Myocardial Infarction (GUARDIAN; NCT01124942 ). We hope that the results of this trial will address whether the MGuard stent is comparable with manual thrombectomy plus bare-metal stenting in STEMI.