In the Impact of Thrombectomy With Export Catheter in Infarct-Related Artery During Primary Percutaneous Coronary Intervention (EXPIRA) trial, we demonstrated that thrombectomy during primary percutaneous coronary intervention prevents thrombus embolization, improving myocardial blush grade and ST-segment resolution (the first primary end point). The contrast-enhanced magnetic resonance imaging substudy showed, in the thrombectomy group, a lower incidence and extent of microvascular obstruction and a reduced infarct size at 3 months (the second primary end point). In the same trial, we also observed, a reduced incidence of cardiac death at 9 and 24 months.
With regard to the aspects pointed out by Cassese et al, first, considering the negative results of other “all comers” randomized trials of thrombectomy (except the Thrombus Aspiration During Percutaneous Coronary Intervention in Acute Myocardial Infarction Study [TAPAS]), which however were not powered for clinical major adverse cardiovascular events in terms of cumulative major adverse cardiovascular events, we decided to consider strict inclusion and exclusion criteria to point out the real adjunctive value of thrombectomy in the definite setting of ST-segment elevation myocardial infarction (STEMI). We excluded rescue percutaneous coronary intervention and patients in cardiogenic shock to avoid an inhomogeneity of the sample to reach the predetermined end points.
Second, we agree that predilation accentuates embolization, and thus in a randomized population, direct stenting is among the well-known advantages of thromboaspiration. Third, the high symptom-to-balloon time in the 2 groups, also comparing with TAPAS, in our opinion is a positive adjunctive factor for the use of thromboaspiration. The data reported by Cassese et al are quite interesting, although the study is a registry and not a randomized controlled trial, as the investigators point out. When the MGuard Stent in ST-Elevation Myocardial Infarction (GUARDIAN) trial will be completed, more data on this type of stent may become available, particularly regarding the percentage of direct implanting and embolization due to the high profile of the stent. At the moment, the gold-standard treatment in a patient with STEMI with an evident angiographic thrombus and limited coronary flow during primary percutaneous coronary intervention is the pretreatment with manual thrombectomy, as the new STEMI guidelines also indicate. The association of thromboaspiration with the new MGuard bare-metal stent (InspireMD, Tel Aviv, Israel) should be an optimal option in this setting of patients and should be better investigated.