Ascertainment of silent myocardial infarction in patients undergoing percutaneous coronary intervention (from the GLOBAL LEADERS Trial)

Abstract: Q-wave myocardial infarction (QWMI) comprises 2 entities. First, a clinically evident MI, which can occur spontaneously or be related to a coronary procedure. Second, silent MI which is incidentally detected on serial electrocardiographic (ECG) assessment. The prevalence of silent MI after percutaneous coronary intervention (PCI) in the drug-eluting stent era has not been fully investigated. The GLOBAL LEADERS is an all-comers multicenter trial which randomized 15,991 patients who underwent PCI to 2 antiplatelet treatment strategies. The primary end point was a composite of all-cause death or nonfatal new QWMI at 2-years follow-up. ECGs were collected at discharge, 3-month and 2-year visits, and analyzed by an independent ECG core laboratory following the Minnesota code. All new QWMI were further reviewed by a blinded independent cardiologist to identify a potential clinical correlate by reviewing clinical information. Of 15,968 participants, ECG information was complete in 14,829 (92.9%) at 2 years. A new QWMI was confirmed in 186 (1.16%) patients. Transient new Q-waves were observed in 28.5% (53 of 186) of them during the follow-up. The majority of new QWMI (78%, 146 of 186) were classified as silent MI due to the absence of a clinical correlate. Silent MI accounted for 22.1% (146 of 660) of all MI events. The prevalence of silent MI did not differ significantly between treatment strategies (experimental vs reference: 0.88% vs 0.98%, p = 0.5027). In conclusion, we document the prevalence of silent MI in an all-comers population undergoing PCI in this large-scale randomized trial. (AU)

Outcomes after thrombus aspiration for ST elevation myocardial infarction: 1-year follow-up of the prospective randomised TOTAL trial

BackgroundTwo large trials have reported contradictory results at 1 year after thrombus aspiration in ST elevation myocardial infarction (STEMI). In a 1-year follow-up of the largest randomised trial of thrombus aspiration, we aimed to clarify the longer-term benefits, to help guide clinical practice.MethodsThe trial of routine aspiration ThrOmbecTomy with PCI versus PCI ALone in Patients with STEMI (TOTAL) was a prospective, randomised, investigator-initiated trial of routine manual thrombectomy versus percutaneous coronary intervention (PCI) alone in 10 732 patients with STEMI. Eligible adult patients (aged ≥18 years) from 87 hospitals in 20 countries were enrolled and randomly assigned (1:1) within 12 h of symptom onset to receive routine manual thrombectomy with PCI or PCI alone. Permuted block randomisation (with variable block size) was done by a 24 h computerised central system, and was stratified by centre. Participants and investigators were not masked to treatment assignment. The trial did not show a difference at 180 days in the primary outcome of cardiovascular death, myocardial infarction, cardiogenic shock, or heart failure. However, the results showed improvements in the surrogate outcomes of ST segment resolution and distal embolisation, but whether or not this finding would translate into a longer term benefit remained unclear...

Design and rationale of the TOTAL trial: A randomizedtrial of routine aspiration ThrOmbecTomy withpercutaneous coronary intervention (PCI) versus PCIALone in patients with ST-elevation myocardialinfarction undergoing primary PCI

Background A major limitation of primary percutaneous coronary intervention (PPCI) for the treatment of ST-elevation

myocardial infarction (STEMI) is impaired microvascular perfusion due to embolization and obstruction of microcirculation with

thrombus. Manual thrombectomy has the potential to reduce distal embolization and improve microvascular perfusion. Clinical

trials have shown mixed results regarding thrombectomy.

Objective The objective of this study is to evaluate the efficacy of routine upfront manual aspiration thrombectomy during

PPCI compared with percutaneous coronary intervention alone in patients with STEMI.

Design This is a multicenter, prospective, open, international, randomized trial with blinded assessment of outcomes.

Patients with STEMI undergoing PPCI are randomized to upfront routine manual aspiration thrombectomy with the Export

catheter (Medtronic CardioVascular, Santa Rosa, CA) or to percutaneous coronary intervention alone. The primary outcome is

the composite of cardiovascular death, recurrent myocardial infarction, cardiogenic shock, or new or worsening New York

Heart Association class IV heart failure up to 180 days. The trial uses an event-driven design and will recruit 10,700 patients.

Summary The TOTAL trial will determine the effect of routine manual aspiration thrombectomy during PPCI on clinically