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

Outcomes in patients undergoing multivessel percutaneouscoronary intervention using sirolimus-eluting stents: a reportfrom the e-SELECT registry

Aims: Performing percutaneous coronary intervention (PCI) to multiple coronary lesions during the same procedurehas potential economic and social advantages. However comprehensive outcome data of real world practicein a large population is limited. We aimed to compare short- and long-term outcomes between patients with multivesselcoronary artery disease who either underwent single- or multivessel PCI within the e-SELECT registry.Methods and results: The e-SELECT registry combines data collected at 320 medical centres in 56 countrieswhere patients received CYPHER Select® or CYPHER Select® Plus sirolimus-eluting stent (SES). Rates of myocardialinfarction and major adverse cardiac event (MACE) (defined as any death, myocardial infarction or targetlesion revascularisation) were compared between patients undergoing single-vessel versus multivessel PCI. A totalof 15,147 patients who satisfied the inclusion criteria were included in the e-SELECT registry. Two thousand twohundred and seventy-eight (2,278) subjects (15%) underwent multivessel PCI and 12,869 (85%) had single-vesselPCI. The mean age was higher in the multivessel PCI group (63 vs. 62 years, p<0.001) and there was a higherprevalence of diabetes mellitus (32.4 vs. 30.0%, p=0.02). Lesions were more complex in the single-PCI groupwhile pre- and post-dilatation were less common in the multivessel PCI group. Myocardial infarction within thefirst 30 days post PCI was more common in the multivessel PCI group (1.9 vs. 0.8%, p<0.001) and most of theinfarctions were periprocedural (1.3 vs. 0.6%, p=0.001). Mortality and myocardial infarction at one-year werehigher in the multivessel PCI group resulting in a significantly higher MACE (6.1 vs. 4.6%, p=0.005)...

Stent thrombosis and bleeding complications after implantation of sirolimus-eluting coronary stentsin an unselected worldwide population a report from the e-SELECT (Multi-Center Post-Market Surveillance) registry

Objectives The aim of this study was to ascertain the 1-year incidence of stent thrombosis (ST) and major bleeding (MB) ina large, unselected population treated with sirolimus-eluting stents (SES).Background Stent thrombosis and MB are major potential complications of drug-eluting stent implantation. Their relativeincidence and predisposing factors among large populations treated worldwide are unclear.Methods The SES were implanted in 15,147 patients who were entered in a multinational registry. We analyzed the incidenceof: 1) definite and probable ST as defined by the Academic Research Consortium; and 2) MB, with theSTEEPLE (Safety and efficacy of Enoxaparin in PCI) definition, together with their relation to dual antiplatelettherapy (DAPT) and to 1-year clinical outcomes.Results The mean age of the sample was 62 11 years, 30.4% were diabetic, 10% had a Charlson comorbidity index 3, and 44% presented with acute coronary syndrome or myocardial infarction. At 1 year, the reported compliancewith DAPT as recommended by the European Society of Cardiology guidelines was 86.3%. Adverse eventrates were: ST 1.0%, MB 1.0%, mortality 1.7%, myocardial infarction 1.9%, and target lesion revascularization2.3%. Multivariate analysis identified 9 correlates of ST and 4 correlates of MB. Advanced age and a high Charlsonindex were associated with an increased risk of both ST and MB. After ST, the 7-day and 1-year all-causemortality was 30% and 35%, respectively, versus 1.5% and 10% after MB. Only 2 of 13,749 patients (0.015%)experienced both MB and ST during the entire 1-year follow-up period.Conclusions In this worldwide population treated with 1 SES, the reported compliance with DAPT was good, and the incidenceof ST and MB was low. Stent thrombosis and MB very rarely occurred in the same patient.