Dataset Information

Design and rationale of the ATTRACTIVE trial: a randomised trial of intrAThrombus Thrombolysis versus aspiRAtion thrombeCTomy during prImary percutaneous coronary interVEntion in ST-segment elevation myocardial infarction patients with high thrombus burden.

ABSTRACT:

Introduction

ST-segment elevation myocardial infarction (STEMI) with high thrombus burden is associated with a poor prognosis. Manual aspiration thrombectomy reduces coronary vessel distal embolisation, improves microvascular perfusion and reduces cardiovascular deaths, but it promotes more strokes and transient ischaemic attacks in the subgroup with high thrombus burden. Intrathrombus thrombolysis (ie, the local delivery of thrombolytics into the coronary thrombus) is a recently proposed treatment approach that theoretically reduces thrombus volume and the risk of microvascular dysfunction. However, the safety and efficacy of intrathrombus thrombolysis lack sufficient clinical evidence.

Methods and analysis

The intrAThrombus Thrombolysis versus aspiRAtion thrombeCTomy during prImary percutaneous coronary interVEntion trial is a multicentre, prospective, open-label, randomised controlled trial with the blinded assessment of outcomes. A total of 2500 STEMI patients with high thrombus burden who undergo primary percutaneous coronary intervention will be randomised 1:1 to intrathrombus thrombolysis with a pierced balloon or upfront routine manual aspiration thrombectomy. The primary outcome will be the composite of cardiovascular death, recurrent myocardial infarction, cardiogenic shock, heart failure readmission, stent thrombosis and target-vessel revascularisation up to 180 days.

Ethics and dissemination

The trial was approved by Ethics Committees of China-Japan Friendship Hospital (2022-KY-013) and all other participating study centres. The results of this trial will be published in peer-reviewed journals.

Trial registration number

NCT05554588.

SUBMITTER: Zhang Z

PROVIDER: S-EPMC10649700 | biostudies-literature | 2023 Nov

REPOSITORIES: biostudies-literature

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Publications

Design and rationale of the ATTRACTIVE trial: a randomised trial of intrAThrombus Thrombolysis versus aspiRAtion thrombeCTomy during prImary percutaneous coronary interVEntion in ST-segment elevation myocardial infarction patients with high thrombus burden.

Zhang Zhen Z Sheng Zhaoxue Z Che Wuqiang W An Shuoyan S Sun Di D Zhai Zhengqin Z Zhao Xuecheng X Yang Yaliu Y Meng Zhen Z Ye Zixiang Z Xie Enmin E Li Peizhao P Yu Changan C Gao Yanxiang Y Xiao Zhu Z Wu Yanfen Y Dong Fen F Ren Jingyi J Zheng Jingang J

BMJ open 20231110 11

<h4>Introduction</h4>ST-segment elevation myocardial infarction (STEMI) with high thrombus burden is associated with a poor prognosis. Manual aspiration thrombectomy reduces coronary vessel distal embolisation, improves microvascular perfusion and reduces cardiovascular deaths, but it promotes more strokes and transient ischaemic attacks in the subgroup with high thrombus burden. Intrathrombus thrombolysis (ie, the local delivery of thrombolytics into the coronary thrombus) is a recently propose ...[more]

PMID: 37949622

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Project description:ImportancePatients with shorter ischemic times have a greater viable myocardium and may derive greater benefit from thrombus aspiration.ObjectiveTo study the association of thrombus aspiration with outcomes among patients presenting with ST-segment elevation myocardial infarction (STEMI) based on time.Design, setting, and participantsThe TOTAL (Thrombectomy With PCI vs PCI Alone in Patients with STEMI) trial was an international randomized clinical trial of 10 732 patients with STEMI undergoing primary percutaneous coronary intervention (PCI) within 12 hours of symptom onset. Patients were recruited between August 5, 2010, and July 25, 2014, and were followed up for 1 year. Data analysis was performed from February 22, 2019, to January 5, 2021.InterventionsThrombus aspiration vs PCI alone.Main outcomes and measuresPost hoc subgroup analyses were performed for total ischemic time and first medical contact (FMC)-to-device time for the primary outcomes (cardiovascular [CV] mortality, myocardial Infarction [MI], cardiogenic shock, and New York Heart Association class IV heart failure) and angiographically determined distal embolization. In addition, a multivariable analysis was performed to assess the association of total ischemic time and FMC-to-device time with CV mortality at 1 year.ResultsThe study randomized 10 732 patients, and 9986 underwent primary PCI and had time data available (7737 men [77.5%]; mean [SD] age, 61.0 [12.0] years). For the randomized comparison of thrombus aspiration, there was a reduction in angiographic distal embolization with thrombus aspiration that was more pronounced in patients with short ischemic times (<2 hours: odds ratio [OR], 0.23 [95% CI, 0.09-0.62]; 2-6 hours: OR, 0.54 [95% CI, 0.39-0.73]; >6 hours: OR, 0.70 [95% CI, 0.33-1.50]; P = .12 for interaction). However, for the primary composite outcome, there was no benefit based on (1) total ischemic time (<2 hours: hazard ratio [HR], 0.77 [95% CI, 0.46-1.28]; 2-6 hours: HR, 1.03 [95% CI, 0.85-1.25]; >6 hours: HR, 0.87 [95% CI, 0.60-1.27]; P = .46 for interaction) or (2) FMC-to-device time (<60 minutes: HR, 1.14 [95% CI, 0.66-1.95]; 60-90 minutes: HR, 0.94 [95% CI, 0.67-1.32]; >90-120 minutes: HR, 1.19 [95% CI, 0.85-1.67]; >120 minutes: HR, 0.89 [95% CI, 0.70-1.14]; P = .54 for interaction). In a multivariable analysis, both total ischemic time (>2 hours: HR, 1.26 [95% CI, 1.00-1.58) and FMC-to-device time (>120 minutes: HR, 1.45 [95% CI, 1.18-1.79]) were independently associated with CV mortality.Conclusions and relevanceThis analysis suggests that thrombus aspiration does not appear to be associated with an improvement in clinical outcomes regardless of ischemic time. In the current STEMI era, both total ischemic time and FMC-to-device times continue to be important factors associated with mortality.Trial registrationClinicalTrials.gov Identifier: NCT01149044.

Project description:ObjectiveTo investigate the impact of optimized thrombus aspiration on myocardial perfusion, prognosis, and safety in patients with acute ST-segment elevation myocardial infarction (STEMI) undergoing primary percutaneous coronary intervention(primary PCI).MethodsA total of 129 patients with STEMI were randomly allocated into control group (Subgroup A and B) and experimental group(Subgroup C and D). Control group received percutaneous transluminal coronary angioplasty (PTCA),thrombus aspiration and primary PCI. Experimental group received optimized thrombus aspiration and primary PCI. The number of thrombus aspiration was less than 4 times in Subgroup A and C. The number of thrombus aspiration was performed more than 4 times in Subgroups B and D. The classification of thrombi extracted, the TIMI flow grade, the incidence of no-reflow and slow flow, cTFC, TPI and CK-MB at 12 h and 24 h after stenting, ST segment resolution of ECG after stenting, NT-proBNP, LVEFat 24 h, 30 days and 180 days after stenting were compared between groups. The incidence of intraoperative and postoperative bleeding complications, stroke events and major cardiovascular events (MACE) were recorded and compared between groups.ResultsThe classification of thrombi extracted in the experimental group was higher than that in the control group. The TIMI flow grade of the experimental group was better than the control group after thrombus aspiration. After stenting, the advantage still existed, but the difference was not statistically significant. On cTFC, the experimental group was lower than the control group, but the difference was not statistically significant; After stenting the experimental group was significantly lower than the control group. The CK-MB at 12 h and 24 h of the experimental group was lower than the control group. After thrombus aspiration the incidence of no-reflow in the experimental group was significantly lower than that in the control group; after stenting the incidence of no-reflow in the experimental group was still lower than the control group, but no statistically difference. After thrombus aspiration and stenting the incidence of slow flow in the experimental group were lower than that in the control group. After stenting, NT-proBNP at 24 h was lower in the experimental group than that in the control group, However, there was no statistical difference; after stenting, The NT-proBNP in the experimental group was lower than that in the control group at 30 days and 180 days. After stenting, LVEF of the experimental group was significantly higher than the control group at 24 h and 30 days; superiority remained after 180 days but no statistical difference. There was no statistical difference between two groups for intraoperative and postoperative bleeding complications, stroke events, and MACE events. In Subgroup analysis,there was no significant difference in the classification of thrombi extracted, TIMI flow grade, cTFC, CK-MB,NT-proBNP and LVEF between group C and D, but group A was better than group B. Analysis of variance showed that the optimal number of suction was 4-5 times.ConclusionsOptimized thrombus aspiration can significantly improve myocardial perfusion and short-term and medium-term prognosis of STEMI patients after PCI, and reduce the incidence of slow flow and no-reflow. The optimal suction times were 4-5 times. Traditional aspiration method with more aspiration times is harmful to cardiac prognosis. Thrombus aspiration does not increase the incidence of stroke events and is safe.Clinical Trial Registration: identifier, ChiCTR2300073410.

Project description: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. In this longer-term follow-up of the TOTAL study, we report the results on the primary outcome (cardiovascular death, myocardial infarction, cardiogenic shock, or heart failure) and secondary outcomes at 1 year. Analyses of the primary outcome were by modified intention to treat and only included patients who underwent index PCI. This trial is registered with ClinicalTrials.gov, number NCT01149044.FindingsBetween Aug 5, 2010, and July 25, 2014, 10,732 eligible patients were enrolled and randomly assigned to thrombectomy followed by PCI (n=5372) or to PCI alone (n=5360). After exclusions of patients who did not undergo PCI in each group (337 in the PCI and thrombectomy group and 331 in the PCI alone group), the final study population comprised 10,064 patients (5035 thrombectomy and 5029 PCI alone). The primary outcome at 1 year occurred in 395 (8%) of 5035 patients in the thrombectomy group compared with 394 (8%) of 5029 in the PCI alone group (hazard ratio [HR] 1·00 [95% CI 0·87-1·15], p=0·99). Cardiovascular death within 1 year occurred in 179 (4%) of the thrombectomy group and in 192 (4%) of 5029 in the PCI alone group (HR 0·93 [95% CI 0·76-1·14], p=0·48). The key safety outcome, stroke within 1 year, occurred in 60 patients (1·2%) in the thrombectomy group compared with 36 (0·7%) in the PCI alone group (HR 1·66 [95% CI 1·10-2·51], p=0·015).InterpretationRoutine thrombus aspiration during PCI for STEMI did not reduce longer-term clinical outcomes and might be associated with an increase in stroke. As a result, thrombus aspiration can no longer be recommended as a routine strategy in STEMI.FundingCanadian Institutes of Health Research, Canadian Network and Centre for Trials Internationally, and Medtronic Inc.

Dataset Information

Design and rationale of the ATTRACTIVE trial: a randomised trial of intrAThrombus Thrombolysis versus aspiRAtion thrombeCTomy during prImary percutaneous coronary interVEntion in ST-segment elevation myocardial infarction patients with high thrombus burden.

Introduction

Methods and analysis

Ethics and dissemination

Trial registration number

Publications

Design and rationale of the ATTRACTIVE trial: a randomised trial of intrAThrombus Thrombolysis versus aspiRAtion thrombeCTomy during prImary percutaneous coronary interVEntion in ST-segment elevation myocardial infarction patients with high thrombus burden.

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