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Thrombus aspiration in patients with ST elevation myocardial infarction: meta-analysis of 16 randomized trials.

ABSTRACT: The mortality rate is high in some patients undergoing primary percutaneous coronary intervention (PPCI) because of ineffective epicardial and myocardial perfusion. The use of thrombus aspiration (TA) might be beneficial in this group but there is contradictory evidence in current trials. Therefore, using PRISMA statement, we performed a meta-analysis that compares PPCI+TA with PPCI alone.Sixteen studies in which PPCI (n=5262) versus PPCI+TA (n=5256) were performed, were included in this meta-analysis. We calculated the risk ratio (RR) for epicardial and myocardial perfusion, such as the Thrombolysis In myocardial Infarction (TIMI) flow, myocardial blush grade (MBG) and stent thrombosis (ST) resolution (STR), and clinical outcomes, such as all-cause death, recurrent infarction (Re-MI), target vessel revascularization/target lesion revascularization (TVR/TLR), stent thrombosis (ST), and stroke.Postprocedural TIMI-III flow frequency, postprocedural MBG II-III flow frequency, and postprocedural STR were significantly high in TA+PPCI compared with the PPCI alone group. However, neither all-cause mortality [6.6% vs. 7.4%, RR=0.903, 95% confidence interval (CI): 0.785-1.038, p=0.149] nor Re-MI (2.3% vs. 2.6%, RR=0.884, 95% CI: 0.693-1.127, p=0.319), TVR/TLR (8.2% vs. 8.0%, RR=1.028, 95% CI: 0.900-1.174, p=0.687), ST (0.93% vs. 0.90%, RR=1.029, 95% CI: 0.668-1.583, p=0.898), and stroke (0.5% vs. 0.5%, RR=1.073, 95% CI: 0.588-1.959, p=0.819) rates were comparable between the groups.This meta-analysis is the first updated analysis after publishing the 1-year result of the "Thrombus Aspiration during ST-Segment Elevation Myocardial Infarction" trial, and it showed that TA did not reduce the rate of all-cause mortality, Re-MI, TVR/TLR, ST, and stroke.

SUBMITTER: Tanboga IH

PROVIDER: S-EPMC5337052 | biostudies-literature | 2015 Mar

REPOSITORIES: biostudies-literature

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Thrombus aspiration in patients with ST elevation myocardial infarction: meta-analysis of 16 randomized trials.

Tanboğa İbrahim Halil İH Topçu Selim S Aksakal Enbiya E Kurt Mustafa M Kaya Ahmet A Oduncu Vecih V Sevimli Serdar S

Anatolian journal of cardiology 20150301 3

<h4>Objective</h4>The mortality rate is high in some patients undergoing primary percutaneous coronary intervention (PPCI) because of ineffective epicardial and myocardial perfusion. The use of thrombus aspiration (TA) might be beneficial in this group but there is contradictory evidence in current trials. Therefore, using PRISMA statement, we performed a meta-analysis that compares PPCI+TA with PPCI alone.<h4>Methods</h4>Sixteen studies in which PPCI (n=5262) versus PPCI+TA (n=5256) were perfor ...[more]

PMID: 25880174

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Project description:We aimed to summarize the evidence from randomized clinical trials studies examining the efficacy of ischemic postconditioning (IPost) in ST-elevation myocardial infarction.The study was a systematic review and critical appraisal, with meta-analysis of randomized clinical trials.We searched the literature. A total of 21 randomized clinical trials were identified. Both fixed effect and random effects models were used to synthesize the results of individual studies. Heterogeneity between studies was examined by subgroup and random effects meta-regression analyses, considering ptient-related and study-level variables. Publication bias, or "small-study effect", was evaluated.Substantial heterogeneity was present. The random effects model pooled estimate for the outcome infarct size assessed by cardiac magnetic resonance was estimated by the standardized mean difference (SMD) =-0.06, 95% confidence interval (CI): -0.34 to 0.21, ie, no effect of IPost. For the end point infarct size, estimated by biomarkers of myocardial necrosis, an overall pooled effect was SMD =-0.58, 95% CI: -0.96 to -0.19. This effect disappeared in powered and nonbiased studies (SMD =0.03, 95% CI: -0.48 to 0.55). Finally, for the outcome left ventricular ejection fraction, SMD =0.47 95% CI: 0.20 to 0.74. Unfortunately, selection bias (small-study effect) was present. For this outcome, the meta-regression showed that both presence of hypertension and the inclusion of nonbiased studies explained 28.3% of the heterogeneity among the studies. Simulation by the "trim and fill" method, which controlled for selection bias using random effects model, diluted the effect (SMD =0.17 95% CI: -0.13 to 0.48). No effects by IPost on ST-segment resolution or on the majority of adverse clinical events were observed during follow up, except the incidence of congestive heart failure was found.Evidence from this study suggests no cardioprotection from IPost, on surrogate and the majority of clinical end points. A possible beneficial effect on the incidence of congestive heart failure needs to be replicated by a large clinical trial.

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.

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.

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Thrombus aspiration in patients with ST elevation myocardial infarction: meta-analysis of 16 randomized trials.

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Thrombus aspiration in patients with ST elevation myocardial infarction: meta-analysis of 16 randomized trials.

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