Dataset Information

Association of Thrombus Aspiration With Time and Mortality Among Patients With ST-Segment Elevation Myocardial Infarction: A Post Hoc Analysis of the Randomized TOTAL Trial.

ABSTRACT:

Importance

Patients with shorter ischemic times have a greater viable myocardium and may derive greater benefit from thrombus aspiration.

Objective

To study the association of thrombus aspiration with outcomes among patients presenting with ST-segment elevation myocardial infarction (STEMI) based on time.

Design, setting, and participants

The 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.

Interventions

Thrombus aspiration vs PCI alone.

Main outcomes and measures

Post 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.

Results

The 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 relevance

This 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 registration

ClinicalTrials.gov Identifier: NCT01149044.

SUBMITTER: Moxham R

PROVIDER: S-EPMC7998077 | biostudies-literature |

REPOSITORIES: biostudies-literature

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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: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:ImportanceChallenges to improving ST-segment elevation myocardial infarction (STEMI) care are formidable in low- to middle-income countries because of several system-level factors.ObjectiveTo examine access to reperfusion and percutaneous coronary intervention (PCI) during STEMI using a hub-and-spoke model.Design, setting, and participantsThis multicenter, prospective, observational study of a quality improvement program studied 2420 patients 20 years or older with symptoms or signs consistent with STEMI at primary care clinics, small hospitals, and PCI hospitals in the southern state of Tamil Nadu in India. Data were collected from the 4 clusters before implementation of the program (preimplementation data). We required a minimum of 12 weeks for the preimplementation data with the period extending from August 7, 2012, through January 5, 2013. The program was then implemented in a sequential manner across the 4 clusters, and data were collected in the same manner (postimplementation data) from June 12, 2013, through June 24, 2014, for a mean 32-week period.ExposuresCreation of an integrated, regional quality improvement program that linked the 35 spoke health care centers to the 4 large PCI hub hospitals and leveraged recent developments in public health insurance schemes, emergency medical services, and health information technology.Main outcomes and measuresPrimary outcomes focused on the proportion of patients undergoing reperfusion, timely reperfusion, and postfibrinolysis angiography and PCI. Secondary outcomes were in-hospital and 1-year mortality.ResultsA total of 2420 patients with STEMI (2034 men [84.0%] and 386 women [16.0%]; mean [SD] age, 54.7 [12.2] years) (898 in the preimplementation phase and 1522 in the postimplementation phase) were enrolled, with 1053 patients (43.5%) from the spoke health care centers. Missing data were common for systolic blood pressure (213 [8.8%]), heart rate (223 [9.2%]), and anterior MI location (279 [11.5%]). Overall reperfusion use and times to reperfusion were similar (795 [88.5%] vs 1372 [90.1%]; P = .21). Coronary angiography (314 [35.0%] vs 925 [60.8%]; P < .001) and PCI (265 [29.5%] vs 707 [46.5%]; P < .001) were more commonly performed during the postimplementation phase. In-hospital mortality was not different (52 [5.8%] vs 85 [5.6%]; P = .83), but 1-year mortality was lower in the postimplementation phase (134 [17.6%] vs 179 [14.2%]; P = .04), and this difference remained consistent after multivariable adjustment (adjusted odds ratio, 0.76; 95% CI, 0.58-0.98; P = .04).Conclusions and relevanceA hub-and-spoke model in South India improved STEMI care through greater use of PCI and may improve 1-year mortality. This model may serve as an example for developing STEMI systems of care in other low- to middle-income countries.