Immediate non-culprit vessel percutaneous coronary intervention (PCI) in patients with acute myocardial infarction and cardiogenic shock: a swinging pendulum.
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SUBMITTER: Russo JJ
PROVIDER: S-EPMC5864600 | biostudies-literature |
REPOSITORIES: biostudies-literature
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Project description:BackgroundThe CULPRIT-SHOCK trial compared two treatment strategies for patients with acute myocardial infarction and multivessel coronary artery disease complicated by cardiogenic shock: (a) culprit vessel only percutaneous coronary intervention (CO-PCI), with additional staged revascularisation if indicated, and (b) immediate multivessel PCI (MV-PCI).MethodsA German societal and national health service perspective was considered for three different analyses. The cost utility analysis (CUA) estimated costs and quality adjusted life years (QALYs) based on a pre-trial decision analytic model taking a lifelong time horizon. In addition, a within trial CUA estimated QALYs and costs for 1 year. Finally, the cost effectiveness analysis (CEA) used the composite primary outcome, mortality and renal failure at 30-day follow-up, and the within trial costs. Econometric and survival analysis on the trial data was used for the estimation of the model parameters. Subgroup analysis was performed following an economic protocol.ResultsThe lifelong CUA showed an incremental cost effectiveness ratio (ICER), CO-PCI vs. MV-PCI, of €7010 per QALY and a probability of CO-PCI being the most cost-effective strategy > 64% at a €30,000 threshold. The ICER for the within trial CUA was €14,600 and the incremental cost per case of death/renal failure avoided at 30-day follow-up was €9010. Cost-effectiveness improved with patient age and for those without diabetes.ConclusionsThe estimates of cost-effectiveness for CO-PCI vs. MV-PCI have been shown to change depending on the time horizon and type of economic evaluation performed. The results favoured a long-term horizon analysis for avoiding underestimation of QALY gains from the CO-PCI arm.
| S-EPMC7561561 | biostudies-literature
Project description:IntroductionEmergency percutaneous coronary intervention (PCI) of the culprit lesion for patients with acute myocardial infarctions is an accepted practice. A majority of patients present with multivessel disease with additional relevant stenoses apart from the culprit lesion. In haemodynamically stable patients, there is increasing evidence from randomised trials to support the practice of immediate complete revascularisation. However, in the presence of cardiogenic shock, the optimal management strategy for additional non-culprit lesions is unknown. A multicentre randomised controlled trial, CULPRIT-SHOCK, is examining whether culprit vessel only PCI with potentially subsequent staged revascularisation is more effective than immediate multivessel PCI. This paper describes the intended economic evaluation of the trial.Methods and analysisThe economic evaluation will be conducted using a pre-trial decision model and within-trial analysis. The modelling-based analysis will provide expected costs and health outcomes, and incremental cost-effectiveness ratio over the lifetime for the cohort of patients included in the trial. The within-trial analysis will provide estimates of cost per life saved at 30 days and in 1 year, and estimates of health-related quality of life. Bootstrapping and cost-effectiveness acceptability curves will be used to address any uncertainty around these estimates. Different types of regression models within a generalised estimating equation framework will be used to examine how the total cost and quality-adjusted life years are explained by patients' characteristics, revascularisation strategy, country and centre. The cost-effectiveness analysis will be from the perspective of each country's national health services, where costs will be expressed in euros adjusted for purchasing power parity.Ethics and disseminationEthical approval for the study was granted by the local Ethics Committee at each recruiting centre. The economic evaluation analyses will be published in peer-reviewed journals of the concerned literature and communicated through the profiles of the authors at www.twitter.com and www.researchgate.net.Trial registration numberNCT01927549; Pre-results.
| S-EPMC5724099 | biostudies-literature
Project description:BackgroundEarly revascularization of the culprit vessel is the most effective treatment for reducing the risk of mortality from acute STEMI with and without cardiogenic shock. However, the most recent trends and impact of multivessel percutaneous coronary intervention (PCI) during the index hospitalization on in-hospital outcomes are unknown.MethodsThe National Inpatient Sample was queried from October 2015 to 2019 for hospitalizations with STEMI. The impact of multivessel PCI on in-hospital outcomes of patients with and without cardiogenic shock was evaluated.ResultsOf 624,605 STEMI hospitalizations treated with PCI, 12.5% were complicated by cardiogenic shock. Among hospitalizations without cardiogenic shock, 15.7% were treated by multivessel PCI, which declined from 20.8% in 2015 to 13.9% in 2019 (P trend < 0.001). Multivessel and culprit-only PCI had similar rates of In-hospital mortality (2.4 vs. 2.3%, p = 0.027) and major adverse cardiac and cerebrovascular events (MACCE; 7.4 vs. 7.2%, p = 0.072). Among hospitalizations with cardiogenic shock, 22.1% were treated by multivessel PCI, which declined from 29.2% in 2015 to 19.4% in 2019 (P trend < 0.001). Multivessel PCI was associated with higher rates of in-hospital mortality (30.9 vs. 28.4%, p < 0.001) and MACCE (39.9 vs. 36.5%, p < 0.001) than culprit-only PCI.ConclusionThe frequency of multivessel PCI for STEMI with and without cardiogenic shock is declining. Multivessel PCI is associated with worse in-hospital outcomes for STEMI with cardiogenic shock but not for STEMI without cardiogenic shock.
| S-EPMC9731335 | biostudies-literature
Project description:BackgroundThe optimal revascularization strategy in patients with ST-segment elevation myocardial infarction (STEMI) complicating by cardiogenic shock (CS) remains controversial. This study aims to evaluate the clinical outcomes of multivessel percutaneous coronary intervention (MV-PCI) compared to culprit vessel-only PCI (CO-PCI) for the treatment, only in patients with STEMI with CS.MethodsA comprehensive literature search was conducted. Studies assessed the efficacy outcomes of short (in-hospital or 30 days)/long-term mortality, cardiac death, myocardial reinfarction, repeat revascularization, and safety outcomes of stroke, bleeding, acute renal failure with MV-PCI vs. CO-PCI in patients with STEMI with CS were included. The publication bias and sensitivity analysis were also performed.ResultsA total of 15 studies were included in this meta-analysis. There was no significant difference in short- and long-term mortality in patients treated with MV-PCI compared to CO-PCI group [odds ratio (OR) = 1.17; 95% confidence interval (CI), 0.92-1.48; OR = 0.86; 95% CI, 0.58-1.28]. Similarly, there were no significant differences in cardiac death (OR = 0.67; 95% CI, 0.44-1.00), myocardial reinfarction (OR = 1.24; 95% CI, 0.77-2.00), repeat revascularization (OR = 0.75; 95% CI, 0.40-1.42), bleeding (OR = 1.53; 95% CI, 0.53-4.43), or stroke (OR = 1.42; 95% CI, 0.90-2.23) between the two groups. There was a higher risk in acute renal failure (OR = 1.33; 95% CI, 1.04-1.69) in patients treated with MV-PCI when compared with CO-PCI.ConclusionThis meta-analysis suggests that there may be no significant benefit for patients with STEMI complicating CS treated with MV-PCI compared with CO-PCI, and patients are at increased risk of developing acute renal failure after MV-PCI intervention.
| S-EPMC9051032 | biostudies-literature
Project description:ImportanceMyocardial infarction with a culprit lesion located in the left main or proximal left anterior descending artery compared with other coronary segments is associated with more myocardium at risk and worse clinical outcomes.ObjectiveTo evaluate the association of culprit lesion location with outcomes of culprit-lesion-only percutaneous coronary intervention with optional staged revascularization vs immediate multivessel percutaneous coronary intervention in patients with multivessel disease, myocardial infarction, and cardiogenic shock.Design, setting, and participantsPost hoc analysis of the Culprit Lesion Only Coronary Intervention vs Multivessel Coronary Intervention in Cardiogenic Shock (CULPRIT-SHOCK), an investigator-initiated randomized, open-label clinical trial. Patients with multivessel disease, acute myocardial infarction, and cardiogenic shock were enrolled at 83 European centers from April 2013 through April 2017.InterventionsPatients were randomized to culprit-lesion-only percutaneous coronary intervention with optional staged revascularization or immediate multivessel percutaneous coronary intervention (1:1). For this analysis, patients were stratified by culprit lesion location in the left main or proximal left anterior descending artery group and other-culprit-lesion location group.Main outcomes and measuresEnd points included a composite of death or kidney replacement therapy at 30 days and death at 1 year.ResultsThe median age of the study population was 70 (interquartile range, 60-78 years) and 524 of the study participants were men (76.4%). Of the 685 patients, 33.4% constituted the left main or proximal left anterior descending artery group and 66.6% the other-culprit-lesion location group. The left main or proximal left anterior descending artery group had worse outcomes compared with the other-culprit-lesion location group (56.8% vs 47.5%; P = .02 for the composite end point at 30 days and 59.8% vs 50.1%; P = .02 for death at 1 year). In both groups, culprit-lesion-only vs immediate multivessel percutaneous coronary intervention was associated with a reduced risk of the composite end point at 30 days (49.1% vs 64.3% and 44.1% vs 50.9%; P for interaction = .27). At 1 year, culprit-lesion-only vs immediate multivessel percutaneous coronary intervention was associated with a significantly reduced risk of death in the left main or proximal left anterior descending artery but not the other-culprit-lesion location group (50.0% vs 69.6%; P = .003 and 49.8% vs 50.4%; P = .89; P for interaction = 0.02).Conclusions and relevanceIn patients with multivessel disease with myocardial infarction and cardiogenic shock, a culprit lesion located in the left main or proximal left anterior descending artery vs other coronary segments was associated with worse outcomes. These patients may especially benefit from culprit-lesion-only percutaneous coronary intervention with optional staged revascularization, although further investigation is needed to confirm this finding.Trial registrationClinicalTrials.gov Identifier: NCT01927549.
| S-EPMC7450400 | biostudies-literature
Project description:The aim of the study was a comparison of culprit-lesion-only (CL-PCI) with the multivessel percutaneous coronary intervention (MV-PCI) in terms of 30-day and 12-month mortality in a national registry. Patients from the PL-ACS registry with MI and CS were analyzed. Patients meeting the criteria of the CULPRIT-SHOCK trial were divided into two groups: CL-PCI and MV-PCI groups. Of the 3265 patients in the PL-ACS registry with MI complicated by CS, the criteria of the CULPRIT-SHOCK trial were met by 2084 patients (63.8%). The CL-PCI was performed in 883 patients, and MV-PCI was performed in 1045 patients. After the propensity score matching analysis, 617 well-matched pairs were obtained. In a 30-day follow-up, death from any cause occurred in 49.3% in the CL-PCI group and 57.0% in the MV-PCI group (RR 0.86, 95% CI 0.58-0.92, p = 0.0081). After 12 months, the rate of mortality was 62.5% in the CL-PCI group and 68.0% in the MV-PCI group (RR 0.92, 95% CI 0.84-1.01, p = 0.066). The results confirm the validity of CULPRIT-SHOCK findings in a national registry and current guideline-recommended strategy of revascularization limited to the infarct-related artery.
| S-EPMC8122818 | biostudies-literature
Project description:OBJECTIVES:To analyze the use and prognostic impact of active mechanical circulatory support (MCS) devices in a large prospective contemporary cohort of patients with cardiogenic shock (CS) complicating acute myocardial infarction (AMI). BACKGROUND:Although increasingly used in clinical practice, data on the efficacy and safety of active MCS devices in patients with CS complicating AMI are limited. METHODS:This is a predefined subanalysis of the CULPRIT-SHOCK randomized trial and prospective registry. Patients with CS, AMI and multivessel coronary artery disease were categorized in two groups: (1) use of at least one active MCS device vs. (2) no active MCS or use of intra-aortic balloon pump (IABP) only. The primary endpoint was a composite of all-cause death or renal replacement therapy at 30 days. RESULTS:Two hundred of 1055 (19%) patients received at least one active MCS device (n = 112 Impella®; n = 95 extracorporeal membrane oxygenation (ECMO); n = 6 other devices). The primary endpoint occurred significantly more often in patients treated with active MCS devices compared with those without active MCS devices (142 of 197, 72% vs. 374 of 827, 45%; p < 0.001). All-cause mortality and bleeding rates were significantly higher in the active MCS group (all p < 0.001). After multivariable adjustment, the use of active MCS was significantly associated with the primary endpoint (odds ratio (OR) 4.0, 95% confidence interval (CI) 2.7-5.9; p < 0.001). CONCLUSIONS:In the CULPRIT-SHOCK trial, active MCS devices were used in approximately one fifth of patients. Patients treated with active MCS devices showed worse outcome at 30 days and 1 year.
| S-EPMC7356113 | biostudies-literature
Project description:Little is known about clinical outcomes of patients with acute myocardial infraction (AMI) complicated by cardiogenic shock (CS) requiring mechanical ventilation (MV). The aim of this study was to identify the characteristics, risk factors, and outcomes associated with the provision of MV in this specific high-risk population. Patients with CS complicating AMI and multivessel coronary artery disease from the CULPRIT-SHOCK trial were included. We explored 30 days of clinical outcomes in patients not requiring MV, those with MV on admission, and those in whom MV was initiated within the first day after admission. Among 683 randomized patients included in the analysis, 17.4% received no MV, 59.7% were ventilated at admission and 22.8% received MV within or after the first day after admission. Patients requiring MV had a different risk-profile. Factors independently associated with the provision of MV on admission included higher body weight, resuscitation within 24 h before admission, elevated heart rate and evidence of triple vessel disease. Requiring MV in patients with CS complicating AMI is common and independently associated with mortality after adjusting for covariates. Patients with delayed MV initiation appear to be at higher risk of adverse outcomes. Further research is necessary to identify the optimal timing of MV in this high-risk population.
| S-EPMC7141492 | biostudies-literature
Project description:AimsThere are limited contemporary data on the use of initial fibrinolysis in ST-segment elevation myocardial infarction cardiogenic shock (STEMI-CS). This study sought to compare the outcomes of STEMI-CS receiving initial fibrinolysis vs. primary percutaneous coronary intervention (PPCI).MethodsUsing the National (Nationwide) Inpatient Sample from 2009 to 2017, a comparative effectiveness study of adult (>18 years) STEMI-CS admissions receiving pre-hospital/in-hospital fibrinolysis were compared with those receiving PPCI. Admissions with alternate indications for fibrinolysis and STEMI-CS managed medically or with surgical revascularization (without fibrinolysis) were excluded. Outcomes of interest included in-hospital mortality, development of non-cardiac organ failure, complications, hospital length of stay, hospitalization costs, use of palliative care, and do-not-resuscitate status.ResultsDuring 2009-2017, 5297 and 110 452 admissions received initial fibrinolysis and PPCI, respectively. Compared with those receiving PPCI, the fibrinolysis group was more often non-White, with lower co-morbidity, and admitted on weekends and to small rural hospitals (all P < 0.001). In the fibrinolysis group, 95.3%, 77.4%, and 15.7% received angiography, PCI, and coronary artery bypass grafting, respectively. The fibrinolysis group had higher rates of haemorrhagic complications (13.5% vs. 9.9%; P < 0.001). The fibrinolysis group had comparable all-cause in-hospital mortality [logistic regression analysis: 28.8% vs. 28.5%; propensity-matched analysis: 30.8% vs. 30.3%; adjusted odds ratio 0.97 (95% confidence interval 0.90-1.05); P = 0.50]. The fibrinolysis group had comparable rates of acute organ failure, hospital length of stay, rates of palliative care referrals, do-not-resuscitate status use, and lesser hospitalization costs.ConclusionsThe use of initial fibrinolysis had comparable in-hospital mortality than those receiving PPCI in STEMI-CS in the contemporary era in this large national observational study.
| S-EPMC8120407 | biostudies-literature
Project description: Not available
| S-EPMC4339057 | biostudies-literature