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Improved clinical outcome after invasive management of patients with recent myocardial infarction and proven myocardial viability: primary results of a randomized controlled trial (VIAMI-trial).

ABSTRACT: Patients with ST-elevation myocardial infarction (STEMI) not treated with primary or rescue percutaneous coronary intervention (PCI) are at risk for recurrent ischemia, especially when viability in the infarct-area is present. Therefore, an invasive strategy with PCI of the infarct-related coronary artery in patients with viability would reduce the occurrence of a composite end point of death, reinfarction, or unstable angina (UA).Patients admitted with an (sub)acute myocardial infarction, who were not treated by primary or rescue PCI, and who were stable during the first 48 hours after the acute event, were screened for the study. Eventually, we randomly assigned 216 patients with viability (demonstrated with low-dose dobutamine echocardiography) to an invasive or a conservative strategy. In the invasive strategy stenting of the infarct-related coronary artery was intended with abciximab as adjunct treatment. Seventy-five (75) patients without viability served as registry group. The primary endpoint was the composite of death from any cause, recurrent myocardial infarction (MI) and unstable angina at one year. As secondary endpoint the need for (repeat) revascularization procedures and anginal status were recorded.The primary combined endpoint of death, recurrent MI and unstable angina was 7.5% (8/106) in the invasive group and 17.3% (19/110) in the conservative group (Hazard ratio 0.42; 95% confidence interval [CI] 0.18-0.96; p = 0.032). During follow up revascularization-procedures were performed in 6.6% (7/106) in the invasive group and 31.8% (35/110) in the conservative group (Hazard ratio 0.18; 95% CI 0.13-0.43; p < 0.0001). A low rate of recurrent ischemia was found in the non-viable group (5.4%) in comparison to the viable-conservative group (14.5%). (Hazard-ratio 0.35; 95% CI 0.17-1.00; p = 0.051).We demonstrated that after acute MI (treated with thrombolysis or without reperfusion therapy) patients with viability in the infarct-area benefit from a strategy of early in-hospital stenting of the infarct-related coronary artery. This treatment results in a long-term uneventful clinical course. The study confirmed the low risk of recurrent ischemia in patients without viability.ClinicalTrials.gov: NCT00149591.

SUBMITTER: van Loon RB

PROVIDER: S-EPMC3261086 | biostudies-literature | 2012 Jan

REPOSITORIES: biostudies-literature

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Improved clinical outcome after invasive management of patients with recent myocardial infarction and proven myocardial viability: primary results of a randomized controlled trial (VIAMI-trial).

van Loon Ramon B RB Veen Gerrit G Baur Leo H B LH Kamp Otto O Bronzwaer Jean G F JG Twisk Jos W R JW Verheugt Freek W A FW van Rossum Albert C AC

Trials 20120103

<h4>Background</h4>Patients with ST-elevation myocardial infarction (STEMI) not treated with primary or rescue percutaneous coronary intervention (PCI) are at risk for recurrent ischemia, especially when viability in the infarct-area is present. Therefore, an invasive strategy with PCI of the infarct-related coronary artery in patients with viability would reduce the occurrence of a composite end point of death, reinfarction, or unstable angina (UA).<h4>Methods</h4>Patients admitted with an (sub ...[more]

PMID: 22214287

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Project description:Background The randomized DOREMI (Dobutamine Compared to Milrinone) clinical trial evaluated the efficacy and safety of milrinone and dobutamine in patients with cardiogenic shock. Whether the results remain consistent when stratified by acute myocardial infarction remains unknown. In this substudy, we sought to evaluate differences in clinical management and outcomes of acute myocardial infarction complicated by cardiogenic shock (AMICS) versus non-AMICS. Methods and Results Patients in cardiogenic shock (n=192) were randomized 1:1 to dobutamine or milrinone. The primary composite end point in this subgroup analysis was all-cause in-hospital mortality, cardiac arrest, non-fatal myocardial infarction, cerebrovascular accident, the need for mechanical circulatory support, or initiation of renal replacement therapy (RRT) at 30-days. Outcomes were evaluated in patients with (n=65) and without (n=127) AMICS. The primary composite end point was significantly higher in AMICS versus non-AMICS (hazard ratio [HR], 2.21; 95% CI, 1.47-3.30; P=0.0001). The primary end point was driven by increased rates of all-cause mortality, mechanical circulatory support, and RRT. No differences in other secondary outcomes including cardiac arrest or cerebrovascular accident were observed. AMICS remained associated with the primary composite outcome, 30-day mortality, and RRT after adjustment for age, sex, procedural contrast use, multivessel disease, and inotrope type. Conclusions AMI was associated with increased rates of adverse clinical outcomes in cardiogenic shock along with increased rates of mortality and initiation of mechanical circulatory support and RRT. Contrast administration during revascularization likely contributes to increased rates of RRT. Heterogeneity of outcomes in AMICS versus non-AMICS highlights the need to study interventions in specific subgroups of cardiogenic shock. Registration URL: https://www.clinicaltrials.gov; Unique identifier: NCT03207165.

Project description:BackgroundVentricular septal rupture (VSR) is a rare complication after acute myocardial infarction (AMI) especially in the reperfusion era but its associated mortality has remained high. This case series evaluated in-hospital and intermediate-term mortality in VSR patients. Additionally, we also analyzed risk factors, clinical presentation, intervention, and predictors of in-hospital mortality in VSR patients.MethodsData of 67 patients with echocardiography confirmed diagnosis of VSR from January 2011 to April 2020 was extracted from hospital medical records. Records were also reviewed to document 30 day and 1-year mortality, recurrent heart failure admission, repeat myocardial infarction, and revascularization. In addition, telephonic follow-up was done to assess health-related quality of life(HRQOL) assessed by KCCQ-12. SCAI shock classification was used to categorize severity of cardiogenic shock. Univariate and multivariable logistic regression was used to determine predictors of in-hospital mortality. Survival function was presented using the Kaplan-Meier survival curve.ResultsMean age of patients was 62.7 ± 11.1 years, 62.7% were males. 65.7% of the patients presented more than 24 hours after MI and did not receive reperfusion therapy. Median time from AMI to VSR diagnosis was 2 (1-5) days. VSR closure was attempted in 53.7% patients. In-hospital mortality was 65.7%. At univariate level, predictors of in-hospital mortality were non-surgical management, basal VSR, right ventricular dysfunction, early VSR post-MI, and severe cardiogenic shock at admission (class C, D, or E). Adjusted predictors of in-hospital mortality included non-surgical management, basal VSR and advanced cardiogenic shock. There were 5 deaths during median followup of 44.1 months. HRQOL in patients available on followup was good (54.5%) or excellent (45.5%).ConclusionHigh in-hospital mortality was seen in VSR patients. VSR closure is the preferred treatment to get long-term survival, however, timing of repair as well as severity of cardiogenic shock plays a significant role in determining prognosis.

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Improved clinical outcome after invasive management of patients with recent myocardial infarction and proven myocardial viability: primary results of a randomized controlled trial (VIAMI-trial).

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Improved clinical outcome after invasive management of patients with recent myocardial infarction and proven myocardial viability: primary results of a randomized controlled trial (VIAMI-trial).

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