Cost-Effectiveness of Fractional Flow Reserve-Guided Treatment for Acute Myocardial Infarction and Multivessel Disease: A Prespecified Analysis of the FRAME-AMI Randomized Clinical Trial.

Importance: Complete revascularization by non-infarct-related artery (IRA) percutaneous coronary intervention (PCI) in patients with acute myocardial infarction is standard practice to improve patient prognosis. However, it is unclear whether a fractional flow reserve (FFR)-guided or angiography-guided treatment strategy for non-IRA PCI would be more cost-effective. Objective: To evaluate the cost-effectiveness of FFR-guided compared with angiography-guided PCI in patients with acute myocardial infarction and multivessel disease. Design, Setting, and Participants: In this prespecified cost-effectiveness analysis of the FRAME-AMI randomized clinical trial, patients were randomly allocated to either FFR-guided or angiography-guided PCI for non-IRA lesions between August 19, 2016, and December 24, 2020. Patients were aged 19 years or older, had ST-segment elevation myocardial infarction (STEMI) or non-STEMI and underwent successful primary or urgent PCI, and had at least 1 non-IRA lesion (diameter stenosis >50% in a major epicardial coronary artery or major side branch with a vessel diameter of ≥2.0 mm). Data analysis was performed on August 27, 2023. Intervention: Fractional flow reserve-guided vs angiography-guided PCI for non-IRA lesions. Main Outcomes and Measures: The model simulated death, myocardial infarction, and repeat revascularization. Future medical costs and benefits were discounted by 4.5% per year. The main outcomes were quality-adjusted life-years (QALYs), direct medical costs, incremental cost-effectiveness ratio (ICER), and incremental net monetary benefit (INB) of FFR-guided PCI compared with angiography-guided PCI. State-transition Markov models were applied to the Korean, US, and European health care systems using medical cost (presented in US dollars), utilities data, and transition probabilities from meta-analysis of previous trials. Results: The FRAME-AMI trial randomized 562 patients, with a mean (SD) age of 63.3 (11.4) years. Most patients were men (474 [84.3%]). Fractional flow reserve-guided PCI increased QALYs by 0.06 compared with angiography-guided PCI. The total cumulative cost per patient was estimated as $1208 less for FFR-guided compared with angiography-guided PCI. The ICER was -$19 484 and the INB was $3378, indicating that FFR-guided PCI was more cost-effective for patients with acute myocardial infarction and multivessel disease. Probabilistic sensitivity analysis showed consistent results and the likelihood iteration of cost-effectiveness in FFR-guided PCI was 97%. When transition probabilities from the pairwise meta-analysis of the FLOWER-MI and FRAME-AMI trials were used, FFR-guided PCI was more cost-effective than angiography-guided PCI in the Korean, US, and European health care systems, with an INB of $3910, $8557, and $2210, respectively. In probabilistic sensitivity analysis, the likelihood iteration of cost-effectiveness with FFR-guided PCI was 85%, 82%, and 31% for the Korean, US, and European health care systems, respectively. Conclusions and Relevance: This cost-effectiveness analysis suggests that FFR-guided PCI for non-IRA lesions saved medical costs and increased quality of life better than angiography-guided PCI for patients with acute myocardial infarction and multivessel disease. Fractional flow reserve-guided PCI should be considered in determining the treatment strategy for non-IRA stenoses in these patients. Trial Registration: ClinicalTrials.gov Identifier: NCT02715518.

QFR Assessment and Prognosis After Nonculprit PCI in Patients With Acute Myocardial Infarction.

BACKGROUND: Complete revascularization using either angiography-guided or fractional flow reserve (FFR)-guided strategy can improve clinical outcomes in patients with acute myocardial infarction (AMI) and multivessel disease. However, there is concern that angiography-guided percutaneous coronary intervention (PCI) may result in un-necessary PCI of the non-infarct-related artery (non-IRA), and its long-term prognosis is still unclear. OBJECTIVES: This study sought to evaluate clinical outcomes after non-IRA PCI according to the quantitative flow ratio (QFR). METHODS: We performed post hoc QFR analysis of non-IRA lesions of AMI patients enrolled in the FRAME-AMI (FFR Versus Angiography-Guided Strategy for Management of AMI With Multivessel Disease) trial, which randomly allocated 562 patients into either FFR-guided PCI (FFR ≤0.80) or angiography-guided PCI (diameter stenosis >50%) for non-IRA lesions. Patients were classified by non-IRA QFR values into the QFR ≤0.80 and QFR >0.80 groups. The primary outcome was a major adverse cardiac event (MACE), a composite of cardiac death, myocardial infarction, and repeat revascularization. RESULTS: A total of 443 patients (552 lesions) were eligible for QFR analysis. Of 209 patients in the angiography-guided PCI group, 30.0% (n = 60) underwent non-IRA PCI despite having QFR >0.80 in the non-IRA. Conversely, only 2.7% (n = 4) among 209 patients in the FFR-guided PCI group had QFR >0.80 in the non-IRA. At a median follow-up of 3.5 years, the rate of MACEs was significantly higher among patients with non-IRA PCI despite QFR >0.80 than in patients with deferred PCI for non-IRA lesions (12.9% vs 3.1%; HR: 4.13; 95% CI: 1.10-15.57; P = 0.036). Non-IRA PCI despite QFR >0.80 was associated with a higher risk of non-IRA MACEs than patients with deferred PCI for non-IRA lesions (12.9% vs 2.1%; HR: 5.44; 95% CI: 1.13-26.19; P = 0.035). CONCLUSIONS: In AMI patients with multivessel disease, 30.0% of angiography-guided PCI resulted in un-necessary PCI for the non-IRA with QFR >0.80, which was significantly associated with an increased risk of MACEs than in those with deferred PCI for non-IRA lesions. (FFR Versus Angiography-Guided Strategy for Management of AMI With Multivessel Disease [FRAME-AMI] ClinicalTrials.gov number; NCT02715518).

Assessment of the conventional radial artery with optical coherent tomography after the snuffbox approach.

BACKGROUND: This study aimed to evaluate acute injuries of the radial artery (RA) using optical coherence tomography (OCT) in patients who underwent coronary intervention via the snuffbox approach. METHODS: Forty-six patients, who underwent coronary intervention and assessment of the conventional RA using OCT via the snuffbox approach, were enrolled from two university hospitals between August 2018 and August 2019. RESULTS: The mean age of the patients was 65.1 years. In this study population, 6-French (Fr) sheaths were used. The mean diameter of the conventional RA was 2.89 ± 0.33 mm, and the mean lumen area of the conventional RA was 6.68 ± 1.56 mm2. Acute injuries of the conventional RA, after the snuffbox approach, were observed in 5 (10.9%) patients. Intimal tear was observed in the RA in 1 (2.2%) case. Intraluminal thrombi, without vessel injuries, were detected in the RA in 4 (8.7%) cases. However, medial dissection was not observed in the OCT analysis. CONCLUSIONS: This retrospective OCT-based study showed that the diameter of the conventional RA was 2.89 mm and acute vessel injury of the conventional RA was rare in patients who underwent coronary intervention via the snuffbox approach.

The CHA2DS2VASc score can be used to stratify the prognosis of acute myocardial infarction patients irrespective of presence of atrial fibrillation.

BACKGROUND: The CHA2DS2VASc score has been used to evaluate the risk of thromboembolic events in atrial fibrillation. However, because all the components of CHA2DS2VASc are important cardiovascular risk factors, we decided to evaluate the effectiveness of CHA2DS2VASc score as a long-term predictor for prognosis in acute myocardial infarction (AMI) patients. METHODS: We enrolled 15,681 AMI patients for the Korean Working Group in Acute Myocardial Infarction (KORMI) consecutively and analyzed retrospectively. We divided the all the patients into four groups according to CHADS2VASc score (Group I: 0-1, n=3317; Group II: 2-3, n=6794; Group III: 4-5, n=4457; Group IV: 6-9, n=1113). The cardiac event was defined as the sum of all-cause mortality and recurrence of myocardial infarction. RESULTS: As the risk score increased, the incidence of cardiac events was higher at 1, 6, 12, and 24 months. The cardiac event-free survival rate was lower as the risk score increased (Group I vs Group II, p<0.001; Group II vs Group III, p<0.001; Group III vs Group IV, p=0.037). After adjusting confounding variables, the Cox-regression multivariate analysis showed that the CHA2DS2VASc score was an independent predictor for the long-term prognosis in total AMI patients (p<0.001, hazard ratio=1.414 per scale). CONCLUSION: The AMI patients with higher CHA2DS2VASc score had worse cardiovascular outcome. Therefore, CHADS2VASc score can be used to stratify AMI patients according to long-term prognosis irrespective of presence of atrial fibrillation.

The association of socioeconomic status with three-year clinical outcomes in patients with acute myocardial infarction who underwent percutaneous coronary intervention.

The aim of this study was to evaluate whether the clinical outcomes were associated with socioeconomic status (SES) in patients with acute myocardial infarction (AMI) who underwent percutaneous coronary intervention (PCI). The author analyzed 2,358 patients (64.9 ± 12.3 yr old, 71.5% male) hospitalized with AMI between November 2005 and June 2010. SES was measured by the self-reported education (years of schooling), the residential address (social deprivation index), and the national health insurance status (medical aid beneficiaries). Sequential multivariable modeling assessed the relationship of SES factors with 3-yr major adverse cardiovascular events (MACEs) and mortality after the adjustment for demographic and clinical factors. During the 3-yr follow-up, 630 (26.7%) MACEs and 322 (13.7%) all-cause deaths occurred in 2,358 patients. In multivariate Cox proportional hazards regression modeling, the only lower education of SES variables was associated with MACEs (hazard ratio [HR], 1.41; 95% confidence interval [CI], 1.04-1.91) and mortality (HR, 1.93; 95% CI, 1.16-3.20) in the patients with AMI who underwent PCI. The study results indicate that the lower education is a significant associated factor to increased poor clinical outcomes in patients with AMI who underwent PCI.

Comparative assessment of angiotensin II type 1 receptor blockers in the treatment of acute myocardial infarction: surmountable vs. insurmountable antagonist.

BACKGROUND: The mechanisms of antagonism vary between the angiotensin II type 1 receptor blockers (ARBs): insurmountable antagonism and surmountable antagonism. Recent retrospective observational studies suggest that ARBs may not have equivalent benefits in various clinical situations. The aim of this study was to compare the effect of two categories of ARBs on the long-term clinical outcomes of patients with acute myocardial infarction (AMI). METHODS: We analyzed the large-scale, prospective, observational Korea Acute Myocardial Infarction Registry study, which enrolled 2740 AMI patients. They divided by the prescription of surmountable ARBs or insurmountable ARBs at discharge. Primary outcome was major adverse cardiac events (MACEs), defined as a composite of cardiac death, nonfatal MI, and re-percutaneous coronary intervention, coronary artery bypass graft surgery. RESULTS: In the overall population, the MACEs rate in 1 year was significantly higher in the surmountable ARB group (14.3% vs. 11.2%, p=0.025), which was mainly due to increased cardiac death (3.3% vs. 1.9%, p=0.031). Matching by propensity-score showed consistent results (MACEs rate: 14.9% vs. 11.4%, p=0.037). In subgroup analysis, the insurmountable ARB treatment significantly reduced the incidence of MACEs in patients with left ventricular ejection fraction greater than 40%, with a low killip class, with ST segment elevation MI, and with normal renal function. CONCLUSIONS: In our study, insurmountable ARBs were more effective on long-term clinical outcomes than surmountable ARBs in patients with AMI.

Hospital discharge risk score system for the assessment of clinical outcomes in patients with acute myocardial infarction (Korea Acute Myocardial Infarction Registry [KAMIR] score).

Assessment of risk at time of discharge could be a useful tool for guiding postdischarge management. The aim of this study was to develop a novel and simple assessment tool for better hospital discharge risk stratification. The study included 3,997 hospital-discharged patients with acute myocardial infarction who were enrolled in the nationwide prospective Korea Acute Myocardial Infarction Registry-1 (KAMIR-1) from November 2005 through December 2006. The new risk score system was tested in 1,461 hospital-discharged patients who were admitted from January 2007 through January 2008 (KAMIR-2). The new risk score system was compared to the Global Registry of Acute Coronary Events (GRACE) postdischarge risk model during a 12-month clinical follow-up. During 1-year follow-up, all-cause death occurred in 228 patients (5.7%) and 81 patients (5.5%) in the development and validation cohorts, respectively. The new risk score (KAMIR score) was constructed using 6 independent variables related to the primary end point using a multivariable Cox regression analysis: age, Killip class, serum creatinine, no in-hospital percutaneous coronary intervention, left ventricular ejection fraction, and admission glucose based on multivariate-adjusted risk relation. The KAMIR score demonstrated significant differences in its predictive accuracy for 1-year mortality compared to the GRACE score for the developmental and validation cohorts. In conclusion, the KAMIR score for patients with acute myocardial infarction is a simpler and better risk scoring system than the GRACE hospital discharge risk model in prediction of 1-year mortality.

Gender differences in clinical features and in-hospital outcomes in ST-segment elevation acute myocardial infarction: from the Korean Acute Myocardial Infarction Registry (KAMIR) study.

BACKGROUND: Studies have suggested that women are biologically different and that female gender itself is independently associated with poor clinical outcome after an acute myocardial infarction (AMI). HYPOTHESIS: We analyzed data from the Korean Acute Myocardial Infarction Registry (KAMIR) to assess gender differences in in-hospital outcomes post ST-segment elevation myocardial infarction (STEMI). METHODS: Between November 2005 and July 2007, 4037 patients who were admitted with STEMI to 41 facilities were registered into the KAMIR database; patients admitted within 72 hours of symptom onset were selected and included in this study. RESULTS: The proportion of patients who had reperfusion therapy within 12 hours from chest pain onset was lower in women. Women had higher rates of in-hospital mortality (8.6% vs 3.2%, P < .01), noncardiac death (1.5% vs 0.4%, P < .01), cardiac death (7.1% vs 2.8%, P < .01), and stroke (1.2% vs 0.5%, P < .05) than men. Multivariate logistic regression analysis identified age, previous angina, hypertension, a Killip class > or = II, a left ventricular ejection fraction (LVEF) < 40%, and a thrombolysis in myocardial infarction flow (TIMI) grade < or = 3 after angioplasty as independent risk factors for in-hospital death for all patients; however, female gender itself was not an independent risk factor. CONCLUSIONS: The results of this study show that although women have a higher in-hospital mortality than men, female gender itself is not an independent risk factor for in-hospital mortality.

A new risk score system for the assessment of clinical outcomes in patients with non-ST-segment elevation myocardial infarction.

BACKGROUND AND OBJECTIVES: Prediction for long-term clinical outcomes in patients with non-ST elevation acute coronary syndrome is important as well as early risk stratification. The aim of this study is to develop a simple assessment tool for better early bedside risk stratification for both short- and long-term clinical outcomes. SUBJECTS AND METHODS: 2148 patients with non-ST-segment elevation myocardial infarction (NSTEMI) (64.9±12.2 years, 35.0% females) were enrolled in a nationwide prospective Korea Acute Myocardial Infarction Registry (KAMIR). A new risk score was constructed using the variables related to one year mortality: TIMI risk index (17.5-30: 1 point, >30: 2 points), Killip class (II: 1 point, >II: 2 points) and serum creatinine (≥1.5 mg/dL: 1 point), based on the multivariate-adjusted risk relationship. The new risk score system was compared with the Global Registry of Acute Coronary Events (GRACE) and TIMI risk scores during a 12-month clinical follow-up. RESULTS: During a one year follow-up, all causes of death occurred in 362 patients (14.3%), and 184 (8.6%) patients died in the hospital. The new risk score showed good predictive value for one year mortality. The accuracy for in-hospital and one year post-discharge mortality rates, the new risk score demonstrated significant differences in predictive accuracy when compared with TIMI and GRACE risk scores. CONCLUSION: A new risk score in the present study provides simplicity with accuracy simultaneously for early risk stratification, and also could be a powerful predictive tool for long-term prognosis in NSTEMI.