Intravascular Imaging and Angiography Guidance in Complex Percutaneous Coronary Intervention Among Patients With Diabetes: A Secondary Analysis of a Randomized Clinical Trial.

Importance: Data are limited regarding the effects of intravascular imaging guidance during complex percutaneous coronary intervention (PCI) in patients with diabetes. Objective: To compare the clinical outcomes of intravascular imaging-guided vs angiography-guided complex PCI in patients with or without diabetes. Design, Setting, and Participants: This prespecified secondary analysis of a subgroup of patients in RENOVATE-COMPLEX-PCI (Randomized Controlled Trial of Intravascular Imaging Guidance Versus Angiography-Guidance on Clinical Outcomes After Complex Percutaneous Coronary Intervention), an investigator-initiated, open-label multicenter trial, analyzed enrolled patients who underwent complex PCI at 20 sites in Korea from May 2018 through May 2021. Eligible patients were randomly assigned in a 2:1 ratio to undergo either the intravascular imaging-guided PCI or angiography-guided PCI. Data analyses were performed from June 2023 to April 2024. Interventions: Percutaneous coronary intervention was performed either under the guidance of intravascular imaging or angiography alone. Main Outcomes and Measures: The primary end point was target vessel failure (TVF), defined as a composite of cardiac death, target vessel-related myocardial infarction, or target vessel revascularization. Results: Among the 1639 patients included in the analysis (mean [SD] age, 65.6 [10.2] years; 1300 males [79.3%]), 617 (37.6%) had diabetes. The incidence of TVF was significantly higher in patients with diabetes than patients without diabetes (hazard ratio [HR], 1.86; 95% CI, 1.33-2.60; P < .001). Among patients without diabetes, the intravascular imaging-guided PCI group had a significantly lower incidence of TVF compared with the angiography-guided PCI group (4.7% vs 12.2%; HR, 0.41 [95% CI, 0.25-0.67]; P < .001). Conversely, in patients with diabetes, the risk of TVF was not significantly different between the 2 groups (12.9% vs 12.3%; HR, 0.97 [95% CI, 0.60-1.57]; P = .90). There was a significant interaction between the use of intravascular imaging and diabetes for the risk of TVF (P for interaction = .02). Among patients with diabetes, only those with good glycemic control (hemoglobin A1c level ≤7.5%) and who achieved stent optimization by intravascular imaging showed a lower risk of future ischemic events (HR, 0.31; 95% CI, 0.12-0.82; P = .02). Conclusions and Relevance: In this secondary analysis of a subgroup of patients in the RENOVATE-COMPLEX-PCI trial, intravascular imaging guidance reduced the risk of TVF compared with angiography guidance in patients without diabetes (but not in patients with diabetes) during complex PCI. In patients with diabetes undergoing complex PCI, attention should be paid to stent optimization using intravascular imaging and glycemic control to improve outcomes. Trial Registration: ClinicalTrials.gov Identifier: NCT03381872.

Impact of Intravascular Imaging-Guided Stent Optimization According to Clinical Presentation in Patients Undergoing Complex PCI.

BACKGROUND: It is unclear whether the beneficial effects of intravascular imaging-guided stent optimization vary by clinical presentation during complex percutaneous coronary intervention (PCI). OBJECTIVES: In this prespecified, stratified subgroup analysis from RENOVATE-COMPLEX-PCI (Randomized Controlled Trial of Intravascular Imaging Guidance versus Angiography-Guidance on Clinical Outcomes After Complex PCI), we sought to compare the outcomes between intravascular imaging vs angiography guidance according to clinical presentation. METHODS: Patients with complex coronary artery lesions were randomly assigned to undergo either intravascular imaging-guided PCI or angiography-guided PCI in a 2:1 ratio. The primary endpoint was target vessel failure (TVF), which is a composite of cardiac death, target vessel-related myocardial infarction, or clinically driven target vessel revascularization. RESULTS: Of 1,639 patients, 832 (50.8%) presented with acute coronary syndrome (ACS) and 807 (49.2%) with chronic coronary syndrome. During a median follow-up of 2.1 years (Q1-Q3: 1.4-3.0 years), there was no significant interaction between the treatment effect of intravascular imaging and clinical presentation (P for interaction = 0.19). Among patients with ACS, the incidences of TVF were 10.4% in the intravascular imaging group and 14.6% in the angiography group (HR: 0.74; 95% CI: 0.48-1.15; P = 0.18). Among patients with CCS, the incidences of TVF were 5.0% in the intravascular imaging group and 10.4% in the angiography group (HR: 0.46; 95% CI: 0.27-0.80; P = 0.006). Achieving stent optimization by intravascular imaging resulted in a reduced risk of TVF among patients with ACS who were randomly assigned to intravascular imaging-guided PCI for complex coronary lesions (optimized vs unoptimized, 6.5% vs 14.1%; HR: 0.49; 95% CI: 0.27-0.87; P = 0.02) but not those with CCS (5.4% vs 4.7%, HR: 1.18; 95% CI: 0.53-2.59; P = 0.69). CONCLUSIONS: No significant interaction was observed between the benefits of intravascular imaging and clinical presentation in the risk of TVF. Stent optimization by intravascular imaging was particularly important for ACS patients. (Intravascular Imaging- Versus Angiography-Guided Percutaneous Coronary Intervention For Complex Coronary Artery Disease [RENOVATE]; NCT03381872).

Intravascular Imaging-Guided Optimization of Complex Percutaneous Coronary Intervention by Sex: A Subgroup Analysis of the RENOVATE-COMPLEX-PCI Trial.

Importance: There have been heterogeneous results related to sex differences in prognosis after percutaneous coronary artery intervention (PCI) for complex coronary artery lesions. Objective: To evaluate potential differences in outcomes with intravascular imaging-guided PCI of complex coronary artery lesions between women and men. Design, Setting, and Participants: This prespecified substudy evaluates the interaction of sex in the investigator-initiated, open-label, multicenter RENOVATE-COMPLEX-PCI randomized clinical trial, which demonstrated the superiority of intravascular imaging-guided PCI compared with angiography-guided PCI in patients with complex coronary artery lesions. The trial was conducted at 20 sites in Korea. Patients with complex coronary artery lesions undergoing PCI were enrolled between May 2018 and May 2021, and the median (IQR) follow-up period was 2.1 (1.4-3.0) years. Data were analyzed from December 2022 to December 2023. Interventions: After diagnostic coronary angiography, eligible patients were randomly assigned in a 2:1 ratio to receive intravascular imaging-guided PCI or angiography-guided PCI. The choice and timing of the intravascular imaging device were left to the operators' discretion. Main Outcomes and Measures: The primary end point was target vessel failure, defined as a composite of cardiac death, target vessel-related myocardial infarction, or clinically driven target vessel revascularization. Secondary end points included individual components of the primary end point. Results: Of 1639 included patients, 339 (20.7%) were women, and the mean (SD) age was 65.6 (10.2) years. There was no difference in the risk of the primary end point between women and men (9.4% vs 8.3%; adjusted hazard ratio [HR], 1.39; 95% CI, 0.89-2.18; P = .15). Intravascular imaging-guided PCI tended to have lower incidence of the primary end point than angiography-guided PCI in both women (5.2% vs 14.5%; adjusted HR, 0.34; 95% CI, 0.15-0.78; P = .01) and men (8.3% vs 11.7%; adjusted HR, 0.72; 95% CI, 0.49-1.05; P = .09) without significant interaction (P for interaction = .86). Conclusions and Relevance: In patients undergoing complex PCI, compared with angiographic guidance, intravascular imaging guidance was associated with similar reduction in the risk of target vessel failure among women and men. The treatment benefit of intravascular imaging-guided PCI showed no significant interaction between treatment strategy and sex. Trial Registration: ClinicalTrials.gov Identifier: NCT03381872.

The Association of CHADS-P2A2RC Risk Score With Clinical Outcomes in Patients Taking P2Y12 Inhibitor Monotherapy After 3 Months of Dual Antiplatelet Therapy Following Percutaneous Coronary Intervention.

BACKGROUND AND OBJECTIVES: Concerns remain that early aspirin cessation may be associated with potential harm in subsets at high risk of ischemic events. This study aimed to assess the effects of P2Y12 inhibitor monotherapy after 3-month dual antiplatelet therapy (DAPT) vs. prolonged DAPT (12-month or longer) based on the ischemic risk stratification, the CHADS-P2A2RC, after percutaneous coronary intervention (PCI). METHODS: This was a sub-study of the SMART-CHOICE trial. The effect of the randomized antiplatelet strategies was assessed across 3 CHADS-P2A2RC risk score categories. The primary outcome was a major adverse cardiac and cerebral event (MACCE), a composite of all-cause death, myocardial infarction, or stroke. RESULTS: Up to 3 years, the high CHADS-P2A2RC risk score group had the highest incidence of MACCE (105 [12.1%], adjusted hazard ratio [HR], 2.927; 95% confidence interval [CI], 1.358-6.309; p=0.006) followed by moderate-risk (40 [1.4%], adjusted HR, 1.786; 95% CI, 0.868-3.674; p=0.115) and low-risk (9 [0.5%], reference). In secondary analyses, P2Y12 inhibitor monotherapy reduced the Bleeding Academic Research Consortium (BARC) types 2, 3, or 5 bleeding without increasing the risk of MACCE as compared with prolonged DAPT across the 3 CHADS-P2A2RC risk strata without significant interaction term (interaction p for MACCE=0.705 and interaction p for BARC types 2, 3, or 5 bleeding=0.055). CONCLUSIONS: The CHADS-P2A2RC risk score is valuable in discriminating high-ischemic-risk patients. Even in such patients with a high risk of ischemic events, P2Y12 inhibitor monotherapy was associated with a lower incidence of bleeding without increased risk of ischemic events compared with prolonged DAPT. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT02079194.

Clinical Benefit of Intravascular Imaging Compared With Conventional Angiography in Left Main Coronary Artery Intervention.

BACKGROUND: The RENOVATE-COMPLEX-PCI (Randomized Controlled Trial of Intravascular Imaging Guidance Versus Angiography-Guidance on Clinical Outcomes After Complex Percutaneous Coronary Intervention) demonstrated that intravascular imaging-guided percutaneous coronary intervention (PCI) improved clinical outcome compared with angiography-guided PCI for patients with complex coronary artery lesions. This study aims to assess whether the prognostic benefit of intravascular imaging-guided procedural optimization persists in patients undergoing PCI for left main coronary artery disease. METHODS: Of 1639 patients enrolled in the RENOVATE-COMPLEX-PCI, 192 patients with left main coronary artery disease were selected for the current prespecified substudy. Selected patients were randomly assigned to either the intravascular imaging-guided PCI group (n=138) or the angiography-guided PCI group (n=54). The primary end point was target vessel failure defined as a composite of cardiac death, target vessel-related myocardial infarction, or clinically driven target vessel revascularization. RESULTS: At a median follow-up of 2.1 years (interquartile range 1.1 to 3.0 years), intravascular imaging-guided PCI was associated with lower incidence of primary end point compared with angiography-guided PCI (6.8% versus 25.1%; hazard ratio, 0.31 [95% CI, 0.13-0.76]; P=0.010). This significant reduction in primary end point was mainly driven by a lower risk of cardiac death or spontaneous target vessel-related myocardial infarction (1.6% versus 12.7%; hazard ratio, 0.16 [95% CI, 0.03-0.82]; P=0.028). Intravascular imaging-guided PCI was independently associated with a lower risk of primary end point, even after adjusting for various clinical factors (hazard ratio, 0.29 [95% CI, 0.12-0.72]; P=0.007). CONCLUSIONS: Intravascular imaging-guided PCI showed clinical benefit over angiography-guided PCI for left main coronary artery disease in reducing the risk of cardiac death, target vessel-related myocardial infarction, or target vessel revascularization. REGISTRATION: URL: https://www.clinicaltrials.gov; Unique identifier: NCT03381872.

Intravascular Imaging in Patients With Complex Coronary Lesions and Chronic Kidney Disease.

Importance: As patients with chronic kidney disease (CKD) are more likely to have complex coronary lesions, intravascular imaging guidance in percutaneous coronary intervention (PCI) for this population could be potentially beneficial. Objectives: To investigate whether the outcomes of intravascular imaging-guided procedural optimization would be different according to the presence of CKD. Design, Setting, and Participants: This was a prespecified substudy of RENOVATE-COMPLEX-PCI, a recently published multicenter randomized clinical trial in Korea studying the benefits of intravascular imaging for complex coronary lesions. Patients with complex coronary lesions, with or without CKD, were enrolled between May 2018 and May 2021. Data were analyzed from January to June 2023. Interventions: PCI in each group was done either under the guidance of intravascular imaging or angiography alone. Main Outcomes and Measures: The primary end point was target vessel failure (TVF) at the 3-year point, defined as a composite of cardiac death, target vessel-related myocardial infarction, or clinically driven target vessel revascularization. Results: A total of 1639 patients (1300 male [79.3%]) treated with PCI for complex coronary lesions were stratified into CKD (296 participants) and non-CKD (1343 participants) groups. The mean (SD) age of each group was 70.3 (9.4) and 64.5 (10.1) years, and mean (SD) estimated serum creatinine was 2.9 (5.3) and 0.8 (0.2) mg/dL for CKD and non-CKD groups, respectively. Intravascular imaging-guided revascularization was associated with significantly lower incidence of the primary end point compared with angiography-guided revascularization in both CKD (13.3% vs 23.3%; hazard ratio [HR], 0.51; 95% CI, 0.27-0.93; P = .03) and non-CKD (6.4% vs 9.9%; HR, 0.66; 95% CI, 0.44-0.99; P = .05) groups. The significantly lower incidence of the primary end point was mainly associated with the lower risk of cardiac death or target vessel-related myocardial infarction (9.4% vs 22.2%; HR, 0.39; 95% CI, 0.20-0.76; P = .006) in the CKD group and by target vessel revascularization (3.0% vs 5.5%; HR, 0.55; 95% CI, 0.30-0.99; P = .05) in the non-CKD group. Those with a glomerular filtration rate of at least 30 mL/min/1.73m2 and less than 60 ml/kg/1.73m2 showed the greatest benefit from imaging-guided complex PCI (8.8% vs 21.2%; HR, 0.28; 95% CI, 0.11-0.68; P = .02). Conclusions and Relevance: In this prespecified cohort substudy of the Randomized Controlled Trial of Intravascular Imaging Guidance versus Angiography-Guidance on Clinical Outcomes After Complex Percutaneous Coronary Intervention trial, intravascular imaging guidance showed clinical benefit over angiography guidance in reducing the risk of TVF, regardless of the presence of CKD. The greatest benefits of imaging-guided complex PCI were observed in stage 3 CKD. Trial Registration: ClinicalTrials.gov Identifier: NCT03381872.

Prevalence and Prognostic Implications of Worsening Renal Function After Acute Myocardial Infarction.

We sought to investigate the relation between worsening renal function (WRF) at 1-year follow-up and clinical outcomes at 3 years after acute myocardial infarction (AMI). We analyzed data from 13,104 patients enrolled in the national AMI registry from November 2011 to December 2015. Patients with all-cause death, recurrent myocardial infarction (re-MI), and rehospitalization for heart failure at 1-year follow-up after AMI were excluded. A total of 6,235 patients were extracted and divided into WRF and non-WRF groups. WRF was defined as a ≥25% decrease in estimated glomerular filtration rate (eGFR) from baseline to 1-year follow-up. The primary outcome was 3-year major adverse cardiac events, a composite of all-cause death, re-MI, and rehospitalization for heart failure. On average, a -1.5 ml/min/1.73 m2/y rate of decrease in eGFR was exhibited, and 575 patients (9.2%) exhibited WRF at 1-year follow-up. After multiple adjustments, WRF at 1-year follow-up was independently associated with increased risks of major adverse cardiac events (adjusted hazard ratio 1.498, 95% confidence interval 1.113 to 2.016, p = 0.01), all-cause death, and re-MI at 3-year follow-up. Older age, female, diabetes mellitus, hypertension, non-ST-segment elevation AMI, anterior AMI, anemia, left ventricular ejection fraction <35%, and baseline eGFR <30 ml/min/1.73 m2 were identified as independent predictors of WRF after AMI. In conclusion, WRF at 1-year follow-up after AMI intuitively seems like a risk marker indicating multiple co-morbidities. Monitoring serum creatinine in patients at 1-year follow-up after AMI may help to identify those who are at the highest risk and guide effective long-term therapeutics.

Intravascular Imaging-Guided or Angiography-Guided Complex PCI.

BACKGROUND: Data regarding clinical outcomes after intravascular imaging-guided percutaneous coronary intervention (PCI) for complex coronary-artery lesions, as compared with outcomes after angiography-guided PCI, are limited. METHODS: In this prospective, multicenter, open-label trial in South Korea, we randomly assigned patients with complex coronary-artery lesions in a 2:1 ratio to undergo either intravascular imaging-guided PCI or angiography-guided PCI. In the intravascular imaging group, the choice between intravascular ultrasonography and optical coherence tomography was at the operators' discretion. The primary end point was a composite of death from cardiac causes, target-vessel-related myocardial infarction, or clinically driven target-vessel revascularization. Safety was also assessed. RESULTS: A total of 1639 patients underwent randomization, with 1092 assigned to undergo intravascular imaging-guided PCI and 547 assigned to undergo angiography-guided PCI. At a median follow-up of 2.1 years (interquartile range, 1.4 to 3.0), a primary end-point event had occurred in 76 patients (cumulative incidence, 7.7%) in the intravascular imaging group and in 60 patients (cumulative incidence, 12.3%) in the angiography group (hazard ratio, 0.64; 95% confidence interval, 0.45 to 0.89; P = 0.008). Death from cardiac causes occurred in 16 patients (cumulative incidence, 1.7%) in the intravascular imaging group and in 17 patients (cumulative incidence, 3.8%) in the angiography group; target-vessel-related myocardial infarction occurred in 38 (cumulative incidence, 3.7%) and 30 (cumulative incidence, 5.6%), respectively; and clinically driven target-vessel revascularization in 32 (cumulative incidence, 3.4%) and 25 (cumulative incidence, 5.5%), respectively. There were no apparent between-group differences in the incidence of procedure-related safety events. CONCLUSIONS: Among patients with complex coronary-artery lesions, intravascular imaging-guided PCI led to a lower risk of a composite of death from cardiac causes, target-vessel-related myocardial infarction, or clinically driven target-vessel revascularization than angiography-guided PCI. (Supported by Abbott Vascular and Boston Scientific; RENOVATE-COMPLEX-PCI ClinicalTrials.gov number, NCT03381872).

Inodilators May Improve the In-Hospital Mortality of Patients with Cardiogenic Shock Undergoing Veno-Arterial Extracorporeal Membrane Oxygenation.

Although inodilators (dobutamine and milrinone) are widely used empirically for cardiogenic shock (CS), the efficacy of inodilators for patients with CS undergoing veno-arterial extracorporeal membrane oxygenation (VA-ECMO) is controversial. We evaluated the effects of inodilators on clinical outcomes using the RESCUE (REtrospective and prospective observational Study to investigate Clinical oUtcomes and Efficacy of left ventricular assist device for Korean patients with cardiogenic shock; NCT02985008) registry. We selected and analyzed the clinical outcomes of 496 patients who underwent VA-ECMO and did or did not receive inodilators. Of the 496 patients, 257 (51.8%) died during hospitalization. We selected 191 matched pairs to adjust for baseline clinical characteristics after 1:1 propensity score matching (PSM). The univariate and multivariate analyses showed that the inodilator group had significantly lower in-hospital mortality than the no-inodilator group (unadjusted hazard ratio [HR], 0.768; 95% confidence interval [CI], 0.579-1.018; p = 0.066, adjusted HR, 0.702; 95% CI, 0.552-0.944; p = 0.019). For patients with CS undergoing VA-ECMO, inodilators may improve clinical outcomes.

Age-related difference in the impact of diabetes mellitus on all-cause mortality after acute myocardial infarction.

AIM: To test the hypothesis that the impact of diabetes mellitus on clinical outcomes after acute myocardial infarction (AMI) can vary by age. METHODS: A total of 12,600 AMI patients from the Korea Acute Myocardial Infarction Registry-National Institute of Health (KAMIR-NIH) between November 2011 and December 2015 was classified into young (n = 3,590 [29%]) and old (n = 9,010 [72%]). Those less than 55 years of age were considered young. We performed comparisons of baseline characteristics, in-hospital treatments, and 3-year clinical outcomes between patients with and without diabetes after stratification according to age group. RESULTS: The prevalence of diabetes mellitus was 27% in the young AMI group. In the multivariable adjusted model of the entire cohort, diabetes mellitus was associated strongly with 3-year all-cause mortality (13% vs. 6.8%; adjusted hazard ratio [HR], 1.318; 95% confidence interval [CI], 1.138-1.526; P<0.001). When the entire cohort was subdivided into two age groups, young diabetic patients showed a 107% higher mortality rate than those without diabetes (adjusted HR, 2.07 [1.15-3.72];P = 0.015). Meanwhile, old diabetic patients had a 25% higher risk of mortality than non-diabetic patients (adjusted HR, 1.25 [1.08-1.46];P = 0.004). The interaction of diabetes with age was significant (adjusted P for interaction = 0.008). CONCLUSIONS: Diabetes mellitus is not uncommon in younger AMI patients, and the relative risk of 3-year mortality is significantly higher in young patients than in older counterparts. More aggressive treatments are needed to prevent future cardiovascular events in younger patients after AMI.

Gender Differences in All-Cause Mortality after Acute Myocardial Infarction: Evidence for a Gender-Age Interaction.

Gender difference studies in mortality after acute myocardial infarction (AMI) have shown inconsistent results. A total of 13,104 patients from the KAMIR-NIH between November 2011 and December 2015 were classified into young (n = 3837 [29.3%]) and elderly (n = 9267 [70.7%]) patients. For the study, women <65 and men <55 years of age were considered "young". In the adjusted model of the entire cohort, there was no significant difference in three-year all-cause mortality between women and men (17.8% vs. 10.3%; adjusted hazard ratio [HR], 0.953; 95% confidence interval [CI], 0.799-1.137). However, when the entire cohort was subdivided into two age groups, young women showed an 84.3% higher mortality rate than young men (adjusted HR, 1.843; 95% CI, 1.098-3.095). Contrariwise, elderly women patients had a 20.4% lower hazard of mortality compared with elderly men (adjusted HR, 0.796; 95% CI, 0.682-0.929). The interaction of gender with age was significant, even after multiple adjustments (adjusted p for interaction = 0.003). The purpose of this study was to assess whether gender differences depend on the patients' age. Based on our analysis, higher mortality of young women remains even in the contemporary era of AMI. A better understanding of the mechanisms underlying these differences is warranted.

Comparison of in-hospital outcomes of patients with vs. without ischaemic cardiomyopathy undergoing veno-arterial-extracorporeal membrane oxygenation.

AIMS: This study aimed to investigate differences in baseline and treatment characteristics, and in-hospital mortality according to the aetiologies of cardiogenic shock in patients undergoing veno-arterial-extracorporeal membrane oxygenation (VA-ECMO). METHODS AND RESULTS: The RESCUE registry is a multicentre, observational cohort that includes 1247 patients with cardiogenic shock from 12 centres. A total of 496 patients requiring VA-ECMO were finally selected, and the study population was stratified by cardiogenic shock aetiology [ischaemic cardiomyopathy (ICM, n = 342) and non-ICM (NICM, n = 154)]. The primary outcome of interest was in-hospital mortality. Sensitivity analyses including propensity-score matching adjustments were performed. Mean age of the entire population was 61.8 ± 14.2, and 30.8% were women. There were significant differences in baseline characteristics; notable differences included the older age of patients with ICM (65.1 ± 13.7 vs. 58.2 ± 13.8, P < 0.001), preponderance of males [258 (75.4%) vs. 85 (55.2%), P < 0.001], and higher prevalence of diabetes mellitus [140 (40.9%) vs. 39 (25.3%), P = 0.001] compared with patients in the NICM aetiology group. Patients with ischaemic cardiogenic shock were more likely to have longer shock duration before VA-ECMO implantation (518.7 ± 941.4 min vs. 292.4 ± 707.8 min, P = 0.003) and were less likely to undergo distal limb perfusion than those with NICM [108 (31.6%) vs. 79 (51.3%), P < 0.001]. In-hospital mortality in the overall cohort was 52.2%; patients with ICM had a higher unadjusted risk of in-hospital mortality [203 (59.4%) vs. 56 (36.4%); unadjusted hazard ratio, 2.295; 95% confidence interval, 1.698-3.100; P < 0.001]. There were no significant differences in the primary outcome between the two aetiologies following propensity-score matching multiple adjustments (adjusted hazard ratio, 1.265; 95% confidence interval, 0.840-1.906; P = 0.260). CONCLUSIONS: Results of the current study indicated among patients with cardiogenic shock undergoing VA-ECMO, ischaemic aetiology does not seem to impact in-hospital mortality. These findings underline that early initiation and appropriate treatment strategies of VA-ECMO for patients with ICM shock are required.

Heart failure with mid-range ejection fraction and the effect of ß-blockers after acute myocardial infarction.

There is currently an ongoing debate about the 'grey area' of heart failure with mid-range ejection fraction (HFmrEF). We evaluated characteristics, prognosis, and the effect of ß-blockers on clinical outcomes in patients with HFmrEF after acute myocardial infarction (AMI). We included a total of 10,785 patients and divided them into three groups: EF 40-49% (HFmrEF; n = 2717; reference); EF < 40% (reduced EF [HFrEF]; n = 1194); and EF ≥ 50% (preserved EF [HFpEF]; n = 6874). The primary outcome was 2-year all-cause mortality. HFmrEF was intermediate between HFrEF and HFpEF for baseline characteristics. The risk of all-cause mortality was lower for HFmrEF patients compared to HFrEF patients (adjusted hazard ratio [HR] 0.710; 95% confidence interval [CI] 0.544-0.927; P = 0.012). However, HFmrEF patients tended to be at higher risk for 2-year all-cause mortality than HFpEF patients (adjusted HR 1.235; 95% CI 0.989-1.511; P = 0.090). ß-blockers were associated with reductions in all-cause mortality for the entire cohort (adjusted HR 0.760; 95% CI 0.592-0.975; P = 0.031). ß-blockers were effective in patients with HFrEF (adjusted HR 0.667; 95% CI 0.471-0.944; P = 0.022), tended to be effective in patients with HFmrEF (adjusted HR 0.665; 95% CI 0.426-1.038; P = 0.072), but not effective in patients with HFpEF (adjusted HR 0.852; 95% CI 0.548-1.326; P = 0.478; interaction P = 0.026). In conclusion, clinical profiles and prognosis of patients with post-AMI HFmrEF are largely intermediate between HFrEF and HFpEF. ß-blockers reduced or tended to reduce 2-year all-cause mortality in patients with HFrEF or HFmrEF, respectively, but not those with HFpEF after AMI.

P2Y12 Inhibitor Monotherapy Versus Conventional Dual Antiplatelet Therapy or Aspirin Monotherapy in Acute Coronary Syndrome: A Pooled Analysis of the SMART-DATE and SMART-CHOICE Trials.

Controversy remains regarding the optimal antiplatelet regimen in patients with acute coronary syndrome (ACS). This study sought to investigate the efficacy and safety of P2Y12 inhibitor monotherapy compared with conventional dual antiplatelet therapy (DAPT) and aspirin monotherapy in patients with ACS undergoing percutaneous coronary intervention. Data on 4,453 patients were pooled from SMART-DATE and SMART-CHOICE randomized trials. Antiplatelet therapy regimens were categorized as P2Y12 inhibitor monotherapy (P2Y12 inhibitor monotherapy after 3-month DAPT), conventional DAPT (12-month or longer DAPT), and aspirin monotherapy (aspirin monotherapy after 6-month DAPT). The primary endpoint was major adverse cardiac and cerebrovascular events (MACCE, a composite of all-cause death, myocardial infarction, and stroke). Inverse-probability of treatment-weighted (IPTW) analysis was performed. At 1 year, patients in the P2Y12 inhibitor monotherapy had a comparable risk of MACCE compared with those in the conventional DAPT (IPTW-adjusted hazard ratio [HR], 0.655; 95% confidence interval [CI] 0.393 to 1.094; p = 0.106), and tended to have a lower risk of MACCE than those in the aspirin monotherapy (IPTW-adjusted HR, 0.606; 95% CI, 0.347 to 1.058; p = 0.078). The adjusted hazard for the Bleeding Academic Research Consortium (BARC) type 2 to 5 bleeding was significantly lower in P2Y12 inhibitor monotherapy than in conventional DAPT (IPTW-adjusted HR, 0.341; 95% CI, 0.190 to 0.614; p < 0.001) and in aspirin monotherapy (IPTW-adjusted HR, 0.359; 95% CI, 0.182 to 0.708; p = 0.003). In conclusion, among patients with ACS undergoing PCI, P2Y12 inhibitor monotherapy after 3-month DAPT reduced risk of bleeding compared with conventional DAPT and aspirin monotherapy after 6-month DAPT without increasing MACCE.

Association of baseline platelet count with all-cause mortality after acute myocardial infarction.

BACKGROUND: We sought to evaluate baseline platelet count as a prognostic indicator in patients with acute myocardial infarction (AMI). METHODS: Data of 13,085 patients with AMI were retrieved from a prospective nationwide AMI registry from November 2011 to December 2015. Using Cox hazards models, cumulative risks for adverse outcomes were compared among patients with baseline platelet count of less than 150 K/µL (lowest quartile), 150 to 249 K/µL, 250 to 349 K/µL (reference) and equal to or greater than 350 K/µL (higher quartile). The primary outcome of interest was all-cause mortality. Secondary outcomes included myocardial infarction, re-hospitalisation for heart failure, and stroke. RESULTS: During a median follow-up of 2.1 years, a steep U-shaped association was observed for the occurrence of all-cause mortality (p for non-linearity <0.001). For stroke, a similar U-shaped curve was also seen (p for non-linearity = 0.095). After multiple adjustments, the lowest and higher quartiles of baseline platelet count were positively associated with all-cause mortality (adjusted hazard ratio: 2.120; 95% confidence interval: 1.345-3.341; p = 0.001, and adjusted hazard ratio: 1.642; 95% confidence interval: 0.957-2.817; p = 0.072, respectively). Similar results were observed in sensitivity analyses even after excluding patients with age ≥75 years or patients with heart failure. CONCLUSIONS: In patients with AMI, baseline platelet count demonstrated a U-shaped association with an increased risk of all-cause mortality at two years. If validated, these findings suggest that baseline platelet count could serve as a preferred prognostic marker in AMI due to its low cost and universal availability.

Blood Pressure at 6 Months After Acute Myocardial Infarction and Outcomes at 2 Years: The Perils Associated With Excessively Low Blood Pressures.

BACKGROUND: This study aimed to determine the association between achieved blood pressure at 6-month follow-up and cardiovascular outcomes at 2 years in patients treated with ß-blockers and renin-angiotensin-aldosterone blockers after acute myocardial infarction (AMI). METHODS: We analyzed data from 5503 patients enrolled in the national AMI registry. Patients with myocardial reinfarction (MrI), rehospitalization for heart failure (rHHF), or stroke before 6-month follow-up were excluded. Achieved blood pressures were categorized into 10-mm Hg increments. The primary outcome was all-cause death. The secondary outcome was a composite of all-cause death, MrI, and rHHF. Hazard ratios (HRs) were estimated with multivariable-adjusted Cox hazards models using 125- to 134-mm Hg systolic blood pressure (SBP) and 75- to 84-mm Hg diastolic blood pressure (DBP) subgroups as reference. RESULTS: After a median follow-up of 2.1 years, SBP < 115 mm Hg was associated with increased risks for all-cause death (adjusted HR: 2.202 [1.158-4.188]) and for a composite outcome (HR: 1.682 [1.075-2.630]). Likewise, DBP < 75 mm Hg tended to be associated with an increase in all-cause death (HR: 2.078 [0.998-4.327] for DBP of 65 to 74 mm Hg; HR: 2.610 [1.256-5.423] for DBP < 65 mm Hg). Even in patients <75 years, the risk of a composite outcome was increased for DBP < 65 mm Hg (HR: 2.492 [1.401-4.434]). CONCLUSIONS: Low blood pressure achieved with ß-blocker and renin-angiotensin-aldosterone blocker at 6 months was associated with an increased risk of all-cause mortality independently of confounding factors in patients with AMI. This finding suggests that caution should be taken for patients with AMI who use blood-pressure-lowering treatments.

Association of baseline platelet count with all-cause mortality after acute myocardial infarction.

BACKGROUND: We sought to evaluate baseline platelet count as a prognostic indicator in patients with acute myocardial infarction (AMI). METHODS: Data of 13,085 patients with AMI were retrieved from a prospective nationwide AMI registry from November 2011 to December 2015. Using Cox hazards models, cumulative risks for adverse outcomes were compared among patients with baseline platelet count of less than 150 K/µL (lowest quartile), 150 to 249 K/µL, 250 to 349 K/µL (reference) and equal to or greater than 350 K/µL (higher quartile). The primary outcome of interest was all-cause mortality. Secondary outcomes included myocardial infarction, re-hospitalisation for heart failure, and stroke. RESULTS: During a median follow-up of 2.1 years, a steep U-shaped association was observed for the occurrence of all-cause mortality (p for non-linearity <0.001). For stroke, a similar U-shaped curve was also seen (p for non-linearity = 0.095). After multiple adjustments, the lowest and higher quartiles of baseline platelet count were positively associated with all-cause mortality (adjusted hazard ratio: 2.120; 95% confidence interval: 1.345-3.341; p = 0.001, and adjusted hazard ratio: 1.642; 95% confidence interval: 0.957-2.817; p = 0.072, respectively). Similar results were observed in sensitivity analyses even after excluding patients with age ≥75 years or patients with heart failure. CONCLUSIONS: In patients with AMI, baseline platelet count demonstrated a U-shaped association with an increased risk of all-cause mortality at two years. If validated, these findings suggest that baseline platelet count could serve as a preferred prognostic marker in AMI due to its low cost and universal availability.