An updated meta-analysis of optimal medical therapy with or without invasive therapy in patients with stable coronary artery disease.

BACKGROUND: The efficacy of optimal medical therapy (OMT) with or without revascularization therapy in patients with stable coronary artery disease (SCAD) remains controversial. We performed a meta-analysis of randomized controlled trials (RCTs) that compared OMT with or without revascularization therapy for SCAD patients. METHODS: Studies were searched in PubMed, EMBASE, and the Cochrane Central Register of Clinical Trials from January 1, 2005, to December 30, 2023. The main efficacy outcome was a composite of all-cause death, myocadiac infarction, revascularization, and cerebrovascular accident. Results were pooled using random effects model and fixed effects model and are presented as odd ratios (ORs) with 95% confidence intervals (CI). RESULTS: Ten studies involving 12,790 participants were included. The arm of OMT with revascularization compared with OMT alone was associated with decreased risks for MACCE (OR 0.55 [95% CI 0.38-0.80], I²=93%, P = 0.002), CV death (OR 0.84 [95% CI 0.73-0.97], I²=36%, P = 0.02), revascularization (OR 0.32 [95% CI 0.20-0.50], I²=92%, P < 0.001), and MI (OR 0.85 [95% CI 0.76-0.96], I²=45%, P = 0.007). While there was no significant difference between OMT with revascularization and OMT alone in the odds of all-cause death (OR 0.94 [95% CI 0.84-1.05], I²=0%, P = 0.30). CONCLUSIONS: The current updated meta-analysis of 10 RCTs shows that in patients with SCAD, OMT with revascularization would reduce the risk for MACCE, cardiovascular death, and MI. However, the invasive strategy does not decrease the risks for all-cause mortality when comparing with OMT alone.

Outcomes With Limus- vs Paclitaxel-Coated Balloons for Percutaneous Coronary Intervention: Meta-Analysis of Randomized Controlled Trials.

BACKGROUND: Randomized controlled trials (RCTs) examining the outcomes with limus drug-coated balloons (DCBs) vs paclitaxel DCBs were small and underpowered for clinical endpoints. OBJECTIVES: This study sought to compare the angiographic and clinical outcomes with limus DCBs vs paclitaxel DCBs for percutaneous coronary intervention (PCI). METHODS: An electronic search of Medline, EMBASE, and Cochrane databases was performed through January 2024 for RCTs comparing limus DCBs vs paclitaxel DCBs for PCI. The primary endpoint was clinically driven target lesion revascularization (TLR). The secondary endpoints were late angiographic findings. Summary estimates were constructed using a random effects model. RESULTS: Six RCTs with 821 patients were included; 446 patients received a limus DCB, and 375 patients received a paclitaxel DCB. There was no difference between limus DCBs and paclitaxel DCBs in the incidence of TLR at a mean of 13.4 months (10.3% vs 7.8%; risk ratio [RR]: 1.32; 95% CI: 0.84-2.08). Subgroup analysis suggested no significant interaction among studies for de novo coronary lesions vs in-stent restenosis (Pinteraction = 0.58). There were no differences in the risk of major adverse cardiovascular events, cardiac mortality, or target vessel myocardial infarction between groups. However, limus DCBs were associated with a higher risk of binary restenosis (RR: 1.89; 95% CI: 1.14-3.12), late lumen loss (mean difference = 0.16; 95% CI: 0.03-0.28), and a smaller minimum lumen diameter (mean difference = -0.12; 95% CI: -0.22 to -0.02) at late follow-up. In addition, late lumen enlargement occurred more frequently (50% vs 27.5%; RR: 0.59; 95% CI: 0.45-0.77) with paclitaxel DCBs. CONCLUSIONS: Among patients undergoing DCB-only PCI, there were no differences in the risk of clinically driven TLR and other clinical outcomes between limus DCBs and paclitaxel DCBs. However, paclitaxel DCBs were associated with better late angiographic outcomes. These findings support the need for future trials to establish the role of new-generation limus DCBs for PCI.

Critical appraisal and assessment of bias among studies evaluating risk prediction models for in-hospital and 30-day mortality after percutaneous coronary intervention: a systematic review.

OBJECTIVE: We systematically assessed prediction models for the risk of in-hospital and 30-day mortality in post-percutaneous coronary intervention (PCI) patients. DESIGN: Systematic review and narrative synthesis. DATA SOURCES: Searched PubMed, Web of Science, Embase, Cochrane Library, CINAHL, CNKI, Wanfang Database, VIP Database and SinoMed for literature up to 31 August 2023. ELIGIBILITY CRITERIA: The included literature consists of studies in Chinese or English involving PCI patients aged ≥18 years. These studies aim to develop risk prediction models and include designs such as cohort studies, case-control studies, cross-sectional studies or randomised controlled trials. Each prediction model must contain at least two predictors. Exclusion criteria encompass models that include outcomes other than death post-PCI, literature lacking essential details on study design, model construction and statistical analysis, models based on virtual datasets, and publications such as conference abstracts, grey literature, informal publications, duplicate publications, dissertations, reviews or case reports. We also exclude studies focusing on the localisation applicability of the model or comparative effectiveness. DATA EXTRACTION AND SYNTHESIS: Two independent teams of researchers developed standardised data extraction forms based on CHecklist for critical Appraisal and data extraction for systematic Reviews of prediction Modelling Studies to extract and cross-verify data. They used Prediction model Risk Of Bias Assessment Tool (PROBAST) to assess the risk of bias and applicability of the model development or validation studies included in this review. RESULTS: This review included 28 studies with 38 prediction models, showing area under the curve values ranging from 0.81 to 0.987. One study had an unclear risk of bias, while 27 studies had a high risk of bias, primarily in the area of statistical analysis. The models constructed in 25 studies lacked clinical applicability, with 21 of these studies including intraoperative or postoperative predictors. CONCLUSION: The development of in-hospital and 30-day mortality prediction models for post-PCI patients is in its early stages. Emphasising clinical applicability and predictive stability is vital. Future research should follow PROBAST's low risk-of-bias guidelines, prioritising external validation for existing models to ensure reliable and widely applicable clinical predictions. PROSPERO REGISTRATION NUMBER: CRD42023477272.

Culprit-Only Revascularization, Single-Setting Complete Revascularization, and Staged Complete Revascularization in Acute Myocardial Infarction: Insights From a Mixed Treatment Comparison Meta-Analysis of Randomized Trials.

BACKGROUND: Complete revascularization improves cardiovascular outcomes compared with culprit-only revascularization in patients with acute myocardial infarction ([MI]; ST-segment-elevation MI or non-ST-segment-elevation MI) and multivessel coronary artery disease. However, the timing of complete revascularization (single-setting versus staged revascularization) is uncertain. The aim was to compare the outcomes of single-setting complete, staged complete, and culprit vessel-only revascularization in patients with acute MI and multivessel disease. METHODS: PubMed, EMBASE, and clinicaltrials.gov databases were searched for randomized controlled trials that compared 3 revascularization strategies. RESULTS: From 16 randomized controlled trials that randomized 11 876 patients with acute MI and multivessel disease, both single-setting complete and staged complete revascularization reduced primary outcome (cardiovascular mortality/MI; odds ratio [OR], 0.52 [95% CI, 0.41-0.65]; OR, 0.74 [95% CI, 0.62-0.88]), composite of all-cause mortality/MI (OR, 0.52 [95% CI, 0.40-0.67]; OR, 0.78 [95% CI, 0.67-0.91]), major adverse cardiovascular event (OR, 0.42 [95% CI, 0.32-0.56]; OR, 0.62 [95% CI, 0.47-0.82]), MI (OR, 0.39 [95% CI, 0.26-0.57]; OR, 0.73 [95% CI, 0.59-0.90]), and repeat revascularization (OR, 0.30 [95% CI, 0.18-0.47]; OR, 0.46 [95% CI, 0.30-0.71]) compared with culprit-only revascularization. Single-setting complete revascularization reduced cardiovascular mortality/MI (OR, 0.70 [95% CI, 0.55-0.91]), major adverse cardiovascular event (OR, 0.67 [95% CI, 0.50-0.91]), and all-cause mortality/MI driven by a lower risk of MI (OR, 0.53 [95% CI, 0.36-0.77]) compared with staged complete revascularization. Single-setting complete revascularization ranked number 1, followed by staged complete revascularization (number 2) and culprit-only revascularization (number 3) for all outcomes. The results were largely consistent in subgroup analysis comparing ST-segment-elevation MI versus non-ST-segment-elevation MI cohorts. CONCLUSIONS: Single-setting complete revascularization may offer the greatest reductions in cardiovascular events in patients with acute MI and multivessel disease. A large-scale randomized trial of single-setting complete versus staged complete revascularization is warranted to evaluate the optimal timing of complete revascularization.

High stress hyperglycemia ratio predicts adverse clinical outcome in patients with coronary three-vessel disease: a large-scale cohort study.

BACKGROUND: Coronary three-vessel disease (CTVD) accounts for one-third of the overall incidence of coronary artery disease, with heightened mortality rates compared to single-vessel lesions, including common trunk lesions. Dysregulated glucose metabolism exacerbates atherosclerosis and increases cardiovascular risk. The stress hyperglycemia ratio (SHR) is proposed as an indicator of glucose metabolism status but its association with cardiovascular outcomes in CTVD patients undergoing percutaneous coronary intervention (PCI) remains unclear. METHODS: 10,532 CTVD patients undergoing PCI were consecutively enrolled. SHR was calculated using the formula: admission blood glucose (mmol/L)/[1.59×HbA1c (%)-2.59]. Patients were divided into two groups (SHR Low and SHR High) according to the optimal cutoff value of SHR. Multivariable Cox regression models were used to assess the relationship between SHR and long-term prognosis. The primary endpoint was cardiovascular (CV) events, composing of cardiac death and non-fatal myocardial infarction (MI). RESULTS: During the median follow-up time of 3 years, a total of 279 cases (2.6%) of CV events were recorded. Multivariable Cox analyses showed that high SHR was associated with a significantly higher risk of CV events [Hazard Ratio (HR) 1.99, 95% Confidence interval (CI) 1.58-2.52, P < 0.001). This association remained consistent in patients with (HR 1.50, 95% CI 1.08-2.10, P = 0.016) and without diabetes (HR 1.97, 95% CI 1.42-2.72, P < 0.001). Additionally, adding SHR to the base model of traditional risk factors led to a significant improvement in the C-index, net reclassification and integrated discrimination. CONCLUSIONS: SHR was a significant predictor for adverse CV outcomes in CTVD patients with or without diabetes, which suggested that it could aid in the risk stratification in this particular population regardless of glucose metabolism status.

Ticagrelor vs Clopidogrel in Clopidogrel-Naive Patients With Chronic Coronary Syndrome.

BACKGROUND: Whether ticagrelor may reduce periprocedural myocardial necrosis after elective percutaneous coronary intervention (PCI) in patients with and without chronic clopidogrel therapy is unclear. OBJECTIVES: This study sought to compare ticagrelor vs clopidogrel in patients with and without chronic clopidogrel therapy before undergoing elective PCI. METHODS: In this prespecified analysis of the ALPHEUS (Assessment of Loading With the P2Y12 Inhibitor Ticagrelor or Clopidogrel to Halt Ischemic Events in Patients Undergoing Elective Coronary Stenting) trial, patients were defined as clopidogrel(+) and clopidogrel(-) according to the presence and absence of clopidogrel treatment for ≥7 days before PCI, respectively. The primary endpoint was the composite of PCI-related myocardial infarction and major injury as defined by the third and fourth universal definition 48 hours after PCI. RESULTS: A total of 1,882 patients were included, 805 (42.7%) of whom were clopidogrel(+). These patients were older, had more comorbidities, and had more frequent features of complex PCI. The primary endpoint was less frequently present in clopidogrel(-) compared to clopidogrel(+) patients (32.8% vs 40.0%; OR: 0.73; 95% CI: 0.60-0.88), but no significant differences were reported for the risk of death, myocardial infarction, stroke, or transient ischemic attack at 48 hours or 30 days. Ticagrelor did not reduce periprocedural myocardial necrosis or the risk of adverse outcomes, and there was no significant interaction regarding the presence of chronic clopidogrel treatment. CONCLUSIONS: Clopidogrel-naive patients presented less periprocedural complications compared to clopidogrel(+) patients, a difference related to a lower risk profile and less complex PCI. The absence of clopidogrel at baseline did not affect the absence of a difference between ticagrelor and clopidogrel in terms of PCI-related complications supporting the use of clopidogrel as the standard of care in elective PCI in patients with or without chronic clopidogrel treatment.

Combined effect of inflammation and malnutrition for long-term prognosis in patients with acute coronary syndrome undergoing percutaneous coronary intervention: a cohort study.

BACKGROUND: Inflammation is a key driver of atherosclerotic diseases and is often accompanied by disease-related malnutrition. However, the long-term burden of dysregulated inflammation with superimposed undernutrition in patients with acute coronary syndrome (ACS) remains unclear. This study sought to investigate the double burden and interplay of inflammation and malnutrition in patients with ACS undergoing percutaneous Coronary Intervention (PCI). METHODS: We retrospectively included 1,743 ACS patients undergoing PCI from June 2016 through November 2017 and grouped them according to their baseline nutritional and inflammatory status. Malnutrition was determined using the nutritional risk index (NRI) with a score lower than 100 and a high-inflamed condition defined as hs-CRP over 2 mg/L. The primary outcome was major adverse cardiovascular events (MACEs), compositing of cardiac mortality, non-fatal myocardial infarction, non-fatal stroke, and unplanned revascularization. Long-term outcomes were examined using the Kaplan-Meier method and compared with the log-rank test. Multivariable Cox proportional hazards regression analysis was applied to adjust for confounding. The reclassification index (NRI)/integrated discrimination index (IDI) statistics estimated the incremental prognostic impact of NRI and hs-CRP in addition to the Global Registry of Acute Coronary Events (GRACE) risk score. RESULTS: During a median follow-up of 30 months (ranges 30-36 months), 351 (20.1%) MACEs occurred. Compared with the nourished and uninflamed group, the malnourished and high-inflamed group displayed a significantly increased risk of MACEs with an adjusted hazard ratio of 2.446 (95% CI: 1.464-4.089; P < 0.001). The prognostic implications of NRI were influenced by patients' baseline inflammatory status, as it was only associated with MACEs among those high-inflamed (P for interaction = 0.005). Incorporating NRI and hs-CRP into the GRACE risk score significantly improved its predictive ability for MACEs (NRI: 0.210, P < 0.001; integrated discrimination index; IDI: 0.010, P < 0.001) and cardiac death (NRI: 0.666, P < 0.001; IDI: 0.023, P = 0.002). CONCLUSIONS: Among patients with ACS undergoing PCI, the double burden of inflammation and malnutrition signifies poorer outcomes. Their prognostic implications may be amplified by each other and jointly improve the GRACE risk score's risk prediction performance.

Trends in Regional Disparities in Cardiovascular Surgery and Mortality in Korea: A National Cross-sectional Study.

OBJECTIVES: Regional disparities in cardiovascular care in Korea have led to uneven patient outcomes. Despite the growing need for and access to procedures, few studies have linked regional service availability to mortality rates. This study analyzed regional variation in the utilization of major cardiovascular procedures and their associations with short-term mortality to provide better evidence regarding the relationship between healthcare resource distribution and patient survival. METHODS: A cross-sectional study was conducted using nationwide claims data for patients who underwent coronary artery bypass grafting (CABG), percutaneous coronary intervention (PCI), stent insertion, or aortic aneurysm resection in 2022. Regional variation was assessed by the relevance index (RI). The associations between the regional RI and 30-day mortality were analyzed. RESULTS: The RI was lowest for aortic aneurysm resection (mean, 26.2; standard deviation, 26.1), indicating the most uneven regional distribution among the surgical procedures. Patients undergoing this procedure in regions with higher RIs showed significantly lower 30-day mortality (adjusted odds ratio [aOR], 0.73; 95% confidence interval, 0.55 to 0.96; p=0.026) versus those with lower RIs. This suggests that cardiovascular surgery regional availability, as measured by RI, has an impact on mortality rates for certain complex surgical procedures. The RI was not associated with significant mortality differences for more widely available procedures like CABG (aOR, 0.96), PCI (aOR, 1.00), or stent insertion (aOR, 0.91). CONCLUSIONS: Significant regional variation and underutilization of cardiovascular surgery were found, with reduced access linked to worse mortality for complex procedures. Disparities should be addressed through collaboration among hospitals and policy efforts to improve outcomes.

Prognostic value of geriatric nutritional risk index in patients with stable coronary artery disease undergoing percutaneous coronary intervention.

BACKGROUND: Malnutrition increases the risk of poor prognosis in patients with cardiovascular disease, and our current research was designed to assess the predictive performance of the Geriatric Nutrition Risk Index (GNRI) for the occurrence of poor prognosis after percutaneous coronary intervention (PCI) in patients with stable coronary artery disease (SCAD) and to explore possible thresholds for nutritional intervention. METHODS: This study retrospectively enrolled newly diagnosed SCAD patients treated with elective PCI from 2014 to 2017 at Shinonoi General Hospital, with all-cause death as the main follow-up endpoint. Cox regression analysis and restricted cubic spline (RCS) regression analysis were used to explore the association of GNRI with all-cause death risk and its shape. Receiver operating characteristic curve (ROC) analysis and piecewise linear regression analysis were used to evaluate the predictive performance of GNRI level at admission on all-cause death in SCAD patients after PCI and to explore possible nutritional intervention threshold points. RESULTS: The incidence of all-cause death was 40.47/1000 person-years after a mean follow-up of 2.18 years for 204 subjects. Kaplan-Meier curves revealed that subjects at risk of malnutrition had a higher all-cause death risk. In multivariate Cox regression analysis, each unit increase in GNRI reduced the all-cause death risk by 14% (HR 0.86, 95% CI 0.77, 0.95), and subjects in the GNRI > 98 group had a significantly lower risk of death compared to those in the GNRI < 98 group (HR 0.04, 95% CI 0.00, 0.89). ROC analysis showed that the baseline GNRI had a very high predictive performance for all-cause death (AUC = 0.8844), and the predictive threshold was 98.62; additionally, in the RCS regression analysis and piecewise linear regression analysis we found that the threshold point for the GNRI-related all-cause death risk was 98.28 and the risk will be significantly reduced when the subjects' baseline GNRI was greater than 98.28. CONCLUSIONS: GNRI level at admission was an independent predictor of all-cause death in SCAD patients after PCI, and GNRI equal to 98.28 may be a useful threshold for nutritional intervention in SCAD patients treated with PCI.

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).

Optical coherence tomography (OCT) - versus angiography-guided strategy for percutaneous coronary intervention: a meta-analysis of randomized trials.

BACKGROUND: Optical coherence tomography (OCT) guidance in percutaneous coronary intervention (PCI) has been shown to improve procedural outcomes. However, evidence supporting its superiority over angiography-guided PCI in terms of clinical outcomes is still emerging and limited. This study aimed to compare the efficacy and safety of OCT-guided PCI versus angiography-guided PCI in patients with coronary artery disease (CAD). METHODS: A systematic search of electronic databases was conducted to identify randomized control trials (RCTs) comparing the clinical outcomes of OCT-guided and angiography-guided PCI in patients with CAD. Clinical endpoints including all-cause mortality, myocardial infarction (MI), target lesion revascularization (TLR), stent thrombosis and major adverse cardiac events (MACE) were assessed. RESULTS: Eleven RCTs, comprising 2,699 patients in the OCT-guided group and 2,968 patients in the angiography-guided group met inclusion criteria. OCT-guided PCI was associated with significantly lower rates of cardiovascular death(RR 0.56; 95%CI: 0.32-0.98; p = 0.04; I2 = 0%), stent thrombosis(RR 0.56; 95%CI: 0.33-0.95; p = 0.03; I2 = 0%), and MACE (RR 0.79; 95%CI: 0.66-0.95; p = 0.01; I2 = 5%). The incidence of all-cause death (RR 0.71; 95%CI: 0.49-1.02; p = 0.06; I2 = 0%), myocardial infarction (RR 0.86; 95%CI: 0.67-1.10; p = 0.22; I2 = 0%) and TLR (RR 0.98; 95%CI: 0.73-1.33; p = 0.91; I2 = 0%) was non-significantly lower in the OCT-guided group. CONCLUSIONS: Among patients undergoing PCI, OCT-guided PCI was associated with lower incidences of cardiovascular death, stent thrombosis and MACE compared to angiography-guided PCI. TRIAL REGISTRATION: PROSPERO registration number: CRD42023484342.

The clinical and geographical characteristics, health-seeking behaviours of ST-segment elevation myocardial infarction patients with their total ischaemic time and short-term cardiac mortality outcomes: a local geographical perspective from a developing country.

INTRODUCTION: Ischaemic heart disease including ST-segment elevation myocardial infarction (STEMI) is the leading cause of death among Malaysians. Total ischaemic time (TIT) which consists of patient delay and systemic delay is a strong predictor of cardiovascular outcome in STEMI. Primary percutaneous coronary intervention (PPCI) is superior to medical thrombolysis in improving STEMI patients' survival outcomes. Our study aims to provide an insight into the clinical and geographical characteristics of STEMI patients, their health-seeking behaviour, TIT, interventions received and short-term cardiac mortality outcomes in the effort to improve the existing coronary care service. MATERIALS AND METHODS: This is a descriptive study looking into patients who were diagnosed with STEMI and presented to or were referred to Sarawak Heart Centre between 1st July 2022 and 31st December 2022. RESULTS: A total of 183 patients were recruited and 33.3% were <50 years old. The majority were in a different division during symptom onset from where the local PPCI centre is located and some underwent one or two transits before arrival at the revascularisation centre. More presented outof- hour and they were more likely to present within the PPCI window. The median TIT for the study population was 3.3 hours. The short-term cardiac mortalities were 9.3% and only the Killip class was found to have a significant association. In this study, TIT was not significantly associated with short-term mortalities but those who died had a longer median TIT. CONCLUSION: A local STEMI network should be set up using the 'Hub-and-Spoke' model in a staged-wise approach to reduce TIT given that PPCI is now the gold standard of treatment alongside continuous effort in patient education.

Three-Year Outcomes With Fractional Flow Reserve-Guided or Angiography-Guided Multivessel Percutaneous Coronary Intervention for Myocardial Infarction.

BACKGROUND: In patients with multivessel disease with successful primary percutaneous coronary intervention for ST-segment-elevation myocardial infarction, the FLOWER-MI trial (Flow Evaluation to Guide Revascularization in Multivessel ST-Elevation Myocardial Infarction) showed that a fractional flow reserve (FFR)-guided strategy was not superior to an angiography-guided strategy for treatment of noninfarct-related artery lesions regarding the 1-year risk of death from any cause, myocardial infarction, or unplanned hospitalization leading to urgent revascularization. The extension phase of the trial was planned using the same primary outcome to determine whether a difference in outcomes would be observed with a longer follow-up. METHODS: In this multicenter trial, we randomly assigned patients with ST-segment-elevation myocardial infarction and multivessel disease with successful percutaneous coronary intervention of the infarct-related artery to receive complete revascularization guided by either FFR (n=586) or angiography (n=577). RESULTS: After 3 years, a primary outcome event occurred in 52 of 498 patients (9.40%) in the FFR-guided group and in 44 of 502 patients (8.17%) in the angiography-guided group (hazard ratio, 1.19 [95% CI, 0.79-1.77]; P=0.4). Death occurred in 22 patients (4.00%) in the FFR-guided group and in 23 (4.32%) in the angiography-guided group (hazard ratio, 0.96 [95% CI, 0.53-1.71]); nonfatal myocardial infarction in 23 (4.13%) and 14 (2.56%), respectively (hazard ratio, 1.63 [95% CI, 0.84-3.16]); and unplanned hospitalization leading to urgent revascularization in 21 (3.83%) and 18 (3.36%; hazard ratio, 1.15 [95% CI, 0.61-2.16]), respectively. CONCLUSIONS: Although event rates in the trial were lower than expected, in patients with ST-segment-elevation myocardial infarction undergoing complete revascularization, an FFR-guided strategy did not have a significant benefit over an angiography-guided strategy with respect to the risk of death, myocardial infarction, or urgent revascularization up to 3 years. REGISTRATION: URL: https://www.clinicaltrials.gov; Unique identifier: NCT02943954.

Machine learning prediction of one-year mortality after percutaneous coronary intervention in acute coronary syndrome patients.

BACKGROUND: Machine learning (ML) models have the potential to accurately predict outcomes and offer novel insights into inter-variable correlations. In this study, we aimed to design ML models for the prediction of 1-year mortality after percutaneous coronary intervention (PCI) in patients with acute coronary syndrome. METHODS: This study was performed on 13,682 patients at Tehran Heart Center from 2015 to 2021. Patients were split into 70:30 for testing and training. Four ML models were designed: a traditional Logistic Regression (LR) model, Random Forest (RF), Extreme Gradient Boosting (XGBoost), and Ada Boost models. The importance of features was calculated using the RF feature selector and SHAP based on the XGBoost model. The Area Under the Receiver Operating Characteristic Curve (AUC-ROC) for the prediction on the testing dataset was the main measure of the model's performance. RESULTS: From a total of 9,073 patients with >1-year follow-up, 340 participants died. Higher age and higher rates of comorbidities were observed in these patients. Body mass index and lipid profile demonstrated a U-shaped correlation with the outcome. Among the models, RF had the best discrimination (AUC 0.866), while the highest sensitivity (80.9%) and specificity (88.3%) were for LR and XGBoost models, respectively. All models had AUCs of >0.8. CONCLUSION: ML models can predict 1-year mortality after PCI with high performance. A classic LR statistical approach showed comparable results with other ML models. The individual-level assessment of inter-variable correlations provided new insights into the non-linear contribution of risk factors to post-PCI mortality.

Insulin resistance, coronary artery lesion complexity and adverse cardiovascular outcomes in patients with acute coronary syndrome.

BACKGROUND: Insulin resistance (IR) is linked to both the complexity of coronary artery lesions and the prognosis of acute coronary syndrome (ACS). However, the precise extent of this correlation and its impact on adverse cardiovascular outcomes in ACS patients remain unclear. Therefore, this study aims to investigate the intricate relationship between IR, coronary artery lesion complexity, and the prognosis of ACS through a cohort design analysis. METHOD: A total of 986 patients with ACS who underwent percutaneous coronary intervention (PCI) were included in this analysis. IR was assessed using the triglyceride-glucose (TyG) index, while coronary artery lesion complexity was evaluated using the SYNTAX score. Pearson's correlation coefficients were utilized to analyze the correlations between variables. The association of the TyG index and SYNTAX score with major adverse cardiovascular events (MACEs) in ACS was investigated using the Kaplan-Meier method, restricted cubic splines (RCS), and adjusted Cox regression. Additionally, a novel 2-stage regression method for survival data was employed in mediation analysis to explore the mediating impact of the SYNTAX score on the association between the TyG index and adverse cardiovascular outcomes, including MACEs and unplanned revascularization. RESULTS: During a median follow-up of 30.72 months, 167 cases of MACEs were documented, including 66 all-cause deaths (6.69%), 26 nonfatal myocardial infarctions (MIs) (2.64%), and 99 unplanned revascularizations (10.04%). The incidence of MACEs, all-cause death, and unplanned revascularization increased with elevated TyG index and SYNTAX score. Both the TyG index (non-linear, P = 0.119) and SYNTAX score (non-linear, P = 0.004) displayed a positive dose-response relationship with MACEs, as illustrated by the RCS curve. Following adjustment for multiple factors, both the TyG index and SYNTAX score emerged as significant predictors of MACEs across the total population and various subgroups. Mediation analysis indicated that the SYNTAX score mediated 25.03%, 18.00%, 14.93%, and 11.53% of the correlation between the TyG index and MACEs in different adjusted models, respectively. Similar mediating effects were observed when endpoint was defined as unplanned revascularization. CONCLUSION: Elevated baseline TyG index and SYNTAX score were associated with a higher risk of MACEs in ACS. Furthermore, the SYNTAX score partially mediated the relationship between the TyG index and adverse cardiovascular outcomes.

Final 5-year report of BIONYX comparing the thin-composite wire-strut zotarolimus-eluting stent versus ultrathin-strut sirolimus-eluting stent.

BACKGROUND: The BIONYX randomized trial is the first study to evaluate the Resolute Onyx durable polymer-coated zotarolimus-eluting stent (ZES) in all-comers. Furthermore, it is the first trial to assess safety and efficacy of this stent versus the Orsiro biodegradable-polymer sirolimus-eluting stent (SES) in all-comers, paying particular attention to patients with diabetes. It has previously shown promising results until 3 years of follow-up. AIMS: We aimed to assess long-term clinical outcome after percutaneous coronary intervention (PCI) with Onyx ZES versus Orsiro SES at 5-year follow-up. METHODS: The main composite endpoint was target vessel failure (TVF): cardiac death, target vessel myocardial infarction, or target vessel revascularization. Time to primary and secondary endpoints was assessed using Kaplan-Meier methods, applying the log-rank test for between-group comparison. RESULTS: Follow-up was available in 2414/2488 (97.0%) patients. After 5 years, TVF showed no significant difference between Onyx ZES and Orsiro SES (12.7% vs. 13.7%, hazard ratio [HR] 0.94, 95% confidence interval [CI] [0.75-1.17], plog-rank = 0.55). Landmark analysis between 3- and 5-year follow-up found a lower target lesion revascularization rate for Onyx ZES (1.1% vs. 2.4%, HR 0.47, 95% CI [0.24-0.93], plog-rank = 0.026). A prespecified subgroup analysis showed no significant between-stent difference in clinical outcome among patients with diabetes. After treatment with Onyx ZES, patients aged ≥75 years had significantly lower rates of TVF (13.8% vs. 21.9%, HR 0.60, 95% CI [0.39-0.93], plog-rank = 0.023). CONCLUSIONS: The final 5-year analysis of the randomized BIONYX trial showed favorable and similar long-term outcomes of safety and efficacy for Onyx ZES and Orsiro SES in both all-comers and patients with diabetes.

An analysis of long-term clinical outcome following the use of excimer laser coronary atherectomy in a large UK PCI center.

BACKGROUND: Excimer laser atherectomy (ELCA) is an established adjunctive technique to facilitate acute success in percutaneous coronary intervention (PCI). Despite this there are a lack of contemporary outcome data, particulary longer-term, forpatients treated with ELCA PCI. AIMS: To evaluate the contemporary use ofELCA in PCI, the frequency of periprocedural complications and the longer-term outcomes associated with ELCA PCI. METHODS: This was a retrospective study that included all patients undergoing PCI (with or without ELCA) between April 2005 and May 2021. Relevant features from all cases were downloaded from the patient record and matched to hospital data on mortality on November 22, 2022. Kaplan Meier curves were used to compare mortality between the ELCA PCI and non-ELCA PCI cohorts with a landmark at 1 year. Multivariable Cox regression was performed to assess whether ELCA PCI was independently associated with long-term mortality. RESULT: There were 21,256 patients in this analysis, of which 448 (2.1%) were treated with ELCA PCI. ELCA PCI was associated with a higher frequency of any periprocedural complication. Median follow-up was 2812 days (IQR, 1577-4245 days) with higher mortality in ELCA PCI (38.2% vs. 29.0%, p < 0.001). However, on multivariable analysis, ELCA PCI was not independently associated with long-term mortality. The TVR frequency in ELCA PCI was 16.7% but TVR was significantly higher for cases of in-stent restenosis (ISR) (29.5%). CONCLUSION: Despite ELCA PCI being used in higher risk populations with complex coronary artery disease there was no long-term increased mortality associated with the use of this device. ELCA PCI for ISR is highly effective and safe although TVR in this cohort remains high in long-term follow-up.

An Aspirin-Free Strategy for Immediate Treatment Following Complex Percutaneous Coronary Intervention.

BACKGROUND: There was no study evaluating the effects of an aspirin-free strategy in patients undergoing complex percutaneous coronary intervention (PCI). OBJECTIVES: The authors aimed to evaluate the efficacy and safety of an aspirin-free strategy in patients undergoing complex PCI. METHODS: We conducted the prespecified subgroup analysis based on complex PCI in the STOPDAPT-3 (ShorT and OPtimal duration of Dual AntiPlatelet Therapy after everolimus-eluting cobalt-chromium stent-3), which randomly compared low-dose prasugrel (3.75 mg/d) monotherapy to dual antiplatelet therapy (DAPT) with low-dose prasugrel and aspirin in patients with acute coronary syndrome or high bleeding risk. Complex PCI was defined as any of the following 6 criteria: 3 vessels treated, ≥3 stents implanted, ≥3 lesions treated, bifurcation with 2 stents implanted, total stent length >60 mm, or a target of chronic total occlusion. The coprimary endpoints were major bleeding events (Bleeding Academic Research Consortium 3 or 5) and cardiovascular events (a composite of cardiovascular death, myocardial infarction, definite stent thrombosis, or ischemic stroke) at 1 month. RESULTS: Of the 5,966 study patients, there were 1,230 patients (20.6%) with complex PCI. Regardless of complex PCI, the effects of no aspirin relative to DAPT were not significant for the coprimary bleeding (complex PCI: 5.30% vs 3.70%; HR: 1.44; 95% CI: 0.84-2.47; P = 0.18 and noncomplex PCI: 4.26% vs 4.97%; HR: 0.85; 95% CI: 0.65-1.11; P = 0.24; P for interaction = 0.08) and cardiovascular (complex PCI: 5.78% vs 5.93%; HR: 0.98; 95% CI: 0.62-1.55; P = 0.92 and noncomplex PCI: 3.70% vs 3.10%; HR: 1.20; 95% CI: 0.88-1.63; P = 0.25; P for interaction = 0.48) endpoints without significant interactions. CONCLUSIONS: The effects of the aspirin-free strategy relative to standard DAPT for the cardiovascular and major bleeding events were not different regardless of complex PCI. (ShorT and OPtimal duration of Dual AntiPlatelet Therapy after everolimus-eluting cobalt-chromium stent-3 [STOPDAPT-3]; NCT04609111).

Biodegradable Polymer Versus Polymer-Free Ultrathin Sirolimus-Eluting Stents: Analysis of the Stent Arm Registry From the HOST-IDEA Randomized Trial.

BACKGROUND: The efficacy and safety of each third-generation drug-eluting stent with ultrathin struts and advanced polymer technology remain unclear. We investigated the clinical outcomes of percutaneous coronary intervention using the Coroflex ISAR polymer-free sirolimus-eluting stent (SES) or Orsiro biodegradable polymer SES. METHODS: The HOST-IDEA trial (Harmonizing Optimal Strategy for Treatment of Coronary Artery Stenosis-Coronary Intervention With Next-Generation Drug-Eluting Stent Platforms and Abbreviated Dual Antiplatelet Therapy), initially designed with a 2×2 factorial approach, sought to randomize patients undergoing percutaneous coronary intervention based on dual antiplatelet therapy duration (3 versus 12 months) and stent type (Coroflex ISAR versus Orsiro). Despite randomizing 2013 patients for dual antiplatelet therapy duration, the stent arm transitioned to a registry format during the trial. Among these, 328 individuals (16.3%) were randomized for Coroflex ISAR or Orsiro SES, while 1685 (83.7%) underwent percutaneous coronary intervention without stent-type randomization. In this study, the Coroflex ISAR (n=559) and Orsiro groups (n=1449) were matched using a propensity score. The prespecified primary end point was target lesion failure, a composite of cardiac death, target vessel myocardial infarction, and clinically driven target lesion revascularization at 12 months. RESULTS: The baseline patient and procedural characteristics were well balanced between the Coroflex ISAR and Orsiro groups after propensity score matching (n=559, each group). The Coroflex ISAR group was significantly associated with a higher rate of target lesion failure, mainly driven by clinically driven target lesion revascularization, compared with the Orsiro group (3.4% versus 1.1%; hazard ratio, 3.21 [95% CI, 1.28-8.05]; P=0.01). A higher risk of target lesion failure in the Coroflex ISAR group was consistently observed across various subgroups. The rates of any bleeding (hazard ratio, 0.85 [95% CI, 0.51-1.40]; P=0.52) and major bleeding (hazard ratio, 1.58 [95% CI, 0.61-4.08]; P=0.34) were comparable between the 2 groups. CONCLUSIONS: In this propensity score-matched analysis of the stent arm registry from the HOST-IDEA trial, the Orsiro SES was associated with significantly better outcomes in terms of 1-year target lesion failure, mainly driven by clinically driven target lesion revascularization, than the Coroflex ISAR SES. REGISTRATION: URL: https://www.clinicaltrials.gov; Unique identifier: NCT02601157.

Prognostic Value of Microvascular Resistance Reserve Measured Immediately After PCI in Stable Coronary Artery Disease.

BACKGROUND: Microvascular resistance reserve (MRR) has been proposed as a specific metric to quantify coronary microvascular function. The long-term prognostic value of MRR measured in stable patients immediately after percutaneous coronary intervention (PCI) is unknown. This study sought to determine the prognostic value of MRR measured immediately after PCI in patients with stable coronary artery disease. METHODS: This study included 502 patients with stable coronary artery disease who underwent elective PCI and coronary physiological measurements, including pressure and flow estimation using a bolus thermodilution method after PCI. MRR was calculated as coronary flow reserve divided by fractional flow reserve times the ratio of mean aortic pressure at rest to that at maximal hyperemia induced by hyperemic agents. An abnormal MRR was defined as ≤2.5. Major adverse cardiac events (MACEs) were defined as a composite of all-cause mortality, any myocardial infarction, and target-vessel revascularization. RESULTS: During a median follow-up of 3.4 years, the cumulative MACE rate was significantly higher in the abnormal MRR group (12.5 versus 8.3 per 100 patient-years; hazard ratio 1.53 [95% CI, 1.10-2.11]; P<0.001). A higher all-cause mortality rate primarily drove this difference. On multivariable analysis, a higher MRR value was independently associated with lower MACE and lower mortality. When comparing 4 subgroups according to MRR and the index of microcirculatory resistance, patients with both abnormal MRR and index of microcirculatory resistance (≥25) had the highest MACE rate. CONCLUSIONS: An abnormal MRR measured immediately after PCI in patients with stable coronary artery disease is an independent predictor of MACE, particularly all-cause mortality.