Immediate versus staged complete revascularisation in patients presenting with STEMI and multivessel disease.

BACKGROUND: Complete revascularisation is supported by recent trials in patients with ST-elevation myocardial infarction (STEMI) and multivessel disease (MVD) without cardiogenic shock. However, the optimal timing of non-culprit lesion revascularisation is currently debated. AIMS: This prespecified analysis of the BioVasc trial aims to determine the effect of immediate complete revascularisation (ICR) compared to staged complete revascularisation (SCR) on clinical outcomes in patients with STEMI. METHODS: Patients presenting with STEMI and MVD were randomly assigned to ICR or SCR. The primary endpoint was the composite of all-cause mortality, myocardial infarction, any unplanned ischaemia-driven revascularisation, or cerebrovascular events at 1-year post-index procedure. RESULTS: Between June 2018 and October 2021, 608 (ICR: 305, SCR: 303) STEMI patients were enrolled. No significant differences between ICR and SCR were observed at 1-year follow-up in terms of the primary endpoint (7.0% vs 8.3%, hazard ratio [HR] 0.84, 95% confidence interval [CI]: 0.47-1.50; p=0.55): all-cause mortality (2.3% vs 1.3%, HR 1.77, 95% CI: 0.52-6.04; p=0.36), myocardial infarction (1.7% vs 3.3%, HR 0.50, 95% CI: 0.17-1.47; p=0.21), unplanned ischaemia-driven revascularisation (4.1% vs 5.0%, HR 0.80, 95% CI: 0.38-1.71; p=0.57) and cerebrovascular events (1.4% vs 1.3%, HR 1.01, 95% CI: 0.25-4.03; p=0.99). At 30-day follow-up, a trend towards a reduction of the primary endpoint in the ICR group was observed (ICR: 3.0% vs SCR: 6.0%, HR 0.50, 95% CI: 0.22-1.11; p=0.09). ICR was associated with a reduction in overall hospital stay (ICR: median 3 [interquartile range {IQR} 2-5] days vs SCR: median 4 [IQR 3-6] days; p<0.001). CONCLUSIONS: Clinical outcomes at 1 year were similar for STEMI patients who had undergone ICR and those who had undergone SCR.

Role of Lipid-Lowering and Anti-Inflammatory Therapies on Plaque Stabilization.

Atherosclerosis is the predominant underlying etiopathology of coronary artery disease. Changes in plaque phenotype from stable to high risk may spur future major adverse cardiac events (MACE). Different pharmacological therapies have been implemented to mitigate this risk. Over the last two decades, intravascular imaging modalities have emerged in clinical studies to clarify how these therapies may affect the composition and burden of coronary plaques. Lipid-lowering agents, such as statins, ezetimibe, and proprotein convertase subtilisin/kexin type 9 inhibitors, were shown not only to reduce low-density lipoprotein levels and MACE but also to directly affect features of coronary plaque vulnerability. Studies have demonstrated that lipid-lowering therapy reduces the percentage of atheroma volume and number of macrophages and increases fibrous cap thickness. Future studies should answer the question of whether pharmacological plaque stabilization may be sufficient to mitigate the risk of MACE for selected groups of patients with atherosclerotic coronary disease.

Timing of Complete Revascularization Stratified by Index Presentation During On- and Off-Hours.

Recent trials suggested immediate complete revascularization (ICR) as a safe alternative to staged complete revascularization (SCR), but the impact of the respective percutaneous coronary intervention strategies between on- versus off-hours is unclear. On-hours was defined as an index revascularization performed between 8:00 a.m. and 6:00 p.m., Monday to Friday, or else the procedure was defined as performed during off-hours. The primary end point consisted of a composite of all-cause mortality, myocardial infarction, unplanned ischemia-driven revascularization, and cerebrovascular events at 1-year follow-up. We used Cox regression models to relate randomized treatment with study end points. We evaluated multiplicative and additive interactions between on- versus off-hours and randomized treatment. The BIOVASC (Percutaneous Complete Revascularization Strategies Using Sirolimus Eluting Biodegradable Polymer Coated Stents in Patients Presenting With Acute Coronary Syndromes and Multivessel Disease) trial enrolled 1,097 and 428 patients during on- and off-hours, respectively. Patients randomized during off-hours were more likely to present with ST-segment elevation myocardial infarction (66.4% vs 29.5%, p <0.001). The composite primary outcome occurred in 8.4% and 10.1% of patients randomized to ICR and SCR, respectively, during on-hours (hazard ratio 0.80, 95% confidence interval 0.54 to 1.19). During off-hours, the primary composite outcome occurred in 5.4% and 7.7% in ICR and SCR (0.69, 95% confidence interval 0.32 to 1.46) with no evidence of a differential effect (interaction pmultiplicative = 0.70, padditive = 0.56). No differential effect was found between treatment allocation and on- versus off-hours in any of the secondary outcomes. In conclusion, no differential treatment effect was found when comparing ICR versus SCR in patients presenting with acute coronary syndrome and multivessel disease during on- or off-hours.

Impact of Bifurcation Involvement and Location in Chronic Total Occlusion Percutaneous Coronary Intervention: Insights From the EuroCTO Registry.

Bifurcation involvement close to or within the occluded segment poses increasing difficulties for chronic total occlusion (CTO)-percutaneous coronary intervention (PCI). However, this variable is not considered in the angiography-based CTO scoring systems nor has been extensively investigated in large multicenter series. Accordingly, we analyzed a CTO-PCI registry involving 92 European centers to explore the incidence, angiographic and procedural characteristics, and outcomes specific to CTO-PCIs with bifurcation involvement. A total of 3,948 procedures performed between January and November 2023 were examined (33% with bifurcation involvement). Among bifurcation lesions, 38% and 37% were located within 5 mm of the proximal and distal cap, respectively, 16% within the CTO body, and in 9% of cases proximal and distal bifurcations coexisted. When compared with lesions without bifurcation involvement, CTO bifurcation lesions had higher complexity (J-CTO 2.33 ± 1.21 vs 2.11 ± 1.27, p <0.001) and were associated with higher use of additional devices (dual-lumen microcatheter in 27.6% vs 8.4%, p <0.001, and intravascular ultrasound in 32.2% vs 21.7%, p <0.001). Radiation dose (1,544 [836 to 2,819] vs 1,298.5 [699.1 to 2,386.6] mGy, p <0.001) and contrast volume (230 [160 to 300] vs 190 [130 to 250] ml, p <0.001) were also higher. Technical success was similar (91.5% with bifurcation involvement vs 90.4% without bifurcation involvement, p = 0.271). However, the bifurcation lesions within the CTO segment (intralesion) were associated with lower technical success than the other bifurcation-location subgroups (83.7% vs 93.3% proximal, 93.4% distal, and 89.0% proximal and distal, p <0.001). On multivariable analysis, the presence of an intralesion bifurcation was independently associated with technical failure (odds ratio 2.04, 95% confidence interval 1.24 to 3.35, p = 0.005). In conclusion, bifurcations are present in approximately one-third of CTOs who underwent PCI. PCI of CTOs with bifurcation can be achieved with high success rates except for bifurcations within the occluded segment, which were associated with higher technical failure.

Prehospital crushed versus integral prasugrel loading dose in STEMI patients with a large myocardial area.

BACKGROUND: The effect of administering a crushed prasugrel loading dose is uncertain in patients presenting with a large myocardial infarction and ST-segment elevation myocardial infarction (STEMI). AIMS: The aim of this study was to investigate if patients with a large myocardial infarction may benefit from prehospital administration of a crushed prasugrel loading dose. METHODS: Patients from the CompareCrush trial with an available ambulance electrocardiography (ECG) were included in the study. An independent core laboratory confirmed a prehospital large myocardial area. We compared pre- and postprocedural angiographic markers, including Thrombolysis in Myocardial Infarction (TIMI) 3 flow in the infarct-related artery, high thrombus burden, and myocardial blush grade 3, in STEMI patients with and without a prehospital large myocardial area. RESULTS: Ambulance ECG was available for 532 patients, of whom 331 patients were identified with a prehospital large myocardial area at risk. Crushed prasugrel significantly improved postprocedural TIMI 3 flow rates in STEMI patients with a prehospital large myocardial area at risk (92% vs 79%, odds ratio [OR] 3.00, 95% confidence interval [CI]: 1.50-6.00) but not in STEMI patients without a prehospital large myocardial area at risk (91% vs 95%, OR 0.47, 95% CI: 0.14-1.57; pinteraction=0.009). CONCLUSIONS: Administration of crushed prasugrel may improve postprocedural TIMI 3 flow in STEMI patients with signs of a large myocardial area at risk on the ambulance ECG. The practice of crushing tablets of prasugrel loading dose might, therefore, represent a safe, fast and cost-effective strategy to improve myocardial reperfusion in this high-risk STEMI subgroup undergoing primary percutaneous coronary intervention.

Immediate or staged complete revascularisation in patients presenting with acute coronary syndrome by number of diseased vessels: a substudy of the BIOVASC randomised trial.

BACKGROUND: In patients presenting with acute coronary syndrome (ACS), the number of diseased vessels may affect the efficacy of a complete revascularisation strategy. AIMS: The authors sought to evaluate the safety and efficacy of immediate complete revascularisation (ICR) and staged complete revascularisation (SCR) in patients presenting with ACS stratified by the number of diseased vessels. METHODS: In this prespecified analysis of the BIOVASC trial, ICR was compared with SCR in patients with two-vessel disease (2VD) or three-vessel disease (3VD). The primary endpoint was a composite of all-cause mortality, myocardial infarction (MI), any unplanned ischaemia-driven revascularisation or cerebrovascular events at 1 year after the index procedure. Comparisons were performed using Cox regression. RESULTS: A total of 1,525 patients were enrolled in the BIOVASC trial, of whom 1,177 presented with 2VD and 265 with 3VD. In the 2VD group, 613 patients were assigned to ICR and 564 to SCR. In the 3VD group, 117 patients were assigned to ICR and 148 to SCR. ICR and SCR led to similar results in both the 2VD (hazard ratio [HR] 0.76, 95% confidence interval [CI]: 0.50-1.13; p=0.18) and 3VD groups (HR 0.79, 95% CI: 0.39-1.59; p=0.51) (pinteraction=0.91) in terms of the primary endpoint. ICR was associated with a lower rate of MI in patients with 3VD (HR 0.21, 95% CI: 0.046-0.93; p=0.04) (pinteraction=0.30). CONCLUSIONS: ICR might be an option in patients presenting with extensive 3VD and might be associated with a lower rate of myocardial infarction compared with SCR.

Benefits of immediate complete revascularization in patients with acute coronary syndromes.

Acute coronary syndrome is one of the leading causes of death worldwide. Up to 60% of patients present with additional significant non-culprit lesions. Complete revascularization (CR) of all (culprit and non-culprit) lesions is recommended and recent randomized trials showed the benefit of performing complete multivessel percutaneous coronary intervention in a single setting. Immediate CR is associated with a reduced risk of repeat myocardial infarction and unplanned ischemia driven revascularization. Furthermore, immediate CR resulted in less implanted stents, total contrast use and a shorter duration of hospitalization while maintaining a similar success rate of complete revascularization. Further studies need to evaluate the role of coronary physiology and intravascular imaging for enhanced understanding of the pathophysiology of early events in non-culprit lesions.

Timing of Complete Multivessel Revascularization in Patients Presenting With Non-ST-Segment Elevation Acute Coronary Syndrome.

BACKGROUND: Complete revascularization of the culprit and all significant nonculprit lesions in patients with non-ST-segment elevation acute coronary syndrome (NSTE-ACS) and multivessel disease (MVD) reduces major adverse cardiac events, but optimal timing of revascularization remains unclear. OBJECTIVES: This study aims to compare immediate complete revascularization (ICR) and staged complete revascularization (SCR) in patients presenting with NSTE-ACS and MVD. METHODS: This prespecified substudy of the BIOVASC (Percutaneous Complete Revascularization Strategies Using Sirolimus Eluting Biodegradable Polymer Coated Stents in Patients Presenting With Acute Coronary Syndrome and Multivessel Disease) trial included patients with NSTE-ACS and MVD. Risk differences of the primary composite outcome of all-cause mortality, myocardial infarction (MI), unplanned ischemia-driven revascularization (UIDR), or cerebrovascular events and its individual components were compared between ICR and SCR at 1 year. RESULTS: The BIOVASC trial enrolled 1,525 patients; 917 patients presented with NSTE-ACS, of whom 459 were allocated to ICR and 458 to SCR. Incidences of the primary composite outcome were similar in the 2 groups (7.9% vs 10.1%; risk difference 2.2%; 95% CI: -1.5 to 6.0; P = 0.15). ICR was associated with a significant reduction of MIs (2.0% vs 5.3%; risk difference 3.3%; 95% CI: 0.9 to 5.7; P = 0.006), which was maintained after exclusion of procedure-related MIs occurring during the index or staged procedure (2.0% vs 4.4%; risk difference 2.4%; 95% CI: 0.1 to 4.7; P = 0.032). UIDRs were also reduced in the ICR group (4.2% vs 7.8%; risk difference 3.5%; 95% CI: 0.4 to 6.6; P = 0.018). CONCLUSIONS: ICR is safe in patients with NSTE-ACS and MVD and was associated with a reduction in MIs and UIDRs at 1 year.

Impacto pronóstico a diez años del fallo del vaso diana tras un IAMCEST. Perspectivas del ensayo EXAMINATION-EXTEND / Ten-year prognostic impact of target versus non-target vessel failure after STEMI. Insight from the EXAMINATION-EXTEND trial

Introducción y objetivos Se desconoce el impacto pronóstico de los diferentes tipos de eventos adversos tras el infarto agudo de miocardio con elevación del segmento ST (IAMCEST). El objetivo de este trabajo es evaluar los predictores a largo plazo del objetivo combinado orientado al paciente (POCE) y si tener un fallo del vaso diana (FVD) como primer evento puede influir en los resultados. Métodos El ensayo EXAMINATION-EXTEND aleatorizó a pacientes con IAMCEST a tratamiento con stents liberadores de everolimus o a stents convencionales, con un seguimiento de hasta 10 años. En la población del estudio, se evaluaron los predictores de POCE (combinado de mortalidad por cualquier causa, infarto de miocardio y cualquier revascularización). Se clasificó a los pacientes según el tipo de primer evento (FVD primero o FDV no primero) y comparado en términos de POCE posterior. El FVD se definió como el compuesto de muerte cardiaca, IAMCEST del vaso diana y revascularización del vaso diana. Resultados De los 1.498 pacientes del estudio, 529 (35,3%) tuvieron POCE durante el seguimiento a los 10 años. Los predictores independientes de POCE fueron la edad, la diabetes mellitus, el infarto de miocardio previo, la enfermedad arterial periférica y la enfermedad coronaria multivaso. El primer evento fue un FVD o no FVD en 296 y 233 casos respectivamente. No hubo diferencias estadísticamente significativas entre quienes tuvieron primero un FVD y los que tuvieron un evento no FVD en cuanto a POCE (el 21,7 frente al 39,3%; razón de tiempo, 1,79; IC95%, 0,87-3,67; p=0,12) o sus componentes individuales. Conclusiones En el seguimiento a 10 años, alrededor de un tercio de los pacientes con IAMCEST tuvo al menos 1 evento de POCE, cuyos predictores independientes fueron la edad, la diabetes mellitus y una mayor extensión de la enfermedad ateroesclerótica... (AU)

Introduction and objectivesAfter ST-segment myocardial infarction (STEMI), the impact of different adverse events on prognosis remains unknown. We aimed to assess very long-term predictors of patient-oriented composite endpoints (POCE) and investigate whether the occurrence of target vessel failure (TVF) vs a non-TVF event as the first event could potentially influence subsequent outcomes. Methods The EXAMINATION.EXTEND trial randomized STEMI patients to receive either an everolimus-eluting stent or a bare-metal stent. The follow-up period was 10 years. Predictors of POCE (a composite of all-cause death, any myocardial infarction, or any revascularization) were evaluated in the overall study population. The patients were stratified based on the type of first event (TVF-first vs non–TVF-first) and were compared in terms of subsequent POCE. TVF was defined as a composite of cardiac death, TV myocardial infarction, or TV revascularization. Results Out of the 1498 enrolled patients, 529 (35.3%) experienced a POCE during the 10-year follow-up. Independent predictors of POCE were age, diabetes mellitus, previous myocardial infarction, peripheral arterial disease, and multivessel coronary disease. The first event was a TVF in 296 patients and was a non-TVF in 233 patients. No significant differences were observed between TVF-first and non–TVF-first patients in terms of subsequent POCE (21.7% vs 39.3%, time ratio 1.79; 95%CI, 0.87-3.67; P=.12) or its individual components. Conclusions At the 10-year follow-up, approximately one-third of STEMI patients had experienced at least 1 POCE. Independent predictors of these events were age, diabetes, and more extensive atherosclerotic disease. The occurrence of a TVF or a non-TVF as the first event did not seem to influence subsequent outcomes. Trial registration number: NCT04462315. (AU)

Contemporary outcomes of chronic total occlusion percutaneous coronary intervention in Europe: the ERCTO registry.

BACKGROUND: Percutaneous coronary interventions (PCI) of chronic total occlusions (CTO) have reached high procedural success rates thanks to dedicated equipment, evolving techniques, and worldwide adoption of state-of-the-art crossing algorithms. AIMS: We report the contemporary results of CTO PCIs performed by a large European community of experienced interventionalists. Furthermore, we investigated the impact of different risk factors for procedural major adverse cardiac and cerebrovascular events (MACCE) and trends of employment of specific devices like dual lumen microcatheters, guiding catheter extensions, intravascular ultrasound and calcium-modifying tools. METHODS: We evaluated data from 8,673 CTO PCIs included in the European Registry of Chronic Total Occlusion (ERCTO) between January 2021 and October 2022. RESULTS: The overall technical success rate was 89.1% and was higher in antegrade as compared with retrograde cases (92.8% vs 79.3%; p<0.001). Compared with antegrade procedures, retrograde procedures had a higher complexity of attempted lesions (Japanese CTO [J-CTO] score: 3.0±1.0 vs 1.9±1.2; p<0.001), a higher procedural and in-hospital MACCE rate (3.1% vs 1.2%; p<0.018) and a higher perforation rate with and without tamponade (1.5% vs 0.4% and 8.3% vs 2.1%, respectively; p<0.001). As compared with mid-volume operators, high-volume operators had a higher technical success rate in antegrade and retrograde procedures (93.4% vs 91.2% and 81.5% vs 69.0%, respectively; p<0.001), and had a lower MACCE rate (1.47% vs 2.41%; p<0.001) despite a higher mean complexity of the attempted lesions (J-CTO score: 2.42±1.28 vs 2.15±1.27; p<0.001). CONCLUSIONS: The adoption of different recanalisation techniques, operator experience and the use of specific devices have contributed to a high procedural success rate despite the high complexity of the lesions documented in the ERCTO.

Complete Revascularization Strategies in Women and Men With Acute Coronary Syndrome and Multivessel Disease.

This prespecified substudy of the randomized Percutaneous Complete Revascularization Strategies Using Sirolimus Eluting Biodegradable Polymer Coated Stents in Patients Presenting With Acute Coronary Syndromes and Multivessel Disease (BIOVASC) trial aimed to compare immediate complete revascularization (ICR) and staged complete revascularization (SCR) in patients with acute coronary syndrome and multivessel disease, stratified by gender. The primary end point consisted of a composite of all-cause mortality, myocardial infarction, unplanned ischemia-driven revascularization, and cerebrovascular events at 1-year follow-up. The secondary end points included the individual components of the primary composite and major bleedings. We used Cox regression models to relate randomized treatment with study end points. We evaluated the multiplicative and additive interactions between gender and randomized treatment. The BIOVASC trial enrolled 338 women and 1,187 men. Women were older than men (median age 71.6 vs 63.7 years, p <0.001) and had a higher prevalence of chronic obstructive pulmonary disease (10.1% vs 5.6%, p = 0.003), renal insufficiency (7.7% vs 4.4%, p = 0.015), and hypertension (60.4% vs 51.7%, p = 0.005). In women, the composite primary outcome occurred in 7.3% versus 12.9% (hazard ratio 0.53, 95% confidence interval 0.26 to 1.08) in patients randomly allocated to ICR and SCR, respectively, and in men in 7.7% versus 8.4% (hazard ratio 0.89, 95% confidence interval 0.60 to 1.34), with no evidence of a differential effect (interaction pmultiplicative = 0.20, padditive = 0.87). No evidence of heterogeneity between women and men was found when comparing ICR with SCR in terms of the secondary outcomes. In conclusion, no differential treatment effect was found when comparing ICR versus SCR in women or men presenting with acute coronary syndrome and multivessel disease.

Incidence of ventricular arrhythmias in patients with chronic total coronary occlusion: Results of the VACTOR study.

Background: A chronic total coronary occlusion (CTO) is associated with ventricular arrhythmias (VA) in patients with an implantable cardioverter-defibrillator (ICD). Limited data is available on the incidence of VA in CTO patients without an ICD. Objectives: To investigate the incidence of sustained VA in CTO patients after successful CTO revascularization and in patients with untreated CTO or failed CTO revascularization. Methods: Prospective, multicenter observational pilot study including CTO patients who were not eligible for an ICD and had a left ventricular ejection fraction >35 %. We enrolled patients with a successful CTO revascularization (group A) and patients with untreated CTO or failed CTO revascularization (group B). All patients received an implantable loop recorder with remote monitoring. The primary endpoint was sustained VA. Results: Ninety patients were enrolled (mean age 63 ± 10 years, 83.3 % man, mean LVEF 55 ± 8 %). Group A (n = 45) had a higher prevalence of CTO in the left anterior descending artery in comparison to group B (n = 45) (28.9 % versus 4.4 %, P = 0.002). Other baseline characteristics were similar. During a median follow-up time of 26 months (IQR, 19-35), five patients (5.6 %) had a sustained VA. There was no difference in the incidence of sustained VA between groups (3-year cumulative event rate: 8.8 % (group A) versus 4.5 % (Group B), log-rank P = 0.71). Conclusion: Patients with an CTO, who do not qualify for an ICD, have a substantial risk of sustained VA. In our study the incidence was not different between patients with revascularized and those with untreated CTO.

Ten-year prognostic impact of target versus non-target vessel failure after STEMI. Insight from the EXAMINATION-EXTEND trial.

INTRODUCTION AND OBJECTIVES: After ST-segment myocardial infarction (STEMI), the impact of different adverse events on prognosis remains unknown. We aimed to assess very long-term predictors of patient-oriented composite endpoints (POCE) and investigate whether the occurrence of target vessel failure (TVF) vs a non-TVF event as the first event could potentially influence subsequent outcomes. METHODS: The EXAMINATION-EXTEND trial randomized STEMI patients to receive either an everolimus-eluting stent or a bare-metal stent. The follow-up period was 10 years. Predictors of POCE (a composite of all-cause death, any myocardial infarction, or any revascularization) were evaluated in the overall study population. The patients were stratified based on the type of first event (TVF-first vs non-TVF-first) and were compared in terms of subsequent POCE. TVF was defined as a composite of cardiac death, TV myocardial infarction, or TV revascularization. RESULTS: Out of the 1498 enrolled patients, 529 (35.3%) experienced a POCE during the 10-year follow-up. Independent predictors of POCE were age, diabetes mellitus, previous myocardial infarction, peripheral arterial disease, and multivessel coronary disease. The first event was a TVF in 296 patients and was a non-TVF in 233 patients. No significant differences were observed between TVF-first and non-TVF-first patients in terms of subsequent POCE (21.7% vs 39.3%, time ratio 1.79; 95%CI, 0.87-3.67;P=.12) or its individual components. CONCLUSIONS: At the 10-year follow-up, approximately one-third of STEMI patients had experienced at least 1 POCE. Independent predictors of these events were age, diabetes, and more extensive atherosclerotic disease. The occurrence of a TVF or a non-TVF as the first event did not seem to influence subsequent outcomes. TRIAL REGISTRATION NUMBER: NCT04462315.

Reproducibility of an artificial intelligence optical coherence tomography software for tissue characterization: Implications for the design of longitudinal studies.

BACKGROUND: To assess the reproducibility of coronary tissue characterization by an Artificial Intelligence Optical Coherence Tomography software (OctPlus, Shanghai Pulse Medical Imaging Technology Inc.). METHODS: 74 patients presenting with multivessel ST-segment elevation myocardial infarction (STEMI) underwent optical coherence tomography (OCT) of the infarct-related artery at the end of primary percutaneous coronary intervention (PPCI) and during staged PCI (SPCI) within 7 days thereafter in the MATRIX (Minimizing Adverse Hemorrhagic Events by Transradial Access Site and angioX) Treatment-Duration study (ClinicalTrials.gov, NCT01433627). OCT films were run through the OctPlus software. The same region of interest between either side of the stent and the first branch was identified on OCT films for each patient at PPCI and SPCI, thus generating 94 pairs of segments. 42 pairs of segments were re-analyzed for intra-software difference. Five plaque characteristics including cholesterol crystal, fibrous tissue, calcium, lipid, and macrophage content were analyzed for various parameters (span angle, thickness, and area). RESULTS: There was no statistically significant inter-catheter (between PPCI and SPCI) or intra-software difference in the mean values of all the parameters. Inter-catheter correlation for area was best seen for calcification [intraclass correlation coefficient (ICC) 0.86], followed by fibrous tissue (ICC 0.87), lipid (ICC 0.62), and macrophage (ICC 0.43). Some of the inter-catheter relative differences for area measurements were large: calcification 9.75 %; cholesterol crystal 74.10 %; fibrous tissue 5.90 %; lipid 4.66 %; and macrophage 1.23 %. By the intra-software measurements, there was an excellent correlation (ICC > 0.9) for all tissue types. The relative differences for area measurements were: calcification 0.64 %; cholesterol crystal 5.34 %; fibrous tissue 0.19 %; lipid 1.07 %; and macrophage 0.60 %. Features of vulnerable plaque, minimum fibrous cap thickness and lipid area showed acceptable reproducibility. CONCLUSION: The present study demonstrates an overall good reproducibility of tissue characterization by the Artificial Intelligence Optical Coherence Tomography software. In future longitudinal studies, investigators may use discretion in selecting the imaging endpoints and sample size, accounting for the observed relative differences in this study.

Direct Stenting versus Conventional Stenting in Patients with ST-Segment Elevation Myocardial Infarction-A COMPARE CRUSH Sub-Study.

BACKGROUND: Direct stenting (DS) compared with conventional stenting (CS) after balloon predilatation may reduce distal embolization during percutaneous coronary intervention (PCI), thereby improving tissue reperfusion. In contrast, DS may increase the risk of stent underexpansion and target lesion failure. METHODS: In this sub-study of the randomized COMPARE CRUSH trial (NCT03296540), we reviewed the efficacy of DS versus CS in a cohort of contemporary, pretreated ST-segment elevation myocardial infarction (STEMI) patients undergoing primary PCI. We compared DS versus CS, assessing (1) stent diameter in the culprit lesion, (2) thrombolysis in myocardial infarction (TIMI) flow in the infarct-related artery post-PCI and complete ST-segment resolution (STR) one-hour post-PCI, and (3) target lesion failure at one year. For proportional variables, propensity score weighting was applied to account for potential treatment selection bias. RESULTS: This prespecified sub-study included 446 patients, of whom 189 (42%) were treated with DS. Stent diameters were comparable between groups (3.2 ± 0.5 vs. 3.2 ± 0.5 mm, p = 0.17). Post-PCI TIMI 3 flow and complete STR post-PCI rates were similar between groups (DS 93% vs. CS 90%, adjusted OR 1.16 [95% CI, 0.56-2.39], p = 0.69, and DS 72% vs. CS 58%, adjusted OR 1.29 [95% CI 0.77-2.16], p = 0.34, respectively). Moreover, target lesion failure rates at one year were comparable (DS 2% vs. 1%, adjusted OR 2.93 [95% CI 0.52-16.49], p = 0.22). CONCLUSION: In this contemporary pretreated STEMI cohort, we found no difference in early myocardial reperfusion outcomes between DS and CS. Moreover, DS seemed comparable to CS in terms of stent diameter and one-year vessel patency.

Long-term clinical outcomes in patients with non-ST-segment Elevation Acute Coronary Syndrome and ST-segment elevation myocardial infarction with thrombolysis in myocardial infarction 0 flow.

Background: Thrombolysis in Myocardial Infarction (TIMI) 0 flow often characterizes ST-segment Elevation Myocardial Infarction (STEMI) patients, but may also feature in non-ST-segment Elevation Acute Coronary Syndrome (NSTE-ACS). Since recanalization usually occurs later in NSTE-ACS patients, the aim of this study was to assess whether patients presenting with NSTE-ACS and TIMI 0 flow have worse clinical outcomes as compared to patients presenting with STEMI and TIMI 0 flow. Methods: A single-center retrospective cohort study was conducted with patients treated for NSTE-ACS and STEMI with TIMI 0 flow at diagnostic angiogram between January 2015 and December 2019. The two patient groups were 1:1 matched using a propensity score logistic regression model. The primary outcome was Major Adverse Cardiac Events (MACE), a composite of all-cause mortality, any myocardial infarction, coronary artery bypass graft, urgent target vessel revascularization or stroke during long term follow-up. Results: The total population consisted of 1255 ACS patients, of which 249 NSTE-ACS and 1006 STEMI patients. After propensity score matching, 234 NSTE-ACS patients were matched with 234 STEMI patients. In this matched population, the mean age was 62.6 (±12.4) years and 75.2 % of the patients was male. The median follow-up time was 3.2 years. MACE rates during follow-up were similar between the two matched groups (HR = 0.84 [95 % CI 0.60 - 1.12] with p = 0.33) with cumulative event-free survival of 63.3 % in the NSTE-ACS group vs 59.3 % in the STEMI group at 6 year follow-up. Conclusion: In this retrospective study, a culprit lesion with TIMI 0 flow has similar clinical outcome in NSTE-ACS and STEMI patients. Further research is warranted to determine optimal the timing of PCI in NSTE-ACS patients with TIMI 0 flow.

Immediate versus staged complete revascularization in acute coronary syndrome: A meta-analysis of randomized controlled trials.

BACKGROUND: Clinical guidelines recommend a complete revascularization (CR) in patients with acute coronary syndromes (ACS) and multivessel disease (MVD). However, its optimal timing is unclear. The aim of this meta-analysis was to compare the clinical outcomes following immediate versus staged CR in ACS. METHODS: PubMed and Scopus were searched until March 2023 for randomized controlled trials (RCTs) comparing immediate versus staged CR. The primary endpoint was major adverse cardiovascular event (MACE) at the longest follow-up. Secondary outcomes were all-cause death, cardiovascular death, myocardial infarction (MI), any unplanned revascularization, target-vessel revascularization (TVR), and stent thrombosis. Safety outcomes were major bleeding, contrast volume, procedure duration, and length of hospitalization. RESULTS: Eight RCTs were included (3559 patients, weighted mean follow-up 12.5 months). There were no differences in the primary endpoint (OR 0.74, 95%CI: 0.54-1.01) and in the secondary endpoints of death, and stent thrombosis between the two CR strategies. Immediate CR was associated with a lower risk of recurrent MI (OR 0.51, 95% CI 0.34-0.76), any unplanned revascularization (OR 0.59, 95%CI: 0.43-0.80), and TVR (OR 0.61, 95% CI 0.45-0.84) compared to staged CR. Immediate CR was also associated with lower total contrast volume and shorter total procedure duration and hospitalization length compared to staged CR without differences in major bleedings. CONCLUSION: No difference was found between immediate and staged CR regarding MACE, or deaths rates at one year. Immediate CR may be associated with a lower risk of recurrent MI and unplanned coronary revascularization than staged CR.

Clinical and Vessel Characteristics Associated With Hard Outcomes After PCI and Their Combined Prognostic Implications.

Background Cardiac death or myocardial infarction still occurs in patients undergoing contemporary percutaneous coronary intervention (PCI). We aimed to identify adverse clinical and vessel characteristics related to hard outcomes after PCI and to investigate their individual and combined prognostic implications. Methods and Results From an individual patient data meta-analysis of 17 cohorts of patients who underwent post-PCI fractional flow reserve measurement after drug-eluting stent implantation, 2081 patients with available clinical and vessel characteristics were analyzed. The primary outcome was cardiac death or target-vessel myocardial infarction at 2 years. The mean age of patients was 64.2±10.2 years, and the mean angiographic percent diameter stenosis was 63.9%±14.3%. Among 11 clinical and 8 vessel features, 4 adverse clinical characteristics (age ≥65 years, diabetes, chronic kidney disease, and left ventricular ejection fraction <50%) and 2 adverse vessel characteristics (post-PCI fractional flow reserve ≤0.80 and total stent length ≥54 mm) were identified to independently predict the primary outcome (all P<0.05). The number of adverse vessel characteristics had additive predictability for the primary end point to that of adverse clinical characteristics (area under the curve 0.72 versus 0.78; P=0.03) and vice versa (area under the curve 0.68 versus 0.78; P=0.03). The cumulative event rate increased in the order of none, either, and both of adverse clinical characteristics ≥2 and adverse vessel characteristics ≥1 (0.3%, 2.4%, and 5.3%; P for trend <0.01). Conclusions In patients undergoing drug-eluting stent implantation, adverse clinical and vessel characteristics were associated with the risk of cardiac death or target-vessel myocardial infarction. Because these characteristics showed independent and additive prognostic value, their integrative assessment can optimize post-PCI risk stratification. Registration URL: https://www.clinicaltrials.gov; Unique identifier: NCT04684043. www.crd.york.ac.uk/prospero/. Unique Identifier: CRD42021234748.