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Background In January 2021, the Diamondback 360 orbital atherectomy (OA) system received CE mark approval and became available in Europe. The first procedure in Europe was performed at the Thoraxcenter, Erasmus Medical Center, Rotterdam, the Netherlands. Aims To report the procedural safety and efficacy of the initial experience with OA in a tertiary care institution in the Netherlands. Methods Patients with de novo severely calcified coronary artery disease who were treated with intended invasive imaging-guided OA were included in a prospective single-centre registry. Device success, defined as less than 50% stenosis after OA, and procedural success, defined as successful stent implantation with less than 50% residual stenosis, were evaluated. Calcium debulking effects were assessed by invasive imaging. Safety was assessed up to 30 days after the index procedure. Results Between February 2021 and June 2021, 29 patients with a total of 39 coronary arteries underwent OA. Target lesions were heavily calcified with a mean length of 32 mm and a calcium arc of 320 degrees. Invasive imaging was applied in all but one patient and 36 vessels. Superficial sanding was observed in almost all vessels (90%) and fracturing of deeper medial calcium in more than half of the vessels (63%), with a device success of 66% and procedural success of 94%. The mean stent symmetry index was 0.84, indicating good circular stent expansion. No primary safety events occurred during 30 days of follow-up. Conclusion Our initial experience with OA for heavily calcified coronary lesions demonstrated favourable debulking effects and plaque modification, with high procedural success and clinical safety.

BACKGROUND: In patients with acute coronary syndrome and multivessel coronary disease, complete revascularisation by percutaneous coronary intervention (PCI) is associated with improved clinical outcomes. We aimed to investigate whether PCI for non-culprit lesions should be attempted during the index procedure or staged.METHODS: This prospective, open-label, non-inferiority, randomised trial was done at 29 hospitals across Belgium, Italy, the Netherlands, and Spain. We included patients aged 18-85 years presenting with ST-segment elevation myocardial infarction or non-ST-segment elevation acute coronary syndrome and multivessel (ie, two or more coronary arteries with a diameter of 2·5 mm or more and ≥70% stenosis based on visual estimation or positive coronary physiology testing) coronary artery disease with a clearly identifiable culprit lesion. A web-based randomisation module was used to randomly assign patients (1:1), with a random block size of four to eight, stratified by study centre, to undergo immediate complete revascularisation (PCI of the culprit lesion first, followed by other non-culprit lesions deemed to be clinically significant by the operator during the index procedure) or staged complete revascularisation (PCI of only the culprit lesion during the index procedure and PCI of all non-culprit lesions deemed to be clinically significant by the operator within 6 weeks after the index procedure). The primary outcome was the composite of all-cause mortality, myocardial infarction, any unplanned ischaemia-driven revascularisation, or cerebrovascular events at 1 year after the index procedure. Secondary outcomes included all-cause mortality, myocardial infarction, and unplanned ischaemia-driven revascularisation at 1 year after the index procedure. Primary and secondary outcomes were assessed in all randomly assigned patients by intention to treat. Non-inferiority of immediate to staged complete revascularisation was considered to be met if the upper boundary of the 95% CI of the hazard ratio (HR) for the primary outcome did not exceed 1·39. This trial is registered with ClinicalTrials.gov, NCT03621501.FINDINGS: Between June 26, 2018, and Oct 21, 2021, 764 patients (median age 65·7 years [IQR 57·2-72·9] and 598 [78·3%] males) were randomly assigned to the immediate complete revascularisation group and 761 patients (median age 65·3 years [58·6-72·9] and 589 [77·4%] males) were randomly assigned to the staged complete revascularisation group, and were included in the intention-to-treat population. The primary outcome at 1 year occurred in 57 (7·6%) of 764 patients in the immediate complete revascularisation group and in 71 (9·4%) of 761 patients in the staged complete revascularisation group (HR 0·78, 95% CI 0·55-1·11, pnon-inferiority=0·0011). There was no difference in all-cause death between the immediate and staged complete revascularisation groups (14 [1·9%] vs nine [1·2%]; HR 1·56, 95% CI 0·68-3·61, p=0·30). Myocardial infarction occurred in 14 (1·9%) patients in the immediate complete revascularisation group and in 34 (4·5%) patients in the staged complete revascularisation group (HR 0·41, 95% CI 0·22-0·76, p=0·0045). More unplanned ischaemia-driven revascularisations were performed in the staged complete revascularisation group than in the immediate complete revascularisation group (50 [6·7%] patients vs 31 [4·2%] patients; HR 0·61, 95% CI 0·39-0·95, p=0·030).INTERPRETATION: In patients presenting with acute coronary syndrome and multivessel disease, immediate complete revascularisation was non-inferior to staged complete revascularisation for the primary composite outcome and was associated with a reduction in myocardial infarction and unplanned ischaemia-driven revascularisation.FUNDING: Erasmus University Medical Center and Biotronik.

The aim of this substudy of the EXAMINATION-EXTEND was to analyze 10-year outcomes according to the patient's age at the time of the first ST-elevation myocardial infarction (STEMI). Of 1,498 patients with STEMI included in the EXAMINATION-EXTEND study, those with a previous history of coronary ischemic even or ischemic stroke were excluded from this analysis. The remaining 1,375 patients were divided into 4 age groups: 75 years. The primary end point was 10-year patient-oriented composite end point (POCE) of all-cause death, any MI, or any revascularization. At 10-year follow-up, patients aged 75 years, led by a lower incidence of all-cause death (75 years: 61.6%, p = 0.001). Cardiac death was more prevalent in the older group (75 years: 35.5%, p = 0.001). In the landmark analyses, between 5- and 10-year follow-up, young patients exhibited a higher incidence of any revascularization (65 years: 1.6%, p = 0.001). In conclusion, in patients with a first STEMI, advanced age was associated with high rates of POCE at 10-year follow-up due to all-cause and cardiac death. Conversely, younger patients exhibited a high risk of revascularization at long-term follow-up.

Background: Vessel Fractional Flow Reserve (vFFR) as assessed by three-dimensional quantitative coronary angiography has high correlation with pressure wire-based fractional flow reserve in both a pre- and post-PCI setting. The present study aims to assess the prognostic value of post-PCI vFFR on the incidence of target vessel failure (TVF), a composite endpoint of cardiac death, target vessel myocardial infarction and target vessel revascularization (TVR) at 5-year follow up. Methods: Post-PCI vFFR was calculated after routine PCI in a total of 748 patients (832 vessels) with available orthogonal angiographic projections of the stented segment. Results: Median age was 65 (IQR 55–74) years, 18.2% were diabetic, and 29.1% presented with stable angina. Median post-PCI vFFR was 0.91 (IQR 0.86–0.95). Vessels were categorized into tertiles based on post-PCI vFFR: low (vFFR

Background Multivessel coronary artery disease (MVD) is highly prevalent in patients presenting with non-ST-segment elevation myocardial infarction (NSTE-ACS) and is associated with worse clinical outcomes compared with single vessel disease patients. Complete revascularization of the culprit and all significant non-culprit lesions reduces the incidence of major adverse cardiac events, but the optimal timing of non-culprit artery revascularization remains unclear. Methods This prespecified substudy of the randomized BIOVASC trial included patients who presented with NSTE-ACS and MVD, defined as ≥ 1 non-culprit related coronary artery with a diameter of ≥ 2.5 mm and ≥ 70% stenosis as per visual estimation or positive coronary physiology testing. Risk differences of the composite of all-cause mortality, myocardial infarction, unplanned ischemia driven revascularization or cerebrovascular events and its individual components were compared between the patients who were randomized to immediate and staged complete revascularization at 30 days and 1 year. Results The BIOVASC trial enrolled 1525 patients, 917 patients presented with NSTE-ACS, of whom 459 were allocated to the immediate complete and 458 to the staged complete revascularization group. The incidences of the primary composite outcome were similar in the two groups (7.9% vs. 10.1%, risk difference 2.2%, 95%CI -1.5 to 6.0, p = 0.24). Immediate complete revascularization was associated with a significant reduction in the incidence of myocardial infarction (2.0% vs. 5.3%, risk difference 3.3%, 95% confidence interval [CI] 0.9 to 5.7, p = 0.008), which was maintained after exclusion of procedure related myocardial infarctions occurring at the index or staged procedure (2.0% vs. 4.4%, risk difference 2.4%, 95%CI 0.1 to 4.7, p = 0.039). Unplanned ischemia driven revascularizations were also reduced in the immediate complete revascularization group (4.2% vs. 7.8%, risk difference 3.5%, 95%CI 0.4 to 6.6, p = 0.025). Conclusions Immediate complete revascularization is safe in NSTE-ACS and was associated with a reduction in myocardial infarctions and unplanned ischemia driven revascularizations in patients presenting with NSTE-ACS and MVD at 1 year.

Background: Severe coronary artery calcification is associated with stent underexpansion and subsequent stent failure. Aims: We aimed to identify optical coherence tomography (OCT)-derived predictors of absolute (minimal stent area [MSA]) and relative stent expansion in calcified lesions. Methods: This retrospective cohort study included patients who underwent percutaneous coronary intervention (PCI) with OCT assessment before and after stent implantation between May 2008 and April 2022. Pre-PCI OCT was used to assess calcium burden and post-PCI OCT was used to assess absolute and relative stent expansion. Results: A total of 361 lesions in 336 patients were analyzed. Target lesion calcification (defined as OCT-detected maximum calcium angle ≥ 30°) was present in 242 (67.0%) lesions. Following PCI, median MSA was 5.37 mm2 in calcified lesions and 6.24 mm2 in noncalcified lesions (p < 0.001). Median stent expansion was 78% in calcified lesions and 83% in noncalcified lesions (p = 0.325). In the subset of calcified lesions, average stent diameter, preprocedural minimal lumen area, and total calcium length were independent predictors of MSA in multivariable analysis (mean difference 2.69 mm2/mm2, 0.52 mm2/mm, and −0.28 mm2/5 mm, respectively, all p < 0.001). Total stent length was the only independent predictor of relative stent expansion (mean difference −0.465% per mm, p < 0.001). Calcium angle, thickness, and the presence of nodular calcification were not significantly associated with MSA or stent expansion in multivariable analyses. Conclusion: Calcium length appeared to be the most important OCT-derived predictor of MSA, whereas stent expansion was mainly determined by total stent length.

Background: The mechanisms underlying the increased risk of bleeding that female patients with ST-segment Elevation Myocardial Infarction (STEMI) exhibit, remains unclear. The present report assessed sex-related differences in response to pre-hospital dual antiplatelet therapy (DAPT) initiation in patients with STEMI. Methods: The COMPARE CRUSH trial randomized patients presenting with STEMI to receive a pre-hospital loading dose of crushed or integral prasugrel tablets in the ambulance. In this substudy, we compared platelet reactivity levels and the occurrence of high platelet reactivity (HPR; defined as platelet reactivity ≥208) between sexes at 4 prespecified time points after DAPT initiation, and evaluated post-PCI bleeding between groups. Results: Out of 633 STEMI patients, 147 (23%) were female. Females compared with males presented with significantly higher levels of platelet reactivity and higher HPR rates at baseline (232 [IQR, 209-256] vs 195 [IQR, 171-220], P < .01, and 76% vs 41%, OR 4.58 [95%CI, 2.52-8.32], P < .01, respectively). Moreover, female sex was identified as the sole independent predictor of HPR at baseline (OR 5.67 [95%CI, 2.56-12.53], P < .01). Following DAPT initiation, levels of platelet reactivity and the incidence of HPR were similar between sexes. Post-PCI bleeding occurred more frequently in females compared with males (10% vs 2%, OR 6.02 [95%CI, 2.61-11.87], P < .01). Female sex was an independent predictor of post-PCI bleeding (OR 3.25 [95%CI, 1.09-9.72], P = .04). Conclusions: In this contemporary STEMI cohort, female STEMI patients remain at risk of bleeding complications after primary PCI. However, this is not explained by sex-specific differences in the pharmacodynamic response to pre-hospital DAPT initiation.

BACKGROUND: Fractional flow reserve (FFR)-guided percutaneous coronary intervention (PCI) is superior to angiography-guided PCI. The clinical uptake of FFR has been limited, however, by the need to advance a wire in the coronary artery, the additional time required and the need for hyperaemic agents which can cause patient discomfort. FFR derived from routine coronary angiography eliminates these issues. AIMS: The aim of this study was to assess the diagnostic performance and accuracy of three-dimensional quantitative coronary angiography (3D-QCA)-based vessel FFR (vFFR) compared to pressure wire-based FFR (≤0.80). METHODS: The FAST II (Fast Assessment of STenosis severity) study was a prospective observational multicentre study designed to evaluate the diagnostic accuracy of vFFR compared to the reference standard (pressure wire-based FFR ≤0.80). A total of 334 patients from six centres were enrolled. Both site-determined and blinded independent core lab vFFR measurements were compared to FFR. RESULTS: The core lab vFFR was 0.83±0.09 and pressure wire-based FFR 0.83±0.08. A good correlation was found between core lab vFFR and pressure wire-based FFR (R=0.74; p

Objectives To compare stent recoil (SR) of the thin-strut durable-polymer Zotarolimus-eluting stent (dp-ZES) and the ultrathin-strut bioabsorbable-polymer Sirolimus-eluting stent (bp-SES) in chronic total occlusions (CTOs) and to investigate the predictors of high SR in CTOs. Background Newer ultrathin drug eluting stent might be associated with lower radial force and higher elastic recoil due to the thinner strut design, possibly impacting on the rate of in-stent restenosis and thrombosis. Methods Between January 2017 and November 2019, consecutive patients with CTOs undergoing percutaneous coronary intervention were evaluated. Only patients treated with dp-ZES or bp-SES were included and stratified accordingly. Quantitative coronary angiography analysis was used to assess absolute SR, relative SR, absolute focal SR, relative focal SR, high absolute, and high relative focal SR. Results A total of 128 lesions (67 treated with dp-ZES and 61 with bp-SES) in 123 patients were analyzed. Between bp-SES and dp-ZES no differences were found in absolute SR (p = .188), relative SR (p = .138), absolute focal SR (p = .069), and relative focal SR (p = .064). High absolute and high relative focal SR occurred more frequently in bp-SES than in dp-ZES (p = .004 and p = .015). Bp-SES was a predictor of high absolute focal SR (Odds ratio [OR] 3.29, 95% confidence interval [CI] 1.50-7.22, p = .003]. High-pressure postdilation and bp-SES were predictors of high relative focal SR (OR 2.22, 95% CI 1.01-4.86, p = .047; OR 2.74, 95% CI 1.24-6.02, p = .012, respectively). Conclusions Both stents showed an overall low SR. However, ultra-thin strut bp-SES was a predictor of high absolute and high relative focal SR.

RESUMEN El intervencionismo coronario complejo es aún un escenario desafiante que todavía se asocia con resultados subóptimos. A lo largo de los años han surgido diferentes estrategias y tecnologías con el objetivo de mejorar dichos resultados. En concreto, el desarrollo y la evolución de herramientas de imagen intravascular para guiar el procedimiento han permitido perfeccionar la evaluación de la lesión y su preparación, y asegurar su optimización. No obstante, los posibles beneficios de su uso en este escenario particular son aún objeto de estudio. En este artículo, el objetivo es resumir brevemente los principales estudios realizados previamente con estas técnicas, así como los ensayos que en la actualidad están en marcha en intervencionismo coronario complejo guiado por imagen.

Objectives: To validate novel dedicated 3D-QCA based on the software to calculate post PCI vessel-FFR (vFFR) in a consecutive series of patients, to assess the diagnostic accuracy, and to assess inter-observer variability. Background: Low post percutaneous coronary intervention (PCI) fractional flow reserve (FFR) predicts future adverse cardiac events. However, FFR assessment requires the insertion of a pressure wire in combination with the use of a hyperemic agent. Methods: FAST POST study is an observational, retrospective, single-center cohort study. One hundred patients presenting with stable angina or non ST-elevation myocardial infarction, who underwent post PCI FFR assessment using a dedicated microcatheter were included. Two orthogonal angiographic projections were acquired to create a 3D reconstruction of the coronary artery using the CAAS workstation 8.0. vFFR was subsequently calculated using the aortic root pressure. Results: Mean age was 65±12 years and 70% were male. Mean microcatheter based FFR and vFFR were 0.91±0.07 and 0.91±0.06, respectively. A good linear correlation was found between FFR and vFFR (r = 0.88; p

tabletop{ vertical-align: top; } ABSTRACT Percutaneous coronary intervention of complex coronary artery disease remains challenging and is still associated with suboptimal cardiovascular outcomes. Over the years, different strategies and technologies have been developed to improve these results. Particularly, the development and evolution of intravascular imaging modalities to guide the procedure have improved lesion assessment and preparation, and stent optimization. However, whether these advantages are beneficial in this particular setting is still under discussion. In this article we intend to briefly summarize previous imaging-guided trials and give an outline on the ongoing large trials that are being conducted on imaging-guided interventions in complex coronary disease.

Background: In patients with prior coronary artery bypass graft surgery (CABG), acute coronary syndrome (ACS) is not uncommon. This study investigated treatment strategy and compared clinical outcomes for native, graft and absent culprit lesions. Methods: Single-center retrospective cohort study. From July 2010 to July 2019, 642 consecutive ACS patients with prior CABG were screened for eligibility. The primary endpoint was major adverse cardiovascular events (MACE) at 1 year, a composite of all-cause mortality, myocardial infarction, stroke and ischemia-driven revascularization. Results: A total of 549 patients were included, with 215 (39.2 %) having native culprits, 256 (46.6 %) graft culprits and 78 (14.2 %) no clear culprits. Patients with native culprits were treated with native PCI in 94.0 %, re-CABG in 0.9 % and optimal medical therapy (OMT) in 5.1 %. Patients with graft culprits were treated with native PCI in 14.1 %, graft PCI in 81.2 %, re-CABG in 0.8 % and OMT in 3.9 %. All patients without a clear culprit received OMT. The cumulative incidence of 1-year MACE was 24.7 % for native vs 26.2 % for graft vs 21.8 % for absent culprits. Kaplan-Meier curves did not differ significantly. In patients with graft culprit, no significant difference in 1-year MACE was observed between native PCI and graft PCI (30.6 % vs 25.5 %, p = 0.36). Conclusions: This retrospective study shows that in ACS patients with prior CABG, MACE occurred frequently and was comparable for native, graft and absent culprits. Native PCI as treatment strategy for patients with a graft culprit was relatively common, with no significant difference in MACE as compared to graft PCI.

Thinner stent struts might lead to a higher risk of recoil and subsequently a smaller minimal stent area (MSA), which is known to be the strongest predictor of stent failure. We compared procedural performance between an ultrathin-strut biodegradable-polymer sirolimus-eluting stent (BP-SES) and a durable-polymer zotarolimus-eluting stent (DP-ZES) using intracoronary imaging.A consecutive cohort of patients underwent percutaneous coronary intervention (PCI) with either BP-SES or DP-ZES in a pseudorandomized fashion between July 2018 and October 2019. In the present subanalysis, we included cases in which post-PCI imaging with intravascular ultrasound (IVUS) or optical coherence tomography (OCT) was performed. The primary endpoint of the study was MSA. Secondary endpoints included percentage stent expansion and presence of residual edge disease, malapposition, tissue protrusion, submedial edge dissections, or edge hematoma.A total of 141 treated lesions (78 BP-SES and 63 DP-ZES) in 127 patients were analyzed. Median age was 69.3 years (interquartile range [IQR], 57.3-75.6) and 74.0% of patients were male. All baseline and procedural characteristics were comparable between both groups. Median MSA was 5.80 mm² (IQR, 4.40-7.24) for BP-SES and 6.35 mm² (IQR, 4.76-8.31) for DP-ZES (P=.15). No significant differences in stent expansion, residual edge disease and presence of malapposition, tissue protrusion, submedial edge dissections, or edge hematomas were found. Stent diameter and stent length were found to be independent predictors of MSA.No significant differences in MSA were found between lesions treated with BP-SES vs DP-ZES. BP-SES and DP-ZES were comparable in terms of procedural performance.

ImportanceFractional flow reserve (FFR) after percutaneous coronary intervention (PCI) is generally considered to reflect residual disease. Yet the clinical relevance of post-PCI FFR after drug-eluting stent (DES) implantation remains unclear.ObjectiveTo evaluate the clinical relevance of post-PCI FFR measurement after DES implantation.Data SourcesMEDLINE, Embase, and the Cochrane Central Register of Controlled Trials were searched for relevant published articles from inception to June 18, 2022.Study SelectionPublished articles that reported post-PCI FFR after DES implantation and its association with clinical outcomes were included.Data Extraction and SynthesisPatient-level data were collected from the corresponding authors of 17 cohorts using a standardized spreadsheet. Meta-estimates for primary and secondary outcomes were analyzed per patient and using mixed-effects Cox proportional hazard regression with registry identifiers included as a random effect. All processes followed the Preferred Reporting Items for Systematic Review and Meta-analysis of Individual Participant Data.Main Outcomes and MeasuresThe primary outcome was target vessel failure (TVF) at 2 years, a composite of cardiac death, target vessel myocardial infarction (TVMI), and target vessel revascularization (TVR). The secondary outcome was a composite of cardiac death or TVMI at 2 years.ResultsOf 2268 articles identified, 29 studies met selection criteria. Of these, 28 articles from 17 cohorts provided data, including a total of 5277 patients with 5869 vessels who underwent FFR measurement after DES implantation. Mean (SD) age was 64.4 (10.1) years and 4141 patients (78.5%) were men. Median (IQR) post-PCI FFR was 0.89 (0.84-0.94) and 690 vessels (11.8%) had a post-PCI FFR of 0.80 or below. The cumulative incidence of TVF was 340 patients (7.2%), with cardiac death or TVMI occurring in 111 patients (2.4%) at 2 years. Lower post-PCI FFR significantly increased the risk of TVF (adjusted hazard ratio [HR] per 0.01 FFR decrease, 1.04; 95% CI, 1.02-1.05; P P = .049). These associations were consistent regardless of age, sex, the presence of hypertension or diabetes, and clinical diagnosis.Conclusions and RelevanceReduced FFR after DES implantation was common and associated with the risks of TVF and of cardiac death or TVMI. These results indicate the prognostic value of post-PCI physiologic assessment after DES implantation.

Background: Angiography-based vessel fractional flow reserve (vFFR) demonstrated a strong correlation with invasive fractional flow reserve (FFR) in both a pre- and post-percutaneous coronary intervention (PCI) setting. However, the role of vFFR and its correlation with post-PCI FFR in chronic coronary occlusions (CTO) has not been evaluated yet. We sought to investigate the diagnostic performance of post-PCI vFFR with post-PCI FFR as a reference in patients undergoing successful CTO PCI. Methods: Between March 2016 and April 2020, a total of 80 patients from the FFR-SEARCH (prospective registry) and FFR REACT (randomized controlled trial) studies underwent successful CTO recanalization with post-PCI FFR measurements. Results: A total of 50 patients (median age 66 (interquartile range [IQR]: 56−74) years, 76% were male) were eligible for the analysis. Median post-PCI FFR was 0.89 (IQR: 0.84−0.94), while median post-PCI vFFR was 0.91 (IQR: 0.85−0.94) (p 0.10). Suboptimal physiological results, defined as FFR and vFFR

BACKGROUND/PURPOSE: Direct Stenting (DS) could be associated with reduced distal embolization and improved reperfusion in patients with ST-segment elevation myocardial infarction (STEMI). However, the impact of DS on long-term outcomes remains unclear, therefore we evaluated the impact of DS on very long-term clinical outcome in STEMI.METHODS/MATERIALS: Between April 2002 and December 2004, patients presenting with STEMI undergoing percutaneous coronary intervention were investigated. The study population was divided into two groups: DS and conventional stenting (CS) and stratified according to initial TIMI flow. Major adverse cardiac events (MACE) were assessed at 10 years and all-cause mortality at 15 years. Cox proportional hazards models were used. When the proportional hazards assumption was not satisfied, landmark analysis at mid-term (2 years) was performed.RESULTS: A total of 812 consecutive patients were evaluated, 6 patients were excluded due to inadequate angiographic images, 450 (55.8%) underwent DS and 356 (44.2%) CS. At 15 years follow-up, DS was associated with a reduction in all-cause mortality (DS 35.0% vs. CS 45.3%, aHR 0.74, 95% CI 0.58-0.93, p = 0.010). The landmark analysis at 2 years identifies reduced 2-year MACE in DS compared with CS (6.8% vs.14%, aHR 0.67, 95% CI 0.49-0.93, p = 0.015) and beyond 2 years no significant differences were found between the groups (27.4% vs. 29.3%, aHR 1.00, 95% CI 0.74-1.36, p = 0.999). In patients with baseline TIMI 0-1, DS was associated with lower 10-year MACE and 15-year mortality compared with CS (aHR0.71, 95%CI 0.55-0.92, p = 0.010 and aHR0.65, 95%CI 0.50-0.84, p = 0.001, respectively).CONCLUSIONS: DS was associated with reduced 15-year all-cause mortality and reduced mid-term MACE rate in patients with STEMI. Clinical events reduction associated with DS was particularly relevant in patients with initial TIMI flow 0-1.

Large thrombus burden (LTB) during ST-segment elevation myocardial infarction (STEMI) could translate into worse clinical outcomes. The impact of a LTB in terms of long-term clinical outcomes on different myocardial infarct territories has not yet been fully evaluated. From April 2002 to December 2004, consecutive patients with STEMI undergoing percutaneous coronary intervention with drug eluting stent were evaluated. The study sample was stratified in two groups: anterior STEMI and non-anterior STEMI. LTB was considered as a thrombus larger than or equal to 2-vessel diameters, and small thrombus burden less than 2-vessel diameters. Major adverse cardiac events (MACE) were evaluated at 10-year and survival data were collected up to 15-year. A total of 812 patients were evaluated, 6 patients were excluded due to inadequate angiographic images, 410 (50.9%) had an anterior STEMI and 396 (49.1%) a non-anterior STEMI. Patients with LTB had higher rates of 10-year mortality (aHR 2.27, 95%CI 1.42–3.63; p = 0.001) and 10-year MACE (aHR 1.46, 95%CI 1.03–2.08; p = 0.033) in anterior STEMI, but not in non-anterior STEMI (aHR 0.78, 95%CI 0.49–1.24; p = 0.298; aHR 0.71, 95%CI 0.50–1.02; p = 0.062). LTB was associated with increased 30-day mortality (aHR 5.60, 95%CI 2.49–12.61; p

Objectives: This study sought to compare the pharmacodynamic effects of pre-hospitally administered P2Y12 inhibitor prasugrel in crushed versus integral tablet formulation in patients with ST-segment elevation myocardial infarction (STEMI) undergoing primary percutaneous coronary intervention (pPCI). Background: Early dual antiplatelet therapy is recommended in STEMI patients. Yet, onset of oral P2Y12 inhibitor effect is delayed and varies according to formulation administered. Methods: The COMPARE CRUSH (Comparison of Pre-hospital Crushed Versus Uncrushed Prasugrel Tablets in Patients With STEMI Undergoing Primary Percutaneous Coronary Interventions) trial randomized patients with suspected STEMI to crushed or integral prasugrel 60-mg loading dose in the ambulance. Pharmacodynamic measurements were performed at 4 time points: before antiplatelet treatment, at the beginning and end of pPCI, and 4 h after study treatment onset. The primary endpoint was high platelet reactivity at the end of pPCI. The secondary endpoint was impact of platelet reactivity status on markers of coronary reperfusion. Results: A total of 441 patients were included. In patients with crushed prasugrel, the occurrence of high platelet reactivity at the end of pPCI was reduced by almost one-half (crushed 34.7% vs. uncrushed 61.6%; odds ratio [OR] = 0.33; 95% confidence interval [CI] = 0.22 to 0.50; p < 0.01). Platelet reactivity 12 reactivity units at the beginning of coronary angiography correlated with improved Thrombolysis In Myocardial Infarction flow grade 3 in the infarct artery pre-pPCI (OR: 1.78; 95% CI: 1.08 to 2.94; p = 0.02) but not ST-segment resolution (OR: 0.80; 95% CI: 0.48 to 1.34; p = 0.40). Conclusions: Oral administration of crushed compared with integral prasugrel significantly improves platelet inhibition during the acute phase in STEMI patients undergoing pPCI. However, a considerable number of patients still exhibit inadequate platelet inhibition at the end of pPCI, suggesting the need for alternative agents to bridge the gap in platelet inhibition.

espanolIntroduccion y objetivos: Los pacientes con una reserva fraccional de flujo (FFR) reducida tras intervencion coronaria percutanea (ICP) tienen mayor riesgo de futuros eventos cardiacos adversos. El objetivo del presente estudio fue evaluar predictores especificos de pacientes y procedimientos para el valor de FFR tras una ICP. Metodos: El estudio FFR-SEARCH es un registro prospectivo de un solo centro que incluyo 1.000 pacientes consecutivos que se sometieron a una evaluacion de la FFR tras una ICP con exito angiografico utilizando un microcateter especifico. Se utilizaron modelos de efectos mixtos para buscar predictores independientes de FFR tras la ICP. Resultados: La media de presion distal dividida entre la presion aortica tras la ICP fue de 0,96 ± 0,04, y la media de la FFR tras la ICP fue de 0,91 ± 0,07. Tras ajustar por predictores independientes de FFR tras la ICP, la arteria descendente anterior izquierda como vaso medido fue el predictor mas fuerte (β ajustado = −0,063; IC95%, −0,070 a −0,056; p Conclusiones: Se identificaron diversos predictores independientes relacionados con los pacientes y con los vasos para la FFR posprocedimiento, incluyendo el sexo, la arteria descendente anterior izquierda como vaso medido y el diametro luminal minimo posprocedimiento. EnglishIntroduction and objectives: Patients with a low post-percutaneous coronary intervention (PCI) fractional flow reserve (FFR) are at a higher risk for future adverse cardiac events. The objective of the current study was to assess specific patient and procedural predictors of post-PCI FFR. Methods: The FFR-SEARCH study is a prospective single-center registry of 1000 consecutive all-comer patients who underwent FFR measurements after an angiographically successful PCI with a dedicated microcatheter. Mixed effects models were used to search for independent predictors of post-PCI FFR. Results: The mean post-PCI distal coronary pressure divided by the aortic pressure (Pd/Pa) was 0.96 ± 0.04 and the mean post-PCI FFR, 0.91 ± 0.07. After adjusting for the independent predictors of post-PCI FFR, the left anterior descending coronary artery as the measured vessel was the strongest predictor of post-PCI FFR (adjusted β = –0.063; 95%CI, –0.070 to –0.056; P Conclusions: Multiple independent patient and vessel related predictors of postprocedural FFR were identified, including sex, the left anterior descending coronary artery as the measured vessel, and postprocedural minimum lumen diameter.

BackgroundTreatment preferences in patients with left main (LM) stem disease and no prior revascularization are unknown. The objectives of this study were to determine (i) patient-reported importance ratings of particular features related to percutaneous coronary intervention (PCI) and coronary artery bypass graft (CABG) surgery, (ii) how these features determine treatment preference, and (iii) how educational and psychosocial background influence this preference.MethodsIn this prospective, multicenter study a total of 500 patients without previous revascularization who underwent diagnostic angiography for suspected coronary disease were asked to complete a case-vignette on a (hypothetical) LM stenosis qualifying for both PCI and CABG, in addition to 6 validated questionnaires to assess the influence of psychosocial factors on treatment preference.ResultsOverall, 90% favored PCI over CABG because of the lower bleeding and stroke risk despite a higher likelihood for repeat revascularization. By multivariable regression, the only independent determinant of treatment preference for CABG was lower educational level (14% in low vs. 8% in higher educated patients, OR: 3.22, CI: 1.16–8.95, p = 0.025) while psychosocial variables were not associated. Compared to higher educated patients, those with lower educational level suffered more from depression, anxiety, loneliness, and uncertainty.ConclusionsOverall, patients who are informed about risk and benefits of each treatment modality clearly favor PCI over CABG and particularly value lower short-term morbidity while being aware of higher risk of repeat revascularization. Lower educational level was associated with a higher prevalence of psychosomatic phenotypes and a 14% preference for CABG. Educational and psychosocial background matter in the revascularization strategy decision-making process.

Objectives The aim of this study was to compare ticagrelor monotherapy with dual-antiplatelet therapy (DAPT) after percutaneous coronary intervention (PCI) with drug-eluting stents. Background The role of abbreviated DAPT followed by an oral P2Y12 inhibitor after PCI remains uncertain. Methods Two randomized trials, including 14,628 patients undergoing PCI, comparing ticagrelor monotherapy with standard DAPT on centrally adjudicated endpoints were identified, and individual patient data were analyzed using 1-step fixed-effect models. The protocol was registered in PROSPERO ( CRD42019143120 ). The primary outcomes were the composite of Bleeding Academic Research Consortium type 3 or 5 bleeding tested for superiority and, if met, the composite of all-cause death, myocardial infarction, or stroke at 1 year, tested for noninferiority against a margin of 1.25 on a hazard ratio (HR) scale. Results Bleeding Academic Research Consortium type 3 or 5 bleeding occurred in fewer patients with ticagrelor than DAPT (0.9% vs. 1.7%, respectively; HR: 0.56; 95% confidence interval [CI]: 0.41 to 0.75; p Conclusions Ticagrelor monotherapy was associated with a lower risk for major bleeding compared with standard DAPT, without a concomitant increase in ischemic events.

Contains fulltext : 235262.pdf (Publisher’s version ) (Open Access) Little data are available on access strategy outcomes for cardiac catheterizations in patients with prior coronary artery bypass graft surgery (CABG). We investigated the effect of transradial access (TRA) and transfemoral access (TFA) on short-term major vascular complications (MVC) and long-term major adverse cardiovascular events (MACE). In this single-center, retrospective cohort study, 1084 patients met our inclusion criteria (TRA = 469; TFA = 615). The cumulative incidence for the primary safety endpoint MVC at 30 days (a composite of major bleeding, retroperitoneal hematoma, dissection, pseudoaneurysm, and arteriovenous fistula) was lower with TRA (0.7% vs 3.0%, P < .01) and this difference remained significant after propensity score adjustment (odds ratio: 0.24; 95% CI, 0.07-0.83; P = .024). The cumulative incidence for the primary efficacy endpoint MACE at 36 months (a composite of all-cause mortality, myocardial infarction, stroke, and urgent target vessel revascularization) was 28.6% with TRA and 27.6% with TFA, respectively. Kaplan-Meier curves showed no difference for the primary efficacy endpoint (P = .65). Contrast use (mL) was significantly lower with TRA (130 [100-180] vs 150 [100-213], P < .01). In conclusion, in patients with prior CABG, TRA was associated with significantly fewer short-term MVC and contrast use, but not with a difference in long-term MACE, compared with TFA.

ObjectivesTo evaluate the feasibility of three-vessel three-dimensional (3D) quantitative coronary angiography (QCA)-based fractional flow reserve (FFR) computation in patients discussed within the Heart Team in whom the treatment decision was based on angiography alone, and to evaluate the concordance between 3D QCA-based vessel FFR (vFFR)-confirmed functional lesion significance and revascularisation strategy as proposed by the Heart Team.DesignRetrospective, cohort.Setting3D QCA-based FFR indices have not yet been evaluated in the context of Heart Team decision-making; consecutive patients from six institutions were screened for eligibility and three-vessel vFFR was computed by blinded analysts.ParticipantsConsecutive patients with chronic coronary syndrome or unstable angina referred for Heart Team consultation. Exclusion criteria involved: presentation with acute myocardial infarction (MI), significant valve disease, left ventricle ejection fraction Primary and secondary outcome measuresDiscordance between vFFR-confirmed lesion significance and revascularisation was assessed as the primary outcome measure. Rates of major adverse cardiac events (MACE) defined as cardiac death, MI and clinically driven revascularisation were reported.ResultsOf a total of 1003 patients were screened for eligibility, 416 patients (age 65.6±10.6, 71.2% male, 53% stable angina) were included. The most important reason for screening failure was insufficient quality of the angiogram (43%). Discordance between vFFR confirmed lesion significance and revascularisation was found in 124/416 patients (29.8%) corresponding to 149 vessels (46/149 vessels (30.9%) were reclassified as significant and 103/149 vessels (69.1%) as non-significant by vFFR). Over a median of 962 days, the cumulative incidence of MACE was 29.7% versus 18.5% in discordant versus concordant patients (p=0.031).ConclusionsvFFR computation is feasible in around 40% of the patients referred for Heart Team discussion, a limitation that is mostly based on insufficient quality of the angiogram. Three vessel vFFR screening indicated discordance between vFFR confirmed lesion significance and revascularisation in 29.8% of the patients.

Introduction: The presence of a chronic total occlusion (CTO) is associated with an increased risk of ventricular arrhythmias. Areas covered: This review provides an overview of the relationship between CTO and ventricular arrhythmias, arrhythmogenic mechanisms, and the effect of revascularization. Expert opinion: Studies in recipients of an implantable cardioverter-defibrillator (ICD) have shown that a CTO is an independent predictor of appropriate ICD therapy. The myocardial territory supplied by a CTO is a pro-arrhythmogenic milieu characterized by scar tissue, large scar border zone, hibernating myocardium, residual ischemia despite collaterals, areas of slow conduction, and heterogeneity in repolarization. Restoring coronary flow by revascularization might be associated with electrical homogenization as reflected by a decrease in QT(c) dispersion, decrease in T wave peak-to-end interval, reduction of late potentials, and decrease in scar border zone area. Future research should explore whether CTO revascularization results in a lower burden of ventricular arrhythmias. Furthermore, risk stratification of CTO patients without severe LV dysfunction is interesting to identify potential ICD candidates. Potential tools for risk stratification are the use of electrocardiographic parameters, body surface mapping, electrophysiological study, and close rhythm monitoring using an insertable cardiac monitor.

Objectives: We aimed to evaluate the feasibility of using three dimensional-quantitative coronary angiography (3D-QCA) based fractional flow reserve (FFR) (vessel fractional flow reserve [vFFR], CAAS8.1, Pie Medical Imaging) and to correlate vFFR values with intravascular ultrasound (IVUS) for the evaluation of intermediate left main coronary artery (LMCA) stenosis. Background: 3D-QCA derived FFR indices have been recently developed for less invasive functional lesion assessment. However, LMCA lesions were vastly under-represented in first validation studies. Methods: This observational single-center cohort study enrolled consecutive patients with stable angina, unstable angina, or non-ST-segment elevation myocardial infarction and nonostial, intermediate grade LMCA stenoses who underwent IVUS evaluation. vFFR was computed based on two angiograms with optimal LMCA stenosis projection and correlated with IVUS-derived minimal lumen area (MLA). Results: A total of 256 patients with intermediate grade LMCA stenosis evaluated with IVUS were screened for eligibility; 147 patients met the clinical inclusion criteria and had a complete IVUS LMCA footage available, of them, 63 patients (63 lesions) underwent 3D-QCA and vFFR analyses. The main reason for screening failure was insufficient quality of the angiogram (51 patients,60.7%). Mean age was 65 ± 11 years, 75% were male. Overall, mean MLA within LMCA was 8.77 ± 3.17 mm2, while mean vFFR was 0.87 ± 0.09. A correlation was observed between vFFR and LMCA MLA (r =.792, p =.001). The diagnostic accuracy of vFFR ≤0.8 in identifying lesions with MLA < 6.0 mm2 (sensitivity 98%, specificity 71.4%, area under the curve (AUC) 0.95, 95% confidence interval (CI) 0.89–1.00, p =.001) was good. Conclusions: In patients with good quality angiographic visualization of LMCA and available complete LMCA IVUS footage, 3D-QCA based vFFR assessment of LMCA disease correlates well to LMCA MLA as assessed by IVUS.

International audience; Background: Dual antiplatelet therapy constitutes the cornerstone of medical treatment in patients with ST elevation myocardial infarction (STEMI). However, oral antiplatelet agents, such as prasugrel or ticagrelor, are characterized by slow gastrointestinal drug absorption in the acute phase of STEMI, leading to decreased bioavailability and therefore delayed onset of platelet inhibition. Evidence suggests that administration of crushed tablets of the P2Y12 inhibitor prasugrel improves drug absorption and achieves earlier antiplatelet effects in STEMI patients undergoing primary percutaneous coronary intervention (PCI). However, the clinical implications of these pharmacokinetic and pharmacodynamic findings are unknown.Hypothesis: The present study is designed to test the hypothesis that patients presenting with STEMI planned for primary PCI will have improved markers of optimal reperfusion and clinical outcomes by prehospital administration of crushed tablets of prasugrel loading dose.Study design: COMPARE CRUSH (NCT03296540) is a randomized trial in a regionally organized ambulance care setting evaluating the efficacy and safety of pre-hospital loading dose with prasugrel crushed tablets versus integral tablets in approximately 674 patients presenting with STEMI planned for primary PCI. The independent primary endpoints are percentage of patients reaching thrombolysis in myocardial infarction (TIMI) flow grade 3 in the infarct-related artery at initial angiography, or achieving ≥70% ST-segment elevation resolution at 1 hour post-PCI. Secondary clinical endpoints are death, myocardial infarction, revascularization, and stent thrombosis followed up to 1 year. Moreover, the primary safety endpoint is bleeding events assessed at 48 hours.Conclusions: The COMPARE CRUSH trial will assess whether prehospital administration of loading dose prasugrel in form of crushed tablets - which is expected to provide faster platelet inhibition compared to standard treatment with integral tablets - results in improved reperfusion and clinical outcomes.

The optimal revascularization strategy for residual coronary stenosis following primary percutaneous coronary intervention in patients with ST-segment elevation myocardial infarction (STEMI) and multivessel disease (MVD) remains controversial. This is a retrospective single-centre study including patients with STEMI and MVD. Based on the revascularization strategy, 3 groups were identified: (1) culprit only (CO), (2) ad hoc multivessel revascularization (MVR), and (3) staged MVR. Clinical outcomes were compared in terms of major adverse cardiac events (MACE), a composite of cardiac death, any myocardial infarction, and any unplanned revascularization at a long-term follow-up. A total of 958 patients were evaluated, 489 in the CO, 254 in the ad hoc, and 215 in the staged group. In the staged group, 65.6% of the patients received planned percutaneous coronary intervention, 9.7% coronary artery bypass grafting, 8.4% no further intervention after lesion reassessment, and in 16.3% an event occurred before the planned procedure. At 1,095 days, MACE was 36.1%, 16.7%, and 31% for CO, ad hoc, and staged groups, respectively. A MVR strategy was associated with lower rate of all-cause death compared with CO (HR 0.50; 95%CI [0.31 to 0.80]; p = 0.004). Complete revascularization reduced the rate of MACE (HR 0.30 [0.21 to 0.43] p < 0.001) compared with incomplete revascularization. Ad hoc MVR had lower rate of MACE compared with staged MVR (HR 0.61 [0.39 to 0.96] p = 0.032) mainly driven by less unplanned revascularizations. In conclusion, in patients with STEMI and MVD, complete revascularization reduced the risk of MACE. Ad hoc MVR appeared a reasonable strategy with lower contrast and stent usage and costs.