Treatment of in-stent restenosis (ISR) is challenging. Drug-coated balloons (DCB) are widely used in this setting to avoid deploying another metal layer to the vessel wall. This first-in-man study sought to assess the safety and efficacy of a novel everolimus-DCB (CVT-DCB) using a new coating formulation and crystalline everolimus in patients with ISR. A total of 51 patients (mean age 69.2 years) with single ISR lesions (≤24 mm in length) were prospectively enrolled at nine sites in Europe. The primary safety endpoint, freedom from target lesion failure at 180 days, was 92.2%, with the lower bound of the 95% CI (81.1%), above the protocol-defined objective performance criterion (65% for conventional balloon angioplasty, p <0.05). The primary efficacy endpoint, in-stent late lumen loss, was 0.40 mm, lower than the protocol-defined objective performance criterion of balloon angioplasty historical control (late lumen loss 0.80 mm, p <0.001). Three-year clinical follow-up was obtained in all (100%) patients. During the first year, 4 patients required ischemia-driven target lesion revascularization. No new episodes of TVF (cardiac death, myocardial infarction, or ischemia-driven target lesion revascularization) occurred beyond the first year. The target lesion failure rate at 3 years was 9.8% (95% CI 3.3%-21.4%). The clinical follow-up of this first-in-man study confirms the sustained safety and efficacy of this novel everolimus DCB in patients with ISR. (Clinical Trials Registration: NCT05731700).

Identifying significant coronary artery disease (CAD) in patients with reduced left ventricular ejection fraction (rLVEF) is essential for guiding therapeutic decisions, including medical management, device implantation and potential revascularisation. Prior studies suggested that rest cardiac MRI (CMR) with late gadolinium enhancement (LGE) could reliably detect significant CAD. We aimed to evaluate the diagnostic accuracy of rest LGE-CMR for predicting significant CAD in rLVEF patients. In this prospective, multicentre cohort study across 10 centres, adults with new-onset rLVEF≤45% without obvious cause were included. All patients underwent rest CMR and coronary angiography. Independent, blinded committees reviewed images. Significant CAD was defined as ≥70% stenosis in major coronary arteries. Ischaemic scars were identified on CMR as subendocardial LGE. The primary outcome was the sensitivity of CMR in detecting significant CAD. Among 380 patients (median age 63 years, 68% male), significant CAD was present in 49 (13%). CMR identified ischaemic scars in 106 (28%). The sensitivity of CMR for detecting significant CAD was 57% (95% CI: 43% to 71%), specificity 76% (95% CI: 72% to 81%), positive predictive value 26% (95% CI: 18% to 35%) and negative predictive value 92% (95% CI: 89% to 95%). A CMR-first strategy would have missed 43% of significant CAD cases, many requiring revascularisation (86% of missed cases). In this large, prospective multicentre study with independent image review, rest LGE-CMR demonstrated limited sensitivity for detecting significant CAD in patients with rLVEF. Relying solely on CMR could lead to missed diagnoses and undertreatment. CMR should be integrated with other diagnostic tools to optimise care in this population. NCT03231189.

BACKGROUND AND AIMS:Myocardial infarction with nonobstructive coronary arteries (MINOCA) is a heterogeneous group of clinical entities requiring further investigation to assess prognosis and guide treatment. We evaluated current diagnostic practices across European academic centres in its diagnosis and management, to focus on current gaps in clinical practice. METHODS:Between June and October 2023, we distributed an electronic survey to 42 centres selected from a 2023 list of European Association of Percutaneous Cardiovascular Interventions Hosting Academic Centres, obtaining information on demographics of MINOCA, perceived clinical impact, testing and treatments. RESULTS:The analysis was based on data from 41 centres. According to the survey, MINOCA accounts for approximately 10% of MI cases. Only 38% of the respondents perceived MINOCA as increasing the risk for future major adverse cardiovascular events. Sixty-three percent of centres agreed on the need for further testing after MINOCA diagnosis, and 22% reported proceeding with a comprehensive diagnostic algorithm. Intravascular (51%) and cardiac magnetic resonance imaging (50%) were the most common diagnostic tools used. Coronary plaque disruption was perceived as the most frequent cause based on respondents' opinions. Sixty-nine percent of centres considered 'empiric' therapy acceptable without functional testing. CONCLUSIONS:This survey revealed a significant heterogeneity in the diagnostic approaches to MINOCA in academic European centres, with variable belief of its clinical impact, wide variation in diagnostic algorithms, noteworthy diagnostic inertia, and poor adherence to guideline recommendations. All these point to a pressing need for a unified approach to MINOCA testing and a much closer alignment to guidelines.

BACKGROUND:Treatment of patients with in-stent restenosis (ISR) remains challenging. In this setting the use of drug-coated balloons (DCB) represents an attractive approach to avoid adding another metal layer to the coronary wall. AIMS:The Chansu Vascular Technologies (CVT)-ISR trial aimed to evaluate the safety and efficacy of a novel everolimus-DCB (CVT-DCB) using a new coating formulation and crystalline everolimus. METHODS:The CVT-ISR trial was a prospective, multicenter, open, single-arm, first-in-man (FIM) study. A total of 51 patients (mean age 69.2 years, 74.5% male) with single ISR coronary lesions (≤24 mm in length) were enrolled at nine sites in Europe. RESULTS:The primary safety endpoint, freedom from target lesion failure (TLF) at 180 days, was 92.2%, with the lower bound of the 95% confidence interval (81.1%), above the protocol-defined objective performance criterion (OPC) (65% for conventional balloon angioplasty, P  < 0.05). At 1 year freedom from TLF was 90.2%. The primary efficacy endpoint, in-stent late lumen loss at 180 days (evaluated in a predefined subgroup of 25 patients scheduled for late angiography), was 0.40 mm (median 0.30 mm), lower than the protocol-defined OPC of the plain balloon angioplasty historical control (0.80 mm, P  < 0.001). CONCLUSION:This FIM study demonstrated the superior efficacy of the new everolimus CVT-DCB compared with conventional balloon angioplasty in the treatment of patients with ISR. CLINICAL TRIALS REGISTRATION:NCT05731700.

OBJECTIVES:This study aimed to detail the technical management of Medina 0.0.1 lesions, assess their outcomes, and identify predictors of Major Adverse Cardiovascular Events (MACE). BACKGROUND:Medina 0.0.1 bifurcations are rare and under-researched, with their optimal treatment strategy still debated and poorly described in daily practice. METHODS:A multicenter international registry enrolled 273 patients (277 lesions) undergoing PCI for de novo Medina 0,0,1 lesions (2017-2022). Data were systematically collected, and clinical follow-up was performed. The primary endpoint was 3-year MACE (cardiovascular death, myocardial infarction, and target vessel revascularization). Target lesion revascularization and stent thrombosis were secondary endpoints. RESULTS:Median follow-up was 1180 days. Most cases were treated with planned one-stent PCI (84.1 %), mainly inverted provisional and ostial stenting (53.6 % and 45.9 %, respectively). The incidence of MACE and TLR was 16.9 % and 13.4 %, respectively. Univariate analysis identified dyslipidemia, diabetes, prior PCI, and left main bifurcation as predictors of MACE. Proximal optimization technique significantly reduced 3-year MACE (HR 0.28, 95 % CI 0.10-0.80, p = 0.03). Multivariate analysis identified diabetes as the only independent predictor of 3-year MACE (adjusted HR 2.35, 95 % CI 1.23-4.49, p = 0.01). No significant difference in 3-year MACE was found between inverted provisional and ostial stenting (17.2 % vs. 12.1 %). CONCLUSION:Medina 0.0.1 bifurcations show high levels of MACE and TLR in the long-term. Diabetes emerged as the only independent 3-year MACE predictor. While current recommendations are widely adhered to in left main bifurcation angioplasty, they are less frequently applied in smaller bifurcations and acute settings.

Background Patient-specific 3-dimensional (3D) computational modelling offers a tailored approach with promising results, but experience using digital-twin fusion on real-time fluoroscopy to guide left atrial appendage closure (LAAC) is unreported. Objectives To assess whether LAAC guided by fusion of a 3D computational model on real-time fluoroscopy is safe and effective. Methods We included retrospectively through a multicenter registry all consecutive patients with non-valvular atrial fibrillation (AF) who underwent LAAC guided by artificial intelligence (AI)-enabled computer simulations (FEops, Gent, Belgium) fusion with real-time fluoroscopy. Operators selected the appropriate device size and position in relation to the LAA using FEops HEARTguide™, and a digital twin was provided for image fusion. The primary efficacy endpoint was successful LAAC with the use of a single device, without moderate or greater peri-device leak and/or device related thrombus (DRT) on follow-up imaging. The primary safety endpoint was a composite of major procedural complications including tamponade, stroke, systemic embolism, major bleeding, and device embolization. Results A total of 106 patients underwent LAAC with an Amulet™ or Watchman FLX™ device using CT-model-fluoroscopy fusion imaging. Device implantation was successful in 100 % of cases. The primary efficacy endpoint was met in 82 patients (89 %). A single-device SINGLE-deployment LAAC procedure was observed in 49 cases (46 %). The primary safety endpoint occurred in 2 patients (1.9 %). After a median follow-up of 405 days, two patients suffered an ischemic stroke and four expired. Conclusions Fusion of a CT-based 3D computational model on real-time fluoroscopy is a safe and effective approach that may optimize transcatheter LAAC outcomes.

Background: Cardiac magnetic resonance imaging may provide a non-invasive alternative to coronary angiography for differentiating between ischaemic and non-ischaemic cardiomyopathy in cases of unexplained reduced left ventricular ejection fraction.Aim: The CAMAREC study aims to evaluate the diagnostic accuracy of cardiac magnetic resonance imaging in predicting significant coronary artery disease in patients with reduced left ventricular ejection fraction, using coronary angiography as the gold standard for comparison.Methods: CAMAREC is a prospective cohort study of 406 patients in 10 centres with newly diagnosed, unexplained left ventricular ejection fraction <= 45%. Cardiac magnetic resonance imaging and coronary angiography will be conducted within a 2-week interval, starting with cardiac magnetic resonance imaging; independent committees will review the results blindly. Primary outcome is sensitivity of detecting ischaemic scar on cardiac magnetic resonance imaging for predicting significant coronary artery disease on coronary angiography according to Felker's criteria. Secondary outcomes include specificity and positive and negative predictive values (with 95% confidence intervals) of cardiac magnetic resonance imaging for predicting significant coronary artery disease in patients with reduced left ventricular ejection fraction, kappa concordance coefficient between cardiac magnetic resonance imaging and coronary angiography for diagnosing the affected myocardial territory, and the impact of cardiac magnetic resonance imaging on revascularization decisions. Two ancillary studies will evaluate the incremental cost-effectiveness of using cardiac magnetic resonance imaging firstversus coronary angiography first, and the sensitivity of pre-and postcontrast T1-mapping for predicting significant coronary artery disease in patients with reduced left ventricular ejection fraction. Conclusion: Our study protocol is designed to rigorously evaluate cardiac magnetic resonance imaging as a non-invasive alternative to coronary angiography in patients with unexplained reduced left ventricular ejection fraction. The results will have significant implications for patient management, and may support growing evidence for the clinical utility of cardiac magnetic resonance imaging.(c) 2023 Elsevier Masson SAS. All rights reserved.

Background: Because rotational atherectomy (RA) is associated with arterial trauma and platelet activation, patients treated with RA may benefit from more potent antiplatelet drugs. The aim of this trial was to assess the superiority of ticagrelor over clopidogrel in reducing post procedure troponin release. Methods: TIRATROP (TIcagrelor in Rotational Atherectomy to reduce TROPonin enhancement) is a multicenter double-blind randomized controlled trial that included 180 patients with severe calcified lesions requiring RA who received either clopidogrel (300 mg loading dose, then 75 mg/d) or ticagrelor (loading dose 180 mg then 90 mg twice daily). Blood samples were collected at the beginning (T0), and 6, 12, 18, 24 and 36 h after the procedure. Primary end point was troponin release within the first 24 h using area under the curve analysis (troponin level as a function of time). Results: The mean age of patients was 76 ± 10 years, 35% had diabetes. RA was used to treat 1, 2 or 3 calcified lesions in 72%, 23% and 5% of patients, respectively. Troponin release within the first 24 h was similar in both the ticagrelor (adjusted mean ±SD of ln AUC 8.85 ± 0.33) and the clopidogrel (8.77 ± 0.34, p = 0.60) arms. Independent predictors for troponin enhancement were acute coronary syndrome presentation, renal failure, elevated C-Reactive protein and multiple lesions treated with RA. Conclusion: Troponin release did not differ among treatment arms. Our results suggest that greater platelet inhibition does not affect periprocedural myocardial necrosis in the setting of RA.

Background:Personalized prognosis plays a vital role in deciding between percutaneous coronary intervention (PCI) and coronary artery bypass grafting (CABG) in patients with three-vessel disease (3VD). The aim of this study is to compare the modality of revascularization chosen by the local heart team to that recommended by using individualized predictions of medium, and long-term all-cause mortality amongst patients with 3VD screened in the Multivessel TALENT trial. Methods:The SYNTAX score II (SS-II) and SS-2020 were evaluated in 200 consecutive patients by a core laboratory and compared to the decision of the "on site" heart team. Results:According to the SS-II, CABG was the recommended treatment in 51 patients (25.5%) however 34 (66.6%) of them received PCI. According to SS-2020 the predicted absolute risk differences (ARD) between PCI and CABG were significantly higher in patients receiving CABG compared to those treated by PCI for major adverse cardiovascular and cerebrovascular events, a composite of all-cause mortality, stroke or myocardial infarction at 5-years (8.8 ± 4.6% vs 6.0 ± 4.0%, p < 0.001) and all-cause mortality at 5- (5.2 ± 3.5% vs 3.7 ± 3.0%, p = 0.008) and 10-years (9.3 ± 4.8% vs 6.2 ± 4.2%, p < 0.001). Based on the novel threshold of equipoise (individual absolute risk differences [ARD] < 4.5%), 133 patients were eligible for PCI however 23 of them underwent CABG; conversely, amongst the 67 patients where CABG was recommendation (individual ARD > 4.5%), only 19 received it. Conclusions:Despite the robustness of the risk models proposed for screening, several deviations from the recommended mode of revascularization were observed by the core laboratory among the first 200 patients with 3VD screened in the Multivessel TALENT trial. Clinical Trial Registration:ClinicalTrials.gov reference: NCT04390672.

Background: Intravascular lithotripsy (IVL) is a promising new technology for disrupting de-novo calcified cor-onary lesions (DNL) before percutaneous coronary intervention (PCI). We assessed 12-month outcomes of IVL in patients undergoing PCI for DNL or intra stent restenosis (ISR) lesions related to device underexpansion. Methods: Prospective analysis of patients in the multicentre all-comers French Shock Initiative IVL registry. The primary safety endpoints in this analysis were in-hospital and 12-month major adverse cardiovascular events (MACE: cardiac death, myocardial infarction or target vessel revascularization). The primary effectiveness endpoint was procedural success, defined as <30% residual stenosis without severe angiographic complications. Event rates were analysed for the cohort and for DNL and ISR procedures separately. Results: A total of 220 lesions were treated (76.7% DNL and 23.3% ISR) in 202 patients. Procedural success was achieved in 95.5% of patients (DNL group: 96.5%; ISR group: 92.0%). In-hospital MACE occurred in 6.4% of cases, mainly driven by periprocedural infarctions. The rate of MACE-free survival at 1 year was 86.6% in the overall cohort. Rates of target vessel (TVR) and lesion (TLR) revascularisation were 6.4% and 2.5%, respectively. The 1-year MACE rate was 91.5% in DNL group and 83.8% in ISR group. Conclusions: In this large all-comers IVL cohort, rates of in-hospital and 1-year MACE were moderate. The safety and efficiency of IVL was comparable in DNL and ISR lesions. A comparative study of the impact of IVL on outcomes appears warranted.

We report the case of an extended pseudo-subarachnoid hemorrhage (PSAH) related to contrast intracerebral diffusion from blood-brain barrier breakdown on periprocedural percutaneous coronary intervention right corticofrontal ischemic stroke. PSAH is a rare and complex phenomenon, and it is important to differentiate PSAH from subarachnoid hemorrhage to avoid inappropriate treatment with potentially severe consequences. (Level of Difficulty: Beginner.)

Background The increased use of reperfusion therapy in ST-segment-elevation myocardial infarction (STEMI) patients in the past decades is generally considered the main determinant of improved outcomes. The aim was to assess 20-year trends in profile, management, and one-year outcomes in STEMI patients in relation with use or non-use of reperfusion therapy (primary percutaneous coronary intervention (pPCI) or fibrinolysis). Methods We used data from 5 one-month French nationwide registries, conducted 5 years apart from 2005 to 2015, including 8579 STEMI patients (67% with and 33% without reperfusion therapy) admitted to cardiac intensive care units in France. Results Use of reperfusion therapy increased from 49% in 1995 to 82% in 2015, with a shift from fibrinolysis (37.5% to 6%) to pPCI (12% to 76%). Early use of evidence-based medications gradually increased over the period in both patients with and without reperfusion therapy, although it remained lower at all times in those without reperfusion therapy. One-year mortality decreased in patients with reperfusion therapy (from 11.9% in 1995 to 5.9% in 2010 and 2015, hazard ratio [HR] adjusted on baseline profile 0.40; 95% CI: 0.29-0.54, P < .001) and in those without reperfusion therapy (from 25.0% to 18.2% in 2010 and 8.1% in 2015, HR: 0.33; 95% CI: 0.24-0.47, P < .001). Conclusions In STEMI patients, one-year mortality continues to decline, both related to increased use of reperfusion therapy and progress in overall patient management. In patients with reperfusion therapy, mortality has remained stable since 2010, while it has continued to decline in patients without reperfusion therapy.

AIMSLong-term data on bioabsorbable polymer-coated everolimus-eluting stents (BP-EES) are limited. The EVOLVE trial compared the safety and efficacy of two dose formulations of the SYNERGY BP-EES with the permanent polymer-coated PROMUS Element EES (PE).METHODS AND RESULTSThe EVOLVE study was a prospective, multicentre, non-inferiority trial that randomised 291 patients with de novo coronary lesions (length: ≤28 mm; diameter: ≥2.25 to ≤3.5 mm) to receive PE (n=98), SYNERGY (n=94), or SYNERGY half-dose (n=99). At five years, there were no significant differences in the rates of TLF or individual components between groups. TLR rates trended lower in both SYNERGY arms than in the PE arm (TLR: 1.1% SYNERGY and 1.0% SYNERGY half-dose vs. 6.1% PE; p=0.07 and p=0.06, respectively). TVR was numerically lower in the SYNERGY arms compared to the PE arm (TVR: 3.3% SYNERGY and 4.2% SYNERGY half-dose vs. 10.2% PE; p=0.06 and p=0.11, respectively). No incidence of stent thrombosis was reported in any arm up to five years.CONCLUSIONSThe EVOLVE trial represents the longest-term follow-up of the SYNERGY stent available to date, demonstrating its continued safety and efficacy for the treatment of selected de novo atherosclerotic lesions up to five years.

Significant left main coronary artery disease (LMCAD) occurs in 5–7% of patients undergoing coronary angiography. Patients with LMCAD have a 50% 3-year mortality despite optimal medical therapy. As such, coronary artery bypass grafting (CABG) emerged as the gold standard therapy for the treatment of patients with LMCAD either in isolation or in association with disease elsewhere in the coronary circulation. Advances in stent and adjunctive intracoronary imaging as well as pharmacotherapy has enabled percutaneous coronary intervention (PCI) to challenge CABG in such patients, with a host of randomized and observational studies comparing the safety and efficacy of PCI with CABG. This chapter covers historical data on CABG in LMCAD, compares various PCI techniques with CABG, and finally evaluates the differences in efficacy and safety.

The COMPASS trial applied trial-specific high risk criteria. We sought to determine whether 3-year mortality in a routine-practice population would differ according to the inclusion and exclusion criteria used in COMPASS. We used data from the FAST-MI 2005 and 2010 registries, restricted to

Background. - The FAST-MI programme, consisting of 1-month surveys of patients admitted to hospital for acute myocardial infarction (AMI) in France, has run since 2005.Aim. - To gather data on the characteristics, management and outcomes of patients hospitalized for AMI at the end of 2015 in France and to provide comparisons with the previous surveys.Methods. - Consecutive adults with ST-segment elevation myocardial infarction (STEMI) or non-ST-segment-elevation myocardial infarction (NSTEMI) with symptom onset <= 48 hours were included over a 1-month period, with a possible extension of recruitment for 1 additional month. Patients with AMI following cardiovascular procedures were excluded. In all, 204 centres participated in the survey (114 community hospitals, 40 academic, 48 private clinics, 2 army hospitals), representing 78% of French centres managing AMI patients. Inclusion started from 5 October 2015. Data were collected on-site from source files by external research technicians, using an electronic case record form with automatic quality checks. Centralized biology was organized in voluntary centres to collect RNA and DNA samples, serum and stools. Long-term follow-up was organized centrally with interrogation of municipal registry offices, physicians and by direct contact with the patients or their families.Results. - A total of 5291 patients were included over the entire recruitment period, with 3813 included during the first month (STEMI: 49%, NSTEMI: 51%). Mean age was 66 +/- 14 years, 29% were >= 75 years of age, 28% were women; 80% presented with typical chest pain. In STEMI patients, 6% received intravenous fibrinolysis and 71% underwent primary PCI. The hospital death rate was 2.7% (STEMI: 2.8%, NSTEMI: 2.5%).Conclusions. - Recruitment was in line with expectations and the first data show that management has continued to evolve since the 2010 survey, with continued improvement in hospital outcomes. (C) 2017 Published by Elsevier Masson SAS.