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.

Les calcifications coronaires sont fréquemment identifiées au sein des lésions coronaires et leur incidence augmente avec l’âge et les facteurs de risque cardiovasculaires. Leur localisation peut être superficielle ou profonde, correspondant à des physiopathologies différentes. Dans tous les cas, la présence de calcifications au sein de la paroi vasculaire est un facteur de mauvais pronostic clinique et d’évolution défavorable après revascularisation percutanée. Les calcifications coronaires peuvent être analysées par angiographie, scanner ou imagerie endocoronaire (IVUS ou OCT) avec des performances variables. L'angiographie est la méthode la plus utilisée mais est peu sensible (sensibilité proche de 50 %) et insuffisante pour leur quantification précise. Le scanner est une méthode non invasive plus efficace permettant une bonne analyse de la lésion avant coronarographie. L'IVUS et l'OCT sont, grâce à leur résolution spatiale, les méthodes les plus sensibles pour l'identification des calcifications (présents dans près de 75–80 % des lésions) et leur quantification. Ces deux dernières techniques offrent des perspectives intéressantes pour l'identification des lésions les plus à risque de mauvais pronostic post revascularisation, la planification des procédures d'angioplastie (dont le choix des outils de préparation de plaque), le monitorage de leur exécution et l’évaluation du résultat post-stenting immédiat.

Data regarding rotational atherectomy percutaneous coronary intervention (RA PCI) angioplasty in the left main (LM) coronary artery are scarce, and mostly outdated. We aimed to describe clinical outcomes of RA PCI in LM. Patients requiring RA in 8 European countries and 19 centers were prospectively and consecutively included in the European registry of Cardiac Care of Calcified and Complex patients registry. In-hospital data collection and 1-year follow-up were performed for each patient. Between October 2016 and July 2018, 966 patients with complete data were included. Among them, 241 presented with an LM lesion, and 171 required an LM lesion preparation by RA. The latter, allocated to the LM-RA group, were compared with the 725 patients in the non-LM-RA group. Clinical success of the RA procedure was comparable in both groups, but in-hospital major adverse cardiac events were higher in the RA-LM group (7.6% vs 3.2%, adjusted p = 0.04), mainly driven by a higher in-hospital mortality rate (5.3 vs 0.3%, adjusted p = 0.005). At 1-year follow-up, mortality and major adverse cardiac event rates were comparable in both groups (12.9% vs 8.0%, adjusted p value: 0.821, and 15.8% vs 10.9%, adjusted p value: 0.329, respectively), but the rate of target vessel revascularization remained higher in the RA-LM group (5.3% vs 3.2%, adjusted p = 0.021). In conclusion, RA PCI is an efficient option for calcified LM lesions, providing acceptable outcomes regarding this population with high risk at 1 year, and yields comparable outcomes with RA PCI performed on non-LM lesions.

Coronary calcifications are frequently identified within coronary lesions as their incidence increases with age and cardiovascular risk factors. Their location can be superficial or deep, according to different pathological process. In all cases, the presence of calcifications within the vascular wall predicts poor clinical prognosis and unfavorable evolution after percutaneous revascularization. Coronary calcifications can be analyzed by angiography, CT or intracoronary imaging (IVUS or OCT) with variable accuracies. Angiography is the most frequently used method but is not very sensitive (sensitivity close to 50%) and insufficient for their precise quantification. The CT scan is a more effective non-invasive method leading to an accurate analysis of the lesion before coronary angiography. IVUS and OCT have an excellent spatial resolution and are the most sensitive methods for the identification (present in nearly 75-80% of lesions) and quantification of calcifications. These intracoronary imaging techniques offer interesting perspectives for identification of the highest-risk lesions, PCI procedures planning (including the choice of an optimal dedicated plaque preparation devices), the monitoring of their execution and the evaluation of the immediate post-stenting results.

Background: Improvements in drug-eluting stent design have led to a reduced frequency of repeat revascularisation and new biodegradable polymer coatings may allow a shorter duration of dual antiplatelet therapy (DAPT) after percutaneous coronary intervention (PCI). Aims: The Improved Drug-Eluting stent for All-comers Left Main (IDEAL-LM) study aims to investigate long-term clinical outcomes after implantation of a biodegradable polymer platinum-chromium everolimuseluting stent (BP-PtCr-EES) followed by 4 months DAPT compared to a durable polymer cobalt-chromium everolimus-eluting stent (DP-CoCr-EES) followed by 12 months DAPT in patients undergoing PCI of unprotected left main coronary artery (LMCA) disease. Methods: This is a multicentre randomised clinical trial study in patients with an indication for coronary artery revascularisation who have been accepted for PCI for LMCA disease after Heart Team consultation. Patients were randomly assigned in a 1:1 ratio to receive either the BP-PtCr-EES or the DP-CoCr-EES. The primary endpoint was a non-inferiority comparison of the rate of major adverse cardiovascular events (MACE), defined as all-cause death, myocardial infarction, or ischaemia-driven target vessel revascularisation at 2 years. Results: Between December 2014 and October 2016, 818 patients (410 BP-PtCr-EES and 408 DP-Co-CrEES) were enrolled at 29 centres in Europe. At 2 years, the primary endpoint of MACE occurred in 59 patients (14.6%) in the BP-PtCr-EES group and 45 patients (11.4%) in the DP-CoCr-EES group; 1-sided upper 95% confidence interval (CI) 7.18%; p=0.04 for non-inferiority; p=0.17 for superiority. The secondary endpoint event of BARC 3 or 5 bleeding occurred in 11 patients (2.7%) in the BP-PtCr-EES group and 2 patients (0.5%) in the DP-CoCr-EES group (p=0.02). Conclusions: In patients undergoing PCI of LMCA disease, after two years of follow-up, the use of a BP-PtCr-EES with 4 months of DAPT was non-inferior to a DP-CoCr-EES with 12 months of DAPT with respect to the composite endpoint of all-cause death, myocardial infarction or ischaemia-driven target vessel revascularisation.

Data regarding the potential influence of gender on outcomes of rotational atherectomy (RA) percutaneous coronary intervention (PCI) are scarce and conflicting. Using the Euro4C registry, an international prospective multicentric registry of RA PCI, we evaluated the influence of gender on clinical outcomes of RA PCI. Between October 2016 and July 2018, 966 patients were included. In them, 267 (27.6%) were females. Female patients were older than males (77.7 years old +/- 9.8 vs 73.3 +/- 9.5 years old respectively, p < 0.001) had a poorer renal function (43,1% of females had a GFR < 60 ml/min:1.73m(2) vs 30.4% of males, p < 0.001) and were more frequently admitted for an acute coronary syndrome (32.2% vs 22.3% p = 0.002). During RA procedure, women were less likely to be treated by radial approach (65.0% vs 74.4%, p = 0.004). In-hospital major adverse cardiac event rate-defined as cardiovascular death, myocardial infarction, stroke/transient ischemic attack, target lesion revascularization, and coronary artery bypass grafting surgery-was higher in the female group (7.1% vs 3.7%, p = 0.043). However, coronary perforation, dissection, slow/low flow and tamponade did not significantly differ in gender, neither did cardiovascular medications at discharge. At 1 year follow-up, rate of major adverse cardiac event was 18.4% in the female group vs 11.2% in the male group (adjusted Hazard Ratio 1.82 [1.24 to 2.67], p = 0.002). No significant bleeding differences were observed in gender, neither in hospital, nor during follow-up. In conclusion women had worse clinical outcomes following RA PCI during hospitalization and at 1 year follow-up than did men (C) 2020 Published by Elsevier Inc.

AIMS:Despite the use of rotational atherectomy (RA) in interventional cardiology for over three decades, data regarding factors affecting the clinical outcomes of the RA procedure remain scarce. The aim of the present study was to describe the contemporary use and outcomes of RA in Europe. METHODS AND RESULTS:We conducted, for the first time, a prospective international registry in 8 European countries and 19 centres and included patients treated by percutaneous coronary intervention with RA. Between October 2016 and July 2018, 966 patients with complete data were recruited. Mean age was 74.5 years, 72.4% were male and 43.4% had diabetes. Initial presentation was an acute coronary syndrome (ACS) for 25.1% of the patients. Clinical success was observed in 91.9% of the procedures. The rate of in-hospital major adverse cardiac events (MACE) - defined as cardiovascular death, myocardial infarction, target lesion revascularisation, stroke and coronary artery bypass grafting - was 4.7%. At one year, the rate of MACE was 13.2%. Factors independently associated with the occurrence of MACE at one year were female gender, renal failure, ACS at admission, depressed left ventricular ejection fraction (LVEF) and presence of a significant left main coronary artery (LMCA) lesion. CONCLUSIONS:Despite the high level of complexity of the studied population, RA turned out to be an effective procedure with a low rate of in-hospital complications and demonstrated good immediate and midterm results.

Background: The treatment of chronic total occlusion of coronary arteries by percutaneous coronary intervention (CTO PCI) is one of the most representative technical advances in ischemic cardiomyopathy of last decade. However, how the complex histopathological remodeling and the new techniques affect healing processes after stent implantation remains unknown. Objective: The objective of the PERFE-CTO study is to analyze stent coverage, malapposition and other mechanical abnormalities 3 months after CTO recanalization using intravascular imaging. Methods: In a French prospective interventional multicenter study, stent strut coverage, acquired malapposition and neointimal hyperplasia (NIH) proliferation will be systematically assessed with 3 months angiogram control and intracoronary optical frequency domain imaging (OFDI) after successful CTO PCI of >20 mm in length. The impact of routine systematical intracoronary imaging after these complex procedures will also be evaluated by measuring the rate of significant mechanical abnormalities (strut malapposition, edge dissection, thrombus) that was undetected by fluoroscopy alone and by complementary PCI when needed. Secondarily, these data will be compared according to clinical characteristics, antiplatelet therapy use or desobstruction technique (antegrade vs. retrograde, true lumen vs. subintima). Each patient will undergo a one-year clinical follow-up. A total of 150 analyzed CTO lesions is expected. Conclusion: The PERFE-CTO study will provide essential understanding of the early history after CTO recanalization and the identification of inadequate evolution (stent thrombosis, restenosis or late delayed stent endothelization and cardiovascular outcomes) using intravascular imaging to improve long-term CTO results. (c) 2020 Elsevier Inc. All rights reserved.

AIMS:The aim of this study was to investigate the use of a drug-coated balloon (DCB) in daily clinical practice and provide further evidence on the safety and efficacy of paclitaxel-coated balloon treatment using urea as an inert excipient.METHODS AND RESULTS:Between December 2013 and December 2015, 757 patients treated for coronary lesions with the IN.PACT Falcon balloon were enrolled in this prospective real-world all-comers registry. The primary outcome was the clinically driven target lesion revascularisation (TLR) rate at 12 months. The secondary outcome was major adverse cardiac events (MACE) defined as cardiac death, myocardial infarction, TLR and target vessel revascularisation (TVR). Out of 805 lesions, 43.1% were de novo, and 53.2% drug-eluting stent (DES) or bare metal stent (BMS) in-stent restenosis (ISR). TLR at 12 months was 6.2% and TVR 8.3%. MACE occurred in 9.7% of patients with a composite of cardiac death in 0.8% and myocardial infarction in 2.7% plus TLR/TVR. Subgroup analysis confirmed a TLR rate of 7.5% for ISR (2.1% BMS and 9.5% DES) and 4.9% for de novo lesions.CONCLUSIONS:The IN.PACT Falcon urea-based paclitaxel-coated balloon is safe and efficient in de novo and ISR lesions with low rates of TLR/TVR. The high proportion of treatment of de novo lesions indicates that a DCB-only strategy is nowadays common.

OBJECTIVES:Percutaneous coronary intervention (PCI) of chronic total occlusion (CTO) has historically been associated with higher event rates during follow-up. The hybrid algorithm and contemporary wiring and dissection re-entry (DR) techniques can potentially improve long-term outcomes after CTO-PCI. This study assessed the long-term clinical outcomes of the hybrid CTO practice, when applied by operators with varying experience levels.METHODS:We examined the 1-year clinical events after hospital discharge of the RECHARGE population, according to technical outcome and final technique. The primary endpoint was major adverse cardiac event (MACE) rate. Centers that provided ≥90% complete 12-month follow-up were included.RESULTS:Follow-up data of 1067 out of 1165 patients (92%) were provided by 13 centers. Mean follow-up duration was 362.8 ± 0.9 days. One-year MACE-free survival rate was 91.3% (974/1067). MACE included death (1.9%; n = 20), myocardial infarction (1.4%; n = 15), target-vessel failure (5.9%; n = 63), and target-vessel revascularization (TVR) (5.5%; n = 59). Non-TVR was performed in 6.7% (n = 71). MACE was significantly in favor of successful CTO-PCI (8.0% vs 13%; P=.04), even after adjusting for baseline differences (adjusted hazard ratio, 0.59; 95% confidence interval, 0.36-0.98; P=.04). Other events, including individual MACE components, were comparable with respect to technical outcome and final technique (DR vs non-DR techniques).CONCLUSIONS:The use of the hybrid algorithm with contemporary techniques by moderate to highly experienced operators for CTO-PCI is safe and associated with a low 1-year event rate. Successful procedures are associated with a better MACE rate. DR techniques can be used as first-line strategies alongside intimal wiring techniques without compromising clinical outcomes.

Percutaneous coronary intervention (PCI) of chronic total occlusions (CTO) has historically been associated with higher event rates during follow-up (FU). The hybrid algorithm and contemporary antegrade and retrograde wiring and dissection re-entry (DR) techniques have the potential to further

ObjectivesThis study sought to create a contemporary scoring tool to predict technical outcomes of chronic total occlusion (CTO) percutaneous coronary intervention (PCI) from patients treated by hybrid operators with differing experience levels.BackgroundCurrent scoring systems need regular updating to cope with the positive evolutions regarding materials, techniques, and outcomes, while at the same time being applicable for a broad range of operators.MethodsClinical and angiographic characteristics from 880 CTO‐PCIs included in the REgistry of CrossBoss and Hybrid procedures in FrAnce, the NetheRlands, BelGium and UnitEd Kingdom (RECHARGE) were analyzed by using a derivation and validation set (2:1 ratio). Variables significantly associated with technical failure in the multivariable analysis were incorporated in the score. Subsequently, the discriminatory capacity was assessed and the validation set was used to compare with the J‐CTO score and PROGRESS scores.ResultsTechnical success in the derivation and validation sets was 83% and 85%, respectively. Multivariate analysis identified six parameters associated with technical failure: blunt stump (beta coefficient (b) = 1.014); calcification (b = 0.908); tortuosity ≥45° (b = 0.964); lesion length 20 mm (b = 0.556); diseased distal landing zone (b = 0.794), and previous bypass graft on CTO vessel (b = 0.833). Score variables remained significant after bootstrapping. The RECHARGE score showed better discriminatory capacity in both sets (area‐under‐the‐curve (AUC) = 0.783 and 0.711), compared to the J‐CTO (AUC = 0.676) and PROGRESS (AUC = 0.608) scores.ConclusionsThe RECHARGE score is a novel, easy‐to‐use tool for assessing the risk for technical failure in hybrid CTO‐PCI and has the potential to perform well for a broad community of operators. © 2017 Wiley Periodicals, Inc.

Background— Development of the CrossBoss and Stingray devices for antegrade dissection and reentry (ADR) of chronic total occlusions has improved historically suboptimal outcomes. However, the outcomes, safety, and failure modes of the technique have to be studied in a larger patient cohort. This preplanned substudy of the RECHARGE registry (Registry of CrossBoss and Hybrid Procedures in France, the Netherlands, Belgium and United Kingdom) aims to evaluate the value and use of ADR and determine its future position in contemporary chronic total occlusion intervention. Methods and Results— Patients were selected if an ADR strategy was applied. Outcomes, safety, and failure modes of the technique were assessed. The ADR technique was used in 23% (n=292/1253) of the RECHARGE registry and was mainly applied for complex lesions (Japanese chronic total occlusion score=2.7±1.1). ADR was the primary strategy in 30% (n=88/292), of which 67% were successful. Bail-out ADR strategies were successful in 63% (n=133/210). The Controlled ADR (ie, combined CrossBoss-Stingray) subtype was applied most frequently (32%; n=93/292) and successfully (81%; n=75/93). Overall per-lesion success rate was 78% (n=229/292), after use of additional bail-out strategies. The inability to reach the distal target zone (n=48/100) or to reenter (n=43/100) most commonly led to failure. ADR-associated major events occurred in 3.4% (n=10/292). Conclusions— Although mostly applied as a bail-out strategy for complex lesions, the frequency, outcomes, and low complication rate of the ADR technique and its subtypes confirm the benefit and value of the technique in hybrid chronic total occlusion percutaneous coronary intervention, especially when antegrade wiring or retrograde approaches are not feasible. Clinical Trial Registration— URL: http://www.clinicaltrials.gov. Unique identifier: NCT02075372.

Background— Development of the CrossBoss and Stingray devices for antegrade dissection and reentry (ADR) of chronic total occlusions has improved historically suboptimal outcomes. However, the outcomes, safety, and failure modes of the technique have to be studied in a larger patient cohort. This preplanned substudy of the RECHARGE registry (Registry of CrossBoss and Hybrid Procedures in France, the Netherlands, Belgium and United Kingdom) aims to evaluate the value and use of ADR and determine its future position in contemporary chronic total occlusion intervention. Methods and Results— Patients were selected if an ADR strategy was applied. Outcomes, safety, and failure modes of the technique were assessed. The ADR technique was used in 23% (n=292/1253) of the RECHARGE registry and was mainly applied for complex lesions (Japanese chronic total occlusion score=2.7±1.1). ADR was the primary strategy in 30% (n=88/292), of which 67% were successful. Bail-out ADR strategies were successful in 63% (n=133/210). The Controlled ADR (ie, combined CrossBoss-Stingray) subtype was applied most frequently (32%; n=93/292) and successfully (81%; n=75/93). Overall per-lesion success rate was 78% (n=229/292), after use of additional bail-out strategies. The inability to reach the distal target zone (n=48/100) or to reenter (n=43/100) most commonly led to failure. ADR-associated major events occurred in 3.4% (n=10/292). Conclusions— Although mostly applied as a bail-out strategy for complex lesions, the frequency, outcomes, and low complication rate of the ADR technique and its subtypes confirm the benefit and value of the technique in hybrid chronic total occlusion percutaneous coronary intervention, especially when antegrade wiring or retrograde approaches are not feasible. Clinical Trial Registration— URL: http://www.clinicaltrials.gov . Unique identifier: NCT02075372.

The hybrid algorithm for the treatment of Chronic Total Occlusions (CTO) is a framework that can be used to perform effective and safe CTO percutaneous coronary intervention (PCI). The Registry of CrossBoss and Hybrid Procedures in France, the Netherlands, Belgium and United Kingdom (RECHARGE) seeks

BACKGROUND The hybrid algorithm for chronic total occlusion (CTO) percutaneous coronary intervention (PCI) was developed to improve procedural outcomes. Large, prospective studies validating the algorithm in a broad multicenter setting with operators of different experience levels are lacking.OBJECTIVES The RECHARGE (REgistry of Crossboss and Hybrid procedures in FrAnce, the NetheRlands, BelGium and UnitEd Kingdom) registry aims to report achievable results using the hybrid algorithm.METHODS Between January 2014 and October 2015, consecutive patients undergoing hybrid CTO-PCI were prospectively enrolled in 17 centers. Procedural techniques, outcomes, and in-hospital complications were analyzed.RESULTS A total of 1,253 CTO-PCIs were performed in 1,177 patients, of which 86% were men. Mean age was 66 +/- 11 years. The average Japanese CTO score was 2.0 +/- 1.0, and was higher in the failure group (2.6 +/- 0.6 vs. 1.9 +/- 1.0; p < 0.001). Overall procedure success was 86% and major in-hospital complications occurred in 2.6%. Antegrade wire escalation was the preferred primary strategy in 77%, followed by retrograde (17%) and antegrade dissection re-entry strategies (7%). Primary strategies were successful in 60%. Consecutive strategies were applied in 34% and were successful in 74%. Antegrade dissection re-entry and retrograde strategies were the most common bailout strategies and were successful in 67% and 62%, respectively. Median procedure and fluoroscopy time were 90 (interquartile range [ IQR]: 60 to 120) min and 35 (IQR: 21 to 55) min, contrast volume was 250 (IQR: 180 to 340) ml, and radiation doses (air kerma and dose area product) were 1.6 (IQR: 1.0 to 2.7) Gy and 98 (IQR: 57 to 168) Gy.cm(2), respectively.CONCLUSIONS High procedure and patient success rates, combined with a low event rate and improved procedural characteristics, support further use of the hybrid algorithm for a broad community of appropriately trained CTO operators. (C) 2016 by the American College of Cardiology Foundation.

Rotational atherectomy is the treatment of choice for calcified coronary lesions. It should not be used routinely but only in some appropriate cases, especially when the successful deployment of a stent may be uncertain. Complications are rare but serious. Several cases of "off label" use, however, have been reported in the literature without additional complications.