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The 2023 European Bifurcation Club (EBC) meeting took place in Warsaw in October, and the latest evidence for the use of intravascular ultrasound (IVUS) and optical coherence tomography (OCT) to optimise percutaneous coronary interventions (PCI) on coronary bifurcation lesions (CBLs) was a major focus. The topic generated deep discussions and general appraisal on the potential benefits of IVUS and OCT in PCI procedures. Nevertheless, despite an increasing recognition of IVUS and OCT capabilities and their recognised central role for guidance in complex CBL and left main PCI, it is expected that angiography will continue to be the primary guidance modality for CBL PCI, principally due to educational and economic barriers. Mindful of the restricted access/adoption of intracoronary imaging for CBL PCI, the EBC board decided to review and describe a series of tips and tricks which can help to optimise angiography-guided PCI for CBLs. The identified key points for achieving an optimal angiography-guided PCI include a thorough analysis of pre-PCI images (computed tomography angiography, multiple angiographic views, quantitative coronary angiography vessel estimation), a systematic application of the technical steps suggested for a given selected technique, an intraprocedural or post-PCI use of stent enhancement and a low threshold for bailout use of intravascular imaging.

Background: The impact of intracoronary imaging on outcomes, after provisional versus dual-stenting for bifurcation left main (LM) lesions, is unknown., Objectives: We investigated the effect of intracoronary imaging in the EBC MAIN trial (European Bifurcation Club LM Coronary Stent study)., Methods: Four hundred and sixty-seven patients were randomized to dual-stenting or a stepwise provisional strategy. Four hundred and fifty-five patients were included. Intravascular ultrasound (IVUS) or optical coherence tomography (OCT) was undertaken at the operator's discretion. The primary endpoint was death, myocardial infarction or target vessel revascularization at 1-year., Results: Intracoronary imaging was undertaken in 179 patients (39%; IVUS = 151, OCT = 28). As a result of IVUS findings, operators reintervened in 42 procedures. The primary outcome did not differ with intracoronary imaging versus angiographic-guidance (17% vs. 16%; odds ratio [OR]: 0.92 (95% confidence interval [CI]: 0.51-1.63) p = 0.767), nor for reintervention based on IVUS versus none (14% vs. 16%; OR: 0.88 [95% CI: 0.32-2.43] p = 0.803), adjusted for syntax score, lesion calcification and ischemic symptoms. With angiographic-guidance, primary outcome events were more frequent with dual versus provisional stenting (21% vs. 10%; adjusted OR: 2.11 [95% CI: 1.04-4.30] p = 0.039). With intracoronary imaging, there were numerically fewer primary outcome events with dual versus provisional stenting (13% vs. 21%; adjusted OR: 0.56 [95% CI: 0.22-1.46] p = 0.220)., Conclusions: In EBC MAIN, the primary outcome did not differ with intracoronary imaging versus none. However, in patients with angiographic-guidance, outcomes were worse with a dual-stent than provisional strategy When intracoronary imaging was used, there was a trend toward better outcomes with the dual-stent than provisional strategy., (© 2023 Wiley Periodicals LLC.)

Provisional stenting has become the default technique for the treatment of most coronary bifurcation lesions. However, the side branch (SB) can become compromised after main vessel (MV) stenting and restoring SB patency can be difficult in challenging anatomies. Angiographic and intracoronary imaging criteria can predict the risk of side branch closure and may encourage use of side branch protection strategies. These protective approaches provide strategies to avoid SB closure or overcome compromise following MV stenting, minimising periprocedural injury. In this article, we analyse the strategies of SB preservation discussed and developed during the most recent European Bifurcation Club (EBC) meetings.

Background: Techniques for provisional and dual-stent left main bifurcation stenting require optimization., Aim: To identify technical variables influencing procedural outcomes and periprocedural myocardial infarction following left main bifurcation intervention., Methods: Procedural and outcome data were analyzed in 438 patients from the per-protocol cohort of the European Bifurcation Club Left Main Trial (EBC MAIN). These patients were randomized to the provisional strategy or a compatible dual-stent extension (T, T-and-protrude, or culotte)., Results: Mean age was 71 years and 37.4% presented with an acute coronary syndrome. Transient reduction of side vessel thrombolysis in myocardial infarction flow occurred after initial stent placement in 5% of procedures but was not associated with periprocedural myocardial infarction. Failure to rewire a jailed vessel during any strategy was more common when jailed wires were not used (9.5% vs. 2.5%, odds ratio [OR]: 6.4, p = 0.002). In the provisional cohort, the use of the proximal optimization technique was associated with less subsequent side vessel intervention (23.3% vs. 41.9%, OR: 0.4, p = 0.048). Side vessel stenting was predominantly required for dissection, which occurred more often following side vessel preparation (15.3% vs. 4.4%, OR: 3.1, p = 0.040). Exclusive use of noncompliant balloons for kissing balloon inflation was associated with reduced need for side vessel intervention in provisional cases (20.5% vs. 38.5%, OR: 0.4, p = 0.013), and a reduced risk of periprocedural myocardial infarction across all strategies (2.9% vs. 7.7%, OR: 0.2, p = 0.020)., Conclusion: When performing provisional or compatible dual-stent left main bifurcation intervention, jailed wire use is associated with successful jailed vessel rewiring. Side vessel preparation in provisional patients is linked to increased side vessel dissection requiring stenting. Use of the proximal optimization technique may reduce the need for additional side vessel intervention, and noncompliant balloon use for kissing balloon inflation is associated with a reduction in both side vessel stenting and periprocedural myocardial infarction., Clinical Trial Registration: ClinicalTrials.gov Identifier NCT02497014., (© 2023 Wiley Periodicals LLC.)

The European Bifurcation Club (EBC) supports a continuous review of the field of coronary artery bifurcation interventions and aims to facilitate a scientific discussion and an exchange of ideas on the management of bifurcation disease. The recent focus of meetings and consensus statements has been on the technical issues in bifurcation stenting, recognising that the final result of a bifurcation procedure and the long-term outcome for our patients are strongly influenced by factors, including preprocedural strategy, stenting technique selection, performance of optimal procedural steps, the ability to identify and correct complications and finally, and most important, the overall performance of the operator. Continuous refinement of bifurcation stenting techniques and the promotion of education and training in bifurcation stenting techniques represent a major clinical need. Accordingly, the consensus from the latest EBC meeting in Brussels, October 2021, was to promote education and training in bifurcation stenting based on the EBC principle. Part II of this 16th EBC consensus document aims to provide a step-by-step overview of the pitfalls and technical troubleshooting during the implantation of the second stent either in the provisional stenting (PS) strategy or in upfront 2-stent techniques (e.g., 2-stent PS pathway and double kissing crush stenting). Finally, a detailed overview and discussion of the numerous modalities available to provide continuous education and technical training in bifurcation stenting techniques are discussed, with consideration of their future application in enhancing training and practice in coronary bifurcation lesion treatment.

Stepwise layered provisional stenting (PS) is the most commonly used strategy to treat coronary bifurcation lesions (CBL). The term 'stepwise layered' emphasises the versatility of this approach that allows the adjustment of the procedure plan according to the CBL complexity, starting with stent implantation in one branch and implantation of a second stent in the other branch only when required. A series of refinements have been implemented over the years to facilitate the achievement of predictable procedural results using this approach. However, despite its simplicity and versatility, operators using this technique require full knowledge of the pitfalls of each procedural step. Part I of this 16 th European Bifurcation Club consensus paper provides a detailed step-by-step overview of the pitfalls and technical troubleshooting during the implantation of the first stent using the PS strategy for the treatment of CBL.

Coronary artery bifurcation lesions are frequently encountered in cardiac catheterization laboratories and are associated with more complex procedures and worse clinical outcomes than nonbifurcation lesions. Therefore, anatomical and physiological assessment of bifurcation lesions before, during, and after percutaneous coronary intervention is of paramount clinical importance. Physiological assessment can help interventionalists appreciate the hemodynamic significance of coronary artery disease and guide ischemia-directed revascularization. However, it is important to understand that the physiological approach for bifurcation disease is more important than simply using physiological indexes for its assessment. This joint consensus document by the Korean, Japanese, and European bifurcation clubs presents the concept of a physiological approach for coronary bifurcation lesions, as well as current knowledge, practical tips, pitfalls, and future directions of applying physiological indexes in bifurcation percutaneous coronary intervention. This document aims to guide interventionalists in performing appropriate physiology-based assessments and treatment decisions for coronary bifurcation lesions., Competing Interests: Funding Support and Author Disclosures Dr Pan has received minor lecture fees from Abbott and Philips. Dr Banning has received institutional funding of a fellowship from Boston Scientific; and has received speaker fees from Boston Scientific, Abbott, Medtronic, Philips/Volcano, and Miracor. Dr Johnson has received consultancy and speaker fees from Abbott Vascular, Boston Scientific, and Terumo; and has received institutional funding for fellowships from Boston Scientific and Terumo. Dr Lefèvre has received speaker and proctorship fees from Abbott, Boston Scientific, Terumo, and Edwards Lifesciences. Dr Chatzizisis has received speaker honoraria, advisory board fees, and research grant support from Boston Scientific; and has received advisory board fees and research grant support from Medtronic. Dr Lassen has received speaker fees from Medtronic, Boston Scientific, Biotronik, Abbott, and Biosensors. Dr Stankovic has received speaker fees from Medtronic, Abbott, Boston Scientific, and Terumo. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2022 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Background: Patients with non-left-main coronary bifurcation lesions are usually best treated with a stepwise provisional approach. However, patients with true left main stem bifurcation lesions have been shown in one dedicated randomized study to benefit from systematic dual stent implantation., Methods and Results: Four hundred and sixty-seven patients with true left main stem bifurcation lesions requiring intervention were recruited to the EBC MAIN study in 11 European countries. Patients were aged 71 ± 10 years; 77% were male. Patients were randomly allocated to a stepwise layered provisional strategy (n = 230) or a systematic dual stent approach (n = 237). The primary endpoint (a composite of death, myocardial infarction, and target lesion revascularization at 12 months) occurred in 14.7% of the stepwise provisional group vs. 17.7% of the systematic dual stent group (hazard ratio 0.8, 95% confidence interval 0.5-1.3; P = 0.34). Secondary endpoints were death (3.0% vs. 4.2%, P = 0.48), myocardial infarction (10.0% vs. 10.1%, P = 0.91), target lesion revascularization (6.1% vs. 9.3%, P = 0.16), and stent thrombosis (1.7% vs. 1.3%, P = 0.90), respectively. Procedure time, X-ray dose and consumables favoured the stepwise provisional approach. Symptomatic improvement was excellent and equal in each group., Conclusions: Among patients with true bifurcation left main stem stenosis requiring intervention, fewer major adverse cardiac events occurred with a stepwise layered provisional approach than with planned dual stenting, although the difference was not statistically significant. The stepwise provisional strategy should remain the default for distal left main stem bifurcation intervention., Study Registration: http://clinicaltrials.gov NCT02497014., (Published on behalf of the European Society of Cardiology. All rights reserved. © The Author(s) 2021. For permissions, please email: journals.permissions@oup.com.)

Patient-specific and lesion-specific computational simulation of bifurcation stenting is an attractive approach to achieve individualized pre-procedural planning that could improve outcomes. The objectives of this work were to describe and validate a novel platform for fully computational patient-specific coronary bifurcation stenting. Our computational stent simulation platform was trained using n = 4 patient-specific bench bifurcation models (n = 17 simulations), and n = 5 clinical bifurcation cases (training group, n = 23 simulations). The platform was blindly tested in n = 5 clinical bifurcation cases (testing group, n = 29 simulations). A variety of stent platforms and stent techniques with 1- or 2-stents was used. Post-stenting imaging with micro-computed tomography (μCT) for bench group and optical coherence tomography (OCT) for clinical groups were used as reference for the training and testing of computational coronary bifurcation stenting. There was a very high agreement for mean lumen diameter (MLD) between stent simulations and post-stenting μCT in bench cases yielding an overall bias of 0.03 (- 0.28 to 0.34) mm. Similarly, there was a high agreement for MLD between stent simulation and OCT in clinical training group [bias 0.08 (- 0.24 to 0.41) mm], and clinical testing group [bias 0.08 (- 0.29 to 0.46) mm]. Quantitatively and qualitatively stent size and shape in computational stenting was in high agreement with clinical cases, yielding an overall bias of < 0.15 mm. Patient-specific computational stenting of coronary bifurcations is a feasible and accurate approach. Future clinical studies are warranted to investigate the ability of computational stenting simulations to guide decision-making in the cardiac catheterization laboratory and improve clinical outcomes., (© 2021. The Author(s).)

The 15th European Bifurcation Club (EBC) meeting was held in Barcelona in October 2019. It facilitated a renewed consensus on coronary bifurcation lesions (CBL) and unprotected left main (LM) percutaneous interventions. Bifurcation stenting techniques continue to be refined, developed and tested. It remains evident that a provisional approach with optional side branch treatment utilising T, T and small protrusion (TAP) or culotte continues to provide flexible options for the majority of CBL patients. Debate persists regarding the optimal treatment of side branches, including assessment of clinical significance and thresholds for bail-out treatment. In more complex CBL, especially those involving the LM, adoption of dedicated two-stent techniques should be considered. Operators using such techniques have to be fully familiar with their procedural steps and should acknowledge associated limitations and challenges. When using two-stent techniques, failure to perform a final kissing inflation is regarded as a technical failure, since it may jeopardise clinical outcome. The development of novel technical tools and drug regimens deserves attention. In particular, intracoronary imaging, bifurcation simulation, drug-eluting balloon technology and tailored antiplatelet therapy have been identified as promising tools to enhance clinical outcomes. In conclusion, the evolution of a broad spectrum of bifurcation PCI components has resulted from studies extending from bench testing to randomised controlled trials. However, further advances are still needed to achieve the ambitious goal of optimising the clinical outcomes for every patient undergoing PCI on a CBL.

Background: Defining the optimal conduction of percutaneous-coronary-intervention (PCI) to treat bifurcation lesions has been the subject of many clinical studies showing that the applied stenting technique may influence clinical outcome. Accordingly, bifurcation stenting classifications and technical sequences should be standardized to allow proper reporting and comparison., Methods: The European Bifurcation Club (EBC) is a multidisciplinary group dedicated to optimize the treatment of bifurcations and previously created a classification of bifurcation stenting techniques that is based on the first stent implantation site. Since some techniques have been abandoned, others have been refined and dedicated devices became available, EBC promoted an international task force aimed at updating the classification of bifurcation stenting techniques as well as at highlighting the best practices for most popular techniques. Original descriptive images obtained by drawings, bench tests and micro-computed-tomographic reconstructions have been created in order to serve as tutorials in both procedure reporting and clinical practice., Results: An updated Main-Across-Distal-Side (MADS)-2, classification of bifurcation stenting techniques has been realized and is reported in the present article allowing standardized procedure reporting in both clinical practice and scientific studies. The EBC-promoted task force deeply discussed, agreed on and described (using original drawings and bench tests) the optimal steps for the following major bifurcation stenting techniques: (a) 1-stent techniques ("provisional" and "inverted provisional") and (b) 2-stent techniques ("T/TAP," "culotte," and "DK-crush")., Conclusions: The present EBC-promoted paper is intended to facilitate technique selection, reporting and performance for PCI on bifurcated lesions during daily clinical practice., (© 2020 Wiley Periodicals LLC.)

Background: Drug-eluting stents with biodegradable polymers have been designed to improve safety and efficacy. However, drug-eluting stents with biodegradable polymers may not be a class effect, as stent strut thickness, polymer coating, and drug resorption differ between these groups of stents. Twelve months results of Scandinavian Organization for Randomized Trials With Clinical Outcome VII showed that ultrathin-strut sirolimus-eluting Orsiro stent was noninferior to the biolimus-eluting Nobori stent. The sirolimus-eluting Orsiro stent was associated with a reduced risk of definite stent thrombosis., Methods: The Scandinavian Organization for Randomized Trials With Clinical Outcome VII trial is a prospective multicenter randomized clinical trial comparing sirolimus-eluting Orsiro stent and biolimus-eluting Nobori stent in all-comers patients. The endpoint target lesion failure was a composite of cardiac death, myocardial infarction (not related to other than index lesion) and target lesion revascularization., Results: A total of 1261 patients were randomized to treatment with sirolimus-eluting Orsiro stent and 1264 patients to biolimus-eluting Nobori stent and followed for 3 years. At 3-year the target lesion failure was comparable for sirolimus-eluting Orsiro stent (9.0%) and the biolimus-eluting Nobori stent (9.1%), (rate ratio, 0.99; 95% confidence interval, 0.77-1.29). Cardiac death (sirolimus-eluting Orsiro stent 3.0% vs. biolimus-eluting Nobori stent 2.6% [rate ratio, 1.16; 95% confidence interval, 0.73-1.86]), target lesion revascularization (sirolimus-eluting Orsiro stent 5.2% vs. biolimus-eluting Nobori stent 5.9% [rate ratio, 0.90; 95% confidence interval, 0.64-1.25]), myocardial infarction (sirolimus-eluting Orsiro stent 4.7% vs. biolimus-eluting Nobori stent 4.5% [rate ratio, 1.04; 95% confidence interval, 0.72-1.50]), and definite stent thrombosis (sirolimus-eluting Orsiro stent 1.0% vs. biolimus-eluting Nobori stent 1.7% [rate ratio, 0.59; 95% confidence interval, 0.30-1.18]) did not differ significantly between the two groups., Conclusion: At 3-year follow-up, target lesion failure did not differ among ultrathin-strut sirolimus-eluting Orsiro stent and biolimus-eluting Nobori stent with biodegradable polymers.

Background: In patients with increased bleeding risk, the biolimus A9-coated BioFreedom stent, a stainless steel drug-coated stent free from polymer, has shown superiority compared with a bare-metal stent. The aim of this study was to investigate whether the BioFreedom stent is noninferior to a modern ultrathin strut biodegradable polymer cobalt-chromium sirolimus-eluting Orsiro stent in an all-comers patient population treated with percutaneous coronary intervention., Methods: The SORT OUT IX trial (Scandinavian Organization for Randomized Trials With Clinical Outcome IX), was a large-scale, registry-based, randomized, multicenter, single-blind, 2-arm, noninferiority trial. The primary end point, major adverse cardiovascular events, was defined as the composite of cardiac death, myocardial infarction not related to any segment other than the target lesion, or target lesion revascularization within 1 year, analyzed by intention-to-treat. The trial was powered to assess noninferiority for major adverse cardiovascular events of the BioFreedom stent compared with the Orsiro stent with a predetermined noninferiority margin of 0.021., Results: Between December 14, 2015 and April 21, 2017, 3151 patients were assigned to treatment with the BioFreedom stent (1572 patients, 1966 lesions) or to the Orsiro stent (1579 patients, 1985 lesions). Five patients were lost to follow-up because of emigration (99.9% follow-up rate). Mean age was 66.3±10.9, diabetes mellitus was seen in 19.3% of patients, and 53% of the patients had acute coronary syndromes. At 1 year, intention-to-treat analysis showed that 79 (5.0%) patients, who were assigned the BioFreedom stent, and 59 (3.7%), who were assigned the Orsiro stent, met the primary end point (absolute risk difference 1.29% [upper limit of one-sided 95% CI 2.50%]; P noni nferiority =0.14). Significantly more patients in the BioFreedom stent group had target lesion revascularization than those in the Orsiro stent group (55 [3.5%] vs 20 [1.3%], rate ratio 2.77 [95% CI, 1.66-4.62]; P <0.0001)., Conclusions: The biolimus A9-coated BioFreedom polymer-free stent did not meet criteria for noninferiority for major adverse cardiovascular events at 12 months when compared with the ultrathin strut biodegradable polymer sirolimus-eluting Orsiro stent in an all-comers population Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT02623140.

Objectives: The aim of this study was to compare the thin-strut biodegradable-polymer everolimus-eluting platinum-chromium stent (EES) with the biodegradable-polymer biolimus-eluting stainless-steel stent (BES)., Background: Currently available drug-eluting coronary stents have been refined to reduce the risk for coronary events following implantation., Methods: This randomized, multicenter, all-comers, noninferiority trial was undertaken at 3 sites in western Denmark. Patients with clinical indications for percutaneous coronary intervention were eligible for inclusion. Patients were randomly assigned (1:1) to either EES or BES. The primary endpoint, target lesion failure, was a composite of safety (cardiac death and myocardial infarction not clearly attributable to a nontarget lesion) and efficacy (target lesion revascularization) at 12 months, analyzed using intention-to-treat principles. The trial was powered to assess target lesion failure noninferiority of the EES compared with the BES with a predetermined noninferiority margin of 3%., Results: A total of 1,385 patients were assigned to treatment with EES and 1,369 patients to treatment with BES. The analysis showed that 55 patients (4.0%) assigned to the EES and 60 (4.4%) assigned to the BES met the primary endpoint (absolute risk difference 0.4%; upper limit of 1-sided 95% confidence interval: 1.7%; p < 0.001)., Conclusions: At 1-year follow-up, the EES was found to be noninferior to the BES with respect to target lesion failure. (Everolimus-eluting SYNERGY Stent Versus Biolimus-Eluting Biomatrix NeoFlex Stent-SORT-OUT VIII; NCT02093845)., (Copyright © 2019. Published by Elsevier Inc.)

Coronary artery bifurcation lesions comprise approximately 15-20% of all percutaneous coronary interventions (PCI) and constitute a complex lesion subgroup. Intravascular optical coherence tomography (OCT) is a promising adjunctive tool for guiding coronary bifurcation with its unrivalled high resolution. Compared to angiography, intravascular OCT has a clear advantage in that it depicts ostial lesion(s) in bifurcation without the misleading two-dimensional appearance of conventional angiography such as overlap and foreshortening. In addition, OCT has the ability to reconstruct a bifurcation in three dimensions and to assess the side branch ostium from 3D reconstruction of the main vessel pullback, which can be applied to ensure the optimal recrossing position of the wire after main vessel stenting. Recently, online co-registration of OCT and angiography became widely available, helping the operator to position a stent in precise landing zones, reducing the risk of geographic miss. Despite these technological advances, the currently available clinical data are based mainly on observational studies with a small number of patients; there is little evidence from randomised trials. The joint working group of the European Bifurcation Club and the Japanese Bifurcation Club reviewed all the available literature regarding OCT use in bifurcation lesions and here provides recommendations on OCT guiding of coronary interventions in bifurcation lesions.

Aims: FANTOM II is a prospective multicentre trial assessing the safety and efficacy of the Fantom sirolimus-eluting bioresorbable coronary scaffold (BRS). The present substudy focuses on the six- and nine-month IVUS findings., Methods and Results: A total of 240 patients with de novo coronary artery lesions presenting with stable or unstable disease were included in two sequential cohorts (cohort A [n=117] and cohort B [n=123]) in which angiographic follow-up was performed at either six or nine months, respectively. Matched IVUS data were available for 35 paired cases in cohort A and 26 paired cases in cohort B. At six months, mean and minimum scaffold area (SA) decreased from 6.09±1.08 mm2 to 5.88±1.07 mm2, p=0.009, and 5.27±0.99 mm2 to 5.05±0.99 mm2, p=0.01, respectively. At nine months, no significant change in mean scaffold and minimum scaffold area was observed (6.46±1.11 mm2 to 6.38±0.96 mm2; p=0.35, and 5.45±1.00 mm2 to 5.36±0.86 mm2; p=0.32, respectively). Neointimal hyperplasia area was low at both six (0.11±0.12 mm2) and nine months (0.20±0.21 mm2), as was in-scaffold obstruction volume (1.94±2.25% at six months, and 3.40±4.11% at nine months)., Conclusions: The use of the Fantom BRS in stable coronary artery disease was associated with low rates of neointimal hyperplasia volume and in-scaffold volume obstruction at both six and nine months.

Aims: The aim of the study was to determine whether patients treated with drug-eluting stents in the proximal left anterior descending artery (LAD) carried a different long-term prognosis from patients treated in other coronary artery segments., Methods and Results: Ten-year clinical outcome expressed as all-cause mortality and major adverse cardiac events (MACE: cardiac death, acute myocardial infarction, or target vessel revascularisation) was determined for 1,479 patients with a single non-left main coronary stenosis treated with a first-generation drug-eluting stent in the SORT OUT II trial. The outcome of patients treated with stents in the proximal LAD (n=365) was compared with that of patients treated in a non-proximal LAD segment (n=1,114). Follow-up was 99.3% complete. All-cause mortality was 24.9% in the proximal LAD group vs. 26.3% in the non-proximal LAD group (p=0.60). MACE occurred less frequently in the proximal LAD group, 24.6% vs. 31.0% with a hazard ratio of 0.77 (95% confidence interval [CI]: 0.61-0.97, p=0.024). After multivariate analysis which included baseline characteristics that were unevenly distributed between the groups, the hazard ratio for MACE was 0.82 (95% CI: 0.65-1.03, p=0.09)., Conclusions: Patients treated with a drug-eluting stent in the proximal LAD have similar, if not better, long-term clinical outcome compared with patients stented in other coronary artery segments.

Interventional cardiology and coronary stent insertion have an increasing role in the optimal management of left main coronary artery (LMCA) stenosis. Assessing the extent of obstructive disease of the LMCA by angiography alone can be challenging. However, in contrast to the two-dimensional, shadow graphic nature of coronary angiography, intravascular ultrasound (IVUS) is an accurate tomographic technique for assessing both the coronary lumen and the vessel wall characteristics. Consequently, it is a particularly useful technique in imaging the LMCA before, during and after intervention. The European Bifurcation Club (EBC) recommends the use of IVUS during most LMCA interventions. The purpose of this consensus document is to review the available IVUS data on LMCA disease evaluation and treatment. It is a practical guide to show "how and when" to use the imaging modality. It is hoped that a standardisation of the practical approach to imaging may allow consolidation of learning and, ultimately, improve patient outcomes.

The 2017 European Bifurcation Club (EBC) meeting was held in Porto (Portugal) and allowed a multidisciplinary international faculty to review and discuss the latest data collected in the field of coronary bifurcation interventions. In particular, the topic of percutaneous coronary intervention (PCI) on left main coronary artery (LM) disease was highlighted as a contemporary priority. Herein, we summarise the key LM anatomy features, the diagnostic modalities and available data that are relevant for a patient's procedural management. Since the clinical outcomes of patients undergoing PCI on LM disease may depend on both PCI team organisation and PCI performance, the optimal catheterisation laboratory set-up and the rationales for device and technique selection are critically reviewed. The best lesion preparation modalities, the different DES implantation technique choices and the strategies to be considered during PCI on unprotected LM for optimal PCI results are reviewed step by step.

The European Bifurcation Club (EBC) was initiated in 2004 to support a continuous overview of the field of coronary artery bifurcation interventions and aims to facilitate a scientific discussion and an exchange of ideas on the management of bifurcation disease. The EBC hosts an annual, two-day compact meeting, dedicated to bifurcations, which brings together physicians, pathologists, engineers, biologists, physicists, mathematicians, epidemiologists and statisticians for detailed discussions. Every meeting is finalised with a consensus statement that reflects the unique opportunity of combining the opinion of interventional cardiologists with the opinion of a large variety of other scientists on bifurcation management. A series of consensus sessions dedicated to specific topics, to strengthen the consensus debates and focus the discussions, was introduced at this year's meeting. The sessions comprise an intensive overview of the present literature, a pro and con debate and a voting system, to guide the consensus-building process. The present document represents the summary of the up-to-date EBC consensus and recommendations from the 12th annual EBC meeting in 2016 in Rotterdam.

Aims: Our aim was to report the long-term safety and efficacy of the biodegradable polymer-coated biolimus- eluting Nobori stent compared to the durable polymer-coated sirolimus-eluting CYPHER stent., Methods and Results: SORT OUT V randomised 2,468 patients 1:1 to the Nobori (n=1,229) versus the CYPHER stent (n=1,239). Clinically driven event detection based on Danish registries was used. The primary endpoint was a composite of safety (cardiac death, myocardial infarction, definite stent thrombosis) and efficacy (target vessel revascularisation). Individual components of the primary endpoint comprise the secondary endpoints. At five-year follow-up, the composite endpoint rate was found to be similar in patients treated with the two study stents (Nobori 182/1,229 [14.8%] vs. CYPHER 197/1,239 [15.8%]; odds ratio [OR] 0.93, 95% CI: 0.75-1.16; p=0.53). The rates of definite stent thrombosis were also found to be similar in patients treated with the two study stents (Nobori 23/1,229 [1.9%] vs. CYPHER 18/1,239 [1.5%]; OR 1.31, 95% CI: 0.70-2.47; p=0.40), as were the other secondary endpoints., Conclusions: At five-year follow-up, the Nobori stent with a biodegradable polymer coating provided a similar safety and efficacy profile when compared to the durable polymer first-generation CYPHER stent.

Bifurcation lesions represent one of the most challenging lesion subsets in interventional cardiology. The European Bifurcation Club (EBC) is an academic consortium whose goal has been to assess and recommend the appropriate strategies to manage bifurcation lesions. The quantitative coronary angiography (QCA) methods for the evaluation of bifurcation lesions have been subject to extensive research. Single-vessel QCA has been shown to be inaccurate for the assessment of bifurcation lesion dimensions. For this reason, dedicated bifurcation software has been developed and validated. These software packages apply the principles of fractal geometry to address the "step-down" in the bifurcation and to estimate vessel diameter accurately. This consensus update provides recommendations on the QCA analysis and reporting of bifurcation lesions based on the most recent scientific evidence from in vitro and in vivo studies and delineates future advances in the field of QCA dedicated bifurcation analysis.

Background: Coronary bifurcated lesions (CBL) represent a hot topic of interventional cardiology. Provisional stenting, i.e. implantation of a drug-eluting (DES) in the main branch followed by side-branch (SB) intervention in case of suboptimal SB result, represents the gold standard to treat the vast majority of CBL undergoing percutaneous coronary interventions (PCI). The best technique for bail-out SB stenting has not been established. Prospective randomized trials comparing different stenting techniques may help provide important insights regarding the best way to conduct PCI in patients with CBL., Methods: The recently published Bifurcations Bad Krozingen (BBK) II trial is the last important randomized study in the field of bifurcation PCI and is focused on the search for the best management of those patients with suboptimal SB result during provisional stenting. Two different SB implantation strategies after provisional stenting have been compared. In the present manuscript, we employed BBK II results in the context of available literature highlighting important specific features of the study with main emphasis on patient selection process and techniques applied., (Copyright© Bentham Science Publishers; For any queries, please email at epub@benthamscience.org.)

Background: Coronary drug-eluting stents with biodegradable polymers have been designed to improve safety and efficacy., Methods and Results: The Scandinavian Organization for Randomized Trials With Clinical Outcome (SORT OUT) VII trial-a large-scale registry-based randomized, multicenter, single-blind, 2-arm, noninferiority trial-compared 2 biodegradable polymer drug-eluting stents: the thin-strut cobalt-chromium sirolimus-eluting Orsiro stent and the stainless steel biolimus-eluting Nobori stent in an all-comer patient population. The primary end point target lesion failure was a composite of cardiac death, myocardial infarction (not related to other than index lesion), or target lesion revascularization within 1 year, analyzed by intention to treat (noninferiority margin of 3.0%). Clinically driven event detection based on Danish registries was used. A total of 1261 patients were assigned to receive the sirolimus-eluting stent (1590 lesions) and 1264 patients to the biolimus-eluting stent (1588 lesions). At 1 year, the composite end point target lesion failure occurred in 48 patients (3.8%) in the sirolimus-eluting group and in 58 patients (4.6%) in the biolimus-eluting group (absolute risk difference, -0.78% [upper limit of 1-sided 95% confidence interval, 0.61%]; P<0.0001). Rates of definite stent thrombosis occurred in 5 (0.4%) of the sirolimus-eluting group compared with 15 (1.2%) biolimus-eluting stent-treated patients (rate ratio, 0.33; 95% confidence interval, 0.12-0.92; P=0.034), which largely was attributable to a lower risk of subacute definite stent thrombosis: 0.1% versus 0.6% (rate ratio, 0.12; 95% confidence interval, 0.02-1.00; P=0.05)., Conclusions: The thin-strut sirolimus-eluting Orsiro stent was noninferior to the biolimus-eluting Nobori stent in unselected patients for target lesion failure at 1 year., Clinical Trial Registration: URL: http://www.clinicaltrials.gov. Unique identifier: NCT01879358., (© 2016 American Heart Association, Inc.)

Coronary bifurcations are involved in 15-20% of all percutaneous coronary interventions (PCI) and remain one of the most challenging lesions in interventional cardiology in terms of procedural success rate as well as long-term cardiac events. The optimal management of bifurcation lesions is, despite a fast growing body of scientific literature, the subject of considerable debate. The European Bifurcation Club (EBC) was initiated in 2004 to support a continuous overview of the field, and aims to facilitate a scientific discussion and an exchange of ideas on the management of bifurcation disease. The EBC hosts an annual, compact meeting, dedicated to bifurcations, which brings together physicians, engineers, biologists, physicists, epidemiologists and statisticians for detailed discussions. Every meeting is finalised with a consensus statement which reflects the unique opportunity of combining the opinions of interventional cardiologists with the opinions of a large variety of other scientists on bifurcation management. The present 11th EBC consensus document represents the summary of the up-to-date EBC consensus and recommendations. It points to the fact that there is a multitude of strategies and approaches to bifurcation stenting within the provisional strategy and in the different two-stent strategies. The main EBC recommendation for PCI of bifurcation lesions remains to use main vessel (MV) stenting with a proximal optimisation technique (POT) and provisional side branch (SB) stenting as a preferred approach. The consensus document covers a moving target. Much more scientific work is needed in non-left main (LM) and LM bifurcation lesions for continuous improvement of the outcome of our patients.

Background: Long-term safety and efficacy for everolimus-eluting stents (EES) versus those of sirolimus-eluting stents (SES) are unknown., Objectives: This study compared 5-year outcomes for EES with those for SES from the SORT OUT IV (Scandinavian Organization for Randomized Trials with Clinical Outcome) trial., Methods: Five-year follow-up was completed for 2,771 patients (99.9%). Primary endpoint was a composite of major adverse cardiac events (MACE), including cardiac death, myocardial infarction (MI), target vessel revascularization (TVR), and definite stent thrombosis., Results: At 5-years, MACE occurred in 14.0% and 17.4% in the EES and SES groups, respectively (hazard ratio [HR]: 0.80, 95% confidence interval [CI]: 0.66 to 0.97; p = 0.02). The MACE rate did not differ significantly within the first year (HR: 0.96, 95% CI: 0.71 to 1.19; p = 0.79), but from years 1 through 5, the MACE rate was lower with EES (HR: 0.71, 95% CI: 0.55 to 0.90; p = 0.006; p interaction = 0.12). Definite stent thrombosis was lower with EES (0.4%) than with SES (2.0%; HR: 0.18, 95% CI: 0.07 to 0.46), with a lower risk of very late definite stent thrombosis in the EES group (0.2% vs. 1.4%, respectively; HR: 0.16, 95% CI: 0.05 to 0.53). When censoring the patients at the time of stent thrombosis, we found no significant differences between the 2 stent groups for MACE rates (HR: 0.89, 95% CI: 0.73 to 1.08; p = 0.23), target lesion revascularization (HR: 0.90, 95% CI: 0.64 to 1.27; p = 0.55), and MI (HR: 0.93, 95% CI: 0.64 to 1.36; p = 0.72)., Conclusions: At 5-year follow-up, MACE rate was significantly lower with EES- than with SES-treated patients, due largely due to a lower risk of very late definite stent thrombosis. (Randomized Clinical Comparison of the Xience V and the Cypher Coronary Stents in Non-selected Patients With Coronary Heart Disease [SORT OUT IV]; NCT00552877)., (Copyright © 2016 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Background: Third-generation coronary drug-eluting stents (DES) with biodegradable polymers have been designed to improve safety and efficacy. We designed a large scale registry-based randomized clinical trial to compare 2 third-generation DES: a thin strut, cobalt-chromium DES with silicon carbide-coating releasing sirolimus from a biodegradable polymer (O-SES, Orsiro; Biotronik, Bülach, Switzerland) with the stainless steel biodegradable polymer biolimus-eluting Nobori stents (N-BES, Nobori; Terumo, Tokyo, Japan) in an all-comer patient population., Design: The multicenter SORT OUT VII trial (NCT01879358) randomly assigned 2,530 patients to treatment with biodegradable polymer O-SES or biodegradable polymer N-BES at 3 sites in Western Denmark. Patients were eligible, if they were ≥18 years old; had chronic stable coronary artery disease or acute coronary syndromes; and ≥1 coronary lesion with >50% diameter stenosis, requiring treatment with a DES. The primary end point target lesion failure is a composite of cardiac death, myocardial infarction (not related to other than index lesion), or target lesion revascularization within 12 months. Clinically, driven event detection based on Danish registries will be used. An event rate of 6.5% is assumed in each stent group. With a sample size of 1,157 patients in each treatment arm, a 2-group large-sample normal approximation test of proportions with a 1-sided 5% significance level will have 90% power to detect noninferiority of the O-SES compared with the N-BES with a predetermined noninferiority margin of 3.0%., Conclusion: The SORT OUT VII trial will determine whether the biodegradable polymers O-SES is noninferior to the N-BES with respect to driven event., (Copyright © 2015 Elsevier Inc. All rights reserved.)

Background: Intracoronary imaging provides accurate lesion delineation and precise measurements for sizing and positioning of coronary stents. During percutaneous coronary intervention (PCI), it may be challenging to identify corresponding segments between intracoronary imaging and angiography. Computer based online co-registration may aid the target segment identification., Methods: The DOCTOR fusion study was a prospective, single arm, observational study including patients admitted for elective PCI. Optical coherence tomography (OCT) was acquired pre-stent implantation for sizing of stents. The operator subsequently indicated on the angiogram the target area as identified by OCT. Computer based co-registration was performed on-line immediately after pre-stent acquisition to assess feasibility. The cumulated numerical difference between operator based, and computer based co-registration was assessed as the "Operator Registration Error". The operator implanted the stent blind to the co-registrated angiogram. The difference between the co-registered stent border positions and the actual stent deployment border positions was the "Geographic Miss Distance"., Results: Twenty-two patients were included in the study. Two patients were excluded due to missing pre or post-OCT acquisitions. Online co-registration pre-stenting was successful in all analyzed cases. The mean "Operator Registration Error" was 5.4±3.5mm. The mean "Geographic Miss Distance" was 5.4±2.6mm. Without access to the computer-based co-registration, segments of the target lesion indicated on OCT were left uncovered by stent in 14 patients (70%)., Conclusion: Computer based online co-registration of OCT and angiography is feasible. Frequent inaccuracies in operator based registration indicate that computer aided co-registration may reduce errors in corresponding OCT findings to the angiogram., (Copyright © 2015. Published by Elsevier Ireland Ltd.)

Bioresorbable coronary scaffolds (BRS) may offer potential advantages compared to metallic DES, aiming to restore vessel patency without implanting a permanent prosthesis, which may be especially important for bifurcation treatment. On the other hand, there are some inherent limitations, which may impact on the widespread use of BRS. In the current article we discuss the bench testing data and initial clinical results on BRS use in bifurcation lesions presented during European Bifurcation Club (EBC) meetings and review some of the limited number of published real-world registry results.

The left main is the largest bifurcation of the coronary tree and is, therefore, easier to access. Nevertheless, the risks of untoward consequences associated with the loss of the side branch are much higher. Although the usual technical strategies implemented in coronary bifurcations can generally be applied to left main lesions, several inherent characteristics (the ostial position of the main branch, the size of the side branch, the amount of calcification, the angle which is often in a T shape, the use of stents of variable suitability, the crucial role of POT) need to be taken into account in order to achieve optimal acute and long-term results.

The culotte technique provides near perfect coverage of the carina and side branch ostium at the expense of an excess of metal covering the proximal end. It can be used in almost all true bifurcation lesions, but should be avoided in bifurcations when there is a large mismatch between the proximal main branch and the side branch diameters. The main disadvantage of this technique is that rewiring of both branches through the stent struts is required, which can be difficult, technically demanding, and time-consuming.

The European Bifurcation Club (EBC) is an independent, non-political and informal "think tank" of scientists with a particular interest in clinical, technical and fundamental aspects of the management of coronary artery bifurcation disease. Bifurcations account for 15-20% of all percutaneous coronary interventions (PCI) and remain one of the most challenging lesions in interventional cardiology in terms of procedural success rate as well as long-term cardiac events. The optimal management is, despite a fast growing scientific literature, still the subject of considerable debate, one of the main concerns being the potential increased risk of late stent thrombosis associated with treatment complexity. The EBC was initiated in 2004 and aims to facilitate an exchange of ideas on management of bifurcation disease. The EBC hosts an annual, compact meeting dedicated to bifurcations which brings together physicians, engineers, biologists, physicists, epidemiologists and statisticians for detailed discussions. Every meeting is finalised with a consensus statement which reflects the unique opportunity of combining the opinion of interventional cardiologists with the opinion of a large variety of other scientists on bifurcation management. This year the EBC celebrates its 10-year anniversary. This consensus document represents the summary of the consensus from the last ten years of the annual EBC meetings.

Objectives: The study sought to compare the risk of late outcome with a focus on very late definite stent thrombosis of the everolimus-eluting stent (EES) with that of the sirolimus-eluting stent (SES) at 3-year follow-up., Background: In the SORT OUT IV (SORT OUT IV Trial), comparing the EES with the SES in patients with coronary artery disease, the EES was noninferior to the SES at 9 months. The SORT OUT IV trial provides long-term head-to-head randomized comparison of the EES with the SES., Methods: We prospectively randomized 2,774 patients in the SORT OUT IV trial. Follow-up through 3 years was complete in 2,771 patients (99.9%). The 3-year pre-specified endpoints were composites of safety and efficacy (major adverse cardiac events [MACE]: cardiac death, myocardial infarction, target vessel revascularization, and definite stent thrombosis)., Results: At 3 years, the composite endpoint MACE occurred in 9.8% of the EES group and in 11.1% of the SES group (hazard ratio [HR]: 0.89, 95% confidence interval [CI]: 0.70 to 1.12). Overall rate of definite stent thrombosis was lower in the EES group (0.2% vs. 1.4%; HR: 0.15, 95% CI: 0.04 to 0.50), which was largely attributable to a lower risk of very late definite stent thrombosis: 0.1% versus 0.8% (HR: 0.09, 95% CI: 0.01 to 0.70)., Conclusions: At 3-year follow-up, the MACE rate did not differ significantly between EES- and SES-treated patients. A significant reduction of overall and very late definite stent thrombosis was found in the EES group. (The SORT OUT IV TRIAL [SORT OUT IV]; NCT00552877)., (Copyright © 2014 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Background: Pain and discomfort in relation to vascular closure are the predominant patient complaints after coronary angiography (CAG). No large-scale randomized studies have evaluated pain and discomfort after CAG with access site closure by manual compression versus a vascular closure device (VCD)., Aim: To compare pain and discomfort after femoral artery closure by manual compression versus FemoSeal® VCD., Methods: The study is a sub study to the CLOSE-UP study, a randomized, single centre comparison of FemoSeal(®) VCD versus manual compression after CAG. Pain and discomfort score was assessed immediately after the closure procedure, at time for mobilization, at discharge and after 14 days., Results: 1014 patients were included and 1001 patients entered analysis. In-hospital follow-up was obtained for all patients and 14-day follow-up was completed for 96% of patients. The closure procedure lasted 1 (1-1) min in the FemoSeal(®)VCD group and 8 (6-10) min in the manual compression group. Pain and discomfort score at the procedure was significantly higher in the FemoSeal(®)VCD group. No differences in pain and discomfort were detected after leaving the catheterization laboratory., Conclusion: Closure of femoral access after CAG by the FemoSeal(®)VCD was associated with significantly more pain and discomfort compared with closure by manual compression. No difference in pain and discomfort was found at follow-up.

Objective: To evaluate the effects of the everolimus-eluting Xience™/Promus™ stent (EES) and the sirolimus-eluting Cypher™ stent (SES) on intimal hyperplasia (IH) in diabetic patients., Background: Patients with diabetes mellitus have increased risk of in-stent restenosis after coronary stent implantation due to intimal hyperplasia (IH)., Methods: In a sub study of the Randomized Comparison of Everolimus-Eluting and Sirolimus-Eluting Stents in Patients Treated with Percutaneous Coronary Intervention (SORT OUT IV trial), serial intravascular ultrasound (IVUS) 10-month follow-up data were available in 88 patients, including 48 EES and 40 SES treated patients. IVUS endpoints included IH volume, in-stent % volume obstruction and changes in external elastic membrane (EEM) volume., Results: Compared with the SES group, IH volume was increased in the EES group [median (interquartile range): 2.8 mm(3) (0.0-12.6) vs. 0.0 mm(3) (0.0-1.1), P = 0.001]. In-stent % volume obstruction was increased in EES compared to SES [median (interquartile range): 1.6% (0.0-8.2) vs. 0.0% (0.0-1.0), P = 0.001]. Peri-stent external elastic membrane (EEM) volume: (post procedure vs. follow-up EES [300 mm(3) (219-491) vs. 307 mm(3) (223-482), P = 0.73] and SES [316 mm(3) (235-399) vs. 323 mm(3) (246-404), P = 0.05]) and peri-stent plaque volume: EES [163 mm(3) (103-273) vs. 184 mm(3) (115-291), P = 0.18] and SES [186 mm(3) (139-248) vs. 175 mm(3) (153-243), P = 0.26]) were unchanged in both groups. In the proximal reference segment a significant increase in plaque area was seen in the EES group only, without vascular remodeling., Conclusion: In diabetic patients, EES stent implantation was associated with increased IH volume obstruction without involvement of vascular remodeling., (Copyright © 2013 Wiley Periodicals, Inc.)

Background: The optimal long-term antithrombotic treatment of patients with coexisting atrial fibrillation and stable coronary artery disease is unresolved, and commonly, a single antiplatelet agent is added to oral anticoagulation. We investigated the effectiveness and safety of adding antiplatelet therapy to vitamin K antagonist (VKA) in atrial fibrillation patents with stable coronary artery disease., Methods and Results: Atrial fibrillation patients with stable coronary artery disease (defined as 12 months from an acute coronary event) between 2002 and 2011 were identified. The subsequent risk of cardiovascular events and serious bleeding events (those that required hospitalization) was examined with adjusted Cox regression models according to ongoing antithrombotic therapy. A total of 8700 patients were included (mean age, 74.2 years; 38% women). During a mean follow-up of 3.3 years, crude incidence rates were 7.2, 3.8, and 4.0 events per 100 person-years for myocardial infarction/coronary death, thromboembolism, and serious bleeding, respectively. Relative to VKA monotherapy, the risk of myocardial infarction/coronary death was similar for VKA plus aspirin (hazard ratio, 1.12 [95% confidence interval, 0.94-1.34]) and VKA plus clopidogrel (hazard ratio, 1.53 [95% confidence interval, 0.93-2.52]). The risk of thromboembolism was comparable in all regimens that included VKA, whereas the risk of bleeding increased when aspirin (hazard ratio, 1.50 [95% confidence interval, 1.23-1.82]) or clopidogrel (hazard ratio, 1.84 [95% confidence interval, 1.11-3.06]) was added to VKA., Conclusions: In atrial fibrillation patients with stable coronary artery disease, the addition of antiplatelet therapy to VKA therapy is not associated with a reduction in risk of recurrent coronary events or thromboembolism, whereas risk of bleeding is increased significantly. The common practice of adding antiplatelet therapy to oral VKA anticoagulation in patients with atrial fibrillation and stable coronary artery disease warrants reassessment.

Objective: Obesity is paradoxically associated with enhanced survival in patients with established cardiovascular disease. We explored this paradox further by examining the influence of obesity on survival in patients with verified atherosclerotic heart disease., Design and Patients: This retrospective registry based cohort study included all patients from the Western Denmark Heart Registry with coronary atherosclerosis confirmed by coronary angiography from January 2000 to December 2010. Patients were divided into eight groups according to body mass index (BMI) based on WHO BMI classification., Setting: Department of Cardiology, Copenhagen University Hospital Gentofte, Hellerup, Denmark., Results: The study included 37 573 patients (70.7% men) with a mean age of (66.3 ± 11.1) years. During the 11 years of follow-up, 5866 (15.6%) patients died. Multivariable analysis confirmed that the risk of death was the lowest among the preobese patients (27.5 ≤ BMI<30 kg/m(2)) with adjusted HR of 0.82 (95% CI 0.71 to 0.95; p=0.008) and increased with both low (BMI<18.50 kg/m(2)) and very high (BMI ≥ 40 kg/m(2)) BMI, HR 2.04 (95% CI 1.63 to 2.57; p<0.001) and HR 1.35 (95% CI 1.05 to 1.72; p<0.01), respectively. Also the normal weight class I (18.5 ≤ BMI<23 kg/m(2)) had a significant risk of mortality HR 1.28 (95% CI 1.13 to 1.45; p<0.001). Obese classes I and II did not differ from the reference group (23 ≤ BMI<25 kg/m(2))., Conclusions: Overweight atherosclerotic heart disease patients have improved survival compared with normal weight patients. Underweight and severely obese patients have increased mortality. Our results lean more towards an overweight paradox than an obesity paradox.

Background: Third-generation biodegradable polymer drug-eluting stents might reduce the risk of stent thrombosis compared with first-generation permanent polymer drug-eluting stents. We aimed to further investigate the effects of a biodegradable polymer biolimus-eluting stent compared with a durable polymer-coated sirolimus-eluting stent in a population-based setting., Methods: This randomised, multicentre, all-comer, non-inferiority trial was undertaken at three sites across western Denmark. Eligible patients were aged 18 years or older with chronic stable coronary artery disease or acute coronary syndromes, and at least one coronary artery lesion (>50% diameter stenosis). We randomly assigned patients (1:1) using an independently managed computer-generated allocation sequence to receive either a biolimus-eluting biodegradable polymer stent (Nobori, Terumo, Tokyo, Japan) or a sirolimus-eluting permanent polymer stent (Cypher Select Plus, Cordis, Johnson & Johnson, Warren, NJ, USA). The primary endpoint was a composite of safety (cardiac death, myocardial infarction, definite stent thrombosis) and efficacy (target vessel revascularisation) at 9 months, analysed by intention to treat (non-inferiority margin of 0·02). This trial is registered with ClinicalTrials.gov, number NCT01254981., Findings: From July, 2009, to January, 2011, we assigned 1229 patients (1532 lesions) to receive the biolimus-eluting stent and 1239 (1555 lesions) to receive the sirolimus-eluting stent. One patient was lost to follow-up because of emigration. Intention-to-treat analysis showed that 50 (4·1%) patients who were assigned the biolimus-eluting stent and 39 (3·1%) who were assigned the sirolimus-eluting stent met the primary endpoint (risk difference 0·9% [upper limit of one-sided 95% CI 2·1%]; p(non-inferiority)=0·06). Significantly more patients in the biolimus-eluting stent group had definite stent thrombosis at 12 months than did those in the sirolimus-eluting stent group (9 [0·7%] vs 2 [0·2%], risk difference 0·6% [95% CI 0·0-1·1]; p=0·034). Per-protocol analysis showed that 45 (3·8%) of 1193 patients who received a biolimus-eluting stent and 39 (3·2%) of 1208 who received a sirolimus-eluting stent met the primary endpoint (risk difference 0·5% [upper limit of one-sided 95% CI 1·8%]; p(non-inferiority)=0·03)., Interpretation: At 1 year follow-up, the biodegradable polymer biolimus-eluting Nobori stent did not improve clinical results compared with a first-generation sirolimus-eluting stent. We will need to obtain long-term data before we can make recommendations for the role of this biolimus-eluting stent in routine clinical practice., Funding: Terumo and Cordis (Johnson & Johnson)., (Copyright © 2013 Elsevier Ltd. All rights reserved.)

Diabetes is associated with increased risk of major adverse cardiac events (MACEs) after percutaneous coronary intervention. The purpose of this substudy of the SORT OUT IV trial was to compare clinical outcomes in patients with and without diabetes mellitus treated with everolimus-eluting stents (EESs) or sirolimus-eluting stents (SESs). In total 2,774 patients (390 with diabetes, 14.1%) were randomized to stent implantation with EESs (n = 1,390, diabetes in 14.0%) or SESs (n = 1,384, diabetes in 14.2%). Randomization was stratified by presence/absence of diabetes. The primary end point was MACEs, a composite of cardiac death, myocardial infarction, definite stent thrombosis, or target vessel revascularization within 18 months. MACEs were higher in diabetic than in nondiabetic patients (13.1% vs 6.4%, hazard ratio [HR] 2.08, 95% confidence interval [CI] 1.51 to 2.86). In diabetic patients, MACEs were seen in 10.3% of those treated with EESs and in 15.8% of those treated with SESs (HR 0.63, 95% CI 0.36 to 1.11). In nondiabetic patients, MACEs occurred in 6.6% of EES-treated and in 6.3% SES-treated patients (HR 1.06, 95% CI 0.77 to 1.46). In diabetics, cardiac death occurred in 3.1% of EES-treated and in 4.6% of SES-treated patients (HR 0.67, 95% CI 0.24 to 1.89), myocardial infarction occurred in 0.5% of EES-treated and in 3.6% of SES-treated patients (HR 0.14, 95% CI 0.02 to 1.16), and clinically driven target lesion revascularization was needed in 3.1% of EES-treated and in 7.7% of SES-treated patients (HR 0.40, 95% CI 0.15 to 1.02). No interaction between diabetes status and type of drug-eluting stent was found for the end points. In conclusion, patients with diabetes have higher MACE rates than nondiabetics. No significant differences in safety or efficacy outcomes after EES or SES implantation were present in nondiabetic or diabetic patients., (Copyright © 2012 Elsevier Inc. All rights reserved.)

Objectives: There are limited head-to-head randomized data on patient-related versus stent-related outcomes for everolimus-eluting stents (EES) and sirolimus-eluting stents (SES)., Background: In the SORT OUT IV (Scandinavian Organization for Randomized Trials With Clinical Outcome IV) trial, comparing the EES with the SES in patients with coronary artery disease, the EES was noninferior to the SES at 9 months., Methods: The primary endpoint was a composite: cardiac death, myocardial infarction (MI), definite stent thrombosis, or target vessel revascularization. Safety and efficacy outcomes at 2 years were further assessed with specific focus on patient-related composite (all death, all MI, or any revascularization) and stent-related composite outcomes (cardiac death, target vessel MI, or symptom-driven target lesion revascularization). A total of 1,390 patients were assigned to receive the EES, and 1,384 patients were assigned to receive the SES., Results: At 2 years, the composite primary endpoint occurred in 8.3% in the EES group and in 8.7% in the SES group (hazard ratio [HR]: 0.94, 95% confidence interval [CI]: 0.73 to 1.22). The patient-related outcome: 15.0% in the EES group versus 15.6% in the SES group, (HR: 0.95, 95% CI: 0.78 to 1.15), and the stent-related outcome: 5.2% in the EES group versus 5.3% in the SES group (HR: 0.97, 95% CI: 0.70 to 1.35) did not differ between groups. Rate of definite stent thrombosis was lower in the EES group (0.2% vs. 0.9%, (HR: 0.23, 95% CI: 0.07 to 0.80)., Conclusions: At 2-year follow-up, the EES was found to be noninferior to the SES with regard to both patient-related and stent-related clinical outcomes., (Copyright © 2012 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Objectives: This study sought to examine the 3-year clinical outcomes in patients treated with the Endeavor (Medtronic, Santa Rosa, California) zotarolimus-eluting stent (ZES) or the Cypher (Cordis, Johnson & Johnson, Warren, New Jersey) sirolimus-eluting stent (SES) in routine clinical practice., Background: The long-term clinical outcome in patients treated with ZES in comparison with SES is unclear., Methods: The authors randomized 2,332 patients to ZES (n = 1,162) or SES (n = 1,170) implantation. Endpoints included major adverse cardiac events (MACE), a composite of cardiac death, myocardial infarction, or target vessel revascularization; the individual endpoints of MACE; and definite stent thrombosis., Results: At 3-year follow-up, the MACE rate was higher in patients treated with ZES than in patients treated with SES (148 [12.9%] vs. 116 [10.1%]; hazard ratio [HR]: 1.33, 95% confidence interval [CI]: 1.04 to 1.69; p = 0.022). Target vessel revascularization was more frequent in the ZES group compared with the SES group (103 [9.1%] vs. 76 [6.7%]; HR: 1.40, 95% CI: 1.04 to 1.89; p = 0.025), whereas the occurrence of myocardial infarction (3.8% vs. 3.3%) and cardiac death (2.8% vs. 2.8%) did not differ significantly. Although the rate of definite stent thrombosis was similar at 3-year follow-up (1.1% vs. 1.4%), very late (12 to 36 months) definite stent thrombosis occurred in 0 (0%) patients in the ZES group versus 12 (1.1%) patients in the SES group (p = 0.0005)., Conclusions: Although the 3-year MACE rate is higher in patients treated with ZES versus SES, our data highlight a late safety problem concerning definite stent thrombosis with the use of SES. This finding underscores the importance of long-term follow-up in head-to-head comparisons of drug-eluting stents. (Randomized Clinical Comparison of the Endeavor and the Cypher Coronary Stents in Non-selected Angina Pectoris Patients [SORT OUT III]; NCT00660478)., (Copyright © 2012 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Background: Among drug-eluting stents released to date, the sirolimus-eluting stent has demonstrated the least amount of late lumen loss, but its efficacy and safety have not been compared head-to-head with the next-generation everolimus-eluting stent., Methods and Results: The Scandinavian Organization for Randomized Trials with Clinical Outcome IV (SORT OUT IV) trial was a randomized multicenter, single-blind, all-comer, 2-arm, noninferiority trial comparing the everolimus-eluting stent with the sirolimus-eluting stent in patients with coronary artery disease. The primary end point was a composite of safety (cardiac death, myocardial infarction, definite stent thrombosis) and efficacy (target vessel revascularization) parameters. The noninferiority criterion was a risk difference of 0.015. Intention-to-treat analyses were done at 9- and 18-month follow-ups. A total of 1390 patients were assigned to receive the everolimus-eluting stent and 1384 patients to the sirolimus-eluting stent. At the 9-month follow-up, 68 patients (4.9%) treated with the everolimus-eluting stent compared with 72 patients (5.2%) treated with the sirolimus-eluting stent experienced the primary end point (hazard ratio, 0.94; 95% confidence interval, 0.67-1.31; P for noninferiority=0.01). At the 18-month follow-up, this differential remained: 99 patients (7.2%) treated with the everolimus-eluting stent versus 105 (7.6%) treated with the sirolimus-eluting stent (hazard ratio, 0.94; 95% confidence interval, 0.71-1.23). At the 9-month follow-up, the rate of definite stent thrombosis was higher in the sirolimus-eluting group (2 patients [0.1%] versus 9 patients [0.7%]; hazard ratio, 0.22; 95% confidence interval, 0.05-1.02). At the 18-month follow-up, this difference was sustained (3 patients [0.2%] versus 12 patients [0.9%]; hazard ratio, 0.25; 95% confidence interval, 0.07-0.88)., Conclusion: The everolimus-eluting stent was found to be noninferior to the sirolimus-eluting stent., Clinical Trial Registration: URL: http://www.clinicaltrials.gov. Unique identifier: NCT00552877.

Patients ≥ 80 years old with coronary artery disease constitute a particular risk group in relation to percutaneous coronary intervention (PCI). From 2002 through 2008 we examined the annual proportion of patients ≥ 80 years old undergoing PCI in western Denmark, their indications for PCI, and prognosis. From 2002 through 2009 all elderly patients treated with PCI were identified in a population of 3.0 million based on the Western Denmark Heart Registry. Cox regression analysis was used to compare mortality rates according to clinical indications controlling for potential confounding. In total 3,792 elderly patients (≥ 80 years old) were treated with PCI and the annual proportion increased from 224 (5.4%) in 2002 to 588 (10.2%) in 2009. The clinical indication was stable angina pectoris (SAP) in 30.2%, ST-segment elevation myocardial infarction (STEMI) in 35.0%, UAP/non-STEMI in 29.7%, and "ventricular arrhythmia or congestive heart failure" in 5.1%. Overall 30-day and 1-year mortality rates were 9.2% and 18.1%, respectively. Compared to patients with SAP the adjusted 1-year mortality risk was significantly higher for patients presenting with STEMI (hazard ratio 3.86, 95% confidence interval 3.08 to 4.85), UAP/non-STEMI (hazard ratio 1.95, 95% confidence interval 1.53 to 2.50), and ventricular arrhythmia or congestive heart failure (hazard ratio 2.75, 95% confidence interval 1.92 to 3.92). In patients with SAP target vessel revascularization decreased from 7.1% in 2002 to 2.5% in 2008. In conclusion, the proportion of patients ≥ 80 years old treated with PCI increased significantly over an 8-year period. Patients with SAP had the lowest mortality rates and rates of clinically driven target vessel revascularization decreased over time., (Copyright © 2011 Elsevier Inc. All rights reserved.)

Aims: Patients with diabetes mellitus have increased risk of in-stent restenosis after coronary stent implantation due to neointimal hyperplasia (NIH). The aim of this study was to use quantitative coronary angiography (QCA) and volumetric intravascular ultrasound (IVUS) to evaluate the effects of the sirolimus-eluting Cypher® stent (SES) and the zotarolimus-eluting Endeavor® stent (ZES) on angiographic late lumen loss and intima hyperplasia in diabetic patients., Methods and Results: In the DiabeDES III trial, 127 patients were randomised to SES or ZES stent implantation. Angiographic 10-month follow-up data were available in 105 patients, including 48 SES and 57 ZES treated patients. Angiographic endpoints were in-stent late lumen loss and minimal lumen diameter. IVUS endpoints included NIH volume and in-stent percent volume obstruction. Baseline clinical characteristics and lesion parameters were similar in the two groups. At 10-month follow-up, angiographic in-stent late lumen loss (0.14±0.37 mm vs. 0.74±0.45 mm, p<0.001) was reduced and minimum lumen diameter was higher (2.36±0.53 mm vs. 1.96±0.65, p<0.001) in the SES group as compared to the ZES group. As compared to the ZES group, NIH volume was significantly reduced in the SES group (median [interquartile range]: 0.0 mm3 [0.0 to 1.2] vs. 16.5 mm3 [6.2 to 31.1], p<0.001). In-stent% volume obstruction was significantly reduced in SES as compared to ZES (median [interquartile range]: 0.0% [0.0-0.7] vs. 13.0% [6.7-20.8], p<0.001)., Conclusions: In diabetic patients, the SES reduced angiographic late lumen loss and inhibited NIH more effectively than ZES.