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Background: The optimal revascularization strategy for the elderly with complex coronary artery disease remains unclear.Objectives: The goal of this study was to investigate 10-year all-cause mortality, life expectancy, 5-year major adverse cardiac or cerebrovascular events (MACCE), and 5-year quality of life (QOL) after percutaneous coronary intervention (PCI) or coronary artery bypass graft (CABG) in elderly individuals (>70 years old) with 3-vessel disease (3VD) and/or left main disease (LMD).Methods: In the present pre-specified analysis on age of the SYNTAX Extended Survival study, 10-year all-cause death and 5-year MACCE were compared with Kaplan-Meier estimates and Cox proportional hazards models among elderly or nonelderly patients. Life expectancy was estimated by restricted mean survival time within 10 years, and QOL status according to the Seattle Angina Questionnaire up to 5 years was assessed by linear mixed-effects models.Results: Among 1,800 randomized patients, 575 patients (31.9%) were elderly. Ten-year mortality did not differ significantly between PCI and CABG in elderly (44.1% vs. 41.1%; hazard ratio [HR]: 1.08; 95% confidence interval [CI]: 0.84 to 1.40) and nonelderly patients (21.1% vs. 16.6%; HR: 1.30; 95% CI: 1.00 to 1.69; pinteraction = 0.332). Among elderly patients, 5-year MACCE was comparable between PCI and CABG (39.4% vs. 35.1%; HR: 1.18; 95% CI: 0.90 to 1.56), whereas it was significantly higher in PCI over CABG among nonelderly patients (36.3% vs. 23.0%; HR: 1.69; 95% CI: 1.36 to 2.10; pinteraction = 0.043). There were no significant difference in life expectancy (mean difference: 0.2 years in favor of CABG; 95% CI: -0.4 to 0.7) and 5-year QOL status between PCI and CABG among elderly patients.Conclusions: Elderly patients with 3VD and/or LMD had comparable 10-year all-cause death, life expectancy, 5-year MACCE, and 5-year QOL status irrespective of revascularization mode. (Synergy Between PCI With TAXUS and Cardiac Surgery: SYNTAX Extended Survival [SYNTAXES]; NCT03417050) (SYNTAX Study: TAXUS Drug-Eluting Stent Versus Coronary Artery Bypass Surgery for the Treatment of Narrowed Arteries [SYNTAX]; NCT00114972). [ABSTRACT FROM AUTHOR]

Background: Long-term benefits of coronary stenosis treatment with an everolimus-eluting bioresorbable scaffold are unknown.Objectives: This study sought to evaluate clinical and imaging outcomes 5 years after bioresorbable scaffold implantation.Methods: In the ABSORB multicenter, single-arm trial, 45 (B1) and 56 patients (B2) underwent coronary angiography, intravascular ultrasound (IVUS), and optical coherence tomography (OCT) at different times. At 5 years, 53 patients without target lesion revascularization underwent final imaging.Results: Between 6 months/1 year and 5 years, angiographic luminal late loss remained unchanged (B1: 0.14 ± 19 mm vs. 0.13 ± 0.33 mm; p = 0.7953; B2: 0.23 ± 0.28 mm vs. 0.18 ± 0.32 mm; p = 0.5685). When patients with a target lesion revascularization were included, luminal late loss was 0.15 ± 0.20 mm versus 0.15 ± 0.24 mm (p = 0.8275) for B1 and 0.30 ± 0.37 mm versus 0.32 ± 0.48 mm (p = 0.8204) for B2. At 5 years, in-scaffold and -segment binary restenosis was 7.8% (5 of 64) and 12.5% (8 of 64). On IVUS, the minimum lumen area of B1 decreased from 5.23 ± 0.97 mm(2) at 6 months to 4.89 ± 1.81 mm(2) at 5 years (p = 0.04), but remained unchanged in B2 (4.95 ± 0.91 mm(2) at 1 year to 4.84 ± 1.28 mm(2) at 5 years; p = 0.5). At 5 years, struts were no longer discernable by OCT and IVUS. On OCT, the minimum lumen area in B1 decreased from 4.51 ± 1.28 mm(2) at 6 months to 3.65 ± 1.39 mm(2) at 5 years (p = 0.01), but remained unchanged in B2, 4.35 ± 1.09 mm(2) at 1 year and 4.12 ± 1.38 mm(2) at 5 years (p = 0.24). Overall, the 5-year major adverse cardiac event rate was 11.0%, without any scaffold thrombosis.Conclusions: At 5 years, bioresorbable scaffold implantation in a simple stenotic lesion resulted in stable lumen dimensions and low restenosis and major adverse cardiac event rates. (ABSORB Clinical Investigation, Cohort B [ABSORB B]; NCT00856856). [ABSTRACT FROM AUTHOR]

OBJECTIVES: To investigate the until now undefined extent of differences in baseline characteristics, practice patterns and clinical outcomes of patients undergoing coronary artery bypass grafting (CABG) for complex coronary artery disease in the USA versus Europe. METHODS: The impact of geographic enrolment on clinical outcomes was explored using the as-treated population of 1510 patients with de novo left main and/or three-vessel disease who underwent CABG in either the SYNTAX randomized trial or registries, and who were followed up for 5 years. RESULTS: There were 259 (17%) patients enrolled in the USA. Patients in the USA had more comorbidities. Off-pump procedures were more frequent in the USA (32 vs 13% in Europe; P < 0.001), and crystalloid cardioplegia was used less often (17 vs 38% in Europe; P < 0.001). In the USA, more grafts per patient were used (3.1 ± 0.8 vs 2.7 ± 0.7 in Europe; P < 0.001), with less complete arterial grafting (5 vs 18% in Europe; P < 0.001) but more complete revascularization (80 vs 66% in Europe; P < 0.001). At 5-year follow-up, patients treated in the USA versus Europe had comparable rates of major adverse cardiac and cerebrovascular events (MACCEs: 28.7 vs 24.3%, respectively; P = 0.11) and the composite safety endpoint of death, stroke and myocardial infarction (MI; 15.3 vs 17.5%, respectively; P = 0.43), but a significantly higher rate of repeat revascularization (15.0 vs 9.8%, respectively; P = 0.011) driven by repeat percutaneous coronary intervention (14.6 vs 9.2%; P = 0.005) and not repeat CABG (0.4 vs 0.8%; P = 0.48). Rates of graft occlusion were significantly higher in the USA versus Europe (8.7 vs 3.2%; P < 0.001). In multivariate analysis, enrolment in the USA was a non-significant predictor of MACCE [hazard ratio (HR) = 1.31, 95% confidence interval (95% CI) 1.00-1.73; P = 0.053], but independently predicted repeat revascularization (HR = 1.66, 95% CI 1.12-2.46; P = 0.011) and graft occlusion (HR = 2.65, 95% CI 1.52-4.62; P = 0.001). It was also a non-significant predictor of reduced rates of MI (HR = 0.38, 95% CI 0.14-1.06; P = 0.064). Differences between the USA and Europe were most pronounced among patients who underwent off-pump CABG. CONCLUSIONS: Repeat revascularization rates following CABG in the USA versus Europe were increased at 5 years, particularly in off-pump patients. There was no significant difference in the rate of death, stroke and MI. [ABSTRACT FROM AUTHOR]

Background: First-generation drug-eluting stents (DES) still have significant rates of restenosis and stent thrombosis, especially in complex lesions. A second- generation stent eluting everolimus from a thin, non-adhesive, non-inflammatory durable polymer coated onto a low-profile, cobalt- chromium stent has been developed and evaluated in patients with coronary artery disease. Methods: Following the SPIRIT First proof-of-concept trial, the everolimus-eluting stent (EES) was compared to a widely used paclitaxel-eluting stent (PES) in patients with non-complex coronary artery disease in 2 successive randomized trials in Europe and Asia (SPIRIT II) and the United States (SPIRIT III). The databases from these trials were pooled for a patient-level meta-analysis. Results: Collectively, the SPIRIT II and SPIRIT III trials randomized 1,302 patients to either EES (n = 892) or PES (n = 410), with a total of 1,501 randomized lesions treated. EES compared to PES resulted in reduced mean in-segment late loss (0.11 ± 0.37 vs. 0.22 ± 0.44 mm, P = 0.0004) and binary angiographic restenosis (4.1% vs. 7.8%, P = 0.039) at 6–8 months. The 30-day rates of myocardial infarction (MI) were lower with EES than PES (1.0% vs. 2.9%, P = 0.02). At 1-year, EES compared to PES resulted in reduced rates of target lesion revascularization (TLR; 3.1% vs. 5.8%, P = 0.02), a trend toward less MI (2.3% vs. 4.0%, P = 0.08), and comparable rates of cardiac death (0.6% vs. 1.0%, P = 0.39) and stent thrombosis (0.7% vs. 0.8%, P = 0.90). As a result, patients treated with EES compared to PES had significantly reduced rates of major adverse cardiac events (cardiac death, MI, or TLR) at 1 year (5.2% vs. 10.0%, P = 0.002). Conclusions: The EES stent is a second-generation DES which results in improved clinical and angiographic outcomes compared to PES at 1 year. Longer-term follow-up from these trials and larger comparative trials are under way to evaluate the durability and utility of this device in more complex patients and lesions. [ABSTRACT FROM AUTHOR]

The article presents a study which aims to improve the safety of durable polymer drug-eluting stents by avoiding the persistent inflammatory stimulus of durable polymers. The study uses multicentre and non-inferiority trial which was done in ten centres in Europe and applied broad inclusion criteria. Results show that patients with lesions were randomly allocated to receive biodegradable polymer biolimus-eluting stents (BES) or durable polymer sirolimus-eluting stent (SES).

Background: The long-term clinical benefit after percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG) in patients with total occlusions (TOs) and complex coronary artery disease has not yet been clarified.Objectives: The objective of this analysis was to assess 10-year all-cause mortality in patients with TOs undergoing PCI or CABG.Methods: This is a subanalysis of patients with at least 1 TO in the SYNTAXES (Synergy Between PCI With Taxus and Cardiac Surgery Extended Survival) study, which investigated 10-year all-cause mortality in the SYNTAX (Synergy Between PCI With Taxus and Cardiac Surgery) trial, beyond its original 5-year follow-up. Patients with TOs were further stratified according to the status of TO recanalization or revascularization.Results: Of 1,800 randomized patients to the PCI or CABG arm, 460 patients had at least 1 lesion of TO. In patients with TOs, the status of TO recanalization or revascularization was not associated with 10-year all-cause mortality, irrespective of the assigned treatment (PCI arm: 29.9% vs. 29.4%; adjusted hazard ratio [HR]: 0.992; 95% confidence interval [CI]: 0.474 to 2.075; p = 0.982; and CABG arm: 28.0% vs. 21.4%; adjusted HR: 0.656; 95% CI: 0.281 to 1.533; p = 0.330). When TOs existed in left main and/or left anterior descending artery, the status of TO recanalization or revascularization did not have an impact on the mortality (34.5% vs. 26.9%; adjusted HR: 0.896; 95% CI: 0.314 to 2.555; p = 0.837).Conclusions: At 10-year follow-up, the status of TO recanalization or revascularization did not affect mortality, irrespective of the assigned treatment and location of TOs. The present study might support contemporary practice among high-volume chronic TO-PCI centers where recanalization is primarily offered to patients for the management of angina refractory to medical therapy when myocardial viability is confirmed. (Synergy Between PCI With TAXUS and Cardiac Surgery: SYNTAX Extended Survival [SYNTAXES]; NCT03417050; SYNTAX Study: TAXUS Drug-Eluting Stent Versus Coronary Artery Bypass Surgery for the Treatment of Narrowed Arteries [SYNTAX]; NCT00114972). [ABSTRACT FROM AUTHOR]

Background: Data for the safety and efficacy of new-generation drug-eluting stents at long-term follow-up, and specifically in patients with ST-segment elevation myocardial infarction, are scarce. In the EXAMINATION trial, we compared everolimus-eluting stents (EES) with bare-metal stents (BMS) in an all-comer population with ST-segment elevation myocardial infarction. In this study, we assessed the 5-year outcomes of the population in the EXAMINATION trial.Methods: In the multicentre EXAMINATION trial, done in Italy, Spain, and the Netherlands, patients with ST-segment elevation myocardial infarction were randomly assigned in a 1:1 ratio to receive EES or BMS. The random allocation schedule was computer-generated and central randomisation (by telephone) was used to allocate patients in blocks of four or six, stratified by centre. Patients were masked to treatment assignment. At 5 years, we assessed the combined patient-oriented outcome of all-cause death, any myocardial infarction, or any revascularisation. Analysis was by intention to treat. This trial is registered with ClinicalTrials.gov, number NCT00828087.Findings: 1498 patients were randomly assigned to receive either EES (n=751) or BMS (n=747). At 5 years, complete clinical follow-up data were obtained for 731 patients treated with EES and 727 treated with BMS (97% of both groups). The patient-oriented endpoint occurred in 159 (21%) patients in the EES group versus 192 (26%) in the BMS group (hazard ratio 0·80, 95% CI 0·65-0·98; p=0·033). This difference was mainly driven by a reduced rate of all-cause mortality (65 [9%] vs 88 [12%]; 0·72, 0·52-0·10; p=0·047).Interpretation: Our findings should be taken as a point of reference for the assessment of new bioresorbable polymer-based metallic stents or bioresorbable scaffolds in patients with ST-segment elevation myocardial infarction.Funding: Spanish Heart Foundation. [ABSTRACT FROM AUTHOR]

The article presents a study on the results of a RESOLUTE All Comers trial. The study uses data from patients with at least one coronary lesion, who were assigned to a Resolute zotarolimus-eluting stent or a Xience V everolimus-eluting stent in Europe and Israel. It reveals that the greater number of patient-related than stent-related results highlights that the optimisation of secondary prevention is at least as significant as choosing the drug-eluting stent to implant in a lesion.

The Bifurcation Academic Research Consortium (Bif-ARC) project originated from the need to overcome the paucity of standardization and comparability between studies involving bifurcation coronary lesions. This document is the result of a collaborative effort between academic research organizations and the most renowned interventional cardiology societies focused on bifurcation lesions in Europe, the United States, and Asia. This consensus provides standardized definitions for bifurcation lesions; the criteria to judge the side branch relevance; the procedural, mechanistic, and clinical endpoints for every type of bifurcation study; and the follow-up methods. Considering the complexity of bifurcation lesions and their evaluation, detailed instructions and technical aspects for site and core laboratory analysis of bifurcation lesions are also reported. The recommendations included within this consensus will facilitate pooled analyses and the effective comparison of data in the future, improving the clinical relevance of trials in bifurcation lesions, and the quality of care in this subset of patients.

The Bifurcation Academic Research Consortium (Bif-ARC) project originated from the need to overcome the paucity of standardization and comparability between studies involving bifurcation coronary lesions. This document is the result of a collaborative effort between academic research organizations and the most renowned interventional cardiology societies focused on bifurcation lesions in Europe, the United States, and Asia. This consensus provides standardized definitions for bifurcation lesions; the criteria to judge the side branch relevance; the procedural, mechanistic, and clinical endpoints for every type of bifurcation study; and the follow-up methods. Considering the complexity of bifurcation lesions and their evaluation, detailed instructions and technical aspects for site and core laboratory analysis of bifurcation lesions are also reported. The recommendations included within this consensus will facilitate pooled analyses and the effective comparison of data in the future, improving the clinical relevance of trials in bifurcation lesions, and the quality of care in this subset of patients., Competing Interests: Funding Support and Author Disclosures This work is supported by a Science Foundation Ireland Research Professorship Award (RSF 1413) including grants to Drs Lunardi and Wijns. Dr Lefèvre has received speaker fees from Abbott, Medtronic and Terumo. Dr Burzotta has received speaker fees from Medtronic, Abiomed, and Abbott. Dr Lassen has received speaker fees from Medtronic, Boston Scientific, Biotronik, Abbott and Biosensors. Dr Darremont has received speaker fees from Edwards. Dr Holm has received institutional research grants and speaker fees from St. Jude Medical and Terumo. Dr Johnson has received speaker fees from Abbott, Boston Scientific, Medtronic, and Terumo; and has received institutional funding for fellowships from Boston Scientific and Terumo. Dr Pan has received speaker fees from Abbott, Terumo, and Volcano. Dr Chatzizisis has received speaker fees and consultation fees from Boston Scientific; and has received research support from Boston Scientific and Medtronic. Dr Banning has received institutional funding of a fellowship from Boston Scientific; and has received speaker fees from Boston, Abbott, Medtronic, Philips/Volcano, and Miracor. Dr Chieffo has received speaker fees from Abiomed and GADA. Dr Dudek has received grants and personal fees from Boston Scientific, Philips, Abbott, Medtronic, and Biotronik. Dr Hildick-Smith has received advisory board, consultancy, and research funding from Terumo, Medtronic, Abbott, and Boston Scientific. Dr Dangas has received lecture fees from Bayer and Daiichi-Sankyo; has received institutional and grant support from Daiichi-Sankyo; and has held equity in Medtronic. Dr Stone has received lecture fees from Terumo and Amaranth; has received consulting fees from Shockwave Medical, TherOx, Reva, Vascular Dynamics, Robocath, HeartFlow, Gore, Ablative Solutions, Matrizyme, Miracor Medical, Neovasc, V-Wave, Abiomed, Claret Medical, Sirtex Medical, MAIA Pharmaceuticals, VALFIX Medical, SpectraWAVE, Ancora, and Vectorious Medical Technologies; holds equity in VALFIX Medical, Ancora, Qool Therapeutics, Orchestra BioMed, Cagent Vascular, Applied Therapeutics, Biostar, MedFocus, Aria CV, Cardiac Success, and SpectraWAVE; holds stock options in Ancora, Qool Therapeutics, Orchestra BioMed, Cagent Vascular, Applied Therapeutics, Biostar, MedFocus, Aria CV, and Cardiac Success; and has received personal fees from Qool Therapeutics and Orchestra BioMed. Dr Cutlip has received grant support from Cordis; has received travel reimbursement from Abbott Vascular; and has received additional funding for the Clinical Events Committee from Boston Scientific. Dr Mehran has received institutional grant support from Abbott Laboratories, AstraZeneca, Bayer, CSL Behring, Daiichi-Sankyo, Medtronic, Novartis, Bristol Myers Squibb, and OrbusNeich; has received consulting fees from Abbott Laboratories (paid to her institution), Spectranetics (Philips Volcano) (paid to her institution), Boston Scientific, Medscape (WebMD), Siemens Medical Solutions, Roivant Services, Sanofi, Regeneron, and Janssen Scientific Affairs; has received lecture fees from Abbott Laboratories (paid to her institution), and Medtelligence (Janssen Scientific Affairs); has served on advisory boards for Bristol Myers Squibb (fees paid to her institution), PLx Opco, and Medtelligence (Janssen Scientific Affairs); has served on a data and safety monitoring board (fees paid to her institution) for Watermark Research Partners; has received nonfinancial support from Regeneron; and holds equity in Claret Medical and Elixir Medical. Dr Wijns has received institutional research grants from Terumo, MiCell, and MicroPort; has received honoraria from MicroPort; has been a medical advisor of Rede Optimus Research; and is cofounder of Argonauts, an innovation accelerator. Dr Serruys has received personal fees from Philips/Volcano, SMT, Novartis, Xeltis, and Merillife. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2022 The Authors. Published by Elsevier Inc. All rights reserved.)

Background Aspirin is widely administered to prevent cardiovascular disease (CVD). However, appropriate use of aspirin depends on patient understanding of its risks, benefits, and indications, especially where aspirin is available over the counter (OTC). Methods and Results We did a survey of patient-reported 10-year cardiovascular risk; aspirin therapy status; form of aspirin access (OTC versus prescription); and knowledge of the risks, benefits, and role of aspirin in CVD prevention. Consecutive adults aged ≥50 years with ≥1 cardiovascular risk factor attending outpatient clinics in America and Europe were recruited. We also systematically reviewed national policies regulating access to low-dose aspirin for CVD prevention. At each site, 150 responses were obtained (300 total). Mean±SD age was 65±10 years, 40% were women, and 41% were secondary prevention patients. More than half of the participants at both sites did not know (1) their own level of 10-year CVD risk, (2) the expected magnitude of reduction in CVD risk with aspirin, or (3) aspirin's bleeding risks. Only 62% of all participants reported that aspirin was routinely indicated for secondary prevention, whereas 47% believed it was routinely indicated for primary prevention ( P =0.048). In America, 83.5% participants obtained aspirin OTC compared with 2.5% in Europe ( P <0.001). Finally, our review of European national policies found only 2 countries where low-dose aspirin was available OTC. Conclusions Many patients have poor insight into their objectively calculated 10-year cardiovascular risk and do not know the risks, benefits, and role of aspirin in CVD prevention. Aspirin is mainly obtained OTC in America in contrast to Europe, where most countries restrict access to low-dose aspirin.

Background: Appropriate size selection of transcatheter heart valves (THVs) is fundamental to reduce transcatheter aortic valve implantation (TAVI) related complications, particularly paravalvular aortic regurgitation, new permanent pacemaker implantation, and annular rupture. We sought to investigate the frequency of operator selection of intermediate-size balloon-expandable Myval THVs (Meril Life Sciences Pvt. Ltd., India) for TAVI in a real-world dataset., Methods: In this retrospective survey of patients treated with TAVI using the Myval THV, 20, 23, 26, and 29 mm are conventional-size THVs, 21.5, 24.5 and 27.5 mm are intermediate-size THVs, and 30.5 and 32 mm are extra-large THVs. Operator size selection for implantation was based on multislice computed tomography (MSCT) derived aortic-root dimensions., Results: A total of 1115 patients underwent Myval THV implantation in 27 countries worldwide. The Myval intermediate-size THVs were used in 468 (42.0%) patients. MSCT data were available in 562 patients. There was no statistical difference between the Intermediate/Upsized and Appropriately sized groups or Intermediate/Downsized and Appropriately sized groups in terms of different variables measured with MSCT except for annular dimensions and degree of calcification., Conclusions: Intermediate-size Myval balloon-expandable THVs are used in nearly half of all cases in contemporary real-world TAVI practice, addressing the unmet need of TAVI operators for a more calibrated THV choice. Our hypothesis should be tested in randomized prospective studies currently initiated in Europe, including clinical outcomes of patients treated with both conventional- and intermediate-size THVs., (Copyright © 2021 The Author(s). Published by Elsevier B.V. All rights reserved.)

Background: Despite the overall neutral results of the GLOBAL-LEADERS trial, results from a prespecified subgroup analysis showed that patients from Western Europe had a significantly lower rate of the primary endpoint when treated with ticagrelor monotherapy. Therefore, we aimed to examine the regional disparities in patients' baseline characteristics and their response to ticagrelor monotherapy., Methods: Patients' baseline characteristics and the treatment effects of ticagrelor combined with aspirin for 1 month, followed by ticagrelor monotherapy for 23-months versus 12-months of standard dual antiplatelet therapy (DAPT) were compared according to participating countries. The primary endpoint was a composite endpoint of all-cause death or new Q-wave myocardial infarction at two years., Results: Significant variances in patients' baseline characteristics were found between participating countries. The primary endpoint varied significantly according to the country (P interaction  = 0.027). Patients from France (1.6% versus 5.2%, HR: 0.31, 95%CI: 0.13-0.73) and The Netherlands (2.4% versus 4.8%, HR, 0.50, 95%CI: 0.26-0.94) had lower rates of the primary endpoint when allocated to ticagrelor monotherapy, compared with the standard DAPT regimen. Of the 26 baseline and post-randomization factors explored, variance in the rate of complex PCI between countries was identified as the top contributor to this regional interaction., Conclusions: Patients' baseline characteristics varied between participating countries in the GLOBAL-LEADERS trial. There is a significant regional variance in the treatment effect of ticagrelor monotherapy, which could partly be explained by the differences in complex PCI being performed., Clinical Trial Registration: ClinicalTrials.gov (NCT01813435)., Competing Interests: Declaration of Competing Interest None., (Copyright © 2020 Elsevier B.V. All rights reserved.)

Background: We investigated the association of insulin resistance (IR) with coronary plaque morphology and the risk of cardiovascular events in patients enrolled in the Providing Regional Observations to Study Predictors of Events in Coronary Tree (PROSPECT) study., Methods: Patients with acute coronary syndromes (ACS) were divided based on DM status. Non-DM patients were further stratified according to homeostasis-model-assessment IR (HOMA-IR) index as insulin sensitive (IS; HOMA-IR ≤ 2), likely-IR (LIR; 2 < HOMA-IR < 5), or diabetic-IR (DIR; HOMA-IR ≥ 5). Coronary plaque characteristics were investigated by intravascular ultrasound. The primary endpoint was major adverse cardiac events (MACE); a composite of cardiac death, cardiac arrest, myocardial infarction, and rehospitalization for unstable/progressive angina., Results: Among non-diabetic patients, 109 patients (21.5%) were categorized as LIR, and 65 patients (12.8%) as DIR. Patients with DIR or DM had significantly higher rates of echolucent plaque compared with LIR and IS. In addition, DIR and DM were independently associated with increased risk of MACE compared with IS (adjusted hazard ratio [aHR] 2.29, 95% confidence interval [CI] 1.22-4.29, p = 0.01 and aHR 2.12, 95% CI 1.19-3.75, p = 0.009, respectively)., Conclusions: IR is common among patients with ACS. DM and advanced but not early stages of IR are independently associated with increased risk of adverse cardiovascular events. Trial Registration ClinicalTrials.gov Identifier: NCT00180466.

Background: Patients with both diabetes mellitus (DM) and chronic kidney disease (CKD) are a subpopulation characterized by ultrahigh ischemic and bleeding risk after percutaneous coronary intervention. There are limited data on the impact of ticagrelor monotherapy among these patients., Methods: In this post hoc analysis of the GLOBAL-LEADERS trial, the treatment effects of the experimental (one-month dual-antiplatelet therapy [DAPT] followed by 23-month ticagrelor monotherapy) versus the reference regimen (12-month DAPT followed by 12-month aspirin alone) were analyzed according to DM/CKD status. The primary endpoint was a composite endpoint of all-cause death or new Q-wave myocardial infarction at 2-years. The patient-oriented composite endpoint (POCE) was defined as the composite of all-cause death, any stroke, site-reported MI and any revascularization, whereas net adverse clinical events (NACE) combined POCE with BARC type 3 or 5 bleeding events., Results: At 2 years, the DM + /CKD + patients had significantly higher incidences of the primary endpoint (9.5% versus 3.1%, adjusted HR 2.16; 95% CI [1.66-2.80], p < 0.001), BARC type 3 or 5 bleeding events, stroke, site-reported myocardial infraction, all revascularization, POCE, and NACE, compared with the DM-/CKD- patients. Among the DM + /CKD + patients, after adjustment, there were no significant differences in the primary endpoints between the experimental and reference regimen; however, the experimental regimen was associated with lower rates of POCE (20.6% versus 25.9%, HR 0.74; 95% CI [0.55-0.99], p = 0.043, p interaction  = 0.155) and NACE (22.7% versus 28.3%, HR 0.75; 95% CI [0.56-0.99], p = 0.044, p interaction  = 0.310), which was mainly driven by a lower rate of all revascularization, as compared with the reference regimen. The landmark analysis showed that while the experimental and reference regimen had similar rates of all the clinical endpoints during the first year, the experimental regimen was associated with significantly lower rates of POCE (5.8% versus 11.0%, HR 0.49; 95% CI [0.29-0.82], p = 0.007, p interaction  = 0.040) and NACE (5.8% versus 11.2%, HR 0.48; 95% CI [0.29-0.82], p = 0.007, p interaction  = 0.013) in the second year., Conclusion: Among patients with both DM and CKD, ticagrelor monotherapy was not associated with lower rates of all-cause death or new Q-wave, or major bleeding complications; however, it was associated with lower rates of POCE and NACE. These findings should be interpreted as hypothesis-generating., Clinical Trial Registration: ClinicalTrials.gov (NCT01813435).

Background: Numerous randomized clinical trials have demonstrated the superiority of thin-strut biodegradable polymer second-generation drug-eluting stent to the first-generation drug-eluting stent and the noninferiority to the thin-strut second-generation permanent polymer drug-eluting stent. Data on long-term clinical outcomes with a novel ultrathin drug-eluting stent, to date, are limited., Methods: The DESSOLVE III trial (Multicenter Randomized Study of the MiStent Sirolimus Eluting Absorbable Polymer Stent System for Revascularization of Coronary Arteries; n=1398) is a prospective, multicenter, single-blinded, all-comers, randomized controlled trial (NCT02385279), allocating in a 1:1 ratio to either ultrathin-strut biodegradable polymer MiStent sirolimus-eluting stent or to thin-strut permanent polymer Xience everolimus-eluting stent. The primary end point was device-oriented composite end point, defined as the composite of cardiac death, target vessel myocardial infarction, or clinically indicated target lesion revascularization. The secondary end point was patient-oriented composite end point, defined as the composite of all-cause mortality, any myocardial infarction, or any revascularization., Results: At 3 years, follow-up data were available in 1381 patients (98.8%). The primary end point of device-oriented composite end point occurred in 10.5% for MiStent sirolimus-eluting stent and in 11.5% for Xience everolimus-eluting stent ( P =0.55). Rates of cardiac death (3.9% versus 3.8%; P =0.88), target vessel myocardial infarction (3.2% versus 2.5%; P =0.43), and clinically indicated target lesion revascularization (5.2% versus 6.5%; P =0.30) did not differ significantly between the 2 devices. The rate of definite or probable stent thrombosis was infrequent and similar between the 2 arms (1.2% versus 1.5%; P =0.64). The 90-day landmark analysis showed no significant difference in device-oriented composite end point between the 2 groups after polymer degradation of MiStent. The risk of patient-oriented composite end point was comparable between the 2 groups (22.7% versus 22.9%; P =0.34)., Conclusions: In the DESSOLVE III trial, early safety and efficacy with MiStent sirolimus-eluting bioabsorbable polymer-coated stent are confirmed at a longer term follow-up when compared with Xience everolimus-eluting permanent polymer-coated stent in a large all-comers population. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT02385279.

Objectives: The aim of this study was to report the 2-year results of the SURTAVI (Surgical Replacement and Transcatheter Aortic Valve Implantation) trial and confirm the interim Bayesian analysis., Background: Transcatheter aortic valve replacement (TAVR) with a self-expanding valve was noninferior to surgery in patients with severe aortic stenosis and intermediate operative risk using Bayesian statistical methods. Novel Bayesian designs have been used to shorten the time to primary endpoint analysis in randomized clinical trials, although the predictive value of Bayesian analysis compared with frequentist approaches remains debated., Methods: The SURTAVI trial randomized 1,660 patients. An interim analysis was performed 1 year after the 1,400th patient was treated to estimate the primary 2-year endpoint of all-cause mortality or disabling strokes for all patients., Results: The Kaplan-Meier rate for the complete 2-year primary endpoint was 12.7% in the TAVR group and 12.6% in the surgery group (0.0% difference; 95% confidence interval: -3.4% to 3.5%), compared with 12.6% with TAVR and 14.0% with surgery (-1.4% difference; Bayesian credible interval: -5.2% to 2.3%) in the interim Bayesian analysis. A comparison of individual clinical, hemodynamic, and quality-of-life endpoints using Bayesian and frequentist methods found no significant differences., Conclusions: The complete analysis of all patients with aortic stenosis at intermediate risk for surgery in the SURTAVI trial confirmed the noninferiority, with respect to the frequency of all-cause mortality or disabling stroke, of TAVR to surgery, as determined in the interim Bayesian analysis. Follow-up will extend out to 10 years., (Copyright © 2020 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Background: Patients with severe aortic stenosis (AS) often have coronary artery disease. Both the aortic valve and the coronary disease influence the blood flow to the myocardium and its ability to respond to stress; leading to exertional symptoms. In this study, we aim to quantify the effect of severe AS on the coronary microcirculation and determine if this is influenced by any concomitant coronary disease. We then compare this to the effect of coronary stenoses on the coronary microcirculation., Methods: Group 1: 55 patients with severe AS and intermediate coronary stenoses treated with transcatheter aortic valve implantation (TAVI) were included. Group 2: 85 patients with intermediate coronary stenoses and no AS treated with percutaneous coronary intervention were included. Coronary pressure and flow were measured at rest and during hyperemia in both groups, before and after TAVI (group 1) and before and after percutaneous coronary intervention (group 2)., Results: Microvascular resistance over the wave-free period of diastole increased significantly post-TAVI (pre-TAVI, 2.71±1.4 mm Hg·cm·s -1 versus post-TAVI 3.04±1.6 mm Hg·cm·s -1 [ P =0.03]). Microvascular reserve over the wave-free period of diastole significantly improved post-TAVI (pre-TAVI 1.88±1.0 versus post-TAVI 2.09±0.8 [ P =0.003]); this was independent of the severity of the underlying coronary stenosis. The change in microvascular resistance post-TAVI was equivalent to that produced by stenting a coronary lesion with an instantaneous wave-free ratio of ≤0.74., Conclusions: TAVI improves microcirculatory function regardless of the severity of underlying coronary disease. TAVI for severe AS produces a coronary hemodynamic improvement equivalent to the hemodynamic benefit of stenting coronary stenoses with instantaneous wave-free ratio values <0.74. Future trials of physiology-guided revascularization in severe AS may consider using this value to guide treatment of concomitant coronary artery disease.

Background: Fractional flow reserve (FFR) is a reliable tool for the functional assessment of coronary stenoses. FFR computed tomography (CT) derived (FFR CT ) has shown to be accurate, but its clinical usefulness in patients with complex coronary artery disease remains to be investigated. The present study sought to determine the impact of FFR CT on heart team's treatment decision-making and selection of vessels for revascularization in patients with 3-vessel coronary artery disease., Methods: The trial was an international, multicenter study randomizing 2 heart teams to make a treatment decision between percutaneous coronary interventions and coronary artery bypass grafting using either coronary computed tomography angiography or conventional angiography. The heart teams received the FFR CT and had to make a treatment decision and planning integrating the functional component of the stenoses. Each heart team calculated the anatomic SYNTAX score, the noninvasive functional SYNTAX score and subsequently integrated the clinical information to compute the SYNTAX score III providing a treatment recommendation, that is, coronary artery bypass grafting, percutaneous coronary intervention, or equipoise coronary artery bypass grafting-percutaneous coronary intervention. The primary objective was to determine the proportion of patients in whom FFR CT changed the treatment decision and planning., Results: Overall, 223 patients were included. Coronary computed tomography angiography assessment was feasible in 99% of the patients and FFR CT analysis in 88%. FFR CT was available for 1030 lesions (mean FFR CT value 0.64±13). A treatment recommendation of coronary artery bypass grafting was made in 24% of the patients with coronary computed tomography angiography with FFR CT . The addition of FFR CT changed the treatment decision in 7% of the patients and modified selection of vessels for revascularization in 12%. With conventional angiography as reference, FFR CT assessment resulted in reclassification of 14% of patients from intermediate and high to low SYNTAX score tertile., Conclusions: In patients with 3-vessel coronary artery disease, a noninvasive physiology assessment using FFR CT changed heart team's treatment decision-making and procedural planning in one-fifth of the patients., Clinical Trial Registration: URL: https://www.clinicaltrials.gov. Unique identifier: NCT02813473.

Aims: The aim of this study is to compare the SUPRAFLEX sirolimus-eluting stent (SES) with the XIENCE everolimus-eluting stent (EES) with respect to target lesion failure (TLF) at 12 months in a non-inferiority trial in a "real-world" patient population., Methods and Results: This is a prospective, randomised, 1:1 balanced, controlled, single-blind, multicentre study comparing clinical outcomes at 12 months between SUPRAFLEX and XIENCE in an "all-comers" patient population, comprising a total of 1,430 enrolled subjects with symptomatic coronary artery disease who qualify for percutaneous coronary interventions at 23 centres in Europe. The primary endpoint is a non-inferiority comparison of the device-oriented composite endpoint target lesion failure (cardiac death, target vessel myocardial infarction and clinically indicated target lesion revascularisation) of the SUPRAFLEX group to the XIENCE group at 12 months post procedure. Secondary endpoints include the patient-oriented composite endpoint, target vessel failure, mortality, myocardial infarction, revascularisation and stent thrombosis rates (ARC classification)., Conclusions: The TALENT trial aims to assess the safety and effectiveness of the thin-strut SUPRAFLEX compared to the current standard of care (XIENCE EES) in patients with atherosclerotic lesions. This will provide valuable information on the impact of this thin-strut device in an all-comers population.

Background: ACEF score has been shown to have predictive ability in the patients undergoing percutaneous coronary intervention (PCI). The ACEF II score has recently been developed to predict short-term mortality after cardiac surgery. We compared the predictive ability of the ACEF and ACEF II scores to predict mortality after PCI in the all-comers population., Methods: The ACEF and ACEF II scores were calculated in 15,968 patients enrolled in the GLOBAL LEADERS study. Discrimination and calibration were assessed for outcomes after PCI. Recalibration of the regression model by updating the intercept and slope were performed to adjust the original ACEF model to the PCI setting. In a stratified approach, patients were divided into quintiles according to the score. Outcomes were compared between quintiles., Results: The ACEF and ACEF II score were available in 14,941 and 14,355 patients respectively. Discrimination for 30-day all-cause mortality was acceptable for both scores (C-statistic ACEF 0.75 and ACEF II 0.77). For 2-year all-cause mortality, the discrimination of ACEF score was acceptable (C-statistic 0.72) while the discrimination of ACEF II score was moderate (C-statistic 0.69). Both scores identified patients at high risk of mortality but overestimated all-cause mortality at 30 days in all quintiles. After recalibration, agreement between predicted and observed 30-day all-cause mortality in both scores are close to the identity line., Conclusions: The ACEF II model did not improve the predictive ability of the ACEF score. Recalibrated ACEF model can be used to estimated all-cause mortality rate at 30 days after PCI., (Copyright © 2019 Elsevier B.V. All rights reserved.)

Objectives: The aim of this study was to investigate the impact of pre-diabetes (pre-DM) on coronary plaque characteristics and ischemic outcomes in patients with acute coronary syndromes (ACS)., Background: Pre-DM (i.e., the early stages of glucometabolic disturbance) is common among patients with ACS, but the extent to which pre-DM influences coronary plaque characteristics and the risk for adverse ischemic events is unclear., Methods: In the PROSPECT (Providing Regional Observations to Study Predictors of Events in Coronary Tree) study, patients with ACS underwent quantitative coronary angiography, grayscale intravascular ultrasound, and radiofrequency intravascular ultrasound after successful percutaneous coronary intervention. Patients were divided into 3 groups according to their glucometabolic status, as defined by the American Diabetes Association: normal glucose metabolism (NGM), pre-DM, and diabetes mellitus (DM). These groups were compared with regard to coronary plaque characteristics and the risk for major adverse cardiac events (MACEs) (defined as cardiac death or arrest, myocardial infarction, or rehospitalization for unstable or progressive angina)., Results: Among 547 patients, 162 (29.6%) had NGM, 202 (36.9%) had pre-DM, and 183 (33.4%) had DM. There were no significant differences between the groups with regard to intravascular ultrasound findings indicative of vulnerable plaques. Patients with DM had a higher crude rate of MACEs than those with pre-DM or NGM (25.9% vs. 16.3% and 16.1%; p = 0.03 and p = 0.02, respectively). In an adjusted Cox regression model using NGM as the reference group, DM (hazard ratio: 2.20; 95% confidence interval: 1.25 to 3.86; p = 0.006) but not pre-DM (hazard ratio: 1.29; 95% confidence interval: 0.71 to 2.33; p = 0.41) was associated with increased risk for MACEs., Conclusions: Impaired glucose metabolism is common among patients presenting with ACS. DM but not pre-DM is associated with an increased risk for MACEs. Thus, preventing patients from progressing from pre-DM to DM is important. (PROSPECT: An Imaging Study in Patients With Unstable Atherosclerotic Lesions; NCT00180466)., (Copyright © 2019 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Objectives: To investigate the impact of minimal stent area (MSA) evaluated by post-procedural intravascular ultrasound (IVUS) on clinical outcomes after contemporary PCI in patients with three-vessel disease (TVD)., Background: The impact of post-procedural MSA on clinical outcomes has not yet been extensively studied in patients with TVD., Methods: The SYNTAX II study is a multicenter, all-comers, open-label, single arm study that investigated the impact of a state-of-the-art PCI strategy on clinical outcomes in patients with TVD (454 patients with 1,559 lesions). The relationships between post-procedural MSA and lesion-level outcomes at 2 years were investigated. Clinical events adjudicated per patient by clinical event committee were assessed per lesion. Lesion-oriented composite endpoint (LOCE) was defined as the composite of cardiac death, target-vessel myocardial infarction, and ischemia-driven target lesion revascularization., Results: Eight hundred and nineteen lesions with post-procedural MSA available in 367 patients were included in the analysis. The post-procedural MSA per lesion was divided into terciles (smallest tercile: ≤5.0 mm 2 , intermediate tercile: 5.0-6.7 mm 2 , and largest tercile: >6.7 mm 2 ). LOCE was observed in 16/288 (5.6%), 15/265 (5.7%), and 8/266 (3.0%) (P = 0.266). Target lesion revascularization (TLR) was observed in 16/288(5.6%), 12/265 (4.5%), and 4/266 (1.5%) (P = 0.042). The multivariate analysis demonstrated that smaller post-procedural MSA, as well as creatinine clearance, history of previous stroke, chronic total occlusion, and lesion SYNTAX Score was an independent predictor of TLR., Conclusions: In the SYNTAX II trial, larger post-procedural MSA was independently associated with the lower rate of TLR at 2 years., (© 2019 Wiley Periodicals, Inc.)

Aims: Durable polymer drug-eluting stents (DP-DES) may contribute to persistent inflammation, delayed endothelial healing and subsequent late DES thrombosis. The aim of this optical coherence tomography (OCT) substudy was to compare healing and neointimal coverage of a novel bioabsorbable polymer sirolimus-eluting stent (Firehawk®) (BP-DES) versus the DP-DES (XIENCE) at 90 days in an all-comers patient population., Methods and Results: The TARGET All Comers study is a prospective multicentre randomised post-market trial of 1,656 patients randomised 1:1 to Firehawk or XIENCE at 21 centres in 10 European countries. The TARGET OCT substudy enrolled 36 consecutive patients with 52 lesions at six centres proficient in OCT. Follow-up OCT was performed at three months or prior to revascularisation when occurring before the three-month window. The substudy was designed for non-inferiority of the primary endpoint of neointimal thickness. At follow-up, the mean neointimal thickness by OCT (52 lesions: Firehawk, n=24; XIENCE, n=28), was not significantly different between groups (Firehawk 75.5 μm vs. XIENCE V 82.3 μm) meeting the primary endpoint of non-inferiority (pnoninferiority<0.001). The percentage of stent strut coverage was high in both groups (strut level: 99.9±0.3% vs. 100±0.1%, p=0.26), and the proportion of malapposed struts (1.0±1.6% vs. 1.2±2.0%, p=0.51) was low in both groups., Conclusions: Based on OCT, the Firehawk BP-DES has a similar healing response three months after implantation compared to the DP-DES, with near complete strut coverage, moderate neointima formation and minimal strut malapposition.

The Academic Research Consortium (ARC)-2 initiative revisited the clinical and angiographic end point definitions in coronary device trials, proposed in 2007, to make them more suitable for use in clinical trials that include increasingly complex lesion and patient populations and incorporate novel devices such as bioresorbable vascular scaffolds. In addition, recommendations for the incorporation of patient-related outcomes in clinical trials are proposed. Academic Research Consortium-2 is a collaborative effort between academic research organizations in the United States and Europe, device manufacturers, and European, US, and Asian regulatory bodies. Several in-person meetings were held to discuss the changes that have occurred in the device landscape and in clinical trials and regulatory pathways in the last decade. The consensus-based end point definitions in this document are endorsed by the stakeholders of this document and strongly advocated for clinical trial purposes. This Academic Research Consortium-2 document provides further standardization of end point definitions for coronary device trials, incorporating advances in technology and knowledge. Their use will aid interpretation of trial outcomes and comparison among studies, thus facilitating the evaluation of the safety and effectiveness of these devices.

Objectives: This study sought to determine whether low endothelial shear stress (ESS) adds independent prognostication for future major adverse cardiac events (MACE) in coronary lesions in patients with high-risk acute coronary syndrome (ACS) from the United States and Europe., Background: Low ESS is a proinflammatory, proatherogenic stimulus associated with coronary plaque development, progression, and destabilization in human-like animal models and in humans. Previous natural history studies including baseline ESS characterization investigated low-risk patients., Methods: In the PROSPECT (Providing Regional Observations to Study Predictors of Events in the Coronary Tree) study, 697 patients with ACS underwent 3-vessel intracoronary imaging. Independent predictors of MACE attributable to untreated nonculprit (nc) coronary lesions during 3.4-year follow-up were large plaque burden (PB), small minimum lumen area (MLA), and thin-cap fibroatheroma (TCFA) morphology. In this analysis, baseline ESS of nc lesions leading to new MACE (nc-MACE lesions) and randomly selected control nc lesions without MACE (nc-non-MACE lesions) were calculated. A propensity score for ESS was constructed for each lesion, and the relationship between ESS and subsequent nc-MACE was examined., Results: A total of 145 lesions were analyzed in 97 patients: 23 nc-MACE lesions (13 TCFAs, 10 thick-cap fibroatheromas [ThCFAs]), and 122 nc-non-MACE lesions (63 TCFAs, 59 ThCFAs). Low local ESS (<1.3 Pa) was strongly associated with subsequent nc-MACE compared with physiological/high ESS (≥1.3 Pa) (23 of 101 [22.8%]) versus (0 of 44 [0%]). In propensity-adjusted Cox regression, low ESS was strongly associated with MACE (hazard ratio: 4.34; 95% confidence interval: 1.89 to 10.00; p < 0.001). Categorizing plaques by anatomic risk (high risk: ≥2 high-risk characteristics PB ≥70%, MLA ≤4 mm 2 , or TCFA), high anatomic risk, and low ESS were prognostically synergistic: 3-year nc-MACE rates were 52.1% versus 14.4% versus 0.0% in high-anatomic risk/low-ESS, low-anatomic risk/low-ESS, and physiological/high-ESS lesions, respectively (p < 0.0001). No lesion without low ESS led to nc-MACE during follow-up, regardless of PB, MLA, or lesion phenotype at baseline., Conclusions: Local low ESS provides incremental risk stratification of untreated coronary lesions in high-risk patients, beyond measures of PB, MLA, and morphology., (Copyright © 2018 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Aims: The aim of this study was to assess neoatherosclerotic plaque morphology in bare metal (BMS) and first- and second-generation drug-eluting stents (DES) in patients presenting with an event attributed to stent failure., Methods and Results: Thirty-five patients (11 implanted with BMS, 13 with a first-generation and 11 with a second-generation DES) admitted with an event due to stent failure who had neoatherosclerotic lesions on optical coherence tomography were included in the analysis. The lumen and stent borders were detected and the lipid and calcific tissue were identified in the neointima and their burden was estimated. The neointima attenuation and backscatter indices were computed and compared between the different stent types. Although there were no differences in the neointima burden, the BMS group exhibited thinner fibrous caps (p<0.001), and a numerically increased incidence of lipid-rich plaques (p=0.052) and macrophage accumulation (p=0.012). Neointima discontinuities (p=0.009) and thrombus (p=0.032) were seen more often in first-generation DES. In all stent types, neoatherosclerosis had focal manifestations. In neoatherosclerotic lesions the attenuation and backscatter indices were increased in BMS (p=0.031 and p=0.018, respectively) compared to DES; however, there were no differences between stents in the attenuation indices in subsegments located distally to neoatherosclerotic lesions which had low values in all stent types., Conclusions: Although there are differences in lipid burden and neointima characteristics in different stent types, in all stents neoatherosclerosis has focal manifestations indicating that, irrespective of the stent type, focal triggers are involved in the generation of vulnerable neolesions.

Objective: Despite various evidence supporting the advantages of multiple arterial grafting, inconsistencies in use of the procedure have resulted in high variability in the acceptance and practice of arterial grafting. The purpose of this study was to assess the effects of an arterial versus venous second grafts on outcomes at 5-year follow-up in the coronary artery bypass grafting population from the Synergy Between Percutaneous Coronary Intervention With TAXUS and Cardiac Surgery (SYNTAX) trial., Methods: Patients (n = 1419) with an arterial graft to the left anterior descending artery and ≥1 other graft were included and divided according to the second graft's type: 2nd-graft-arterial group (n = 456) and 2nd-graft-venous group (n = 963). Five-year outcomes were compared between subgroups. Event rates were estimated with Kaplan-Meier analyses. Propensity-score matching was used, to control for selection bias due to nonrandom group assignment in a 1:1 manner, resulting in 432 pairs with balanced baseline characteristics., Results: In unmatched groups, the 2nd-graft-arterial group had significantly lower rates of death (8.9% vs 13.1%; P = .02), and composite safety endpoint of death/stroke/myocardial infarction (13.3% vs 18.7%; P = .02), compared with the 2nd-graft-venous group. The rate of major adverse cardiac or cerebrovascular events was similar between groups (22.9% vs 25.5%; P = .30), because it includes the rate of repeat revascularization (12.6% in the 2nd-graft-arterial group vs 9.6% in the 2nd-graft-venous group; P = .10). After propensity-score matching, no statistically significant differences were found between groups., Conclusions: This study reveals comparable 5-year outcomes with arterial and venous conduits as second grafts after an arterial graft anastomosed to the left anterior descending artery. This study demonstrates the multi-institutional variation in patient selection and operator technique with regard to arterial revascularization, although extended follow-up beyond 5 years is required to estimate its impact on long-term outcomes., Clinical Trial Number: NCT00114972., (Copyright © 2015 The American Association for Thoracic Surgery. Published by Elsevier Inc. All rights reserved.)

Objectives: This study sought to evaluate the mechanism of post-procedural cardiac biomarker (CB) rise following device implantation., Background: A fully bioresorbable Absorb scaffold, compared with everolimus-eluting metallic stents (EES), might be associated with a higher incidence of periprocedural myocardial injury., Methods: In 501 patients with stable or unstable angina randomized to either Absorb (335 patients) or EES (n = 166) in the ABSORB II trial, 3 types of CB (creatine kinase, creatine kinase-myocardial band, and troponin) were obtained before and after procedure. Per protocol, periprocedural myocardial infarction (PMI) was defined as creatine kinase rise >2× the upper limit of normal with creatine kinase-myocardial band rise., Results: Incidence of side branch occlusion and any anatomic complications assessed by angiography was similar between the 2 treatment arms (side branch occlusion: Absorb: 5.3% vs. Xience: 7.6%, p = 0.07; any anatomic complication: Absorb: 16.4% vs. EES: 19.9%, p = 0.39). Fourteen patients who presented with recent myocardial infarction at entry with normalized creatine kinase-myocardial band according to the protocol were excluded for post-CB analysis. The overall compliance for CB was 97.8%. The CB rise subcategorized in 7 different ranges was comparable between the 2 treatment arms. PMI rate was numerically higher in the Absorb arm according to the per-protocol definitions, and treatment with overlapping devices was the only independent determinant of per-protocol PMI (odds ratio: 5.07, 95% confidence interval: 1.78 to 14.41, p = 0.002)., Conclusions: There were no differences in the incidence of CB rise and PMI between Absorb and EES. Device overlap might be a precipitating factor of myocardial injury. (ABSORB II Randomized Clinical Trial: A Clinical Evaluation to Compare the Safety, Efficacy, and Performance of Absorb Everolimus Eluting Bioresorbable Vascular Scaffold System Against Xience Everolimus Eluting Coronary Stent System in the Treatment of Subjects With Ischemic Heart Disease Caused by De Novo Native Coronary Artery Lesions [ABSORB II]; NCT01425281)., (Copyright © 2015 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Aims: To investigate the incidence of incomplete stent apposition and to explore the impact of the presence of thrombus and protruding plaque after stent implantation on neointima formation at follow-up in ST-segment elevation myocardial infarction (STEMI) patients with serial optical frequency domain imaging (OFDI) investigations., Methods and Results: In a multi-centre study, 141 patients with ST elevation myocardial infarction <12 h from onset were randomized to either PPCI with thrombectomy (TB) using an Eliminate catheter (TB: n = 71) or without TB (non-TB: n = 70). OFDI after drug-eluting stenting was performed using TERUMO OFDI system. Per protocol, at follow-up 49 patients segments were reimaged. At post-procedure and follow-up, there were no differences in stent and lumen areas between the two groups. At follow-up, per strut-level analysis, percentage of incompletely apposed struts was 0.42 ± 0.94 vs. 0.38 ± 0.77% (P = 0.76), and percentage of covered struts was 92.7 ± 7.2 vs. 94.4 ± 9.2% (P = 0.47) in the TB and non-TB groups, respectively. There was a positive correlation between intra-stent structure (ISS) volume at post-procedure and the neointima volume at 6-month follow-up (Pearson's r = 0.409, P = 0.04). Up to 12 months, there have been two and four patients having target vessel failure in the TB and in the non-TB groups, respectively., Conclusions: In patients with STEMI, there were no significant differences in OFDI parameters between TB and non-TB groups at both post-procedure and 6-month follow-up. However, ISS volume at post-procedure was positively associated with neointimal volume at 6-month follow-up., (Published on behalf of the European Society of Cardiology. All rights reserved. © The Author 2014. For permissions please email: journals.permissions@oup.com.)

Objectives: The aim of this study was to report the long-term clinical outcomes after percutaneous coronary intervention (PCI) with drug-eluting stents (DES) versus coronary artery bypass grafting (CABG) for ostial/midshaft lesions in an unprotected left main coronary artery (ULMCA)., Background: Data regarding outcomes in these patients are limited., Methods: Of a total of 2,775 patients enrolled in the DELTA multinational registry, 856 patients with isolated ostial/midshaft lesions in an ULMCA treated by PCI with DES (n = 482) or CABG (n = 374) were analyzed., Results: At a median follow-up period of 1,293 days, there were no significant differences in the propensity score-adjusted analyses for the composite endpoint of all-cause death, myocardial infarction (MI), and cerebrovascular accident (hazard ratio [HR]: 1.21, 95% confidence interval [CI]: 0.79 to 1.86; p = 0.372), all-cause death (HR: 1.35, 95% CI: 0.80 to 2.27; p = 0.255), the composite endpoint of all-cause death and MI (HR: 1.33, 95% CI: 0.83 to 2.12; p = 0.235) and major adverse cardiac and cerebrovascular events (HR: 1.34, 95% CI: 0.93 to 1.93; p = 0.113). These results were sustained after propensity-score matching. However, a higher incidence of target vessel revascularization (HR: 1.94, 95% CI: 1.03 to 3.64; p = 0.039) was observed in the PCI compared with the CABG group, with a trend toward higher target lesion revascularization (HR: 2.00, 95% CI: 0.90 to 4.45; p = 0.090)., Conclusions: This study demonstrates that PCI for ostial/midshaft lesions in an ULMCA is associated with clinical outcomes comparable to those observed with CABG at long-term follow-up, despite the use of older first-generation DES., (Copyright © 2014 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Background: There are no direct comparisons between transapical aortic valve implantation (TA-AVI) and transfemoral aortic valve implantation (TF-AVI). Therefore, the aim of this study was to compare the short-term and midterm outcomes of TA-AVI versus TF-AVI., Methods: Data from four European centers were pooled and analyzed. To minimize differences between TA-AVI and TF-AVI multivariable analysis was used. Study endpoints were defined according to the Valve Academic Research Consortium-I criteria at 30 days and 1 year. Primary endpoints of this study were 30-day all-cause mortality and mortality during follow-up., Results: A total of 882 patients underwent TAVI, of whom 793 (89.9%) underwent TF-AVI and 89 (10.1%) underwent TA-AVI. Patients undergoing TA-AVI had a higher estimated risk of mortality as defined by the logistic European System for Cardiac Operative Risk Evaluation score (median 27.0, interquartile range [IQR]: 20.2 to 33.8 versus median 20.0, IQR: 12.3 to 27.7; p < 0.001) and The Society of Thoracic Surgeons Score (median 10.2, IQR: 5.3 to 9.9 versus median 6.7, IQR: 3.5 to 9.9; p < 0.001) and had more comorbidities. At 30 days, there was an increased risk of all-cause mortality in the TA-AVI group (odds ratio [OR] 3.12, 95% confidence interval [CI]: 1.43 to 6.82; p = 0.004). TF-AVI was associated with a higher frequency of major (OR 0.33, 95% CI: 0.12 to 0.90; p = 0.031) and minor vascular complications (OR 0.17, 95% CI: 0.04 to 0.71; p = 0.0015). In-hospital stay was significantly longer among patients undergoing TA-AVI (OR 2.29, 95% CI: 1.28 to 4.09; p = 0.05). During a median follow-up of 365 days (IQR: 174 to 557), TA-AVI was associated with an increased risk of all-cause mortality (hazard ratio 1.88, 95% CI: 1.23 to 2.87; p = 0.004)., Conclusions: In institutions performing a low volume of TA-AVI, the technique is associated with an increased risk of all-cause mortality and longer hospital stay but less vascular complications in comparison with TF-AVI. The interaction between experience and type of treatment on outcome requires further investigation before advocating one treatment over the other., (Copyright © 2014 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.)

Objectives: This study sought to assess the 2-year outcomes of the population included in the EXAMINATION (Everolimus-Eluting Stents Versus Bare-Metal Stents in ST-Segment Elevation Myocardial Infarction) trial beyond the 1-year prescription period of dual antiplatelet therapy., Background: The EXAMINATION trial compared the performance of everolimus-eluting stents (EES) versus bare-metal stents (BMS) in an all-comer ST-segment elevation myocardial infarction (STEMI) population., Methods: This was a multicenter, multinational, prospective, randomized, single-blind, controlled trial in patients with STEMI. The primary endpoint, which was the combined endpoint of all-cause death, any recurrent myocardial infarction, and any revascularization, and the endpoints target lesion revascularization and stent thrombosis were assessed at 2 years., Results: Between December 31, 2008, and May 15, 2010, 1,498 patients were randomized to receive EES (n = 751) or BMS (n = 747). Compliance with dual antiplatelet regimen was reduced at 2 years to a similar degree (17.3% vs. 17.2%, p = 0.91). At 2 years, the primary endpoint occurred in 108 (14.4%) patients of the EES group and in 129 (17.3%) patients of the BMS group (p = 0.11). Rate of target lesion revascularization was significantly lower in the EES group than in the BMS group (2.9% vs. 5.6%; p = 0.009). Rates of definite and definite or probable stent thrombosis were also significantly reduced in the EES group (0.8% vs. 2.1%; p = 0.03, and 1.3% vs. 2.8%; p = 0.04, respectively)., Conclusions: The 2-year follow-up of the EXAMINATION trial confirms the safety and efficacy of the EES compared with BMS in the setting of STEMI. Specifically, both rates of target lesion revascularization and stent thrombosis were reduced in recipients of EES without any signs of late attrition for either of these endpoints. (A Clinical Evaluation of Everolimus Eluting Coronary Stents in the Treatment of Patients With ST-Segment Elevation Myocardial Infarction: EXAMINATION Study; NCT00828087)., (Copyright © 2014 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Objectives: The aim of this study was to compare, in a large all-comer registry, the long-term clinical outcomes after percutaneous coronary intervention (PCI) with drug-eluting stents (DES) for ostial/mid-shaft lesions versus distal bifurcation lesions in unprotected left main coronary artery (ULMCA) stenosis., Background: Limited data are available regarding clinical outcomes following DES implantation at the different ULMCA sites., Methods: Patients with ULMCA stenosis treated by PCI with DES were analyzed in this multinational registry., Results: A total of 1,612 patients were included: 482 were treated for ostial/mid-shaft lesions versus 1,130 for distal bifurcation lesions. At a median follow-up period of 1,250 (interquartile range: 987 to 1,564) days, PCI for distal bifurcation lesions was associated with a higher incidence of major adverse cardiac events (propensity-score adjusted hazard ratio [HR]: 1.48, 95% confidence interval [CI]: 1.16 to 1.89; p = 0.001), largely because of the higher target vessel revascularization rate observed in this group as compared to the ostial/mid-shaft lesions group (propensity-score adjusted HR: 1.68, 95% CI: 1.19 to 2.38; p = 0.003). These results were sustained following propensity-score matched analysis. With regard to all-cause death and the composite endpoint of all-cause death and myocardial infarction, propensity-score adjusted analysis suggested a trend toward higher rates of these in the distal ULMCA PCI group, although this was not observed in the propensity-score matched analysis., Conclusions: This study demonstrates that PCI for ostial/mid-shaft lesions is associated with better clinical outcomes than are distal bifurcation lesions in ULMCA, largely because there is a lower need for repeat revascularization in ostial/mid-shaft lesions., (Copyright © 2013 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Objectives: This study sought to compare all-cause mortality in patients at intermediate surgical risk undergoing transcatheter aortic valve implantation (TAVI) or surgical aortic valve replacement (SAVR)., Background: Physicians are selecting "lower" surgical risk patients to undergo TAVI. No clinical data exist about the clinical outcomes of TAVI versus SAVR among intermediate-surgical-risk patients., Methods: We prospectively enrolled symptomatic patients with severe aortic stenosis who underwent TAVI or SAVR. Propensity-score matched pairs of TAVI and SAVR patients with Society of Thoracic Surgeons (STS) scores between 3% and 8% made up the study population. Primary endpoint was all-cause mortality at 1 year., Results: Between November 2006 and January 2010, 3,666 consecutive patients underwent either TAVI (n = 782) or SAVR (n = 2,884). Four hundred five TAVI patients were matched to 405 SAVR patients. Of matched TAVI patients, 99 (24%) patients had STS scores <3%, 255 (63%) had scores between 3% and 8%, and 51 (13%) had scores >8%. Among patients with STS scores between 3% and 8%, 20 (7.8%) versus 18 (7.1%) patients had died up to 30 days (hazard ratio: 1.12, 95% confidence interval: 0.58 to 2.15, p = 0.74) and 42 (16.5%) versus 43 (16.9%) patients had died up to 1 year (hazard ratio: 0.90, 95% confidence interval: 0.57 to 1.42, p = 0.64) after TAVI and SAVR, respectively. Effects of treatment on 1-year mortality were similar across all subgroups except for sex, with some evidence for a beneficial effect of TAVI in women but not in men (test for interaction p = 0.024)., Conclusions: Cumulative all-cause mortality at 30 days and 1 year was similar among propensity-score matched TAVI and SAVR patients at intermediate surgical risk. (Surgical Replacement and Transcatheter Aortic Valve Implantation [SURTAVI]; NCT01586910)., (Copyright © 2013 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Objectives: This study sought to analyze stroke rates in the SYNTAX (Synergy Between Percutaneous Coronary Intervention With Taxus and Cardiac Surgery) trial's randomized and registry cohorts of patients being treated with coronary artery bypass grafting (CABG) or percutaneous coronary intervention (PCI) for treatment of complex coronary artery disease., Background: The SYNTAX trial compared PCI to CABG in patients with de novo 3-vessel and/or left main coronary disease., Methods: The SYNTAX randomized trial was conducted at 85 U.S. and European sites (n = 1,800). All strokes (up to 4 years) were independently adjudicated by a clinical events committee that included a neurologist. An additional 1,077 (of which 644 were followed for 5 years) and 198 patients were included in the CABG and PCI registries, respectively., Results: In the randomized cohort, 31 CABG and 19 PCI patients experienced 33 and 20 strokes post-randomization at 4-year follow-up, respectively (p = 0.062). Three strokes occurred pre-procedurally but following randomization in CABG-treated patients. After CABG, a large proportion of strokes occurred acutely (0 to 30 days: 9 of 33), whereas in the PCI arm, most strokes occurred >30 days after the procedure (18 of 20). Stroke resulted in death in 3 patients in both the PCI and CABG groups. Of the patients who developed stroke, 68% (21 of 31) in the CABG group had residual deficits at discharge; in the PCI group, 47% (9 of 19) had residual deficits. In a multivariate analysis, treatment with CABG was not significantly associated with increased stroke rates (odds ratio: 1.67, 95% confidence interval: 0.93 to 3.01, p = 0.089). The incidence and outcomes of stroke were similar in the randomized trial and registries., Conclusions: There is a higher risk of periprocedural stroke in patients undergoing CABG versus PCI; however, the risk converges over the first 4 years of follow-up. (SYNTAX Study: TAXUS Drug-Eluting Stent Versus Coronary Artery Bypass Surgery for the Treatment of Narrowed Arteries; NCT00114972)., (Copyright © 2013 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Background: Transfemoral transcatheter aortic valve implantation (TF-TAVI) is a viable and safe treatment strategy for patients with symptomatic severe aortic stenosis and high operative risk and has been introduced as such in the recently updated European guidelines on the management of valvular heart disease.Our aim was to assess trends in outcome after TF-TAVI., Methods: Propensity score-matched analysis of a multicenter registry of consecutive patients undergoing TF-TAVI subdivided into 3 tertiles based on enrollment date was performed. Three tertiles of 214 propensity score-matched patients were compared., Results: With mounting experience and moving from the initial to the last cohort, procedural contrast volume and radiation time decreased. Over time, there were less major vascular complications (15% vs 7.9%, P = .023), life-threatening bleedings (17.8% vs 7.9%, P = .003), and major bleedings (22.4% vs 12.1%, P = .007). Major vascular complications and life-threatening bleedings caused by closure device failure decreased significantly (9.2% vs 3.1% [P = .01] and 5.7% vs 1 % [P = .01], respectively). The combined safety end point dropped from 31.3% in tertile (T) (T1) to 17.8% in T3 (P < .001). By multivariable analysis, the last cohort as compared with the initial cohort was associated with significant reductions in 30-day mortality (odds ratio [OR] 0.35, 95% CI 0.12-0.96), stage 3 AKI (OR 0.12, 95% CI 0.29-0.93), and the combined safety end point (OR 0.52, 95% CI 0.29-0.93). One-year survival improved significantly (T1 79% vs T3 86%, P = .016)., Conclusions: Over time, TAVI is performed with significant reductions in major vascular complications, life-threatening bleedings, and the combined clinical safety end point and improved 1-year survival., (Copyright © 2013 Mosby, Inc. All rights reserved.)

Better outcomes have been reported after percutaneous cardiac intervention in obese patients ("obesity paradox"). However, limited information is available on the effect of the body mass index on the outcomes after transcatheter aortic valve implantation (TAVI). We, therefore, sought to determine the effect of the body mass index on the short- and long-term outcomes in patients who underwent TAVI. The population consisted of 940 patients, of whom 25 (2.7%) were underweight, 384 had a (40.9%) normal weight, 372 (39.6%) were overweight, and 159 (16.9%) were obese. Overall, the obese patients were younger (79.7 ± 6.4 years vs 81.7 ± 7.3 and 80.8 ± 7.0 years, p = 0.008) and had a greater prevalence of preserved left ventricular and renal function. On univariate analysis, obese patients had a greater incidence of minor stroke (1.3% vs 0 and 0.3%, p = 0.03), minor vascular complications (15.7% vs 9.1% and 11.6%, p = 0.028) and acute kidney injury stage I (23.3% vs 10.7% and 16.1%, p <0.001). After adjustment, body mass index, as a continuous variable, was associated with a lower risk of mortality at 30 days (odds ratio 0.93, 95% confidence interval 0.86 to 0.98, p = 0.023) and no effect on survival after discharge (hazard ratio 1.01, 95% confidence interval 0.96 to 1.07, p = 0.73). In conclusion, obesity was associated with a greater incidence of minor, but no major, perioperative complications after TAVI. After adjustment, obesity was associated with a lower risk of 30-day mortality and had no adverse effect on mortality after discharge, underscoring the "obesity paradox" in patients undergoing TAVI., (Copyright © 2013 Elsevier Inc. All rights reserved.)

Background: Currently, no data are available on the direct comparison between the Absorb everolimus-eluting bioresorbable vascular scaffold (Absorb BVS) and conventional metallic drug-eluting stents., Methods: The ABSORB II study is a randomized, active-controlled, single-blinded, multicenter clinical trial aiming to compare the second-generation Absorb BVS with the XIENCE everolimus-eluting metallic stent. Approximately 501 subjects will be enrolled on a 2:1 randomization basis (Absorb BVS/XIENCE stent) in approximately 40 investigational sites across Europe and New Zealand. Treated lesions will be up to 2 de novo native coronary artery lesions, each located in different major epicardial vessels, all with an angiographic maximal luminal diameter between 2.25 and 3.8 mm as estimated by online quantitative coronary angiography (QCA) and a lesion length of ≤48 mm. Clinical follow-up is planned at 30 and 180 days and at 1, 2, and 3 years. All subjects will undergo coronary angiography, intravascular ultrasound (IVUS) and IVUS-virtual histology at baseline (pre-device and post-device implantation) and at 2-year angiographic follow-up. The primary end point is superiority of the Absorb BVS vs XIENCE stent in terms of vasomotor reactivity of the treated segment at 2 years, defined as the QCA quantified change in the mean lumen diameter prenitrate and postnitrate administration. The coprimary end point is the noninferiority (reflex to superiority) of the QCA-derived minimum lumen diameter at 2 years postnitrate minus minimum lumen diameter postprocedure postnitrate by QCA. In addition, all subjects allocated to the Absorb BVS group will undergo multislice computed tomography imaging at 3 years., Conclusions: The ABSORB II randomized controlled trial (ClinicalTrials.gov NCT01425281) is designed to compare the safety, efficacy, and performance of Absorb BVS against the XIENCE everolimus-eluting stent in the treatment of de novo native coronary artery lesions., (Copyright © 2012 Mosby, Inc. All rights reserved.)