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Angiography alone is the most commonly used imaging modality for guidance of percutaneous coronary interventions. Angiography is limited, however, by several factors, including that it only portrays a low resolution, two-dimensional outline of the lumen and does not inform on plaque composition and functional stenosis severity. Optical coherence tomography (OCT) is an intracoronary imaging technique that has superior spatial resolution compared to all other imaging modalities. High-resolution imaging of the vascular wall enables precise measurement of vessel wall and luminal dimensions, more accurately informing about the anatomic severity of epicardial stenoses, and also provides input for computational models to assess functional severity. The very high-resolution images also permit plaque characterization that may be informative for prognostication. Moreover, periprocedural imaging provides valuable information to guide lesion preparation, stent implantation and to evaluate acute stent complications for which iterative treatment might reduce the occurrence of major adverse stent events. As such, OCT represent a potential future all-in-one tool that provides the data necessary to establish the indications, procedural planning and optimization, and final evaluation of percutaneous coronary revascularization. ispartof: TRENDS IN CARDIOVASCULAR MEDICINE vol:33 issue:2 pages:92-106 ispartof: location:United States status: published

Aims The aim of this article was to compare rates of all-cause death at 10 years following coronary artery bypass grafting (CABG) or percutaneous coronary intervention (PCI) in patients with or without diabetes. Methods and results The SYNTAXES study evaluated up to 10-year survival of 1800 patients with three-vessel disease (3VD) and/or left main coronary artery disease (LMCAD) randomized to receive either PCI or CABG in the SYNTAX trial. Ten-year all-cause death according to diabetic status and revascularization strategy was examined. In diabetics (n = 452), the risk of mortality was numerically higher with PCI compared with CABG at 5 years [19.6% vs. 13.3%, hazard ratio (HR): 1.53, 95% confidence interval (CI): 0.96, 2.43, P = 0.075], with the opposite seen between 5 and 10 years (PCI vs. CABG: 20.8% vs. 24.4%, HR: 0.82, 95% CI: 0.52, 1.27, P = 0.366). Irrespective of diabetic status, there was no significant difference in all-cause death at 10 years between patients receiving PCI or CABG, the absolute treatment difference was 1.9% in diabetics (PCI vs. CABG: 36.4% vs. 34.5%, difference: 1.9%, 95% CI: −7.6%, 11.1%, P = 0.551). Among insulin-treated patients (n = 182), all-cause death at 10 years was numerically higher with PCI (47.9% vs. 39.6%, difference: 8.2%, 95% CI: −6.5%, 22.5%, P = 0.227). Conclusions The treatment effects of PCI vs. CABG on all-cause death at 10 years in patients with 3VD and/or LMCAD were similar irrespective of the presence of diabetes. There may, however, be a survival benefit with CABG in patients with insulin-treated diabetes. The association between revascularization strategy and very long-term ischaemic and safety outcomes for patients with diabetes needs further investigation in dedicated trials. Trial registration SYNTAX: ClinicalTrials.gov reference: NCT00114972 and SYNTAX Extended Survival: ClinicalTrials.gov reference: NCT03417050., Graphical Abstract The treatment effects of PCI versus CABG on all-cause death at 10 years in 3VD/LMCAD patients with pharmacologically treated diabetes and insulin-treated diabetes.

ObjectiveTo investigate percutaneous coronary intervention (PCI) practice in an international cohort of patients with spontaneous coronary artery dissection (SCAD). To explore factors associated with complications and study angiographic and longer term outcomes.MethodsSCAD patients (n=215, 94% female) who underwent PCI from three national cohort studies were investigated and compared with a matched cohort of conservatively managed SCAD patients (n=221).ResultsSCAD-PCI patients were high risk at presentation with only 8.8% undergoing PCI outside the context of ST-elevation myocardial infarction/cardiac arrest, thrombolysis in myocardial infarction (TIMI) 0/1 flow or proximal dissections. PCI complications occurred in 38.6% (83/215), with 13.0% (28/215) serious complications. PCI-related complications were associated with more extensive dissections (multiple vs single American Heart Association coronary segments, OR 1.9 (95% CI: 1.06–3.39),p=0.030), more proximal dissections (proximal diameter per mm, OR 2.25 (1.38–3.67), p=0.001) and dissections with no contrast penetration of the false lumen (Yip-Saw 2 versus 1, OR 2.89 (1.12–7.43), p=0.028). SCAD-PCI involved long lengths of stent (median 46mm, IQR: 29–61mm). Despite these risks, SCAD-PCI led to angiographic improvements in those with reduced TIMI flow in 84.3% (118/140). Worsening TIMI flow was only seen in 7.0% (15/215) of SCAD-PCI patients. Post-PCI major adverse cardiovascular and cerebrovascular events (MACCE) and left ventricular function outcomes were favourable.ConclusionWhile a conservative approach to revascularisation is favoured, SCAD cases with higher risk presentations may require PCI. SCAD-PCI is associated with longer stent lengths and a higher risk of complications but leads to overall improvements in coronary flow and good medium-term outcomes in patients.

Aims To evaluate long-term safety and efficacy of ticagrelor monotherapy in patients undergoing percutaneous coronary interventions (PCIs) in relation to chronic obstructive pulmonary disease (COPD) at baseline and the occurrence of dyspnoea reported as adverse event (AE) that may lead to treatment non-adherence. Methods and results This is a non-prespecified, post hoc analysis of the randomized GLOBAL LEADERS trial (n = 15 991), comparing the experimental strategy of 23-month ticagrelor monotherapy following 1-month dual antiplatelet therapy (DAPT) after PCI with the reference strategy of 12-month DAPT followed by 12-month aspirin monotherapy. Impact of COPD and dyspnoea AE (as a time-dependent covariate) on clinical outcomes was evaluated up to 2 years. The primary endpoint was a 2-year all-cause mortality or non-fatal, centrally adjudicated, new Q-wave myocardial infarction. The presence of COPD (n = 832) was the strongest clinical predictor of 2-year all-cause mortality after PCI [hazard ratio (HR) 2.84; 95% confidence interval (CI) 2.21–3.66; P adjusted = 0.001] in this cohort (n = 15 991). No differential treatment effects on 2-year clinical outcomes were found in patients with and without COPD (primary endpoint: HR 0.88; 95% CI 0.58–1.35; P = 0.562; P int = 0.952). Overall, at 2 years dyspnoea was reported as an AE in 2101 patients, more frequently among COPD patients, irrespective of treatment allocation (27.2% in experimental arm vs. 14.5% in reference arm, P = 0.001). Its occurrence was not associated with a higher rate of the primary endpoint (P adjusted = 0.640) in the experimental vs. the reference arm. Conclusion In this exploratory analysis, COPD negatively impacted long-term prognosis after PCI. Despite higher incidence of dyspnoea in the experimental arm, in particular among COPD patients, the safety of the experimental treatment strategy appeared not to be affected. Clinical trial registration unique identifier NCT01813435.

AIMS: Scaffold design and plaque characteristics influence implantation outcomes and local flow dynamics in treated coronary segments. Our aim is to assess the impact of strut embedment/protrusion of bioresorbable scaffold on local shear stress distribution in different atherosclerotic plaque types. METHODS AND RESULTS: Fifteen Absorb everolimus-eluting Bioresorbable Vascular Scaffolds were implanted in human epicardial coronary arteries. Optical coherence tomography (OCT) was performed post-scaffold implantation and strut embedment/protrusion were analysed using a dedicated software. OCT data were fused with angiography to reconstruct 3D coronary anatomy. Blood flow simulation was performed and wall shear stress (WSS) was estimated in each scaffolded surface and the relationship between strut embedment/protrusion and WSS was evaluated. There were 9083 struts analysed. Ninety-seven percent of the struts (n = 8840) were well-apposed and 243 (3%) were malapposed. At cross-section level (n = 1289), strut embedment was significantly increased in fibroatheromatous plaques (76 ± 48 µm) and decreased in fibrocalcific plaques (35 ± 52 µm). Compatible with strut embedment, WSS was significantly higher in lipid-rich fibroatheromatous plaques (1.50 ± 0.81 Pa), whereas significantly decreased in fibrocalcified plaques (1.05 ± 0.91 Pa). After categorization of WSS as low (

Objectives: This study explores the safety and efficacy of thin strut MeRes100 sirolimus-eluting bioresorbable vascular scaffold (BRS) in patients with de novo coronary artery lesions. Background: In interventional cardiology, the emergence of BRS technology is catalyzing the next paradigm shift. Methods: The MeRes-1 Extend was a multicenter, prospective, single-arm, open-label study enrolling 64 patients in Spain, Macedonia, Brazil, South Africa, Malaysia, and Indonesia. The safety endpoint was major adverse cardiac events (MACE) which composed of cardiac death, myocardial infarction (MI), and ischemia-driven target lesion revascularization (ID-TLR). The imaging efficacy endpoint was mean in-scaffold late lumen loss (LLL) evaluated by quantitative coronary angiography (QCA). Optical coherence tomography (OCT) imaging was performed at baseline and 6-month follow-up. Results: A total of 69 target lesions were identified in 64 enrolled patients (mean age 58.30 ± 9.02 years). Of the treated lesions, 49 (71.01%) lesions were of type B2/C. Procedural and device success was achieved in 64 and 62 patients, respectively. At 2-year follow-up, MACE was reported in one patient (1.61%) in the form of ID-TLR. There was no case of MI, cardiac death or scaffold thrombosis through 2-year. In a subset of 32 patients, paired QCA showed mean in-scaffold LLL of 0.18 ± 0.31 mm at 6-month follow-up. In a subset of 21 patients, OCT revealed 97.95 ± 3.69% strut coverage with mean scaffold area of 7.56 ± 1.79 mm2 and no evidence of strut malapposition. Conclusions: The clinical and imaging outcomes of MeRes-1 Extend trial demonstrated favorable safety and efficacy of MeRes100 sirolimus-eluting BRS in patients with de novo coronary artery lesions.

Contains fulltext : 245655.pdf (Publisher’s version ) (Open Access) Historically, aspirin has been the primary treatment for the prevention of ischaemic events in patients with coronary artery disease. For patients undergoing percutaneous coronary intervention (PCI) standard treatment has been 12 months of dual antiplatelet therapy (DAPT) with aspirin and clopidogrel, followed by aspirin monotherapy; however, DAPT is undeniably associated with an increased risk of bleeding. For over a decade novel P2Y12 inhibitors, which have increased specificity, potency, and efficacy have been available, prompting studies which have tested whether these newer agents can be used in aspirin-free antiplatelet regimens to augment clinical benefits in patients post-PCI. Among these studies, the GLOBAL LEADERS trial is the largest by cohort size, and so far has provided a wealth of evidence in a variety of clinical settings and patient groups. This article summarizes the state-of-the-art evidence obtained from the GLOBAL LEADERS and other trials of aspirin-free strategies.

Background: In clinical trials, the optimal method of adjudicating revascularization events as clinically or nonclinically indicated (CI) is to use an independent Clinical Events Committee (CEC). However, the Academic Research Consortium-2 currently recommends using physiological assessment. The level of agreement between these methods of adjudication remains unknown. Methods: Data for all CEC adjudicated revascularization events among the 3457 patients followed-up for 2-years in the TALENT trial, and 3-years in the DESSOLVE III, PIONEER, and SYNTAX II trial were collected and readjudicated according to a quantitative flow ratio (QFR) analysis of the revascularized vessels, by an independent core lab blinded to the results of the conventional CEC adjudication. The κ statistic was used to assess the level of agreement between the 2 methods. Results: In total, 351 CEC-adjudicated repeat revascularization events occurred, with retrospective QFR analysis successfully performed in 212 (60.4%). According to QFR analysis, 104 events (QFR ≤0.80) were adjudicated as CI revascularizations and 108 (QFR >0.80) were not. The agreement between CEC and QFR based adjudication was just fair (κ=0.335). Between the 2 methods of adjudication, there was a disagreement of 26.4% and 7.1% in CI and non-CI revascularization, respectively. Overall, the concordance and discordance rates were 66.5% and 33.5%, respectively. Conclusions: In this event-level analysis, QFR based adjudication had a relatively low agreement with CEC adjudication with respect to whether revascularization events were CI or not. CEC adjudication appears to overestimate CI revascularization as compared with QFR adjudication. Direct comparison between these 2 strategies in terms of revascularization adjudication is warranted in future trials. Registration: URL: https://www.clinicaltrials.gov ; Unique identifier: TALENT trial: NCT02870140, DESSOLVE III trial: NCT02385279, SYNTAX II: NCT02015832, and PIONEER trial: NCT02236975.

Objectives This study aimed to assess the predictive ability of the Global Registry of Acute Coronary Events (GRACE) risk score 2.0 in contemporary acute coronary syndrome (ACS) patients, and its relation to antiplatelet strategies.Background The predictive value of the GRACE risk score in the contemporary ACS cohort and the appropriate antiplatelet regimen according to the risk remain unclear.Methods This is a subgroup analysis of the all-comers, randomized GLOBAL LEADERS trial, comparing ticagrelor monotherapy versus conventional dual-antiplatelet therapy (DAPT) after percutaneous coronary intervention (PCI). The GRACE risk score 2.0 with 1-year mortality prediction was implemented. The randomized antiplatelet effect was assessed in predefined three GRACE risk-groups; low-risk (GRACE 140).Results The GRACE risk score was available in 6,594 out of 7,487 ACS patients among whom 1,743, 2,823, and 2,028 patients were classified as low-risk, moderate-risk, and high-risk, respectively. At 1 year, all-cause mortality occurred in 120 patients (1.8%). The discrimination ability of the GRACE model was moderate (C-statistic = 0.742), whereas 1-year mortality risk was overestimated (mean predicted mortality rate: 3.9%; the Hosmer-Lemeshow chi-square: 21.47; p = 0.006). There were no significant interactions between the GRACE risk strata and effects of the ticagrelor monotherapy on ischemic or bleeding outcomes at 1 year compared to the reference strategy.Conclusion The GRACE risk score 2.0 is valuable in discriminating high risk ACS patients, however, the recalibration of the score is recommended for better risk stratification. There is no significant differences in efficacy and safety of ticagrelor monotherapy across the three GRACE risk strata. WOA Institution: National University of Ireland Galway Blended DEAL: IReL

Background Coronary bypass artery grafting (CABG) has a higher procedural risk of stroke than percutaneous coronary intervention (PCI), but may offer better long-term survival. The optimal revascularization strategy for patients with prior cerebrovascular disease (CEVD) remains unclear. Methods and results The SYNTAXES study assessed the vital status out to 10 year of patients with three-vessel disease and/or left main coronary artery disease enrolled in the SYNTAX trial. The relative efficacy of PCI vs. CABG in terms of 10 year all-cause death was assessed according to prior CEVD. The primary endpoint was 10 year all-cause death. The status of prior CEVD was available in 1791 (99.5%) patients, of whom 253 patients had prior CEVD. Patients with prior CEVD were older and had more comorbidities (medically treated diabetes, insulin-dependent diabetes, metabolic syndrome, peripheral vascular disease, chronic obstructive pulmonary disease, impaired renal function, and congestive heart failure), compared with those without prior CEVD. Prior CEVD was an independent predictor of 10 year all-cause death (adjusted HR: 1.35; 95% CI: 1.04–1.73; p = 0.021). Patients with prior CEVD had a significantly higher risk of 10 year all-cause death (41.1 vs. 24.1%; HR: 1.92; 95% CI: 1.54–2.40; p -interaction = 0.624). Conclusion Prior CEVD was associated with a significantly increased risk of 10 year all-cause death which was similar in patients treated with PCI or CABG. These results do not support preferential referral for PCI rather than CABG in patients with prior CEVD. Trial registration: SYNTAX: ClinicalTrials.gov reference: NCT00114972. SYNTAX Extended Survival: ClinicalTrials.gov reference: NCT03417050. Graphic abstract

The aims of this first-in-human pilot study of intravascular polarimetry were to investigate polarization properties of coronary plaques in patients and to examine the relationship of these features with established structural characteristics available to conventional optical frequency domain imaging (OFDI) and with clinical presentation.Polarization-sensitive OFDI measures birefringence and depolarization of tissue together with conventional cross-sectional optical frequency domain images of subsurface microstructure.Thirty patients undergoing polarization-sensitive OFDI (acute coronary syndrome, n = 12; stable angina pectoris, n = 18) participated in this study. Three hundred forty-two cross-sectional images evenly distributed along all imaged coronary arteries were classified into 1 of 7 plaque categories according to conventional OFDI. Polarization features averaged over the entire intimal area of each cross section were compared among plaque types and with structural parameters. Furthermore, the polarization properties in cross sections (n = 244) of the fibrous caps of acute coronary syndrome and stable angina pectoris culprit lesions were assessed and compared with structural features using a generalized linear model.The median birefringence and depolarization showed statistically significant differences among plaque types (p 0.001 for both, one-way analysis of variance). Depolarization differed significantly among individual plaque types (p 0.05), except between normal arteries and fibrous plaques and between fibrofatty and fibrocalcified plaques. Caps of acute coronary syndrome lesions and ruptured caps exhibited lower birefringence than caps of stable angina pectoris lesions (p 0.01). In addition to clinical presentation, cap birefringence was also associated with macrophage accumulation as assessed using normalized SD.Intravascular polarimetry provides quantitative metrics that help characterize coronary arterial tissues and may offer refined insight into coronary arterial atherosclerotic lesions in patients.

Aims The efficacy and safety of continued bivalirudin infusion after percutaneous coronary intervention (PCI) remains uncertain. We sought to investigate the association between post-PCI bivalirudin infusion and the risk of net adverse clinical events (NACE) at 30 days. Methods and results In the GLOBAL LEADERS study, all patients who received bivalirudin during PCI were categorized according to the use of bivalirudin infusion after the procedure. The primary endpoint of the present analysis was NACE [a composite of all-cause death, any stroke, any myocardial infarction, all revascularization, and bleeding assessed according to the Bleeding Academic Research Consortium (BARC) criteria Type 3 or 5] at 30 days. The key safety endpoint was BARC Type 3 or 5 bleeding and definite stent thrombosis. Of 15 968 patients, 13 870 underwent PCI with the use of bivalirudin. In total, 7148 patients received continued bivalirudin infusion after procedure, while 6722 patients received standard care. After propensity score covariate adjustment, the risk of NACE did not significantly differ between two treatments after PCI [continued bivalirudin infusion vs. no bivalirudin infusion: 3.2% vs. 3.1%, adjusted hazard ratio (aHR) 1.35, 95% confidence interval (CI) 0.99–1.84, P = 0.06] nor the BARC Type 3 or 5 bleeding (0.7% vs. 0.7%, aHR 0.89, 95% CI 0.44–1.79; P = 0.743) and definite stent thrombosis (0.5% vs. 0.3%, aHR 1.71, 95% CI 0.77–3.81, P = 0.189). However, continued bivalirudin infusion was associated with an increased risk of NACE and definite stent thrombosis in ST-elevation myocardial infarction (STEMI) patients. Conclusion In an all-comers population undergoing PCI, there was no significant difference in the risk of NACE at 30 days between continued bivalirudin infusion vs. no bivalirudin infusion after procedure but continued bivalirudin infusion was associated with a higher risk of NACE in STEMI patients when compared with no infusion.

OBJECTIVES The aim of this study was to investigate the impact of post-percutaneous coronary intervention (PCI) quantitative flow ratio (QFR) on clinical outcomes in patients with de novo 3-vessel disease (3VD) treated with contemporary PCI.BACKGROUND The clinical impact of post-PCI QFR in patients treated with state-of-the-art PCI for de novo 3VD is undetermined.METHODS All vessels treated in the SYNTAX (SYNergy between percutaneous coronary intervention with TAXus and cardiac surgery) II trial were retrospectively screened and analyzed for post-PCI QFR. The primary endpoint of this substudy was vessel-oriented composite endpoint (VOCE) at 2 years, defined as the composite of vessel-related cardiac death, vessel-related myocardial infarction, and target vessel revascularization. The receiver-operating characteristic curve was used to calculate the optimal cutoff value of post-PCI QFR for predicting 2-year VOCE. All the analyzable vessels were stratified on the basis of the optimal cutoff value.RESULTS A total of 968 vessels treated with PCI were screened. Post-PCIQFR was analyzable in 771 (79.6%) vessels. A total of 52 (6.7%) VOCEs occurredat 2 years. The mean value of post-PCIQFR was 0.91 +/- 0.07. The diagnostic performance of post-PCI QFR to predict 2-year VOCE was moderate (area under the curve: 0.702; 95% confidence interval: 0.633 to 0.772), with the optimal cutoff value of post-PCI QFR for predicting 2-year VOCE 0.91 (sensitivity 0.652, specificity 0.635). The incidence of 2-year VOCE in the vessels with post-PCIQFR= 0.91 (n = 487) (12.0% vs. 3.7%; hazard ratio: 3.37; 95% confidence interval: 1.91 to 5.97; p < 0.001).CONCLUSIONS A higher post-PCI QFR value is associated with improved vessel-related clinical outcomes in state-of the art PCI practice for de novo 3VD. Achieving a post-PCI QFR value >= 0.91 in all treated vessels should be a target when treating de novo 3VD. These findings require confirmation in future prospective trials. (C) 2019 by the American College of Cardiology Foundation.

AIMS The aim of this study was to investigate the predictors of long-term adverse clinical events after implantation of the everolimus-eluting Absorb bioresorbable vascular scaffold (BVS). METHODS AND RESULTS We pooled patient-level databases derived from the large-scale ABSORB EXTEND study and five high-volume international centres. Between November 2011 and November 2015, 1,933 patients underwent PCI with a total of 2,372 Absorb BVS implanted. The median age was 61.0 (IQR 53.0 to 68.6) years, 24% had diabetes, and 68.2% presented with stable coronary artery disease. At a median follow-up of 616 days, MACE occurred in 93 (4.9%) patients, all-cause death in 36 (1.9%) patients, myocardial infarction in 47 (2.5%) patients, and target vessel revascularisation in 72 (3.8%) patients. Definite or probable scaffold thrombosis occurred in 26 (1.3%) patients. On multivariable logistic regression analysis, acute coronary syndromes (hazard ratio [HR] 2.79, 95% confidence interval [CI]: 1.47 to 5.29; p=0.002), dyslipidaemia (HR 1.43, 95% CI: 1.23 to 1.79; p=0.007), scaffold/reference diameter ratio >1.25 (HR 1.49, 95% CI: 1.18 to 1.88; p=0.001), and residual stenosis >15% (HR 1.67, 95% CI: 1.34 to 2.07; p

Aims The SYNTAX II study evaluated the impact of advances in percutaneous coronary intervention (PCI), integrated into a single revascularization strategy, on outcomes of patients with de novo three-vessel disease. The study employed decision-making utilizing the SYNTAX score II, use of coronary physiology, thin-strut biodegradable polymer drug-eluting stents, intravascular ultrasound, enhanced treatments of chronic total occlusions, and optimized medical therapy. Patients treated with this approach were compared with predefined patients from the SYNTAX I trial. Methods and results SYNTAX II was a multicentre, single-arm, open-label study of patients requiring revascularization who demonstrated clinical equipoise for treatment with either coronary artery bypass grafting (CABG) or PCI, predicted by the SYNTAX score II. The primary endpoint was major adverse cardiac and cerebrovascular events (MACCE), which included any revascularization. The comparators were a matched PCI cohort trial and a matched CABG cohort, both from the SYNTAX I trial. At 5 years, MACCE rate in SYNTAX II was significantly lower than in the SYNTAX I PCI cohort (21.5% vs. 36.4%, P < 0.001). This reflected lower rates of revascularization (13.8% vs. 23.8%, P < 0.001), and myocardial infarction (MI) (2.7% vs. 10.4%, P < 0.001), consisting of both procedural MI (0.2% vs. 3.8%, P < 0.001) and spontaneous MI (2.3% vs. 6.9%, P = 0.004). All-cause mortality was lower in SYNTAX II (8.1% vs. 13.8%, P = 0.013) reflecting a lower rate of cardiac death (2.8% vs. 8.4%, P < 0.001). Major adverse cardiac and cerebrovascular events’ outcomes at 5 years among patients in SYNTAX II and predefined patients in the SYNTAX I CABG cohort were similar (21.5% vs. 24.6%, P = 0.35). Conclusions Use of the SYNTAX II PCI strategy in patients with de novo three-vessel disease led to improved and durable clinical results when compared to predefined patients treated with PCI in the original SYNTAX I trial. A predefined exploratory analysis found no significant difference in MACCE between SYNTAX II PCI and matched SYNTAX I CABG patients at 5-year follow-up.

IntroductionIn patients with myocardial infarction, the decision to treat a nonculprit lesion is generally based on its physiological significance. However, deferral of revascularisation based on nonischaemic fractional flow reserve (FFR) values in these patients results in less favourable outcomes compared with patients with stable coronary artery disease, potentially caused by vulnerable nonculprit lesions. Intravascular optical coherence tomography (OCT) imaging allows for in vivo morphological assessment of plaque ‘vulnerability’ and might aid in the detection of FFR-negative lesions at high risk for recurrent events.Methods and analysisThe PECTUS-obs study is an international multicentre prospective observational study that aims to relate OCT-derived vulnerable plaque characteristics of nonflow limiting, nonculprit lesions to clinical outcome in patients with myocardial infarction. A total of 438 patients presenting with myocardial infarction (ST-elevation myocardial infarction and non-ST-elevation myocardial infarction) will undergo OCT-imaging of any FFR-negative nonculprit lesion for detection of plaque vulnerability. The primary study endpoint is a composite of major adverse cardiovascular events (all-cause mortality, nonfatal myocardial infarction or unplanned revascularisation) at 2-year follow-up. Secondary endpoints will be the same composite at 1-year and 5-year follow-up, target vessel failure, target vessel revascularisation, target lesion failure and target lesion revascularisation.Ethics and disseminationThis study has been approved by the Medical Ethics Committee of the region Arnhem-Nijmegen. The results of this study will be disseminated in a main paper and additional papers with subgroup analyses.Trial registration numberNCT03857971.

Aims To evaluate the impact of chronic obstructive pulmonary disease (COPD) on 10-year all-cause death and the treatment effect of CABG versus PCI on 10-year all-cause death in patients with three-vessel disease (3VD) and/or left main coronary artery disease (LMCAD) and COPD. Methods Patients were stratified according to COPD status and compared with regard to clinical outcomes. Ten-year all-cause death was examined according to the presence of COPD and the revascularization strategy. Results COPD status was available for all randomized 1800 patients, of whom, 154 had COPD (8.6%) at the time of randomization. Regardless of the revascularization strategy, patients with COPD had a higher risk of 10-year all-cause death, compared with those without COPD (43.1% vs. 24.9%; hazard ratio [HR]: 2.03; 95% confidence interval [CI]: 1.56–2.64; p p = 0.858), whereas among those without COPD, CABG had a significantly lower risk of 10-year all-cause death (22.7% vs. 27.1%; HR: 0.81; 95% CI: 0.67–0.99, p = 0.041). There was no significant differential treatment effect of CABG versus PCI on 10-year all-cause death between patients with and without COPD (pinteraction = 0.544). Conclusions COPD was associated with a higher risk of 10-year all-cause death after revascularization for complex coronary artery disease. The presence of COPD did not significantly modify the beneficial effect of CABG versus PCI on 10-year all-cause death. Trial registration: SYNTAX: ClinicalTrials.gov reference: NCT00114972. SYNTAX Extended Survival: ClinicalTrials.gov reference: NCT03417050 Graphic abstract

Background We hypothesised that ticagrelor, in combination with aspirin for 1 month, followed by ticagrelor alone, improves outcomes after percutaneous coronary intervention compared with standard antiplatelet regimens. Methods GLOBAL LEADERS was a randomised, open-label superiority trial at 130 sites in 18 countries. Patients undergoing percutaneous coronary intervention with a biolimus A9-eluting stent for stable coronary artery disease or acute coronary syndromes were randomly assigned (1:1) to 75-100 mg aspirin daily plus 90 mg ticagrelor twice daily for 1 month, followed by 23 months of ticagrelor monotherapy, or standard dual antiplatelet therapy with 75-100 mg aspirin daily plus either 75 mg clopidogrel daily (for patients with stable coronary artery disease) or 90 mg ticagrelor twice daily (for patients with acute coronary syndromes) for 12 months, followed by aspirin monotherapy for 12 months. Randomisation was concealed, stratified by centre and clinical presentation (stable coronary artery disease vs acute coronary syndrome), and blocked, with randomly varied block sizes of two and four. The primary endpoint at 2 years was a composite of all-cause mortality or non-fatal centrally adjudicated new Q-wave myocardial infarction as assessed by a core lab in a blinded manner. The key secondary safety endpoint was site-reported bleeding assessed according to the Bleeding Academic Research Consortium criteria (grade 3 or 5). Analysis was by intention to treat. This trial is registered with ClinicalTrials.gov, number NCT01813435, and is closed to new participants, with followup completed. Findings Between July 1, 2013, and Nov 9, 2015, 15 968 participants were randomly assigned, 7980 to the experimental group and 7988 to the control group. At 2 years, 304 (3.81%) participants in the experimental group had died or had a non-fatal centrally adjudicated new Q-wave myocardial infarction, compared with 349 (4.37%) participants in the control group (rate ratio 0.87 [95% CI 0. 75-1. 01]; p=0.073]). There was no evidence for a difference in treatment effects for the primary endpoint across prespecified subgroups of acute coronary syndromes and stable coronary artery disease (p=0.93). Grade 3 or 5 bleeding occurred in 163 participants in the experimental group and 169 in the control group (2.04% vs 2.12%; rate ratio 0.97 [95% CI 0. 78-1. 20]; p=0.77). Interpretation Ticagrelor in combination with aspirin for 1 month followed by ticagrelor alone for 23 months was not superior to 12 months of standard dual antiplatelet therapy followed by 12 months of aspirin alone in the prevention of all-cause mortality or new Q-wave myocardial infarction 2 years after percutaneous coronary intervention. Copright (C) 2018 Elsevier Ltd. All rights reserved. European Clinical Research Institute; Biosensors International; AstraZeneca; Medicines Company; Canada Research Chairs Programme

AIMS We aimed to update the logistic clinical SYNTAX score to predict 2��year all-cause mortality after contemporary percutaneous coronary intervention (PCI). METHODS AND RESULTS We analyzed 15,883 patients in the GLOBAL LEADERS study who underwent PCI. The logistic clinical SYNTAX model was updated after imputing missing values by refitting the original model (refitted original model) and fitting an extended new model (new model, with, selection based on the Akaike Information Criterion). External validation was performed in 10,100 patients having PCI at Fu Wai hospital. Chronic obstructive pulmonary disease, prior stroke, current smoker, hemoglobin level, and white blood cell count were identified as additional independent predictors of 2��year all-cause mortality and included into the new model. The c-indexes of the original, refitted original and the new model in the derivation cohort were 0.74 (95% CI 0.72-0.76), 0.75 (95% CI 0.73-0.77), and 0.78 (95% CI 0.76-0.80), respectively. The c-index of the new model was lower in the validation cohort than in the derivation cohort, but still showed improved discriminative ability of the newly developed model (0.72; 95% CI 0.67-0.77) compared to the refitted original model (0.69; 95% CI 0.64-0.74). The models overestimated the observed 2��year all-cause mortality of 1.11% in the Chinese external validation cohort by 0.54 percentage points, indicating the need for calibration of the model to the Chinese patient population. CONCLUSIONS The new model of the logistic clinical SYNTAX score better predicts 2��year all-cause mortality after PCI than the original model. The new model could guide clinical decision making by risk stratifying patients undergoing PCI.

Aims To investigate the impact of established cardiovascular disease (CVD) on 10-year all-cause death following coronary revascularization in patients with complex coronary artery disease (CAD). Methods The SYNTAXES study assessed vital status out to 10 years of patients with complex CAD enrolled in the SYNTAX trial. The relative efficacy of PCI versus CABG in terms of 10-year all-cause death was assessed according to co-existing CVD. Results Established CVD status was recorded in 1771 (98.3%) patients, of whom 827 (46.7%) had established CVD. Compared to those without CVD, patients with CVD had a significantly higher risk of 10-year all-cause death (31.4% vs. 21.7%; adjusted HR: 1.40; 95% CI 1.08–1.80, p = 0.010). In patients with CVD, PCI had a non-significant numerically higher risk of 10-year all-cause death compared with CABG (35.9% vs. 27.2%; adjusted HR: 1.14; 95% CI 0.83–1.58, p = 0.412). The relative treatment effects of PCI versus CABG on 10-year all-cause death in patients with complex CAD were similar irrespective of the presence of CVD (p-interaction = 0.986). Only those patients with CVD in ≥ 2 territories had a higher risk of 10-year all-cause death (adjusted HR: 2.99, 95% CI 2.11–4.23, p Conclusions The presence of CVD involving more than one territory was associated with a significantly increased risk of 10-year all-cause death, which was non-significantly higher in complex CAD patients treated with PCI compared with CABG. Acceptable long-term outcomes were observed, suggesting that patients with established CVD should not be precluded from undergoing invasive angiography or revascularization. Trial registration SYNTAX: ClinicalTrials.gov reference: NCT00114972. SYNTAX Extended Survival: ClinicalTrials.gov reference: NCT03417050. Graphic abstract

Background: Angiography-based functional assessment of coronary stenoses emerges as a novel approach to assess coronary physiology. We sought to investigate the agreement between invasive coronary wire-based fractional flow reserve (FFR), resting full-cycle ratio (RFR), and angiography-based vessel FFR (vFFR) for the functional assessment of coronary stenoses in patients with coronary artery disease.Materials and Methods: Between Jan 01, 2018, and Dec 31, 2020, 298 patients with 385 intermediate lesions received invasive coronary wire-based functional assessment (FFR, RFR or both) at a single tertiary medical center. Coronary lesions involving ostium or left main artery were excluded. vFFR analysis was performed retrospectively based on aortic root pressure and two angiographic projections.Results: In total, 236 patients with 291 lesions were eligible for vFFR analysis. FFR and RFR were performed in 258 and 162 lesions, respectively. The mean FFR, RFR and vFFR value were 0.84 ± 0.08, 0.90 ± 0.09, and 0.83 ± 0.10. vFFR was significantly correlated with FFR (r = 0.708, P < 0.001) and RFR (r = 0.673, P < 0.001). The diagnostic performance of vFFR vs. FFR was accuracy 81.8%, sensitivity 77.4%, specificity 83.9%, positive predictive value 69.9%, and negative predictive value 88.5%. The discriminative power of vFFR for FFR ≤ 0.80 or RFR ≤ 0.89 was excellent. Area under the receiver operating characteristic curve (AUC) was 0.87 (95% CI:0.83–0.92) for FFR and 0.80 (95% CI:0.73–0.88) for RFR.Conclusion: Angiography-based vFFR has a substantial agreement with invasive wire-based FFR and RFR in patients with intermediate coronary stenoses. vFFR can be utilized to assess coronary physiology without a pressure wire in a post hoc manner.

Background: Radial artery access has been shown to reduce mortality and bleeding events, especially in patients with acute coronary syndromes. Despite this, interventional cardiologists experienced in femoral artery access still prefer that route for percutaneous coronary intervention. Little is known regarding the merits of each vascular access in patients stratified by their risk of bleeding. Methods: Patients from the Global Leaders trial were dichotomized into low or high risk of bleeding by the median of the PRECISE-DAPT score. Clinical outcomes were compared at 30 days. Results: In the overall population, there were no statistical differences between radial and femoral access in the rate of the primary end point, a composite of all-cause mortality, or new Q-wave myocardial infarction (MI) (hazard ratio [HR] 0.70, 95% confidence interval [CI] 0.42-1.15). Radial access was associated with a significantly lower rate of the secondary safety end point, Bleeding Academic Research Consortium (BARC) 3 or 5 bleeding (HR 0.55, 95% CI 0.36-0.84). Compared by bleeding risk strata, in the high bleeding score population, the primary (HR 0.47, 95% CI 0.26-0.85; P = 0.012; Pinteraction = 0.019) and secondary safety (HR 0.57, 95% CI 0.35-0.95; P = 0.030; Pinteraction = 0.631) end points favoured radial access. In the low bleeding score population, however, the differences in the primary and secondary safety end points between radial and femoral artery access were no longer statistically significant. Conclusions: Our findings suggest that the outcomes of mortality or new Q-wave MI and BARC 3 or 5 bleeding favour radial access in patients with a high, but not those with a low, risk of bleeding. Because this was not a primary analysis, it should be considered hypothesis generating.

BackgroundThe relative frequency of psychological factors in patients with spontaneous coronary artery dissection (SCAD) compared to patients with traditional atherosclerosis-related type 1 acute coronary syndrome (ACS) is unknown. This study examines whether psychological factors and emotional or physical precipitants are more common in SCAD patients versus atherosclerosis-related ACS patients.MethodsParticipants with SCAD were recruited from a Dutch SCAD database. Given the predominance of SCAD in women (>90%), only female patients were included. The age- and sex-matched atherosclerosis-related ACS group was identified from a registry database. Online questionnaires and medical records were used to investigate psychological factors and clinical information. Univariate and multivariate logistic regression models were used to examine differences between 172 SCAD patients and 76 ACS patients on emotional and physical precipitants prior to the event and psychological factors after the event.ResultsPatients with SCAD were more likely to experience an emotional precipitant in the 24 h prior to the event (56%), compared with the ACS group (39%) (OR = 1.98, 95%CI 1.14-3.44). Multivariate analyses showed that this association remained significant after adjustment for covariates (OR = 2.17, 95%CI 1.08-4.36). At an average of 3.2 years post-hospitalization for the SCAD or atherosclerosis-related ACS event, both patient groups had similar high levels of perceived stress (50% vs. 45%, p = .471) and fatigue (56% vs. 53%, p = .643).ConclusionsThis study shows that risk profiles for SCAD differ from traditional atherosclerosis-related ACS. Our findings may help health professionals to recognize SCAD and offer tailored rehabilitation and prevention programs.

Contains fulltext : 235282.pdf (Publisher’s version ) (Closed access) BACKGROUND: The risk for cardiovascular adverse events after acute myocardial infarction (AMI) remains high despite potent medical treatment including low-density lipoprotein cholesterol (LDL-C) lowering with statins. Proprotein convertase subtilisin/kexin type 9 (PCSK9) antibodies substantially reduce LDL-C when added to statin. Alirocumab, a monoclonal antibody to PCSK9, reduces major adverse cardiovascular events after AMI. The effects of alirocumab on coronary atherosclerosis including plaque burden, plaque composition and fibrous cap thickness in patients presenting with AMI remains unknown. AIMS: To determine the effect of LDL-C lowering with alirocumab on top of high-intensity statin therapy on intravascular ultrasound (IVUS)-derived percent atheroma volume (PAV), near-infrared spectroscopy (NIRS)-derived maximum lipid core burden index within 4 mm (maxLCBI(4 mm)) and optical coherence tomography (OCT)-derived fibrous cap thickness (FCT) in patients with AMI. METHODS: In this multicenter, double-blind, placebo-controlled trial, 300 patients with AMI (ST-elevation or non-ST-elevation myocardial infarction) were randomly assigned to receive either biweekly subcutaneous alirocumab (150 mg) or placebo beginning

Background Dissemination of cardiopulmonary resuscitation (CPR) skills is essential for cardiac arrest survival. Virtual reality (VR)‐training methods are low cost and easily available, but to meet depth requirements adaptations are required, as confirmed in a recent randomized study on currently prevailing CPR quality criteria. Recently, the promising clinical performance of new CPR quality criteria was demonstrated, based on the optimal combination of compression depth and rate. We now study compliance with these newly proposed CPR quality criteria. Methods and Results Post hoc analysis of a randomized trial compared standardized 20‐minute face‐to‐face CPR training with VR training using the Lifesaver VR smartphone application. During a posttraining test, compression depth and rate were measured using CPR mannequins. We assessed compliance with the newly proposed CPR criteria, that is, compression rate within ±20% of 107/minute and depth within ±20% of 47 mm. We studied 352 participants, age 26 (22–31) years, 56% female, and 15% with CPR training ≤2 years. Among VR‐trained participants, there was a statistically significant difference between the proportions complying with newly proposed versus the currently prevailing quality criteria (52% versus 23%, P P P =0.45). Conclusions Lifesaver VR training, although previously found to be inferior to face‐to‐face training, may lead to CPR quality compliant with recently proposed, new quality criteria. If the prognostic importance of these new criteria is confirmed in additional studies, Lifesaver VR in its current form would be an easily available vector to disseminate CPR skills.

Background Spontaneous Coronary Artery Dissection (SCAD) has emerged as an important cause of acute coronary syndrome (ACS) particularly in young-middle aged women. The mechanism of coronary obstruction, acute vessel response to percutaneous coronary intervention (PCI) and natural course of conservatively managed lesions differs significantly in SCAD when compared with atherosclerotic ACS. Revascularization is challenging due to an underlying disrupted and friable coronary vessel wall leading to widely reported worse outcomes than for atherosclerotic coronary disease. Therefore, a conservative approach where possible is favoured however in some cases haemodynamic instability, ongoing ischaemia and reduced distal flow mandates consideration of revascularization. Purpose To compare SCAD survivors managed with PCI or conservatively in terms of presentation characteristics, complications and long-term outcomes. Methodology and Results Two hundred and twenty-five angiographically confirmed SCAD survivors (95% female, 47±9.7yrs) who underwent PCI were compared in a case control study with two hundred and twenty-five angiographically confirmed SCAD survivors (92% female, 49±9.9yrs) who were conservatively managed. Patients were recruited from UK, Spanish and Dutch SCAD registries and both groups were well matched in terms of baseline demographics. Those treated with PCI were more likely to present with proximal SCAD (30.8% vs 7.6% P Analysis of all cases reveal complications in 85 (38.8%). SCAD lesion length was associated with presence of complications (P=0.025). However, when assessed for the clinical significance of that complication (defined by a reduction in flow in a proximal/mid vessel, stent extension into left main stem, iatrogenic dissection requiring PCI and CABG as a consequence of PCI), only 26 cases (11.6%) met seriousness criteria with iatrogenic dissection accounting for nearly half (44.6%). There was a non-significant trend towards major adverse cardiovascular events (MACE) occurring more frequently in those undergoing PCI (18 % vs 11% P=0.067) driven by revascularisation (5% vs 1% P=0.036). Median follow up was 2.7 years. Conclusions PCI in SCAD is most often performed in higher risk cases. Whilst overall complication rates were similar to those widely reported, clinically significant complications were uncommon and most interventions in this context were associated with improved angiographic endpoints. Conflict of Interest NA

Contains fulltext : 225405.pdf (Publisher’s version ) (Open Access) BACKGROUND AND AIMS: The prognostic impact of pre-procedure heart rate (PHR) following percutaneous coronary intervention (PCI) has not yet been fully investigated. This post-hoc analysis sought to assess the impact of PHR on medium-term outcomes among patients having PCI, who were enrolled in the "all-comers" GLOBAL LEADERS trial. METHODS AND RESULTS: The primary endpoint (composite of all-cause death or new Q-wave myocardial infarction [MI]) and key secondary safety endpoint (bleeding according to Bleeding Academic Research Consortium [BARC] type 3 or 5) were assessed at 2 years. PHR was available in 15,855 patients, and when evaluated as a continuous variable (5 bpm increase) and following adjustment using multivariate Cox regression, it significantly correlated with the primary endpoint (hazard ratio [HR] 1.06, 95% confidence interval [CI] 1.03-1.09, p 67 bpm was associated with increased all-cause mortality (HR 1.38, 95%CI 1.13-1.69, p = 0.002) and more frequent new Q-wave MI (HR 1.41, 95%CI 1.02-1.93, p = 0.037). No significant association was found between PHR and BARC 3 or 5 bleeding (HR 1.04, 95% CI 0.99-1.09, p = 0.099). There was no interaction with the primary (p-inter = 0.236) or secondary endpoint (p-inter = 0.154) when high and low PHR was analyzed according to different antiplatelet strategies. CONCLUSIONS: Elevated PHR was an independent predictor of all-cause mortality at 2 years following PCI in the "all-comer" GLOBAL LEADERS trial. The prognostic value of increased PHR on outcomes was not affected by the different antiplatelet strategies in this trial.

Q-wave myocardial infarction (QWMI) comprises 2 entities. First, a clinically evident MI, which can occur spontaneously or be related to a coronary procedure. Second, silent MI which is incidentally detected on serial electrocardiographic (ECG) assessment. The prevalence of silent MI after percutaneous coronary intervention (PCI) in the drug-eluting stent era has not been fully investigated. The GLOBAL LEADERS is an all-comers multicenter trial which randomized 15,991 patients who underwent PCI to 2 antiplatelet treatment strategies. The primary end point was a composite of all-cause death or nonfatal new QWMI at 2-years follow-up. ECGs were collected at discharge, 3-month and 2-year visits, and analyzed by an independent ECG core laboratory following the Minnesota code. All new QWMI were further reviewed by a blinded independent cardiologist to identify a potential clinical correlate by reviewing clinical information. Of 15,968 participants, ECG information was complete in 14,829 (92.9%) at 2 years. A new QWMI was confirmed in 186 (1.16%) patients. Transient new Q-waves were observed in 28.5% (53 of 186) of them during the follow-up. The majority of new QWMI (78%, 146 of 186) were classified as silent MI due to the absence of a clinical correlate. Silent MI accounted for 22.1% (146 of 660) of all MI events. The prevalence of silent MI did not differ significantly between treatment strategies (experimental vs reference: 0.88% vs 0.98%, p = 0.5027). In conclusion, we document the prevalence of silent MI in an all-comers population undergoing PCI in this large-scale randomized trial. info:eu-repo/semantics/publishedVersion

Item does not contain fulltext AIMS: The European Collaborative Project on Inflammation and Vascular Wall Remodeling in Atherosclerosis - Intravascular Ultrasound (ATHEROREMO-IVUS) study was designed as an exploratory clinical study in order to investigate the associations between genetic variation, coronary atherosclerosis phenotypes, and plaque vulnerability as determined by IVUS. METHODS AND RESULTS: The ATHEROREMO-IVUS study was a prospective, observational study of 581 patients with stable angina pectoris or acute coronary syndrome (ACS) who were referred for coronary angiography to the Thoraxcenter, Rotterdam, enriched with 265 IBIS-2 participants (total population, n=846). Prior to catheterisation, blood samples were drawn for genetic analyses. During the catheterisation procedure, IVUS was performed in a non-culprit coronary artery. The primary endpoint was the presence of vulnerable plaque as determined by IVUS virtual histology (VH). In addition, we performed a genome-wide association study of plaque morphology. We observed strong signals associated with plaque morphology in several chromosomal regions: twelve SNPs (rs17300022, rs6904106, rs17177818, rs2248165, rs2477539, rs16865681, rs2396058, rs4753663, rs4082252, rs6932, rs12862206, rs6780676) in or near eight different genes (GNA12, NMBR, SFMBT2, CUL3, SESN3, SLC22A25, EFBN2, SEC62) were most significant. CONCLUSIONS: In conclusion, we found twelve SNPs in or in the proximity of eight genes, which were possibly associated with markers of vulnerable plaque. ClinicalTrials.gov Identifier: NCT01789411.

Aims: Near-infrared spectroscopy (NIRS) is able to quantify cholesterol within coronary arteries by the lipid core burden index (LCBI). We studied the prognostic value of NIRS-derived LCBI in patients with coronary artery disease (CAD) for adverse cardiac outcome during long-term follow-up. Methods and results: During 2009-2013, NIRS was performed in a non-culprit artery of 275 patients undergoing coronary angiography for acute coronary syndrome (ACS) or stable angina. LCBI was quantified by an independent corelab for the region of interest (LCBIROI) and the 4 and 10 mm long segment with the maximum LCBI (MaxLCBI4mm and MaxLCBI10mm). The primary endpoint was major adverse cardiac events (MACE), defined as the composite of all-cause death, non-fatal ACS, or unplanned revascularization. Hazard ratios (HR) were adjusted for age, gender, clinical risk factors, and segment plaque burden based on intravascular ultrasound. During a median follow-up of 4.1 years, 79 patients (28.7%) had MACE. There was a statistically significant and independent continuous relationship between higher MaxLCBI4mm values and a higher risk of MACE. Each 100 units increase of MaxLCBI4mm was associated with a 19% increase in MACE [hazard ratios (HR) 1.19, 95% confidence intervals (95% CI): 1.07-1.32, P = 0.001]. Continuous MaxLCBI4mm remained independently associated with MACE after exclusion of target lesion-related events (HR 1.21, 95% CI: 1.08-1.35), as well as after exclusion of adverse events related to the NIRS-imaged coronary segment (HR 1.19, 95% CI: 1.06-1.34). Results for MaxLCBI10mm were comparable. Conclusion: NIRS-derived LCBI is associated with adverse cardiac outcome in CAD patients during long-term follow-up independent of clinical risk factors and plaque burden.

Item does not contain fulltext OBJECTIVES: We aimed to develop a model to predict long-term mortality after percutaneous coronary intervention (PCI), to aid in selecting patients with sufficient life expectancy to benefit from bioabsorbable scaffolds. BACKGROUND: Clinical trials are currently designed to demonstrate superiority of bioabsorbable scaffolds over metal devices up to 5 years after implantation. METHODS: From 2000 to 2011, 19.532 consecutive patients underwent PCI in a tertiary referral hospital. Patients were randomly (2:1) divided into a training (N = 13,090) and validation (N = 6,442) set. Cox regression was used to identify determinants of long-term mortality in the training set and used to develop a risk model. Model performance was studied in the training and validation dataset. RESULTS: Median age was 63 years (IQR 54-72) and 72% were men. Median follow-up was 3.6 years (interquartile range [IQR] 2.4-6.8). The ratio elective vs. non-elective PCIs was 42/58. During 88,620 patient-years of follow-up, 3,156 deaths occurred, implying an incidence rate of 35.6 per 1,000. Estimated 5-year mortality was 12.9%.Regression analysis revealed age, body mass index, diabetes mellitus, renal insufficiency, prior myocardial infarction, PCI indication, lesion location, number of diseased vessels and cardiogenic shock at presentation as determinants of mortality. The long-term risk model showed good discrimination in the training and validation sets (c-indices 0.76 and 0.74), whereas calibration was appropriate. CONCLUSIONS: A simple risk model, containing 9 baseline clinical and angiographic variables effectively predicts long-term mortality after PCI and may possibly be used to select suitable patients for bioabsorbable scaffolds.

textabstractAims: Cardiac involvement is the main determinant of poor outcomes in sarcoidosis. Right ventricular (RV) dysfunction and left ventricular (LV) late gadolinium enhancement (LGE) have been reported to be predictive of adverse outcome in non-ischaemic cardiomyopathies. The aim of our study was to determine whether delayed RV LGE with cardiovascular magnetic resonance would be predictive of adverse events in addition to LV LGE during the long-term follow-up of pulmonary sarcoidosis patients. Methods and results: Eighty-four consecutive biopsy-proven pulmonary sarcoidosis patients were followed for a median of 56 months [38–74] after baseline delayed contrast-enhanced cardiac magnetic resonance. The composite primary endpoint consisted of admission for congestive heart failure, sustained ventricular tachycardia, appropriate implantable cardioverter defibrillator therapy, pacemaker implantation for high degree atrio-ventricular block, or cardiac death. The composite secondary endpoint included all-cause mortality in addition to the primary endpoint. RV and LV LGE were demonstrated in respectively 12 and 27 patients. Five of 10 events included in the primary endpoint occurred in the group with RV LGE. RV LGE, LV, or biventricular LGE yielded Cox hazard ratios of 8.71 [95% confidence interval (CI) 1.90–23.81], 9.22 (95% CI 1.96–43.45), and 12.09 (95% CI 3.43–42.68) for the composite primary endpoint. In a multivariate model, the predictive value of biventricular LGE for the composite primary and secondary endpoints was strongest. Kaplan–Meier event-free survival curves were most significant for RV LGE and biventricular LGE (log rank with P < 0.001). Conclusions: Biventricular LGE at presentation is the strongest, independent predictor of adverse outcome during long-term follow-up. Asymptomatic myocardial scar

Objectives: The aim of this study was to assess calcium growth with fused grayscale intravascular ultrasound (IVUS), IVUS–virtual histology, and optical coherence tomography (OCT) from base...

Aims Cardiac involvement in sarcoidosis is reported in up to 30% of patients. Left ventricular involvement demonstrated by contrast-enhanced cardiac magnetic resonance has been well validated. We sought to determine the prevalence and distribution of right ventricular late gadolinium enhancement in patients diagnosed with pulmonary sarcoidosis. Methods and results We prospectively evaluated 87 patients diagnosed with pulmonary sarcoidosis with contrast-enhanced cardiac magnetic resonance for right ventricular involvement. Pulmonary artery pressures were non-invasively evaluated with Doppler echocardiography. Patient characteristics were compared between the groups with and without right ventricular involvement, and right ventricular enhancement was correlated with pulmonary hypertension, ventricular mass, volume, and systolic function. Left ventricular late gadolinium enhancement was demonstrated in 30 patients (34%). Fourteen patients (16%) had right ventricular late gadolinium enhancement, with sole right ventricular enhancement in only two patients. The pattern of right ventricular enhancement consisted of right ventricular outflow tract enhancement in 1 patient, free wall enhancement in 8 patients, ventricular insertion point enhancement in 10 patients, and enhancement of the right side of the interventricular septum in 11 patients. Pulmonary arterial hypertension correlated with the presence of right ventricular enhancement (P

Objectives To compare the occurrence of acute stent recoil in two different stent types (platinum chromium and cobalt chromium) and identify the potential predictors of significant acute stent recoil. Background Acute stent recoil is frequently observed after percutaneous coronary intervention and has been associated with in-stent restenosis and in-stent thrombosis. Different stent designs may result in varying degrees of stent recoil. Methods From a registry of “all-comers” treated with either the Xience Prime Cobalt Chromium or Promus Premier Platinum Chromium stent, a random sample of 100 patients was drawn. Acute stent recoil was defined as the minimal luminal diameter (MLD) of the last inflated balloon minus the MLD after, divided by the MLD of the last inflated balloon. Significant acute stent recoil was defined as recoil ≥10%. Results A total of 123 lesions (61 Xience Prime vs 62 Promus Premier) in 100 patients were analyzed. Acute stent recoil of 8.6 ± 4.9% was observed in the Xience Prime group versus 8.7 ± 4.2% in the Promus Premier group, P = 0.970. In a multivariate model for significant acute stent recoil, a stent/vessel ratio ≥1 (hazard ratio 4.64 [1.94–11.12], P = 0.001), a balloon/stent ratio >1 (hazard ratio 3.83 [1.12–13.14], P = 0.032) and direct stenting (hazard ratio 0.42 [0.18–0.96], P = 0.039) were identified as predictors. Conclusions No significant differences were observed in the extent of acute stent recoil between the Xience Prime and the Promus Premier stent. A larger stent/vessel ratio, a larger balloon/stent ratio, and direct stenting were associated with significant acute stent recoil ≥10%. © 2017 Wiley Periodicals, Inc.

IntroductionBecause of the lack of prehospital protocols to rule out a non-ST-segment elevation acute coronary syndrome (NSTE-ACS), patients with chest pain are often transferred to the emergency department (ED) for thorough evaluation. However, in low-risk patients, an ACS is rarely found, resulting in unnecessary healthcare consumption. Using the HEART (History, ECG, Age, Risk factors and Troponin) score, low-risk patients are easily identified. When a point-of-care (POC) troponin measurement is included in the HEART score, an ACS can adequately be ruled out in low-risk patients in the prehospital setting. However, it remains unclear whether a prehospital rule-out strategy using the HEART score and a POC troponin measurement in patients with suspected NSTE-ACS is cost-effective.Methods and analysisThe ARTICA trial is a randomised trial in which the primary objective is to investigate the cost-effectiveness after 30 days of an early rule-out strategy for low-risk patients suspected of a NSTE-ACS, using a modified HEART score including a POC troponin T measurement. Patients are included by ambulance paramedics and 1:1 randomised for (1) presentation at the ED (control group) or (2) POC troponin T measurement (intervention group) and transfer of the care to the general practitioner in case of a low troponin T value. In total, 866 patients will be included. Follow-up will be performed after 30 days, 6 months and 12 months.Ethics and disseminationThis trial has been accepted by the Medical Research Ethics Committee region Arnhem-Nijmegen. The results of this trial will be disseminated in one main paper and in additional papers with subgroup analyses.Trial registration numberNetherlands Trial Register (NL7148).

Early mechanical reperfusion of the epicardial coronary artery by primary percutaneous coronary intervention (PCI) is the guideline-recommended treatment for ST-elevation myocardial infarction (STEMI). Successful restoration of epicardial coronary blood flow can be achieved in over 95% of PCI procedures. However, despite angiographically complete epicardial coronary artery patency, in about half of the patients perfusion to the distal coronary microvasculature is not fully restored, which is associated with increased morbidity and mortality. The exact pathophysiological mechanism of post-ischaemic coronary microvascular dysfunction (CMD) is still debated. Therefore, the current review discusses invasive and non-invasive techniques for the diagnosis and quantification of CMD in STEMI in the clinical setting as well as results from experimental in vitro and in vivo models focusing on ischaemic-, reperfusion-, and inflammatory damage to the coronary microvascular endothelial cells. Finally, we discuss future opportunities to prevent or treat CMD in STEMI patients., Graphical Abstract Graphical Abstract

Aims: The aim of this study was to investigate clinical outcomes of patients at high risk of restenosis after implantation of a bioresorbable vascular scaffold (BVS). Methods and results: The COMPARE-ABSORB trial was an investigator-initiated, prospective randomised study. Patients at high risk of restenosis were randomly assigned to receive either a BVS or an everolimus-eluting stent (EES). A dedicated implantation technique was recommended for BVS. The primary endpoint was target lesion failure (TLF), defined as the composite of cardiac death, target vessel myocardial infarction (TVMI) or clinically indicated target lesion revascularisation at one year. The enrolment was discontinued prematurely because of a high thrombosis and TVMI rate in the BVS arm. A total of 1,670 patients were recruited (BVS 848 patients and EES 822 patients). TLF occurred in 43 patients (5.1%) of the BVS group and 34 patients (4.2%) of the EES group (absolute difference 0.9%, 95% confidence interval [CI]: −1.2%-3.0%, p non-inferiority

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 interaction = 0.155) and NACE (22.7% versus 28.3%, HR 0.75; 95% CI [0.56–0.99], p = 0.044, pinteraction = 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, pinteraction = 0.040) and NACE (5.8% versus 11.2%, HR 0.48; 95% CI [0.29–0.82], p = 0.007, pinteraction = 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).

AIMS: Antiplatelet treatment in the elderly post percutaneous coronary interventions (PCI) remains a complex issue. Here we report the results of the pre-specified subgroup analysis of the GLOBAL LEADERS trial evaluating the long-term safety and cardiovascular efficacy of ticagrelor monotherapy among patients categorised according to the pre-specified cut-off value of 75 years of age. METHODS AND RESULTS: This was a pre-specified analysis of the randomised GLOBAL LEADERS trial (n=15,991), comparing 23-month ticagrelor monotherapy (after one month of DAPT) with the reference treatment (12-month DAPT followed by 12 months of aspirin). Among elderly patients (>75 years; n=2,565), the primary endpoint (two-year all-cause mortality or new Q-wave core lab-adjudicated myocardial infarction [MI]) occurred in 7.2% and 9.4% of patients in the ticagrelor monotherapy and the reference group, respectively (hazard ratio [HR] 0.75, 95% confidence interval [CI]: 0.58-0.99, p=0.041; pint=0.23); BARC-defined bleeding type 3/5 occurred in 5.2% and 4.1%, respectively (HR 1.29, 95% CI: 0.89-1.86; p=0.180; pint=0.06). The elderly with stable CAD had a higher rate of BARC 3/5 type bleeding (HR 2.05, 95% CI: 1.18-3.55) with ticagrelor monotherapy versus the reference treatment (pint=0.02). Elderly patients had a lower rate of definite or probable stent thrombosis (ST) with ticagrelor monotherapy (0.4% vs 1.4%, p=0.015, pint=0.01), compared with the reference group. CONCLUSIONS: In this pre-specified, exploratory analysis of the overall neutral trial, there was no differential treatment effect of ticagrelor monotherapy (after one-month dual therapy with aspirin) found in elderly patients undergoing PCI with respect to the rate of the primary endpoint of all-cause death or new Q-wave MI. The lower rate of ST in the elderly with ticagrelor monotherapy is hypothesis-generating. ClinicalTrials.gov identifier: NCT01813435.

Background The advent of bioresorbable vascular scaffolds (BVS) was considered as a potential improvement in percutaneous coronary intervention (PCI) after the groundbreaking development of drug eluting stents (DES). However, the clinical performance, long-term safety and efficacy of BVS in complex coronary lesions remain uncertain. COMPARE ABSORB, a multicenter, single blind, prospective randomized trial, aims to compare the clinical outcomes between the Absorb BVS and Xience everolimus-eluting metallic stent (EES) in patients with coronary artery disease and a high risk of restenosis. Design COMPARE ABSORB is designed to enroll 2100 patients at up to 45 European sites. Enrolled patients will possess high risk for restenosis due to clinical profile or coronary lesion complexity and will undergo elective or emergent PCI. Once included in the study, patients will receive either Absorb BVS or Xience EES. Specific advice on implantation technique including mandatory pre-dilatation, sizing and post-dilatation (PSP), will be used in the Absorb BVS arm. The primary endpoint is target lesion failure (TLF), a device-oriented composite endpoint (cardiac death, target vessel myocardial infarction and clinically-indicated target lesion revascularization). The trial is powered to assess non-inferiority of Absorb BVS compared with Xience EES with a predetermined non-inferiority margin of 4.5% at 1 year after index procedure. The clinical follow-up will continue for 7 years. Conclusions The prospective COMPARE ABSORB randomized trial ( ClinicalTrials.gov NCT02486068 ) will help to assess the long-term safety and efficacy of Absorb BVS compared with Xience EES in the treatments of patients with complex coronary artery disease and a high attendant risk of restenosis.

Item does not contain fulltext AIMS: The aim of the study was to investigate whether bivalirudin versus unfractionated heparin (UFH) reduces infarct size (IS) for primary percutaneous coronary intervention (PPCI) in large acute myocardial infarction (AMI). METHODS AND RESULTS: This multicentre open-label trial randomised 78 patients undergoing PPCI for large AMI to bivalirudin or UFH. The primary endpoint was IS, assessed by cardiac magnetic resonance (CMR) five days after PPCI. Secondary endpoints included index of microcirculatory resistance (IMR), CMR-assessed microvascular obstruction (MVO) and ejection fraction, and biomarkers for thrombin activity and cell injury. No difference was observed in mean IS at five days (25.0+/-19.7 g for bivalirudin vs. 27.1+/-20.7 g for UFH; p=0.75). Early MVO was numerically lower with bivalirudin (5.3+/-5.8 g vs. 7.7+/-6.3 g; p=0.17), with no significant difference in ejection fraction at 90 days (54.6+/-12.0% vs. 49.1+/-12.1%; p=0.11). In the biomarkers, thrombin-antithrombin complexes were reduced by 4.8 ug/L over the first day for bivalirudin versus an increase of 1.9 ug/L in the heparin arm (p=0.0003). Acute IMR was lower (43.5+/-21.6 vs. 68.7+/-35.8 mmHgxs, respectively; p=0.014). In a planned interim analysis, an approximate 11% reduction in IS was observed with bivalirudin; the trial was discontinued for futility. CONCLUSIONS: This study did not achieve its primary endpoint of significant infarct size reduction in PPCI by prolonged bivalirudin infusion compared to UFH, even though complete thrombin inhibition was achieved in the acute phase, with a lower myocardial microcirculation resistance at the end of the procedure.

Background: Accuracy of high sensitive troponin (hs-cTn) to detect coronary artery disease (CAD) in patients with renal insufficiency is not established. The aim of this study was to evaluate the prognostic role of hs-cTn T and I in patients with chronic kidney disease (CKD). Methods: All consecutive patients with chest pain, renal insufficiency (eGFR < 60 mL/min/1.73 m2) and high sensitive troponin level were included. The predictive value of baseline and interval troponin (hs-cTnT and hs-cTnI) for the presence of CAD was assessed. Results: One hundred and thirteen patients with troponin I and 534 with troponin T were included, with 95 (84%) and 463 (87%) diagnosis of CAD respectively. There were no differences in clinical, procedural and outcomes between the two assays. For both, baseline hs-cTn values did not differ be­tween patients with/without CAD showing low area under the curve (AUC). For interval levels, hs-cTnI was significantly higher for patients with CAD (0.2 ± 0.8 vs. 8.9 ± 4.6 ng/mL; p = 0.04) and AUC was more accurate for troponin I than hs-cTnT (AUC 0.85 vs. 0.69). Peak level was greater for hs-cTnI in patients with CAD or thrombus (0.4 ± 0.6 vs. 15 ± 20 ng/mL; p = 0.02; AUC 0.87: 0.79–0.93); no differences were found for troponin T assays (0.8 ± 1.5 vs. 2.2 ± 3.6 ng/mL; p = 1.7), with lower AUC (0.73: 0.69–0.77). Peak troponin levels (both T and I) independently predicted all cause death at 30 days. Conclusions: Patients with CKD presenting with altered troponin are at high risk of coronary disease. Peak level of both troponin assays predicts events at 30 days, with troponin I being more accurate than troponin T. (Cardiol J 2017; 24, 2: 139–150)

Item does not contain fulltext Aims: Previous studies have reported the safety and feasibility of both time-domain optical coherence tomography (TD-OCT) and Fourier-domain OCT (FD-OCT) in highly selected patients and clinical settings. However, the generalizability of these data is limited, and data in unselected patient populations reflecting a routine cathlab practice are lacking. We compared safety of intracoronary FD-OCT imaging to intravascular ultrasound (IVUS) imaging in a large real-world series of consecutive patients who underwent invasive imaging during coronary catheterization in our centre. Methods and results: This is a prospective, single-centre registry of patients scheduled for coronary angiography or intervention undergoing intracoronary imaging with FD-OCT or IVUS between April 2008 and December 2013. Intra-procedural and major in-hospital adverse events that could be possibly related to invasive imaging were registered routinely by the operator as part of our clinical report and prospectively recorded in our database. These events were retrospectively individually adjudicated by an independent safety committee. Between April 2008 and December 2013, 13 418 diagnostic or interventional coronary catheterization procedures were performed. Of these, 1142 procedures used OCT and 2476 procedures used IVUS. Invasive imaging-related complications were rare, did not differ between the two imaging methods (OCT: n = 7, 0.6%; IVUS: n = 12, 0.5%; P = 0.6), and were self-limiting after retrieval of the imaging catheter or easily treatable in the catheterization laboratory. No major adverse events, prolongation of hospital stay, or permanent patient harm was observed. Conclusion: FD-OCT is safe in an unselected and heterogeneous group of patients with varying clinical settings.

To investigate the additional value of transmural perfusion ratio (TPR) in dynamic CT myocardial perfusion imaging for detection of haemodynamically significant coronary artery disease compared with fractional flow reserve (FFR). Subjects with suspected or known coronary artery disease were prospectively included and underwent a CT-MPI examination. From the CT-MPI time-point data absolute myocardial blood flow (MBF) values were temporally resolved using a hybrid deconvolution model. An absolute MBF value was measured in the suspected perfusion defect. TPR was defined as the ratio between the subendocardial and subepicardial MBF. TPR and MBF results were compared with invasive FFR using a threshold of 0.80. Forty-three patients and 94 territories were analysed. The area under the receiver operator curve was larger for MBF (0.78) compared with TPR (0.65, P = 0.026). No significant differences were found in diagnostic classification between MBF and TPR with a territory-based accuracy of 77 % (67-86 %) for MBF compared with 70 % (60-81 %) for TPR. Combined MBF and TPR classification did not improve the diagnostic classification. Dynamic CT-MPI-based transmural perfusion ratio predicts haemodynamically significant coronary artery disease. However, diagnostic performance of dynamic CT-MPI-derived TPR is inferior to quantified MBF and has limited incremental value. • The transmural perfusion ratio from dynamic CT-MPI predicts functional obstructive coronary artery disease • Performance of the transmural perfusion ratio is inferior to quantified myocardial blood flow • The incremental value of the transmural perfusion ratio is limited

Item does not contain fulltext AIMS: Renal sympathetic denervation (RDN) is being studied as a therapeutic option for patients with therapy-resistant hypertension. It remains unclear if the procedure affects the renal arteries in such a way that luminal narrowing might occur at the mid to longer term. The aim of the present study was to assess renal artery integrity accurately at the medium to long term using recently validated quantitative magnetic resonance angiography software in patients treated with four different RDN devices. METHODS AND RESULTS: In a prospective cohort of 27 patients referred for RDN, quantitative magnetic resonance angiography (MRA) was used to assess 52 vessels at baseline, six, and 12 months post treatment with one of four different devices. No renal artery stenosis was seen at six or 12 months. The average mean lumen area was 26.6+/-7.3 mm2 at baseline versus 25.0+/-7.1 mm(2) and 25.0+/-6.1 mm(2) at six and 12 months, respectively, resulting in a late loss of 1.6 mm2 at six months and 1.9 mm2 at 12 months. No differences were observed in the arterial response to RDN with the four different systems used. There was no correlation between post-procedural dissections, oedema or thrombi as detected with invasive imaging, and luminal narrowing at follow-up. CONCLUSIONS: Quantitative MRA of patients treated with RDN revealed no significant change in renal artery dimensions up to 12-month follow-up. The lack of a change in renal artery luminal dimensions was irrespective of the arterial response to the individual devices used.

Objectives The acute expansion of bioresorbable vascular scaffolds (BRS) and drug-eluting stents (DES) in lesions with different extent of calcification was compared by Optical Coherence Tomography (OCT). Background The acute mechanical performance of polymeric BRS in calcified lesions is poorly understood. Methods Acute device performance in lesions treated with either BRS(N = 50) or DES (N = 50) was compared using Optical Coherence Tomography (OCT). According to angiographic degree of calcification the lesions were divided in three groups: no/mild, moderate and heavy calcification. Device performance was assessed with the following parameters by OCT: mean scaffold area, eccentricity index (EI), symmetry index (SI) and percentage incomplete strut apposition (ISA). Results One hundred lesions from 85 patients (BRS/DES; 37/48) were analyzed. Scaffold area and SI were similar between BRS and DES groups in the three calcification subgroups. Compared to DES, EI in BRS was marginally lower in the no/mild calcification group (0.86 ± 0.03 versus 0.88 ± 0.03, p = 0.018) but was similar in the moderate and heavy calcification groups. Compared to DES, percentage ISA struts in BRS was similar in the no/mild calcification group and was significantly lower in the moderate and heavy calcification groups (2.96 ± 2.36 versus 6.78 ± 4.61%, p = 0.002 and 1.82 ± 2.40 versus 8.89 ± 8.25%, p = 0.025 respectively). Conclusions With adequate lesion preparation, implantation of BRS in a population reflective of clinical practice, resulted in a similar luminal gain compared to DES as measured by OCT, regardless of the degree of angiographic calcification, while acute malapposition is lower with BRS in moderately and heavily calcified lesions. The clinical significance of our findings warrants further evaluation in future studies. © 2016 Wiley Periodicals, Inc.