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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.

Background Near-infrared spectroscopy (NIRS) and intravascular ultrasound are promising imaging modalities to identify non-obstructive plaques likely to cause coronary-related events. We aimed to assess whether combined NIRS and intravascular ultrasound can identify high-risk plaques and patients that are at risk for future major adverse cardiac events (MACEs). Methods PROSPECT II is an investigator-sponsored, multicentre, prospective natural history study done at 14 university hospitals and two community hospitals in Denmark, Norway, and Sweden. We recruited patients of any age with recent (within past 4 weeks) myocardial infarction. After treatment of all flow-limiting coronary lesions, three-vessel imaging was done with a combined NIRS and intravascular ultrasound catheter. Untreated lesions (also known as non-culprit lesions) were identified by intravascular ultrasound and their lipid content was assessed by NIRS. The primary outcome was the covariate-adjusted rate of MACEs (the composite of cardiac death, myocardial infarction, unstable angina, or progressive angina) arising from untreated non-culprit lesions during follow-up. The relations between plaques with high lipid content, large plaque burden, and small lumen areas and patient-level and lesion-level events were determined. This trial is registered with ClinicalTrials.gov, NCT02171065. Findings Between June 10, 2014, and Dec 20, 2017, 3629 non-culprit lesions were characterised in 898 patients (153 [17 women, 745 [83 men; median age 63 [IQR 55-70] years). Median follow-up was 3.7 (IQR 3.0-4.4) years. Adverse events within 4 years occurred in 112 (13.2 951.0-15.6) of 898 patients, with 66 (8.0 95.2-10.0) arising from 78 untreated non-culprit lesions (mean baseline angiographic diameter stenosis 46.9[SD 15.9]). Highly lipidic lesions (851 [24 of 3500 lesions, present in 520 [59 of 884 patients) were an independent predictor of patient-level non-culprit lesion-related MACEs (adjusted odds ratio 2.27, 95.25-4.13) and nonculprit lesion-specific MACEs (7.83, 4.12-14.89). Large plaque burden (787 [22 of 3629 lesions, present in 530 [59 of 898 patients) was also an independent predictor of non-culprit lesion-related MACEs. Lesions with both large plaque burden by intravascular ultrasound and large lipid-rich cores by NIRS had a 4-year non-culprit lesion-related MACE rate of 7.095.0-10.0). Patients in whom one or more such lesions were identified had a 4-year non-culprit lesion-related MACE rate of 13.295.4-17.6). Interpretation Combined NIRS and intravascular ultrasound detects angiographically non-obstructive lesions with a high lipid content and large plaque burden that are at increased risk for future adverse cardiac outcomes. Copyright (C) 2021 Elsevier Ltd. All rights reserved. BackgroundNear-infrared spectroscopy (NIRS) and intravascular ultrasound are promising imaging modalities to identify non-obstructive plaques likely to cause coronary-related events. We aimed to assess whether combined NIRS and intravascular ultrasound can identify high-risk plaques and patients that are at risk for future major adverse cardiac events (MACEs).MethodsPROSPECT II is an investigator-sponsored, multicentre, prospective natural history study done at 14 university hospitals and two community hospitals in Denmark, Norway, and Sweden. We recruited patients of any age with recent (within past 4 weeks) myocardial infarction. After treatment of all flow-limiting coronary lesions, three-vessel imaging was done with a combined NIRS and intravascular ultrasound catheter. Untreated lesions (also known as non-culprit lesions) were identified by intravascular ultrasound and their lipid content was assessed by NIRS. The primary outcome was the covariate-adjusted rate of MACEs (the composite of cardiac death, myocardial infarction, unstable angina, or progressive angina) arising from untreated non-culprit lesions during follow-up. The relations between plaques with high lipid content, large plaque burden, and small lumen areas and patient-level and lesion-level events were determined. This trial is registered with ClinicalTrials.gov, NCT02171065.FindingsBetween June 10, 2014, and Dec 20, 2017, 3629 non-culprit lesions were characterised in 898 patients (153 [17%] women, 745 [83%] men; median age 63 [IQR 55–70] years). Median follow-up was 3·7 (IQR 3·0–4·4) years. Adverse events within 4 years occurred in 112 (13·2%, 95% CI 11·0–15·6) of 898 patients, with 66 (8·0%, 95% CI 6·2–10·0) arising from 78 untreated non-culprit lesions (mean baseline angiographic diameter stenosis 46·9% [SD 15·9]). Highly lipidic lesions (851 [24%] of 3500 lesions, present in 520 [59%] of 884 patients) were an independent predictor of patient-level non-culprit lesion-related MACEs (adjusted odds ratio 2·27, 95% CI 1·25–4·13) and non-culprit lesion-specific MACEs (7·83, 4·12–14·89). Large plaque burden (787 [22%] of 3629 lesions, present in 530 [59%] of 898 patients) was also an independent predictor of non-culprit lesion-related MACEs. Lesions with both large plaque burden by intravascular ultrasound and large lipid-rich cores by NIRS had a 4-year non-culprit lesion-related MACE rate of 7·0% (95% CI 4·0–10·0). Patients in whom one or more such lesions were identified had a 4-year non-culprit lesion-related MACE rate of 13·2% (95% CI 9·4–17·6).InterpretationCombined NIRS and intravascular ultrasound detects angiographically non-obstructive lesions with a high lipid content and large plaque burden that are at increased risk for future adverse cardiac outcomes.FundingAbbott Vascular, Infraredx, and The Medicines Company.

Objectives The aim of this study was to evaluate 1-year clinical safety and efficacy of the dual-therapy COMBO stent in a large, all-comers patient-level pooled cohort. Background The COMBO stent (OrbusNeich Medical, Fort Lauderdale, Florida) is a novel stent with abluminal sirolimus elution from a biodegradable polymer and a luminal pro-healing anti-CD34+ antibody layer, which attracts circulating endothelial progenitor cells. These endothelial progenitor cells can quickly mature into normal endothelium, providing rapid endothelialization. Methods The MASCOT (Multinational Abluminal Sirolimus Coated biO-engineered stenT) (N = 2,614, 61 global sites) and REMEDEE (Randomized study to Evaluate the safety and effectiveness of an abluMinal sirolimus coatED bio-Engineered StEnt Post Market Registry) (N = 1,000, 9 European sites) registries are 2 prospective, multicenter studies evaluating clinical outcomes after attempted COMBO stent placement in all-comer patients undergoing percutaneous coronary intervention. In this patient-level pooled analysis we analyzed 1-year target lesion failure (TLF), a composite of cardiac death, target vessel myocardial infarction, or clinically driven target lesion revascularization. Furthermore, we determined predictors of 1-year TLF. Results A total of 3,614 patients (63.5 ± 11.2 years of age; 23.8% women) were included in this analysis. The prevalence of diabetes mellitus was 29.3%, and 54.3% patients presented with acute coronary syndrome. The primary endpoint of 1-year TLF occurred in 140 (3.9%) patients, with incidence of cardiac death in 1.6%, target vessel myocardial infarction in 1.2%, clinically driven target lesion revascularization in 2.2%, and definite stent thrombosis in 0.5% patients. Insulin-treated diabetes mellitus, chronic renal failure, and American College of Cardiology/American Heart Association lesion type B2/C were independent predictors of 1-year TLF. Conclusions In this large patient-level pooled analysis of patients treated with the dual-therapy COMBO stent excellent results at 1-year were observed. (MASCOT - Post Marketing Registry [MASCOT]; NCT02183454; Prospective Registry to Assess the Long-term Safety and Performance of the COMBO Stent [REMEDEE Reg]; NCT01874002)

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

Background Optimal antithrombotic treatment after transcatheter aortic valve replacement (TAVR) is unknown and determined empirically. The direct factor Xa inhibitor rivaroxaban may potentially reduce TAVR-related thrombotic complications and premature valve failure. Design GALILEO is an international, randomized, open-label, event-driven, phase III trial in more than 1,520 patients without an indication for oral anticoagulation who underwent a successful TAVR (ClinicalTrials. gov NCT02556203). Patients are randomized (1: 1 ratio), 1 to 7 days after a successful TAVR, to either a rivaroxaban-based strategy or an antiplateletbased strategy. In the experimental arm, subjects receive rivaroxaban (10 mg once daily [ OD]) plus acetylsalicylic acid (ASA, 75-100 mg OD) for 90 days followed by rivaroxaban alone. In the control arm, subjects receive clopidogrel (75 mg OD) plus ASA (as above) for 90 days followed by ASA alone. In case new-onset atrial fibrillation occurs after randomization, full oral anticoagulation will be implemented with maintenance of the original treatment assignment. The primary efficacy end point is the composite of all-cause death, stroke, myocardial infarction, symptomatic valve thrombosis, pulmonary embolism, deep venous thrombosis, and systemic embolism. The primary safety end point is the composite of life-threatening, disabling, and major bleeding, according to the Valve Academic Research Consortium definitions. Conclusions GALILEO will test the hypothesis that a rivaroxaban-based antithrombotic strategy reduces the risk of thromboembolic complications post-TAVR with an acceptable risk of bleeding compared with the currently recommended antiplatelet therapy-based strategy in subjects without need of chronic oral anticoagulation.

Objectives This study sought to investigate the differences in detecting (e.g., triggering) periprocedural myocardial infarction (PMI) among 3 current definitions. Background PMI is a frequent component of primary endpoints in coronary device trials. Identification of all potential suspected events is critical for accurate event ascertainment. Automatic triggers based on study databases prevent underreporting of events. Methods We generated automated algorithms to trigger PMI based on each definition and compared results using data from the RESOLUTE all comers trial. Results The operationalization of current PMI definitions was achieved by defining programmable algorithms used to interrogate the study database. From a total of 636 PMI triggers, we identified 234 for the World Health Organization extended definition, 382 for the Third Universal definition, and 216 for the Society for Cardiovascular Angiography and Interventions definition. Differences among the biomarkers used, different cutoff values, and in the hierarchy among biomarkers within definitions, yielded a different number of triggers, and identified unique triggers for each definition. Only 38 triggers were consistently identified by all definitions. Availability of ECG data, eCRF data on clinical presentation, and the reporting of >2 post-procedural values of the same biomarker influenced considerably the number of PMI triggers identified. Conclusions PMI definitions are not interchangeable. The number of triggers identified and consequently the potential number of events varies significantly, highlighting the importance of rigorous methodology when PMI is a component of a powered endpoint. Emphasis on collection of biomarkers, ECG data, and clinical status at baseline may improve the correct identification of PMI triggers.

Background Coexistence of moderate aortic stenosis (AS) in patients with heart failure (HF) with reduced ejection fraction is not uncommon. Moderate AS increases afterload, whereas pharmacologic reduction of afterload is a pillar of contemporary HF management. Hypothesis Unloading the left ventricle by reducing the transaortic gradient with transfemoral transcatheter aortic valve replacement (TAVR) may improve clinical outcomes in patients with moderate AS and HF with reduced ejection fraction. Study design The TAVR UNLOAD (NCT02661451) is an international, multicenter, randomized, open-label, clinical trial comparing the efficacy and safety of TAVR with the Edwards SAPIEN 3 Transcatheter Heart Valve in addition to optimal heart failure therapy (OHFT) vs OHFT alone in patients with moderate AS (defined by a mean transaortic gradient ≥20 mm Hg and 1.0 cm 2 and ≤1.5 cm 2 at rest or after dobutamine stress echocardiography) and reduced ejection fraction. A total of 600 patients will be randomized in a 1:1 fashion. Clinical follow-up is scheduled at 1, 6, and 12 months, and 2 years after randomization. The primary end point is the hierarchical occurrence of all-cause death, disabling stroke, hospitalizations related to HF, symptomatic aortic valve disease or nondisabling stroke, and the change in the Kansas City Cardiomyopathy Questionnaire at 1 year. Secondary end points capture effects on clinical outcome, biomarkers, echocardiographic parameters, and quality of life. Summary The TAVR UNLOAD trial aims to test the hypothesis that TAVR on top of OHFT improves clinical outcomes in patients with moderate AS and HF with reduced ejection fraction.

Aims In the drug-eluting stent (DES) era, patients with acute coronary syndrome (ACS) had a higher risk of early stent thrombosis compared with stable patients. The present study aimed to evaluate whether the same is true for the bioresorbable vascular scaffold (BVS) (Abbott Vascular, Santa Clara, CA, USA). Methods and results We assessed the relationship between the incidence of definite/probable scaffold thrombosis (ScT) (overall ScT and early ScT) and ACS percentage with the latest publications, including the most recent large randomised controlled trials. Out of a total study population of 13,708 devices in 45 trials, overall ScT was observed in 185 devices (1.35%) at a weighted mean follow-up period of 9.4 months, while early ScT was reported in 125 devices (0.97%) out of 12,896 devices in 44 trials. Meta-regression analysis demonstrated no significant correlation between overall/early ScT and the percentage of patients with ACS (overall ScT: R2=0.030, p=0.255; early ScT: R2=0.067, p=0.090). Conclusions ACS appeared to have little impact on the incidence of ScT after the implantation of BVS. Further clinical study is warranted to investigate the predictors of ScT using multivariate analysis with sufficient statistical power.

Sudden cardiac death (SCD) remains a daunting problem. It is a major public health issue for several reasons: from its prevalence (20% of total mortality in the industrialized world) to the devastating psycho-social impact on society and on the families of victims often still in their prime, and it represents a challenge for medicine, and especially for cardiology. This text summarizes the discussions and opinions of a group of investigators with a long-standing interest in this field. We addressed the occurrence of SCD in individuals apparently healthy, in patients with heart disease and mild or severe cardiac dysfunction, and in those with genetically based arrhythmic diseases. Recognizing the need for more accurate registries of the global and regional distribution of SCD in these different categories, we focused on the assessment of risk for SCD in these four groups, looking at the significance of alterations in cardiac function, of signs of electrical instability identified by ECG abnormalities or by autonomic tests, and of the progressive impact of genetic screening. Special attention was given to the identification of areas of research more or less likely to provide useful information, and thereby more or less suitable for the investment of time and of research funds. ? The Author 2014. Published by Oxford University Press on behalf of the European Society of Cardiology.

The COMPARE-ABSORB trial has shown noninferiority between the bioresorbable vascular scaffold (BVS) and the metallic everolimus-eluting stents (EES) at 1 year in composite safety and effectiveness outcomes, although BVS carries a higher device thrombosis rate than EES. Several studies indicated an

Acute coronary syndrome (ACS) is associated with higher rates of recurrent ischemic events, myocardial infarction (MI), and stent thrombosis (ST). The dual-therapy COMBO stent combines a sirolimus-eluting biodegradable polymer with anti-CD34+ antibodies promoting rapid endothelialization of the

Hydrophilic coatings are currently used on numerous devices in endovascular interventions, e.g. microcatheters, guidewires and guiding sheets. These hydrophilic coatings provide a lubricious, low-friction layer to prevent vessel dissection, when manoeuvring through the vessels. However, numerous

We aimed to describe the logistics of a prehospital triage system for patients with acute chest pain in the region of Amsterdam, The Netherlands. Ambulance electrocardiograms (ECGs) were evaluated immediately in 1 of the percutaneous coronary intervention (PCI)-capable centers. Patients accepted for primary PCI (PPCI) were directly transferred to the catheterization laboratory. Two thousand three hundred fifty ECGs of 2,192 patients were transmitted to the region's intervention centers. Median duration of chest complaints before ambulance dispatch was 67 minutes; ambulance crews recorded the first ECG within 7 minutes after arrival. Actual transmission of the ECG took an additional (median) 10 minutes. Seven hundred eleven patients (32.4%) were transported to the catheter laboratory and were treated with PPCI. Time between first prehospital ECG and start of PPCI procedure was 66 minutes. The PPCI procedure started 36 minutes after ambulance arrival at the hospital. In conclusion, the results of this study compare favorably to other reported performances of prehospital triage systems of PPCI for ST-segment elevated myocardial infarction and demonstrate that the European Society of Cardiology and American Heart Association guidelines for treatment of patients with ST-segment elevated myocardial infarction can be met. (C) 2010 Elsevier Inc. All rights reserved. (Am J Cardiol 2010;106: 931-935)

Atrial fibrillation (AF), the most common atrial arrhythmia, has a complex aetiology and causes relevant morbidity and mortality due to different mechanisms, including but not limited to stroke, heart failure, and tachy- or bradyarrhythmia. Current therapeutic options (rate control, rhythm control, antithrombotic therapy, ‘upstream therapy’) only prevent a part of this burden of disease. Several new treatment modalities are therefore under evaluation in controlled trials. Given the multifold clinical consequences of AF, trials in AF patients should assess the effect of therapy in each of the main outcome domains. This paper describes an expert consensus of required outcome parameters in seven relevant outcome domains, namely death, stroke, symptoms and quality of life, rhythm, left ventricular function, cost, and emerging outcome parameters. In addition to these ‘requirements’ for outcome assessment in AF trials, further, more detailed outcome parameters are described. In addition to a careful selection of a relevant primary outcome parameter, coverage of outcomes in all major domains of AF-related morbidity and mortality is desirable for any clinical trial in AF.

AIMS: To investigate the role of guidelines in structuring the clinical care for adult patients with congenital heart disease (CHD), and to assess adherence to the guidelines in Europe. METHODS AND RESULTS: A selected number of current guidelines were chosen pertaining to operative procedures, investigations, and the use of medication ('interventions'). The source for this analysis was the database of the Euro Heart Survey on adult CHD, which contains retrospectively collected data on 4110 patients followed-up for a median of 5.1 years. For each guideline investigated, patients were selected from the database for whom the particular guideline was relevant. The selected cases were classified according to two criteria: was there an indication for the particular intervention and did the intervention take place? In this manner, cases of 'undue treatment' and 'insufficient treatment' were identified. Adherence to guidelines was found to be good in the case of operative procedures and prophylactic drug treatment. However, regarding diagnostic procedures there had been adherence to guidelines in only slightly more than half of the cases. CONCLUSION: Guidelines have an important role in the actual clinical care of adults with CHD. However, large outcome studies are needed to develop more precise guidelines

Patients with Non-ST-segment Elevation Acute Coronary Syndrome (NSTE-ACS) and diabetes mellitus (DM) have less favorable outcomes compared to patients without DM, due to advanced multivessel coronary artery disease in patients with DM. In the ICTUS trial, an early invasive strategy did not reduce 10

The presence of reperfusion arrhythmias have shown to be correlated with larger infarct size (IS). Inadequate microvascular reperfusion, as determined by microvascular obstruction (MVO), is known to be associated with larger IS. We tested the hypothesis that ventricular arrhythmias (VA) bursts are a

Limited data are available on the predictors and implications of gastrointestinal (GI) bleeding in STEMI patients. Identifying baseline predictors for GI bleeding may be useful, as hemorrhage in the intestinal tract provides an attractive target for preventive measures. Therefore we assessed the

Aims: Mechanical left ventricular (LV) unloading may reduce infarct size when combined with primary percutaneous coronary intervention (PCI) in patients with ST-elevation myocardial infarction (STEM I). The Impella LP2.5 is a novel percutaneous left ventricular assist device. Although the short-term safety and feasibility of this device have been demonstrated, the long-term effects are unknown. The purpose of the current study was to evaluate the long-term effects of the Impella LP2.5 support on the aortic valve and left ventricular ejection fraction (LVEF). Methods and results: In 2006, 10 patients with anterior STEMI received 3-day support with the Impella LP2.5 after PCI. The control group consisted of 10 comparable patients, treated according to routine care. For the current study, echocardiography was performed and adverse events were recorded. Mean duration of follow-up was 2.9+/-0.6 years in the Impella group and 3.0+/-0.3 years in the control group. No differences in aortic valve abnormalities and LVEF were demonstrated between the groups; nevertheless, LVEF increase from baseline was significantly greater in Impella-treated patients (23.6+/-8.9% versus 6.7+/-7.0%, P=0.008). Conclusions: Three-day support with the Impella LP2.5 is not associated with adverse effects on the aortic valve at long-term follow-up. LVEF was similar in both groups; however, recovery was significantly greater in the Impella group

Background: There is a lack of evidence regarding treatment options for adults with an atrial septal defect (ASD) who present with an open defect or with sequelae after closure of the defect. The aim of this study was to describe the clinical characteristics and treatment of a large cohort of adult patients born with an ASD type II. Methods and results: Data on the clinical characteristics of 882 ASD II patients (mean follow-up of 4.2 years) included in the Euro Heart Survey on adult congenital heart disease were analysed. At baseline, the defects of 377 patients (mean age 39.2 (16.1) years; 65% females) had been closed, leaving 505 patients (mean age 41.1 (16.4) years; 68% females) with an open ASD. Hemodynamic abnormalities were more prevalent among patients with an open compared to those with a closed defect at baseline: pulmonary arterial hypertension 35% versus 13%; right ventricular (RV) dysfunction 31% versus 8%; and severe RV volume overload 18% versus 1% (all P-values

Aims To describe clinical and demographic characteristics at baseline of a European cohort of adults with congenital heart disease (CHD) and to assess mortality and morbidity in a 5 year follow-up period. Methods and results Data collected as part of the Euro Heart Survey on adult CHD was analysed. This entailed information transcribed from the files of 4110 patients diagnosed with one of eight congenital heart conditions ('defects'), who consecutively visited the outpatient clinics of one of the participating centres in 1998. The patients were included retrospectively and followed until the end of 2003 for a median follow-up of 5.1 years. Notwithstanding their overall relatively good functional class and low mortality over the follow-up period, a considerable proportion of the patients had a history of endocarditis, arrhythmias, or vascular events. There were major differences between the eight defects, both in morbidity and regarding specific characteristics. Outcomes were worst in cyanotic defects and in the Fontan circulation, but a considerable proportion of the other patients also suffer from cardiac symptoms. In particular, arrhythmias are common. Conclusion The spectrum of adult CHD in Europe emerging from this survey is one of a predominantly young population with substantial morbidity but relatively low mortality in a 5 year period.

We previously reported promising outcomes after treatment of coronary bifurcation lesions with the Tryton Side Branch Stent™ in more than 900 patients. Surprisingly, acute coronary syndrome (ACS) as percutaneous coronary intervention (PCI) indication did not predict for adverse outcomes compared

BACKGROUND Ketanserin is a serotonin S2-receptor antagonist that inhibits the platelet activation and vasoconstriction induced by serotonin and also inhibits the mitogenic effect of serotonin on vascular smooth muscle cells. METHODS AND RESULTS We conducted a randomized, double blind, placebo-controlled trial to assess the effect of ketanserin in restenosis prevention after percutaneous transluminal coronary angioplasty (PTCA). Patients received either ketanserin (loading dose, 40 mg 1 hour before PTCA; maintenance dose, 40 mg bid for 6 months) or matched placebo. In addition, all patients received aspirin for 6 months. Coronary angiograms before PTCA, after PTCA, and at 6 months were quantitatively analyzed. Six hundred fifty-eight patients were entered into the intention-to-treat analysis. The primary clinical end point of the study was the occurrence between PTCA and 6 months of any one of the following: cardiac death, myocardial infarction, the need for repeat angioplasty, or bypass surgery. It also included the need for revascularization actuated by findings at 6-month follow-up angiography. The primary clinical end point was reached by 92 (28%) patients in the ketanserin group and 104 (32%) in the placebo group (RR, 0.89; 95% CI, 0.70, 1.13; P = .38). Quantitative angiography after PTCA and at follow-up was available in 592 patients (ketanserin, 287; control, 305). The mean difference in minimal lumen diameter between post-PTCA and follow-up angiogram (primary angiographic end point) was 0.27 +/- 0.49 mm in the ketanserin group and 0.24 +/- 0.52 mm in the control group (difference, 0.03 mm; 95% CI, -0.05, 0.11; P = .50). CONCLUSIONS Ketanserin at the dose administered in this trial failed to reduce the loss in minimal lumen diameter during follow-up after PTCA and did not significantly improve the clinical outcome.

The diagnostic accuracy of the following methods of analysing exercise tests were evaluated: (a) the cumulative area of ST segment depression during exercise normalised for workload and heart rate (exercise score); (b) discriminant analysis of electrocardiographic exercise variables, workload, and symptoms; and (c) ST segment amplitude changes during exercise adjusted for heart rate. Three hundred and forty five men without a history of myocardial infarction were studied. One hundred and twenty three were apparently healthy. Less than half (170) had coronary artery disease. All had a normal electrocardiogram at rest. A Frank lead electrocardiogram was computer processed during symptom limited bicycle ergometry. The accuracy of the exercise score (a) was low (sensitivity 67%, specificity 90%). Discriminant analysis (b) and ST segment amplitude changes adjusted for heart rate (c) had excellent diagnostic characteristics (sensitivity 80%, specificity 90%), which were little affected by concomitant use of beta blockers. Both methods seem well suited for diagnostic application in clinical practice.

Two hundred patients (mean age 56 years, range 36 to 74) with unstable angina (chest pain at rest, associated with ST-T changes) underwent coronary angioplasty. In 65 patients with multivessel disease, only the "culprit" lesion was dilated. The initial success rate was 89.5% (179 of 200 patients). At least one major procedure-related complication occurred in 21 patients (10.5%): (death in 1, myocardial infarction in 16 and urgent surgery in 18). All patients were followed up for 2 years. Five patients died late; 8 had a late nonfatal myocardial infarction and 52 had recurrence of angina pectoris. The restenosis rate was 32% (51 of 158) in the patients with initial successful angioplasty who had repeat angiography. At the 2 year follow-up, after attempted coronary angioplasty in all 200 patients, the total incidence rate of death was 3% (one procedure related; five late deaths), of nonfatal myocardial infarction 12% (16 procedure related and 8 late after angioplasty), and 13% (26 patients) were still symptomatic although they had improved in functional class. Multivariate analysis showed that variables indicating an increased risk 1) for major procedure-related complications were: ST segment elevation, persistent negative T wave and stenosis greater than or equal to 65% (odds ratio 3.7, 3.7 and 3.3, respectively); 2) for angiographic restenosis were: presence of collateral vessels, ST segment depression, multivessel disease, left anterior descending coronary artery stenosis and history of recent onset of symptoms (odds ratio: 2.2, 2.0, 1.9, 1.9 and 0.54, respectively); and 3) for late coronary events (recurrence of angina, late myocardial infarction or late death) were: multivessel disease, total occluded vessel and ST segment elevation (odds ratio 3.7, 2.8 and 0.44, respectively). Thus, coronary angioplasty for unstable angina can be performed with a high initial success rate, but at an increased risk of major complications. The prognosis is favorable after initial successful coronary angioplasty.

INTRODUCTION: The aim of this paper was to determine the incidence of bioresorbable vascular scaffold thrombosis. EVIDENCE ACQUISITION: Asystematic review of the published literature between October 2012 and August 2016 was performed using PubMed, Medline and Embase databases. Articles published in the English language that reported the rate of bioresorbable scaffold thrombosis according to Academic Research Consortium criteria were included. Titles and abstracts were screened independently by two authors and further evaluated and assessed for study details, population characteristics and scaffold thrombosis rates. Scaffold thrombosis rates were pooled with meta-analysis using a random effect model. Meta-regression was performed to explore the predictors of device thrombosis. Randomized clinical trials (RCT), observational registries and case series of patients with obstructive coronary artery disease treated with the ABSORB bioresorbable scaffolds (BVS) that reported the rate of definite or probable scaffold thrombosis and the time of the event after implantation (i.e., acute, sub-acute, late and very late) were selected. EVIDENCE SYNTHESIS: Overall, 16,830 patients treated with ABSORB BVS in 59 studies were included. Atotal of 256 definite or probable scaffold thrombosis (ScT) were identified and included in the present analysis. The overall rate of definite or probable ScT was 1.8% (CI 95% 1.5% to 2.0%) the median follow-up was 12.0 months (interquartile range 7.5 to 15). The rate of very late definite or probable ScT was 1.0% (95% CI 0.6% to 1.5%; 10 studies, 2331 patients). A higher rate of definite and probable scaffold thrombosis was found in studies with patients presenting with acute myocardial infarction (3.6% vs. 1.8%, Q=13.9, df=1, P=0.010). In the meta-regression analysis, the residual per cent diameter stenosis was the only factor associated with ST after scaffold implantation (coefficient 0.091, 95% CI -0.0009 to 0.183, P=0.052). CONCLUSIONS: Using the largest available dataset of patients treated in randomized trials and observational registries, the present meta-analysis shows that the overall rate of definite or probable ScT is 1.8%, with a rate of very late ST of 1.0%. Residual stenosis after scaffold implantation was associated with the occurrence of scaffold thrombosis.