Explore the vast range of titles available.

No medium-term data are available on the random comparison between everolimus-eluting bioresorbable vascular scaffolds and everolimus-eluting metallic stents. The study aims to demonstrate two mechanistic properties of the bioresorbable scaffold: increase in luminal dimensions as a result of recovered vasomotion of the scaffolded vessel. The ABSORB II trial is a prospective, randomised, active-controlled, single-blind, parallel two-group, multicentre clinical trial. We enrolled eligible patients aged 18–85 years with evidence of myocardial ischaemia and one or two de-novo native lesions in different epicardial vessels. We randomly assigned patients (2:1) to receive treatment with an everolimus-eluting bioresorbable scaffold (Absorb; Abbott Vascular, Santa Clara, CA, USA) or treatment with an everolimus-eluting metallic stent (Xience; Abbott Vascular, Santa Clara, CA, USA). Randomisation was stratified by diabetes status and number of planned target lesions. At 3 year follow-up, the primary endpoint was superiority of the Absorb bioresorbable scaffold versus the Xience metallic stent in angiographic vasomotor reactivity after administration of intracoronary nitrate. The co-primary endpoint is the non-inferiority of angiographic late luminal loss. For the endpoint of vasomotion, the comparison was tested using a two-sided t test. For the endpoint of late luminal loss, non-inferiority was tested using a one-sided asymptotic test, against a non-inferiority margin of 0·14 mm. The trial is registered at ClinicalTrials.gov, number NCT01425281. Between Nov 28, 2011, and June 4, 2013, we enrolled 501 patients and randomly assigned them to the Absorb group (335 patients, 364 lesions) or the Xience group (166 patients, 182 lesions). The vasomotor reactivity at 3 years was not statistically different (Absorb group 0·047 mm [SD 0·109] vs Xience group 0·056 mm [0·117]; psuperiority=0·49), whereas the late luminal loss was larger in the Absorb group than in the Xience group (0·37 mm [0·45] vs 0·25 mm [0·25]; pnon-inferiority=0·78). This difference in luminal dimension was confirmed by intravascular ultrasound assessment of the minimum lumen area (4·32 mm2 [SD 1·48] vs 5·38 mm2 [1·51]; p<0·0001). The secondary endpoints of patient-oriented composite endpoint, Seattle Angina Questionnaire score, and exercise testing were not statistically different in both groups. However, a device-oriented composite endpoint was significantly different between the Absorb group and the Xience group (10% vs 5%, hazard ratio 2·17 [95% CI 1·01–4·70]; log-rank test p=0·0425), mainly driven by target vessel myocardial infarction (6% vs 1%; p=0·0108), including peri-procedural myocardial infarction (4% vs 1%; p=0·16). The trial did not meet its co-primary endpoints of superior vasomotor reactivity and non-inferior late luminal loss for the Absorb bioresorbable scaffold with respect to the metallic stent, which was found to have significantly lower late luminal loss than the Absorb scaffold. A higher rate of device-oriented composite endpoint due to target vessel myocardial infarction, including peri-procedural myocardial infarction, was observed in the Absorb group. The patient-oriented composite endpoint, anginal status, and exercise testing, were not statistically different between both devices at 3 years. Future studies should investigate the clinical impact of accurate intravascular imaging in sizing the device and in optimising the scaffold implantation. The benefit and need for prolonged dual antiplatelet therapy after bioresorbable scaffold implantation could also become a topic for future clinical research. Abbott Vascular.

Despite rapid dissemination of an everolimus-eluting bioresorbable scaffold for treatment for coronary artery disease, no data from comparisons with its metallic stent counterpart are available. In a randomised controlled trial we aimed to compare an everolimus-eluting bioresorbable scaffold with an everolimus-eluting metallic stent. Here we report secondary clinical and procedural outcomes after 1 year of follow-up. In a single-blind, multicentre, randomised trial, we enrolled eligible patients aged 18–85 years with evidence of myocardial ischaemia and one or two de-novo native lesions in different epicardial vessels. We randomly assigned patients in a 2:1 ratio to receive treatment with an everolimus-eluting bioresorbable scaffold (Absorb, Abbott Vascular, Santa Clara, CA, USA) or treatment with an everolimus-eluting metallic stent (Xience, Abbott Vascular, Santa Clara, CA, USA). Randomisation was stratified by diabetes status and number of planned target lesions. The co-primary endpoints of this study are vasomotion (change in mean lumen diameter before and after nitrate administration at 3 years) and difference between minimum lumen diameter (after nitrate administration) after the index procedure and at 3 years. Secondary endpoints were procedural performance assessed by quantitative angiography and intravascular ultrasound; composite clinical endpoints based on death, myocardial infarction, and coronary revascularisation; device and procedural success; and angina status assessed by the Seattle Angina Questionnaire and exercise testing at 6 and 12 months. Cumulative angina rate based on adverse event reporting was analysed post hoc. This trial is registered at ClinicalTrials.gov, number NCT01425281. Between Nov 28, 2011, and June 4, 2013, we enrolled 501 patients and randomly assigned them to the bioresorbable scaffold group (335 patients, 364 lesions) or the metallic stent group (166 patients, 182 lesions). Dilatation pressure and balloon diameter at the highest pressure during implantation or postdilatation were higher and larger in the metallic stent group, whereas the acute recoil post implantation was similar (0·19 mm for both, p=0·85). Acute lumen gain was lower for the bioresorbable scaffold by quantitative coronary angiography (1·15 mm vs 1·46 mm, p<0·0001) and quantitative intravascular ultrasound (2·85 mm2vs 3·60 mm2, p<0·0001), resulting in a smaller lumen diameter or area post procedure. At 1 year, however, cumulative rates of first new or worsening angina from adverse event reporting were lower (72 patients [22%] in the bioresorbable scaffold group vs 50 [30%] in the metallic stent group, p=0·04), whereas performance during maximum exercise and angina status by SAQ were similar. The 1-year composite device orientated endpoint was similar between the bioresorbable scaffold and metallic stent groups (16 patients [5%] vs five patients [3%], p=0·35). Three patients in the bioresorbable scaffold group had definite or probable scaffold thromboses (one definite acute, one definite sub-acute, and one probable late), compared with no patients in the metallic stent group. There were 17 (5%) major cardiac adverse events in the bioresorbable scaffold group compared with five (3%) events in the metallic stent group, with the most common adverse events being myocardial infarction (15 cases [4%] vs two cases [1%], respectively) and clinically indicated target-lesion revascularisation (four cases [1%] vs three cases [2%], respectively). The everolimus-eluting bioresorbable scaffold showed similar 1-year composite secondary clinical outcomes to the everolimus-eluting metallic stent. Abbott Vascular.

Optimum duration of dual antiplatelet treatment (DAPT) after coronary stenting remains uncertain, with an unknown efficacy to safety ratio of extended treatment leading to discrepancies between international guidelines and clinical practice. We assessed whether DAPT continuation beyond 1 year after coronary stenting is beneficial. This analysis was a planned extension of the previously published ARCTIC-Monitoring trial, in which we randomly allocated 2440 patients to a strategy of platelet function testing with antiplatelet treatment adjustment or a conventional strategy after coronary stenting with drug-eluting stent (DES). We recruited patients (aged 18 years or older) scheduled for planned DES implantation at 38 centres in France. After 1 year of follow-up, patients without contraindication to interruption of DAPT were eligible for a second randomisation to this second phase of the study (ARCTIC-Interruption). Using a computer-generated randomisation sequence (1:1; stratified by centre), we allocated patients to a strategy of interruption of DAPT where the thienopyridine was interrupted and single aspirin antiplatelet treatment was maintained (interruption group) or a strategy of DAPT continuation for 6–18 months (continuation group). The primary endpoint was the composite of death, myocardial infarction, stent thrombosis, stroke, or urgent revascularisation, analysed by intention to treat. This trial is registered with ClinicalTrials.gov, number NCT00827411. Between Jan 4, 2011, and March 3, 2012, 1259 eligible patients were randomly allocated to treatment in ARCTIC-Interruption: 624 to the interruption group and 635 to the continuation group. After a median follow-up of 17 months (IQR 15–18), the primary endpoint occurred in 27 (4%) patients in the interruption group and 24 (4%) patients in the continuation group (hazard ratio [HR] 1·17 [95% CI 0·68–2·03]; p=0·58). STEEPLE major bleeding events occurred more often in the continuation group (seven [1%] patients) compared with the interruption group (one [<0·5%] patient; HR 0·15 [0·02–1·20]; p=0·073). Major or minor bleedings were also more common in the continuation group compared with the interruption group (12 [2%] patients vs three [1%] patients; HR 0·26 [0·07–0·91]; p=0·04). Our finding suggests no apparent benefit but instead harm with extension of DAPT beyond 1 year after stenting with DES when no event has occurred within the first year after stenting. No conclusion can be drawn for high-risk patients who could not be randomised. The consistency between findings from all trials of such interruption suggests the need for a reappraisal of guidelines for DAPT after coronary stenting towards shorter duration of treatment. Allies in Cardiovascular Trials Initiatives and Organized Networks (ACTION Study Group), Fondation de France, Sanofi-Aventis, Cordis, Medtronic, Boston Scientific, Fondation SGAM.

Coronary artery spasm (CAS) defined by a severe reversible diffuse or focal vasoconstriction is the most common diagnosis among INOCA (ischemia with no obstructive coronary artery disease) patients irrespective to racial, genetic, and geographic variations. However, the prevalence of CAS tends to decrease in correlation with the increasing use of medicines such as calcium channel blockers, angiotensin converting enzyme inhibitor, and statins, the controlling management of atherosclerotic risk factors, and the decreased habitude to perform a functional reactivity test in highly active cardiac catheterization centers. A wide spectrum of clinical manifestations from silent disease to sudden cardiac death was attributed to this complex entity with unclear pathophysiology. Multiple mechanisms such as the autonomic nervous system, endothelial dysfunction, chronic inflammation, oxidative stress, and smooth muscle hypercontractility are involved. Regardless of the limited benefits proffered by the newly emerged cardiac imaging modalities, the provocative test remains the cornerstone diagnostic tool for CAS. It allows to reproduce CAS and to evaluate reactivity to nitrates. Different invasive and noninvasive therapeutic approaches are approved for the management of CAS. Long-acting nondihydropyridine calcium channel blockers are recommended for first line therapy. Invasive strategies such as PCI (percutaneous coronary intervention) and CABG (coronary artery bypass graft) have shown benefits in CAS with significant atherosclerotic lesions. Combination therapies are proposed for refractory cases.

Our study objective was to assess the incidence, predictors, and implications of access site complications related to transfemoral transcatheter aortic valve implantation (TAVI). We pooled the prospective TAVI databases of 5 experienced centers in Europe enrolling only transfemoral cases for this analysis. Access site complications were defined according to the Valve Academic Research Consortium end-point definitions. The global transfemoral TAVI database contained 986 patients. Percutaneous access and closure was performed in 803 patients (81%) and a surgical strategy in 183 (19%). Incidences of major vascular complications, life-threatening/disabling bleeding, and major bleeding were 14.2%, 11%, and 17.8% respectively. In the patient cohort with a completely percutaneous access strategy, major vascular complications and life-threatening/disabling bleedings were related to closure device failure in 64% and 29%, respectively. Female gender (odds ratio 1.63, 95% confidence interval 1.12 to 2.36) and use of >19Fr system (2.87, 1.68 to 4.91) were independent predictors for major vascular complications. Female gender (odds ratio 2.04, 95% confidence interval 1.31 to 3.17), use of >19Fr system (1.86, 1.02 to 3.38), peripheral arterial disease (2.14, 1.27 to 3.61), learning effect (0.45, 0.27 to 0.73), and percutaneous access strategy (2.39, 1.16 to 4.89) were independently associated with life-threatening/disabling bleedings. In conclusion, transfemoral TAVI is associated with a >10% incidence of major vascular-related complications. A considerable number of these events is related to arteriotomy closure failure. Arterial sheath size and female gender are important determinants of major vascular complications and life-threatening/disabling bleeding.

Only limited and conflicting data on the impact of preoperative chronic kidney disease (CKD) on outcomes after transcatheter aortic valve implantation (TAVI) are available. We retrospectively analyzed pooled data from the prospective TAVI databases of 4 centers (942 patients). Valve Academic Research Consortium end point definitions were used. The outcomes were compared among patients with normal estimated glomerular filtration rate (≥90 mL/min), mild (60-89 mL/min), moderate (30-59 mL/min), and severe (<30 mL/min) CKD and those on chronic hemodialysis (HD). The primary end point was 1-year survival. A total of 109 patients had a normal estimated glomerular filtration rate (11.6%); 329 (34.9%) had mild, 399 (42.5%) moderate, 72 (7.5%) severe CKD, and 33 (3.5%) were on HD. Baseline and procedural characteristics were similar among all groups except for Logistic EuroSCORE. Major stroke, life-threatening bleeding, all-cause 30-day mortality (HD 15.2%, severe CKD 8.3%, moderate CKD 8.3%, mild CKD 6.7%, normal 1.8%, P = .007) and 1-year survival (HD 54.8%, severe CKD 67.2%, moderate CKD 80.0%, mild CKD 85.2%, normal eGFR 91.4%, HD vs severe CKD P = .23, severe CKD vs moderate CKD P = .002, moderate CKD vs mild CKD P = .04, moderate CKD vs normal eGFR P = .03, by log-rank test) differed significantly across groups. Through multivariable analysis, HD and severe CKD were independently associated with an increased risk of 1-year mortality (hazard ratios 5.07 [95% CI 1.79-14.35, P = .002] and 4.03 [95% CI 1.52-10.69, P = .005], respectively). Patients with CKD who undergo TAVI have a higher-risk profile and worse 30-day and 1-year outcomes. Chronic hemodialysis and severe preprocedural CKD are independently associated with an increased risk of 1-year mortality after TAVI.

Early repolarization pattern (ERP) has recently been associated with idiopathic ventricular fibrillation and with cardiovascular mortality in the general population. We aimed to identify electrocardiographic tools to differentiate the “malignant” form of ERP from benign ERP in a population-based study. We retrospectively assessed the prevalence of ERP by recording electrocardiograms in 1,161 southwestern French subjects 35 to 64 years old. ERP was defined by an elevation of the J point ≥1 mm in 2 consecutive leads excluding leads V1 through V3. We categorized ERP as notching or slurring pattern as located in inferior and/or lateral leads and measured the J-point elevation amplitude. ST segment after ERP was categorized as ascendant or horizontal/nonascendant and T waves as negative or positive. Association of ERP with all-cause and cardiovascular mortalities was assessed by adjusted Cox proportional hazard models. ERP was found in 157 subjects (13.3%). During a mean follow-up of 14.2 ± 2 years, 77 subjects died (6.6%), of whom 24 (2.1%) died from cardiovascular causes. Subjects with ERP had an increased hazard ratios for all-cause mortality (2.45, 95% confidence interval [CI] 1.44 to 4.15, p = 0.001) and cardiovascular mortality (5.60, 95% CI 2.27 to 11.8, p = 0.001). The highest risk was found for notching ERP and ERP with a nonascendant/horizontal ST segment, yielding when associated increased hazard ratios of 3.84 (95% CI 2.14 to 6.92, p = 0.001) and 8.75 (95% CI 3.48 to 22.0, p = 0.001) for all-cause and cardiovascular mortalities, respectively. Conversely, a slurring ERP or ascendant ST segment was not associated with increased mortality. ERP localization, J-point elevation amplitude, or T-wave morphology did not distinguish benign from malignant forms of ERP. In conclusion, ERP with notching pattern and horizontal/descendant ST segments was associated with the highest risk of all-cause and cardiovascular deaths. These electrocardiographic patterns may be used for risk stratification in subjects with ERP.

Coronary artery bypass graft (CABG) and percutaneous coronary intervention (PCI) are alternative treatments for multivessel coronary disease. Although the procedures have been compared in several randomised trials, their long-term effects on mortality in key clinical subgroups are uncertain. We undertook a collaborative analysis of data from randomised trials to assess whether the effects of the procedures on mortality are modified by patient characteristics. We pooled individual patient data from ten randomised trials to compare the effectiveness of CABG with PCI according to patients' baseline clinical characteristics. We used stratified, random effects Cox proportional hazards models to test the effect on all-cause mortality of randomised treatment assignment and its interaction with clinical characteristics. All analyses were by intention to treat. Ten participating trials provided data on 7812 patients. PCI was done with balloon angioplasty in six trials and with bare-metal stents in four trials. Over a median follow-up of 5·9 years (IQR 5·0–10·0), 575 (15%) of 3889 patients assigned to CABG died compared with 628 (16%) of 3923 patients assigned to PCI (hazard ratio [HR] 0·91, 95% CI 0·82–1·02; p=0·12). In patients with diabetes (CABG, n=615; PCI, n=618), mortality was substantially lower in the CABG group than in the PCI group (HR 0·70, 0·56–0·87); however, mortality was similar between groups in patients without diabetes (HR 0·98, 0·86–1·12; p=0·014 for interaction). Patient age modified the effect of treatment on mortality, with hazard ratios of 1·25 (0·94–1·66) in patients younger than 55 years, 0·90 (0·75–1·09) in patients aged 55–64 years, and 0·82 (0·70–0·97) in patients 65 years and older (p=0·002 for interaction). Treatment effect was not modified by the number of diseased vessels or other baseline characteristics. Long-term mortality is similar after CABG and PCI in most patient subgroups with multivessel coronary artery disease, so choice of treatment should depend on patient preferences for other outcomes. CABG might be a better option for patients with diabetes and patients aged 65 years or older because we found mortality to be lower in these subgroups. Agency for Healthcare Research and Quality.

Takotsubo cardiomyopathy (TTC) is a clinical condition of transient acute heart failure correlated to regional wall motion abnormalities extending beyond the distribution of a single epicardial coronary artery. It is classified into four major types: apical, basal, mid-ventricular and focal. Sympathetic nerve stimulation and catecholamine storm are the main players in the pathogenesis of TTC. The clinical course of disease is generally benign but it may end with life-threatening complications. Coronary angiography, left ventriculogram, transthoracic echocardiography and cardiac magnetic resonance imaging (CMR) are the main tools for making diagnosis. Except for critical cases with hemodynamic instability and/or complications, the overall management is limited to conventional heart failure therapy.

In the Trial to Assess the Use of the Cypher Stent in Acute Myocardial Infarction Treated with Balloon Angioplasty (TYPHOON), patients with an acute myocardial infarction with ST-segment elevation underwent percutaneous coronary intervention with either a sirolimus-eluting stent or an uncoated stent. The use of the sirolimus-eluting stent was associated with significant reductions in the rate of target-vessel failure and the severity of in-stent late luminal loss. Patients with an acute myocardial infarction underwent percutaneous coronary intervention with either a sirolimus-eluting stent or an uncoated stent. The use of the sirolimus-eluting stent was associated with significant reductions in the rate of target-vessel failure and the severity of in-stent late luminal loss. The use of sirolimus-eluting coronary-artery stents significantly reduces the incidence of restenosis after percutaneous coronary intervention (PCI), as compared with the use of uncoated stents. 1 – 3 However, most randomized trials evaluating sirolimus-eluting stents have excluded patients with acute myocardial infarction with ST-segment elevation. Small series of patients with acute myocardial infarction have shown that the implantation of a sirolimus-eluting stent is associated with a low rate of restenosis. 4 , 5 In the Single High-Dose Bolus Tirofiban and Sirolimus-Eluting Stent vs. Abciximab and Bare-Metal Stent in Myocardial Infarction (STRATEGY) trial, the use of sirolimus-eluting stents reduced cardiovascular events, as compared with the . . .