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No randomized studies have thus far evaluated intravascular ultrasound (IVUS) guidance in the drug-eluting stent (DES) era. The aim was to evaluate if IVUS optimized DES implantation was superior to angiographic guidance alone in complex lesions. Randomized, multicentre, international, open label, investigator-driven study evaluating IVUS vs angiographically guided DES implantation in patients with complex lesions (defined as bifurcations, long lesions, chronic total occlusions or small vessels). Primary study endpoint was post-procedure in lesion minimal lumen diameter. Secondary end points were combined major adverse cardiac events (MACE), target lesion revascularization, target vessel revascularization, myocardial infarction (MI), and stent thrombosis at 1, 6, 9, 12, and 24 months. The study included 284 patients. No significant differences were observed in baseline characteristics. The primary study end point showed a statistically significant difference in favor of the IVUS group (2.70 mm ± 0.46 mm vs. 2.51 ± 0.46 mm; P = .0002). During hospitalization, no patient died, had repeated revascularization, or a Q-wave MI. No difference was observed in the occurrence of non-Q wave MI (6.3% in IVUS vs. 7.0% in angio-guided group). At 24-months clinical follow-up, no differences were still observed in cumulative MACE (16.9%vs. 23.2 %), cardiac death (0%vs. 1.4%), MI (7.0%vs. 8.5%), target lesion revascularization (9.2% vs. 11.9%) or target vessel revascularization (9.8% vs. 15.5%), respectively in the IVUS vs. angio-guided groups. In total, only one definite subacute stent thrombosis occurred in the IVUS group. A benefit of IVUS optimized DES implantation was observed in complex lesions in the post-procedure minimal lumen diameter. No statistically significant difference was found in MACE up to 24 months.

Background In patients with myocardial infarction (MI) and multivessel disease, diabetes mellitus is associated with more diffuse coronary atherosclerosis and worse clinical outcomes, often influencing revascularization decisions. The Functional Assessment in Elderly MI Patients with Multivessel Disease (FIRE) trial demonstrated the superiority of physiology-guided complete revascularization in older patients with MI. Whether this benefit is preserved in patients with diabetes remains uncertain. Methods In FIRE, 1445 patients aged ≥ 75 years with MI and multivessel disease were randomized to culprit-only or physiology-guided complete revascularization. In this prespecified analysis, outcomes were assessed according to diabetes status. The primary endpoint was a composite of death, MI, stroke, or revascularization at 3 years. The key secondary endpoint was cardiovascular death or MI. The safety endpoint included contrast-associated acute kidney injury, stroke, or Bleeding Academic Research Consortium type 3–5 bleeding. Results Among 1445 patients, 463 (32%) had diabetes. After adjustment for baseline characteristics, diabetes was independently associated with a higher risk of the primary endpoint (hazard ratio [HR] 1.26, 95% confidence interval [CI] 1.02–1.56) and heart failure (HR 1.35, 95% CI 1.01–1.83) at 3 years. Physiology-guided complete revascularization reduced the primary outcome in both patients with diabetes (HR 0.70, 95% CI 0.50–0.97) and without diabetes (HR 0.75, 95% CI 0.58–0.97), with no evidence of effect modification by diabetes status (p for interaction = 0.712). Similar consistency was observed for the key secondary and safety endpoints. Conclusions In older patients with MI and multivessel disease, physiology-guided complete revascularization reduces ischemic events irrespective of diabetes status, supporting its use in elderly diabetic patients. Trial registration ClinicalTrials.gov Identifier NCT03772743.

Treatment with prasugrel and aspirin improves outcomes compared with clopidogrel and aspirin for patients with acute coronary syndrome who have had angiography and percutaneous coronary intervention; however, no clear benefit has been shown for patients managed first with drugs only. We assessed outcomes from the TRILOGY ACS trial based on whether or not patients had coronary angiography before treatment was chosen. TRILOGY ACS (ClinicalTrials.gov number NCT00699998) was a randomised controlled trial, done at more than 800 sites worldwide. Patients with non-ST-elevation acute coronary syndrome who were selected for management with revascularisation were randomly assigned to clopidogrel or prasugrel. The primary endpoint was cardiovascular death, myocardial infarction, or stroke at 30 months. In the present analysis we assessed differences in the primary endpoint by angiography status and whether the effects of treatment on the primary endpoint differed between patients who had angiography before enrolment and those who had not. 7243 patients younger than 75 years were included in the TRILOGY ACS primary analysis. 3085 (43%) had angiography at baseline, 4158 (57%) had not. Fewer patients who had angiography reached the primary endpoint at 30 months compared with those who did not have angiography, according to Kaplan-Meier analysis (281/3085 [12·8%] vs 480/4158 [16·5%], adjusted hazard ratio [HR] 0·63, 95% CI 0·53–0·75; p<0·0001). The proportion of patients who reached the primary endpoint was lower in the prasugrel group than in the clopidogrel group for those who had angiography (122/1524 [10·7%] vs 159/1561 [14·9%], HR 0·77, 95% CI 0·61–0·98; p=0·032) but did not differ between groups in patients who did not have angiography (242/2096 [16·3%] vs 238/2062 [16·7%], HR 1·01, 0·84–1·20; p=0·94; pinteraction=0·08). Overall, TIMI major bleeding and GUSTO severe bleeding were rare. Bleeding outcomes tended to be higher with prasugrel but did not differ significantly between treatment groups in either angiography cohort. Among patients who had angiography who took prasugrel there were fewer cardiovascular deaths, myocardial infarctions, or strokes than in those who took clopidogrel. This result needs to be corroborated, but it is consistent with previous trials of more versus less intensive antiplatelet treatment. When angiography is done for acute coronary syndrome and anatomic coronary disease confirmed, the benefits and risks of intensive antiplatelet treatment exist whether the patient is treated with drugs or percutaneous coronary intervention. Daiichi Sankyo, Eli Lilly.

In the motorsport industry, the choice of material for manufacturing the heat resistant components often falls on titanium alloys. In most cases, the production flow for this kind of part involves CNC machining and subsequent assembly by welding process, to other parts obtained by cold plastic forming and possibly made using different titanium alloys. Hence, the alloying element-content in the joint area can be extremely heterogeneous and variable point-by-point. To investigate this topic further, dissimilar welding of the alpha/beta alloy Ti6Al4V and of the oxidation-resistant alpha alloy KS-Ti 1.2 ASN-EX was made by GTAW technology and using different filler metals. Chemical and mechanical properties of the welds were investigated by XRD, SEM-EDS, microhardness maps, and tensile and bending tests. Results show that, despite the different alloying elements present in the two filler wires investigated, static properties of the welds are similar. Results also show that the local V/Al content ratio affects the microhardness as it is responsible for the creation of supersaturated alpha phases during the cooling of the weld beads.

The benefit of complete revascularization in older patients (≥75 years of age) with myocardial infarction and multivessel disease remains unclear. In this multicenter, randomized trial, we assigned older patients with myocardial infarction and multivessel disease who were undergoing percutaneous coronary intervention (PCI) of the culprit lesion to receive either physiology-guided complete revascularization of nonculprit lesions or to receive no further revascularization. Functionally significant nonculprit lesions were identified either by pressure wire or angiography. The primary outcome was a composite of death, myocardial infarction, stroke, or any revascularization at 1 year. The key secondary outcome was a composite of cardiovascular death or myocardial infarction. Safety was assessed as a composite of contrast-associated acute kidney injury, stroke, or bleeding. A total of 1445 patients underwent randomization (720 to receive complete revascularization and 725 to receive culprit-only revascularization). The median age of the patients was 80 years (interquartile range, 77 to 84); 528 patients (36.5%) were women, and 509 (35.2%) were admitted for ST-segment elevation myocardial infarction. A primary-outcome event occurred in 113 patients (15.7%) in the complete-revascularization group and in 152 patients (21.0%) in the culprit-only group (hazard ratio, 0.73; 95% confidence interval [CI], 0.57 to 0.93; P = 0.01). Cardiovascular death or myocardial infarction occurred in 64 patients (8.9%) in the complete-revascularization group and in 98 patients (13.5%) in the culprit-only group (hazard ratio, 0.64; 95% CI, 0.47 to 0.88). The safety outcome did not appear to differ between the groups (22.5% vs. 20.4%; P = 0.37). Among patients who were 75 years of age or older with myocardial infarction and multivessel disease, those who underwent physiology-guided complete revascularization had a lower risk of a composite of death, myocardial infarction, stroke, or ischemia-driven revascularization at 1 year than those who received culprit-lesion-only PCI. (Funded by Consorzio Futuro in Ricerca and others; FIRE ClinicalTrials.gov number, NCT03772743.).

The use of drug-eluting stent (DES) instead of bare-metal stent (BMS) in patients at high stent thrombosis or bleeding risk as well as in those at low restenosis risk (ie, uncertain DES candidates) remains a matter of debate. Zotarolimus-Eluting Endeavor Sprint stent (E-ZES) (Santa Rosa, CA) is a hydrophilic polymer-based second-generation device with unique drug fast-release profile, which may allow for a shorter dual antiplatelet therapy (DAPT) duration without safety concerns. The primary objective is to assess whether E-ZES implantation followed by a shorter than currently recommended course of DAPT will decrease the incidence of 12-month major adverse cardiovascular events as compared with BMS in undefined DES recipients. Actual duration of DAPT regimen will be dictated by patients' characteristics and not by stent type and, as such, can be as short as 30 days after intervention in both stent groups. The ZEUS study is an open-label randomized clinical trial conducted at 20 clinical sites in Italy, Switzerland, Portugal, and Hungary. With 1,600 individuals, this study will have 85% power to detect a 33% difference in the primary end point consisting of the composite of death, nonfatal myocardial infarction, or target vessel revascularization. The ZEUS trial aims to assess whether the use of E-ZES, followed by a DAPT duration regimen based on patients' characteristics and not by stent type, is superior to conventional BMS implantation in undefined DES recipients who qualify for the presence of high thrombosis, bleeding, or low restenosis risk criteria.

We report the case of a 65­-year-old woman admitted for inferior ST-segment elevation myocardial infarction complicated by complete atrioventricular block. The patient was under treatment with a novel oral anticoagulant (NOAC, rivaroxaban) because of a history of recurrent idiopathic pulmonary embolism. Emergency angiography showed complete acute thrombotic occlusion of the right coronary artery. After manual thrombectomy, there was no angiographic evidence of underlying atherosclerosis, therefore no further percutaneous coronary intervention was performed. Subsequent clinical course was uneventful. Laboratory tests demonstrated the presence of a heterozygous mutation of the factor II gene (G20210A), confirming the clinical evidence of a thrombophilic state. As rivaroxaban seemed to be ineffective in preventing spontaneous coronary thrombosis in this patient, antithrombotic therapy was shifted to warfarin plus low-dose aspirin. No further ischemic events occurred during the 1-year follow-up. It can be hypothesized that factor Xa inhibition by NOACs, such as rivaroxaban, could be insufficient in case of a thrombophilic state due to thrombin mutation. A brief review of the current literature on use of NOACs in acute coronary syndromes is also reported.

Razionale. Gli scaffold vascolari bioriassorbibili (BRS) rappresentano l’ultima evoluzione del trattamento interventistico della malattia aterosclerotica coronarica. Nel novembre del 2013, quando dei tre BRS attualmente presenti sul mercato solo il dispositivo Absorb BVS era disponibile, la Commissione Regionale Dispositivi Medici e la Commissione Cardiologica e Cardiochirurgica della Regione Emilia-Romagna hanno redatto una valutazione tecnico-scientifica. Il documento era finalizzato a fornire indicazioni per l’introduzione dei BVS nella pratica clinica. Sono state individuate 5 indicazioni preferenziali: lesioni coronariche lunghe (>28 mm), pazienti con lesioni ostiali (escluso tronco comune), rivascolarizzazione completa in pazienti di età <50 anni, patologia diffusa (>40 mm) o coinvolgente il tratto medio-distale del ramo discendente anteriore in pazienti con età <70 anni, dissezione coronarica spontanea.Materiali e metodi. L’analisi raccoglie i dati sull’utilizzo dei BRS provenienti dai laboratori di emodinamica della Regione Emilia-Romagna. Risultati. In un periodo di 3 anni sono stati impiantati 546 BRS in 328 pazienti, che corrispondono all’1.5% del totale degli stent medicati (DES) utilizzati, con un trend in progressiva crescita (0.3% nel 2013, 0.9% nel 2014, 3.2% nel 2015). Le indicazioni inizialmente promosse sono state seguite in 200/328 (61.0% dei pazienti, di cui un terzo ne possedeva più d’una) tra le quali principalmente: trattamento di lesioni lunghe in rami di calibro >2.5 mm (67%), pazienti giovani (31.5%), tratto medio-distale del ramo discendente anteriore (28%). Le indicazioni cliniche sono state: infarto miocardico con sopraslivellamento del tratto ST in 74 pazienti (22.6%), sindrome coronarica acuta senza sopraslivellamento del tratto ST in 129 (39.3%), coronaropatia stabile in 94 (28.7%). L’imaging intracoronarico (ecografia intravascolare) è stato utilizzato nel 24.7% dei casi. In 85 procedure (25.9%) è stata eseguita una rivascolarizzazione ibrida con utilizzo combinato di BRS e DES.Conclusioni. L’impiego dei BRS è stato inferiore alle aspettative, con discreta variabilità tra i Centri e seguendo le indicazioni regionali nella maggioranza dei casi. Il basso utilizzo potrebbe essere dovuto alla prudenza degli operatori nella loro iniziale esperienza. Il progressivo aumento nell’impiego dei BRS sembra rivelare una maggiore confidenza nella tecnica di impianto e fiducia nell’interezza dei dati pubblicati circa la sicurezza ed efficacia del dispositivo.

Outcome data on using cangrelor in older patients are limited. This post hoc analysis of the itAlian pRospective Study on CANGrELOr (ARCANGELO) study aims to assess bleeding and ischemic outcomes with the transition from cangrelor to any oral P2Y12 inhibitors in age-stratified subgroups (≥75 years—older, <75 years—younger) of patients with acute coronary syndrome who underwent percutaneous coronary intervention (PCI). Of 995 patients, 215 (21.6%) were older, 115 of whom (11.6%) were aged ≥80 years. Presentation with ST-elevation myocardial infarction was less frequent in older than in younger patients (52.6% vs 62.1%, p = 0.0119). At 30 days after PCI, rates of the study's primary end point of overall bleeding defined according to the Bleeding Academic Research Consortium were not significantly different between the 2 age subgroups (4.6% in the younger vs 7.4% in the older, p = 0.1179). Rates of major adverse cardiac events, defined as the composite of death, myocardial infarction, ischemia-driven revascularization, and stent thrombosis, were significantly lower in younger than in older patients (0.9% vs 3.3%, p = 0.0170). Intraprocedural thrombotic events occurring in the 48 hours after PCI arose in similar proportions in the subgroups (1.4% vs 1.4%, p = 1.000). In conclusion, these data suggest that using cangrelor with transition to any oral P2Y12 inhibitor is a safe and effective antithrombotic treatment in older patients who undergo PCI for acute coronary syndrome in the setting of routine clinical practice. Clinical Trial Registration Number: NCT04471870.