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Aims Left atrial appendage (LAA) membranes are rare congenital anomalies. Those involving the appendage orifice may obstruct its emptying flows, thus promoting blood stasis and clot formation. However, the epidemiology of LAA membranes has never been studied and a correlation with appendage thrombosis has never been proved. Very few case reports described LAA membranes, therefore, their frequency and clinical significance are not known. Moreover, their presence and degree are of crucial importance in planning LAA percutaneous closure, a procedure whose indication is evolving, and whether their presence can represent technical issues during the device implantation is not known. This study aimed to evaluate the incidence and the clinical significance of LAA membranes. Methods and results A population of 6030 consecutive transoesophageal echo (TOE) studies has been retrospectively reviewed in order to find those patients in whom an LAA membrane has been found. A literature research has been performed to review previous described cases. Among 6030 TOE cases, an LAA membrane has been described in 6 (prevalence of 1/1000). In one case, the membrane was associated to a severe LAA hypoplasia and in another case to an LAA thrombus (these represent the first cases ever described). All patients had an atrial fibrillation (AF) history and two were in AF during the TOE exam. Conclusion LAA membranes are rare congenital abnormalities occasionally discovered during a TOE exam, frequently in patients affected by AF. In half of the cases, they obstruct the LAA flow, thus theoretically pre-disposing to clot formation. They may be rarely associated to an appendage hypoplasia. During a TOE exam, cardiac imagers should always rule out their presence.

Ventricular tachycardia and premature ventricular complexes (PVCs) arising from right ventricular outflow tract (RVOT) are the most common type of ventricular arrhythmias (VAs) in patients without structural heart disease. Radiofrequency ablation is now the gold standard of treatment in this setting due to high efficacy rates and optimal safety profile. During the last few years, the pulmonary valve (PV) and the pulmonary artery (PA) have attracted much attention as reliable sites of origin of RVOT-type arrhythmias. In the mean while intracardiac echocardiogram (ICE) has undoubtedly improved our understanding of the cardiac anatomy. Aim of this paper is to provide an illustrated step-by-step guide on how to use ICE with the CARTOSOUND module to visualize and reconstruct 3D shell of the RV, the PV, as well of other contiguous anatomical structures (i.e., the aortic valve and coronary arteries) to perform aware and safe ablation in this region. This article is protected by copyright. All rights reserved.

Background Although oral P2Y12 inhibitors are key in the management of patients with non-ST elevation acute coronary syndrome (NSTE-ACS), the optimal timing of their administration is not well defined. Objective to compare downstream and upstream oral P2Y12 inhibitors administration strategies in NSTE-ACS patients undergoing invasive management. Methods We performed a randomized, adaptive, open-label, multi-center, clinical trial. Patients were randomly assigned to receive pre-treatment with ticagrelor before angiography (upstream group) or no pre-treatment (downstream group). Patients in the downstream group undergoing percutaneous coronary intervention (PCI) were further randomized to receive ticagrelor or prasugrel. The primary hypothesis was superiority of the downstream over the upstream strategy on the combination of efficacy and safety events (net clinical benefit). Results We randomized 1449 patients to downstream or upstream oral P2Y12 inhibitor administration. A prespecified stopping rule for futility at interim analysis led the trial to be stopped. The rate of the primary endpoint, a composite of death due to vascular causes, non-fatal myocardial infarction or non-fatal stroke, and Bleeding Academic Research Consortium (BARC) type 3, 4 and 5 bleedings through day 30, did not differ significantly between the downstream and upstream groups (Absolute Risk Reduction (ARR%) -0.46 [-2.90; 1.90]).These results were confirmed among patients undergoing PCI (72% of population) and regardless of the timing of coronary angiography (within or after 24 hours from enrolment). Conclusions Downstream and upstream oral P2Y12 inhibitors administration strategies were associated with low incidence of ischemic and bleeding events and minimal numerical difference of event rates between treatment groups. These findings led to premature interruption of the trial and suggest the unlikelihood of enhanced efficacy of one strategy over the other. [Funded by the Italian Society of Interventional Cardiology (SICI-GISE)]

Atrial fibrillation (AF) is the most prevalent form of cardiac arrhythmia. It is often related to diverse pathological conditions affecting the atria and leading to remodeling processes including collagen accumulation, fatty infiltration, and amyloid deposition. All these events generate atrial fibrosis, which contribute to beget AF. In this scenario, cardiac imaging appears as a promising noninvasive tool for monitoring the presence and degree of LA fibrosis and remodeling. The aim of this review is to comprehensively examine the bench mechanisms of atrial fibrosis moving, then to describe the principal imaging techniques that characterize it, such as cardiac magnetic resonance (CMR) and multidetector cardiac computed tomography (MDCT), in order to tailor atrial fibrillation ablation to each individual.

Ventricular tachycardia and premature ventricular complexes (PVCs) arising from right ventricular outflow tract (RVOT) are the most common type of ventricular arrhythmias (VAs) in patients without structural heart disease. Radiofrequency ablation is now the gold standard of treatment in this setting due to high efficacy rates and optimal safety profile [2] During the last few years, the pulmonary valve (PV) and the pulmonary artery (PA) have attracted much attention as reliable sites of origin of RVOT-type arrhythmias. In the mean while intracardiac echocardiogram (ICE) has undoubtedly improved our understanding and approach to manage these arrhythmias accurately characterizing the PV and its contiguous structures. Aim of this paper is to provide an illustrated step-by-step guide on how to use ICE with the CARTOSOUND module to visualize and reconstruct 3D shell of the RV, the PV, as well of other anatomical structures (i.e., the aortic valve and coronary arteries) to perform aware and safe ablation in this region. A new reconsideration of the existent classification of these VAs is also provided.

Background The optimal timing to administer a P2Y12 inhibitor in patients presenting with a non-ST elevation acute coronary syndrome remains a topic of debate. Pretreatment with ticagrelor before coronary anatomy is known as a widely adopted strategy. However, there is poor evidence on how this compares with administration of a P2Y12 inhibitor after defining coronary anatomy (i.e., downstream administration). Moreover, there are limited head-to-head comparisons of the two P2Y12 inhibitors—ticagrelor and prasugrel—currently recommended by the guidelines. Study design DUBIUS is a phase 4, multicenter, parallel-group, double randomized study conducted in NSTE-ACS patients designed to compare a pretreatment strategy (including only ticagrelor) versus a downstream strategy (including prasugrel or ticagrelor) and to compare downstream prasugrel with downstream ticagrelor. A total of 2520 patients will be randomly assigned to pretreatment with ticagrelor or to no pretreatment. The PCI group of the downstream arm will be further randomized to receive prasugrel or ticagrelor. The two primary hypotheses are that the downstream strategy is superior to the upstream strategy and that downstream ticagrelor is non-inferior to downstream prasugrel, both measured by the incidence of a composite efficacy and safety endpoint of death from vascular causes, non-fatal MI, or non-fatal stroke, and Bleeding Academic Research Consortium (BARC) type 3, 4, and 5 bleedings. Conclusions The DUBIUS study will provide important evidence related to the benefits and risks of pretreatment with ticagrelor compared with a strategy of no pretreatment. Moreover, the clinical impact of using downstream ticagrelor compared with downstream prasugrel will be assessed. Trial registration ClinicalTrials.gov NCT02618837. Registered on 1 December 2015.

Background Ticagrelor is a reversibly binding, direct-acting, oral, P2Y12 antagonist used for the prevention of atherothrombotic events in patients with coronary artery disease (CAD). Ticagrelor blocks adenosine reuptake through the inhibition of equilibrative nucleoside transporter 1 (ENT-1) on erythrocytes and platelets, thereby facilitating adenosine-induced physiological responses such as an increase in coronary blood flow velocity. Meanwhile, adenosine plays an important role in triggering ischemic preconditioning through the activation of the A1 receptor. Therefore, an increase in ticagrelor-enhanced adenosine bioavailability may confer beneficial effects through mechanisms related to preconditioning activation and improvement of coronary microvascular dysfunction. Methods To determine whether ticagrelor can trigger ischemic preconditioning and influence microvascular function, we designed this prospective, open-label, pilot study that enrolled patients with stable multivessel CAD requiring staged, fractional flow reserve (FFR)-guided percutaneous coronary intervention (PCI). Participants will be randomized in 1:1 ratios either to ticagrelor (loading dose (LD) 180 mg, maintenance dose (MD) 90 mg bid) or to clopidogrel (LD 600 mg, MD 75 mg) from 3 to 1 days before the scheduled PCI. The PCI operators will be blinded to the randomization arm. The primary endpoint is the delta (difference) between ST segment elevations (in millimeters, mm) as assessed by intracoronary electrocardiogram (ECG) during the two-step sequential coronary balloon inflation in the culprit vessel. Secondary endpoints are 1) changes in coronary flow reserve (CFR), index of microvascular resistance (IMR), and FFR measured in the culprit vessel and reference vessel at the end of PCI, and 2) angina score during inflations. This study started in 2018 with the aim of enrolling 100 patients. Based on the rate of negative FFR up to 30% and a drop-out rate up to 10%, we expect to detect an absolute difference of 4 mm among the study arms in the mean change of ST elevation following repeated balloon inflations. All study procedures were reviewed and approved by the Ethical Committee of the Catholic University of Sacred Heart. Discussion Ticagrelor might improve ischemia tolerance and microvascular function compared to clopidogrel, and these effects might translate to better long-term clinical outcomes. Trial registration EudraCT No. 2016–004746-28. No. NCT02701140. Trial status Information provided in this manuscript refers to the definitive version (n. 3.0) of the study protocol, dated 31 October 2017, and includes all protocol amendments. Recruitment started on 18 September 2018 and is currently ongoing. The enrollment is expected to be completed by the end of 2019. Trial sponsor Fondazione Policlinico Universitario A. Gemelli – Roma, Polo di Scienze Cardiovascolari e Toraciche, Largo Agostino Gemelli 8, 00168 Rome, Italy.

Purpose: To investigate the association of the degree of stent expansion, as assessed by optical coherence tomography (OCT), following stent implantation, and clinical outcomes in ST-segment elevation myocardial infarction (STEMI) patients. Methods: STEMI patients from the MATRIX (Minimizing Adverse Haemorrhagic Events by TRansradial Access Site and angioX) OCT study were selected; Clinical outcomes were collected through 1year. Stent expansion index is a minimum stent area (MSA) divided by average lumen area (average of proximal and distal reference lumen area). The following variables were measured: MSA (< 4.5mm2), dissection (> 200µm in width and < 5mm from stent segment), malapposition (> 200µm distance of stent from vessel wall), a thrombus (area > 5% of lumen area) were compared. Results: A total of 151 patients were included; after excluding patients with suboptimal OCT quality, the population with available OCT was classified into 2 groups: under–expanded < 90% (N = 72, 51%) and well–expanded ≥ 90% (N = 67, 49%). In the well–expanded group, a significant number of the proximal vessels had a lumen area < 4.5mm2 (16.1%, p < 0.001) and a greater thrombus burden within stent (56.7%, p = 0.042). The overall 30day and 1year major adverse cardiovascular event (MACE) rates were 5% and 6.1%, respectively. Conclusion: Irrespective of the degree of stent expansion, the OCT findings, in STEMI patients, and the MACE at 30days and one year follow up was low; further, well–expanded stents led to a more significant residual thrombotic burden within the stent but seemed to have insignificant clinical impact. Acknowledged stent optimization criteria, traditionally related to worse outcomes in stable patients, do not seem to be associated with worse outcomes in this STEMI population.

The combination of atrial fibrillation (AF) and acute coronary syndrome (ACS) is a complex situation in which a three-dimensional risk—cardioembolic, coronary, and hemorrhagic—has to be carefully managed. Triple antithrombotic therapy (TAT) is burdened with a high risk of serious bleeding, while dual antithrombotic therapy with an anticoagulant (DAT) likely provides only suboptimal coronary protection early after stent implantation. Moreover, TAT precludes the advantages provided by the use of the latest and more potent P2Y12 inhibitors in ACS patients. Here, we aimed to simulate and compare the expected coronary, cardioembolic, and hemorrhagic outcomes offered by DAT, TAT, or modern dual antiplatelet therapy (DAPT) with aspirin plus one of the latest P2Y12 inhibitors in AF patients early after an ACS. The comparison of numbers needed to treat to prevent major adverse events with the various antithrombotic regimens suggests that AF–ACS patients at high ischemic and hemorrhagic risk and at moderately low embolic risk (CHA2DS2VASc score 2–4) might safely withhold anticoagulation after revascularization for one month taking advantage of a modern DAPT, with a favorable risk-to-benefit ratio. In conclusion, this strategy, not sufficiently addressed in recent European and North American guidelines or consensus documents, adds to the spectrum of treatment options in these difficult patients; it might be the best choice in a substantial number of patients; and should be prospectively tested in a randomized controlled trial.

BACKGROUND Residual stent strut thrombosis after primary percutaneous coronary intervention (PCI), negatively affects myocardial perfusion, may increase stent thrombosis risk, and it is associated with neointima hyperplasia at follow-up. OBJECTIVES To study the effectiveness of any bivalirudin infusion versus unfractionated heparin (UFH) infusion in reducing residual stent strut thrombosis in patients with ST-elevation myocardial infarction (STEMI). METHODS Multi-vessel STEMI patients undergoing primary PCI and requiring staged intervention were selected among those randomly allocated to two different bivalirudin infusion regimens in the MATRIX (Minimizing Adverse Haemorrhagic Events by TRansradial Access Site and angioX) Treatment-Duration study. Those receiving heparin only were enrolled into a registry arm. Optical coherence tomography (OCT) of the infarct-related artery was performed at the end of primary PCI and 3-5 days thereafter during a staged intervention. The primary endpoint was the change in minimum flow area (ΔMinFA) defined as (stent area + incomplete stent apposition [ISA] area) - (intraluminal defect + tissue prolapsed area) between the index and staged PCI. RESULTS 123 patients in bivalirudin arm and 28 patients in the UFH arm were included. Mean stent area, percentage of malapposed struts, and mean percent thrombotic area were comparable after index or staged PCI. The ΔMinFA in the bivalirudin group was 0.25 versus 0.05 mm2 in the UFH group, which resulted in a between-group significant difference of 0.36 [95% CI: (0.05, 0.71); p = .02]. This was mostly related to a decrease in tissue protrusion in the bivalirudin group (p = .03). There was a trend towards more patients in the bivalirudin group who achieved a 5% difference in the percentage of OCT frames with the area >5% (p = .057). CONCLUSIONS The administration of bivalirudin after primary PCI significantly reduces residual stent strut thrombosis when compared to UFH. This observation should be considered hypothesis-generating since the heparin-treated patients were not randomly allocated.

Background Manual thrombus aspiration and local drug delivery of abciximab have been proposed as a strategy to reduce thrombus burden during percutaneous coronary intervention in patients with ST elevation myocardial infarction; however, the effectiveness of these approaches, is uncertain. In this COCTAIL II substudy, we compared the effect of these strategies on prestenting and poststenting thrombus burden assessed by optical coherence tomography. Patients and methods COCTAIL II trial enrolled patients with ST elevation myocardial infarction randomized to intralesion (IL, by the ClearWay catheter) versus intracoronary (IC, by the guide catheter) abciximab bolus with or without aspiration thrombectomy (AT). The following parameters were used to quantify atherothrombotic burden: thrombus volume (TVol), maximum thrombus area (TA), and thrombus burden (TB). Primary endpoint was the comparison of prestenting TVol after the use of local drug delivery (group IL+IL abciximab plus AT) versus nonlocal drug delivery (group IC abciximab plus AT+IC). Results The final population consisted of 59 patients undergoing both prestenting and poststenting optical coherence tomography assessment. The amount of thrombus was not significantly different in the groups with local drug delivery of abciximab versus nonlocal drug delivery in both prestenting (TVol: 18.87±26.70 vs. 19.02±18.45; TB: 26.73±12.8 vs. 25.18±13.25; and maximum TA: 59.25±18.84 vs. 53.34±19.30) and poststenting (TVol: 8.46±9.15 vs. 8.05±6.81; TB: 6.68±3.54 vs. 6.24±3.66; and maximum TA: 15.47±7.61 vs. 16.52±11.55) evaluations. A good correlation between thrombus measurements after thrombus removal techniques and intrastent thrombus was observed. Conclusion Either local drug delivery of abciximab or manual thrombus aspiration showed comparable results in terms of prestenting and poststenting thrombus burden removal.

Aims Recent frequency-domain optical coherence tomography studies showed that a complete removal of thrombotic materials is rarely achieved after percutaneous coronary interventions for ST segment elevation myocardial infarction. Residual intrastent thrombus can embolize distally leading to microcirculatory injury. The aim was to find a possible correlation between residual intrastent thrombus and angiographic indexes of myocardial reperfusion. Methods The population consisted of 128 ST segment elevation myocardial infarction patients enrolled in the COCTAIL II trial. Intrastent thrombus at optical coherence tomography was defined as the maximum percentage value of thrombus area (thrombus area/stent area × 100 in the cross-section with largest thrombus). A thrombus area of at least 16% (mean value) was considered indicative of high residual intrastent thrombus. The following angiographic indexes of myocardial reperfusion were evaluated: thrombolysis in myocardial infarction (TIMI) value, corrected TIMI frame count and myocardial blush grade. Results Angiographic and optical coherence tomography results are available in 119 patients: 64 had a maximum percentage value of thrombus area less than 16%, whereas the remaining 55 had a residual intrastent thrombus at least 16%. No differences were found regarding the microcirculatory indexes at baseline angiogram. After intervention, patients with intrastent thrombus less than 16% showed a significant improvement in the final TIMI value (2.87 ± 0.33 vs 2.67 ± 0.54; P = 0.014), final TIMI frame count (11.71 ± 4.58 vs 18.04 ± 17.32; P = 0.012) and a nonsignificant improvement in the final myocardial blush grade value (2.58 ± 0.58 vs 2.43 ± 0.76; P = 0.255). Conclusion Data obtained from this ancillary study of the COCTAIL II suggest that the presence of high residual intrastent thrombus in patients undergoing primary angioplasty is associated with worsened final microcirculatory indexes.

Objective Revascularization of functionally non-significant stenoses in patients with stable coronary artery disease can safely be deferred as rate of adverse cardiovascular events is low. It is not clear whether fractional flow reserve (FFR) is just as accurate in acute coronary syndromes (ACS). The aim of this study is to assess the outcome of coronary lesions whose revascularization was deferred based on negative FFR values in subjects with ACS. Methods Patients with acute coronary syndrome and showing at least one coronary stenosis whose revascularization was deferred based on FFR value >0.80 were included in the study. The primary endpoint of the study was the rate of target lesion failure (TLF), a composite of cardiac events (cardiac death, myocardial infarction and any coronary revascularization) related to the initially deferred stenosis at three-year follow-up. Results A total of 319 patients (237 male), mean age 68 [59–74] years and 355 coronary lesions with deferred revascularization based on negative FFR values (0.88±0.05) were selected. The rate of TLF was 6% at 1-year, 9% at 2-year and 12% at 3-year follow-up. TLF was driven by a new acute coronary syndrome in 75% of cases. The median time interval from FFR assessment to TLF was 457 [138–868] days. Conclusions In patients with acute coronary syndrome, the rate of TLF of the initially deferred coronary stenoses is 12% at 3-year follow-up and TLF occurred because of a new ACS in three quarters of cases.

The radiation dose received by interventional cardiologists during their activity in the catheterization laboratory is a matter of concern in terms of possible deterministic and stochastic risk. At the same time, very often, the knowledge of the effect and consequences of radiation exposure in the interventional cardiology community is limited. This document endorsed by the Italian Society of Interventional Cardiology (SICI-GISE) provides recommendations for cardiologists' radiation protection. Radiation safety considerations dedicated to women and other staff personnel working in the catheterization laboratory are also discussed.

Stroke is a rare but possible complication after atrial fibrillation (AF) ablation. However, its etiopathogenesis is far from being completely characterized. Here we report a case of stroke, with recurrent peripheral embolism after AF ablation procedure. In our patient, an in situ femoral vein thrombosis and iatrogenic atrial septal defect were simultaneously detected. A comprehensive review of multiple pathophysiological mechanisms of stroke in this context is provided. The case underlines the importance of a global evaluation of patients undergoing AF ablation.

Blood stasis is the main cause of left atrial thrombosis (LAT) in atrial tachyarrhythmias. The high-velocity flow inside the left atrium, due to mitral valve regurgitation, may prevent clot formation but the topic has never been investigated in large-scale studies. The aim of our study was to evaluate whether the presence and degree of mitral regurgitation have a protective role against LAT risk.A total of 1302 consecutive adult patients with paroxysmal or persistent atrial fibrillation or flutter undergoing cardioversion, submitted to transesophageal echocardiography, were retrospectively enrolled in the study. The study population was divided into three groups according to the mitral regurgitation degree: absent, mild-to-moderate and severe.Among 1302 patients enrolled in the study, patients without mitral regurgitation were 248 (19%), those with mild-to-moderate 970 (75%), whereas 84 had severe mitral regurgitation (6%). LAT incidence was significantly lower in patients with severe mitral regurgitation compared with those with mild-to-moderate (mitral regurgitation) (2.4 vs. 8.9%, P 0.05), and similar to subjects without mitral regurgitation (2.4%).Despite patients with severe regurgitation having clinical and echo characteristics predisposing to LAT (higher age, heart failure, higher atrial size, lower ventricular function) thrombosis prevalence was significantly lower than for those with mild-to-moderate mitral regurgitation. The percentage of LAT in severe mitral regurgitation cases was very low and similar to that of cases without regurgitation which were characterized by lower age, normal left ventricular function or other risk factors, reinforcing the hypothesis of a protecting role against atrial thrombosis of mitral regurgitation.

Prevalence of obesity, metabolic syndrome (MetS) and type 2 diabetes (T2D) is growing alarmingly, and the number of affected people continues to escalate. Such cardiometabolic states exert many deleterious effects on the heart as they are associated with adverse left ventricular (LV) remodeling and, most notably, with a marked increase in the risk of developing atrial fibrillation (AF) and subsequent stroke. Epidemiological studies clearly show a strong association between obesity and AF, with a 4-5% increase in AF risk for every unit increase in BMI. The increased risk of developing AF in cardiometabolic patients is explained by changes in volume status, energy substrate utilization, tissue metabolism and systemic inflammation, all factors promoting elevation in left atrial and systolic blood pressure, LV systo-diastolic dysfunction, with subsequent atrial stretch and "triggers" for AF. In the present review, we critically discuss available evidence on AF risk in the cardiometabolic patient. Specific aspects will be discussed: 1) epidemiology and prognosis of AF in patients with obesity, MetS and T2D; 2) molecular mechanisms involved in the pathophysiology of metabolic cardiomyopathy and left atrial remodeling; 3) advances in medical therapy including weight loss strategies and lifestyle changes; 4) new oral anticoagulants and stroke risk in obese and diabetic patients; 5) effectiveness and safety of AF catheter ablation. Taken together, these novel insights point to the development of new therapeutic strategies to combat the burden of AF in patients with cardiometabolic disturbances.

Aims The aim of our study was to evaluate the prevalence of left atrial cavity and appendage thrombosis in patients undergoing cardioversion for non-valvular atrial tachyarrhythmias. In persistent atrial tachyarrhythmias, 90% of thromboses are reported to be located inside the left atrial appendage. This prevalence refers to old studies and meta-analysis in a mixed population of valvular and non-valvular atrial fibrillation. Left atrial cavity thrombosis in non-valvular atrial fibrillation has not been investigated recently in large-scale studies. Methods and results A total of 1,420 consecutive adult patients with paroxysmal or persistent atrial tachyarrhythmias, candidates to cardioversion, who opted for a transoesophageal echocardiography-guided strategy, were enrolled in the study. Mitral stenosis, rheumatic valve disease and mechanical prostheses were excluded. In total there were 91 thrombi in 87 patients with a prevalence of 6.13% (87/1,420). Patients with left atrial thrombosis had predisposing clinical and echo characteristics (heart failure, lower ventricular function and higher atrial volume). Except for one case in which the thrombus was located in the left atrial cavity (0.07%), and three in the right appendage, all thromboses were detected in the left atrial appendage. Conclusions Extra-appendage thrombosis is a very rare finding in non-valvular persistent and paroxysmal atrial tachyarrhythmias and, when present, a left appendage thrombus is usually concomitant.

Aims To compare prolonged bivalirudin infusion vs. an intra-procedural only bivalirudin infusion administration in subjects with ST-segment elevation myocardial infarction (STEMI) regarding residual stent strut thrombosis. Methods and results Multivessel STEMI patients undergoing primary percutaneous coronary intervention (PPCI) and scheduled for a staged percutaneous coronary intervention (PCI) before hospital discharge were selected among those allocated to either prolonged bivalirudin or intra-procedural only bivalirudin infusion in the MATRIX (Minimizing Adverse Haemorrhagic Events by TRansradial Access Site and angioX) Treatment-Duration study. Optical coherence tomography (OCT) of the infarct-related artery was performed at the end of PPCI and 4–5 days thereafter during staged intervention. The predefined endpoint was the percentage difference in the number of stent cross-sections with a thrombotic area >5% at the end of PPCI and at the time of staged PCI (ΔThCS). Between September 2013 and November 2015, 137 were randomized to either intra-procedural only bivalirudin infusion (N = 64) or prolonged bivalirudin (N = 73) at 16 European sites. Mean stent area, minimum lumen area, percentage of malapposed struts, and mean percent thrombotic area were comparable after index or staged PCI. The difference in the proportion of frames with percent thrombotic area >5% (ΔTh > 5%) were −7.7 (−22.1 to 5.1) in the intra-procedural bivalirudin infusion group and −8.8 (−23.1 to 2.6) in the prolonged infusion group (P = 0.994). Time from index to follow-up OCT imaging and the infarct vessel artery did not affect this OCT-based endpoint. Conclusion A strategy of prolonged bivalirudin infusion after PPCI did not reduce residual stent strut thrombosis when compared with intra-procedural only bivalirudin infusion administration (funded by The Medicines Company and Terumo; MATRIX ClinicalTrials.gov number, NCT01433627).

Differently from many European and non-European countries, currently in Italy there is not an official, well-defined process for training, evaluation and certification for interventional cardiologists. Interventional Cardiology is an important branch of Cardiology with peculiarities such as to need specific theoretical and practical training. The lack of standardization of training criteria may result in disparities in the quality of care offered to patients in different locations. The Italian Society of Interventional Cardiology (SICI-GISE) has therefore developed an independent certification process for Italian interventional cardiologists. This is a first step towards the implementation of a well-defined training and certification process for both coronary and structural interventions, and for regular re-certification of established operators.The certification will be issued by SICI-GISE and will be based on the recognition of the skills attained by interventional cardiologists in the setting of coronary diagnostic and interventional procedures. This document describes the minimum eligibility criteria for the training centers, which have the task of recording and validating the training activity carried out by each interventional cardiologist, and the minimum competence requirements that should be attained by the operators to obtain the certification.

The exercise electrocardiographic stress test (ExET) is the most widely used non-invasive diagnostic method to detect coronary artery disease. However, the sole ST depression criteria (ST-max) have poor specificity for coronary artery disease in patients with left ventricular hypertrophy. We hypothesised that ST-segment depression/heart rate hysteresis, depicting the relative behaviour of ST segment depression during the exercise and recovery phase of the test might increase the diagnostic accuracy of ExET for coronary artery disease detection in such patients.In three cardiology centres, we studied 113 consecutive patients (mean age 66 ± 2 years; 88% men) with hypertension-related left ventricular hypertrophy at echocardiography, referred to coronary angiography after an ExET. The following ExET criteria were analysed: ST-max, chronotropic index, heart rate recovery, Duke treadmill score, ST-segment depression/heart rate hysteresis.We detected significant coronary artery disease at coronary angiography in 61 patients (53%). At receiver-operating characteristic analysis, ST-segment depression/heart rate hysteresis had the highest area under the curve value (0.75, P 0.001 when compared with the 'neutral' receiver-operating characteristic curve value of 0.5). Area under the curve values were 0.68 (P 0.01) for the chronotropic index, 0.58 (P = NS) for heart rate recovery, 0.57 (P = NS) for ST-max and 0.52 (P = NS) for the Duke treadmill score.Among currently available ExET diagnostic variables, ST-segment depression/heart rate hysteresis offers a substantially better diagnostic accuracy for coronary artery disease than conventional criteria in patients with hypertension-related left ventricular hypertrophy.

In patients with ST-segment elevation myocardial infarction (STEMI) undergoing primary percutaneous coronary intervention (p-PCI), the temporal effect of statin therapy on nonculprit lipid-rich plaques (NCLPs) is unclear. To better characterize the morphological changes of NCLP according to the

BACKGROUND The value of prolonged bivalirudin infusion after percutaneous coronary intervention (PCI) in acute coronary syndrome (ACS) patients with or without ST-segment elevation remains unclear. OBJECTIVES The purpose of this study was to assess efficacy and safety of a full or low post-PCI bivalirudin regimen in ACS patients with or without ST-segment elevation. METHODS The MATRIX program assigned bivalirudin to patients without or with a post-PCI infusion at either a full (1.75 mg/kg/h for #4 h) or reduced (0.25 mg/kg/h for #6 h) regimen at the operator's discretion. The primary endpoint was the 30-day composite of urgent target-vessel revascularization, definite stent thrombosis, or net adverse clinical events (composite of all-cause death, myocardial infarction, or stroke, or major bleeding). RESULTS Among 3,610 patients assigned to bivalirudin, 1,799 were randomized to receive and 1,811 not to receive a post-PCI bivalirudin infusion. Post-PCI full bivalirudin was administered in 612 (ST-segment elevation myocardial infarction [STEMI], n = 399; non-ST-segment elevation acute coronary syndromes [NSTE-ACS], n = 213), whereas the low-dose regimen was administered in 1,068 (STEMI, n = 519; NSTE-ACS, n = 549) patients. The primary outcome did not differ in STEMI or NSTE-ACS patients who received or did not receive post-PCI bivalirudin. However, full compared with low bivalirudin regimen remained associated with a significant reduction of the primary endpoint after multivariable (rate ratio: 0.21; 95% CI: 0.12 to 0.35; p < 0.001) or propensity score (rate ratio: 0.16; 95% CI: 0.09 to 0.26; p < 0.001) adjustment. Full post-PCI bivalirudin was associated with improved outcomes consistently across ACS types compared with the no post-PCI infusion or heparin groups. CONCLUSIONS In ACS patients with or without ST-segment elevation, the primary endpoint did not differ with or without post-PCI bivalirudin infusion but a post-PCI full dose was associated with improved outcomes when compared with no or low-dose post-PCI infusion or heparin (Minimizing Adverse Haemorrhagic Events by TRansradial Access Site and Systemic Implementation of angioX [MATRIX]; NCT01433627). (J Am Coll Cardiol 2019; 73: 758-74) (c) 2019 by the American College of Cardiology Foundation. The trial was sponsored by the Societa Italiana di Cardiologia Invasiva (GISE, a nonprofit organization), which received grant support from The Medicines Company and TERUMO. This substudy did not receive any direct or indirect funding. Dr. Gargiulo has received research grant support from the Cardiopath PhD program. Dr. Vranckx has received consulting fees from AstraZeneca and The Medicines Company during the study; and has received speaking or consulting fees from Bayer HealthCare, Terumo, and Daiichi-Sankyo outside of the submitted work. Dr. Campo has received research grants from AstraZeneca, Boston Scientific, and Abbott Vascular outside of this work. Dr. Varbella has received personal fees from AstraZeneca, Eli Lilly, and Bayer; has received other support from Biosensors; has received grants from Medtronic, Kardia SRL, and Boston Scientific outside of the submitted work; and has received lecture fees for Advisory Board participation from AstraZeneca, Daichi-Sankyo, Bayer, Pfizer, Boehringer Ingelheim, Servier, Amgen, Novartis, Sanofi, and Biotronik. Dr. Ando has received nonfinancial support from Terumo during the conduct of the study; has received personal fees from Daiichi-Sankyo, AstraZeneca, Menarini, Pfizer, Philips, and Bayer; and has received nonfinancial support from Bayer, Boehringer Ingelheim, Chiesi, and Philips outside of the submitted work. Dr. Limbruno has received personal fees from The Medicines Company, AstraZeneca, Lilly, Boston Scientific, Biotronik, and Merck outside of the submitted work. Dr. Windecker's institution has received research contracts from Abbott, Amgen, Boston Scientific, Biotronik, Medtronic, Edwards Lifesciences, St. Jude, and Terumo. Dr. Valgimigli has received grants from The Medicines Company and Terumo during the conduct of the study; has received grants and personal fees from AstraZeneca; has received nonfinancial support from The Medicines Company; and has received personal fees from The Medicines Company, Terumo, St. Jude Vascular, Alvimedica, Abbott Vascular, and Correvio outside of the submitted work. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.

The high spatial resolution of cardiac computed tomography (CT) and cardiac magnetic resonance (CMR) permit the diagnosis of congenital ventricular outpouchings (CVOs), including congenital ventricular diverticula (CVD), congenital ventricular aneurysms (CVA), clefts, and crypts. A unique classification has not been established, and these terms are used interchangeably with confounding terminology. Moreover, their significance is not univocal. A research was performed using PubMed on six subjects: (1) congenital left ventricular outpouchings; (2) congenital ventricular diverticulum; (3) congenital ventricular aneurysm; (4) ventricular clefts; (5) ventricular crypts; and (6) ventricular crevices. Usually, CVOs are small with a preserved contraction and in asymptomatic patients, the clinical relevance may be minimal, although electrocardiographic anomalies are often present. CVA and diverticula may carry an embolic risk and cases of arrhythmia and rupture are described. In the presence of clefts, or crypts a cardiomyopathy should be excluded. A simple classification can be proposed: CVD extend beyond the myocardial wall and fibrous type may be termed CVA, acquired forms should be kept distinct. Clefts, or crypts, are small recesses extending for more than 50% of the ventricular wall but not beyond its margin. The presence of fibrosis may be evaluated by CMR. A multicenter prospective registry would be helpful to investigate potential clinical implications and to exclude dubious forms of hypertrophic cardiomyopathy or ventricular noncompaction. In conclusion, CVOs have been described with different terminologies and classifications. Their significance needs to be interpreted in the clinical setting and with the help of a multimodality imaging, particularly of CMR.

Ischemic heart disease remains a leading cause of death worldwide, responsible for an estimated 17.5 million deaths in 2012. Mortality from ST-elevation myocardial infarction STEMI have decreased over the last 3 decades. However, despite the success of reperfusion therapy by primary percutaneous coronary intervention (PPCI) or thrombolysis, STEMI is still of significant concern. A recent patient-level meta-analysis emphasized the pivotal importance of infarct size within 1 month after PPCI as a determinant of all-cause mortality and hospitalization for heart failure at 1 year. Although timely and complete reperfusion is the most effective way of limiting infarct size (IS) and subsequent ventricular remodeling, reperfusion per se adds an additional component of irreversible injury to the myocardium (known as ischemia/reperfusion injury, IRI), and the coronary circulation and it contributes to final infarct size. The prevention and treatment of lethal IRI and coronary microvascular dysfunction pose a continued and formidable barrier to successful myocardial perfusion as opposed to establishing patency of the epicardial infarct-related artery (IRA), and in this context the need for additional cardioprotective strategies to reduce IS and coronary microvascular dysfunction remains the 'last frontier' of reperfusion therapy.

Summary Background The Minimizing Adverse Haemorrhagic Events by Transradial Access Site and Systemic Implementation of Angiox (MATRIX) programme was designed to assess the comparative safety and effectiveness of radial versus femoral access and of bivalirudin versus unfractionated heparin with optional glycoprotein IIb/IIIa inhibitors in patients with the whole spectrum of acute coronary syndrome undergoing invasive management. Here we describe the prespecified final 1-year outcomes of the entire programme. Methods MATRIX was a programme of three nested, randomised, multicentre, open-label, superiority trials in patients with acute coronary syndrome in 78 hospitals in Italy, the Netherlands, Spain, and Sweden. Patients with ST-elevation myocardial infarction were simultaneously randomly assigned (1:1) before coronary angiography to radial or femoral access and to bivalirudin, with or without post-percutaneous coronary intervention infusion or unfractionated heparin (one-step inclusion). Patients with non-ST-elevation acute coronary syndrome were randomly assigned (1:1) before coronary angiography to radial or femoral access and, only if deemed eligible to percutaneous coronary intervention after angiography (two-step inclusion), entered the antithrombin type and treatment duration programmes. Randomisation sequences were computer generated, blocked, and stratified by intended new or current use of P2Y12 inhibitor (clopidogrel vs ticagrelor or prasugrel), and acute coronary syndrome type (ST-elevation myocardial infarction, troponin-positive, or troponin-negative non-ST-elevation acute coronary syndrome). Bivalirudin was given as a bolus of 0·75 mg/kg, followed immediately by an infusion of 1·75 mg/kg per h until completion of percutaneous coronary intervention. Heparin was given at 70–100 units per kg in patients not receiving glycoprotein IIb/IIIa inhibitors, and at 50–70 units per kg in patients receiving glycoprotein IIb/IIIa inhibitors. Clinical follow-up was done at 30 days and 1 year. Co-primary outcomes for MATRIX access and MATRIX antithrombin type were major adverse cardiovascular events, defined as the composite of all-cause mortality, myocardial infarction, or stroke up to 30 days; and net adverse clinical events, defined as the composite of non-coronary artery bypass graft-related major bleeding, or major adverse cardiovascular events up to 30 days. The primary outcome for MATRIX treatment duration was the composite of urgent target vessel revascularisation, definite stent thrombosis, or net adverse clinical events up to 30 days. Analyses were done according to the intention-to-treat principle. This trial is registered with ClinicalTrials.gov, number NCT01433627. Findings Between Oct 11, 2011, and Nov 7, 2014, we randomly assigned 8404 patients to receive radial (4197 patients) or femoral (4207 patients) access. Of these 8404 patients, 7213 were included in the MATRIX antithrombin type study and were randomly assigned to bivalirudin (3610 patients) or heparin (3603 patients). Patients assigned to bivalirudin were included in the MATRIX treatment duration study, and were randomly assigned to post-procedure infusion (1799 patients) or no post-procedure infusion (1811 patients). At 1 year, major adverse cardiovascular events did not differ between patients assigned to radial access compared with those assigned to femoral access (14·2% vs 15·7%; rate ratio 0·89, 95% CI 0·80–1·00; p=0·0526), but net adverse clinical events were fewer with radial than with femoral access (15·2% vs 17·2%; 0·87, 0·78–0·97; p=0·0128). Compared with heparin, bivalirudin was not associated with fewer major adverse cardiovascular (15·8% vs 16·8%; 0·94, 0·83–1·05; p=0·28) or net adverse clinical events (17·0% vs 18·4%; 0·91, 0·81–1·02; p=0·10). The composite of urgent target vessel revascularisation, stent thrombosis, or net adverse clinical events did not differ with or without post-procedure bivalirudin infusion (17·4% vs 17·4%; 0·99, 0·84–1·16; p=0·90). Interpretation In patients with acute coronary syndrome, radial access was associated with lower rates of net adverse clinical events compared with femoral access, but not major adverse cardiovascular events at 1 year. Bivalirudin with or without post-procedure infusion was not associated with lower rates of major adverse cardiovascular events or net adverse clinical events. Radial access should become the default approach in acute coronary syndrome patients undergoing invasive management. Funding Italian Society of Invasive Cardiology, The Medicines Company, Terumo, amd Canada Research Chairs Programme.

SummaryWhen patients with coronary stents undergo non-cardiac surgery, bridging therapy with low-molecular-weight heparin (LMWH) is not infrequent in clinical practice. However, the efficacy and safety of this approach is poorly understood. This was a retrospective analysis of patients with coronary stent(s) on any antiplatelet therapy undergoing non-cardiac surgery between March 2003 and February 2012. The primary efficacy endpoint was the 30-day incidence of major adverse cardiac or cerebrovascular events (MACCE), defined as the composite of cardiac death, myocardial infarction, acute coronary syndrome leading to hospitalisation, or stroke. The primary safety endpoint was the 30-day composite of Bleeding Academic Research Consortium (BARC) bleedings ≥ 2. Among 515 patients qualifying for the analysis, LMWH bridging was used in 251 (49 %). At 30 days, MACCE occurred more frequently in patients who received LMWH (7.2 % vs 1.1 %, p=0.001), driven by a higher rate of myocardial infarction (4.8 % vs 0 %, p< 0.001). This finding was consistent across several instances of statistical adjustment and after the propensity matching of 179 pairs. Patients bridged with LMWH also experienced a significantly higher risk of BARC bleedings ≥ 2 (21.9 % vs 11.7 %, p=0.002) compared to those who were not, which remained significant across different methods of statistical adjustment and propensity matching. In conclusion, LMWH bridging in patients with coronary stents undergoing surgery is a common and possibly harmful practice, resulting in worse ischaemic outcomes at 30 days, and a significant risk of bleeding.

To compare in patients with ACS (acute coronary syndromes) a PCI (percutaneous coronary intervention) approach based on FFR (fractional flow reserve) vs. one based on OCT (optical coherence tomography).Consecutive patients admitted for ACS and treated with a PCI approach based on OCT or on FFR (recruited in two different studies) were compared and matched with propensity score analysis. Target Lesion revascularization (TLR) was the primary end point, while major adverse cardiovascular events [MACEs defined as the composite of death from cardiac causes, non-fatal MI, clinically driven target vessel revascularization (TVR), or re-hospitalization due to unstable angina] were the secondary ones. Sub-group analysis was performed for patients with FFR/OCT performed on culprit lesions and not. 285 patients were enrolled in the OCT-guided group and 335 in the FFR-guided group, 197 for each being selected after propensity score. After 25months (range: 7-39months), OCT-guided group were exposed to lower incidence of TLR (4.1% vs. 14.2% p0.01) compared with FFR-guided group without impact on MACEs (14.2% vs. 14.2%, p=1) or all-cause death (3.6% vs. 1.1%, p=0.34). At Kaplan-Maier curve analysis for MACEs OCT-guided and FFR-guided groups showed similar outcomes (HR 1.19, CI 0.65-2.2, p=0.54). Subgroup analysis on culprit and not culprit vessel demonstrated consistent results.An OCT based approach in ACS patients offers a reduction in TLR when compared to a PCI-FFR driven. These findings should be confirmed in randomized controlled trial.

Background The potential protective effects of remote ischemic preconditioning (RIPC) on contrast-induced nephropathy (CIN) after percutaneous coronary intervention (PCI) remain to be defined. Methods and results A double blind, randomized, placebo controlled multicenter study was performed. Patients younger than 85years old, with a renal clearance of 30–60ml/min/1.73m 2 , who were candidates for PCI for all clinical indications except for primary PCI, were allocated 1:1 to RIPC or to standard therapy. The primary endpoint was incidence of CIN. The secondary endpoint was incidence of peri-procedural myocardial infarction (PMI). From February 2013 to April 2014, 3108 patients who were scheduled for coronary angiography were screened for the study. 442 fulfilled the inclusion criteria and 223 received PCI. These patients were randomized to sham RIPC ( n =107) or treatment group ( n =116). The only pre-specified subgroup of diabetic patients included 85 (38%) cases. RIPC significantly reduced CIN incidence in the overall population (12.1% vs. 26.1%, p =0.01, with a NNT=9) and in non-diabetic patients (9.2% vs. 25.0%, p =0.02), but showed no benefit in diabetics (16.7% vs. 28.2%, p =0.21). A trend for lower PMI was seen in the intervention arm (creatine kinase - muscle brain >5 URL; 8.4% vs. 16.4%, p =0.07; troponin T >5 URL; 27% vs. 38%, p =0.21). Conclusions Remote ischemic preconditioning significantly reduces the incidence of acute kidney injury in non-diabetic patients undergoing PCI. Larger sample size is presumably needed to assess the effect of RIPC for patients with diabetes mellitus. Clinical Trial number: NCT02195726 https://www.clinicaltrial.gov/.

Objectives This study sought to assess in vivo sex differences in the pathophysiology of ST-segment elevation myocardial infarction (STEMI) and vascular response to primary percutaneous coronary intervention (PCI). Background There is no consensus on whether differences in the pathophysiology of STEMI and response to primary PCI between women and men reflect biological factors as opposed to differences in age. Methods In this prospective, multicenter study, 140 age-matched men and women with STEMI undergoing primary PCI with everolimus-eluting stent were investigated with intravascular optical coherence tomography, histopathology-immunohistochemistry of thrombus aspirates, and serum biomarkers. Primary endpoints were the percentages of culprit plaque rupture at baseline and everolimus-eluting stent strut coverage at 9-month follow-up as determined by optical coherence tomography. Results Men and women had similar rates of plaque rupture (50.0% vs. 48.4%; risk ratio [RR]: 1.03; 95% confidence interval [CI]: 0.73 to 1.47; p = 0.56). Nonruptured/eroded plaques comprised 25% of all cases (p = 0.86 in men vs. women). There were no sex differences in composition of aspirated thrombus and immune and inflammatory serum biomarkers. At 9 months, women had similar strut coverage (90.9% vs. 92.5%; difference in medians: RR: 0.2%; 95% CI: –0.4% to 1.3%; p = 0.89) and amount of in-stent neointimal obstruction (10.3% vs. 10.6%; p = 0.76) as men did. There were no sex differences in clinical outcome either at 30-day or 1-year follow-up. Conclusions In patients presenting with STEMI undergoing primary PCI, no differences in culprit plaque morphology and factors associated with coronary thrombosis were observed between age-matched men and women. Women also showed similar vascular healing response to everolimus-eluting stents as men did. (Optical Coherence Tomography Assessment of Gender Diversity In Primary Angioplasty: The OCTAVIA Trial [OCTAVIA]; NCT01377207 )

Drug-coated balloons are a new tool for the treatment of patients with coronary artery disease. The main feature of this technology is a rapid and homogenous transfer of an antiproliferative drug (paclitaxel) to the vessel wall just at the time of balloon inflation, when neointimal proliferation, in response to angioplasty, is the highest. Moreover, drug-coated balloons share adjuntive advantages over stents: the absence of permanent scaffold and polymer, the respect of the original coronary anatomy, and limited inflammatory stimuli, thereby allowing for short-term dual antiplatelet therapy. To this day, a lot of devices are available in the market, with limited scientific data for the vast majority of them. Thus, the Italian scientific society of interventional cardiologists GISE decided to coordinate the efforts of a group of reknown experts on the field, in order to obtain a Position Paper on the correct use of drug-coated balloons in all the settings of coronary artery disease, giving a class of indication to each one, based on the clinical evidence. This Position Paper represents a quick reference for operators, investigators, and manufactures to promote the understanding and the correct use of the drug-coated balloon technology in everyday clinical practice. © 2013 Wiley Periodicals, Inc.

Patients with acute coronary syndrome (ACS) and nonobstructive coronary artery disease (CAD) have a substantial risk of subsequent coronary events within 1 year. The aim of the present study was to evaluate the prevalence, long-term outcomes, and adherence to oral antiplatelet therapy in patients with ACS and nonobstructive CAD compared with patients with ACS and obstructive CAD who had undergone percutaneous coronary intervention. Nonobstructive CAD was defined as an angiographic finding of50% diameter stenosis in any major epicardial artery. These patients were further stratified into 2 groups: those with normal coronary arteries (0% angiographic stenosis) and those with mild CAD (0% to 50% angiographic stenosis). Major adverse cardiac events, defined as death, myocardial infarction, ACS leading to hospitalization, and nonfatal stroke, were recorded and compared with a historical control group of patients with ACS and obstructive CAD who had undergone percutaneous coronary intervention. Of 2,438 consecutive patients with ACS undergoing coronary angiography, 318 (13%) had nonobstructive CAD. Of the 318 with nonobstructive CAD, 160 had normal coronary arteries and 158 had mild CAD. Patients with obstructive CAD had experienced greater rates of major adverse cardiac events at 26 ± 16 months (16.6% vs 9.1%, p = 0.001), driven by a greater rate of myocardial infarction compared with those without (5.3% vs 0%, p0.001). However, the rate of death, ACS leading to hospitalization, and stroke was similar. After adjusting for baseline characteristics, no difference was found in the risk of major adverse cardiac events across the groups. Only 50% of patients with nonobstructive CAD were prescribed dual antiplatelet therapy. In conclusion, patients with ACS and nonobstructive CAD remain at high risk of long-term recurrent ischemic events.

We sought to assess the impact of different oral P2Y12 receptor inhibitors on residual thrombus and reperfusion indexes in ST-segment elevation myocardial infarction patients enrolled in the COCTAIL II trial, which included 128 primary percutaneous coronary interventions randomized to intracoronary vs. intralesion abciximab bolus with or without thrombectomy.Patients were divided into three groups: clopidogrel (n = 44), prasugrel (n = 45) and ticagrelor (n = 39). Residual intra-stent thrombus was quantified by optical coherence tomography using both the number of cross-sections with thrombus area more than 10% and thrombus volume. Reperfusion indexes included thrombolysis in myocardial infarction (TIMI) flow, corrected TIMI frame count, myocardial blush grade (MBG) and complete ST-segment resolution (≥70%).In the prasugrel group, optical coherence tomography depicted a lower percentage of cross-sections with residual thrombus area more than 10% [4.0 (1.0-8.5)], as compared with clopidogrel [8.0 (1.0-15.0), P = 0.011] and ticagrelor [7.0 (3.0-13.5), P = 0.026].A higher thrombus volume was found in the clopidogrel group 4.0 mm(2.7-6.2) as compared with the prasugrel group [2.8 mm(1.8-4.4), P = 0.023], whereas the other between-group comparisons yield no significant differences. The frequency of MBG 3 was higher in the prasugrel group (73.3%) as compared with clopidogrel (45.5%) and ticagrelor [(56.4%), P = 0.027]. Final TIMI flow, TIMI frame count and ST resolution were not significantly different across the three groups (P = 0.423, 0.179 and 0.848, respectively). At multivariate analysis, pretreatment with prasugrel was independently associated with MBG 3 (odds ratio = 3.93; 95% confidence interval = 1.01-15.39).Prasugrel loading dose was associated with a lower percentage of cross-sections with residual thrombus area more than 10% as compared with both clopidogrel and ticagrelor, although intrastent thrombus volume was not significantly different between prasugrel and ticagrelor.The frequency of MBG 3 was the only reperfusion index that was significantly more prevalent in prasugrel treated group as compared with clopidogrel and ticagrelor groups.

Drug-eluting stents (DES) are the current gold standard for percutaneous treatment of coronary artery disease. However, DES are associated with a non-negligible risk of long-term adverse events related to persistence of foreign material in the coronary artery wall. In addition, DES implantation causes permanent caging of the native vessel, thus impairing normal vasomotricity and the possibility of using non-invasive coronary imaging or preforming subsequent bypass surgery. On the contrary, coronary bioresorbable stents (BRS) may provide temporary mechanical support to coronary wall without compromising the subsequent recovery of normal vascular physiology, and have the potential to prevent late adverse events related to permanent elements. Several types of BRS have been introduced into clinical practice in Europe or are being tested. However, most of available clinical data relate to a single BRS, the Absorb bioresorbable Vascular Scaffold (Absorb BVS) (Abbott Vascular, Santa Clara, CA). Despite encouraging clinical results, no societal guidelines are available on the use of BRS in clinical practice.A panel of Italian expert cardiologists assembled under the auspices of the Italian Society of Interventional Cardiology (SICI-GISE) for comprehensive discussion and consensus development, with the aim to provide recommendations on the use of bioresorbable stents in terms of clinical indications, procedural aspects, post-percutaneous coronary angioplasty pharmacologic treatment and follow-up. Based on current evidence and BRS availability in Italian cath-labs, the panel decided unanimously to provide specific recommendations for the Absorb BVS device. These recommendations do not necessarily extend to other BRS, unless specified, although significant overlap may exist with Absorb BVS, particularly in terms of clinical rationale.

The main goal of primary percutaneous coronary intervention (PPCI) is to achieve not only restoration of flow in the epicardial coronary artery, but also reperfusion at the level of myocardial tissue. Distal embolization is a possible complication of PPCI; in these patients, a microvascular injury occurs, which finally leads to a lack of myocardial reperfusion. Thrombus aspiration during PPCI has been proposed to prevent embolization. Several different thrombectomy devices have been demonstrated to be well tolerated and effective in improving surrogate markers of myocardial reperfusion; furthermore, in a few studies, the use of thrombectomy was associated with an improvement of clinical outcome. Because study results appeared largely inconsistent, especially about clinical outcome data, several meta-analyses have been carried out, showing that thrombectomy is able to improve markers of myocardial reperfusion and that manual thrombectomy is associated with better results in terms of myocardial reperfusion and clinical outcome, compared with embolic protection or mechanical thrombectomy devices, probably due to its easy and time-sparing use with low rate of complication. Literature data, based mainly on the Thrombus Aspiration During Primary Percutaneous Coronary Intervention (TAPAS) trial, indicate a favourable effect on outcome of routine manual thrombectomy strategy and the recent European Society of Cardiology (ESC) and European Association for Cardio-Thoracic Surgery (EACTS) guidelines on myocardial revascularization recommend thrombus aspiration during PPCI. However, data on long-term clinical outcome are still inconsistent and no trials have been, at the present time, designed to assess hard endpoint. In this review, we have carefully analysed literature data on thrombectomy during PPCI, taking into account the most recent studies and the last meta-analyses; study results have been compared to verify if either a routine or a selective use of thrombectomy should be adopted and to assess whether the use of thrombectomy may finally improve clinical outcome.

Conflicting data have been reported on the effects of low-osmolar and iso-osmolar contrast media on contrast-induced acute kidney injury (CI-AKI). In particular, no clinical trial has yet focused on the effect of contemporary contrast media on CI-AKI, epicardial flow, and microcirculatory function in patients with ST-segment elevation acute myocardial infarction who undergo primary percutaneous coronary intervention. The Contrast Media and Nephrotoxicity Following Coronary Revascularization by Angioplasty for Acute Myocardial Infarction (CONTRAST-AMI) trial is a prospective, randomized, single-blind, parallel-group, noninferiority study aiming to evaluate the effects of the low-osmolar contrast medium iopromide compared to the iso-osmolar agent iodixanol on CI-AKI and tissue-level perfusion in patients with ST-segment elevation acute myocardial infarction. Four hundred seventy-five consecutive, unselected patients who underwent primary percutaneous coronary intervention were randomized to iopromide (n = 239) or iodixanol (n = 236). All patients received high-dose N-acetylcysteine and hydration. The primary end point was the proportion of patients with serum creatinine (sCr) increases ≥25% from baseline to 72 hours. Secondary end points were Thrombolysis In Myocardial Infarction (TIMI) myocardial perfusion grade, increase in sCr ≥50%, increase in sCr ≥0.5 or ≥1 mg/dl, and 1-month major adverse cardiac events. The primary end point occurred in 10% of the iopromide group and in 13% of the iodixanol group (95% confidence interval -9% to 3%, p for noninferiority = 0.0002). A TIMI myocardial perfusion grade of 0 or 1 was present in 14% of patients in the 2 groups. No differences between the 2 groups were found in any of the secondary analyses of sCr increase. No significant difference in 1-month major adverse cardiac events was found (8% vs 6%, p = 0.37). In conclusion, in a population of unselected patients with ST-segment elevation acute myocardial infarction who underwent primary percutaneous coronary intervention, iopromide was not inferior to iodixanol in the occurrence of CI-AKI; no significant differences were found in terms of tissue-level reperfusion and major adverse cardiac events between the 2 contrast agents.

Optical coherence tomography (OCT)-defined suboptimal stent deployment is an independent predictor of device failure in the first year of follow-up; however, its impact on long-term outcome remains undefined. The aim of this study is to evaluate clinical consequences of OCT findings on long-term

Bivalirudin is widely used as an anticoagulant during percutaneous coronary intervention (PCI) for ST-segment elevation myocardial infarction. However, an increase in acute stent thrombosis rates has been found in the HORIZONS-AMI trial. A prolonged infusion after PCI has been shown to be a safe and effective tool in patients undergoing urgent or elective PCI in the PROBI VIRI study. We examined the effects of prolonged drug infusion after primary PCI. From databases of 5 high-volume centers we compared a group of patients treated with a 4-hour prolonged infusion after PCI to 2 groups treated with a peri-PCI infusion and heparin plus abciximab. The primary study end point was >70% ST-segment resolution within 90 minutes after PCI; secondary end points were partial (>50%) ST-segment resolution within 90 minutes and intrahospital major and minor bleedings on the Acuity scale. The study population consisted of 264 patients undergoing primary PCI who were pretreated with aspirin and clopidogrel. The 3 study groups did not differ significantly by baseline characteristics. The primary end point was achieved in 69.8%, 48.8%, and 69.6% of patients in the prolonged bivalirudin, bivalirudin, and heparin/abciximab groups, respectively (p = 0.048 for prolonged vs standard infusion, p = 0.98 for prolonged infusion vs abciximab). Major bleedings and other secondary study end points were not significantly different among study groups. In conclusion, a strategy of prolonged bivalirudin infusion after primary PCI seems equivalent to a strategy with heparin plus abciximab, with an improvement in standard infusion in obtaining early microvascular reperfusion.

Background: Drug eluting stent (DES) use has improved clinical outcome after percutaneous coronary interventions. However, DES-treated patients may have a higher risk of stent thrombosis, mainly due to uncorrect stent deployment or lack of reendothelialization. Thus, the availabilily of different approaches with comparable efficacy to DES, but higher safety, especially in bleeding-prone patients, have to be investigated. Study Design: The EREMUS is a multicenter open-label prospective randomized three-arm clinical trial that will investigate the efficacy of a paclitaxel coated balloon + an endothelial progenitor capture stent for the treatment of native coronary lesions, and compare it to a DES strategy, or the sole endothelial progenitor capture stent. An angiographic follow-up with optical coherence tomography analysis will be scheduled 9 months after index procedure. Noninferiority regarding the primary endpoint (late luminal loss) between study group and DES is hypothesized. All patients will undergo clinical follow-up until 24 months from index hospitalization. Conclusions: The EREMUS trial will determine whether a composite approach with a paclitaxel coated balloon + an endothelial progenitor capture stent in coronary lesions at medium-to-high risk of restenosis will achieve similar results compared to DES regarding inhibition of intrastent proliferation; complete stent strut reendothelialization, a safety issue, will also be investigated. © 2011 Wiley-Liss, Inc.

Residual stent strut thrombosis, which is frequently documented after primary PCI, may increase stent thrombosis risk and prevents optimal myocardial perfusion. Objectives: to assess whether a strategy of either high dose (HB) versus low dose (LB) bivalirudin infusion reduces residual stent strut

Residual stent strut thrombosis, which is a consistent finding after primary PCI, negatively affects myocardial perfusion and may increase stent thrombosis risk. Objectives: to assess whether a strategy of either prolonged bivalirudin (PB) or intra-procedural-only (IB) administration infusion

OBJECTIVE Bivalirudin, a direct thrombin inhibitor, provides similar ischemic outcomes with significantly less major bleeding compared with unfractionated heparin (UFH) plus a glycoprotein IIb/IIIa inhibitor (GPI) in patients undergoing percutaneous coronary interventions (PCI). Although the approved labeling for bivalirudin allows for low-dose prolonged postprocedure administration, this practice is not routine. Therefore, we sought to evaluate the safety and efficacy of longer post-PCI infusion. METHODS From our database, we retrospectively compared two groups of patients with acute coronary syndrome undergoing complex PCI, one group treated with UFH+GPI (n = 59) and another with a periprocedural and post-PCI bivalirudin infusion for 4 h (n = 50). Endpoints included periprocedural myocardial infarction (MI), 30-day major adverse cardiac events, and in-hospital major and minor bleeding. RESULTS There were no significant differences in the baseline and procedural characteristics of the two groups; most patients (approximately 90%) had complex coronary lesions (the American College of Cardiology/American Heart Association type B2/C). There was no significant difference in the rates of periprocedural MI (11.9 vs. 8.0%, P = NS) or 30-day major adverse cardiac events (8.5 vs. 6.0%, P = NS) among patients treated with UFH+GPI or bivalirudin. However, patients who received bivalirudin had significantly lower rates of minor bleeding (20.3 vs. 4.0%, P

Background Thrombus burden and distal embolization are predictive of no-reflow during primary percutaneous coronary intervention (PCI) in patients with acute ST-elevation myocardial infarction (STEMI). We sought to compare the efficacy of pharmacological and catheter-based strategies for thrombus in patients with STEMI and high atherothrombotic burden. Methods Between January 2012 and December 2013, 128 STEMI patients undergoing primary PCI at 5 centers were randomly assigned in a 2 × 2 factorial design to intracoronary (IC) abciximab bolus (via the guide catheter) versus intralesion (IL) abciximab bolus, each with versus without aspiration thrombectomy (AT). Study end points were residual intrastent atherothrombotic burden, defined as the number of cross-sections with residual tissue area >10% as assessed by optical coherence tomography, and indices of angiographic and myocardial reperfusion. Results Residual intrastent atherothrombotic burden did not significantly differ with IL versus IC abciximab (median [interquartile range] 6.0 [1-15] vs 6.0 [2-11], P = .806) and with AT versus no aspiration (6.0 [1-13] vs 6.0 [2-12], P = .775). Intralesion abciximab administration was associated with improved angiographic myocardial reperfusion in terms of thrombolysis in myocardial infarction (TIMI) flow (3 [3-3] vs 3 [2-3], P = .040), corrected TIMI frame count (12 ± 5 vs 17 ± 16, P = .021), and myocardial blush grade (3 [2-3] vs 3 [2-3], P = .035). In particular, IL abciximab was associated with higher occurrence of final TIMI 3 flow (90% vs 73.8%, P = .032) and myocardial blush grade 3 (71.6% vs 52.4%, P = .039). Conversely, AT had no significant effect on indices of angiographic or myocardial reperfusion. Conclusions In patients with STEMI and high thrombotic burden, neither IL versus IC abciximab nor AT versus no aspiration reduced postprocedure intrastent atherothrombotic burden in patients with STEMI undergoing primary PCI. However, IL abciximab improved indices of angiographic and myocardial reperfusion compared to IC abciximab, benefits not apparent with AT.

The recent trials of routine use of embolic protection devices for primary percutaneous coronary interventions (PCI) (the EMERALD, PROMISE, and AIMI trials) have demonstrated neutral or even negative effects of these devices on myocardial reperfusion and final infarct size. Despite these results, there is still ground to believe that PCI-induced embolization may be clinically relevant in specific subsets of patients with acute myocardial infarction (AMI). Significant clinical consequences may be expected when embolization is quantitatively relevant and/or is qualitatively characterized by lipid-rich athero-embolism (as is the case of lipid core embolization through the ruptured cap of a fibro-atheroma). Future trials on embolic protection devices in primary PCI should adopt a selective, rather than a routine strategy, through the identification, by angiographic or intravascular imaging parameters, of patients at highest risk of clinically relevant embolization. Such trials should also adopt specific endpoints able to evaluate the effect of micro-embolization, which is currently far from optimally assessed by the standard markers of myocardial reperfusion.