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Objectives To asses mid‐term clinical outcomes of bioresorbable vascular scaffolds (BVS) for the treatment of coronary artery disease in a large‐scale all‐comers population. Background Several clinical settings are underrepresented in randomized studies investigating BVS against drug‐eluting stents. Whether their results can be translated into the heterogeny patient population seen during daily routine requires further investigation. Methods The European ABSORB Consortium comprises the following European registries: GABI‐R, ABSORB UK Registry, ABSORB France, BVS RAI Registry, and REPARA BVS Registry, which all prospectively collected patient‐level data regarding outcomes following unrestricted BVS implantation. The primary endpoint of target lesion failure (TLF) includes cardiac death, target‐vessel myocardial infarction (TVMI) and target‐lesion revascularisation (TLR) at 12 months. The incidence of scaffold thrombosis (ST) according to ARC criteria was also assessed. Multivariable analysis was used to adjust for differences in patient and lesion characteristics. Results A total of 10,312 patients (mean age 58.4 ± 11.4 y) underwent BVS implantation during routine practice. The 12‐month follow‐up was complete in 95.5% of patients. At 12 months, the primary endpoint of TLF occurred in 3.6%; its components cardiac death, TVMI and TLR were documented in 1.2%, 1.8%, and 2.6%, respectively. The definite/probable ST rate was 1.7%. Absence of predilatation, discontinuation of DAPT and scaffold diameter below 3 mm were independent predictors of ST. Conclusions The EAC demonstrates reasonable real‐world clinical outcome data after BVS implantation. However, the rate of scaffold thrombosis remains high.

Health-related quality of life (HRQoL) is impaired in patients with stable angina but patients often present with other forms of chest pain. The aim of this study was to compare the pre-diagnostic HRQoL in patients with suspected coronary artery disease (CAD) according to angina type, gender, and presence of obstructive CAD.From the pilot study for the European DISCHARGE trial, we analysed data from 24 sites including 1263 patients (45.9% women, 61.1 ± 11.3 years) who were clinically referred for invasive coronary angiography (ICA; 617 patients) or coronary computed tomography angiography (CTA; 646 patients). Prior to the procedures, patients completed HRQoL questionnaires: the Short Form (SF)-12v2, the EuroQoL (EQ-5D-3 L) and the Hospital Anxiety and Depression Scale.Fifty-five percent of ICA and 35% of CTA patients had typical angina, 23 and 33% had atypical angina, 18 and 28% had non-anginal chest discomfort and 5 and 5% had other chest discomfort, respectively. Patients with typical angina had the poorest physical functioning compared to the other angina groups (SF-12 physical component score; 41.2 ± 8.8, 43.3 ± 9.1, 46.2 ± 9.0, 46.4 ± 11.4, respectively, all age and gender-adjusted p 0.01), and highest anxiety levels (8.3 ± 4.1, 7.5 ± 4.1, 6.5 ± 4.0, 4.7 ± 4.5, respectively, all adjusted p 0.01). On all other measures, patients with typical or atypical angina had lower HRQoL compared to the two other groups (all adjusted p 0.05). HRQoL did not differ between patients with and without obstructive CAD while women had worse HRQoL compared with men, irrespective of age and angina type.Prior to a diagnostic procedure for stable chest pain, HRQoL is associated with chest pain characteristics, but not with obstructive CAD, and is significantly lower in women.Clinicaltrials.gov, NCT02400229.

In this study we investigated whether the metabolomic analysis could identify a specific fingerprint of coronary blood collected during primary PCI in STEMI patients. Fifteen samples was subjected to metabolomic analysis. Subsequently, the study population was divided into two groups according to the peripheral blood neutrophil-to-lymphocyte ratio (NLR), a marker of the systemic inflammatory response. Regression analysis was then applied separately to the two NLR groups. A partial least square (PLS) regression identified the most significant involved metabolites and the PLS-class analysis revealed a significant correlation between the metabolic profile and the total ischemic time only in patients with an NLR > 5.77.

BACKGROUND Patients with small vessel disease (SVD) are at higher risk of adverse events after PCI compared to non-SVD patients. In this subset, the use of bioresorbable vascular scaffolds (BVS) has raised particular concern. OBJECTIVE We aimed to compare outcomes of Absorb BVS versus a 2nd-generation metallic everolimus-eluting stents (EES) in the SVD setting, by pooling patients from three large, prospective studies. METHODS Patients with SVD (reference vessel diameter ≤2.75 mm by QCA) and treated with Absorb BVS were identified in the Italian RAI and the MAASSTAD-Absorb registries. EES controls were identified in the COMPARE II Trial. We performed a propensity-score matching using several clinical and angiographic variables. Implantation technique was not object of matching, being device-specific. RESULTS Out of 4635 enrolled subjects, 1147 belonged to the SVD population. After matching, we obtained 337 pairs of patients. High clinical and angiographic complexity was found in both groups. Predilation and postdilation rates were significantly higher in BVS patients. No differences were found in terms of the device-oriented composite end-point at 1-year (HR = 1.08, 95%CI 0.5-2.3, P = .8) and 2-years (HR = 1.28, 95% CI: 0.68-2.43, P = .5). Notwithstanding, higher incidence of definite/probable stent thrombosis was observed in the BVS group at 1 year (HR 4.7, 95%CI 0.8-31.4, P = .08) and 2-years (HR = 8.34 95%CI 1.1-60.2, P = .04). CONCLUSION In this propensity-matched analysis pooling SVD patients of three large prospective studies, incidence of composite device-related events was comparable between BVS and EES up to 2 years follow-up. However, higher rates of stent thrombosis were found in the BVS group.

Purpose The primary goal was to evaluate local dose level for fluoroscopically guided invasive cardiac procedures in a high-volume activity catheterization laboratory, using automatic data registration with minimal impact on operator workload. The secondary goal was to highlight the relationship between dose indices and acquisition parameters, in order to establish an effective strategy for protocols optimization. Methods From September 2016 to December 2018, a dosimetric survey was conducted in the 2 rooms of the catheterization laboratory of our institution. Data collection burden was minimized using a commercial Radiation Dose Index Monitoring System (RDIMs) that analyzes dicom files automatically sent by the x-ray equipment. Data were combined with clinical information extracted from the HIS records reported by the interventional cardiologist. Local dose levels were established for different invasive cardiac procedures. Results A total of 3029 procedures performed for 2615 patients were analyzed. Median KAP were 21 Gycm2 for invasive coronary angiography (ICA) procedures, 61 Gycm2 for percutaneous coronary intervention (PCI) procedures, 59 Gycm2 for combined (ICA+PCI) procedures, 87 Gycm2 for structural heart intervention (TAVI) procedures. A significant dose reduction (51% for ICA procedures and 58% for PCI procedures) was observed when noise reduction acquisition techniques were applied. Conclusions RDIMs are effective tools in the establishment of local dose level in interventional cardiology, as they mitigate the burden to collect and register extensive dosimetric data and exposure parameters. Systematic review of data support the multi-disciplinary team in the definition of an effective strategy for protocol management and dose optimization.

Background: Health-related quality of life (HRQoL) is impaired in patients with stable angina but patients often present with other forms of chest pain. The aim of this study was to compare the pre-diagnostic HRQoL in patients with suspected coronary artery disease (CAD) according to angina type, gender, and presence of obstructive CAD.Methods: From the pilot study for the European DISCHARGE trial, we analysed data from 24 sites including 1263 patients (45.9% women, 61.1 ± 11.3 years) who were clinically referred for invasive coronary angiography (ICA; 617 patients) or coronary computed tomography angiography (CTA; 646 patients). Prior to the procedures, patients completed HRQoL questionnaires: the Short Form (SF)-12v2, the EuroQoL (EQ-5D-3 L) and the Hospital Anxiety and Depression Scale.Results: Fifty-five percent of ICA and 35% of CTA patients had typical angina, 23 and 33% had atypical angina, 18 and 28% had non-anginal chest discomfort and 5 and 5% had other chest discomfort, respectively. Patients with typical angina had the poorest physical functioning compared to the other angina groups (SF-12 physical component score; 41.2 ± 8.8, 43.3 ± 9.1, 46.2 ± 9.0, 46.4 ± 11.4, respectively, all age and gender-adjusted p p p Conclusions: Prior to a diagnostic procedure for stable chest pain, HRQoL is associated with chest pain characteristics, but not with obstructive CAD, and is significantly lower in women.Trial registration: Clinicaltrials.gov, NCT02400229.

Aim To compare the long-term outcomes of patients implanted with Absorb bioresorbable scaffold (BRS) with optimal versus suboptimal technique. Methods and results All patients who received an Absorb between March 2012 and January 2016 were selected from 19 Italian centers databases to assess the impact of an optimal implantation technique (CIAO criteria) on long-term device-oriented composite end-point (DOCE) - including cardiac death (CD), target-vessel myocardial infarction (TV-MI) and ischemia-driven target lesion revascularization (ID-TLR) - on its single components and on scaffold thrombosis (ScT). CIAO criteria consist of predilation (balloon/vessel ratio 1:1), correct sizing (BRS/proximal reference vessel diameter -RVD- ratio 0.8–1.2) and high-pressure postdilation with non-compliant (NC) balloon (≥20 atm for balloon/BRS ratio 1:1 or ≥16 atm for a 0.25–0.5 mm oversized balloon). Among the 1.434 patients analyzed, 464 (32.4%) fulfilled all CIAO criteria for every BRS implanted (CIAO 3 group), while 970 (67.6%) did not in at least one of the received BRS (CIAO 0-1-2 group). At 31.0 (interquartile range -IQR- 24.8–38.5) months follow-up, CIAO criteria did not impact on DOCE (8.2% vs. 8.0%, p = 0.92), ID-TLR (6.9% vs. 7.1%, p = 0.72) or ScT (1.9% vs. 1.8%, p = 0.80) in the overall population. At multivariate analysis overall BRS length ( p = 0.001), severely calcified lesions (p = 0.03) and absence of CIAO criteria (CIAO 0, p = 0.005) were independent predictors of DOCE in long-term follow-up. Conclusion Our data suggest that strict application of an optimal Absorb implantation technique doesn't improve long-term DOCE or ScT but may mitigate the worse outcome of patients with calcific lesions.

Objectives: To report 1-year clinical outcomes of bioresorbable vascular scaffold (BVS) in acute coronary syndromes (ACS) population. Background: BVS use has rapidly extended to high-risk patients as those presenting with ACS. To date limited data have been reported on BVS performance in ACS patients. Methods: RAI is a multicenter, prospective registry that included 1,505 patients treated with at least 1 successful BVS implantation. A subgroup analysis on ACS patients was performed and the 1-year outcomes of this cohort compared to the remaining stable coronary artery disease (SCAD) population are reported here. Coprimary endpoints were target-lesion revascularization (TLR) and scaffold thrombosis (ScT) at 1-year follow-up. Results: Fifty-nine percent of the patients presented with ACS, of whom 36.5% with ST-elevation myocardial infarctions. ACS patients were significantly younger, with a better cardiovascular risk profile, a lower rate of multivessel disease, chronic total occlusion or in-stent restenosis and a lower Syntax score. Predilation and postdilation were performed in 97.4% and in 96.5% of cases, respectively. No differences were noted in terms of TIMI 3 final flow, but acute gain was greater in ACS compared to SCAD group (P < 0.001). At one-year follow-up no differences were found in terms of TLR (3.3% vs. 3.3%, P = 0.98), and device-oriented composite end-point (4.3% vs. 3.4%, P = 0.4) between ACS and SCAD groups. The rate of definite/probable ScT was numerically higher in ACS vs. stable CAD patients (1.3% vs. 0.8%, P = 0.2). Conclusions: Our data suggest that the use of BVS in ACS patients is associated with a numerically higher rate of ScT compared to SCAD population numerically higher, but without statistical significance.

Background Large prospective studies on the use of bioresorbable vascular scaffolds (BVS) for diffuse coronary artery disease are lacking. IT DISAPPEARS is a large multicentre prospective registry investigating the short and long-term outcomes of everolimus-eluting BVS in patients with long coronary lesions and/or multivessel coronary artery disease (ClinicalTrials.gov: NCT02004730). We hereby report the 2-year outcomes of the registry. Methods We enrolled 1002 patients with complex lesions undergoing implantation of 2040 BVS with a prespecified technique including predilation, correct sizing, and postdilation with non-compliant balloons. The primary endpoint was the rate of device-oriented composite endpoint (DOCE), consisting of cardiac death, target vessel-related myocardial infarction (MI), and ischaemia-driven target lesion revascularization (TLR). Secondary endpoints included: 1) patient-oriented composite endpoint (POCE), consisting of all-cause mortality, all infarctions and all revascularisations; 2) definite/probable scaffold thrombosis. Results Clinical presentation was an acute coronary syndrome in 59.8% of patients. Total BVS length implanted was 47 ± 22 mm. Postdilation of all scaffolds per patient was performed in 96.8%, while optimal implantation as per study guidelines was applied in 71.4%. Through 2-year follow-up, DOCE occurred in 9.5% of patients (cardiac death 0.6%, target vessel-related MI 5.3%, TLR 6.6%). The rate of POCE was 16.6% and of scaffold thrombosis 1.1%. Female gender, total length of coronary lesions, treatment of bifurcation lesions and use of 2.5 mm scaffolds were independent predictors of DOCE. Conclusions The 2-year results of IT-DISAPPEARS show that BVS may yield acceptable clinical outcomes in patients with complex coronary lesions when the implantation technique is appropriate.

Atherosclerotic plaque deposition within the coronary vessel wall leads to arterial stenosis and severe catastrophic events over time. Identification of these atherosclerotic plaque components is essential to pre-estimate the risk of cardiovascular disease (CVD) and stratify them as a high or low risk. The characterization and quantification of coronary plaque components are not only vital but also a challenging task which can be possible using high-resolution imaging techniques. Atherosclerotic plaque components such as thin cap fibroatheroma (TCFA), fibrous cap, macrophage infiltration, large necrotic core, and thrombus are the microstructural plaque components that can be detected with only high-resolution imaging modalities such as intravascular ultrasound (IVUS) and optical coherence tomography (OCT). Light-based OCT provides better visualization of plaque tissue layers of coronary vessel walls as compared to IVUS. Three dominant paradigms have been identified to characterize atherosclerotic plaque components based on optical attenuation coefficients, machine learning algorithms, and deep learning techniques. This review (condensation of 126 papers after downloading 150 articles) presents a detailed comparison among various methodologies utilized for plaque tissue characterization, classification, and arterial measurements in OCT. Furthermore, this review presents the different ways to predict and stratify the risk associated with the CVD based on plaque characterization and measurements in OCT. Moreover, this review discovers three different paradigms for plaque characterization and their pros and cons. Among all of the techniques, a combination of machine learning and deep learning techniques is a best possible solution that provides improved OCT-based risk stratification.

We report the case of a 72-year-old man admitted to our hospital for chest pain . He had undergone coronary artery bypass graft surgery 23 years before. Contrast-enhanced computer tomography revealed a severe double-lobed dilatation of the saphenous vein graft for the obtuse marginal branch. Coronary angiography did not opacify completely the saphenous vein graft for the huge turbulence in the dilatation. Severe saphenous vein graft dilatation have a significant mortality and it has been generally treated by surgical repair, such as resection with or without bypass of the affected territory. We described an interventional technique, named “ double-layer bridging” that combines metallic DES and covered stent used in a double layer. This percutaneous technique, relatively simple and virtually usable for any type of severe dilatation independently of length, can be a reasonable and safe option to exclude giant aneurysm and maintaining distal flow.

Objective of this study was to assess the clinical performance of bioresorbable vascular scaffold (BVS) compared to everolimus-eluting stent (EES) in subjects with ST-segment elevation myocardial infarction (STEMI). We included all consecutive patients with STEMI who underwent percutaneous coronary intervention (PCI) with BVS implantation in centers participating to the Italian ABSORB Prospective Registry (BVS-RAI) and PCI with EES in the same centers during the same period. The 2 groups were compared. The primary end point was patient-oriented composite end point (POCE) including cardiac death, myocardial infarction, and target lesion revascularization (TLR) at the longest available follow-up. BVS or EES thrombosis at follow-up was also evaluated. Of the 563 patients with STEMI included, 122 received BVS and 441 EES. Procedural success was obtained in 549 (97.5%) cases without significant differences between the 2 groups (BVS 99.3% vs EES 97.0%, p = 0.2). At a median of 220-day (interquartile range 178 to 369) follow-up, no significant differences were observed in terms of POCE (BVS 4.9% vs EES 7.0%, p = 0.4); death (BVS 0.8%, EES 2.0%, p = 0.4), MI (BVS 4.1%, EES 2.0%, p = 0.2), TLR (BVS 4.1%, EES 4.5%, p = 0.8), device thrombosis (BVS 2.5%, EES 1.4%, p = 0.4). All TLR cases were successfully managed with re-PCI in both groups. A propensity matching of the study populations showed no significant differences regarding POCE at the longest available follow-up (odds ratio 0.53, 0.1 to 4.3). In conclusion, in this direct prospective comparison, BVS was associated with similar clinical results compared to EES in the STEMI setting. Larger and adequately powered randomized trials are needed to fully assess the potential clinical benefit of BVS versus the current standard of care in patients with STEMI.

Aims: In this multicentre prospective registry we sought to evaluate the immediate and midterm clinical out-comes following single or multiple overlapping bioresorbable vascular scaffold (BVS) implantation in the STEMI setting. Methods and results: A prospective cohort analysis was performed on all STEMI patients who underwent primary PCI with BVS implantation. Between December 2012 and February 2014, 1,232 STEMI patients underwent primary PCI at the participating centres. Of these, 74 (6.0%) received a BVS, 18 (24.3%) of them were multiple and overlapping. Procedural success was obtained in 72 (97.3%) cases without differences between the groups (overlapping BVS 100% vs. single BVS 96.4%, p=0.5). One patient experienced a rein-farction due to subacute BVS thrombosis which was successfully managed with balloon-only PCI while the other patient had a slow-flow phenomenon (final TIMI flow 2). At six-month follow-up, two non-fatal MI (2.7%), three target lesion revascularisations (4.1%), and one subacute BVS thrombosis were reported in three patients (one [5.6%] overlapping BVS and two [3.6%] in the single BVS group, p=0.5). All the events were successfully managed with re-PCI. Conclusions: BVS implantation in STEMI patients can be successfully performed with a high procedural success rate and encouraging midterm outcomes. Larger randomised trials and longer follow-up are needed to assess the potential clinical benefit of BVS versus new-generation DES in this setting.

Background The bioresorbable vascular scaffold (BVS) technology may be an appealing option in ST-segment elevation myocardial infarction (STEMI) patients. However, the available evidence on its use in this challenging subset is limited. Methods Registro Absorb Italiano (RAI) is a multicenter, prospective registry that aims to assess BVS performance through a 5-year follow-up of all consecutive patients who undergone at least 1 successful BVS implantation. As a part of it, a subgroup analysis in STEMI patients was performed and the outcomes of this cohort compared to the remaining population (defined as "non-STEMI") are reported here. Results Among the 1505 patients enrolled, 317 (21.1%) had STEMI on admission. Among those, 232 (73.2%) underwent primary percutaneous coronary intervention (PCI) within 12 h from symptom onset; 64 (20.2%) were late-comers (>12 h); 16 (5%) underwent PCI after successful thrombolysis while 5 (1.6%) underwent rescue-PCI. At a median follow-up time of 12 months (IQR 6–20 months) no differences were noticed between STEMI and "non-STEMI" groups in terms of device-oriented composite endpoint (4.1% vs. 5.6%; p = 0.3) and its singular components: ischemia-driven target lesion revascularization (3.2% vs. 3.6%; p = 0.7), target-vessel myocardial infarction (3.2% vs. 2.8%; p = 0.7) and cardiac death (0.6% vs. 0.6%; p = 0.9). The rate of definite/probable scaffold thrombosis (ScT) was numerically higher but not significant in the STEMI group (2.5% vs. 1.3%; p = 0.1). Conclusions BVS implantation in an unrestricted cohort of STEMI patients is associated with a numerically higher rate of ScT compared to the non-STEMI group. Further studies exploring the potential clinical impact of a pre-specified BVS implantation strategy in this high-risk clinical setting are needed.

Objectives The objective of this study was to investigate mid-term clinical outcomes of patients treated with ‘full-plastic jacket’ (FPJ) everolimus-eluting Absorb bioresorbable vascular scaffold (BRS) implantation. Background FPJ with BRS may represent an interesting option for patient with diffuse coronary artery disease (CAD), but data on the clinical impact of FPJ using the Absorb BRS are scant. Methods FPJ was defined as the implantation of >56 mm of overlapping BRS in at least one vessel. We compared outcomes of patients receiving Absorb FPJ vs. non-FPJ within the multicenter prospective RAI Registry. Results Out of 1505 consecutive patients enrolled in the RAI registry, 1384 were eligible for this analysis. Of these, 143 (10.3%) were treated with BRS FPJ. At a median follow-up of 649 days, no differences were observed between FPJ and non-FPJ groups in terms of the device-oriented composite endpoint (DoCE) (5.6% vs. 4.4%, p = 0.675) or the patient-related composite endpoint (PoCE) (20.9% vs. 15.9%, p = 0.149). Patients receiving FPJ had higher rates of target vessel repeat revascularization (TVR) (11.2% vs. 6.3%, p = 0.042). In the FPJ group, there was no cardiac death and only one (very late) stent thrombosis (ST) (0.7%). Conclusions Mid-term outcomes of a FPJ PCI strategy in the setting of diffuse CAD did not show a significant increase in composite device- and patient-related events, with rates of cardiac death and ST comparable to non-FPJ Absorb BRS implantation. However, these findings are hypothesis generating and requiring further validation.

ObjectivesTo compare clinical outcomes of patients treated with overlapping versus non-overlapping Absorb BVS. Background: Limited data are available on the clinical impact of stent overlap with the Absorb BVS bioresorbable stent. Methods: We compared outcomes of patients receiving overlapping or non-overlapping Absorb BVS in the multicenter prospective RAI Registry. Results: Out of 1,505 consecutive patients treated with Absorb BVS, 1,384 were eligible for this analysis. Of these, 377 (27%) were in the overlap group, and 1,007 (73%) in the non-overlap group. The most frequent overlap configuration was the marker-to-marker type (48%), followed by marker-over-marker (46%) and marker-inside-marker (6%) types. Patients of the overlap group had higher prevalence of multivessel disease and higher SYNTAX score, and required more frequently the use of intravascular imaging. At a median follow-up of 368 days, no difference was observed between overlap and non-overlap groups in terms of a device-related composite endpoint (cardiac death, TV-MI, ID-TLR) (5.8% vs. 4.1%, P=0.20) or of a patient-related composite endpoint (any death, any MI, any revascularization) (15.4% vs. 12.5%, P=0.18). Cardiac death (1.0% vs. 1.3%, P=0.54), MI (4.5% vs. 3.6%, P=0.51), TVR (4.5% vs. 3.6%, P=0.51) and stent thrombosis (1.1 vs. 1.5%, P=1.00) were also comparable between groups. When assessing outcomes of the overlap population according to overlap configurations used, no difference was observed in terms of the device- or patient-related composite endpoints. Conclusions: Outcomes of patients with or without overlapping BVS were comparable at mid-term follow-up despite higher angiographic complexity of the overlap subset. (c) 2017 Wiley Periodicals, Inc.

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.

AIMS: We aimed to assess the safety and performance of the DREAMS 2G scaffold up to 24 months post implant.METHODS AND RESULTS: The present study population comprises a total of 184 patients with 189 lesions who were enrolled in the prospective, multicentre BIOSOLVE-II and BIOSOLVE-III trials. Clinical follow-up was scheduled at one, six, 12, 24 and 36 months. The present report includes pooled follow-up data at six months and BIOSOLVE-II data at 24 months. Patients were 65.5±10.8 years old, and lesions were 12.5±5.1 mm long with reference diameters of 2.7±0.4 mm. Procedural success was obtained in 97.8%. At six months, the composite clinical endpoint target lesion failure was 3.3% (95% CI: 1.2-7.1), based on two cardiac deaths (1.1%, one unknown and one not device-related), one target vessel myocardial infarction (0.6%), and three clinically driven target lesion revascularisations (1.7%). For BIOSOLVE-II at 24 months, the target lesion failure rate was 5.9% (95% CI: 2.4-11.8), based on two cardiac deaths (1.7%), one target vessel myocardial infarction (0.9%) and four target lesion revascularisations (3.4%). There was no definite or probable scaffold thrombosis.CONCLUSIONS: The present analysis provides additional evidence on the safety of a drug-eluting absorbable metal scaffold with promising clinical outcomes up to 24 months and absence of definite or probable scaffold thrombosis.

The Absorb biovascular scaffold (BVS) is a bioresorbable, everolimus-eluting scaffold whose data on real-world patients with complex lesions are limited. Short-term follow-up from recent studies point to a higher rate of 30-day thrombosis than observed with drug-eluting stents. We aimed to understand the short-term safety and efficacy of BVS. Registro Absorb Italiano (RAI, ClinicalTrials.gov:NCT02298413) is an Italian, prospective, multicenter registry not funded, whose aim is to investigate BVS performance through a 5-year follow-up of all consecutive patients who have undergone successful implantation of >= 1 BVS in different clinical/lesion subsets. Co-primary end points were target lesion revascularization and definite/probable thrombosis. Secondary end point was the occurrence of device oriented cardiac events. The registry involved 23 centers, with patient enrollment from October 2012 to December 2015. We here report the 30-day outcomes of the whole population of the registry. We enrolled 1,505 consecutive patients, of which 82% were men and 22.4% diabetic. At presentation, 59.6% of the patients had an acute coronary syndrome, including 21% ST-elevation myocardial infarction. All lesions were pre-dilated and in 96.8% of the cases BVS was post-dilated. At 30 days, the co-primary study end point target lesion revascularization occurred in 0.6% of patients and definite/probable BVS thrombosis in 0.8%. There were 2 cases of cardiac and overall death (0.13%). Device-oriented cardiac events occurred in 1% of the patients. In conclusion, our data of consecutive patients suggest that current use of BVS in a wide spectrum of coronary narrowings and clinical settings is associated with good outcome at 30 days. (C) 2017 Elsevier Inc. All rights reserved.

Aims The present multicentre prospective study, IT-DISAPPEARS, was designed with the aim of evaluating early and long-term clinical outcomes of the Absorb BVS in patients with long coronary lesions and/or multivessel coronary artery disease. The aim of this article is to present the one-year clinical results of this study. Methods and results Between November 2014 and January 2016, we enrolled 1,002 patients undergoing BVS implantation (long lesion [≥ 24 mm] of a single vessel in 80.4%, at least two BVS in two or three coronary vessels in 8.6% and both criteria in 11%). Clinical presentation was an acute coronary syndrome in 59.8% of patients, including ST-elevation myocardial infarction in 21.8%. The primary endpoint was the device-oriented composite endpoint (DOCE) of cardiac death, target vessel MI, and ischaemia-driven TLR at one year. We implanted 2,040 BVS according to a pre-specified technique. One-year follow-up was available in 956 patients (95.4%). The rate of DOCE was 9.9% (95 patients). Cardiac death occurred in five patients (0.5%), while target vessel MI and TLR each occurred in 45 (4.7%) patients. The one-year rates of all-cause death, non-fatal MI, and any revascularisation were 1.2%, 5.4%, and 10.9%, respectively. The rate of definite/probable scaffold thrombosis was 0.9%. Conclusions This is the first study specifically investigating the Absorb technology in patients with a high atherosclerotic burden and multivessel disease. The mandatory adherence to a pre-specified implantation technique led to minimising the risk of device failure reported by other studies, in particular with respect to the rate of DOCE and scaffold thrombosis.

Objective The aim of this study was to investigate interactions among pre-procedural aortic regurgitation (AR), post-procedural paravalvular leak (PVL) and long-term clinical outcomes. Methods and results We analyzed data prospectively collected in the Italian Transcatheter balloon-Expandable Registry (ITER) on aortic stenosis (AS) patients. The degree of pre-procedural AR and post-procedural PVL was stratified as: absent/trivial, mild, and moderate/severe. VARC definitions were applied to outcomes. Of 1708 patients, preoperatively, AR was absent/trivial in 40% of the patients, mild in 42%, and moderate in 18%. Postoperatively, PVL was moderate–severe in 5%, mild in 32% of patients, and absent/trivial in 63%. Clinical follow-up, median 821days (IQR 585.75), was performed in 99.7% of patients. PVL, but not preoperative AR, was a major predictor of adverse outcome (HR 1.33, CI 95% 0.9–2.05, p =0.012 for mild PVL, HR 1.36, CI 95% 0.9–2.05, p p =0.97 respectively). Patients with moderate–severe PVL and preoperative left ventricle (LV) dilatation (LVEDVi>75ml/m 2 ) showed better survival than those without dilatation (HR 8.63, p =0.001). Conclusions In patients with severe AS treated with balloon-expandable TAVI, the presence of PVL, but not pre-procedural AR, was a major predictor of adverse outcome. Preoperative LV dilatation seemed to offer some clinical advantages.

Aims The aim of this study was to assess outcomes following Absorb bioresorbable scaffold (BVS) implantation in an unrestricted clinical practice according to an "on-label" versus "off-label" indication. Methods and results RAI is a prospective registry, investigating BVS performance in different lesion subsets. No specific exclusion criteria were applied. Co-primary endpoints were target lesion revascularisation (TLR) and definite/probable scaffold thrombosis (ScT) at one year. A total of 1,505 patients (1,969 lesions) were enrolled. In 58% of patients, BVS was implanted in at least one off-label subset according to the manufacturer's instructions for use. Predilatation was performed in 98.5% of the cases, and post-dilatation in 96.8%. At one-year follow-up, TLR and ScT rates were 3.3% and 1.3%, respectively. TLR was significantly higher in the off-label group (4.0% vs. 2.2%, HR 1.8, 95% CI: 1.0-3.4; p=0.05) while a trend towards a higher ScT rate was observed in the off-label group (1.7% vs. 0.6%, HR 2.7, 95% CI: 0.9-8.2; p=0.06). At multivariate analysis, treatment of in-stent restenosis, chronic total occlusion and BVS diameter were independent predictors of TLR. Conclusions Our data from a real-world population suggest that BVS could be associated with acceptable one-year clinical outcomes when meticulously implanted. However, a higher rate of adverse events was observed when this device was used in off-label lesions.

OBJECTIVES The most commonly used accesses for transcatheter aortic valve implantation (TAVI) are the transfemoral (TF-TAVI) and the transapical (TA-TAVI) ones. There are concerns about TA-TAVI use in patients with reduced left ventricular ejection fraction (LVEF). The aim of this retrospective multicentre study was to compare the outcomes of TA-TAVI and TF-TAVI in patients with poor LVEF. METHODS Patients with LVEF ≤35% were included in the analysis. Data were obtained from the Italian Transcatheter Balloon-Expandable Registry (ITER), which enrolled patients undergoing TAVI with the Sapien bioprosthesis in 33 national centres. Patients were divided into 2 groups according to the access: TA or TF. A multivariable logistic regression analysis was performed in order to evaluate whether the type of approach (TA and TF) has an impact on outcomes. RESULTS Between 2007 and 2012, 1882 patients were enrolled in the Registry. LVEF ≤35% was found in 208 (11.1%) patients. TA-TAVI and TF-TAVI were performed in 69 (33.2%) and 139 (66.8%) patients, respectively. Overall 30-day mortality was 11.6% and 7.9% in TA and TF patients, respectively (P = 0.45). Overall Kaplan-Meier survival was significantly higher in the TF-TAVI group (log rank: P = 0.003). Age [odds ratio (OR) 1.066, P = 0.016], creatinine (OR: 2.301, P

Cardiac allograft vasculopathy (CAV) is a form of accelerated atherosclerosis, which represents the leading cause of late morbidity and mortality after heart transplantation. The recent bioresorbable vascular scaffold (BVS) technology represents a potential novel therapeutic tool, in the context of CAV, by allowing transient scaffolding and concomitant vessel healing. Eligible subjects will be treated by using the Absorb Everolimus-Eluting BVS (Abbott Vascular, Santa Clara, CA, USA), and evaluated at pre-determined time points, up to 3 years since the index procedure. Both clinical and imaging data will be collected in dedicated case report forms (CRF). All imaging data will be analyzed in an independent core laboratory. The primary aim of the study is to evaluate the angiographic performance at 1 year of second-generation Absorb BVS, in heart transplant recipients affected by CAV.

Background The Absorb™ BVS is a bioresorbable, everolimus-eluting scaffold approved and marketed for coronary use. Published data on long-term results after treatment are limited to a small number of patients, most of them with elective PCI of simple lesions. The importance of scaffold resorption is variably appreciated among cardiologists, and indications for use from health technology assessment bodies or guidelines are missing. Instruments are needed to collect, share and assess the experience being accumulated with this new device in several centres. Methods/Design The BVS-RAI Registry is a spontaneous initiative of a group of Italian interventional cardiologists in cooperation with Centro di Ricerche Farmacologiche e Biomediche "Mario Negri" Institute, and is not recipient of funding or benefits originating from the BVS manufacturer. It is a prospective registry with 5-year follow-up of all consecutive patients who have undergone successful implantation of 1 or more coronary BVS following the indications, techniques and protocols used in each of the participating institutions. Outcome measures are BVS target lesion failure within one year and device-oriented major adverse cardiac events within 5years. The registry started in October 2012 and will extend enrolment throughout 2015, with the aim to include about 1000 patients. ClinicalTrials.gov identifier is CT02298413. Conclusions The BVS-RAI Registry will contribute observational knowledge on the long-term safety and efficacy of the Absorb™ BVS as used in a number of Italian interventional centres in a broad spectrum of settings. Unrewarded and undirected consecutive patient enrolments are key-features of this observation, which is therefore likely to reflect common clinical practice in those centres.

An integrated network for the management of acute ST-elevation myocardial infarction (STEMI) allows a pre-hospital diagnosis and facilitates the best strategy to provide the most effective reperfusion therapy. This study aims to assess the network impact on timing and mode of reperfusion in the metropolitan area of Cagliari.From January 1, 2008 to December 31, 2010 all patients affected by STEMI with symptom onset12h were enrolled. We evaluated modality of hospital access, reperfusion therapies, and time for avoidable delay. The first medical contact-to-balloon time (FMC-to-balloon) was compared between patients without ECG transmission (No-ECG group) and those with ECG transmission and direct transport to the cath-lab (Cath-Lab-ECG group) or the emergency room/intensive cardiac care unit (ER/ICCU-ECG group).Out of 622 patients enrolled, 324 (52.1%) arrived to hospital by emergency medical systems. In this group a pre-hospital diagnosis was made in 79.3% of cases (n = 257); among them, 138 patients (53.7%) had a direct access to cath-lab, 99 to ICCU (38.5%), and 20 (7.8%) to ER. In the whole study population an urgent coronary angiography was performed in 612 patients (98.4%) and a primary percutaneous coronary intervention (p-PCI) in 589 (96.2%). In the Cath-Lab-ECG group the FMC-to-balloon was 89 ± 29 min (median 87 min, interquartile range 72-100), significantly lower than in the ER/ICCU-ECG group [122 ± 39 min (115 min)] and the No-ECG group [150 ± 54 min (139 min)] (p0.01). A FMC-to-balloon ≤90 min was achieved in 66.4% of Cath-Lab-ECG patients, 22.1% of ER/ICCU-ECG patients, and 8.3% of No-ECG patients (Cath-Lab-ECG vs ER/ICCU-ECG, p0.01).Our results show that an integrated network provides a pre-hospital diagnosis in the majority of STEMI. However, only a direct transport to the cath-lab allows to achieve a FMC-to-balloon ≤90 min in a large proportion of patients. Out of this condition, adherence to guideline-recommended time of ≤90 min is significantly lower.

Background— We investigated the long-term impact of different stent types and diabetes mellitus (DM) in patients undergoing percutaneous coronary intervention (PCI) of bifurcation lesions, based on a large multicenter survey endorsed by the Italian Society of Invasive Cardiology. Methods and Results— Relative benefits of drug eluting stent (DES) over bare metal stent (BMS) in patients with (n=1049) and without (n=3020) DM were analyzed with extensive multivariable adjustment. At 3 years, stenting with DES was associated with lower adjusted risk of major adverse cardiac events (MACE, adjusted hazard ratio [HR] 0.27, 95% confidence interval [CI] 0.15 to 0.49, P Conclusions— In a large observational registry with admitted potential for selection bias and residual confounding, DES in DM patients with coronary bifurcation lesions were associated with improved outcomes in terms of MACE, cardiac death, and repeat revascularization at long-term follow up. These figures were not replicated in non-DM subjects.