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Item does not contain fulltext OBJECTIVES: The authors sought to identify and verify independent correlates of device thrombosis from an analysis of multicenter trials and registries. BACKGROUND: Recent analyses suggest an increased risk of device thrombosis with Absorb bioresorbable vascular scaffold (Abbott Vascular, Santa Clara, California) implantation compared with metallic drug-eluting stents, and data from moderate size studies suggest a risk relationship to vessel size and technique. METHODS: From 8,771 consecutively treated patients, 105 patients (1.2%) were identified with scaffold thrombosis within 1 year of implantation. They were matched 2:1 with controls selected randomly from nonthrombosis patients. Data-restricted multiple logistic analysis was used to identify significant independent covariates of the outcome. RESULTS: Early (within 1 month) scaffold thrombosis occurred in 69 patients and late (1 to 12 months) thrombosis occurred in 36 patients. Modelling found significant correlations of thrombosis to be final minimal lumen diameter 1.1:1 balloon/scaffold ratio (OR: 2.3; p = 0.022), and reference vessel diameter

BACKGROUND: Coronary revascularization guided by fractional flow reserve (FFR) is associated with better patient outcomes after the procedure than revascularization guided by angiography alone. It is unknown whether the instantaneous wave-free ratio (iFR), an alternative measure that does not require the administration of adenosine, will offer benefits similar to those of FFR. METHODS: We randomly assigned 2492 patients with coronary artery disease, in a 1:1 ratio, to undergo either iFR-guided or FFR-guided coronary revascularization. The primary end point was the 1-year risk of major adverse cardiac events, which were a composite of death from any cause, nonfatal myocardial infarction, or unplanned revascularization. The trial was designed to show the noninferiority of iFR to FFR, with a margin of 3.4 percentage points for the difference in risk. RESULTS: At 1 year, the primary end point had occurred in 78 of 1148 patients (6.8%) in the iFR group and in 83 of 1182 patients (7.0%) in the FFR group (difference in risk, -0.2 percentage points; 95% confidence interval [CI], -2.3 to 1.8; P

Patients with high body mass index (BMI) seem to have better outcomes after percutaneous coronary intervention than normal-weight patients. However, contrasting results have been reported on the "obesity paradox" in patients presenting with ST-elevation myocardial infarction (STEMI). The aim of our study was to investigate the impact of BMI on mortality in the population enrolled in the Evaluation of the Xience-V stent in Acute Myocardial INfArcTION (EXAMINATION) trial. The EXAMINATION trial randomized 1,498 patients with STEMI to a bare-metal stent or an everolimus-eluting stent. In this substudy patients were stratified into 3 groups according to BMI values: normal (BMI < 25 kg/m(2)), overweight (BMI = 25 to 29.9 kg/m(2)), and obese (BMI 30 kg/m(2)). The coprimary end points were the all-cause and cardiac deaths among the groups at the 5-year follow-up. BMI was available in 1,421 patients, divided in 401 (28.2%) normal, 702 (49.4%) overweight, and 318 (22.4%) obese. Obese patients were younger (p = 0.012) compared with the other groups, but with a worse cardiovascular risk profile. They were more frequently female (p

Objectives The authors sought to investigate 1-year outcomes in patients treated with bioresorbable everolimus-eluting vascular scaffolds (BVS) for “long coronary lesions.” Background The present substudy derived from the GHOST-EU registry included 1,722 lesions in 1,468 consecutive patients, enrolled between November 2011 and September 2014 at 11 European centers. Methods The lesions were divided into 3 groups according to continuous BVS length: 1) shorter than 30 mm; 2) between 30 and 60 mm; and 3) longer than 60 mm. Primary device-oriented endpoint (target lesion failure [TLF]) was defined as a combination of cardiovascular death, target vessel myocardial infarction, or clinically driven target lesion revascularization. Results Patients with lesions ≥60 mm had more comorbidities and more complex lesion characteristics, including chronic total occlusions (37%), bifurcation lesions (40.3%), higher Syntax score (16.4 ± 7.8), and higher number of scaffolds implanted per lesion (3.3 ± 0.9 mm). The main target vessel was the left anterior coronary artery in all groups. Median follow-up was 384 (interquartile range: 359 to 459) days. One-year follow-up was completed in 70.3% of patients. TLF at 1 year was significantly higher in group C (group A 4.8%, group B 4.5%, group C 14.3%; overall p = 0.001), whereas there were no significant differences between groups A and B. Finally, a numerically higher (but not statistically significant) number of scaffold thromboses were observed in group C when compared with shorter lesions (group A 2.1%, group B 1.1%, group C 3.8%; overall p = 0.29). Conclusions In a real-world setting, treatment of long coronary lesions with BVS ≥60 mm was associated with a higher TLF rate, driven by myocardial infarction and clinically driven target lesion revascularization.

Aims: The aim of the study was to develop a scoring model to evaluate the quality of bioresorbable vascular scaffold (BVS) implantation and determine the model's usefulness in predicting adverse cardiac events. Methods and results: The implantation technique and clinical outcomes of 1,736 lesions treated with BVS were analysed using the GHOST-EU registry. Predilation, scaffold sizing, and post-dilation (PSP) were scored according to the hazard model derived from the weight of these variables. The primary end-point was a one-year device-oriented composite endpoint (DoCE) composed of cardiac death, target vessel myocardial infarction, and clinically driven target lesion revascularisation. Definite/probable scaffold thrombosis was also evaluated as defined by the Academic Research Consortium. The PSP model performance was evaluated by internal validation. Predilation, correct scaffold sizing, and post-dilation with a non-compliant balloon were performed in 95.7%, 50.2%, and 26.2% of the cases and scored 0.63, 1.96 and 1.93 points, respectively, in the PSP-1 model. PSP-1 was an independent predictor of one-year DoCE (HR 0.75, 95% CI: 0.61-0.93; p=0.007), but with poor calibration and discrimination (AUC 0.611, 95% CI: 0.545-0.677). No patient with a maximum PSP-1 score had scaffold thrombosis, compared to those with a non-maximum PSP-1 score (0% vs. 2.3%; p=0.095). Conclusions: At one-year follow-up, the PSP-1 score was an independent predictor of DoCE. External validation and prospective studies are needed to determine the clinical usefulness of this score.

Bioresorbable vascular scaffolds (BRS) represent a novel approach for coronary revascularization offering several advantages as compared to current generation DES, potentially reducing rate of late adverse events and avoiding permanent vessel caging. Nevertheless, safety concerns have been raised for an increased risk of scaffold thrombosis (ScT) in both early and late phases, probably related to a suboptimal scaffold implantation. In this context, the use of different imaging methodologies has been strongly suggested in order to guarantee an optimal implantation. We herein analyze the different imaging methodologies available to assess BRS after implantation and at follow-up.

AIMS Selective use of DES only in patients at higher risk of MACE is common practice, particularly in health care systems with a large premium payable for DES. We aimed to identify subgroups of patients in which the use of BMS in primary percutaneous coronary intervention (PPCI) for STEMI can still be justified. METHODS AND RESULTS We performed a patient-level pooled analysis of COMFORTABLE-AMI and EXAMINATION comparing contemporary DES with BMS in PPCI. A risk score was applied using three parameters: lesion length>15mm, vessel size

Background Patients with diabetes mellitus (DM) remain at high risk for stent restenosis and adverse cardiovascular events in the drug-eluting stent era. The amphilimus-eluting stent (AES) is a third generation reservoir-based polymer-free drug-eluting stent that has shown promising preliminary results in patients with DM. It has been suggested that the formulation of the drug with fatty acids could not only modulate the drug release in a timely manner but also achieve convenient levels of drug concentration in diabetic cardiac cells. The aim of this trial is to assess the efficacy of the AES in patients with DM compared with the cobalt chromium everolimus-eluting stent with non-erodible polymer (EES). Study Design This is an investigator-initiated, multicenter, randomized clinical trial, performed in patients with DM. A total of 112 diabetic patients receiving glucose-lowering agents and requiring percutaneous revascularization of a de novo lesion will be randomized in a 1:1 fashion to receive AES or EES. The primary endpoint is the neointimal volume obstruction at 9 months, evaluated by optical coherence tomography. Secondary endpoints will include strut coverage, angiographic in-stent late loss and clinical endpoints such as target vessel revascularization or probable/definite stent thrombosis. This study completed the inclusion in October 2013. Conclusions The RESERVOIR trial is an investigator-initiated trial that will evaluate whether the polymer-free AES is not inferior to the EES inhibiting the neointimal hyperplasia in patients with DM. These results are also expected to improve our knowledge of the neointimal healing process in this population (Clinicaltrials.gov number NCT01710748). © 2014 Wiley Periodicals, Inc. © 2014 Wiley Periodicals, Inc.

BACKGROUND It is unknown if lack of polymer can provoke a different edge response in drug-eluting stents. The aim of this study was to compare edge vascular response between polymer-free paclitaxel-eluting stent (PF-PES) and polymer-based paclitaxel-eluting stents (PB-PES). METHODS AND RESULTS: A total of 165 eligible patients undergoing percutaneous coronary intervention were prospectively randomized 1:1 to receive either PF-PES or PB-PES. Those patients with paired intravascular ultrasound (IVUS) after procedure and at 9-month follow-up were included in this analysis.Seventy-six patients with 84 lesions, divided into PB-PES (38 patients, 41 lesions) and PF-PES groups (38 patients, 43 lesions) had paired post-procedure and 9-month follow-up IVUS and were therefore included in this substudy. There was a significant lumen decrease at the proximal edge of PF-PES (from 9.02±3.06 mm(2)to 8.47±3.05 mm(2); P=0.040), and a significant plaque increase at the distal edges of PF-PES (from 4.39±2.73 mm(2)to 4.78±2.63 mm(2); P=0.004). At the distal edge there was a significant plaque increase in the PF-PES compared to PB-PES (+8.0% vs. -0.6%, respectively; P=0.015) with subsequent lumen reduction (-5.2% vs. +6.0%, respectively; P=0.024). CONCLUSIONS PF-PES had significant plaque increase and lumen reduction at the distal edge as compared to PB-PES, probably due to difference in polymer-based drug-release kinetics between the 2 platforms.

Objectives This study sought to assess the 2-year outcomes of the population included in the EXAMINATION (Everolimus-Eluting Stents Versus Bare-Metal Stents in ST-Segment Elevation Myocardial Infarction) trial beyond the 1-year prescription period of dual antiplatelet therapy. Background The EXAMINATION trial compared the performance of everolimus-eluting stents (EES) versus bare-metal stents (BMS) in an all-comer ST-segment elevation myocardial infarction (STEMI) population. Methods This was a multicenter, multinational, prospective, randomized, single-blind, controlled trial in patients with STEMI. The primary endpoint, which was the combined endpoint of all-cause death, any recurrent myocardial infarction, and any revascularization, and the endpoints target lesion revascularization and stent thrombosis were assessed at 2 years. Results Between December 31, 2008, and May 15, 2010, 1,498 patients were randomized to receive EES (n = 751) or BMS (n = 747). Compliance with dual antiplatelet regimen was reduced at 2 years to a similar degree (17.3% vs. 17.2%, p = 0.91). At 2 years, the primary endpoint occurred in 108 (14.4%) patients of the EES group and in 129 (17.3%) patients of the BMS group (p = 0.11). Rate of target lesion revascularization was significantly lower in the EES group than in the BMS group (2.9% vs. 5.6%; p = 0.009). Rates of definite and definite or probable stent thrombosis were also significantly reduced in the EES group (0.8% vs. 2.1%; p = 0.03, and 1.3% vs. 2.8%; p = 0.04, respectively). Conclusions The 2-year follow-up of the EXAMINATION trial confirms the safety and efficacy of the EES compared with BMS in the setting of STEMI. Specifically, both rates of target lesion revascularization and stent thrombosis were reduced in recipients of EES without any signs of late attrition for either of these endpoints. (A Clinical Evaluation of Everolimus Eluting Coronary Stents in the Treatment of Patients With ST-Segment Elevation Myocardial Infarction: EXAMINATION Study; NCT00828087 )

Background— Manual thrombus aspiration (TA) is effective to reduce the thrombus burden during primary percutaneous coronary intervention for ST-elevation myocardial infarction. The objective of this study is to assess the impact of manual TA on stent implantation during primary percutaneous coronary intervention. Methods and Results— Population of the EXAMINATION trial (n=1498) was divided into 2 groups according to the use of TA. Immediate angiographic results, primary patient-oriented end point (combination of all-cause death, myocardial infarction, and any revascularization) and secondary device-oriented end point (combination of cardiac death, target vessel myocardial infarction, and clinically driven target lesion revascularization), definite/probable stent thrombosis, and major/minor bleeding were evaluated at 2 years. A total of 976 (65.2%) patients were classified into TA group and 522 (34.8%) patients into nonthrombus aspiration group. Manual TA was most frequently used in patients with worse initial thrombolysis in myocardial infarction flow. The TA group received less number of stents implanted (1.35±0.62 versus 1.45±0.71, P =0.005) with bigger size (3.25±0.44 versus 3.11±0.46 mm, P P P Conclusions— Manual TA during primary percutaneous coronary intervention is associated with a higher rate of direct stenting, a lower rate of postdilatation, and larger and less stents in comparison with conventional primary percutaneous coronary intervention. Conversely, manual TA had no apparent impact on clinical outcomes at long-term follow-up. Clinical Trial Registration— http://www.clinicaltrials.gov . Unique identifier: NCT00828087.

Background Out-of-Hospital Cardiac Arrest (OHCA) and mild therapeutic hypothermia (MTH) have been linked to increased risk of Stent Thrombosis (ST) in comatose survivors who undergo percutaneous coronary intervention (PCI). In this sense, there is no formal recommendation about which antiplatelet regimen should be used in patients with acute coronary syndromes (ACS) after OHCA. Aims To compare the incidence of probable/definite ST and bleeding events between ticagrelor and clopidogrel, in patients with ACS under MTH after an OHCA. Methods and results From January 2010 to August 2016, 144 patients underwent MTH after an OHCA. Overall, 114 had an ACS (79%) and 98 (67,3%) were treated with primary PCI and stent implantation. Among them, 61 (62,2%) were treated with clopidogrel, and 32 (32,6%) with ticagrelor. During hospitalization, the incidence of probable or definite ST was significantly higher in patients receiving clopidogrel compared to ticagrelor (11,4% vs. 0%; p: 0.04), and no significant differences in any (28,6% vs. 25%; p: 0.645) or major bleeding (BARC 3 or 5) (11,4% vs. 12,5%; p: 0.685) were found. Hospital mortality did not differ between groups (26,2% vs. 25%; p: 0.862). Conclusions In this study, as compared to clopidogrel, ticagrelor was associated with a lower rate of ST, without differences in haemorrhagic events in patients with OHCA for an ACS under MTH. Similarly to other settings, ticagrelor might be a valid alternative to clopidogrel in these patients.

Current European Society of Cardiology guidelines encourage complete reperfusion of non-infarct-related artery lesions in ST-segment elevation myocardial infarction patients. However, the influence that multivessel disease and complete myocardial revascularization may have in left ventricular (LV)

Background: iMAP is a new intravascular ultrasound (IVUS) derived technique for tissue characterization using spectral analysis. Since there is a need for reproducibility data to design longitudinal studies, we sought to assess the in vivo reproducibility of this imaging technique. Methods: iMAP (40 MHz, Boston Scientific Corporation) was performed in patients referred for elective percutaneous intervention and in whom a nonintervened vessel was judged suitable for a safe IVUS analysis. Overall 20 patients with 20 non-angiographically significant lesions were assessed by two independent observers. Five of these 20 patients received an additional iMAP analysis using a new IVUS catheter and using the same catheter after its engagement and reengagement. Results: The interobserver relative difference in plaque area was 2.5%. Limits of agreement for lumen, vessel, and plaque area measurements were 1.62, −2.47 mm2; 2.09, −3.71 mm2; 2.80, −3.72 mm2; respectively. Limits of agreement for fibrotic, lipidic, necrotic, and calcified measurements were 1.32, −1.44 mm2; 0.24, −0.36 mm2; 1.50, −2.26 mm2; 0.09, −0.11 mm2; respectively. The intercatheter and intracatheter relative difference in plaque area were 0.9% and 4.1%, respectively. Although the variability for compositional measurements increased using two different catheters or using the same catheter twice, the variability for compositional measurements keeps always below 10%. Conclusions: Our analysis demonstrates that the geometrical and compositional iMAP analysis is acceptably reproducible. © 2011 Wiley Periodicals, Inc.

Background Few data are available about safety of second generation drug eluting stents in an all-comer ST elevation myocardial infarction (STEMI) population. We sought to investigate the predictors and clinical implications of 1-year stent thrombosis (ST) in patients with STEMI, included in the EXAMINATION trial. Methods and results The EXAMINATION trial is an all-comer prospective, randomized 1:1 controlled trial, testing everolimus-eluting stent (EES) vs. cobalt chromium bare metal stent (BMS) in STEMI patients. It included 1498 patients, randomized to EES (n=751) or BMS (n=747). At 1year, definite/probable stent thrombosis, defined according to ARC criteria, occurred in 26 patients (1.73%), including 18 definite and 8 probable events. The incidence of ST was lower in patients treated with EES than in those treated with BMS (HR 0.16, 95% CI 0.03–0.29, p=0.017). Patients with ST have higher 1-year rates of cardiac death (30.8% vs. 2.5%, p Conclusions ST had low frequency in the first year after implantation of EES/BMS in STEMI patients, but it is associated with adverse events. BMS implantation, lack of ST-segment resolution and high Killip class on admission were independent predictors of 1-year ST.

Aim The aim of this study was to determine the relationship between clinical and blood characteristics of a vascular inflammatory milieu and coronary plaque composition visualized by near-infrared spectroscopy (NIRS) in percutaneous coronary intervention (PCI) patients. Methods and results Between April 2009 and January 2011, we performed NIRS in 208 patients who underwent PCI or invasive diagnostic coronary exploration for various indications. Imaging was performed of one non-intervened coronary segment after the initial procedure. Univariate and multivariate linear regression analyses were applied to evaluate the relationship between the acquired NIRS-derived lipid core burden index (LCBI) and clinical and blood (lipids and hs-C-reactive protein) characteristics. Patients with a history of hypercholesterolaemia [median 48 (inter-quartile range 21–101) vs. 38 (13–70), P = 0.043] and multi-vessel disease [55 (24–104) vs. 32 (12–71), P = 0.012] had higher LCBI levels. Men had higher LCBI than women [48 (21–95) vs. 27 (9–59), P = 0.003]. Hypercholesterolaemia and gender remained significant in multivariate regression analysis, whereas also a history of non-cardiac vascular disease and beta-blockers were positively associated with LCBI. Altogether 23.2% of the variability in LCBI could be explained by clinical and blood characteristics. Conclusion Clinical characteristics reflecting patients with a high cardiovascular risk profile explained 23.2% of the variability in LCBI, whereas blood biomarkers added little. Further research is warranted to evaluate whether NIRS has the potential to provide additional prognostic information about patients' cardiovascular risk.

Transcatheter aortic-valve implantation is becoming the standard of care for inoperable patients with severe aortic stenosis and a valid alternative for those at high surgical risk. Since the first percutaneous transcatheter aortic-valve implantation in humans in 2002, over 50,000 transcatheter aortic valves have been implanted in the last decade, with progressive improvement in the available devices. Overall, there are two main families of transcatheter prosthesis: self-expandable and nonself-expandable. The self-expandable devices, for which CoreValve(®) (Medtronic CV Luxembourg S.a.r.l., Luxembourg) represents the prototype, are characterized by a structure composed of shape memory materials, usually nitinol, which acquire its final shape once released. By contrast, the non-self-expandable prostheses, mainly represented by the Edwards(®) valve (Edwards Life Sciences, Inc., CA, USA), require balloon dilatation to reach its final shape. Although several publications have already provided positive data on both technologies, new clinical studies with improved systems are currently being conducted in order to provide more solid data and potentially expand the spectrum of patients who can benefit from this therapy. Thus, the aim of the present paper is to review the salient features of the two most used systems today (third-generation CoreValve and Edwards SAPIEN XT(®)) as well as to provide data on other emerging valves and future perspectives.

Two-dimensional (2D) frequency domain optical coherence tomography (FD-OCT) has enhanced our understanding of coronary atherosclerotic disease and is increasingly being used in conventional percutaneous coronary intervention (PCI) to elucidate mechanisms of disease and improve our understanding of complex coronary anatomy. Since the first report of three-dimensional (3D) OCT applied in human coronary vessels,1 the technology has rapidly progressed.2–10 Currently, the main limitation of this technology is the need for off-line creation of 3D reconstructions—prototypes of current generation ‘real time’ (i.e. available peri-procedurally at the ‘push-of-a-button’) remain experimental, work in progress, and are limited by relatively poor image quality/resolution.4 As of now, the potential clinical application of 3D FD-OCT remains undefined. Recently, the application of this emerging technology to the coronary bifurcation has allowed visualization and assessment of jailed side branches (SideBs) at a level of detail not previously reported.2–7 The assessment of a jailed SideB, after implantation of a bioresorbable scaffold in the main branch (MainB) of a bifurcation, lead to the proposal of a new classification system based on the assessment of the number of compartments the SideB ostium was divided into, with examples of how this may potentially effect the neointimal response and subsequent coverage of the struts.2 More recently, the application of this technology to the coronary bifurcation in patients implanted with conventional metallic stents, utilizing the Terumo optical frequency domain imaging (OFDI) system, was described for the first time.3 Hypotheses related to types of coronary bifurcation (‘parallel’ and ‘perpendicular’ bifurcations) based on the bifurcation angle, and how this leads to certain specific characteristics of the carina, which potentially made the SideB more vulnerable to the effects of carina shift and potential SideB closure, were described. Furthermore, the potential practical application of 3D FD-OCT in guiding the …

OBJECTIVE to compare the vascular healing process between the sirolimus-eluting NEVO and the everolimus-eluting Xience stent by optical coherence tomography (OCT) at 1-year follow-up. BACKGROUND Presence of durable polymer on a drug-eluting metallic stent may be the basis of an inflammatory reaction with abnormal healing response. The NEVO stent, having a bioresorbable polymer eluted by reservoir technology, may overcome this problem. METHODS All consecutive patients, who received NEVO or Xience stent implantation between September 2010 and October 2010 in our institution, were included. Vascular healing was assessed at 1-year as percentage of uncovered struts, neointimal thickness (NIT), in-stent/stent area obstruction and pattern of neointima. RESULTS A total 47 patients (2:1 randomization, n = 32 NEVO, n = 15 Xience) were included. Eighteen patients underwent angiographic follow-up (eight patients with nine lesions for NEVO vs. 10 patients with 11 lesions for Xience). The angiographic late loss was numerically higher but not statistically different in NEVO compared with Xience treated lesions (0.38 ± 0.47 mm vs. 0.18 ± 0.27 mm; P = 0.171). OCT analysis of 4,912 struts demonstrated similar rates of uncovered struts (0.5 vs. 0.7%, P = 0.462), higher mean NIT (177.76 ± 87.76 µm vs. 132.22 ± 30.91 µm; P = 0.170) and in stent/stent area obstruction (23.02 ± 14.74% vs. 14.17 ± 5.94%, P = 0.120) in the NEVO as compared with Xience. CONCLUSION The NEVO stent with a reservoir technology seems to exhibit more neointimal proliferation as compared to Xience stent. The findings of our study, which currently represent the unique data existing on this reservoir technology, would need to be confirmed in a large population.

AIMS Our aim was to assess the safety and efficacy of paclitaxel-eluting balloon (PTX-B) treatment after bare metal stent (BMS) implantation in patients undergoing primary angioplasty. METHODS AND RESULTS After BMS implantation, patients were randomised (1:1) to treatment with a PTX-B or no PTX-B treatment (BMS group). The primary endpoint was in-stent late luminal loss (LLL) at nine-month follow-up. OCT was carried out on the first 20% of consecutive patients included in the study. Two hundred and twenty-three patients were randomised (BMS: 112, PTX-B: 111). At nine months, median LLL was 0.80 mm (interquartile range [IQR] 0.36-1.26) in the BMS group vs. 0.31 mm (IQR 0.00-0.58) in the PTX-B group, p

Introduction and objectives ST-segment elevation myocardial infarction (STEMI) network activation by a noncardiologist reduces delay times but may increase the rate of false-positive STEMI diagnoses. We aimed to determine the prevalence, predictors, and clinical impact of false-positive activations within the Catalonian STEMI network (Codi Infart). Methods From January 2010 through December 2011, all consecutive patients treated within the Codi Infart network were included. Code activations were classified as appropriate if they satisfied both electrocardiogram and clinical STEMI criteria. Appropriate activations were classified as false positives using 2 nonexclusive definitions: a) “angiographic” if a culprit coronary artery was not identified, and b) “clinical” if the discharge diagnosis was other than STEMI. Results In total, 5701 activations were included. Appropriate activation was performed in 87.8% of the episodes. The rate of angiographic false positives was 14.6%, while the rate of clinical false positives was 11.6%. Irrespective of the definition, female sex, left bundle branch block, and previous myocardial infarction were independent predictors of false-positive STEMI diagnoses. Using the clinical definition, hospitals without percutaneous coronary intervention and patients with complications during the first medical contact also had a false-positive STEMI diagnoses rate higher than the mean. In-hospital and 30-day mortality rates were similar for false-positive and true-positive STEMI patients after adjustment for possible confounders. Conclusions False-positive STEMI diagnoses were frequent. Outcomes were similar for patients with a true-positive or false-positive STEMI diagnosis treated within a STEMI network. The presence of any modifiable predictors of a false-positive STEMI diagnosis warrants careful assessment to optimize the use of STEMI networks.

Markers of coronary plaque vulnerability, such as a high lipid burden, increased inflammatory activity, and a thin fibrous cap, have been identified in histological studies. In vivo, grayscale intravascular ultrasound (IVUS) provides more in-depth information on coronary artery plaque burden than conventional angiography but is unable to accurately distinguish between noncalcific tissue types within the plaque. An analysis of IVUS radiofrequency backscatter based on spectral pattern recognition, such as virtual histology IVUS, allows detailed scrutiny of plaque composition and classification of coronary lesions. This review discusses the virtual histology IVUS technology and its accuracy in identifying vulnerable plaque features, focusing on its use in predicting patient outcomes after acute coronary syndrome, and its limitations in clinical practice.

Sheth et al1 compared optical coherence tomography (OCT)–guided versus angiography-guided primary percutaneous coronary intervention for ST-segment–elevation myocardial infarction among patients in the TOTAL trial (Thrombectomy Versus Percutaneous Coronary Intervention Alone). Patients (n=214) were imaged with OCT and were propensity-matched with 428 patients who had angio-guided percutaneous coronary intervention. There were clear OCT guidelines for stent optimization; however, operator compliance to follow those guidelines and whether optimal results were …

We present an 83-year-old woman with history of two aortic valve replacements; 2 years after the last replacement, she developed heart failure and severe paravalvular leak (PVL) was detected. Percutaneous PVL closure was completed with a single Amplatzer Vascular Plug III. Two months later, the patient presented with late coronary obstruction requiring emergent surgical revascularization. To the best of our knowledge, this is the first report of late coronary obstruction after percutaneous PVL closure.

Second-generation drug eluting stents (DES) may reduce costs and improve clinical outcomes compared to first-generation DES with improved cost-effectiveness when compared to bare metal stents (BMS). We aimed to conduct an economic evaluation of a cobalt-chromium everolimus eluting stent (Co-Cr EES) compared with BMS in percutaneous coronary intervention (PCI).To conduct a cost-effectiveness analysis (CEA) of a cobalt-chromium everolimus eluting stent (Co-Cr EES) versus BMS in PCI.A Markov state transition model with a 2-year time horizon was applied from a US Medicare setting with patients undergoing PCI with Co-Cr EES or BMS. Baseline characteristics, treatment effects, and safety measures were taken from a patient level meta-analysis of 5 RCTs (n = 4,896). The base-case analysis evaluated stent-related outcomes; a secondary analysis considered the broader set of outcomes reported in the meta-analysis.The base-case and secondary analyses reported an additional 0.018 and 0.013 quality-adjusted life years (QALYs) and cost savings of $236 and $288, respectively with Co-Cr EES versus BMS. Results were robust to sensitivity analyses and were most sensitive to the price of clopidogrel. In the probabilistic sensitivity analysis, Co-Cr EES was associated with a greater than 99% chance of being cost saving or cost effective (at a cost per QALY threshold of $50,000) versus BMS.Using data from a recent patient level meta-analysis and contemporary cost data, this analysis found that PCI with Co-Cr EES is more effective and less costly than PCI with BMS. © 2016 The Authors. Catheterization and Cardiovascular Interventions Published by Wiley Periodicals, Inc.

To assess the feasibility and the clinical results following a prespecified bioresorbable vascular scaffold (Absorb BVS) implantation strategy in ST-elevation myocardial infarction (STEMI) patients.Concerns raised about the BVS safety in STEMI setting because a not negligible thrombosis rate was reported within 30 days and 12 months after implantation. Technical procedural issues related to the structural BVS features were advocated as probable causes for the thrombotic events.This is an investigators-owned and -directed, prospective, nonrandomized, single-arm multicenter registry intended to obtain data from 500 consecutive STEMI patients undergoing primary PCI with BVS (1.1 or GT1) following a prespecified implantation protocol. The study is recorded in ClinicalTrials.gov with the identifier: NCT02601781.The primary endpoint is a device-oriented composite end-point (DOCE) of cardiac death, any myocardial infarction clearly attributable to the intervention culprit vessel and ischemic-driven target lesion revascularization within 30 days after the index procedure. The DOCE will be assessed even at 6-month, 1-, 3-, and 5-year follow-up.This will be the first study investigating the feasibility and the early- and long-term clinical impact of a prespecified BVS implantation protocol in thrombotic lesions causing STEMI. Here, we describe the rationale and the design of the study. © 2016 Wiley Periodicals, Inc.

Coronary bioresorbable vascular scaffolds (BVS) are a new appealing therapeutic option in interventional cardiology. To date, the Absorb BVS™ (Abbott Vascular, Santa Clara, CA, USA) is the most used and studied device. Its backbone is made of poly-L-lactide and coated by a thin layer of poly-D,L-lactide; everolimus is released and the scaffold is fully degraded to H2O and CO2 in 2-3 years. The BVS technology seems to offer several theoretical advantages over metallic stent implantation. It gives temporary mechanical support to vessel wall, without permanently caging it. Hence, long-term endothelial function may be restored and natural vasomotion in response to external stimuli may be recovered. Finally, an eventual future surgical revascularization is not conditioned. Several observational and randomized trials assessing the performance and clinical outcomes of BVS have been recently published. The main aim of this review is to carry out a systematic analysis and to evaluate long-term efficacy and safety of the Absorb BVS™.

To assess the impact of gender upon the prognosis and medical care in a regional acute ST-elevation myocardial infarction management network.An observational study was made of consecutive patients entered in a prospective database.The Catalan acute ST-elevation myocardial infarction management network.Patients treated between January 2010 and December 2011.Primary angioplasty, thrombolysis or conservative management.Time intervals, proportion and type of reperfusion, overall mortality, and in-hospital complication and overall mortality at 30 days and one year were compared in relation to gender.Of the 5,831 patients attended by the myocardial infarction network, 4,380 had a diagnosis of acute ST-elevation myocardial infarction, and 961 (21.9%) were women. Women were older (69.8±13.4 vs. 60.6±12.8 years; P.001), had a higher prevalence of diabetes (27.1 vs. 18.1%, P.001), Killip classI (24.9 vs. 17.3%; P.001) and no reperfusion (8.8 vs. 5.2%; P.001) versus men. In addition, women had greater delays in medical care (first medical contact-to-balloon: 132 vs. 122min; P.001, and symptoms onset-to-balloon: 236 vs. 210min; P.001). Women presented higher percentages of overall in-hospital complications (20.6 vs. 17.4%; P=.031), in-hospital mortality (4.8 vs. 2.6%; P=.001), 30-day mortality (9.1 vs. 4.5%; P.001) and one-year mortality (14.0 vs. 8.3%; P.001) versus men. Nevertheless, after multivariate adjustment, no gender differences in 30-day and one-year mortality were observed.Despite a higher risk profile and poorer medical management, women present similar 30-day and one-year outcomes as their male counterparts in the context of the myocardial infarction management network.

Two patients with severe aortic paravalvular leaks (PVLs) in a mechanical prosthesis were percutaneously treated. Procedures were performed with mild sedation, angiographic guidance, and a 6-French right radial artery approach with good final results. Percutaneous PVL treatment is routinely performed with general anaesthesia, transesophageal echocardiographic guidance, and femoral access. Although another case of radial aortic PVL closure has been previously reported, it was performed with an 8-French radial sheath, transesophageal echocardiographic guidance, and general anaesthesia. According to our initial experience, aortic PVLs could be treated in a minimally invasive way. Larger studies should be conducted to confirm these observations.

Background Data for the safety and efficacy of new-generation drug-eluting stents at long-term follow-up, and specifically in patients with ST-segment elevation myocardial infarction, are scarce. In the EXAMINATION trial, we compared everolimus-eluting stents (EES) with bare-metal stents (BMS) in an all-comer population with ST-segment elevation myocardial infarction. In this study, we assessed the 5-year outcomes of the population in the EXAMINATION trial. Methods In the multicentre EXAMINATION trial, done in Italy, Spain, and the Netherlands, patients with ST-segment elevation myocardial infarction were randomly assigned in a 1: 1 ratio to receive EES or BMS. The random allocation schedule was computer-generated and central randomisation (by telephone) was used to allocate patients in blocks of four or six, stratified by centre. Patients were masked to treatment assignment. At 5 years, we assessed the combined patient-oriented outcome of all-cause death, any myocardial infarction, or any revascularisation. Analysis was by intention to treat. This trial is registered with ClinicalTrials.gov, number NCT00828087. Findings 1498 patients were randomly assigned to receive either EES (n=751) or BMS (n=747). At 5 years, complete clinical follow-up data were obtained for 731 patients treated with EES and 727 treated with BMS (97% of both groups). The patient-oriented endpoint occurred in 159 (21%) patients in the EES group versus 192 (26%) in the BMS group (hazard ratio 0.80, 95% CI 0.65-0.98; p=0.033). This difference was mainly driven by a reduced rate of all-cause mortality (65 [9%] vs 88 [12%]; 0.72, 0.52-0.10; p=0.047). Interpretation Our findings should be taken as a point of reference for the assessment of new bioresorbable polymer-based metallic stents or bioresorbable scaffolds in patients with ST-segment elevation myocardial infarction.

Vascular complications in transcatheter aortic valve implantation using transfemoral approach are related to higher mortality. Complete percutaneous approach is currently the preferred technique for vascular access. However, some centers still perform surgical cutdown. Our purpose was to determine complications related to vascular access technique in the population of the Spanish TAVI National Registry. From January 2010 to July 2015, 3,046 patients were included in this Registry. Of them, 2,465 underwent transfemoral approach and were treated with either surgical cutdown and closure (cutdown group, n = 632) or percutaneous approach (puncture group, n = 1,833). Valve Academic Research Consortium-2 definitions were used to assess vascular and bleeding complications. Propensity matching resulted in 615 matched pairs. Overall, 30-day vascular complications were significantly higher in the puncture group (109 [18%] vs 42 [6.9%]; relative risk [RR] 2.60; 95% confidence interval [CI] 1.85 to 3.64, p

Imaging techniques, such as angiography and IVUS, are usually used in the diagnosis of left main disease. However, ostial lesions may be difficult to diagnose. FFR can be a helpful tool.

Objective To test the optimal antithrombotic regimen in patients with acute coronary syndrome. Design Randomised controlled trial. Setting Patients with acute coronary syndrome with and without ST segment elevation in 78 centres in Italy, the Netherlands, Spain, and Sweden. Participants 7213 patients with acute coronary syndrome and planned percutaneous coronary intervention: 4010 with ST segment elevation and 3203 without ST segment elevation. The primary study results in the overall population have been reported previously. Interventions Patients were randomly assigned, in an open label fashion, to one of two regimens: bivalirudin with glycoprotein IIb/IIIa inhibitors restricted to procedural complications or heparin with or without glycoprotein IIb/IIIa inhibitors. Main outcome measures Primary endpoints were the occurrence of major adverse cardiovascular events, defined as death, myocardial infarction or stroke; and net adverse clinical events, defined as major bleeding or major adverse cardiovascular events, both assessed at 30 days. Analyses were performed by the principle of intention to treat. Results Use of a glycoprotein IIb/IIIa inhibitor in patients assigned to heparin was planned at baseline in 30.7% of patients with ST segment elevation, in 10.9% without ST segment elevation, and in no patients assigned to bivalirudin. In patients with ST segment elevation, major adverse cardiovascular events occurred in 118 (5.9%) assigned to bivalirudin and 129 (6.5%) assigned to heparin (rate ratio 0.90, 95% confidence interval 0.70 to 1.16; P=0.43), whereas net adverse clinical events occurred in 139 (7.0%) patients assigned to bivalirudin and 163 (8.2%) assigned to heparin (0.84, 0.67 to 1.05; P=0.13). In patients without ST segment elevation, major adverse cardiovascular events occurred in 253 (15.9%) assigned to bivalirudin and 262 (16.4%) assigned to heparin (0.97, 0.80 to 1.17; P=0.74), whereas net adverse clinical events occurred in 262 (16.5%) patients assigned to bivalirudin and 281 (17.6%) assigned to heparin (0.93, 0.77 to 1.12; P=0.43). Conclusions A bivalirudin monotherapy strategy compared with heparin with or without glycoprotein IIb/IIIa inhibitors, did not result in reduced major adverse cardiovascular events or net adverse clinical events in patients with or without ST segment elevation. Trial Registration ClinicalTrials.gov NCT01433627.

This is a case of a long and diffuse diseased and tortuous vessel in which FFR was evaluated before and after implantation of a short stent. FFR helped identify the most serious lesion to be treated, “downgrading” a planned full-metal jacket procedure to a simpler and safer spot stenting.

Objectives We compared the incidence of late increase in hs-cTnI between ACS and non-ACS patients treated with standard of care with or without darapladib. Methods A total of 323 (161 ACS and 162 non-ACS patients) were included. High sensitivity troponin I was measured at baseline and at 4, 13, 26 and 52 weeks. Results ACS patients had statistically higher hs-cTnI values during longer term follow-up at which these patients were no longer in the acute setting of myocardial ischemia, but were regarded to have stable CAD (mean hsTnI value in ACS patients: 1.180 versus 0.886 ng/L in non-ACS patients, p = 0.02). Multivariate logistic regression revealed three predictors of any 2-fold increase in hs-cTnI levels compared to the previous visit when interactions were not considered. Treatment with darapladib (adjusted OR 0.53; 95% CI: 0.30–0.92) and initial presentation with ACS (adjusted OR 0.42; 95% CI: 0.23–0.77) were associated with less frequent occurrence of a 2-fold increase in hs-cTnI levels. In contrast, diabetes was associated with a higher incidence of 2-fold increases in hs-cTnI levels (adjusted OR 2.20; 95% CI: 1.04–4.64). Logistic regression to predict any 2-fold increase in hs-cTnI by ACS status showed that in the ACS group, treatment with darapladib decreased the risk of elevation of hs-cTnI (OR 0.219; 95% CI: 0.087, 0.553, p = 0.0013). Conclusion In patients with ACS, treatment with darapladib is associated with less increase in cardiac troponin I compared to standard of care alone. This beneficial effect may be associated with darapladib's capability of reducing necrotic core in coronary plaques.

Everolimus-eluting ABSORB bioresorbable vascular scaffolds represent a novel approach that provides transient vessel support with drug-delivery capability without the long-term limitations of the metallic drug-eluting stents (DESs). The technology has the potential to overcome many of the safety concerns associated with metallic DESs and possibly even convey further clinical benefit. In particular the scaffold is designed for providing a short-term lumen support (up to 6-12 months) and for thereafter being completely bioresorbed, eliminating the permanent caging typical of the metallic DES. The first clinical studies testing this device in a small number of patients have shown very promising results with good clinical outcome up to 5 years' follow-up, highlighting important morphological and functional modifications at the scaffolded segment level, such as late lumen enlargement and recuperation of a normal vasoreactivity. A randomized trial, comparing ABSORB with the Xience Prime stent, will evaluate the efficacy and safety of this device in a wide population.

Objectives This study sought to investigate in vivo the vascular response at the proximal and distal edges of the second-generation ABSORB everolimus-eluting bioresorbable vascular scaffold (BVS). Background The edge vascular response after implantation of the BVS has not been previously investigated. Methods The ABSORB Cohort B trial enrolled 101 patients and was divided into B 1 (n = 45) and B 2 (n = 56) subgroups. The adjacent (5-mm) proximal and distal vessel segments to the implanted ABSORB BVS were investigated at either 6 months (B 1 ) or 1 year (B 2 ) with virtual histology intravascular ultrasound (VH-IVUS) imaging. Results At the 5-mm proximal edge, the only significant change was modest constrictive remodeling at 6 months (Δ vessel cross-sectional area: −1.80% [−3.18; 1.30], p Conclusions The vascular response up to 1 year after implantation of the ABSORB BVS demonstrated some degree of proximal edge constrictive remodeling and distal edge increase in FF tissue resulting in nonsignificant plaque progression with adaptive expansive remodeling. This morphological and tissue composition behavior appears to not significantly differ from the behavior of metallic drug-eluting stents at the same observational time points.

Objectives The aim of this study was to assess the additional value of the Global Risk—a combination of the SYNTAX Score (SXscore) and additive EuroSCORE—in the identification of a low-risk population, who could safely and efficaciously be treated with coronary artery bypass graft surgery (CABG) or percutaneous coronary intervention (PCI). Background PCI is increasingly acceptable in appropriately selected patients with left main stem or 3-vessel coronary artery disease. Methods Within the SYNTAX Trial (Synergy between PCI with TAXUS and Cardiac Surgery Trial), all-cause death and major adverse cardiac and cerebrovascular events (MACCE) were analyzed at 36 months in low (GRC LOW ) to high Global Risk groups, with Kaplan-Meier, log-rank, and Cox regression analyses. Results Within the randomized left main stem population (n = 701), comparisons between GRC LOW groups demonstrated a significantly lower mortality with PCI compared with CABG (CABG: 7.5%, PCI: 1.2%, hazard ratio [HR]: 0.16, 95% confidence interval [CI]: 0.03 to 0.70, p = 0.0054) and a trend toward reduced MACCE (CABG: 23.1%, PCI: 15.8%, HR: 0.64, 95% CI: 0.39 to 1.07, p = 0.088). Similar analyses within the randomized 3-vessel disease population (n = 1,088) demonstrated no statistically significant differences in mortality (CABG: 5.2%, PCI: 5.8%, HR: 1.14, 95% CI: 0.57 to 2.30, p = 0.71) or MACCE (CABG: 19.0%, PCI: 24.7%, HR: 1.35, 95% CI: 0.95 to 1.92, p = 0.10). Risk-model performance and reclassification analyses demonstrated that the EuroSCORE—with the added incremental benefit of the SXscore to form the Global Risk—enhanced the risk stratification of all PCI patients. Conclusions In comparison with the SXscore, the Global Risk, with a simple treatment algorithm, substantially enhances the identification of low-risk patients who could safely and efficaciously be treated with CABG or PCI.

Background— The purpose of this study was to evaluate the long-term safety of the Igaki-Tamai stent, the first-in-human fully biodegradable coronary stent made of poly- l -lactic acid. Methods and Results— Between September 1998 and April 2000, 50 patients with 63 lesions were treated electively with 84 Igaki-Tamai stents. Overall clinical follow-up (>10 years) of major adverse cardiac events and rates of scaffold thrombosis was analyzed together with the results of angiography and intravascular ultrasound. Major adverse cardiac events included all-cause death, nonfatal myocardial infarction, and target lesion revascularization/target vessel revascularization. During the overall clinical follow-up period (121±17 months), 2 patients were lost to follow-up. There were 1 cardiac death, 6 noncardiac deaths, and 4 myocardial infarctions. Survival rates free of all-cause death, cardiac death, and major adverse cardiac events at 10 years were 87%, 98%, and 50%, respectively. The cumulative rates of target lesion revascularization (target vessel revascularization) were 16% (16%) at 1 year, 18% (22%) at 5 years, and 28% (38%) at 10 years. Two definite scaffold thromboses (1 subacute, 1 very late) were recorded. The latter case was related to a sirolimus-eluting stent, which was implanted for a lesion proximal to an Igaki-Tamai stent. From the analysis of intravascular ultrasound data, the stent struts mostly disappeared within 3 years. The external elastic membrane area and stent area did not change. Conclusion— Acceptable major adverse cardiac events and scaffold thrombosis rates without stent recoil and vessel remodeling suggested the long-term safety of the Igaki-Tamai stent.

Aims We evaluated the distribution and composition of atherosclerotic plaques at bifurcations with intravascular ultrasound-virtual histology (IVUS-VH) and multidetector computed tomography (MDCT) in relation to the bifurcation angle (BA). Methods and results In 33 patients (age 63 ± 11 years, 79% male) imaged with IVUS-VH and MDCT, 33 bifurcations were matched and studied. The analysed main vessel was divided into a 5 mm proximal segment, the in-bifurcation segment, and a 5 mm distal segment. Plaque contours were manually traced on MDCT and IVUS-VH. Plaques with >10% confluent necrotic core and