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The second Accelerating NSW report, supported by Investment NSW, presents an analysis of CAISH-focused data from the 2023 Startup Muster survey of the Australian startup ecosystem. The new report contains quantitative analysis and targeted recommendations, building on the ecosystem mapping, literature review and insights from qualitative interviews in the first Accelerating NSW report.

This report, supported by Investment NSW, shows the state of NSW’s ecosystem of coworking spaces, accelerators, incubators, and startup hubs and outlines how policymakers and partners in the innovation ecosystem can more robustly measure the impact of these entities on the wider economy.

Shame has been identified as a debilitating emotion that impedes entrepreneurial action. Yet, there are many examples of people who experience shame and go on to create entrepreneurial ventures. How then is entrepreneurship possible in the face of such shame? To address this question, we develop a theoretical process model that highlights the connection between individual and collective experiences of shame and elaborates when and how such experiences may lead to entrepreneurship. We suggest that third-person experiences of shame can transform first-person experiences and trigger identification with a community of similarly stigmatized others. We argue that the distinct narratives provided by these communities can reduce or enhance entrepreneurial self-efficacy, and therefore lead to different entrepreneurial pathways: some individuals may create ventures out of necessity, while others will create ventures that act as shame-free havens for themselves and others, and become a source of emancipation and social change. By outlining distinct entrepreneurial pathways out of shame, we extend current research at the intersection of entrepreneurship, necessity, emancipation, and social change.

Our paper explores the complex place-based relations of cross-sector partnerships between Indigenous and non-Indigenous partners. We draw on a longitudinal in-depth case study of the Bundian Way, an Indigenous-led cross-sector partnership of over 40 organisations. Through practices of listening to history and walking ‘on Country’, the non-Indigenous partners and our team came to appreciate the indivisibility of place and time and bear witness to the intergenerational trauma of colonially imposed divisions. By combining a 45-day place-based ethnography with a 36-month participant observation and repeated interviews with the Advisory Committee members, we explain how non-Indigenous members of the cross-sector partnership came to realise, and reverse, these place-time divisions. We contribute to an ethics of custodianship by first contrasting, and then combining, Indigenous and Western ways of knowing place through time.

Blockchain technology has been forwarded as an innovation to address pressing sustainability challenges in global food supply chains. However, limited studies have critically examined the technology's role in advancing sustainability. Drawing on the literature on sustainability-oriented innovation and innovation resistance theory, we explore the potential of blockchain technology to contribute to sustainable transformations within food supply chains. We reflect on 18 expert interviews with various actors across global food supply chains to evaluate the opportunities for, and resistance to, Blockchain technology as a driver of sustainability. The findings reveal that Blockchain is used within food supply chains as both a tool for sustainability as well as a broader philosophical mindset for addressing sustainability challenges. We reveal the opportunities for Blockchain technology as a sustainability-oriented innovation that can ensure fairer supply chains, enhance food traceability, and drive environmental sustainability. We also unpack the resistance to Blockchain that hinder its potential as a sustainability-oriented innovation which include functional and psychological barriers alongside cooperative barriers and protection of the status quo. Our study contributes to the broader literature on sustainability-oriented innovation and innovation resistance theory.

New and established ventures are under increasing pressure to consider how their current actions impact our future world. Whilst many practitioners are paying greater attention to their future impact, most impact assessment research focuses on the retrospective measurement of impact. Limited studies have explored how impact assessment is used as a tool to forecast or predict the intended impact of organisational action. This study aims to overcome this gap by exploring forward-looking approaches to impact assessment. An interdisciplinary systematic review of the impact assessment literature was conducted to answer the question: “How and why do organisations utilise forward-looking, future-oriented approaches to impact assessment?“. The findings elaborate on the common research themes, challenges, and gaps in understanding forward-looking impact assessment. An integrated process model is developed to show the relationships between various antecedents, methods, and effects of forward-looking impact assessment. Based on the review, the paper puts forward a research agenda to provoke further inquiry on forward-looking, future-oriented approaches to impact assessments related to four research themes: uncertainty, values and assumptions, stakeholder cooperation, and learning. The study contributes to the impact assessment literature by providing an overview of how the current literature comprehends forward-looking approaches and insights into how a more holistic view of temporality in impact assessment can be developed.

This book explores the history of social impact measurement, offering justifications for the use of social impact measurement in modern society.

Previous research on entrepreneurial pitching has tended to explain pitching outcomes based on judges' perceptions of both entrepreneurs and their business plans. This focus on judges' perceptions of entrepreneurs fails to appreciate the social practices that play out between judges as they attempt to reach a consensus in their decisions. This research thereby contributes to the fields of entrepreneurial pitching and practice studies of entrepreneurship by unpacking the social practices involved as groups of judges actually make their decisions. The study draws on audio recordings of judging discussions at a three-day hackathon event involving 250 contestants across 30 entrepreneurial teams. Through conversational analysis, we zoom in on the relational and temporal conversational practices that play out in judging discussions to understand how judges move from individual perceptions of pitches towards consensus decisions. Our findings reveal the conversational turns that play out in judging discussions and highlight three dominant practices that shape collective decisions: Alliance Building, Politicking, and Undermining.

Video research methods provide a powerful yet accessible way for researchers to observe and theorize entrepreneurial phenomena by analyzing entrepreneurship “in motion.” Despite the growing uptake of video data in entrepreneurship research, there is no available overview or analysis of current uses of video research methods, which makes it difficult for interested researchers to grasp its value and possibilities. Our systematic review of 142 entrepreneurship research articles published in leading journals reveals three dominant video research methods: (a) videography of entrepreneurship “in the wild” (such as pitching and other naturally occurring practices); (b) video content analysis using entrepreneur-generated videos (such as crowdfunding and archival videos); and (c) video elicitation in “manufactured” contexts (such as interviews and focus groups, experiments and interventions). Building on these studies, we put forward a research agenda for video-based entrepreneurship research that capitalizes on the unique affordances of video to understand the interactional, embodied, material, and emotional nature of entrepreneurial practice.

This article details how shifts in political discourse can reconfigure the intent, and effect the outcomes, of public procurement policy. Through critical discourse analysis of public procurement policies focused on supplier diversity in Australia, we explore how discursive struggles over policy meaning and intent can have real effects. Our findings show how the intent of public procurement policy shifted from stimulating Indigenous entrepreneurial activity to affirmative action in employment. We highlight how this policy mutation shifted responsibility for solving the intractable problem of Indigenous unemployment away from the government and corporate Australia and on to Indigenous business.

This paper explores how diverse stakeholders frame their expectations of Social Impact Bonds (SIBs). Using discourse analysis, the authors examine competing expectations in SIB press releases, showing how they differ between stakeholders, between institutional contexts, and how they evolve over time. The paper highlights how the prioritization of social finance and collaboration discourses privileges the role of private investors, which in turn diminishes the role of service providers as innovators. IMPACT: This paper explains the competing rationales of stakeholders from different sectors and jurisdictions engaging in SIBs, and how these rationales shift over time. Policy-makers need to reprioritize the role of service providers in SIB communications as they are often marginalized in the overall public discourse—particularly in the early stages of SIB structuring. The differences the authors found between jurisdictions reveal that institutional contexts shape the nature of SIBs, and that the SIB model should not be transferred in a standardized way to differing contexts.

Organisations with explicit social missions such as social enterprises, impact investors, nonprofits, and foundations are under increasing pressure to illustrate the impact of their activities on the social problems they claim to be addressing. These trends have resulted in an increasing sophistication of attempts to measure, assess, and report social impact across sectors. However, research in the field of social entrepreneurship has not sufficiently addressed the complex nature of impact assessment, nor how it is enacted in everyday organisational activities. This chapter aims to explain how practitioners cope with the complexity of impact assessment in their everyday activities. Drawing on practice theory, this chapter argues that impact assessment should be grounded in everyday experience and practice. This chapter builds on the emerging evidence of, and develops a research agenda for, the ‘practice turn’ in impact assessment in social entrepreneurship.

Organisations with explicit social missions such as social enterprises, impact investors, nonprofits, and foundations are under increasing pressure to illustrate their impact on the social problems they claim to be addressing. These trends have resulted in an increasing sophistication of attempts to measure and report social impact across sectors. Despite the emerging literature on impact assessment, there is little research on how the growing emphasis on, and drive for, impact assessment is experienced in everyday organisational activities. This paper draws on practice theory to understand the purposes of impact assessment and how it influences, and is enacted in, everyday organisational activities. A multiple case design studies the purpose of impact assessment through qualitative interviews with over 90 practitioners within the Australian and United Kingdom impact investment ecosystems. The findings suggest that impact assessment should be understood as a transdisciplinary practice evolving from, and blending together with, multiple practice worlds such as strategy, accounting, marketing, and organisational learning. The main contributions of the paper are the development of the concept of impact assessment as a transdisciplinary practice and an empirical understanding of how impact assessment links to, and blends with, diverse practice worlds.

In the context of increasing public demand for high-quality and accessible healthcare, and predictions of unmanageable costs in healthcare provision, social entrepreneurship holds the promise of making a cost-effective social impact in healthcare. Although research in the field of healthcare entrepreneurship has rapidly increased, the process of social entrepreneurial action is poorly understood. This chapter contributes to our understanding of the emergence of individual’s social entrepreneurial action in healthcare by conducting an exploratory study of the antecedents of social entrepreneurial action by Ashoka Fellows active in the healthcare sector. Adopting a qualitative biographical approach, we used Gioia’s two-step methodology to analyze the available online profiles of 57 Ashoka Fellows. Our findings reveal 14 antecedents that inform four interlinked aggregate dimensions of socially entrepreneurial antecedents. Our study suggests the dimensions of multi-disciplinarity, exposure, connectedness, and pro-social orientation are the core antecedents for social entrepreneurial pathways in healthcare. While our study focuses only on the profiles of highly successful social entrepreneurs in general, we argue that our research provides novel insights on the emergence of social entrepreneurial action in healthcare.

This chapter aims to understand whether and how impact investment, a novel approach to financing social and sustainable entrepreneurship, is aligned with, and contributing to, the sustainable development goals (SDGs). We theorise the SDGs as a ‘field-level frame’, a cultural template guiding social and environmental change. We analyse performance data of impact investors both in Australia and globally and map this impact data to the 17 SDGs. We find that impact investors are engaging with language consistent with the SDGs a possible field-level frame to guide impact strategy and measurement. To date, impact investors measure social outcomes more frequently than environmental outcomes; this may be explained, in part, by our analysis that reveals some SDGs create greater points of leverage to generate layers of impact across SDGs. This chapter explains how impact investors are engaging with the pursuit of the SDG agenda.

Purpose: This paper aims to explore the emergence and nature of impact investment in Australia and how it is shaping the development of the social enterprise sector. Design/methodology/approach: Impact investment is an emerging approach to financing social enterprises that aims to achieve blended value by delivering both impact and financial returns. In seeking to deliver blended value, impact investment combines potentially conflicted logics from investment, philanthropy and government spending. This paper utilizes institutional theory as a lens to understand the nature of these competing logics in impact investment. The paper adopts a sequential exploratory mixed methods approach to study the emergence of impact investment in Australia. The mixed methods include 18 qualitative interviews with impact investors in the Australian market and a subsequent online questionnaire on characteristics of impact investment products, activity and performance. Findings: The findings provide empirical evidence of the rapid growth in impact investment in Australia. The analysis reveals the nature of institutional complexity in impact investment and highlights the risk that the impact logic may become overshadowed by the investment logic if the difference in rigor around financial performance measurement and impact performance measurement is maintained. The paper discusses the implications of these findings for the development of the Australian social enterprise sector. Originality/value: This paper provides empirical evidence on the emergence of impact investment in Australia and contributes to a growing global body of evidence about the nature, size and characteristics of impact investment.

Background Percutaneous coronary intervention in complex bifurcation lesions is prone to suboptimal implantation results and is associated with increased risk of subsequent clinical events. Angiographic ambiguity is high during bifurcation stenting, but it is unknown if procedural guidance by intravascular optical coherence tomography (OCT) improves clinical outcome.Methods and design OCTOBER is a randomized, investigator-initiated, multicenter trial aimed to show superiority of OCT-guided stent implantation compared to standard angiographic-guided implantation in bifurcation lesions. The primary outcome measure is a 2-year composite end point of cardiac death, target lesion myocardial infarction, and ischemia-driven target lesion revascularization. The calculated sample size is 1,200 patients in total, and allocation is 1: 1. Eligible patients have stable or unstable angina pectoris or stabilized non-ST elevation myocardial infarction, and a coronary bifurcation lesion with significant main vessel stenosis and more than 50 % stenosis in a side branch with a reference diameter >= 2.5mm. Treatment is performed by the provisional side branch stenting technique or 2-stent techniques, and the systematic OCT guiding protocol is aimed to evaluate (1) plaque preparation, (2) lesion length, (3) segmental reference sizes, (4) lesion coverage, (5) stent expansion, (6) malapposition, (7) wire positions, and (8) ostial results.

Item does not contain fulltext, BACKGROUND: Although previous observational studies have documented late luminal enlargement and expansive remodeling following implantation of a bioresorbable vascular scaffold (BVS), no comparison with metallic stents has been conducted in a randomized fashion. OBJECTIVES: This study sought to compare vessel remodeling patterns after either Absorb BVS or Xience metallic drug-eluting stent (DES) implantation (Abbott Vascular, Santa Clara, California) and determine the independent predictors of remodeling. METHODS: In the ABSORB II randomized trial, 383 lesions (n = 359) were investigated by intravenous ultrasound both post-procedure and at 3-year follow-up. According to vessel and lumen area changes over 3 years, we categorized 9 patterns of vessel remodeling that were beyond the reproducibility of lumen and vessel area measurements. RESULTS: The relative change in mean vessel area was significantly greater with the BVS compared to the DES (6.7 +/- 12.6% vs. 2.9 +/- 11.5%; p = 0.003); the relative change in mean lumen area was significantly different between the 2 arms (1.4 +/- 19.1% vs. -1.9 +/- 10.5%, respectively; p = 0.031). Multivariate analysis indicated that use of the BVS, female sex, balloon-artery ratio >1.25, expansion index >/=0.8, previous percutaneous coronary intervention, and higher level of low-density lipoprotein cholesterol were independent predictors of expansive remodeling. Furthermore, in the BVS arm, necrotic core pre-procedure was an independent determinant of expansive remodeling. CONCLUSIONS: Expansive vessel wall remodeling was more frequent and intense with the BVS than the metallic DES and could be determined by patient baseline characteristics and periprocedural factors. The clinical effect of the observed lumen and vessel remodeling must be investigated in further large clinical studies to optimize the clinical outcome of patients and lesions treated by bioresorbable scaffolds. (ABSORB II Randomized Controlled Trial; NCT01425281).

Item does not contain fulltext, Aims: Multimodality invasive imaging of the first-in-man cohort demonstrated at 5 years stable lumen dimensions and a low rate of major adverse cardiac events (MACE). However, the long-term non-invasive assessment of this device remains to be documented. The objective was to describe the 72-month multislice computed tomography (MSCT) angiographic and functional findings after the implantation of the second iteration of the fully resorbable everolimus-eluting polymeric scaffold. Methods and results: In the ABSORB Cohort B trial patients with non-complex de novo lesions were treated with second iteration bioresobable vascular scaffold (BVS). MSCT angiography was performed as an optional investigation at 18 months; patients were reconsented for a second investigation at 72 months. MSCT data were analysed at independent core laboratories for quantitative analysis of lumen dimensions and for calculation of fractional flow reserve derived from computed tomography (FFRCT). From the overall Cohort B (101 patients), 53 patients underwent MSCT imaging at 72 months. The MACE rate was 1.9% (1/53). At 72 months, the median minimal lumen area (MLA) was 4.05 mm2 (interquartile range [IQR]: 3.15-4.90) and the mean percentage area stenosis was 18% (IQR: 4.75-31.25), one scaffold was totally occluded. In 39 patients with paired MSCT analysis, the MLA significantly increased from the first to the second follow-up (Delta = 0.80 mm2, P = 0.002). The change in the median FFRCT scaffold gradient between time points was zero. Conclusion: The long-term serial non-invasive MSCT evaluation with FFRCT assessment after bioresorbable scaffold implantation confirmed in-scaffold late lumen enlargement with the persistence of normalization of the FFRCT. Clinical trial registration: URL: http://www.clinicaltrials.gov. Unique identifier: NCT00856856.

Importance: Early cardiovascular and bleeding events after coronary stenting are associated with high risk of morbidity and mortality. Objective(s): To assess the prognosis of cardiovascular and bleeding events occurring beyond 1 year after coronary stenting. Design, Setting, and Participant(s): This secondary analysis is derived from data from the Dual Antiplatelet Therapy (DAPT) Study, a multi center trial involving 220 US and in ternational clinical sites from 11 countries. The study dateswere August 2009 to May 2014. Individuals who underwent coronary stenting and completed 12 months of thienopyridine plus aspirin therapy without ischemic or bleeding events remained on an aspirin regimen and were randomized to continued thienopyridine therapy vs placebo for 18 additional months. Individuals were then followed up for 3 additional months while receiving aspirin therapy alone. The analysis began in August 2015. Exposures: Ischemic events (myocardial infarction not related to stent thrombosis, stent thrombosis, and ischemic stroke) and bleeding events (Global Utilization of Streptokinase and Tissue Plasminogen Activator for Occluded Arteries [GUSTO] classification moderate or severe bleeding). Main Outcomes and Measures: Ischemic events (myocardial infarction not related to stent thrombosis, stent thrombosis, and ischemic stroke) and bleeding events (GUSTO classification moderate or severe bleeding). Death at 21 months after randomization (33 months after coronary stenting). Result(s): Intotal, 25 682 individuals older than 18 years with an indication for coronarystentingwere enrolled, and 11 648(meanage,61.3 years; 25.1%female)were randomized. After randomization, 478 individuals (4.1%) had 502 ischemic events (306 with myocardial infarction, 113 with stent thrombosis, and 83 with ischemic stroke), and 232 individuals (2.0%) had 235 bleeding events (155 with moderate and 80 with severe bleeding). Among individuals with ischemic events, 52(10.9%) died. The annualize

Aims Multimodality invasive imaging of the first-in-man cohort demonstrated at 5 years stable lumen dimensions and a low rate of major adverse cardiac events (MACE). However, the long-term non-invasive assessment of this device remains to be documented. The objective was to describe the 72-month multislice computed tomography (MSCT) angiographic and functional findings after the implantation of the second iteration of the fully resorbable everolimus-eluting polymeric scaffold. Methods and results In the ABSORB Cohort B trial patients with non-complex de novo lesions were treated with second iteration bioresobable vascular scaffold (BVS). MSCT angiography was performed as an optional investigation at 18 months; patients were reconsented for a second investigation at 72 months. MSCT data were analysed at independent core laboratories for quantitative analysis of lumen dimensions and for calculation of fractional flow reserve derived from computed tomography (FFRCT). From the overall Cohort B (101 patients), 53 patients underwent MSCT imaging at 72 months. The MACE rate was 1.9% (1/53). At 72 months, the median minimal lumen area (MLA) was 4.05 mm2 (interquartile range [IQR]: 3.15-4.90) and the mean percentage area stenosis was 18% (IQR: 4.75-31.25), one scaffold was totally occluded. In 39 patients with paired MSCT analysis, the MLA significantly increased from the first to the second follow-up (delta = 0.80 mm2, P = 0.002). The change in the median FFRCT scaffold gradient between time points was zero. Conclusion The long-term serial non-invasive MSCT evaluation with FFRCT assessment after bioresorbable scaffold implantation confirmed in-scaffold late lumen enlargement with the persistence of normalization of the FFRCT. Clinical trial URL: http://www.clinicaltrials.gov. Unique identifier: NCT00856856.Copyright © 2017 The Author.

During percutaneous coronary intervention, stents are placed in narrowings of the arteries to restore normal blood flow. Despite improvements in stent design, deployment techniques and drug-eluting coatings, restenosis and stent thrombosis remain a significant problem. Population stent design based on statistical shape analysis may improve clinical outcomes. Computed tomographic (CT) coronary angiography scans from 211 patients with a zero calcium score, no stenoses and no intermediate artery, were used to create statistical shape models of 446 major coronary artery bifurcations (left main, first diagonal and obtuse marginal and right coronary crux). Coherent point drift was used for registration. Principal component analysis shape scores were tested against clinical risk factors, quantifying the importance of recognised shape features in intervention including size, angles and curvature. Significant differences were found in (1) vessel size and bifurcation angle between the left main and other bifurcations; (2) inlet and curvature angle between the right coronary crux and other bifurcations; and (3) size and bifurcation angle by sex. Hypertension, smoking history and diabetes did not appear to have an association with shape. Physiological diameter laws were compared, with the Huo-Kassab model having the best fit. Bifurcation coronary anatomy can be partitioned into clinically meaningful modes of variation showing significant shape differences. A computational atlas of normal coronary bifurcation shape, where disease is common, may aid in the design of new stents and deployment techniques, by providing data for bench-top testing and computational modelling of blood flow and vessel wall mechanics.

Background Long-term benefits of coronary stenosis treatment with an everolimus-eluting bioresorbable scaffold are unknown. Objectives This study sought to evaluate clinical and imaging outcomes 5 years after bioresorbable scaffold implantation. Methods In the ABSORB multicenter, single-arm trial, 45 (B1) and 56 patients (B2) underwent coronary angiography, intravascular ultrasound (IVUS), and optical coherence tomography (OCT) at different times. At 5 years, 53 patients without target lesion revascularization underwent final imaging. Results Between 6 months/1 year and 5 years, angiographic luminal late loss remained unchanged (B1: 0.14 +/- 19 mm vs. 0.13 +/- 0.33 mm; p = 0.7953; B2: 0.23 +/- 0.28 mm vs. 0.18 +/- 0.32 mm; p = 0.5685). When patients with a target lesion revascularization were included, luminal late loss was 0.15 +/- 0.20 mm versus 0.15 +/- 0.24 mm (p = 0.8275) for B1 and 0.30 +/- 0.37 mm versus 0.32 +/- 0.48 mm (p = 0.8204) for B2. At 5 years, in-scaffold and -segment binary restenosis was 7.8% (5 of 64) and 12.5% (8 of 64). On IVUS, the minimum lumen area of B1 decreased from 5.23 +/- 0.97 mm2 at 6 months to 4.89 +/- 1.81 mm2 at 5 years (p = 0.04), but remained unchanged in B2 (4.95 +/- 0.91 mm2 at 1 year to 4.84 +/- 1.28 mm2 at 5 years; p = 0.5). At 5 years, struts were no longer discernable by OCT and IVUS. On OCT, the minimum lumen area in B1 decreased from 4.51 +/- 1.28 mm2 at 6 months to 3.65 +/- 1.39 mm2 at 5 years (p = 0.01), but remained unchanged in B2, 4.35 +/- 1.09 mm2 at 1 year and 4.12 +/- 1.38 mm2 at 5 years (p = 0.24). Overall, the 5-year major adverse cardiac event rate was 11.0%, without any scaffold thrombosis. Conclusions At 5 years, bioresorbable scaffold implantation in a simple stenotic lesion resulted in stable lumen dimensions and low restenosis and major adverse cardiac event rates.Copyright © 2016 American College of Cardiology Foundation.

BACKGROUND: Long-term benefits of coronary stenosis treatment with an everolimus-eluting bioresorbable scaffold are unknown. OBJECTIVES: This study sought to evaluate clinical and imaging outcomes 5 years after bioresorbable scaffold implantation. METHODS: In the ABSORB multicenter, single-arm trial, 45 (B1) and 56 patients (B2) underwent coronary angiography, intravascular ultrasound (IVUS), and optical coherence tomography (OCT) at different times. At 5 years, 53 patients without target lesion revascularization underwent final imaging. RESULTS: Between 6 months/1 year and 5 years, angiographic luminal late loss remained unchanged (B1: 0.14 +/- 19 mm vs. 0.13 +/- 0.33 mm; p = 0.7953; B2: 0.23 +/- 0.28 mm vs. 0.18 +/- 0.32 mm; p = 0.5685). When patients with a target lesion revascularization were included, luminal late loss was 0.15 +/- 0.20 mm versus 0.15 +/- 0.24 mm (p = 0.8275) for B1 and 0.30 +/- 0.37 mm versus 0.32 +/- 0.48 mm (p = 0.8204) for B2. At 5 years, in-scaffold and -segment binary restenosis was 7.8% (5 of 64) and 12.5% (8 of 64). On IVUS, the minimum lumen area of B1 decreased from 5.23 +/- 0.97 mm(2) at 6 months to 4.89 +/- 1.81 mm(2) at 5 years (p = 0.04), but remained unchanged in B2 (4.95 +/- 0.91 mm(2) at 1 year to 4.84 +/- 1.28 mm(2) at 5 years; p = 0.5). At 5 years, struts were no longer discernable by OCT and IVUS. On OCT, the minimum lumen area in B1 decreased from 4.51 +/- 1.28 mm(2) at 6 months to 3.65 +/- 1.39 mm(2) at 5 years (p = 0.01), but remained unchanged in B2, 4.35 +/- 1.09 mm(2) at 1 year and 4.12 +/- 1.38 mm(2) at 5 years (p = 0.24). Overall, the 5-year major adverse cardiac event rate was 11.0%, without any scaffold thrombosis. CONCLUSIONS: At 5 years, bioresorbable scaffold implantation in a simple stenotic lesion resulted in stable lumen dimensions and low restenosis and major adverse cardiac event rates. (ABSORB Clinical Investigation, Cohort B [ABSORB B]; NCT00856856).Copyright © 2016 American College of Cardiology Foundati

Stent induced hemodynamic changes in the coronary arteries are associated with higher risk of adverse clinical outcome. The purpose of this study was to evaluate the impact of stent design on wall shear stress (WSS), time average WSS, and WSS gradient (WSSG), in idealized stent geometries using computational fluid dynamics. Strut spacing, thickness, luminal protrusion, and malapposition were systematically investigated and a comparison made between two commercially available stents (Omega and Biomatrix). Narrower strut spacing led to larger areas of adverse low WSS and high WSSG but these effects were mitigated when strut size was reduced, particularly for WSSG. Local hemodynamics worsened with luminal protrusion of the stent and with stent malapposition, adverse high WSS and WSSG were identified around peak flow and throughout the cardiac cycle respectively. For the Biomatrix stent, the adverse effect of thicker struts was mitigated by greater strut spacing, radial cell offset and flow-aligned struts. In conclusion, adverse hemodynamic effects of specific design features (such as strut size and narrow spacing) can be mitigated when combined with other hemodynamically beneficial design features but increased luminal protrusion can worsen the stent’s hemodynamic profile significantly.

Objectives This study sought to compare rates of stent thrombosis and major adverse cardiac and cerebrovascular events (MACCE) (composite of death, myocardial infarction, or stroke) after coronary stenting with drug-eluting stents (DES) versus bare-metal stents (BMS) in patients who participated in the DAPT (Dual Antiplatelet Therapy) study, an international multicenter randomized trial comparing 30 versus 12 months of dual antiplatelet therapy in subjects undergoing coronary stenting with either DES or BMS. Background Despite antirestenotic efficacy of coronary DES compared with BMS, the relative risk of stent thrombosis and adverse cardiovascular events is unclear. Many clinicians perceive BMS to be associated with fewer adverse ischemic events and to require shorter-duration dual antiplatelet therapy than DES. Methods Prospective propensity-matched analysis of subjects enrolled into a randomized trial of dual antiplatelet therapy duration was performed. DES- and BMS-treated subjects were propensity-score matched in a many-to-one fashion. The study design was observational for all subjects 0 to 12 months following stenting. A subset of eligible subjects without major ischemic or bleeding events were randomized at 12 months to continued thienopyridine versus placebo; all subjects were followed through 33 months. Results Among 10,026 propensity-matched subjects, DES-treated subjects (n = 8,308) had a lower rate of stent thrombosis through 33 months compared with BMS-treated subjects (n = 1,718, 1.7% vs. 2.6%; weighted risk difference -1.1%, p = 0.01) and a noninferior rate of MACCE (11.4% vs. 13.2%, respectively, weighted risk difference -1.8%, p = 0.053, noninferiority p < 0.001). Conclusions DES-treated subjects have long-term rates of stent thrombosis that are lower than BMS-treated subjects. (The Dual Antiplatelet Therapy Study [DAPT study]; NCT00977938)Copyright © 2015 American College of Cardiology Foundation.

Aims: To evaluate the safety and efficacy of the balloon-based bipolar Vessix Renal Denervation System in treating patients with resistant hypertension. Methods and Results: In this prospective, multicentre, single-arm study, 146 patients (age 58.6+/-10.5 years; 61% men) with office systolic blood pressure (BP) >=160 mmHg despite >=3 antihypertensive medications at maximally tolerated doses were treated with the Vessix System. Efficacy endpoints were reductions in office and 24-hour ambulatory systolic and diastolic BPs at six months. Acute and long-term safety, with a focus on the renal artery and estimated glomerular filtration rate (eGFR), were assessed. Baseline office and ambulatory BPs were 182.4+/-18.4/100.2+/-14.0 mmHg and 153.0+/-15.1/87.5+/-13.2 mmHg, respectively. No acute renal artery injury requiring intervention or serious periprocedural cardiovascular events occurred. At six months, office BP was reduced by 24.7+/-22.1/10.3+/-12.7 mmHg (p<0.0001) and ambulatory BP was reduced by 8.4+/-14.4/5.9+/-9.1 mmHg (N=69; p<0.0001). Twenty-six patients (18%) achieved an office systolic BP <140 mmHg. One patient had renal artery stenosis which required stenting. Mean eGFR remained stable. Conclusion(s): Renal artery denervation with the Vessix System reduced both office and ambulatory BP at six months in patients with resistant hypertension. Renal artery safety and renal function results are favourable.Copyright © Europa Digital & Publishing 2015. All rights reserved.

Aims: The aim of this IVUS substudy was to assess the efficacy of the Y-shaped Medtronic bifurcation-dedicated stent (BDS) for the treatment of de novo coronary bifurcated lesions. Methods and Results: In the BRANCH trial, post-procedure IVUS was performed in 45 patients. IVUS was available in both branches in 19 lesions and only the main branch (MB) in 26 lesions. IVUS analysis included four distinct locations: proximal MB, bifurcation site, distal MB, and side branch (SB). Lumen symmetry was calculated as minimum/maximum lumen diameters. The quantity of isolated stent struts across the SB ostium was used to assess inadequate strut apposition to the carina resulting in partial jailing of the SB orifice. A minimum stent area (MSA) <4 mm2 was found in 0% of proximal and distal MB, and in 15.4% of SB. In SB, MSA was located mainly at mid or distal segments (84.6%), rather than at the SB ostium. Eccentric stent expansion and edge dissection were seen primarily at proximal MB. Isolated struts were seen in only 20.9% of SB ostia with a minimum length of 0.7+/-0.4 mm. Conclusion(s): Implantation of BDS resulted in adequate stent dimensions and strut apposition at the carina and SB ostium. ClinicalTrials.gov Identifier: NCT0060732Copyright © Europa Digital & Publishing 2015. All rights reserved.

Background: The Vessix Renal Denervation System (Boston Scientific, Natick, MA) consists of a radiofrequency generator and a balloon catheter mounted with a bipolar radiofrequency electrode array. The objective of the REDUCE-HTN Clinical Study is to evaluate the performance of the Vessix System in treating medication-resistant hypertension. Method(s): The REDUCE-HTN trial is a prospective, multicenter, single-arm study. Patients were required to have office-based systolic blood pressure (BP) >=160 mmHg despite compliance with >=3 antihypertensive medications at maximally tolerated doses. The primary efficacy endpoints were the 6-month reductions in office-based systolic and diastolic BPs, and reductions in systolic and diastolic BP as measured by 24-hour ambulatory monitoring. Acute safety (ie, freedom from renal artery dissection or perforation requiring stenting or surgery, renal artery infarction or embolus, cerebrovascular accident, myocardial infarction, or sudden cardiac death at the time of the procedure) and long-term safety, including renal artery patency and renal function, were assessed. Result(s): Mean baseline office BP was 182.4 +/- 18.4/100.1 +/- 14.0 mmHg among enrolled patients (N = 146; age 58.5 +/- 10.5 years, 61% men, 27.4% with type 2 diabetes). No patients experienced any of the prespecified acute safety events. Among 139 patients with 6 month data, mean office BP was reduced to 157.7 +/- 23.8/89.4 +/- 15.7 mmHg; a reduction of 24.6 +/- 22.3/10.3 +/- 12.9 mmHg (p < 0.0001). Mean baseline ambulatory BP was 153.0 +/- 15.1/87.5 +/- 13.2 mmHg (n = 103); at 6 months it was reduced by 8.5 +/- 14.6/5.9 +/- 9.2 mmHg (n = 67; p < 0.0001). Renal artery patency by duplex ultrasound at 6 months was 99.1%. Mean estimated glomerular filtration rate (eGFR) changed -0.9 +/- 16.5 at 6 months, and 11% of patients (15/136) had a reduction in eGFR > 25%. Six-month results for the full cohort of enrolled patients are expected to be available at the time of presenta