Stroke following percutaneous coronary intervention : type-specific incidence, outcomes and determinants seen by the British Cardiovascular Intervention Society 2007-12

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TCT-613 A Prospective Randomized Multi-Center Trial to Assess the Everolimus-Eluting Stent System (Promus Element) for Coronary Revascularization in a Population of Unrestricted Patients

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Smoking status and mortality outcomes following percutaneous coronary intervention

Objective: The aim of this study was to assess the impact of smoking on short (30-day) and intermediate (30-day to 6-month) mortality following percutaneous coronary intervention (PCI). Background: The effect of smoking on mortality post-PCI is lacking in the modern PCI era. Methods: This was a retrospective analysis of prospectively collected data comparing short- and intermediate-term mortality amongst smokers, ex-smokers and non-smokers. Results: The study cohort consisted of 12,656 patients: never-smokers (n = 4288), ex-smokers (n = 4806) and current smokers (n = 3562). The mean age (±standard deviation) was 57 (±11) years in current smokers compared with 67 (±11) in ex-smokers and 67 (±12) in never-smokers; p < 0.0001. PCI was performed for acute coronary syndrome (ACS) in 84.1% of current smokers, 57% of ex-smokers and 62.9% in never-smokers; p < 0.0001. In a logistic regression model, the adjusted odds ratios (95% confidence intervals (CIs)) for 30-day mortality were 1.60 (1.10–2.32) in current smokers and 0.98 (0.70–1.38) in ex-smokers compared with never-smokers. In the Cox proportional hazard model, the adjusted hazard ratios (95% CI) for mortality between 30 days and 6 months were 1.03 (0.65–1.65) in current smokers and 1.19 (0.84–1.67) in ex-smokers compared with never-smokers. Conclusion: This large observational study of non-selected patients demonstrates that ex-smokers and never-smokers are of similar age at first presentation to PCI, and there is no short- or intermediate-term mortality difference between them following PCI. Current smokers undergo PCI at a younger age, more often for ACS, and have higher short-term mortality. These findings underscore the public message on the benefits of smoking cessation and the harmful effects of smoking

Combinations of bleeding and ischemic risk and their association with clinical outcomes in acute coronary syndrome.

Background: Clinical predictors of future ischemic events in patients with acute coronary syndrome (ACS) are also risk factors for bleeding, with patients often at high-risk of both outcomes. We aimed to define the clinical outcomes and provision of guideline-recommended care in ACS management for different combinations of ischemic and bleeding risk defined using a combined GRACE and CRUSADE score.Methods: A retrospective observational analysis of a national ACS database was performed for patients with ACS admitted to three tertiary centres from January 2010 to March 2016. Patients were stratified into 9 groups based on possible CRUSADE-GRACE risk combinations. Multiple logistic regression was used to estimate adjusted odds ratios (ORs [95% CI]) for outcomes (in-hospital net adverse cardiac events (NACE), in-hospital all-cause mortality, 30-day mortality and treatment strategy).Results: A total of 17,701 patients were included in the analysis. We observed a graded risk of mortality and adverse events in the high-risk GRACE strata (Groups 3, 6 and 9). Almost a third of patients with ACS were at a ‘dual high-risk’ (Group 9, 32%) and were independently associated with higher in-hospital NACE (composite of cardiac mortality, all-cause bleeding and re-infarction): aOR 6.33 [3.55, 11.29], all-cause mortality: aOR 14.17 [5.27, 38.1], all-cause bleeding: aOR 4.82 [1.96, 11.86], and 30-day mortality: aOR 10.79 [5.33, 21.81]. This group was also the least likely to be offered coronary angiography (aOR 0.24 [0.20, 0.29]) and dual anti-platelet therapy (aOR 0.26 [0.20, 0.34]). Conclusions: One in five patients presenting with an ACS are high ischemic and high bleeding risk, and these patients are more likely to experience poor clinical outcomes and reduced odds of receiving guideline-recommended therapy. <br/

Design, Development, Testing at ISO standards and in-vivo feasibility study of a novel Polymeric Heart Valve Prosthesis

Clinically available prosthetic heart valves are life-saving, but imperfect: mechanical valves requiring anticoagulation therapy, whilst bioprosthetic valves have limited durability. Polymer valves offer the prospect of good durability without the need for anticoagulation. We report the design and development of a polymeric heart valve, its bench-testing at ISO standards, and preliminary extravivo and in-vivo short-term feasibility. Prototypes were manufactured by injection moulding of styrenic block copolymers to achieve anisotropic mechanical properties. Design was by finite element stress-strain modelling, which has been reported previously, combined with feedback from bench and surgery-based testing using various combinations of materials, valve geometry and processing conditions. Bench testing was according to ISO 5840:2015 standards using an in-vitro cardiovascular hydrodynamic testing system and an accelerated fatigue tester. Bench comparisons were made with a best-in-class bio-prosthesis. Preliminary clinical feasibility evaluations included extra-vivo and short-term (1-24 hours) in-vivo testing in a sheep model. The optimised final prototype met the requirements of ISO standards with hydrodynamic performance equivalent to the best-in-class bioprosthesis. Bench durability of greater than 1.2 billion cycles (30 years equivalent) was achieved (still ongoing). Extra-vivo sequential testing (n=8) allowed refinement of external diameter, 3D shape, a low profile, flexibility, suturability, and testing of compatibility to magnetic resonance imaging and clinical sterilisation. In vivo short-term (1-24 hours) feasibility (n=3) confirmed good suturability, no mechanical failure, no trans-valvular regurgitation, competitive trans-valvular gradients, and good biocompatibility at histopathology. We have developed and tested at ISO standards a novel prosthetic heart valve featuring competitive bench-based hydrodynamics and durability, well beyond the ISO requirements and comparable to a best-in-class bioprosthesis. In-vivo short-term feasibility testing confirmed preliminary safety, functionality and biocompatibility, supporting progression to a long-term efficacy trial.King's College, Cambridg

Determinants and outcomes of stroke following percutaneous coronary intervention by indication

Background and Purpose— Stroke after percutaneous coronary intervention (PCI) is a serious complication, but its determinants and outcomes after PCI in different clinical settings are poorly documented. Methods— The British Cardiovascular Intervention Society (BCIS) database was used to study 560 439 patients who underwent PCI in England and Wales between 2006 and 2013. We examined procedural-type specific determinants of ischemic and hemorrhagic stroke and the likelihood of subsequent 30-day mortality and in-hospital major adverse cardiovascular events (a composite of in-hospital mortality, myocardial infarction or reinfarction, and repeat revascularization). Results— A total of 705 stroke cases were recorded (80% ischemic). Stroke after an elective PCI or PCI for acute coronary syndrome indications was associated with a higher risk of adverse outcomes compared with those without stroke; 30-day mortality and major adverse cardiovascular events outcomes in fully adjusted model were odds ratios 37.90 (21.43–67.05) and 21.05 (13.25–33.44) for elective and 5.00 (3.96–6.31) and 6.25 (5.03–7.77) for acute coronary syndrome, respectively. Comparison of odds of these outcomes between these 2 settings showed no differences; corresponding odds ratios were 1.24 (0.64–2.43) and 0.63 (0.35–1.15), respectively. Conclusions— Hemorrhagic and ischemic stroke complications are uncommon, but serious complications can occur after PCI and are independently associated with worse mortality and major adverse cardiovascular events outcomes in both the elective and acute coronary syndrome setting irrespective of stroke type. Our study provides a better understanding of the risk factors and prognosis of stroke after PCI by procedure type, allowing physicians to provide more informed advice around stroke risk after PCI and counsel patients and their families around outcomes if such neurological complications occur

Clinical outcomes of percutaneous coronary intervention for chronic total occlusion in prior coronary artery bypass grafting patients

OBJECTIVE: To compare the clinical characteristics and outcomes in patients with stable angina who have undergone chronic total occlusion (CTO) percutaneous coronary intervention (PCI) in native arteries with or without prior coronary artery bypass grafting (CABG) surgery in a national cohort. BACKGROUND: There are limited data on outcomes of patients presenting with stable angina undergoing CTO PCI with previous CABG. METHODS: We identified 20,081 patients with stable angina who underwent CTO PCI between 2007-2014 in the British Cardiovascular Intervention Society database. Clinical, demographical, procedural and outcome data were analyzed in two groups; group 1-CTO PCI in native arteries without prior CABG (n = 16,848), group 2-CTO PCI in native arteries with prior CABG (n = 3,233). RESULTS: Patients in group 2 were older, had more comorbidities and higher prevalence of severe left ventricular systolic dysfunction. Following multivariable analysis, no significant difference in mortality was observed during index hospital admission (OR:1.33, CI 0.64-2.78, p = .44), at 30-days (OR: 1.28, CI 0.79-2.06, p = .31) and 1?year (OR:1.02, CI 0.87-1.29, p = .87). Odds of in-hospital major adverse cardiovascular events (MACE) (OR:1.01, CI 0.69-1.49, p = .95) and procedural complications (OR:1.02, CI 0.88-1.18, p = .81) were similar between two groups but procedural success rate was lower in group 2 (OR: 0.34, CI 0.31-0.39, p?<?.001). The adjusted risk of target vessel revascularization (TVR) remained similar between the two groups at 30-days (OR:0.68, CI 0.40-1.16, P-0.16) and at 1?year (OR:1.01, CI 0.83-1.22, P-0.95). CONCLUSION: Patients with prior CABG presenting with stable angina and treated with CTO PCI in native arteries had more co-morbid illnesses but once these differences were adjusted for, prior CABG did not independently confer additional risk of mortality, MACE or TVR

High platelet reactivity in patients with acute coronary syndromes undergoing percutaneous coronary intervention: Randomised controlled trial comparing prasugrel and clopidogrel

Background: Prasugrel is more effective than clopidogrel in reducing platelet aggregation in acute coronary syndromes. Data available on prasugrel reloading in clopidogrel treated patients with high residual platelet reactivity (HRPR) i.e. poor responders, is limited. Objectives: To determine the effects of prasugrel loading on platelet function in patients on clopidogrel and high platelet reactivity undergoing percutaneous coronary intervention for acute coronary syndrome (ACS). Patients: Patients with ACS on clopidogrel who were scheduled for PCI found to have a platelet reactivity ≥40 AUC with the Multiplate Analyzer, i.e. “poor responders” were randomised to prasugrel (60 mg loading and 10 mg maintenance dose) or clopidogrel (600 mg reloading and 150 mg maintenance dose). The primary outcome measure was proportion of patients with platelet reactivity <40 AUC 4 hours after loading with study medication, and also at one hour (secondary outcome). 44 patients were enrolled and the study was terminated early as clopidogrel use decreased sharply due to introduction of newer P2Y12 inhibitors. Results: At 4 hours after study medication 100% of patients treated with prasugrel compared to 91% of those treated with clopidogrel had platelet reactivity <40 AUC (p = 0.49), while at 1 hour the proportions were 95% and 64% respectively (p = 0.02). Mean platelet reactivity at 4 and 1 hours after study medication in prasugrel and clopidogrel groups respectively were 12 versus 22 (p = 0.005) and 19 versus 34 (p = 0.01) respectively. Conclusions: Routine platelet function testing identifies patients with high residual platelet reactivity (“poor responders”) on clopidogrel. A strategy of prasugrel rather than clopidogrel reloading results in earlier and more sustained suppression of platelet reactivity. Future trials need to identify if this translates into clinical benefit