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Background In the GLOBAL LEADERS trial, ticagrelor monotherapy beyond 1 month compared with standard antiplatelet regimens after coronary stent implantation did not improve outcomes at intention‐to‐treat analysis. Considerable differences in treatment adherence between the experimental and control groups may have affected the intention‐to‐treat results. In this reanalysis of the GLOBAL LEADERS trial, we compared the experimental and control treatment strategies in a per‐protocol analysis of patients who did not deviate from the study protocol. Methods and Results Baseline and postrandomization information were used to classify whether and when patients were deviating from the study protocol. With logistic regressions, we derived time‐varying inverse probabilities of nondeviation from protocol to reconstruct the trial population without protocol deviation. The primary end point was a composite of all‐cause mortality or nonfatal Q‐wave myocardial infarction at 2 years. At 2‐year follow‐up, 1103 (13.8%) of 7980 patients in the experimental group and 785 (9.8%) of 7988 patients in the control group qualified as protocol deviators. At per‐protocol analysis, the rate ratio for the primary end point was 0.88 (95% CI, 0.75–1.03; P =0.10) on the basis of 274 versus 325 events in the experimental versus control group. The rate ratio for the key safety end point of major bleeding was 1.00 (95% CI, 0.79–1.26; P =0.99). The per‐protocol and intention‐to‐treat effect estimates were overall consistent. Conclusions Among patients who complied with the study protocol in the GLOBAL LEADERS trial, ticagrelor plus aspirin for 1 month followed by ticagrelor monotherapy was not superior to 1‐year standard dual antiplatelet therapy followed by aspirin alone at 2 years after coronary stenting. Registration URL: https://www.clinicaltrials.gov ; Unique identifier: NCT01813435.

Aims The SYNTAX II study evaluated the impact of advances in percutaneous coronary intervention (PCI), integrated into a single revascularization strategy, on outcomes of patients with de novo three-vessel disease. The study employed decision-making utilizing the SYNTAX score II, use of coronary physiology, thin-strut biodegradable polymer drug-eluting stents, intravascular ultrasound, enhanced treatments of chronic total occlusions, and optimized medical therapy. Patients treated with this approach were compared with predefined patients from the SYNTAX I trial. Methods and results SYNTAX II was a multicentre, single-arm, open-label study of patients requiring revascularization who demonstrated clinical equipoise for treatment with either coronary artery bypass grafting (CABG) or PCI, predicted by the SYNTAX score II. The primary endpoint was major adverse cardiac and cerebrovascular events (MACCE), which included any revascularization. The comparators were a matched PCI cohort trial and a matched CABG cohort, both from the SYNTAX I trial. At 5 years, MACCE rate in SYNTAX II was significantly lower than in the SYNTAX I PCI cohort (21.5% vs. 36.4%, P < 0.001). This reflected lower rates of revascularization (13.8% vs. 23.8%, P < 0.001), and myocardial infarction (MI) (2.7% vs. 10.4%, P < 0.001), consisting of both procedural MI (0.2% vs. 3.8%, P < 0.001) and spontaneous MI (2.3% vs. 6.9%, P = 0.004). All-cause mortality was lower in SYNTAX II (8.1% vs. 13.8%, P = 0.013) reflecting a lower rate of cardiac death (2.8% vs. 8.4%, P < 0.001). Major adverse cardiac and cerebrovascular events’ outcomes at 5 years among patients in SYNTAX II and predefined patients in the SYNTAX I CABG cohort were similar (21.5% vs. 24.6%, P = 0.35). Conclusions Use of the SYNTAX II PCI strategy in patients with de novo three-vessel disease led to improved and durable clinical results when compared to predefined patients treated with PCI in the original SYNTAX I trial. A predefined exploratory analysis found no significant difference in MACCE between SYNTAX II PCI and matched SYNTAX I CABG patients at 5-year follow-up.

OBJECTIVES The aim of this study was to investigate the impact of post-percutaneous coronary intervention (PCI) quantitative flow ratio (QFR) on clinical outcomes in patients with de novo 3-vessel disease (3VD) treated with contemporary PCI.BACKGROUND The clinical impact of post-PCI QFR in patients treated with state-of-the-art PCI for de novo 3VD is undetermined.METHODS All vessels treated in the SYNTAX (SYNergy between percutaneous coronary intervention with TAXus and cardiac surgery) II trial were retrospectively screened and analyzed for post-PCI QFR. The primary endpoint of this substudy was vessel-oriented composite endpoint (VOCE) at 2 years, defined as the composite of vessel-related cardiac death, vessel-related myocardial infarction, and target vessel revascularization. The receiver-operating characteristic curve was used to calculate the optimal cutoff value of post-PCI QFR for predicting 2-year VOCE. All the analyzable vessels were stratified on the basis of the optimal cutoff value.RESULTS A total of 968 vessels treated with PCI were screened. Post-PCIQFR was analyzable in 771 (79.6%) vessels. A total of 52 (6.7%) VOCEs occurredat 2 years. The mean value of post-PCIQFR was 0.91 +/- 0.07. The diagnostic performance of post-PCI QFR to predict 2-year VOCE was moderate (area under the curve: 0.702; 95% confidence interval: 0.633 to 0.772), with the optimal cutoff value of post-PCI QFR for predicting 2-year VOCE 0.91 (sensitivity 0.652, specificity 0.635). The incidence of 2-year VOCE in the vessels with post-PCIQFR= 0.91 (n = 487) (12.0% vs. 3.7%; hazard ratio: 3.37; 95% confidence interval: 1.91 to 5.97; p < 0.001).CONCLUSIONS A higher post-PCI QFR value is associated with improved vessel-related clinical outcomes in state-of the art PCI practice for de novo 3VD. Achieving a post-PCI QFR value >= 0.91 in all treated vessels should be a target when treating de novo 3VD. These findings require confirmation in future prospective trials. (C) 2019 by the American College of Cardiology Foundation.

The consequences of severe acute viral respiratory syndrome (COVID 19) pandemic include collateral effects, one of which has been the significant reduction in routine hospital work. With widespread reports indicating reduction of cardiac procedures including MI presentation to hospitals, we aimed to analyze the local data over a 10-week period during lockdown in a tertiary cardiac centre Catheter Laboratory in England. Methods We conducted a retrospective review of the coronary catheterisation procedures and admissions with MI over the peak COVID-19 pandemic 10-week period (23rd March-30th May) in 2020, compared with the same 10-week period (25th March-2nd June) in 2019. Results In 2019, 539 patients were admitted to the Cath lab for coronary catheterisation (M = 385:F = 154; mean age 65 years; STEMI = 186, NSTEMI = 192, elective = 161). In 2020, during peak period of COVID19 pandemic in England, a total of 278 patients were admitted for coronary catheterisation over the 10-week period (M = 201:F = 77; mean age 60.5 years; STEMI = 132, NSTEMI = 118, elective = 28). During peak COVID19 pandemic, this represents a 48.4% drop in all coronary catheterisations. The reduction in STEMI was 29% (54 less), in NSTEMI was 38.9% (74 less) and elective procedures dropped by 83% (133 less). Conclusion During peak COVID hospital admission period in England, we report a 48.5% reduction in coronary catheterisation in our tertiary hospital. These results are consistent with reports from other countries, and highlight the worrying potential consequences for these patients arising from delays in presentation with MI, and the challenges for restoring services post-pandemic., Highlights • Strengths: • This study documents the actual drop in all activity in the Catheter laboratory (48.5% drop), 29% drop in STEMI, 40% drop in NSTEMI and 83% in urgent elective work in a single hospital in England, over a 10-week COVID peak period (23rd March- 30th May 2020), compared to the same months in 2019. • The actual drop in all activities in the Catheter laboratory highlights the impact actual on clinical practice and challenges in post-COVID resumption of services. • Results from this study should encourage the wider review of national UK data to document the final consequence of COVID-19 on all cardiac outcomes as well as informing the potential economic consequences for the eventual restoration of cardiac services. • Limitations: • This is a single hospital service observational study. Nevertheless, it is reassuring that the results reported are in keeping with other similar international observational studies.

Background Impella utilisation is increasing but reimbursement and usage patterns vary significantly around the world. The National Institute for Health and Care Excellence (NICE) recently approved the use of Impella for high-risk percutaneous coronary intervention (PCI) in centres with specific expertise in the use of mechanical circulatory support and with specific arrangements for governance, audit and consent in place. Hypothesis: In the United Kingdom (UK), due to increased selection, Impel is used in higher-risk cases than in randomised controlled trials (RCT). Methods All patients undergoing Impella implants between 2008 - 2019 in the four highest volume UK Impella centres (St. Thomas’ Hospital and King’s College Hospital, London; Queen Elizabeth Hospital, Birmingham; Manchester Royal Infirmary, Manchester) were included. Demographic, clinical, procedural and outcome data were extracted from electronic health records. Patients were stratified by the presence of cardiogenic shock at presentation. Pre-procedural characteristics and outcomes (30-day and 1-year all-cause mortality) were compared to the BCIS-1, PROTECT-2 and IABP-SHOCK2 trial cohorts respectively. Multivariate logistic regression analysis was used to identify independent predictors of complications. Continuous data are presented as mean ± SD or median (IQR) depending on normality. Results Two-hundred and thirty-four patients were included. The indication was cardiogenic shock in 83 (35.5%) and high-risk PCI in 146 (62.4%); of the latter 58.9% had acute coronary syndromes and 41.1% were elective) and bailout in 2.1%. PCI was performed via femoral access in 55.6%. Patients undergoing high-risk PCI were older than those with cardiogenic shock (73.3 ± 10.8 years vs. 59.9 ± 14.0 years, p High-risk PCI patients in UKpella had a higher BCIS-Jeopardy Score, more left main disease and underwent more calcium modification but had a higher left ventricular ejection fraction than in RCTs. UKpella high-risk PCI 30-day and 1-year mortality was 16.4% and 30.7% respectively, significantly higher than in RCTs (Table 1). Cardiogenic shock patients in UKpella had a higher 30-day mortality than RCT patients (56.1% versus 40.5%, p = 0.034) but 1-year mortality was similar. Figure 1 demonstrates mortality over follow up. Major bleeding (Bleeding Academic Research Consortium scale 3-5) occurred in around 20% of both shock and high-risk PCI cases. Femoral access for PCI was related to the risk of bleeding in high-risk PCI (odds ratio 2.65 [1.04-6.74], p=0.040) but not in cardiogenic shock. Vascular complications occurred more frequently in shock than high-risk cases (13.6% vs. 9.0%). Figure 2 shows the rates of implants, bleeding and vascular complications. Conclusions Patients selected for Impella in the UK are a group with a particularly adverse prognosis, in terms of baseline predictors of risk as well as higher short- and medium-term mortality than in RCTs. Bleeding and vascular complications occur in an important minority. Randomised clinical trials are required to define a population in whom the balance of benefit and risk is most favourable. Conflict of Interest None

AIMS The aim of this study was to evaluate the safety and efficacy of the BioMime sirolimus-eluting coronary stent (SES) compared to the XIENCE family of everolimus-eluting coronary stents (EES) in the treatment of patients with de novo native coronary artery lesions. METHODS AND RESULTS The meriT-V is a prospective, multicentre, randomised, open-label, active-controlled, non-inferiority trial. A total of 256 patients with up to two de novo native coronary artery lesions were enrolled and randomly assigned (2:1) to BioMime SES or XIENCE EES. BioMime SES was non-inferior to XIENCE EES for the primary endpoint of in-stent late lumen loss (0.15±0.27 mm vs. 0.15±0.29 mm; difference: -0.006 mm; 95% confidence interval: -0.085 to 0.072; p=0.87; p for non-inferiority

Background We hypothesised that ticagrelor, in combination with aspirin for 1 month, followed by ticagrelor alone, improves outcomes after percutaneous coronary intervention compared with standard antiplatelet regimens. Methods GLOBAL LEADERS was a randomised, open-label superiority trial at 130 sites in 18 countries. Patients undergoing percutaneous coronary intervention with a biolimus A9-eluting stent for stable coronary artery disease or acute coronary syndromes were randomly assigned (1:1) to 75-100 mg aspirin daily plus 90 mg ticagrelor twice daily for 1 month, followed by 23 months of ticagrelor monotherapy, or standard dual antiplatelet therapy with 75-100 mg aspirin daily plus either 75 mg clopidogrel daily (for patients with stable coronary artery disease) or 90 mg ticagrelor twice daily (for patients with acute coronary syndromes) for 12 months, followed by aspirin monotherapy for 12 months. Randomisation was concealed, stratified by centre and clinical presentation (stable coronary artery disease vs acute coronary syndrome), and blocked, with randomly varied block sizes of two and four. The primary endpoint at 2 years was a composite of all-cause mortality or non-fatal centrally adjudicated new Q-wave myocardial infarction as assessed by a core lab in a blinded manner. The key secondary safety endpoint was site-reported bleeding assessed according to the Bleeding Academic Research Consortium criteria (grade 3 or 5). Analysis was by intention to treat. This trial is registered with ClinicalTrials.gov, number NCT01813435, and is closed to new participants, with followup completed. Findings Between July 1, 2013, and Nov 9, 2015, 15 968 participants were randomly assigned, 7980 to the experimental group and 7988 to the control group. At 2 years, 304 (3.81%) participants in the experimental group had died or had a non-fatal centrally adjudicated new Q-wave myocardial infarction, compared with 349 (4.37%) participants in the control group (rate ratio 0.87 [95% CI 0. 75-1. 01]; p=0.073]). There was no evidence for a difference in treatment effects for the primary endpoint across prespecified subgroups of acute coronary syndromes and stable coronary artery disease (p=0.93). Grade 3 or 5 bleeding occurred in 163 participants in the experimental group and 169 in the control group (2.04% vs 2.12%; rate ratio 0.97 [95% CI 0. 78-1. 20]; p=0.77). Interpretation Ticagrelor in combination with aspirin for 1 month followed by ticagrelor alone for 23 months was not superior to 12 months of standard dual antiplatelet therapy followed by 12 months of aspirin alone in the prevention of all-cause mortality or new Q-wave myocardial infarction 2 years after percutaneous coronary intervention. Copright (C) 2018 Elsevier Ltd. All rights reserved. European Clinical Research Institute; Biosensors International; AstraZeneca; Medicines Company; Canada Research Chairs Programme

Background: The coronavirus disease-2019 pandemic has restricted availability of intensive care unit resources Symptomatic patients with coronary artery disease considered surgical candidates have therefore needed revascularization with percutaneous coronary intervention (PCI) We describe demographics/in-hospital clinical outcomes of this novel cohort Methods: From March 1, 2020, to May 31, 2020, anonymized data of 171 patients in 38 U K centers were enrolled in a prospective registry All were considered surgical candidates Results: Tables 1-3 show demographics, procedural characteristics, and outcomes A comparison with routine PCI (British Cardiovascular Intervention Society data) and U K coronary bypass surgical data are listed if available and appropriate There was significantly more prior myocardial infarction, PCI, and coronary artery bypass graft in the routine PCI database than in ReVasc Registry patients, suggesting more acute presentation in latter group However, these were complex patients — mean SYNTAX score of 27 8 (range 9 to 65);and >20 times the number of LMS plus multivessel disease compared to the routine PCI group, with high use of adjunctive imaging Radial use was high at 94 1% PCI success was 97 0% Complete revascularization was 52% and residual SYNTAX score 1 42 (0 to 20) The 2 deaths were acute, and mortality rate comparable to published surgical data A 50% reduction in in-patient stay was observed [Formula presented] Conclusion: In this multicenter U K registry, in-hospital outcomes with PCI for patients with complex coronary disease, normally treated with coronary artery bypass graft, compared well with surgical data suggesting the role of PCI could be extended Future long-term follow-up is planned Categories: CORONARY: Complex and Higher Risk Procedures for Indicated Patients (CHIP)

Objective: To investigate the impact of different anti-platelet strategies on outcomes after percutaneous coronary intervention (PCI) in patients with established cardiovascular disease (CVD). Methods: GLOBAL LEADERS was a randomized, superiority, all-comers trial comparing one-month dual anti-platelet therapy (DAPT) with ticagrelor and aspirin followed by 23-month ticagrelor monotherapy (experimental treatment) with standard 12-month DAPT followed by 12-month aspirin monotherapy (reference treatment) in patients treated with a biolimus A9-eluting stent. Established CVD was defined as ≥1 prior myocardial infarction, PCI, coronary artery bypass operation, stroke, or established peripheral vascular disease. The primary endpoint was a composite of all-cause death or new Q-wave MI at 2-years. The secondary safety endpoint was BARC 3 or 5 bleeding. Exploratory secondary endpoints were the patient-orientated composite endpoint and net adverse clinical events. Results: Among the 15,761 patients in this cohort were 6,693 patients (42.5%) with established CVD. Compared to those without established CVD, these patients had significantly higher rates of the primary (5.1 vs. 3.3%, HR1.59[1.36–1.86], p

Background ACEF score has been shown to have predictive ability in the patients undergoing percutaneous coronary intervention (PCI). The ACEF II score has recently been developed to predict short-term mortality after cardiac surgery. We compared the predictive ability of the ACEF and ACEF II scores to predict mortality after PCI in the all-comers population. Methods The ACEF and ACEF II scores were calculated in 15,968 patients enrolled in the GLOBAL LEADERS study. Discrimination and calibration were assessed for outcomes after PCI. Recalibration of the regression model by updating the intercept and slope were performed to adjust the original ACEF model to the PCI setting. In a stratified approach, patients were divided into quintiles according to the score. Outcomes were compared between quintiles. Results The ACEF and ACEF II score were available in 14,941 and 14,355 patients respectively. Discrimination for 30-day all-cause mortality was acceptable for both scores (C-statistic ACEF 0.75 and ACEF II 0.77). For 2-year all-cause mortality, the discrimination of ACEF score was acceptable (C-statistic 0.72) while the discrimination of ACEF II score was moderate (C-statistic 0.69). Both scores identified patients at high risk of mortality but overestimated all-cause mortality at 30 days in all quintiles. After recalibration, agreement between predicted and observed 30-day all-cause mortality in both scores are close to the identity line. Conclusions The ACEF II model did not improve the predictive ability of the ACEF score. Recalibrated ACEF model can be used to estimated all-cause mortality rate at 30 days after PCI.

Objective To evaluate the long-term follow-up of the unrestricted use of a biodegradable polymer-coated drug-eluting stent in patients undergoing percutaneous coronary intervention (PCI). Methods The Nobori 2 study was a prospective, multicentre, observational registry evaluating the safety and the efficacy of the biodegradable polymer biolimus-eluting stent (BP-BES) among 3067 patients recruited at 125 international sites. The primary combined endpoint was a composite of cardiac death, myocardial infarction and target-lesion revascularisation (TLR). Results Five-year follow-up was available in 2738 (89.3%) patients. The combined endpoint occurred in 268 patients (10%, 95% CIs 8.9% to 11.3%) at 5 years, with 3.9% of events during the first year and 6.2% during years 1–5 of follow-up. Cumulative rates of TLR and definite/probable stent thrombosis were 5.3% (95% CI 4.5% to 6.3%) and 1.1% (95% CI 0.8% to 1.6%), respectively. Between 1 and 5 years, TLR and very late stent thrombosis rates were 3.5% (95% CI 2.8% to 4.4%) and 0.6% (95% CI 0.3% to 1.1%), respectively. Previous PCI (HR, 2.05, 95% CI 1.68 to 2.50), moderate-to-severe renal disease (HR, 1.89, 95% CI 1.30 to 2.74) and peripheral vascular disease (HR, 1.86, 95% CI 1.38 to 2.52) were the three most powerful independent predictors of the combined endpoint at 5 years. Conclusions The final 5-year follow-up of the Nobori 2 registry demonstrates the safety and effectiveness of the BP-BES in an unselected, broadly inclusive cohort of PCI patients, highlighting the excellent performance of this coronary stent technology after polymer biodegradation. Trial registration number ISRCTN81649913; Results.

Aims The inability to optimise stent expansion fully whilst simultaneously preventing distal embolisation during ST-elevation myocardial infarction (STEMI) remains a clinical conundrum. We aimed to describe a newly devised angiographic strategy of "forward" and "back" aspiration that leads to more complete thrombus removal and prevention of distal embolisation, to allow high-pressure post-dilatation of the implanted stent to be performed. Methods and results Forward aspiration was conducted with a conventional aspiration thrombectomy catheter, with bail-out aspiration thrombectomy for angiographically persistent thrombus utilising the larger bore 6 Fr (0.056") guide catheter extension system (GuideLiner; Vascular Solutions, Inc., Minneapolis, MN, USA). Back aspiration was undertaken with a deeply intubated GuideLiner or guide catheter with a vacuum induced within, extending to the inflated angioplasty balloon, to allow for proximal embolic protection during balloon deflation during all stages of the PCI procedure, including high-pressure post-dilatation of the stent to the visually estimated reference vessel diameter (RVD). Over a six-month period 30 consecutive cases were undertaken during working hours. Bail-out GuideLiner-assisted aspiration thrombectomy was performed in 9/30 cases because of inadequate thrombus removal with a conventional aspiration thrombectomy catheter. Back aspiration was performed in all cases. In 27/30 cases high-pressure post-dilatation of the stent was performed. The mean maximum post-dilatation balloon size and mean proximal reference vessel diameter did not significantly differ (3.60±0.41 mm vs. 3.65±0.45 mm, p=0.68). In all cases, implantation +/- post-dilatation of the stent to the visually estimated RVD was achievable without any deterioration in TIMI blood flow or myocardial blush grade. Conclusions The strategy of forward and back aspiration to facilitate stent implantation and high-pressure post-dilatation during STEMI appears to be safe and effective. Randomised controlled trials are required to confirm the safety and efficacy of this newly devised angiographic strategy.

Background\ud Primary percutaneous coronary intervention (PPCI) is the default treatment for patients with ST elevation myocardial infarction (STEMI) and carries a higher risk of adverse outcomes when compared with elective and urgent PCI. Conventional PCI risk scores tend to be complex and may underestimate the risk associated with PPCI due to under-representation of patients with STEMI in their datasets. This study aimed to develop a simple, practical and contemporary risk model to provide risk stratification in PPCI.\ud \ud Methods\ud Demographic, clinical and outcome data were collected for all patients who underwent PPCI between January 2009 and October 2013 at the Northern General Hospital, Sheffield. Multiple regression analysis was used to identify independent predictors of mortality and to construct a risk model. This model was then separately validated on an internal and external dataset.\ud \ud Results\ud The derivation cohort included 2870 patients with a 30-day mortality of 5.1% (145 patients). Only four variables were required to predict 30-day mortality: age [OR:1.047, 95% CI:1.031–1.063], call-to-balloon (CTB) time [OR:1.829, 95% CI:1.198–2.791], cardiogenic shock [OR:13.886, 95% CI:8.284–23.275] and congestive heart failure [OR:3.169, 95% CI:1.420–7.072]. Internal validation was performed in 693 patients and external validation in 660 patients undergoing PPCI. Our model showed excellent discrimination on ROC-curve analysis (C-Stat = 0.87 internal and 0.86, external), and excellent calibration on Hosmer-Lemeshow testing (p = 0.37 internal, 0.55 external).\ud \ud Conclusions\ud We have developed a bedside risk model which can predict 30-day mortality after PPCI using only four variables: age, CTB time, congestive heart failure and shock.

Co-morbidities have typically been considered as prevalent cardiovascular risk factors and cardiovascular diseases rather than systematic measures of general co-morbidity burden in patients who underwent percutaneous coronary intervention (PCI). Charlson co-morbidity index (CCI) is a measure of co-morbidity burden providing a means of quantifying the prognostic impact of 22 co-morbid conditions on the basis of their number and prognostic impact. The study evaluated the impact of the CCI on cardiac mortality and major adverse cardiovascular events (MACE) after PCI through analysis of the Nobori-2 study. The prognostic impact of CCI was studied in 3,067 patients who underwent PCI in 4,479 lesions across 125 centers worldwide on 30-day and 1- and 5-year cardiac mortality and MACE. Data were adjusted for potential confounders using stepwise logistic regression; 2,280 of 3,067 patients (74.4%) had ≥1 co-morbid conditions. CCI (per unit increase) was independently associated with an increase in both cardiac death (odds ratio [OR] 1.47 95% confidence interval [CI] 1.20 to 1.80, p = 0.0002) and MACE (OR 1.29 95% CI 1.14 to 1.47, p ≤0.0011) at 30 days, with similar observations recorded at 1 and 5 years. CCI score ≥2 was independently associated with increased 30-day cardiac death (OR 4.25, 95% CI 1.24 to 14.56, p = 0.02) at 1 month, and this increased risk was also observed at 1 and 5 years. In conclusion, co-morbid burden, as measured using CCI, is an independent predictor of adverse outcomes in the short, medium, and long term. Co-morbidity should be considered in the decision-making process when counseling patients regarding the periprocedural risks associated with PCI, in conjunction with traditional risk factors.

Contains fulltext : 182263.pdf (Publisher’s version ) (Open Access) Aims: To investigate if recent technical and procedural developments in percutaneous coronary intervention (PCI) significantly influence outcomes in appropriately selected patients with three-vessel (3VD) coronary artery disease. Methods and results: The SYNTAX II study is a multicenter, all-comers, open-label, single arm study that investigated the impact of a contemporary PCI strategy on clinical outcomes in patients with 3VD in 22 centres from four European countries. The SYNTAX-II strategy includes: heart team decision-making utilizing the SYNTAX Score II (a clinical tool combining anatomical and clinical factors), coronary physiology guided revascularisation, implantation of thin strut bioresorbable-polymer drug-eluting stents, intravascular ultrasound (IVUS) guided stent implantation, contemporary chronic total occlusion revascularisation techniques and guideline-directed medical therapy. The rate of major adverse cardiac and cerebrovascular events (MACCE [composite of all-cause death, cerebrovascular event, any myocardial infarction and any revascularisation]) at one year was compared to a predefined PCI cohort from the original SYNTAX-I trial selected on the basis of equipoise 4-year mortality between CABG and PCI. As an exploratory endpoint, comparisons were made with the historical CABG cohort of the original SYNTAX-I trial. Overall 708 patients were screened and discussed within the heart team; 454 patients were deemed appropriate to undergo PCI. At one year, the SYNTAX-II strategy was superior to the equipoise-derived SYNTAX-I PCI cohort (MACCE SYNTAX-II 10.6% vs. SYNTAX-I 17.4%; HR 0.58, 95% CI 0.39-0.85, P = 0.006). This difference was driven by a significant reduction in the incidence of MI (HR 0.27, 95% CI 0.11-0.70, P = 0.007) and revascularisation (HR 0.57, 95% CI 0.37-0.9, P = 0.015). Rates of all-cause death (HR 0.69, 95% CI 0.27-1.73, P = 0.43) and stroke (HR 0.69, 95% CI 0.10-4.89, P = 0.71) were similar. The rate of definite stent thrombosis was significantly lower in SYNTAX-II (HR 0.26, 95% CI 0.07-0.97, P = 0.045). Conclusion: At one year, clinical outcomes with the SYNTAX-II strategy were associated with improved clinical results compared to the PCI performed in comparable patients from the original SYNTAX-I trial. Longer term follow-up is awaited and a randomized clinical trial with contemporary CABG is warranted. ClinicalTrials.gov Identifier: NCT02015832.

Background Anomalies of the origin and course of the circumflex artery are amongst the most common seen at coronary angiography. There is limited information regarding patient and procedural characteristics, technical feasibility and outcomes associated with percutaneous intervention (PCI) to these vessels. The aim of this study is to examine our experience with PCI to anomalous circumflex vessels and compare this to some aspects of percutaneous intervention on non-anomalous circumflex vessels. Methods Over a 41month period, 20 PCI procedures on anomalous circumflex vessels were identified and 1550 PCI procedures on non-anomalous circumflex arteries. Results In 9 anomalous cases, the circumflex arose from the left coronary cusp, in 7 cases from the right coronary cusp, and in the remaining 4 cases from the proximal right coronary artery. There were no differences in demographics or pattern or severity of coronary disease between the 2 groups. A higher proportion of patients with anomalous vessels presented acutely. Screening times were longer in the anomalous group. All 20 procedures were associated with immediate procedural success. There was one peri-procedural myocardial infarction unrelated to anomalous circumflex intervention. After a median follow-up period of 7.3months, the only major adverse cardiac event recorded in the anomalous group was an ischaemia-driven revascularisation to a non-target vessel branch. We describe techniques which can be used to improve support and facilitate successful PCI to anomalous circumflex vessels. Conclusion PCI to anomalous circumflex vessels may be technically challenging, but is feasible and carries favourable short and long-term clinical outcomes. Summary This single centre observational study demonstrates that percutaneous coronary intervention to anomalous circumflex coronary arteries although technically challenging can be performed with satisfactory procedural success rates and favourable short and longer-term clinical outcomes. It describes various techniques that can be employed to optimise successful intervention.

Women have a higher risk of adverse outcomes after percutaneous coronary intervention (PCI) than men. However, in acute coronary syndrome (ACS), long-term outcomes after contemporary PCI with drug-eluting stent (DES) have not been fully investigated. We aimed to test the impact of gender on outcomes in patients with ACS after PCI with DES. We analyzed all patients with ACS from the prospective NOBORI-2 trial who underwent PCI with a Nobori DES from 2008 through 2009 in 125 centers worldwide. End points of the study were target lesion failure, cardiac death, myocardial infarction (MI), and clinically driven target lesion revascularization, and major adverse cardiac events (composite of cardiac death, MI, and target vessel revascularization) at 1 year and yearly up to 5 years. There were 1,640 patients with ACS, 1,268 men (77%) and 372 women (23%). Compared to men, women were 5 years older and more frequently had co-morbidities such as diabetes mellitus and hypertension. There were no gender differences for cardiac death (1.3% vs 2.7%), MI (2.1% vs 3.2%), or target lesion revascularization (2.6% vs 3.8%) at 1 year after the procedure for men and women, respectively. The trend was the same at 2 years (cardiac death 2.0% vs 2.3%, MI 2.5% vs 3.5%, target lesion revascularization 3.2% vs 4.6%). Target lesion failure rates were 4.5% and 5.9% at 1 year and 5.7% and 7.3% at 2 years in men and women, respectively (p = NS). Multivariate analysis, which included age, hypertension, diabetes mellitus, and number of diseased vessels, showed that gender was not a predictor for outcome. There were no differences in bleeding or stent thrombosis rates. Relief from anginal symptoms was similar. The same rate of adherence to dual antiplatelet therapy was observed and reached 73% at 1 year and 31% at 2 years after the ACS event and PCI. In conclusion, although women had worse baseline characteristics, no differences in outcomes were observed between men and women treated for ACS with contemporary DES.

AIMS: Modern drug-eluting stents are constructed with thin struts and are easy to deliver and highly conformable. However, although innovative designs have enabled maintenance of radial strength, longitudinal strength may be lower with these stents and there have been recent reports of longitudinal stent compression of ostially deployed stents. We report the experience in our centre on longitudinal stent deformation and explore mechanisms of this complication and its frequency with various drug-eluting stent platforms. METHODS AND RESULTS: Nine cases of longitudinal stent deformation were identified over a four year period representing 0.2% of cases and affected 0.097% of stents deployed. There were several mechanisms for this complication including compression by post-dilatation balloons, guide catheter extensions and proximal embolic protection devices. The rate of stent deformation varied from 0% in several stent types to 0.86% in the case of the Promus Element stent. There was one case of late stent thrombosis attributable to longitudinal stent deformation. CONCLUSIONS: Longitudinal stent deformation can occur secondary to a variety of mechanisms and identification is important as, left untreated, it may be associated with a risk of stent thrombosis. Although seen with several different stents, in our series it was more commonly observed with the Promus Element stent.

Aims: Coronary perforation during percutaneous coronary intervention (PCI) is associated with a high risk of mortality and morbidity. However there has been little data on perforation in the current era despite significant changes in PCI practice. We set out to identify incidence, risk factors and management strategies of coronary perforation in the current era. Methods and results: We performed a retrospective analysis of the Manchester Heart Centre PCI database from June 2004 to May 2008. Detailed analysis of all cases of suspected perforation was undertaken by case note and angiographic review. Demographic data was collected regarding all patients undergoing intervention. A total of 12,729 coronary lesions were treated in 7,903 patients over four years, during which drug-eluting stent (DES) uptake was 77%. The incidence of perforation was 0.56% (44/12,729). Perforation was associated with an inpatient mortality of 15.9% (7/44). Factors associated with perforation were female sex (p=0.003), increasing age (p

We investigated whether plasma long-chain sphingoid base (LCSB) concentrations are altered by transient cardiac ischemia during percutaneous coronary intervention (PCI) in humans and examined the signaling through the sphingosine-1-phosphate (S1P) cascade as a mechanism underlying the S1P cardioprotective effect in cardiac myocytes. Venous samples were collected from either the coronary sinus ( n = 7) or femoral vein ( n = 24) of 31 patients at 1 and 5 min and 12 h, following induction of transient myocardial ischemia during elective PCI. Coronary sinus levels of LCSB were increased by 1,072% at 1 min and 941% at 5 min ( n = 7), while peripheral blood levels of LCSB were increased by 579% at 1 min, 617% at 5 min, and 436% at 12 h ( n = 24). In cultured cardiac myocytes, S1P, sphingosine (SPH), and FTY720, a sphingolipid drug candidate, showed protective effects against CoCl induced hypoxia/ischemic cell injury by reducing lactate dehydrogenase activity. Twenty-five nanomolars of FTY720 significantly increased phospho-Pak1 and phospho-Akt levels by 56 and 65.6% in cells treated with this drug for 15 min. Further experiments demonstrated that FTY720 triggered nitric oxide release from cardiac myocytes is through pertussis toxin-sensitive phosphatidylinositol 3-kinase/Akt/endothelial nitric oxide synthase signaling. In ex vivo hearts, ischemic preconditioning was cardioprotective in wild-type control mice (Pak1f/f), but this protection appeared to be ineffective in cardiomyocyte-specific Pak1 knockout (Pak1cko) hearts. The present study provides the first direct evidence of the behavior of plasma sphingolipids following transient cardiac ischemia with dramatic and early increases in LCSB in humans. We also demonstrated that S1P, SPH, and FTY720 have protective effects against hypoxic/ischemic cell injury, likely a Pak1/Akt1 signaling cascade and nitric oxide release. Further study on a mouse model of cardiac specific deletion of Pak1 demonstrates a crucial role of Pak1 in cardiac protection against ischemia/reperfusion injury.

AIMS: Studies demonstrate that percutaneous coronary intervention (PCI) with drug-eluting stents (DES) is associated with reduced revascularization and major adverse cardiac events (MACE) rates compared to bare metal stents (BMS) in native coronary vessels. Optimal PCI treatment of saphenous vein graft (SVG) lesions remains unclear despite SVG procedures representing up to 10% of PCI cases. We therefore performed a meta-analysis to compare outcomes between BMS and DES in SVG PCI. METHODS AND RESULTS: A search (2004-2009) of MEDLINE and conference proceedings for all relevant studies comparing mortality and MACE outcomes in DES versus BMS in SVG PCI and meta-analysis of the data was performed. Twenty studies were identified from 2005 to 2009 enrolling a total of 5,296 patients. Meta-analysis revealed a decrease in mortality associated with DES use, odds ratio (OR) 0.68; 95% confidence interval (CI) 0.53-0.88; P = 0.004. Similarly, MACE (OR 0.64; 95% CI 0.51-0.82; P < 0.001), total lesion revascularization (OR 0.60; 95% CI 0.43-0.83; P = 0.002), and total vessel revascularization (OR 0.57; 95% CI 0.41-0.80; P = 0.001) were significantly decreased in the patients in which DES were used compared to BMS. This reduction in mortality and MACE events associated with DES use appears to be limited to registry studies and not randomized controlled studies. CONCLUSIONS: Our meta-analysis suggests DES use to be safe in SVG PCI and associated with reduced mortality and MACE rates with reductions in revascularization also observed.

AIMS: Drug eluting stents (DES) have had a great impact in reducing in-stent restenosis (ISR) in de novo lesions. However, long-term data regarding effectiveness and safety of these stents in treating bare metal stent (BMS) ISR are limited. We report long-term clinical outcomes in a cohort of patients with BMS-ISR treated with DES between April 2002 and December 2003 at our institution. METHODS AND RESULTS: Sixty-nine consecutive patients with significant BMS-ISR were treated with DES implantation. Sirolimus DES were used in 43 patients and paclitaxel DES in 26. All patients were followed up to determine the incidence of major adverse cardiac event (MACE) rates (all-cause death, myocardial infarction, or target vessel revascularisation [TVR]), angina class and the need for clinically driven angiography. The mean age of the cohort was 58.6 +/- 10.8 years; 68% were male, 33% were diabetic, 50% had hypertension, 78% were on statin therapy and 59% were current (19%) or previous (41%) smokers. The clinical presentation of ISR was with chronic stable angina in 54 patients, 12 had a non-ST elevation acute coronary syndrome and three presented with ST-elevation myocardial infarction. Multivessel stenting was performed in 21 patients and bifurcation stenting in seven patients. Over a mean follow period of 4.9 years, the first event MACE rate was 20% (17 events in 14 patients - eight deaths of which three were cardiac, two non-fatal myocardial infarctions and seven TVR). Excluding non-cardiac death, the adjusted MACE rate was 14.5% (12 events in 10 patients). At long-term follow-up, mean Canadian angina class decreased from 2.3 +/- 0.7 pre-procedure to 1.2 +/- 0.4, 65% of patients were angina free and 80% were free of MACE. No differences in long-term outcomes were observed between patients receiving paclitaxel and sirolimus DES. CONCLUSIONS: The use of DES for the treatment of BMS-ISR is safe and effective over a mean follow-up period of nearly five years. To our knowledge, this represents the longest follow-up data of real world patients treated in a single interventional centre.

[Chichareon, Ply; Modolo, Rodrigo; Kogame, Norihiro; Takahashi, Kuniaki; Asano, Taku] Acad Med Ctr, Amsterdam, Netherlands. [Katagiri, Yuki] Univ Amsterdam, Acad Med Ctr, Amsterdam, Netherlands. [Chang, Chun-Chin] Taipei Vet Gen Hosp, Taipei, Taiwan. [Collet, Carlos] AMC, Amsterdam, Netherlands. [Neumann, Franz-Josef] Univ Heart Ctr Freiburg Bad Krozingen, Cardiol, Bad Krozingen, Germany. [Oldroyd, Keith] Golden Jubilee Natl Hosp, West Scotland Heart & Lung Ctr, Glasgow, Lanark, Scotland. [Anderson, Richard] Univ Hosp Wales, Cardiff, S Glam, Wales. [Fath-Ordoubadi, Farzin] Manchester Royal Infirm, Manchester, Lancs, England. [Naber, Christoph] Contilia Heart & Vasc Ctr, Essen, Germany. [Garg, Scot] East Lancashire Hosp NHS Trust, Blackburn, Lancs, England. [Petrov, Ivo] Acibadem City Clin Sofia, Sofia, Bulgaria. [Vranckx, Pascal] Hartctr Hasselt, Hasselt, Belgium. [Valgimigli, Marco] Inselspital Bern, Swiss Cardiovasc Ctr, Bern, Switzerland. [Windecker, Stephan] Univ Hosp Bern, Bern, Switzerland. [Onuma, Yoshinobu] Erasmus MC, Thoraxctr, Rotterdam, Netherlands. [Serruys, Patrick] Imperial Coll, London, England.

The aim of this study is to compare the safety and efficacy of the biodegradable polymer coated sirolimus-eluting coronary stent (SES, BioMime™, Meril Life Sciences, India) with durable polymer coated everolimus-eluting coronary stent (EES, XIENCE family, Abbott Vascular, California, USA) in de

The Asahi sheathless guide catheter system is a hydrophilic catheter with a central dilator that does not require an introducer sheath during transradial percutaneous coronary intervention. Conventional sheath introducers are often 1- to 2F larger than the catheter itself; therefore, this system enables the use of a larger French catheter during procedures than would otherwise be possible using conventional techniques. We describe the use of a 7.5F sheathless guide catheter system with a smaller outer diameter than a conventional 6F introducer sheath in 16 cases performed transradially involving rotablation, crush stent bifurcation lesions, 7F proximal protection, and thrombectomy devices. Such cases would otherwise not always be possible if performed using conventional transradial techniques in patients with smaller radial artery sizes.

AIMS: Achievement of the angiographic gold standard TIMI 3 flow (Thrombolysis in Myocardial Infarction) flow grade during PCI (percutaneous coronary intervention) in the setting of AMI (acute myocardial infarction) is insufficient for attainment of optimal prognostic benefit, as there is a poor prognosis for patients with evidence of inadequate flow at the tissue level despite patent coronary arteries. PCI in lesions containing thrombus are associated with an increased risk of complications occurring through dislodgement of thrombotic material resulting and distal embolisation leading to slow flow or even no-reflow. Devices which remove thrombus from coronary arteries (thrombectomy devices) or protect from distal embolisation of thrombus (distal protection devices) are increasingly used in PCI. METHODS AND RESULTS: We have performed a systematic review of the literature to investigate the role of these devices in PCI in the setting of AMI. Use of thrombectomy devices in randomised and multicentre trials in patients undergoing PCI during STEMI is associated with a significant benefit in a number of markers of myocardial perfusion including MBG (myocardial blush grade), ST segment resolution and improvement of distal embolisation, although no significant benefits in mortality have been observed. CONCLUSIONS: There does not appear to be strong evidence for the use of embolic protection devices and distal filter devices in the setting of primary PCI in native coronary arteries, although evidence from trials such as the SAFER trial would make a strong case for their use in SVG interventions.

We evaluated clinical outcome of consecutive patients with in stent restenosis (ISR) treated with drug-eluting stents (DES) at two intervention centres from April 2002 to April 2004, reflecting 'real world' practice.ISR is the major limitation to successful long-term outcome after implantation of bare metal stents during percutaneous coronary intervention (PCI). The optimal strategy for the treatment of ISR has yet to be determined.121 consecutive patients with significant ISR were treated with DES. Sirolimus DES were used in 60 patients and paclitaxel DES in the remainder. All patients were followed up to evaluate the incidence of major adverse cardiac events (MACE), angina class and clinically driven angiography. Data were collected between 7 and 27 months after the procedure (mean follow up of 16.5 months).Overall MACE rate at 16.5 months was 13.2% (16 patients) including 4 deaths (3%). Fifteen (12.3%) patients underwent clinically driven angiography. Eight patients (6.6%) developed ISR within the treated segment, of whom, four underwent further PCI and 4 CABG. Mean Canadian angina class decreased from 2.46+/-0.7 pre-procedure to 0.69+/-0.6 at follow up. All patients achieved an improvement in angina, with 59% being rendered angina free and 87% free of MACE. There were no differences in clinical outcome in those who received a paclitaxel and sirolimus DES.The use of DES implantation for the treatment of ISR is safe, effective and associated with low recurrence rates in a 'real world' large cohort of patients with a complex mix of anatomical and clinical factors.

Background: The limitations of the 12-lead ECG in the detection of myocardial ischaemia are well known. This study sought to test the hypothesis that a Body Surface Mapping (BSM) system can detect and localise the transient regional ischaemia induced by elective percutaneous coronary intervention (PCI) in patients with stable angina. Methods and Results: 25 patients undergoing elective single vessel PCI were studied: 11 with RCA lesions, 9 with LAD lesions and 5 with circumflex lesions. Patients had BSM readings every 30 s following the inflation of a dilating balloon in the target vessel for 1 min. BSMs were analysed for ST segment change at 60 ms after the J point (ST60). Peak ST changes were analysed and colour map reconstruction made. Characteristic ST segment changes in each arterial domain were observed following inflation of the balloon. Maximal change occurred in a standard V lead on only 2/46 occasions. Statistically significant rapid rise and fall of ST 60 readings were observed indicating the onset recovery and location of the transient ischaemia. A novel method for the presentation of colour map reconstruction that removes baseline noise has been developed. Conclusions: These data confirm the hypothesis that this BSM system can detect and display transient myocardial ischaemia. BSM may represent a novel clinical tool for the assessment of clinical ischaemia.

Aims: The aim of this study was to assess the safety and feasibility of manual removal of a non-occlusive coronary thrombus using an open filter device. Between April 2006 and December 2011, 1,102 patients were treated percutaneously for acute coronary syndrome at our institution. Of these, nine (1%) had a large "cannon-ball" non-occlusive intracoronary thrombus, which did not improve with standard thrombectomy aspiration catheters. In these patients, we describe a novel technique of thrombus removal using the ev3 Spider? filter device. Four patients had LAD thrombus, three had RCA thrombus, one LCX thrombus and one SVG thrombus. The primary endpoint of substantial or complete thrombus removal, prevention of no-reflow/slow flow phenomenon and achievement of TIMI 3 flow post stenting was achieved in all cases. Coronary dissection occurred in one case where the lesion was heavily calcified. There were no other complications related to the device. This is the first case series describing the use of the ev3 Spider? filter device for the removal of a large intracoronary thrombus refractory to conventional treatment. This was associated with a high procedural success rate and may reduce the risk of no-reflow in these cases.

OBJECTIVE—Previous studies have suggested that resting myocardial blood flow is within normal limits in most chronically dysfunctional left ventricular segments which improve function after coronary artery revascularisation (hibernating myocardium). The aim of this study was to assess myocardial blood flow and coronary vasodilator reserve in hibernating myocardium before and after coronary revascularisation. PATIENTS AND METHODS— 30 patients with multivessel coronary disease undergoing coronary revascularisation (21 patients with bypass grafting and nine with coronary angioplasty), and 21 age and sex matched healthy volunteers (controls). Myocardial blood flow (MBF, ml/min/g) was measured by positron emission tomography using oxygen-15 water at rest and after dipyridamole (MBFdip, 0.56 mg/kg in four minutes). Coronary vasodilator reserve was calculated as MBFdip/MBF. Regional wall motion was assessed with echocardiography. RESULTS—Before revascularisation there were 48 remote and 275 dysfunctional myocardial segments, of which 163 (59%) improved function after revascularisation (hibernating). In hibernating segments coronary vasodilator reserve before revascularisation was significantly lower than in remote segments (1.97 (0.7), p

Positron emission tomography (PET) in conjunction with (CO2)-O-15 or (H2O)-O-15 can be used to measure myocardial blood flow (MBF) and tissue fraction (TF), i.e, the fraction of the tissue mass in the volume of the region of interest. However, with (CO2)-O-15 inhalation, the tissue fraction in the septum is overestimated. Bolus injection of (H2O)-O-15 together with arterial cannulation gives very precise results but is invasive. The purpose of this study was to develop a method which circumvents these problems. A four-parameter model with parameters for MBF, TF and spill-over fractions from both left and right ventricular cavities was developed. This method was compared with a three-parameter model (no right ventricular cavity spill-over) in both septal and non-septal regions of interest for three different administration protocols: bolus injection of (H2O)-O-15, infusion of (H2O)-O-15 and inhalation of (CO2)-O-15. It was found that MBF can be measured with intravenous administration of (H2O)-O-15 without the requirement for arterial cannulation. The four-parameter protocol with bolus injection was stable in clinical studies. The four-parameter model proved essential for the septum, where it gave highly significantly better fits than did the three-parameter model (P

Background Glucose-insulin-potassium (GIK) therapy has been advocated for the treatment of acute myocardial infarction. However, the results from the clinical trials have been inconclusive, largely because of the small number of patients recruited and discrepancies between protocols used in these studies. Method and Results A systematic MEDLINE search for all the randomized placebo-controlled studies of GIK therapy in acute myocardial infarction was made, and a meta-analysis of the mortality data was performed. Fifteen trials were identified, 5 were excluded because of poor randomization, and 1 was excluded because recruitment was limited to diabetic patients. The 9 remaining trials with a total of 1932 patients were included in the analysis. Hospital mortality was reduced from 21% (205 of 972 patients) in the placebo group to 16.1% (154 of 956) in the GIK group ( P =.004; odds ratio, 0.72; 95% confidence interval [CI], 0.57 to 0.90). The proportional mortality reduction was 28% (CI, 10% to 43%). The number of lives saved per 1000 patients treated was 49 (95% CI, 14 to 83). Conclusions The findings indicate that GIK therapy may have an important role in reducing the in-hospital mortality after acute myocardial infarction. The value of this therapy in the era of thrombolysis and acute revascularization by primary angioplasty can be fully resolved only by conducting a large randomized mortality study.

Aspirin has been reported to cause coronary spasm as well as bronchospasm, but never acute myocardial infarction.

Transradial access for coronary intervention significantly reduces vascular complications and may be associated with a reduced risk of major adverse cardiovascular events. However, the small caliber of the radial artery has been considered a limitation to performing complex coronary intervention. Fifty-three patients with true bifurcation disease, in whom a two-stent strategy was felt to be indicated, were scheduled to undergo crush stenting via the transradial approach. Procedural outcome was recorded and 6- and 18-month clinical follow-up was performed. Successful crush stenting via the radial artery was performed in 51/55 lesions (93%). Crush stenting was performed in 53 lesions overall and successful final kissing inflation was achieved in 51/53 (96%). There were no in-hospital or procedural complications. The overall rate of death, myocardial infarction, or target vessel revascularization was 9.8% at 18-month follow-up. Complex percutaneous coronary intervention requiring large-bore catheters can be performed successfully in a high proportion of patients via the transradial approach. Crush stenting, with a very high rate of final kissing inflation, was associated in this series with excellent procedural and medium-term outcomes.

The Impella Recover LP 2.5® (Abiomed Inc, Danvers, Massachusetts, USA) is an effective and minimally invasive left ventricular assist device and a useful tool in the treatment of patients undergoing high risk percutaneous coronary interventions and critically ill patients with poor left ventricular function. We present the use of the revised Impella Recover LP 2.5® left ventricular assist device, in a patient with acute heart failure and cardiogenic shock secondary to severe Takotsubo cardiomyopathy. The revised Impella Recover LP 2.5® left ventricular assist device is able to provide cardiac output of up to 2.5 l/min. The patient was weaned off the Impella device in 48 hours and was discharged on day 6 of admission without sequelae.

A case is presented of recurrent stent thrombosis unexplained by angiographic appearance, which subsequently revealed a diagnosis of antiphospholipid syndrome secondary to renal cell carcinoma.

Aims: Previous studies for approved indications (on-label) have shown the good safety and efficacy profiles of the Nobori DES. We conducted a prospective, multicentre study to validate the clinical performance of this stent in a real-world setting. Methods and results: A total of 3,067 consecutive patients undergoing a percutaneous coronary intervention with the Nobori DES were enrolled in the NOBORI 2 registry. At one and two years, 97% and 95% of patients, respectively, were available for follow-up. The rates of target lesion failure (TLF), cardiac death, myocardial infarction and target lesion revascularisations were: 3.9%, 1.2%, 1.9% and 2.2% at one year and 5.1%, 1.6%, 2.4% and 3.0% at two years. Overall, 2,242 patients (73%) were treated for at least one off-label indication. When comparing off-label and on-label groups, the results were: TLF 4.5% vs. 2.2%, p=0.003 at one year and 5.9% vs. 2.8%, p=0.001 at two years. The rate of stent thrombosis was 0.68%, and 0.80% at one and two years, respectively with no difference between the off-label and on-label groups (0.76% vs. 0.48%, p=0.6 and 0.89% vs. 0.61%, p=0.5). Conclusions: The promising results previously observed in lower risk patients can be replicated in daily practice. As expected, in off-label indications, rates of adverse events were higher. Nevertheless, our results suggest the good and sustained performance of this stent system in high-risk patients with significant comorbidities and/or complex lesions.

Objective A meta-analysis of all randomised controlled studies that compare outcomes of transradial versus the transfemoral route to better define best practice in patients with ST elevation myocardial infarction (STEMI). Design A Medline and Embase search was conducted using the search terms ‘transradial,’ ‘radial’, ‘STEMI’, ‘myocardial’ and ‘infarction’. Setting Randomised controlled studies that compare outcomes of transradial versus the transfemoral route. Patients A total of nine studies were identified that consisted of 2977 patients with STEMI. Interventions Studies that compare outcomes of transradial versus the transfemoral route. Main outcome measures The primary clinical outcomes of interest were (1) mortality; (2) major adverse cardiac events (MACE); (3) major bleeding and (4) access site complications. Results Transradial PCI was associated with a reduction in mortality (OR 0.53, 95% CI 0.33 to 0.84; p=0.008), MACE (OR 0.62, 95% CI 0.43 to 0.90; p=0.012), major bleeding events (OR 0.63, 95% CI 0.35-1.12; p=0.12) and access site complications (OR 0.30, 95% CI 0.19 to 0.48; p Conclusions This meta-analysis demonstrates a significant reduction in mortality, MACE and major access site complications associated with the transradial access site in STEMI. The meta-analysis supports the preferential use of radial access for STEMI PCI.

Studies demonstrate that percutaneous coronary intervention (PCI) with drug-eluting stents (DES) is associated with reduced revascularization and major adverse cardiac events (MACE) rates compared to bare metal stents (BMS) in native coronary vessels. Optimal PCI treatment of saphenous vein graft (SVG) lesions remains unclear despite SVG procedures representing up to 10% of PCI cases. We therefore performed a meta-analysis to compare outcomes between BMS and DES in SVG PCI.A search (2004-2009) of MEDLINE and conference proceedings for all relevant studies comparing mortality and MACE outcomes in DES versus BMS in SVG PCI and meta-analysis of the data was performed. Twenty studies were identified from 2005 to 2009 enrolling a total of 5,296 patients. Meta-analysis revealed a decrease in mortality associated with DES use, odds ratio (OR) 0.68; 95% confidence interval (CI) 0.53-0.88; P = 0.004. Similarly, MACE (OR 0.64; 95% CI 0.51-0.82; P0.001), total lesion revascularization (OR 0.60; 95% CI 0.43-0.83; P = 0.002), and total vessel revascularization (OR 0.57; 95% CI 0.41-0.80; P = 0.001) were significantly decreased in the patients in which DES were used compared to BMS. This reduction in mortality and MACE events associated with DES use appears to be limited to registry studies and not randomized controlled studies.Our meta-analysis suggests DES use to be safe in SVG PCI and associated with reduced mortality and MACE rates with reductions in revascularization also observed.

AIMS: PCI with drug eluting stents (DES) has been shown to reduce restenosis and major adverse cardiac event (MACE) rates compared to bare metal stents (BMS) in native coronary vessels, although outcomes in saphenous vein graft (SVG) lesions are less clear. We retrospectively studied 388 consecutive patients admitted to our centre for SVG PCI to assess mortality and MACE outcomes (defined as composite endpoint of all-death, stroke, myocardial infarction, stent thrombosis and target lesion (TLR)/vessel (TVR) revascularisation) associated with BMS and DES use. METHODS AND RESULTS: Two hundred and nineteen (219) patients had BMS and 169 had DES (total 388 patients). Mean follow up was 41.9+/-23.5 months. No significant differences were observed in mortality (14.2% vs. 11.8%) or MACE (37.6% vs. 35.8%) between the BMS and DES groups at four years follow-up or at other intervening time points studied. Similarly, no differences in TVR/TLR rates were observed over a similar time period (19.8% vs. 21.6%). CONCLUSIONS: We have observed that DES and BMS use in SVG PCI have comparable mortality and MACE rates, and that in contrast to PCI in native coronary arteries, DES do not reduce revascularisation rates in our study cohort.

AIMS:: Prior coronary artery bypass graft (CABG) surgery is one of the main predictors of failure of transradial PCI. Frequently this is due to difficulty in graft cannulation and/or poor backup support. In addition to Proxis's? embolic protection role, the Proxis?, Heartrail? and GuideLiner? guide catheter extension devices have all been shown to facilitate coronary intervention by increasing backup support and aiding stent delivery. We describe our institution's experiences using these devices to aid transradial graft intervention. METHODS:: Between October 2007-March 2010, the utility and safety of these devices were assessed in consecutive transradial graft intervention procedures. Proxis? cases used for proximal protection alone were excluded. Deep intubation was defined as an intubation depth of ?2cm. RESULTS:: Guide catheter extensions were used in 33 of 41 transradial graft interventions identified. Proxis? was used for proximal protection alone in 3 cases, leaving 30 cases as the study group (Heartrail? n=18, GuideLiner? n=3, Proxis? n=9). In all study cases procedural success with final TIMI-3 flow was achieved. Guide catheter extensions were used to aid during graft cannulation (n=11), to improve backup support via deep intubation (n=26) and as an adjunctive aspiration device (n=11). Filter-based distal embolic protection devices were used in 11/21 Heartrail? and GuideLiner? cases. Deep intubation depths ranged from 30-138mm (mean 61mm) with no complications related to deep intubation seen. CONCLUSIONS:: The use of guide catheter extension systems facilitated transradial graft intervention via several mechanisms including aid to graft cannulation, increasing backup support and as an adjunctive aspiration device. � 2011 Wiley-Liss, Inc.

Failure to deliver stents is one of the commonest causes of procedural failure in contemporary PCI practice. We describe successful use of the Guideliner Catheter, the first purpose designed FDA and CE marked device delivery catheter in 13 complex cases in native coronary vessels and bypass grafts performed via the radial route to enable distal stent delivery following failure of conventional techniques. We discuss how the Guideliner catheter may be used to facilitate difficult radial cases. V C 2010 Wiley-Liss, Inc.

To investigate the relationship between resting distal coronary pressure to aortic pressure ratio (Pd/Pa) and fractional flow reserve (FFR) obtained during maximal hyperemia.FFR is an invasive index of the functional severity of a coronary artery stenosis determined from coronary pressure measurements. It is generally believed that there is little correlation between resting Pd/Pa and FFR obtained during maximal hyperemia. We have therefore studied this relationship in a large cohort of patients who had undergone pressure- wire assessments.528 consecutive pressure-wire studies performed in 483 patients over a 2-year period were retrospectively analyzed.A linear correlation between resting Pd/Pa and FFR post-pharmacological hyperemia was observed (rho = 0.74; p0.0001). When a FFR ofor = 0.75 (oror = 0.80 as per FAME) was defined as positive, a resting Pd/Pa ofor = 0.85 (or = 0.87) had a positive predictive value (PPV) of 95% (94.6%), while a resting Pd/Pa ofor = 0.93 (or = 0.96) had a negative predictive value (NPV) of 95.7% (93%).We demonstrate a strong correlation between resting Pd/Pa and FFR. Resting values of Pd/Pa can be used to predict a positive FFR result with relatively high PPV and NPV. This may potentially obviate the need for adenosine infusion in a proportion of pressure-wire studies.

To the Editor: In a recent article published in the August edition of Circulation: Cardiovascular Interventions , Fokkema et al1 demonstrated that the intracoronary adenosine given during primary percutaneous coronary intervention does not reduce infarct size or the incidence of no reflow phenomenon. In this article, the authors argue that the dose of adenosine they used (240 μg given in 2 120-μg boluses) is sufficient to achieve maximal vasodilation, and they cite an article that suggests 16 μg as the dose sufficient to achieve maximal vasodilatation. This is certainly true for normal coronary circulation. However, we do not feel …