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OBJECTIVES We sought to report details of the incidence, organisms, clinical course, and outcomes of prosthetic valve endocarditis (PVE) after transcatheter aortic valve replacement (TAVR) in low-risk patients. BACKGROUND PVE remains a rare but devastating complication of aortic valve replacement. Data regarding PVE after TAVR in low-risk patients are lacking. METHODS We performed a detailed review of all patients in the low-risk TAVR trials who underwent TAVR from 2016 to 2020 and were adjudicated to have definitive PVE by the independent Clinical Events Committee. RESULTS We analyzed 396 low-risk patients who underwent TAVR (including 72 with bicuspid valves). PVE occurred in 11 patients at a median 379 days (210, 528) from TAVR. The incidence within the first 30 days was 0%; days 31-365, 1.5%; and after day 365, 2.8%. The most common organism identified was Streptococcus (n = 4/11). Early PVE (≤ 365 days) occurred in five patients, of whom three demonstrated evidence of embolic stroke and two underwent surgical aortic valve re-intervention. Late PVE (> 365 days) occurred in six patients, of whom thee demonstrated evidence of embolic stroke and only one underwent surgical aortic valve re-intervention. Of the six patients with evidence of embolic stroke, two died, two were discharged to rehabilitation, and two were discharged home with home care. CONCLUSIONS PVE was infrequent following TAVR in low-risk patients but was associated with substantial morbidity and mortality. Embolic stroke complicated the majority of PVE cases, contributing to worse outcomes in these patients. Efforts must be undertaken to minimize PVE in TAVR.

The Academic Research Consortium (ARC) and the Standardized Data Collection for Cardiovascular Trials Initiative have recently published updated clinical and angiographic endpoint definitions for percutaneous coronary intervention trials. The aim of this document is to provide practical guidance to facilitate and harmonize the implementation of those definitions in randomized trials or registries, as well as to foster consistency among independent adjudication committees. The authors compared the ARC-2 and Standardized Data Collection for Cardiovascular Trials Initiative definitions to identify areas of consistency, complex scenarios, and definitions in need of further standardization. Furthermore, the authors compared the fourth universal definition of myocardial infarction with the ARC-2 definition of myocardial infarction. The Society for Cardiovascular Angiography and Interventions definition of periprocedural myocardial infarction was also compared with the ARC-2 definition and the fourth universal definition of myocardial infarction. An in-depth assessment was done for each individual clinical endpoint to guide clinical investigators on reporting and classifying clinical adverse events. Finally, the authors propose standard streamlined data capture templates for reporting and adjudicating death, myocardial infarction, stroke, revascularization, stent or scaffold thrombosis, and bleeding.

Non-adherence has been well recognized for years to be a common issue that significantly impacts clinical outcomes and health care costs. Medication adherence is remarkably low even in the controlled environment of clinical trials where it has potentially complex major implications. Collection of non-adherence data diverge markedly among cardiovascular randomized trials and, even where collected, is rarely incorporated in the statistical analysis to test the consistency of the primary endpoint(s). The imprecision introduced by the inconsistent assessment of non-adherence in clinical trials might confound the estimate of the calculated efficacy of the study drug. Hence, clinical trials may not accurately answer the scientific question posed by regulators, who seek an accurate estimate of the true efficacy and safety of treatment, or the question posed by payers, who want a reliable estimate of the effectiveness of treatment in the marketplace after approval. The Non-adherence Academic Research Consortium is a collaboration among leading academic research organizations, representatives from the U.S. Food and Drug Administration and physician-scientists from the USA and Europe. One in-person meeting was held in Madrid, Spain, culminating in a document describing consensus recommendations for reporting, collecting, and analysing adherence endpoints across clinical trials. The adoption of these recommendations will afford robustness and consistency in the comparative safety and effectiveness evaluation of investigational drugs from early development to post-marketing approval studies. These principles may be useful for regulatory assessment, as well as for monitoring local and regional outcomes to guide quality improvement initiatives.

Aims The aim of this study was to investigate the effect of ticagrelor monotherapy after one-month dual antiplatelet therapy (DAPT) or conventional DAPT in patients with or without acute coronary syndrome (ACS) in the GLOBAL LEADERS Adjudication Sub-StudY (GLASSY). Methods and results Risk estimates were expressed as rate ratios (RR) with 95% confidence intervals (CI). A total of 3,840 ACS and 3,745 stable ischaemic heart disease (SIHD) patients were included. At two years, rates of the co-primary efficacy endpoint, a composite of death, myocardial infarction, stroke or urgent target vessel revascularisation, were 7.94% in the experimental and 9.68% in the control group (RR 0.82, 95% CI: 0.66-1.01) among ACS patients and 6.31% in the experimental and 7.14% in the control group (RR 0.89, 95% CI: 0.69-1.13) among SIHD patients (pint=0.63). Trends for lower and higher risk of BARC 3 or 5 bleeding with the experimental strategy in ACS (2.27% vs 3.00%, RR 0.76, 95% CI: 0.51-1.12) and SIHD (2.70% vs 1.96%, RR 1.39, 95% CI: 0.91-2.12) patients, respectively, were observed with significant interaction testing (pint=0.039). A net clinical benefit endpoint, the composite of both co-primary study endpoints, favoured the experimental treatment among ACS patients only. Conclusions Ticagrelor monotherapy after one-month DAPT provided consistent treatment effects on ischaemic endpoints in patients with or without ACS but only the former experienced a net clinical benefit. ClinicalTrials.gov identifier: NCT03231059.

The coronavirus disease 2019 (COVID-19) pandemic started in Wuhan, Hubei Province, China, in December 2019, and by 24 April 2020, it had affected >2.73 million people in 185 countries and caused >192,000 deaths. Despite diverse societal measures to reduce transmission of the severe acute respiratory syndrome coronavirus 2, such as implementing social distancing, quarantine, curfews and total lockdowns, its control remains challenging. Healthcare practitioners are at the frontline of defence against the virus, with increasing institutional and governmental supports. Nevertheless, new or ongoing clinical trials, not related to the disease itself, remain important for the development of new therapies, and require interactions among patients, clinicians and research personnel, which is challenging, given isolation measures. In this article, the authors summarise the acute effects and consequences of the COVID-19 pandemic on current cardiovascular trials.

Patients in coronary intervention trials may require more than 1 procedure to complete the intended revascularization strategy. However, these staged interventions are not consistently defined. Standardized definitions are needed to allow meaningful comparisons of this outcome among trials. This document provides guidance on relevant parameters involving staged procedures, including minimum data collection and consistent classification of coronary procedures initially identified as staged; the aim is to achieve consistency among clinical trialists, sponsors, health authorities, and regulators. Definitions were developed jointly among representatives of academic institutions and clinical research organizations based on clinical trial experience and published literature. Reasons for staged procedures were identified and include baseline kidney function, contrast load and radiation exposure, lesion complexity, and patient or operator fatigue. Moreover, nonclinical reasons include procedure scheduling and reimbursement. Management of staged procedures should be a standalone section in clinical trial protocols and clinical events committee charters. These documents should clearly define a time window for staged procedures that allows latitude for local policies, while respecting accepted clinical guidelines, and consistency with study objectives. Investigators should document in the case report form the intent to stage a procedure, the lesions to be treated, and the reasons for staging, preferably before randomization. Ideally, all reinterventions, or at least all procedures performed after the recommended time window, those in which data suggest an anticipated procedure due to a worsening condition and those where a revascularization is attempted in the target vessel, should be reviewed by an independent clinical events committee.

Surgical and catheter-based cardiovascular procedures and adjunctive pharmacology have an inherent risk of neurological complications. The current diversity of neurological endpoint definitions and ascertainment methods in clinical trials has led to uncertainties in the neurological risk attributable to cardiovascular procedures and inconsistent evaluation of therapies intended to prevent or mitigate neurological injury. Benefit-risk assessment of such procedures should be on the basis of an evaluation of well-defined neurological outcomes that are ascertained with consistent methods and capture the full spectrum of neurovascular injury and its clinical effect. The Neurologic Academic Research Consortium is an international collaboration intended to establish consensus on the definition, classification, and assessment of neurological endpoints applicable to clinical trials of a broad range of cardiovascular interventions. Systematic application of the proposed definitions and assessments will improve our ability to evaluate the risks of cardiovascular procedures and the safety and effectiveness of preventive therapies.

Background: Residual and significant post-infarction left ventricular (LV) dysfunction, despite technically successful percutaneous coronary intervention (PCI) for ST-elevation myocardial infarction (STEMI), remains an important clinical issue. In preclinical models low dose insulin-like growth factor 1 (IGF1) has potent cytoprotective and positive cardiac remodelling effects. We studied the safety and efficacy of immediate post PCI low dose intracoronary IGF1 infusion in STEMI patients. Methods: Using a double-blind, placebo controlled, multi-dose study design, we randomized 47 STEMI patients with significantly reduced (≤ 40%) LV ejection fraction (LVEF) after successful PCI to single intracoronary infusion of placebo (n=15), 1.5ng IGF1 (n=16) or 15ng IGF1 (n=16). All received optimal medical therapy. Safety endpoints were freedom from hypoglycaemia, hypotension or significant arrhythmias within 1 hour of therapy. The primary efficacy endpoint was LVEF and secondary endpoints were LV volumes, mass, stroke volume, and infarct size at 2 months follow up, all assessed by MRI. Treatment effects were estimated by analysis of covariance adjusted for baseline (24hrs) outcome. Results: No significant differences in safety endpoints occurred between treatment groups out to 30 days (chi squared test, p-value = 0.77).There were no statistically significant differences in baseline (24 hrs post STEMI) clinical characteristics or LVEF among groups. LVEF at 2 months, compared to baseline, increased in all groups with no statistically significant differences related to treatment assignment. However, compared with placebo or 1.5ng IGF1, treatment with 15ng IGF1 was associated with a significant improvement in indexed LV end-diastolic volume (p=0.018), LV mass (p=0.004) and stroke volume (p=0.016). Late gadolinium enhancement (±SD) at 2 months was lower in 15ng IGF1 (34.5±29.6g) compared to placebo (49.1±19.3g) or 1.5ng IGF1 (47.4±22.4g) treated patients, though the result was not statistically significant (p = 0.095). Conclusion: In this pilot trial, low dose IGF1, given after optimal mechanical reperfusion in STEMI, is safe but does not improve LVEF. However, there is a signal for a dose dependent benefit on post MI remodeling that may warrant further study. Despite timely reperfusion by primary PCI (PPCI) a significant cohort of patients develop adverse left ventricular remodelling with clinical sequelae such as arrhythmia and heart failure[1].Therapeutic approaches to avert such remodeling, including a variety of cell therapy and ischemia- reperfusion-injury mitigation trials have achieved modest success 2.;3. Thus, there remains a significant opportunity for novel therapies in this field.

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 Optimal Reperfusion in STEMI is the key goal of the National ACS Programme. The aims of the programme are a diagnosis to door time [DDT] Methods Consecutive patients from January 2016 to December 2017 diagnosed as STEMI or transferred to CUH as part of the National ACS Programme were identified. Patients initially referred to CUH from University Hospital Kerry and appropriately advised to refer to Limerick were excluded. Results 451 patients met CODE STEMI acceptance criteria at CUH within the study period of which 79% were male, with an average age of 63 year. 104 patients were transfers from other hospitals within the PPCI catchment area. 34/451 (7.5%) patients were thrombolysed, 5/34 of which underwent rescue PCI (table 1). The mean time between diagnostic ECG and thrombolysis was 105.4 minutes. 1/34 cases thrombolytic therapy was administered within 10 minutes of STEMI diagnosis. 32/34 survived to discharge [Both deaths had delay until thrombolysis], 30-day and 1-year mortality were both 5.9%. Mean Left ventricular ejection fraction (LVEF) where measured was 42±10%. 7/34 had ventricular arrhythmia (2 in the context of resuscitated out of hospital cardiac arrest pre diagnosis), 0/34 had mechanical complications. 55/451 (12.2%) Patients had DDT > 90 minutes [average 118±62 minutes] and were not thrombolysed; 17/53 were transfers from other hospitals. 52/55 survived to discharge. Of those who underwent PPCI 30-day and 1 year mortality was 6 and 10% respectively. Mean LVEF was 41.6±9%. 8/55 had ventricular arrhythmia. 2/55 were in cardiogenic shock, 2/55 suffered mechanical complications of their ACS. Compared to those were accepted for PPCI with DDT Conclusion Compared to patients who underwent PPCI with a DDT 90 minutes had a trend to inferior outcomes at one year (p=0.23). Delay until thrombolysis was common in our group undergoing thrombolysis. Where diagnosis to door is over 90 minutes thrombolysis should be administered if no contraindications in a time critical fasion. PPCI remains the method of reperfusion in >80% STEMIs referred to CUH.

The definition and clinical implications of myocardial infarction occurring in the setting of percutaneous coronary intervention have been the subject of unresolved controversy. The definitions of periprocedural myocardial infarction (PMI) are many and have evolved over recent years. Additionally, the recent advancement of different imaging modalities has provided useful information on a patients' pre-procedural risk of myocardial infarction. Nonetheless, questions on the benefit of different approaches to prevent PMI and their practical implementation remain open. This review aims to address these questions and to provide a current and contemporary perspective.

OBJECTIVES This study sought to explore the association between biomarker elevation, with creatine kinase-myocardial band (CK-MB) or cardiac troponin (cTn), following percutaneous coronary intervention (PCI) and mortality in patients undergoing PCI for stable angina with normal baseline values. BACKGROUND Several studies have shown a strong association between post-PCI CK-MB elevation and subsequent mortality. However, the prognostic significance of troponin elevation following coronary intervention is still debated. METHODS Patient-level data from 5 contemporary coronary stent trials and 1 large registry were pooled. Mortality of patients with stable angina, with normal baseline biomarkers, was compared between patients with and those without different cutoff values of cTn and CK-MB. RESULTS A total of 13,452 patients were included in this pooled analysis. The overall percentage of patients with elevated biomarkers following PCI was 23.9% for CK-MB and 68.4% for cTn. In the patient cohort for whom both assays were available (n = 8,859), 2.4% had both CK-MB ≥5 × the upper limit of normal (ULN) and cTn ≥35 × ULN, while 92% had both CK-MB

Background: The GLOBAL LEADERS (GLOBAL LEADERS: A Clinical Study Comparing Two Forms of Anti-platelet Therapy After Stent Implantation) study randomly assigned 15,991 patients undergoing percutaneous coronary intervention to 1-month dual antiplatelet therapy (DAPT) followed by 23-month ticagrelor monotherapy or conventional 12-month DAPT followed by 12-month aspirin. Apart from Q-wave myocardial infarction (MI), all study endpoints were analyzed as investigator reported. Objectives: This was a pre-specified ancillary study assessing whether experimental therapy is noninferior, and if met, superior, to conventional treatment for the coprimary efficacy endpoint of all-cause death, nonfatal MI, nonfatal stroke, or urgent target vessel revascularization and superior in preventing BARC 3 (Bleeding Academic Research Consortium) or 5 bleeding (coprimary safety endpoint) at 2 years with a 0.025 significance level to preserve nominal 5% alpha error. Methods: An independent clinical event committee adjudicated investigator-reported and eventually unreported events of 7,585 patients from the 20 top-enrolling participating sites. Results: The 2-year coprimary efficacy endpoint occurred in 271 (7.14%) and in 319 (8.41%) patients in the experimental and conventional groups, respectively (rate ratio [RR]: 0.85; 95% confidence interval [CI]: 0.72 to 0.99), fulfilling noninferiority (p noninferiority

IntroductionThe GLOBAL LEADERS is an open-label, pragmatic and superiority randomised controlled trial designed to challenge the current treatment paradigm of dual antiplatelet therapy (DAPT) for 12 months followed by aspirin monotherapy among patients undergoing percutaneous coronary intervention. By design, all study endpoints are investigator reported (IR) and not subject to formal adjudication by an independent Clinical Event Committee (CEC), which may introduce detection, reporting or ascertainment bias.Methods and analysisWe designed the GLOBAL LEADERS Adjudication Sub-StudY (GLASSY) to prospectively implement, in a large sample of patients enrolled within the GLOBAL LEADERS trial (7585 of 15 991, 47.5%), an independent adjudication process of reported and unreported potential endpoints, using standardised CEC procedures, in order to assess whether 23-month ticagrelor monotherapy (90 mg twice daily) after 1-month DAPT is non-inferior to a standard regimen of DAPT for 12 months followed by aspirin monotherapy for the primary efficacy endpoint of death, non-fatal myocardial infarction, non-fatal stroke or urgent target vessel revascularisation and superior for the primary safety endpoint of type 3 or 5 bleeding according to the Bleeding Academic Research Consortium criteria.This study will comprehensively assess the comparative safety and efficacy of the two tested antithrombotic strategies on CEC-adjudicated ischaemic and bleeding endpoints and will provide insights into the role of a standardised CEC adjudication process on the interpretation of study findings by quantifying the level of concordance between IR-reported and CEC-adjudicated events.Ethics and disseminationGLASSY has been approved by local ethics committee of all study sites and/or by the central ethics committee for the country depending on country-specific regulations. In all cases, they deemed that it was not necessary to obtain further informed consent from individual subjects.Trial registration numberNCT01813435.

AIMS The purpose of this study was to assess the incidence and predictors of graft failure prior to discharge. Multi-slice computed tomography has the ability to evaluate graft patency in a non-invasive way. METHODS AND RESULTS Of 145 consecutive patients who were screened, 73 were included in the study (78% male, mean age 65 years). A total of 206 grafts were analysed (2.8±0.9 grafts/patient). Of the 206 grafts, 126 were venous, 72 were left internal mammary, five were right internal mammary and three were radial grafts. We evaluated 100% of proximal anastomoses sites and 92% (190/206) of the distal anastomoses. We identified five patients (6.8%) who had at least one occluded graft. A total of seven out of 206 (3.4%) grafts were occluded. Independent predictors of successful graft outcome were left anterior descending artery as a recipient artery, good distal run-off as assessed by a surgeon and vessel size larger than 2 mm. CONCLUSIONS The results demonstrate that the in-hospital acute graft failure rate is 3.4% (6.8% of patients). Multi-slice computed tomography is a robust technique to assess novel therapies to reduce the rate of graft attrition further, and might be clinically useful in patients with persistent or early recurrence of symptoms after CABG.

Introduction Bioresorbable vascular scaffolds (BVS) held great promise of overcoming the shortfalls of metallic stents. Significant concerns regarding device thrombosis has quelled this enthusiasm. Some observers have linked this complication to implantation technique. In our institution, bioresorbable vascular scaffolds were predominantly deployed by a single operator in a uniform manner. We reviewed patients who received bioresorbable vascular scaffolds to ascertain our complication rate. Methods A retrospective review of the case notes of all patients receiving BVS in Cork University Hospital since the date of first to last stent use (October 2013 to March 2017). Demographic, procedural and follow up data was collated. Results Between October 2013 and March 2017, 249 BVS were deployed in 154 patients giving an average of 1.6 scaffolds per patient. Follow up data was available on 215 scaffolds (86.4%) deployed in 127 patients (average 1.7 scaffolds per patient, range 1–5). One-hundred (79%) were male. The average age was 58 years (±10). The indication was STEMI 50 patients (39.5%), NSTEMI 37 patients (29%), unstable angina 24 patients (18.9%), stable angina or silent ischaemia 16 patients (12.6%). A single operator was responsible for >99% of procedures. Access was via the radial artery for 104 (48%)of the scaffolds deployed and femoral for the remaining 111 (52%) scaffolds. Of the 215 scaffolds, 107 were to the LAD, 38 to the left circumflex, 64 to the right coronray artery, one to a ramus intermedius, one to a diagonal, 2 to an obtuse marginal, and 2 to vein grafts. All lesions were predilated prior to deployment of the BVS. The median scaffold diameter used was 3.5 mm. Half of all scaffolds were deployed with imaging guideance: 85 with OCT and 22 with IVUS. Ninety-six percent were post dilated. The median post dilation pressure was 20 atmospheres. Two patients were found to have inadequate aposition of stent struts despite high post dilation inflation pressures on OCT and both had deployment of metallic drug eluting stents inside the BVS at the index procedure. One patient had a dissection into the LMS and also received metallic DES. All patients received dual antiplatelets. The average duration of follow up was 587 days (range 1–1448). One in-hospital death occurred. No evidence of stent thrombosis was found at post mortem. Two (1.5%) patients had unplanned target lesion revascularisation (TLR). One had an acute stent thrombosis 4 days after his initial stenting procedure requiring primary baloon angioplasty. This occurred in the context of non compliance with dual antiplatelets. The second had angina and severe in stent restenosis requiring depolyment of metallic drug eluting stents. These subsequently also became stenosed ultimately requiring coronary artery bypass grafting. One patient had a repeat coronary angiogram at 18 months and was found to have a focal aneurysmal segment inside the BVS and was prescribed prolonged antiplatelet therapy. Discussion Despite initial promise the increased rates of stent thrombosis found in several studies has raised concern such that the use of bioresorbable scaffolds has gone into rapid decline. Rates of up to 2.1% at 6 month follow up have been reported. In our study, one patient experienced a stent thrombosis at 4 days post index procedure representing a rate of 0.78% over an average of 19 months of follow up. This occurred in the context of non-compliance with antiplatelet therapy. A high rate of pre and post dilation as well as high rates of intravascular imaging guided deployment and optomisation may explain our low rates of stent thrombosis. Conclusion Further study is required to ascertain the cause of increased stent thrombosis with the use of bioresorbable scaffolds. Our study suggests that meticulous pre and post dilation with the use of intravascular imaging may decrease the risk of this complication.

Aims The MASTER study was designed to compare the performance of a new biodegradable polymer sirolimus-eluting stent (BP-SES) with a bare metal stent (BMS) in patients with ST-segment elevation myocardial infarction (STEMI). Methods and results The study was a prospective, randomised (3:1), controlled, single-blind multicentre trial that enrolled 500 STEMI patients within 24 hours of symptom onset during 2013-2015. Three hundred and seventy-five patients were treated with BP-SES and 125 with BMS. One hundred and four (104) randomised patients underwent angiographic follow-up at six months. The primary clinical endpoint was target vessel failure (TVF), defined as cardiac death, MI not clearly attributable to a non-target vessel, or clinically driven target vessel revascularisation (TVR) at 12 months. The primary angiographic endpoint was in-stent late lumen loss (LLL) at six months in the angiographic cohort. The major secondary endpoint for safety was a composite of all-cause death, recurrent MI, unplanned infarct-related artery revascularisation, stroke, definite stent thrombosis (ST) or major bleeding at one month. At 12 months, TVF had occurred in 6.1% of BP-SES and 14.4% of BMS patients (pnon-inferiority=0.0004), mainly driven by a higher rate of repeat revascularisation in BMS patients. The safety endpoint occurred in 3.5% of BP-SES and 7.2% of BMS patients (p=0.127). In-stent LLL demonstrated the superiority (p=0.0125) of BP-SES (0.09±0.43 mm) over BMS (0.79±0.67 mm). Conclusions The study showed clinical non-inferiority and angiographic superiority of BP-SES versus a comparator BMS, suggesting that this novel DES may be a potential treatment option in STEMI.

The Academic Research Consortium (ARC)-2 initiative revisited the clinical and angiographic end point definitions in coronary device trials, proposed in 2007, to make them more suitable for use in clinical trials that include increasingly complex lesion and patient populations and incorporate novel devices such as bioresorbable vascular scaffolds. In addition, recommendations for the incorporation of patient-related outcomes in clinical trials are proposed. Academic Research Consortium-2 is a collaborative effort between academic research organizations in the United States and Europe, device manufacturers, and European, US, and Asian regulatory bodies. Several in-person meetings were held to discuss the changes that have occurred in the device landscape and in clinical trials and regulatory pathways in the last decade. The consensus-based end point definitions in this document are endorsed by the stakeholders of this document and strongly advocated for clinical trial purposes. This Academic Research Consortium-2 document provides further standardization of end point definitions for coronary device trials, incorporating advances in technology and knowledge. Their use will aid interpretation of trial outcomes and comparison among studies, thus facilitating the evaluation of the safety and effectiveness of these devices.

Objectives This study sought to report the 5-year outcomes of everolimus-eluting stents (EES) and paclitaxel-eluting stents (PES) in an all-comers population undergoing percutaneous coronary intervention (PCI). Background The medium-term 1 and 2-year results of the prospective randomized COMPARE trial (A Trial of Everolimus-Eluting Stents and Paclitaxel-Eluting Stents for Coronary Revascularization in Daily Practice) showed superior clinical outcomes with EES compared with PES in an all-comers PCI population. Whether this benefit is sustained over longer-term follow-up is unknown. Furthermore, systematic long-term follow-up data on these metallic drug eluting stents with durable polymers are scarce. Methods We randomly assigned 1,800 patients undergoing PCI to EES or PES. The pre-specified composite primary endpoint was death, myocardial infarction (MI), or target vessel revascularization (TVR). Results Follow-up at 5 years was completed in 1,791 (99.5%) patients. Treatment with EES compared with PES led to a relative risk reduction of the primary endpoint by 27% (18.4% vs. 25.1%, p = 0.0005), driven by lower rates of MI (7.0% vs. 11.5%, p = 0.001) and TVR (7.4% vs. 11.4%, p = 0.003), but not with mortality (9.0% vs. 10.3%, relative risk 0.88, p = 0.36). Moreover, patients treated with EES compared with PES had lower rates of definite/probable stent thrombosis at 5 years (3.1% vs. 5.9%, p = 0.005). The hazard curves for TVR, MI, and stent thrombosis diverge over the first 3 years and, subsequently, progress in parallel. Conclusions The early- and medium-term superiority of EES over PES measured both by safety and efficacy endpoints is sustained at 5 years in this all-comer population. (A Trial of Everolimus-Eluting Stents and Paclitaxel-Eluting Stents for Coronary Revascularization in Daily Practice [COMPARE]; NCT01016041 )

BACKGROUND The use of drug-eluting stents (DES) in patients at high risk of bleeding or thrombosis has not been prospectively studied; limited data are available in patients who have a low restenosis risk. OBJECTIVES This study sought to compare a hydrophilic polymer-based, second-generation zotarolimus-eluting stent (ZES) with a unique drug fast-release profile versus bare-metal stents (BMS) under similar durations of dual-antiplatelet therapy (DAPT). METHODS We randomly assigned 1,606 patients with stable or unstable symptoms, and who on the basis of thrombotic bleeding or restenosis risk criteria, qualified as uncertain candidates for DES, to receive ZES or BMS. DAPT duration was on the basis of patient characteristics, rather than stent characteristics, and allowed for a personalized 1-month dual antiplatelet regimen. The primary endpoint was the risk of 1-year major adverse cardiovascular events (MACE), which included death, myocardial infarction (MI), or target vessel revascularization (TVR). RESULTS Median DAPT duration was 32 days (interquartile range [IQR]: 30 to 180 days) and did not differ between the groups. In the ZES group, 140 patients (17.5%) reached the primary endpoint, compared with 178 patients (22.1%) in the BMS group (hazard ratio: 0.76; 95% confidence interval: 0.61 to 0.95; p = 0.011) as a result of lower MI (2.9% vs. 8.1%; p < 0.001) and TVR rates (5.9% vs. 10.7%; p = 0.001) in the ZES group. Definite or probable stent thrombosis was also significantly reduced in ZES recipients (2.0% vs. 4.1%; p = 0.019). CONCLUSIONS Compared with BMS, DES implantation using a stent with a biocompatible polymer and fast drug-eluting characteristics, combined with an abbreviated, tailored DAPT regimen, resulted in a lower risk of 1-year MACE in uncertain candidates for DES implantation. (Zotarolimus-eluting Endeavor Sprint Stent in Uncertain DES Candidates [ZEUS] Study; NCT01385319) (C) 2015 by the American College of Cardiology Foundation.

Background Robust evidence exists for Primary PCI of culprit lesions in the setting of a STEMI. Management of non-culprit lesions remains less clear, with evidence showing intervention of non-culprit lesions immediately following Primary PCI reduces unplanned revascularisation, but with no reduction in non fatal MI, or mortality, even when FFR guided revascularisation is used. Aims To review current management of non-culprit lesions in a primary PCI tertiary referral centre in Ireland; to compare the rate of immediate non-culprit PCI with planned subsequent inpatient/outpatient PCI. Methods We obtained retrospective data from our hospital’s STEMI database of all patients who had a diagnosis of STEMI made between January 1st 2015 and December 31st 2015. We used the hospital’s electronic record to obtain details of the initial diagnosis and Primary PCI procedure, as well as any subsequent interventions. We excluded patients who presented following cardiac arrest, or who were treated for cardiogenic shock with inotropes. We excluded patients who had previously undergone CABG. We excluded non-culprit lesions if they involved the left main stem, or if they were chronic total occlusions. Results 178 patients (36 female (20.2%)) were diagnosed with a STEMI in the study period. 100% of these were taken for Primary PCI, of whom 95.0% underwent successful treatment of the culprit lesion. Of the 169 patients who had successful treatment of the culprit lesion, 116 (68.6%) had more than 1 vessel disease, with 88 (52.1%) having a non-culprit lesion >50%. 25 of these patients had presented following cardiac arrest (12), had cardiogenic shock (5), CTO (1), previous CABG (4), or non culprit LMS (3). Of the remaining 63 STEMI patients who had successful treatment of the culprit lesion, only 3 patients underwent non-culprit PCI during the initial procedure, a further 15 patients underwent staged PCI (10 during the initial admission). Overall, within the 178 patients presenting with STEMI, 19 patients underwent staged PCI following STEMI, with 12 of these occurring during the same inpatient stay. 7 patients were referred for CABG. Conclusions 4.8% of patients who were potentially eligible for non-culprit PCI following successful primary PCI of culprit lesions underwent further PCI of non-culprit lesions during the initial procedure, with a further 25% of these patients undergoing PCI in a staged manner. This shows a low rate of non-culprit PCI during the initial procedure, despite 10.7% of all STEMI patients undergoing staged PCI after the initial primary PCI.

Aims To retrospectively review patients who presented with a STEMI to a primary PCI centre between 1st January 2015 and 31st December 2015, and assess their 1 year mortality, refractory angina, unplanned revascularisation and heart failure, and to compare these data with patients who underwent Primary PCI following cardiac arrest or required inotropic support during the procedure. Methods We used the hospitals STEMI registry to obtain patient records for all patients who presented between 1st January 2015 and 31st December 2015 with a STEMI. We used the local electronic records to obtain details about the initial presentation and follow up details. Results 178 patients, 36 female (20.2%) presented to our institution with a STEMI during the study period. Mean age (mean (+/- SD)) was 62.9 years +/- 12.6. Follow up was obtained on 62.4% of patients, with a mean follow up of 11.8 months (+/- 5.4). 95.0% of patients underwent successful primary PCI. At 1 year, overall rates of complications were as follows: death 11.7%, refractory angina 3.6%, unplanned revascularisation 4.5%, non fatal MI 4.5% and heart failure 17.1%. 10 patients (5.6%) presented following cardiac arrest. 3 (1.7%) additional patients were commenced on inotropes during Primary PCI. For primary PCI patients following cardiac arrest or with commencement of inotropic support, the rates of complications at one year were as follows: death 46.2%, refractory angina 0%, non fatal MI 0%, unplanned revascularisation 0%, heart failure 38.5%. Conclusions Mortality post STEMI at one year remains high at 11.7%, rising up to 46.2% in patients post – arrest or requiring inotropic support. The most frequent complication encountered following STEMI is heart failure, which is more frequent in the post arrest patient cohort.

We thank Dr. Shah and colleagues for their interest in our paper [(1)][1], and agree that the fate of renal function after percutaneous coronary intervention (PCI) with or without staged procedures requires further research. Contrast-induced acute kidney injury (CI-AKI) occurs in 1 of 10 patients

Uncertainty remains regarding the exact prognostic impact of biomarker elevation following percutaneous coronary intervention in patients with stable angina pectoris (SAP) and the subsequent risk of death. This study sought, therefore, to evaluate the effect of periprocedural myocardial infarction (

AIMS: We sought to explore whether global and regional scientific output in cardiovascular medicine is associated with economic variables and follows the same trend as medicine and as science overall. METHODS AND RESULTS: We registered the number of documents, number of citations, citations per document and the h-index for the first 50 countries according to the h-index (a measure to evaluate both the productivity and impact of the publications) in cardiovascular medicine. Economic variables (gross domestic product [GDP] per capita, % expenditure of the GDP in research and development [R&D] and health) were obtained from the World Bank, the UNESCO, and the World Health Organization. In total, the scientific output in cardiology showed the same position as in medicine and science overall (mean difference vs. medicine -0.9±5.3º, p=0.25 vs. science -0.7±5.3º, p=0.39). We found significant correlations between the h-index and the % GDP expenditure in R&D (r=0.67, p

Evaluation of new coronary devices and demonstration of their conformity to essential principles of safety and effectiveness requires clinical trials in human subjects. Today, many trials designed to address device-oriented safety and effectiveness rely on quantitative coronary angiographic lesion severity, as an objective reproducible end point to determine whether revascularization for progressive luminal renarrowing after device therapy is clinically indicated. Given the known limitations of angiography to reflect clinical ischemia, concern exists regarding the applicability of such angiographic end points. An invasive objective functional (physiological) assessment of moderate stenoses by coronary pressure–derived fractional flow reserve has evident potential as an adjunct to quantitative coronary angiography in clinical trials. To be implemented as a potential core laboratory technique, standardization in technique and archiving of permanent data storage are imperative. The intent of this report is to propose standards for fractional flow reserve data acquisition and interpretation in coronary device research. Controlled trials with predefined safety and efficacy end points are a critical element in the assessment of new therapies or devices, for approval by regulatory bodies, and subsequent adoption for clinical use by the medical community. It is important that randomized trials adopt meaningful clinical end points that relate to the pathophysiological mechanism(s) most likely responsible for the clinical outcome.1–3 In coronary device investigations, clinically driven repeat revascularization of the target lesion is a key (device-oriented) outcome measure of clinical effectiveness.1 Adjudication of this end point has been based on the presence of clinical symptoms and angiographic lesion severity as determined by a central core laboratory using quantitative coronary angiography (QCA), such that even moderate stenosis (>50% diameter stenosis) by QCA may be considered clinically significant. Most clinical trial designs do not require functional assessment prior to repeat …

textabstractAims: Although large clinical trials have shown that everolimus-eluting stents (EES) significantly reduce target vessel revascularisation (TVR), myocardial infarction (MI) and stent thrombosis (ST) compared to paclitaxel-eluting stents (PES) in diverse populations, there is a paucity of data comparing EES and PES in patients presenting with MI. Methods and results: We performed a post hoc subgroup analysis on COMPARE, an all-comer trial comparing EES to PES. We identified 863 patients (EES=434, PES=429 treated for MI: 452 ST-elevation MI (STEMI) and 411 non ST-elevation MI (NSTEMI). EES was associated with a significant reduction in the primary endpoint, a composite of all-cause mortality, MI, and TVR, at two years (RR=0.57; 95% CI: 0.40-0.83, p=0.002). While the effect was more marked in the STEMI (RR=0.51; 95% CI: 0.30-0.87, p=0.01) than the NSTEMI subgroup (RR=0.65; 95% CI: 0.39-1.08, p=0.09), the interaction p-value (0.5) suggests that a difference in treatment effect between presentations is unlikely. ST rates were significantly lower with EES (RR=0.30; 95% CI: 0.12-0.73, p=0.005). Conclusions: At two years, EES results are superior to PES in terms of safety and efficacy endpoints in treatment of MI.

Objectives The purpose of this study was to compare the safety and efficacy of the Xience V (Abbott Vascular, Santa Clara, California) everolimus-eluting stent (EES) with the Taxus Liberte (Boston Scientific, Natick, Massachusetts) paclitaxel-eluting stent (PES) at 2-year follow-up. Background COMPARE (Comparison of the everolimus eluting XIENCE-V stent with the paclitaxel eluting TAXUS LIBERTE stent in all-comers: a randomized open label trial) demonstrated a superior clinical outcome of EES over PES at 1 year in all comers. Whether this superiority is maintained after discontinuation, at 12 months, of dual antiplatelet therapy is unclear. Methods Patients undergoing percutaneous coronary intervention with limited exclusion criteria were randomly allocated to EES or PES. The 2-year pre-specified endpoints are composites of safety and efficacy and stent thrombosis. Results Follow-up was completed in 1,795 of 1,800 patients (99.7%). The groups had similar baseline characteristics. At 2 years, significantly fewer EES patients took dual antiplatelet therapy (11.4% vs. 15.4%, p = 0.02). The primary composite of all death, nonfatal myocardial infarction, and target vessel revascularization occurred in 9.0% of EES patients and 13.7% of PES patients (relative risk [RR]: 0.66; 95% confidence interval [CI]: 0.50 to 0.86) driven by a lower rate of myocardial infarction (3.9% vs. 7.5%; RR: 0.52; 95% CI: 0.35 to 0.77) and target vessel revascularization (3.2% vs. 8.0%; RR: 0.41; 95% CI: 0.27 to 0.62), in parallel with a lower rate of definite or probable stent thrombosis (0.9% vs. 3.9%; RR: 0.23; 95% CI: 0.11 to 0.49). Differences significantly increased between 1- and 2-year follow-up for the primary composite endpoint (p = 0.04), target vessel revascularization (p = 0.02), and definite or probable stent thrombosis (p = 0.02). Conclusions The substantial clinical benefit of the EES over the PES with regard to measures of both safety and efficacy is maintained at 2 years in real-life practice with an increasing benefit in terms of safety and efficacy between 1 year and 2 years. Comparison of the everolimus eluting XIENCE-V stent with the paclitaxel eluting TAXUS LIBERTE stent in all-comers: a randomized open label trial: The COMPARE Trial [COMPARE 1]; NCT01016041 )

The authors deal with common coronary anomalies, discuss their anatomy and some diagnostic and clinical aspects, and describe some of the principles of management.

Background Hypoenhanced regions on multidetector CT (MDCT) coronary angiography correlate with myocardial hyperperfusion. In addition to a limited capillary density, chronic myocardial infarction (MI) commonly contains a considerable amount of adipose tissue. Objective We explored whether regional myocardial hypoenhancement on contrast-enhanced MDCT could be identified with standard coronary artery calcium (CAC) scoring acquisitions with noncontrast CT. Methods Consecutive patients with a history of MI who were referred for contrast-enhanced MDCT from November 2006 until March 2009 were studied. Noncontrast CT for CAC scoring was also performed. The correlation between regional myocardial hypoenhancement on contrast-enhanced CT and regional myocardial hypoattenuated areas on noncontrast CT was defined. Results Eighty-three patients (mean age, 61.5 ± 12.5 years; n = 67; 81% male) with previous MI were studied. A total of 1411 myocardial segments were evaluated. Two hundred thirty-nine segments (17%) showed myocardial hypoenhancement by MDCT and 140 segments (9.6%) by CAC. On a patient level, noncontrast CT showed a sensitivity, specificity, positive predictive value, (PPV) and negative predictive value (NPV) of 66% (95% CI, 0.53–0.77), 100% (95% CI, 0.76–1.00), 100% (95% CI, 0.90–1.00), and 41% (95% CI, 0.26–0.58), respectively, to detect myocardial hypoenhancement. On a per segment level, noncontrast CT showed a sensitivity, specificity, PPV, and NPV of 58% (95% CI, 0.51–0.64), 100% (95% CI, 0.99–1.00), 99% (95% CI, 0.94–1.00), and 92% (95% CI, 0.90–0.93), respectively, to detect myocardial hypoenhancement. Conclusions Our findings suggest that chronic MI can be detected with standard CAC scoring acquisitions.

Acute coronary syndrome is associated with intracoronary thrombosis secondary to platelet activation. Previous groups have investigated platelet activation in both stable and unstable vascular disease. Most measures of platelet activation are not routinely available or easily adaptable to large scale clinical use. Recently, measurement of the mean platelet component (MPC) has become part of the routine data provided by an automated full blood count analyser, the Advia 120. MPC measures platelet density which changes on platelet activation. Our objectives were to determine if platelet activation, as measured by MPC, is increased in patients with stable coronary artery disease (CAD) and to determine if MPC could be useful in differentiating people with stable CAD from controls on an everyday clinical basis. Three hundred and forty-five consecutive patients attending for elective coronary angiography had full blood count analysis and MPC measurement performed using an ADVIA-120 analyser. Three hundred and twenty-four were analysed in our final dataset. Two hundred and fifty-three (78%) had CAD. Patients with CAD were significantly (p

To determine the adjunctive value of CT coronary angiography (CTCA) in the diagnostic work-up of patients with typical angina pectoris.CTCA was performed in 62 consecutive patients (45 male, mean age 58.8 +/- 7.7 years) with typical angina undergoing diagnostic work-up including exercise-ECG and conventional coronary angiography. Only patients with sinus heart rhythm and ability to breath hold for 20 s were included. Patients with initial heart rates/=70 beats/min received beta-blockers. We determined the post-test likelihood ratios, to detect or exclude patients with significant (/=50% lumen diameter reduction) stenoses, of exercise-ECG and CTCA separately, and of CT performed after exercise-ECG testing. The prevalence of patients with significant coronary artery disease (CAD) was 74%. Positive and negative likelihood ratios for exercise-ECG were 2.3 [95% confidence interval (CI): 1.0-5.3] and 0.3 (95% CI: 0.2-0.7) and for CTCA 7.5 (95% CI: 2.1-27.1) and 0.0 (95% CI: 0.0-8), respectively. CTCA increased the post-test probability of significant CAD after a negative exercise-ECG from 58 to 91%, and after a positive exercise-ECG from 89 to 99%, while CT correctly identified patients without CAD (probability 0%).Non-invasive CTCA is a potentially useful tool, in the diagnostic work-up of patients with typical angina pectoris, both to detect and to exclude significant CAD.

Studies have indicated varying mortality risks with timing of stent thrombosis (ST), but few have been adequately powered with prospective late follow-up. PROTECT randomized 8,709 subjects to either Endeavor zotarolimus-eluting or Cypher sirolimus-eluting stents. PROTECT Continued Access enrolled 1,018 patients treated with Endeavor zotarolimus-eluting stents. Subjects completed at least 4 and 3 years of follow-up, respectively. ARC-defined definite and probable ST events were stratified by time from index procedure: early (≤30 days), late (30 and ≤360 days), and very late (360 days). Rates of death and myocardial infarction were analyzed by ST timing. Median follow-up was 4.1 years. There were 184 ST events (1.9%): 61 early, 27 late, and 96 very late. Patient and procedural characteristics were similar between timing groups. There was no difference in dual-antiplatelet therapy use at discharge (97%) or 1 year (84%). Cardiac death in patients with ST at 4 years occurred in 32.1% compared with 2.5% in patients without ST (p0.001). Combined rates of cardiac death and myocardial infarction did not differ according to ST timing, yet early ST was more commonly associated with cardiac death at 4 years than later ST (50.8% for early vs 18.5% for late vs 24.0% for very late; p0.001). The relation between ST timing and outcomes did not differ between stent types. In conclusion, in prospective data, cardiac death was more common after early ST than later ST. Although ST remains infrequent, continued efforts to determine how to reduce ST, particularly within the first 30 days, are warranted. (The PROTECT trial is registered with ClinicalTrials.gov, number NCT00476957.).

Objectives Our purpose was to assess noninvasive imaging in detection of subclinical atherosclerosis and to examine novel invasive modalities to describe prevalence and temporal changes in putative characteristics of “high-risk” plaques. Background Conventional coronary imaging cannot identify “high-risk” lesions. Methods Conventional (quantitative angiography and intravascular ultrasound [IVUS]) and novel imaging (IVUS-based palpography and gray scale echogenicity) were performed at baseline and 6 months later in 67 patients with diverse clinical presentations. Different imaging techniques were compared within a common segment defined by multislice computed tomography (MSCT). Results Compared with IVUS, the sensitivity, specificity, and positive and negative predictive value of MSCT for detecting significant plaque was 86%, 69%, 90%, and 61%, respectively. In coronary arteries with Conclusions Mild angiographic disease is associated with large atherosclerotic plaques on MSCT. Conventional invasive coronary imaging reveals static luminal and plaque dimensions on standard medical therapy with plaque hypoechogenicity remaining unchanged over the 6-month period. By contrast, palpography measurements of strain correlate with clinical presentation and significantly decrease on standard medical therapy. Novel imaging modalities, such as palpography, might provide insights into plaque biology and might eventually serve as intermediate end points in interventional trials.

Background— Surveillance conventional coronary angiography (CCA) is recommended 2 to 6 months after stent-supported left main coronary artery (LMCA) percutaneous coronary intervention due to the unpredictable occurrence of in-stent restenosis (ISR), with its attendant risks. Multislice computed tomography (MSCT) is a promising technique for noninvasive coronary evaluation. We evaluated the diagnostic performance of high-resolution MSCT to detect ISR after stenting of the LMCA. Methods and Results— Seventy-four patients were prospectively identified from a consecutive patient population scheduled for follow-up CCA after LMCA stenting and underwent MSCT before CCA. Until August 2004, a 16-slice scanner was used (n=27), but we switched to the 64-slice scanner after that period (n=43). Patients with initial heart rates >65 bpm received β-blockers, which resulted in a mean periscan heart rate of 57±7 bpm. Among patients with technically adequate scans (n=70), MSCT correctly identified all patients with ISR (10 of 70) but misclassified 5 patients without ISR (false-positives). Overall, the accuracy of MSCT for detection of angiographic ISR was 93%. The sensitivity, specificity, and positive and negative predictive values were 100%, 91%, 67%, and 100%, respectively. When analysis was restricted to patients with stenting of the LMCA with or without extension into a single major side branch, accuracy was 98%. When both branches of the LMCA bifurcation were stented, accuracy was 83%. For the assessment of stent diameter and area, MSCT showed good correlation with intravascular ultrasound ( r =0.78 and 0.73, respectively). An intravascular ultrasound threshold value ≥1 mm was identified to reliably detect in-stent neointima hyperplasia with MSCT. Conclusions— Current MSCT technology, in combination with optimal heart rate control, allows reliable noninvasive evaluation of selected patients after LMCA stenting. MSCT is safe to exclude left main ISR and may therefore be an acceptable first-line alternative to CCA.

The objective of this study was to investigate the efficacy of guidewire navigation across coronary artery stenoses using magnetic navigation system (MNS) versus conventional navigation. The MNS is a novel option to facilitate access to target lesions, particularly in tortuous vessels. In an experimental study using a challenging vessel phantom, magnetic-navigated guidewire passage has been reported to reduce fluoroscopy and procedure time significantly. Both magnetic and manual guidewire navigation were attempted in 21 consecutive diseased coronary arteries. The study endpoint was defined as an intraluminal wire position distal to the stenosis. Procedural success was defined as successful guidewire passage without procedural events. Procedure time, amount of contrast, fluoroscopy time, and radiation dose/area product (DAP) were evaluated. There were no procedural events related to either guidewire. Although the lesions attempted had relatively simple and straightforward characteristics, significantly shorter procedure and fluoroscopy time were observed for manual guidewire navigation compared to MNS (median, 40 vs. 120 sec, P = 0.001; 38 vs. 105 sec, P = 0.001, respectively). Contrast amount and DAP were higher in MNS than in conventional method (median, 13 vs. 9 ml, P = 0.018; 215 vs. 73 Gym2, P = 0.002, respectively). The magnetic wire did not cross in two vessels. Guidewire navigation using MNS presented a novel, safe, and feasible approach to address coronary artery lesions. Clinical studies are needed to evaluate the potential benefit of the MNS in more complex coronary lesions and tortuous anatomy. © 2006 Wiley-Liss, Inc.

Data on the nature of coronary artery disease in patients with insulin resistance and its treatment have been obtained mostly in the diabetic population. The 'quantitative' and 'qualitative' changes in the course of coronary artery disease and the relationship with the increased rate of cardiac events in this population will be discussed. The effects of various methods of revascularization (bypass surgery vs. percutaneous revascularization) and the potential benefit of recent adjuncts to percutaneous revascularization (stents, drug-eluting stents, antiplatelet agents) will be discussed.

The most effective strategy for bifurcation stenting is currently undefined. The Culotte technique was developed as a method that ensures complete bifurcation lesion coverage. However, it went out of favour due to a high rate of restenosis when utilizing bare metal stents. Drug-eluting stents reduce the rate of restenosis and need for repeat lesion revascularization compared with bare metal stents; we re-evaluated this technique with drug-eluting stent implantation.Between April 2002 and October 2003, 207 patients were treated for at least one bifurcation lesion with drug-eluting stent implantation to both the main vessel and side branch. Of these, 23 were treated with the Culotte technique (11.1%) for 24 lesions. Sirolimus-eluting stents were used in 8.3%, and paclitaxel-eluting stents in the remaining 92.7%.Clinical follow-up was obtained in 100%. One patient had a myocardial infarction at 14 days (maximum rise in creatine kinase 872 IU/L) related to thrombosis occurring in another lesion, and underwent repeat revascularization. There were no episodes of stent thrombosis in the Culotte lesions. At eight months follow-up, there were no deaths and no further myocardial infarction. One patient required target lesion revascularization (TLR), and a second underwent target vessel revascularization. The cumulative rates of survival-free of TLR and major adverse cardiac events were 94.7% and 84.6% respectively. Angiographic follow-up was obtained in 16 patients (69.6%) at a mean period of 8.3+/-4.3 months. The late lumen loss for the main vessel and side branch were 0.48+/-0.56 mm and 0.53+/-0.33 mm respectively, with binary restenosis rates of 18.8% and 12.5%.In this small study of bifurcation stenting utilizing the Culotte technique with drug-eluting stent implantation, there was a low rate of major adverse events and need for target lesion revascularization at eight months, when compared with historical data of bifurcation stenting with bare metal stents. Further re-evaluation of this technique utilizing drug-eluting stents, is warranted in the setting of larger randomized studies.

OBJECTIVES We investigated the efficacy of paclitaxel-eluting stents (PES) compared to sirolimus-eluting stents (SES) when used without restriction in unselected patients. BACKGROUND Both SES and PES have been separately shown to be efficacious when compared to bare stents. In unselected patients, no direct comparison between the two devices has been performed. METHODS Paclitaxel-eluting stents have been used as the stent of choice for all percutaneous coronary interventions in the prospective Taxus-Stent Evaluated At Rotterdam Cardiology Hospital (T-SEARCH) registry. A total of 576 consecutive patients with de novo coronary artery disease exclusively treated with PES were compared with 508 patients treated with SES from the Rapamycin-Eluting Stent Evaluated At Rotterdam Cardiology Hospital (RESEARCH) registry. RESULTS The PES patients were more frequently male, more frequently treated for acute myocardial infarction, had longer total stent lengths, and more frequently received glycoprotein IIb/IIIa inhibitors. At one year, the raw cumulative incidence of major adverse cardiac events was 13.9% in the PES group and 10.5% in the SES group (unadjusted hazard ratio [HR] 1.33, 95% confidence interval [CI] 0.95 to 1.88, p = 0.1). Correction for differences in the two groups resulted in an adjusted HR of 1.16 (95% CI 0.81 to 1.64, p = 0.4, using significant univariate variables) and an adjusted HR of 1.20 (95% CI 0.85 to 1.70, p = 0.3, using independent predictors). The one-year cumulative incidence of clinically driven target vessel revascularization was 5.4% versus 3.7%, respectively (HR 1.38, 95% CI 0.79 to 2.43, p = 0.3). CONCLUSIONS The universal use of PES in an unrestricted setting is safe and is associated with a similar adjusted outcome compared to SES. The inferior trend in crude outcome seen in PES was due to its higher-risk population. A larger, randomized study enrolling an unselected population may assist in determining the relative superiority of either device.

Background— The impact of drug-eluting stent (DES) implantation on the incidence of major adverse cardiovascular events in patients undergoing percutaneous intervention for left main (LM) coronary disease is largely unknown. Methods and Results— From April 2001 to December 2003, 181 patients underwent percutaneous coronary intervention for LM stenosis at our institution. The first cohort consisted of 86 patients (19 protected LM) treated with bare metal stents (pre-DES group); the second cohort comprised 95 patients (15 protected LM) treated exclusively with DES. The 2 cohorts were well balanced for all baseline characteristics. At a median follow-up of 503 days (range, 331 to 873 days), the cumulative incidence of major adverse cardiovascular events was lower in the DES cohort than in patients in the pre-DES group (24% versus 45%, respectively; hazard ratio [HR], 0.52 [95% CI, 0.31 to 0.88]; P =0.01). Total mortality did not differ between cohorts; however, there were significantly lower rates of both myocardial infarction (4% versus 12%, respectively; HR, 0.22 [95% CI, 0.07 to 0.65]; P =0.006) and target vessel revascularization (6% versus 23%, respectively; HR, 0.26 [95% CI, 0.10 to 0.65]; P =0.004) in the DES group. On multivariate analysis, use of DES, Parsonnet classification, troponin elevation at entry, distal LM location, and reference vessel diameter were independent predictors of major adverse cardiovascular events. Conclusions— When percutaneous coronary intervention is undertaken at LM lesions, routine DES implantation, which reduces the cumulative incidence of myocardial infarction and the need for target vessel revascularization compared with bare metal stents, should currently be the preferred strategy.

The aim of this study was to assess the short- and mid-term clinical impact of intravascular ultrasound guidance in 58 patients referred for elective percutaneous treatment of unprotected left main coronary artery disease with drug-eluting stents. The use of intravascular ultrasound, used in 41% of the procedures, was not associated with additional clinical benefit with respect to angiographic-assisted stent deployment.

We performed coronary plaque imaging with 16-row multislice computed tomography in 85 patients who had stable angina pectoris and a high pretest likelihood of having coronary plaque to evaluate plaque burden, i.e., extent (number of diseased coronary segments) and size (small vs large) of plaque. We also assessed type of plaque (calcified, noncalcified, or mixed) and its anatomic distribution. Of 85 patients included, 78 (92%) had fully evaluable multislice computed tomograms that allowed assessment of coronary plaque burden, including major and side branches (or=2 mm), yielding a total of 855 segments. These 78 patients (92% men; mean age +/- SD 58 +/- 11.5 years) were in sinus rhythm, with heart rates of70 beats/min (spontaneous or induced by beta blocker). Plaque was detected in 57% of all segments (487 of 855). The mean number of segments with plaque per patient +/- SD was 6.2 +/- 3.9. Plaque was classified as large in 33% of segments and small in 67%. Overall, 65% of plaques were calcified, 24% were noncalcified, and 11% were mixed. Plaques were predominantly located in the proximal and middle segments of the main coronary vessels.

This study evaluated and compared the efficacy of sirolimus-eluting stents (n = 145 patients) with that of paclitaxel-eluting stents (n = 148 patients) in 293 consecutive unselected patients who had diabetes mellitus. Baseline clinical characteristics and presentations were similar: mean age of 64 years, 50% presented with unstable angina or myocardial infarction, and 66% had multivessel disease. Angiographic and procedural characteristics differed, with more complex lesions and more vein grafts managed in the paclitaxel-eluting stent group. Overall mean stented length was 46 +/- 32 mm. There were no differences in unadjusted outcomes by stent type (1-year major adverse cardiac event rates of 20.4% for sirolimus-eluting stents vs 15.6% for paclitaxel-eluting stents, p = 0.12) or when adjusted for multivariate predictors (adjusted hazard ratio 0.68, 95% confidence interval 0.37 to 1.24, p = 0.21). Independent predictors of outcome in patients who had diabetes mellitus were stenting of the left main artery, stenting of the left anterior descending artery, creatinine clearance, and female gender. Patients who required insulin had a significantly higher, crude major adverse cardiac event rate at 1 year compared with those who used oral agents, but this rate became nonsignificant when adjusted for independent predictors of outcome.