Defining High Bleeding Risk in Patients Undergoing Percutaneous Coronary Intervention.

Identification and management of patients at high bleeding risk undergoing percutaneous coronary intervention are of major importance, but a lack of standardization in defining this population limits trial design, data interpretation, and clinical decision-making. The Academic Research Consortium for High Bleeding Risk (ARC-HBR) is a collaboration among leading research organizations, regulatory authorities, and physician-scientists from the United States, Asia, and Europe focusing on percutaneous coronary intervention-related bleeding. Two meetings of the 31-member consortium were held in Washington, DC, in April 2018 and in Paris, France, in October 2018. These meetings were organized by the Cardiovascular European Research Center on behalf of the ARC-HBR group and included representatives of the US Food and Drug Administration and the Japanese Pharmaceuticals and Medical Devices Agency, as well as observers from the pharmaceutical and medical device industries. A consensus definition of patients at high bleeding risk was developed that was based on review of the available evidence. The definition is intended to provide consistency in defining this population for clinical trials and to complement clinical decision-making and regulatory review. The proposed ARC-HBR consensus document represents the first pragmatic approach to a consistent definition of high bleeding risk in clinical trials evaluating the safety and effectiveness of devices and drug regimens for patients undergoing percutaneous coronary intervention

Amphilimus-eluting stents in coronary artery disease: finally, a sweet spot for patients with diabetes mellitus?

Coronary artery disease (CAD) is a major cause of morbidity and mortality in patients with diabetes mellitus. In real-world registries of patients undergoing percutaneous coronary intervention (PCI), diabetic patients account for between 20 and 45% of treated of patients. Although improvements in preventive care for patients with diabetes in recent years has substantially reduced rates of cardiovascular complications, the incidence of acute myocardial infarction remains approximately five times higher in patients with versus those without diabetes mellitus.</p

Appraising the safety and efficacy profile of left atrial appendage closure in 2016 and the future clinical perspectives. Results of the EAPCI LAAC survey.

AIMS The aim of this study was to determine the opinion of the scientific community regarding percutaneous left atrial appendage closure (LAAC). The main focus of the survey was on concerns and expectations regarding the safety and efficacy profile of LAAC in clinical practice and on current and future clinical perspectives. METHODS AND RESULTS A voluntary web-based survey was distributed by the European Association of Percutaneous Coronary Interventions (EAPCI) to all individuals registered on the EuroIntervention mailing list (n=21,800). A total of 724 physicians responded to the survey, of whom 31.8% had first operator experience with LAAC. Exclusive use of the Amulet (34.4%) or WATCHMAN (30.3%) was similar, but the former was the most frequently used device in Europe. The majority of respondents (59.3%) deemed LAAC to be as effective as, but safer than oral anticoagulants (OAC) in reducing stroke risk. Periprocedural complications (40.3%) and cost (28.8%) were the major concerns. Most practitioners did not consider novel oral anticoagulants (NOACs) to be a deterrent for performing LAAC procedures. Moreover, a history of serious haemorrhage was not deemed necessary to justify LAAC for 59.8% of physicians. CONCLUSIONS The results of this survey reveal a high level of confidence in percutaneous LAAC amongst surveyed interventional cardiologists, with the majority believing it to be as effective as OAC in terms of stroke prevention and safer in terms of bleeding risk

Association of interleukin 6 -174 G/C polymorphism with coronary artery disease and circulating IL-6 levels: a systematic review and meta-analysis

Introduction: Circulating IL-6 levels and at least one polymorphic form of IL6 gene (IL6 -174 G/C, rs1800795) have been shown to be independently associated with coronary artery disease (CAD) by several investigators. Despite more than 12 published meta-analyses on this subject, association of -174 G/C with CAD, especially amongst distinct ancestral population groups remain unclear. We, therefore, conducted a systematic review and an updated meta-analysis to comprehensively ascertain the association of IL6 -174 G/C with CAD and circulating IL-6 levels. Materials and methods: Relevant case-control/cohort studies investigating association of -174 G/C with CAD and circulating IL-6 levels were identified following a comprehensive online search. Association status for CAD was determined for the pooled sample, as well as separately for major ancestral subgroups. Association status for circulating IL-6 levels was assessed for the pooled sample, as well as separately for CAD cases and CAD free controls. Study-level odds ratios (OR) and 95% confidence intervals (CI) were pooled using random/fixed-effects model. Results: Quantitative synthesis for the CAD endpoint was performed using 55 separate qualifying studies with a collective sample size of 51,213 (19,160 cases/32,053 controls). Pooled association of -174 G/C with CAD was found to be statistically significant through dominant (OR 1.15; 95% CI 1.05-1.25, p = 0.002) as well as allelic genetic model comparisons (OR 1.13, 95% CI 1.06-1.21, p = 0.0003). This effect was largely driven by Asian and Asian Indian ancestral subgroups, which also showed significant association with CAD in both genetic model comparisons (OR range 1.29-1.53, p value range ≤ 0.02). Other ancestral subgroups failed to show any meaningful association. Circulating IL-6 levels were found to be significantly higher amongst the 'C' allele carriers in the pooled sample (Standard mean difference, SMD 0.11, 95% CI 0.01-0.22 pg/ml, p = 0.009) as well as in the CAD free control subgroup (SMD 0.10, 95% CI 0.02-0.17 pg/ml, p = 0.009), though not in the CAD case subgroup (SMD 0.17, 95% CI = - 0.02 to 0.37, p = 0.12). Conclusions: The present systematic review and meta-analysis demonstrate an overall association between IL6 -174 G/C polymorphism and CAD, which seems to be mainly driven by Asian and Asian Indian ancestral subgroups. Upregulation of plasma IL-6 levels in the 'C' allele carriers seems to be at least partly responsible for this observed association. This warrants further investigations with large, structured case-control studies especially amongst Asian and Asian Indian ancestral groups.</p

Patent foramen ovale closure versus medical therapy for prevention of recurrent cryptogenic embolism: updated meta-analysis of randomized clinical trials.

BACKGROUND We performed an updated meta-analysis of all randomized-controlled trials (RCTs) comparing patent foramen ovale (PFO) closure with medical therapy for prevention of recurrent ischemic stroke. METHODS AND RESULTS We searched Medline, EMBASE, and Cochrane databases, and proceedings of international meetings for RCTs of patients with cryptogenic stroke and PFO comparing percutaneous PFO closure versus medical therapy for prevention of recurrent ischemic stroke. The primary outcome was a composite ischemic/embolic endpoint comprising stroke, transient ischemic attack (TIA), peripheral embolism, and early death in the intention-to-treat population. Secondary outcomes were all-cause death, stroke, TIA, atrial fibrillation (AF), and major bleeding. Of 3440 enrolled patients across five RCTs, 1829 were allocated to PFO closure and 1611 to medical therapy. The follow-up ranged from 2 to 5.9 years. PFO closure reduced the risk of the composite outcome [HR 0.52, (0.36-0.77); p < 0.01], and stroke, [HR 0.39, (0.19-0.83); p < 0.01], and increased the risk of AF [OR 3.75, (2.44-5.78); p < 0.01] as compared to medical therapy. NNT for stroke was 37 and NNH for AF 49, indicating a net clinical benefit of PFO closure. The meta-analysis had 95% power to detect a 50% relative risk reduction (RRR) in the primary outcome and 89% power to detect a 70% RRR in ischemic stroke. The risk of all-cause death (HR 1.08, p = 0.90), TIA [HR 0.73, (0.49-1.09); p = 0.12], and major bleeding [OR 0.97, (0.44-2.17); p = 0.95] was comparable between the groups. CONCLUSIONS Among patients with cryptogenic stroke and PFO, percutaneous closure of PFO is superior to medical therapy in preventing recurrent ischemic/embolic events and stroke but is associated with an increased risk of AF

Current use of intracoronary imaging in interventional practice - Results of a European Association of Percutaneous Cardiovascular Interventions (EAPCI) and Japanese Association of Cardiovascular Interventions and Therapeutics (CVIT) Clinical Practice Survey.

AIMS This study evaluated the views of the cardiology community on the clinical use of coronary intravascular imaging (IVI). METHODS AND RESULTS A web-based survey was distributed to 31,893 individuals, with 1,105 responses received (3.5% response rate); 1,010 of 1,097 respondents (92.1%) self-reported as interventional cardiologists, 754 (68.7%) with >10 years experience. Overall, 96.1% had personal experience with IVI (95.5% with intravascular ultrasound [IVUS], 69.8% with optical coherence tomography [OCT], and 7.9% with near-infrared spectroscopy); 34.7% of respondents were from Europe and 52.0% were from Asia (45.4% from Japan). The most commonly reported indications for IVI were optimization of stenting (88.5%), procedural/strategy guidance (79.6%), and guidance of left main interventions (77.0%). Most respondents reported perceived equipoise regarding choice between IVUS and OCT for guidance of coronary intervention. High cost (65.9%) and prolongation of the procedure (35.0%) were the most commonly reported factors limiting use. IVI was used more frequently (>15% of cases guided by IVI) in Japan than Europe (96.6% vs. 10.4%, respectively; P<0.001) and by operators with longer interventional experience. CONCLUSIONS In a sample of predominantly experienced interventional cardiologists, there was a high rate of personal experience with IVI in clinical practice. The most commonly identified indications for IVI were optimization of stenting, procedural/strategy guidance, and guidance of left main interventions. Variability in practice patterns is substantial according to geographic region and interventional experience