The role of glucose lowering agents on restenosis after percutaneous coronary intervention in patients with diabetes mellitus

Introduction: The prevalence of diabetes is increasing rapidly, and individuals with diabetes are at high risk for cardiovascular disorders. Subsequently the percentage of patients with diabetes subjected to revascularisation, i.e. either percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG) also rises rapidly. The outcome of patients with diabetes after PCI is worse than for patients without diabetes. Restenosis is the main limiting factor of the long-term success of PCI. Although stents and antithrombotics improved outcome after PCI in both diabetics and non-diabetics, diabetics still have a worse prognosis. This leads to the suggestion that the restenosis mechanism in diabetics might be different from that in non-diabetics. Conclusion: Several glucose lowering agents have been shown to influence the restenosis process and thus the outcome after PCI. Current data of especially metformin and thiazolidinediones indicate beneficial results as compared to insulin and sulfonylurea on restenosis. However, no large trials have been undertaken in which the effect of glucose lowering agents on restenosis is associated with improved outcome. The purpose of this review is to summarize the effect of diabetes and glucose lowering agents on restenosis

Design and rationale of DUTCH-AF:a prospective nationwide registry programme and observational study on long-term oral antithrombotic treatment in patients with atrial fibrillation

Introduction Anticoagulation therapy is pivotal in the management of stroke prevention in atrial fibrillation (AF). Prospective registries, containing longitudinal data are lacking with detailed information on anticoagulant therapy, treatment adherence and AF-related adverse events in practice-based patient cohorts, in particular for non-vitamin K oral anticoagulants (NOAC). With the creation of DUTCH-AF, a nationwide longitudinal AF registry, we aim to provide clinical data and answer questions on the (anticoagulant) management over time and of the clinical course of patients with newly diagnosed AF in routine clinical care. Within DUTCH-AF, our current aim is to assess the effect of non-adherence and non-persistence of anticoagulation therapy on clinical adverse events (eg, bleeding and stroke), to determine predictors for such inadequate anticoagulant treatment, and to validate and refine bleeding prediction models. With DUTCH-AF, we provide the basis for a continuing nationwide AF registry, which will facilitate subsequent research, including future registry-based clinical trials. Methods and analysis The DUTCH-AF registry is a nationwide, prospective registry of patients with newly diagnosed 'non-valvular' AF. Patients will be enrolled from primary, secondary and tertiary care practices across the Netherlands. A target of 6000 patients for this initial cohort will be followed for at least 2 years. Data on thromboembolic and bleeding events, changes in antithrombotic therapy and hospital admissions will be registered. Pharmacy-dispensing data will be obtained to calculate parameters of adherence and persistence to anticoagulant treatment, which will be linked to AF-related outcomes such as ischaemic stroke and major bleeding. In a subset of patients, anticoagulation adherence and beliefs about drugs will be assessed by questionnaire. Ethics and dissemination This study protocol was approved as exempt for formal review according to Dutch law by the Medical Ethics Committee of the Leiden University Medical Centre, Leiden, the Netherlands. Results will be disseminated by publications in peer-reviewed journals and presentations at scientific congresses

Campylobacter jejuni: Enterocolitis and myopericarditis

Campylobacter jejuni enteritis is the commonest enteric infection in the developed world. There are only few reported cases in the medical literature of cardiac complications associated with C. jejuni enterocolitis, most of the patients in the reported literature were males and most of the cases followed a benign course. Severe left ventricular dysfunction complicated only two cases of C. jejuni myocarditis. We report here a young male with Campylobacter myopericarditis. We believe that this is the first reported case of Campylobacter associated myopericarditis in The Netherlands. The mechanism by which Campylobacter causes myo(peri) carditis remains uncertain, it may be caused by direct bacterial invasion of cardiac tissue, bacterial toxins, circulating immune complexes, or cytotoxic T-cells. Since the number of C. jejuni infection is increasing worldwide, cardiac complications, although rare, are a remarkable manifestation of this pathogen and should be always kept in mind

The role of glucose lowering agents on restenosis after percutaneous coronary intervention in patients with diabetes mellitus

Abstract Introduction The prevalence of diabetes is increasing rapidly, and individuals with diabetes are at high risk for cardiovascular disorders. Subsequently the percentage of patients with diabetes subjected to revascularisation, i.e. either percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG) also rises rapidly. The outcome of patients with diabetes after PCI is worse than for patients without diabetes. Restenosis is the main limiting factor of the long-term success of PCI. Although stents and antithrombotics improved outcome after PCI in both diabetics and non-diabetics, diabetics still have a worse prognosis. This leads to the suggestion that the restenosis mechanism in diabetics might be different from that in non-diabetics. Conclusion Several glucose lowering agents have been shown to influence the restenosis process and thus the outcome after PCI. Current data of especially metformin and thiazolidinediones indicate beneficial results as compared to insulin and sulfonylurea on restenosis. However, no large trials have been undertaken in which the effect of glucose lowering agents on restenosis is associated with improved outcome. The purpose of this review is to summarize the effect of diabetes and glucose lowering agents on restenosis.</p

Autoperfusion balloon catheter for complicated coronary angioplasty: prospective study with retrospective controls

Prolonged angioplasty balloon inflation with an autoperfusion balloon for failed conventional coronary angioplasty, was compared with emergency surgery for this condition. Restenosis was assessed 6 weeks after successful intervention with the autoperfusion balloon. Forty consecutive patients with persistent acute occlusion and/or severe intimal dissection during conventional angioplasty, were treated with the autoperfusion balloon. They were candidates for emergency surgery if it failed. Total inflation time was significantly longer (p <0.001) with the autoperfusion balloon (27.5; 10-180 min) than with the standard balloon (10; 1-20 min) (median; range). The number of inflations was significantly lower (p <0.001) with the autoperfusion balloon (2; 1-5 times) than with the standard balloon (5; 2-14 times) (median; range). Two patients died, one before surgery could be performed. The autoperfusion balloon was successful in 26 patients (65%). After 6 weeks, 16 (62%) were asymptomatic without anti-anginal medication, 24 underwent repeat angiography, 10 (42%) had restenosis, 7 (27%) underwent elective bypass surgery. Emergency surgery remained necessary in 13 patients (33%), 9 received arterial grafts. In 31 retrospective controls, who had undergone immediate surgery for the same indication, only venous grafts could be used. Thus, prolonged autoperfusion balloon inflation was successful in 65% of the cases of failed, conventional angioplasty. The angiographic restenosis rate after 6 weeks was 42%. If emergency surgery remained necessary, the autoperfusion balloon facilitated the use of arterial bypass grafts

Assessment of ICD eligibility in non-ischaemic cardiomyopathy patients:a position statement by the Task Force of the Dutch Society of Cardiology

International guidelines recommend implantation of an implantable cardioverter-defibrillator (ICD) in non-ischaemic cardiomyopathy (NICM) patients with a left ventricular ejection fraction (LVEF) below 35% despite optimal medical therapy and a life expectancy of more than 1 year with good functional status. We propose refinement of these recommendations in patients with NICM, with careful consideration of additional risk parameters for both arrhythmic and non-arrhythmic death. These additional parameters include late gadolinium enhancement on cardiac magnetic resonance imaging and genetic testing for high-risk genetic variants to further assess arrhythmic risk, and age, comorbidities and sex for assessment of non-arrhythmic mortality risk. Moreover, several risk modifiers should be taken into account, such as concomitant arrhythmias that may affect LVEF (atrial fibrillation, premature ventricular beats) and resynchronisation therapy. Even though currently no valid cut-off values have been established, the proposed approach provides a more careful consideration of risks that may result in withholding ICD implantation in patients with low arrhythmic risk and substantial non-arrhythmic mortality risk.</p

Guideline-adherent antithrombotic treatment is associated with improved outcomes compared with undertreatment in high-risk patients with atrial fibrillation. The Euro Heart Survey on Atrial Fibrillation

Background The Euro Heart Survey showed that antithrombotic treatment in patients with atrial fibrillation (AF) was moderately tailored to the 2001 American College of Cardiology, American Heart Association, and European Society of Cardiology (ACC/AHA/ESC) guidelines for the management of AF. What consequences does guideline-deviant antithrombotic treatment have in daily practice? Methods In the Euro Heart Survey on AF (2003-2004), an observational study on AF care in European cardiology practices, information was available on baseline stroke risk profile and antithrombotic drug treatment and on cardiovascular events during 1-year follow-up. Antithrombotic guideline adherence is assessed according to the 2001 ACC/AHA/ESC guidelines. Multivariable logistic regression was performed to assess the association of guideline deviance with adverse outcome. Results The effect of antithrombotic guideline deviance was analyzed exclusively in 3634 high-risk patients with AF because these composed the majority (89%) and because few cardiovascular events occurred in low-risk patients. Among high-risk patients, antithrombotic treatment was in agreement with the guidelines in 61% of patients, whereas 28% were undertreated and 11% overtreated. Compared to guideline adherence, undertreatment was associated with a higher chance of thromboembolism (odds ratio [OR], 1.97; 95% CI, 1.29-3.01; P = .004) and the combined end point of cardiovascular death, thromboembolism, or major bleeding (OR, 1.54; 95% CI, 1.14-2.10; P = .024). This increased risk was nonsignificant for the end point of stroke alone (OR, 1.42; 95% CI, 0.82-2.46; P = .170). Overtreatment was nonsignificantly associated with a higher risk for major bleeding (OR, 1.52; 95% CI, 0.76-3.02; P = .405). Conclusions Antithrombotic undertreatment of high-risk patients with AF was associated with a worse cardiovascular prognosis during 1 year, whereas overtreatment was not associated with a higher chance for major bleeding

Cost Effectiveness of the Angiotensin Receptor Neprilysin Inhibitor Sacubitril/Valsartan for Patients with Chronic Heart Failure and Reduced Ejection Fraction in the Netherlands:A Country Adaptation Analysis Under the Former and Current Dutch Pharmacoeconomic Guidelines

Objectives: To describe the adaptation of a global health economic model to determine whether treatment with the angiotensin receptor neprilysin inhibitor LCZ696 is cost effective compared with the angiotensin-converting enzyme inhibitor enalapril in adult patients with chronic heart failure with reduced left ventricular ejection fraction in the Netherlands; and to explore the effect of performing the cost-effectiveness analyses according to the new pharmacoeconomic Dutch guidelines (updated during the submission process of LCZ696), which require a value-of-information analysis and the inclusion of indirect medical costs of life-years gained. Methods: We adapted a UK model to reflect the societal perspective in the Netherlands by including travel expenses, productivity loss, informal care costs, and indirect medical costs during the life-years gained and performed a preliminary value-of-information analysis. Results: The incremental cost-effectiveness ratio obtained was (sic)17,600 per quality-adjusted life-year (QALY) gained. This was robust to changes in most structural assumptions and across different subgroups of patients. Probability sensitivity analysis results showed that the probability that LCZ696 is cost-effective at a (sic)50,000 per QALY threshold is 99.8%, with a population expected value of perfect information of (sic)297,128. On including indirect medical costs of life-years gained, the incremental cost-effectiveness ratio was (sic)26,491 per QALY gained, and LCZ696 was 99.46% cost effective at (sic)50,000 per QALY, with a population expected value of perfect information of (sic)2,849,647. Conclusions: LCZ696 is cost effective compared with enalapril under the former and current Dutch guidelines. However, the (monetary) consequences of making a wrong decision were considerably different in both scenarios. Copyright (C) 2017, International Society for Pharmacoeconomics and Outcomes Research (ISPOR). Published by Elsevier Inc