Virtual non-contrast series of photon-counting detector computed tomography angiography for aortic valve calcium scoring.

The aim of our study was to evaluate two different virtual non-contrast (VNC) algorithms applied to photon counting detector (PCD)-CT data in terms of noise, effectiveness of contrast media subtraction and aortic valve calcium (AVC) scoring compared to reference true non-contrast (TNC)-based results. Consecutive patients underwent TAVR planning examination comprising a TNC scan, followed by a CTA of the heart. VNC series were reconstructed using a conventional (VNCconv) and a calcium-preserving (VNCpc) algorithm. Noise was analyzed by means of the standard deviation of CT-values within the left ventricle. To assess the effectiveness of contrast media removal, heart volumes were segmented and the proportion of their histograms > 130HU was taken. AVC was measured by Agatston and volume score. 41 patients were included. Comparable noise levels to TNC were achieved with all VNC reconstructions. Contrast media was effectively virtually removed (proportions > 130HU from 81% to < 1%). Median calcium scores derived from VNCconv underestimated TNC-based scores (up to 74%). Results with smallest absolute difference to TNC were obtained with VNCpc reconstructions (0.4 mm, Br36, QIR 4), but with persistent significant underestimation (median 29%). Both VNC algorithms showed near-perfect (r²>0.9) correlation with TNC. Thin-slice VNC reconstructions provide equivalent noise levels to standard thick-slice TNC series and effective virtual removal of iodinated contrast. AVC scoring was feasible on both VNC series, showing near-perfect correlation, but with significant underestimation. VNCpc with 0.4 mm slices and Br36 kernel at QIR 4 gave the most comparable results and, with further advances, could be a promising replacement for additional TNC.

Do patients with diabetes with new onset acute myocardial infarction present with different symptoms than non-diabetic patients?

Background: The objective of this study was to investigate the differences in presenting symptoms between patients with and without diabetes being diagnosed with an acute myocardial infarction (AMI). Methods: A total of 5,900 patients with a first-time AMI were included into the analysis. All patients aged between 25 and 84 years were recorded by the population-based Myocardial Infarction Registry in Augsburg, Germany, between 2010 and 2017. The presence (yes/no) of 12 AMI typical symptoms during the acute event was assessed within the scope of a face-to-face interview. Multivariable adjusted logistic regression models were calculated to analyze the associations between presenting symptoms and diabetes mellitus in AMI patients. Results: Patients with diabetes had significantly less frequent typical pain symptoms, including typical chest pain. Also, other symptoms like sweating, vomiting/nausea, dizziness/vertigo and fear of death/feeling of annihilation occurred significantly more likely in non-diabetic patients. The only exception was the symptom of shortness of breath, which was found significantly more often in patients with diabetes. In multivariable-adjusted regression models, however, the observed effects were attenuated. In patients younger than 55 years, the associations between diabetes and various symptoms were mainly missing. Conclusions: Type 2 diabetes mellitus is a risk factor not only for the development of AMI, but is also associated with an adverse outcome after AMI. Atypical clinical presentation additionally complicates the diagnostic process. It is therefore essential for physicians to be aware of the more often atypical symptoms that diabetic AMI patients report.

Health economic consequences of optimal vs. observed guideline adherence of coronary angiography in patients with suspected obstructive stable coronary artery in Germany: a microsimulation model.

AIMS: While the number of patients with stable coronary artery disease (SCAD) is similar across European countries, Germany has the highest per capita volume of coronary angiographies (CA). This study evaluated the health economic consequences of guideline-non-adherent use of CA in patients with SCAD. METHODS AND RESULTS: As part of the ENLIGHT-KHK trial, a prospective observational study, this microsimulation model compared the number of major adverse cardiac events (MACE) and the costs of real-world use of CA with those of (assumed) complete guideline-adherent use (according to the German National Disease Management Guideline 2019). The model considered non-invasive testing, CA, revascularization, MACE (30 days after CA), and medical costs. Model inputs were obtained from the ENLIGHT-KHK trial (i.e. patients' records, a patient questionnaire, and claims data). Incremental cost-effectiveness ratios were calculated by comparing the differences in costs and MACE avoided from the perspective of the Statutory Health Insurance (SHI). Independent on pre-test probability (PTP) of SCAD, complete guideline adherence for usage of CA would result in a slightly lower rate of MACE (-0.0017) and less cost (€-807) per person compared with real-world guideline adherence. While cost savings were shown for moderate and low PTP (€901 and €502, respectively), for a high PTP, a guideline-adherent process results in slightly higher costs (€78) compared with real-world guideline adherence. Sensitivity analyses confirmed the results. CONCLUSION: Our analysis indicates that improving guideline adherence in clinical practice by reducing the amount of CAs in patients with SCAD would lead to cost savings for the German SHI.

Reticulated Platelets Predict Cardiovascular Death and Adverse Events in Coronary Artery Disease: A Systematic Review and Meta-analysis.

BACKGROUND: The pro-thrombotic immature or reticulated platelets (RPs) are known to be elevated in high-risk patients and in different pathological settings. It has been shown that RPs correlate with an insufficient antiplatelet response to antiplatelet agents. RPs are emerging novel predictors of adverse cardiovascular events in cardiovascular disease. This study, using the totality of existing evidence, evaluated the prognostic role of RPs in patients with coronary artery disease. METHODS: We performed a systematic review and meta-analysis including trials of acute and chronic coronary syndrome reporting clinical outcomes according to RPs levels in the peripheral blood. We compared patients with elevated RPs (RPshigh) to patients without elevated RPs (RPslow). Odds ratios (ORs) and 95% CIs were used as metric of choice for treatment effects with random-effects models. The primary endpoint was major adverse cardiovascular and cerebrovascular events (MACCE). Secondary endpoints were cardiovascular death, myocardial infarction, ischemic stroke, urgent coronary revascularization and bleedings. RESULTS: A total of 7 studies, including 2213 patients, were included. The risk for MACCE was significantly higher in RPshigh compared to RPslow patients (OR 2.67 [1.87; 3.81], I2 = 43.8%). RPshigh were associated with cardiovascular death (OR 2.09 [1.36; 3.22], I2 = 40.4%). No associations for RPshigh were detected with the other singular components of MACCE: myocardial infarction (OR 1.73 [0.89; 3.38] I2 = 60.5%) and stroke (OR 1.72 [0.59; 4.96] I2 = 21%). The risk of bleeding did not differ between groups(OR 0.58 [0.15; 2.22] I2 = 86.1%). CONCLUSION: Elevated RPs are significantly associated with increased risk of cardiovascular events and cardiovascular death.

Guideline adherence in the use of coronary angiography in patients presenting at the emergency department without myocardial infarction - Results from the German ENLIGHT-KHK project.

Background: For patients with acute myocardial infarction (AMI), direct coronary angiography (CA) is recommended, while for non-AMI patients, the diagnostic work-up depends on clinical criteria. This analysis provides initial prospective German data for the degree of guideline-adherence (GL) in the use of CA on non-AMI patients presenting at the emergency department (ED) with suspected acute coronary syndrome (ACS) according to the 2015 ESC-ACS-GL. Furthermore the implications of the application of the 2020 ESC-ACS-GL recommendations were evaluated. Methods: Patient symptoms were identified using a standardized questionnaire; medical history and diagnostic work-up were acquired from health records. In accordance with the 2015 ESC-ACS-GL, CA was considered GL-adherent if intermediate risk criteria (IRC) were present or non-invasive, image-guided testing (NIGT) was pathological. Results: Between January 2019 and August 2021, 229 patients were recruited across seven centers. Patients presented with chest pain, dyspnea, and other symptoms in 66.7%, 16.2% and 17.1%, respectively, were in mean 66.3 ± 10.5 years old, and 36.3% were female. In accordance with the 2015 ESC-ACS-GL, the use of CA was GL-adherent for 64.0% of the patients. GL-adherent compared to non-adherent use of CA resulted in revascularization more often (44.5% vs. 17.1%, p < 0.001). Applying the 2020 ESC-ACS-GL, 20.4% of CA would remain GL-adherent. Conclusions: In the majority of cases, the use of CA was adherent to the 2015 ESC-ACS-GL. With regard to the 2020 and 2023 ESC-ACS-GL, efforts to expand the utilization of NIGT are crucial, especially as GL-adherent use of CA is more likely to result in revascularization.(German Clinical Trials Register DRKS00015638; https://drks.de/search/de/trial/DRKS00015638; (registration date: 19 February 2019)).

Baseline fibroblast growth factor 23 is associated with long-term mortality in ST-elevation myocardial infarction-results from the augsburg myocardial infarction registry.

Background: The aim of this study was to investigate the association between inflammatory plasma protein concentrations and long-term mortality in patients with ST-elevation myocardial infarction (STEMI). Methods: For 343 STEMI patients recorded between 2009 and 2013 by the population-based Myocardial Infarction Registry Augsburg, 92 inflammatory plasma proteins were measured at the index event using the OLINK inflammation panel. In multivariable-adjusted Cox regression models, the association between each plasma protein and all-cause long-term mortality was investigated. Median follow-up time was 7.6 (IQR: 2.4) years. For plasma protein that showed a strong association with long-term mortality, a 5-year survival ROC analysis was performed. Results: One plasma protein, namely Fibroblast Growth Factor 23 (FGF-23), was particularly well associated with long-term mortality in the multivariable-adjusted Cox model with an FDR-adjusted p-value of <0.001 and a Hazard Ratio (HR) of 1.57 [95% CI: 1.29-1.91]. In the 5-years ROC analysis, an AUC of 0.6903 [95% CI: 0.594-0.781] was estimated for FGF-23. All other plasma protein didnt show strong associations, each marker with FDR-adjusted p-values >0.05 in the multivariable-adjusted Cox models. Conclusions: FGF-23 is independently associated with long-term mortality after STEMI and might play an important role in the response to myocardial injury. The results suggest FGF-23 to be a useful marker in the long-term treatment of STEMI patients and a potential target for drug development.

Factors influencing adherence to clinical practice guidelines in patients with suspected chronic coronary syndrome: a qualitative interview study in the ambulatory care sector in Germany.

BACKGROUND: Chronic coronary syndrome (CCS) is a potentially progressive clinical presentation of coronary artery disease (CAD). Clinical practice guidelines (CPGs) are available for prevention, diagnosis, and treatment. Embedded in the "ENLIGHT-KHK" healthcare project, a qualitative study was conducted to identify factors that influence guideline adherence from the perspective of general practitioners (GPs) and cardiologists (CA) in the ambulatory care sector in Germany. METHODS: GPs and CAs were surveyed via telephone using an interview guide. The respondents were first asked about their individual approach to caring for patients with suspected CCS. Subsequently, the accordance of their approach with guideline recommendations was addressed. Finally, potential measures for assisting with guideline adherence were discussed. The semi-structured interviews were transcribed verbatim and analysed using a qualitative content analysis in accordance with Kuckartz and Rädiker. Factors influencing adherence to CPGs were categorised by assessing whether they (i) inhibited or facilitated guideline adherence, (ii) played a role in patients at risk of CCS or with suspected or known CCS, (iii) were mentioned in implicit or explicit thematic reference to CPGs, and (iv) were declared a practical problem. RESULTS: Based on interviews with ten GPs and five CAs, 35 potential influencing factors were identified. These emerged at four levels: patients, healthcare providers, CPGs, and the healthcare system. The most commonly cited barrier to guideline adherence among the respondents was structural aspects at the system level, including reachability of providers and services, waiting times, reimbursement through statutory health insurance (SHI) providers, and contract offers. There was a strong emphasis on interdependencies between factors acting at different levels. For instance, poor reachability of providers and services at the system level may result in inexpedience of guideline recommendations at the CPG level. Likewise, poor reachability of providers and services at the system level may be aggravated or alleviated by factors such as diagnostic preferences at the patient level or collaborations at the provider level. CONCLUSIONS: To assist with adherence to CPGs regarding CCS, promoting measures may be needed that account for interdependencies between barriers and facilitators at various healthcare levels. Respective measures should consider medically justified deviations from guideline recommendations in individual cases. TRIAL REGISTRATION: German Clinical Trials Register: DRKS00015638; Universal Trial Number (UTN): U1111-1227-8055.

Evaluation of the guideline-adherence of coronary angiography in patients with suspected chronic coronary syndrome - Results from the German prospective multicentre ENLIGHT-KHK project.

Background: With 900'000 coronary angiographies (CA) per year, Germany has the highest annual per capita volume in Europe. Until now there are no prospective clinical data on the degree of guideline-adherence in the use of CA in patients with suspected chronic coronary syndrome (CCS) in Germany. Methods: Between January 2019 and August 2021, 458 patients with suspected CCS were recruited in nine German centres. Guideline-adherence was evaluated according to the current European Society of Cardiology and German guidelines. Pre-test probability (PTP) for CAD was determined using age, gender, and a standardized patient questionnaire to identify symptoms. Data on the diagnostic work-up were obtained from health records. Results: Patients were in mean 66.6 years old, male in 57.3 %, had known CAD in 48.4 % and presented with typical, atypical, non-anginal chest pain or dyspnoea in 35.7 %, 41.3 %, 23.0 % and 25.4 %, respectively. PTP according to the European guidelines was in mean 24.2 % (11.9 %-36.5 % 95 % CI). 20.9 % of the patients received guideline-recommended preceding non-invasive image guided testing. The use of CA was adherent to the European and German guideline recommendations in 20.4 % and 25.4 %, respectively. In multivariate-analysis, arterial hypertension and prior revascularization were predictors of guideline non-adherence. Conclusion: These are the first prospective clinical data which demonstrated an overall low degree of guideline-adherence in the use of CA in patients with suspected CCS in the German health care setting. To improve adherence rates, the availability of and access to non-invasive image guided testing needs to be strengthened. (German Clinical Trials Registry DRKS00015638 - Registration Date: 19.02.2019).

Methods for assessing guideline adherence for invasive procedures in the care of chronic coronary artery disease: a scoping review.

OBJECTIVES: In the care of coronary artery disease (CAD), evidence questions the adequate application of guidelines for cardiovascular procedures, particularly coronary angiographies (CA) and myocardial revascularisation. This review aims to examine how care providers' guideline adherence for CA and myocardial revascularisation in the care of chronic CAD was assessed in the literature. DESIGN: Scoping review. DATA SOURCES: PubMed and EMBASE were searched through in June 2021 (rerun in September 2022). ELIGIBILITY CRITERIA: We included studies assessing care providers' adherence to evidence-based guidelines for CA or myocardial revascularisation in the care of chronic CAD. Studies had to list the evaluation of guideline adherence as study objective, describe the evaluation methods used and report the underlying guidelines and recommendations. DATA EXTRACTION AND SYNTHESIS: Two independent reviewers used standardised forms to extract study characteristics, methodological aspects such as data sources and variables, definitions of guideline adherence and quantification methods and the extent of guideline adherence. To elucidate the measurement of guideline adherence, the main steps were described. RESULTS: Twelve studies (311 869 participants) were included, which evaluated guideline adherence by (1) defining guideline adherence, (2) specifying the study population, (3) assigning (classes of) recommendations and (4) quantifying adherence. Thereby, primarily secondary data were used. Studies differed in their definitions of guideline adherence, where six studies each considered only recommendation class I/grade A/strong recommendations as adherent or additionally recommendation classes IIa/IIb. Furthermore, some of the studies reported a priori definitions and allocation rules for the assignment of recommendation classes. Guideline adherence results ranged from 10% for percutaneous coronary intervention with prior heart team discussion to 98% for coronary artery bypass grafting. CONCLUSION: Due to remarkable inconsistencies in the assessment, a cautious interpretation of the guideline adherence results is required. Future efforts should endeavour to establish a consistent understanding of the concept of guideline adherence.

Association between admission ECG changes and long-term mortality in patients with an incidental myocardial infarction: Results from the KORA myocardial infarction registry.

BACKGROUND: The aim of this study was to examine the predictive value of specific changes in admission ECG on long-term outcome in acute myocardial infarction (AMI). METHODS: From 2000 until 2017 all AMI cases (n = 9,689) in the study area of Augsburg, Germany, were prospectively recorded. For this study, all patients with a first-time AMI, who survived the first 28 days, were considered. Median observational time was 6.7 years (IQR: 3.6-10.9). Each case was assigned to one of the following groups according to the admission ECG: 'ST-segment elevation', 'ST-segment depression', 'T-wave inversion', 'unspecific changes', 'normal ECG' and 'bundle branch block' (BBB). Multivariable adjusted COX regression models were calculated to compare long-term all-cause mortality. RESULTS: The final regression model revealed a significantly higher mortality among patients with BBB (HR: 1.52 [1.34-1.73], p-value: < 0.001) and 'ST-segment depression' (HR: 1.16 [1.03-1.29], p-value: 0.01252) compared to the STEMI group (reference group). The 'normal ECG' group (HR: 0.76 [0.66-0.87], p-value: < 0.001) on the other hand was associated with significantly lower long-term mortality. The 'T-wave inversion' group (HR: 1.08 [0.96-1.21]) and the 'unspecific changes' group (HR: 1.05 [0.94-1.17]) did not differ significantly from the STEMI group. CONCLUSION: ST-segment depressions and BBB admission ECGs go along with higher long-term mortality in AMI patients compared to STEMI cases. This should be taken into account by physicians when treating patients with NSTEMIs. Only the complete absence of AMI-related ECG changes predicts a more favorable outcome.

No Difference in 30-Day Outcome and Quality of Life in Transradial Versus Transfemoral Access - Results From the German Austrian ABSORB Registry (GABI-R).

BACKGROUND: Radial (RA) instead of femoral access (FA) for coronary interventions has become a European Society of Cardiology Class-IA guideline recommendation. But when the decision on the access site is left to the discretion of the operator, differences in adverse event rates mitigate. METHODS: We compared the 30-day outcome for RA and FA in all patients recruited for the observational German Austrian ABSORB Registry (GABI-R) in regard to all-cause mortality, stroke, myocardial infarction (MI), TIMI major bleedings (TMB) and quality of life (QoL). All patients were treated with a bioresorbable vascular scaffold. Access site was left to the discretion of the operator. RESULTS: In total, 3137 patients included by 92 centers received percutaneous coronary interventions (PCI) for acute MI in 51.5% and non-acute settings in 48.5%. RA was performed in 47.8% and had a higher median radiation exposure (3896 vs. 3082 cGycm2, p < 0.001). There was no difference in the amount of contrast used. There was also no difference in all-cause mortality (0.53% vs. 0.49%, p = 0.86), the combination of death, MI and stroke (1.87% vs. 1.83%, p = 0.94), but a trend towards more TMB (0.47% vs. 1.04%, p = 0.07) with FA. These outcomes were consistent across the subgroups of patients with ST-elevation MI, non-ST-elevation-ACS and stable coronary artery disease. Finally, QoL did not differ between RA and FA. CONCLUSIONS: In this contemporary GABI-R cohort, in which access site was left to the discretion of the operator, both access routes were safe and equal concerning QoL (ClinicalTrials.gov; NCT02066623).

Evaluation of Guideline Adherence for Cardiac Catheterization in Patients With Presumed Obstructive Coronary Artery Disease in Germany (ENLIGHT-KHK) - A Multicentre, Prospective, Observational Study.

INTRODUCTION: The diagnosis or exclusion of obstructive stable coronary artery disease (SCAD) in clinical practice is challenging and therefore clinical guidelines provide recommendations on the use of non-invasive and invasive testing. For Germany, data obtained from the OECD and health insurances indicate a potential non-adherence to guideline-recommended diagnostic pathways. However, there is a lack of prospective and reliable evidence for appropriate use of invasive coronary angiography (CA) in Germany. OBJECTIVE: To provide evidence on the nature and extent of guideline non-adherence in patients undergoing CA with presumed obstructive SCAD in Germany and, to evaluate the clinical and economic consequences of potential deviations in guideline adherence. METHODS: ENLIGHT-KHK is a multicentre, prospective observational study recruiting 1500 patients being admitted for CA with presumed obstructive SCAD and exclusion of acute myocardial infarction (DRKS00015638). The primary outcome measure is the adherence to clinical guidelines in the decision-making process for use of CA. Therefore, the patients' diagnostic pathways and adherence to German and European guidelines will be assessed using clinical data, health-claims data, and a patient questionnaire. The primary safety outcome is a composite of myocardial infarction, stroke and all-cause death. Secondary outcome measures are periprocedural complications and costs. Using a decision-analytic model, the clinical and economic impact of observed guideline adherence in clinical practice will be assessed. Potential barriers and facilitators of guideline-adherent decision-making will be evaluated via semi-structured interviews. CONCLUSIONS: ENLIGHT-KHK will give insights into the appropriateness of invasive CA in Germany and enable the development of concepts to improve guideline-adherence in the German health-care setting.

Two year efficacy and safety of small versus large ABSORB bioresorbable vascular scaffolds of ≤18 mm device length: A subgroup analysis of the German-Austrian ABSORB RegIstRy (GABI-R).

AIMS: The ABSORB bioresorbable vascular scaffold raised safety concerns due to higher rates of scaffold thrombosis (ScT) and adequate scaffold diameter and length for scaffold technology. Smaller scaffold diameter (SScD, 2.5 mm) was an infrequently quoted predictor of major adverse cardiac events (MACE). Therefore, we evaluated the impact of SScD compared to large scaffold diameter (LScD, ≥3 mm) of ≤18 mm device length on 2 year outcome in the all-comer real life GABI-R cohort. METHODS AND RESULTS: We compared patients with implanted LScD (1341 patients) vs. SScD (444 patients) of ≤18 mm device length. Patients with LScD more often presented with ST-elevation myocardial infarction (35.8% vs. 20.6%, p < 0.0001) and single-vessel disease (50.6% vs. 36.5% p < 0.0001). After a 24 months follow-up, there was no difference in regard of MACE (9.66% vs. 12.31%, p = 0.14) or definite/probable ST (2.47% vs. 2.82%, p = 0.71). Despite no difference in target lesion revascularisations (TLR) (5.81% vs. 7.71%, p = 0.18), there was a higher need for target vessel revascularisation (TVR) in the SScD-group (11.57% vs. 7.51%, p < 0.05). CONCLUSION: Compared to LScD, SScD of ≤18 mm device length demonstrated comparable safety in regard to MACE and ScT as well as efficacy in regard to TLR. Resorbable scaffold technology should not be restricted to large vessel diameters. CLINICAL TRIAL REGISTRATION: https://clinicaltrials.gov/ct2/show/NCT02066623.

Systematic investment in the delivery of guideline-coherent therapy reduces mortality and overall costs in patients with ST-elevation myocardial infarction: Results from the Stent for Life economic model for Romania, Portugal, Basque Country and Kemerovo region.

AIMS: The Stent for Life initiative aims at the reduction of mortality in patients with ST-elevation myocardial infarction by enhancing timely access to primary percutaneous coronary intervention. To assess the associated health and socioeconomic impact, the Stent for Life economic project was launched and applied to four model regions: Romania, Portugal, the Basque Country in Spain, and the Kemerovo region in the Russian Federation. METHODS AND RESULTS: The Stent for Life economic model is based on a decision tree that incorporates primary percutaneous coronary intervention rates and mortality. Healthcare costs and indirect costs caused by loss of productivity were estimated. A baseline scenario simulating the status quo was compared to the Stent for Life scenario which integrated changes initiated by the Stent for Life programme. In the four model regions, primary percutaneous coronary intervention numbers rose substantially between 29-303%, while ST-elevation myocardial infarction mortality was reduced between 3-10%. Healthcare costs increased by 8% to 70%. Indirect cost savings ranged from 2-7%. Net societal costs were reduced in all model regions by 2-4%. CONCLUSION: The joint effort of the Stent for Life initiative and their local partners successfully saves lives. Moreover, the increase in healthcare costs was outweighed by indirect cost savings, leading to a net cost reduction in all four model regions. These findings demonstrate that systematic investments to improve the access of ST-elevation myocardial infarction patients to guideline-coherent therapy is beneficial, not only for the individual, but also for the society at large.

Prasugrel vs. clopidogrel in contemporary Western European patients with acute coronary syndromes receiving drug-eluting stents: Comparative cost-effectiveness analysis from the BASKET-PROVE cohorts.

BACKGROUND: Clinical and cost-effectiveness of prasugrel vs. clopidogrel in acute coronary syndrome (ACS) was only evaluated using TRITON-TIMI 38 event rates. A comparative analysis of both drugs in contemporary European ACS patients is lacking. METHODS: To address this issue, cardiac and bleeding events of 2 "sister" multicenter stent trials, BASKET-PROVE (BP) I with clopidogrel and BPII with prasugrel (for 12months each) were used in a hybrid analysis. Medication costs were 2015 sales prices, event costs modelled for Denmark (DNK), Germany (GER) and Switzerland (SUI) and quality adjusted life years (QALY) by EQ-5D-3L questionnaire. RESULTS: In BPI and II, 1012 and 985 ACS-patients received drug eluting stents, respectively, followed-up for 2years. Compared to clopidogrel, prasugrel-treated patients had no more major cardiac events (5.2% vs. 6.4%, p=0.422) nor cardiac deaths (1.6% vs. 1.0%, p=0.255), but more major bleedings (4.0% vs. 1.7%, p<0.001) and altogether no difference in QALYs (-0.027 (95%CI: -0.064/0.011)). Prasugrel caused higher total expenditures per patient: 1116.3 (DNK), 1063.5 (GER) and 880.8 (SUI) EURO, respectively. Accordingly, incremental cost-effectiveness was negative for prasugrel vs. clopidogrel with ratios of -45,907 (DNK), -39,909 (GER) and -33,435 (SUI) EURO/QALY gained, making clopidogrel an economically dominant strategy, even after accounting for the non-randomized comparison. CONCLUSION: Findings of this contemporary European ACS-cohort showed markedly lower cardiac event rates than TRITON-TIMI 38 and no significant difference in 2-year QALYs between prasugrel and clopidogrel-treated patients. At current drug prices, clopidogrel use resulted in an economically dominant treatment strategy in Western European patients.

Impact of stent diameter and length on in-stent restenosis after DES vs BMS implantation in patients needing large coronary stents-A clinical and health-economic evaluation.

AIMS: The British National Institute of Clinical Excellence (NICE) guidelines recommend to use drug-eluting stents (DES) instead of bare-metal stents (BMS) only in lesions >15 mm in length or in vessels <3 mm in diameter. We analyzed the impact of stent length and stent diameter on in-stent restenosis (ISR) in the BASKET-PROVE study population and evaluated the cost-effectiveness of DES compared to BMS. METHODS/RESULTS: The BASKET-PROVE trial compared DES vs BMS in large coronary arteries (≥3 mm). We calculated incremental cost-effectiveness ratios (ICERs) and cost-effectiveness acceptability curves with regard to quality-adjusted life years (QALYs) gained and target lesion revascularizations (TLRs) avoided. A total of 2278 patients were included in the analysis. A total of 74 ISR in 63 patients were observed. In-stent restenosis was significantly more frequent in segments treated with a BMS compared to segments treated with a DES (5.4% vs 0.76%; P<.001). The benefit of a DES compared to a BMS regarding ISR was consistent among the subgroups of stent length >15 mm and ≤15 mm, respectively. With the use of DES in short lesions, there was only a minimal gain of 0.005 in QALYs. At a threshold of 10 000 CHF per TLR avoided, DES had a high probability of being cost-effective. CONCLUSION: In the BASKET-PROVE study population, the strongest predictor of ISR is the use of a BMS, even in patients in need of stents ≥3.0 mm and ≤15 mm lesion length and DES were cost-effective. This should prompt the NICE to reevaluate its recommendation to use DES instead of BMS only in vessels <3.0 mm and lesions >15 mm length.

Isolated double-orifice mitral valve: a case report.

BACKGROUND: Double-orifice mitral valve is an extremely rare cardiac anomaly possibly originating from insufficient endocardial fusion in embryogenesis. Severe concomitant cardiac anomalies and malfunction of the valve usually lead to an early diagnosis in childhood. Therefore the prevalence of isolated double-orifice mitral valve in adulthood is not known. CASE PRESENTATION: We present the case of a 63 years old, female Caucasian patient with isolated double-orifice mitral valve diagnosed in routine echocardiographic evaluation after chemotherapy presenting without clinical symptoms. CONCLUSION: Trans-thoracic echocardiography is a suitable modality to diagnose and further assess anatomical and functional properties of the anomaly. In the presence of double-orifice mitral valve concomitant cardiac anomalies and valvular stenosis or regurgitation must be excluded. If an isolated double-orifice mitral valve with no functional abnormalities is present, no further follow-up is necessary.