Search

Background: Both patients with obstructive coronary artery disease (CAD) and patients with peripheral arterial disease (PADs) have an increased bleeding risk. Information is scarce on bleeding in CAD patients, treated with percutaneous coronary intervention (PCI), who have comorbid PADs. We assessed whether PCI patients with PADs have a higher bleeding risk than PCI patients without PADs. Furthermore, in PCI patients with PADs we evaluated the extent by which bleeding increased the risk of further adverse events. Methods: Three-year pooled patient-level data of two randomized PCI trials (BIO-RESORT, BIONYX) with drug-eluting stents were analyzed to assess mortality and the composite endpoint major adverse cardiac events (MACE: all-cause mortality, any myocardial infarction, emergent coronary artery bypass surgery, or target lesion revascularization). Results: Among 5989 all-comer patients, followed for 3 years, bleeding occurred in 7.7% (34/440) with comorbid PADs and 5.0% (279/5549) without PADs (HR: 1.59, 95%CI: 1.11–2.23, p = 0.010). Of all PADs patients, those with a bleeding had significantly higher rates of all-cause mortality (HR: 4.70, 95%CI: 2.37–9.33, p < 0.001) and MACE (HR: 2.39, 95%CI: 1.23–4.31, p = 0.003). Furthermore, PADs patients with a bleeding were older (74.4 ± 6.9 vs. 67.4 ± 9.5, p < 0.001). After correction for age and other potential confounders, bleeding remained independently associated with all-cause mortality (adj.HR: 2.97, 95%CI: 1.37–6.43, p = 0.006) while the relation of bleeding with MACE became borderline non-significant (adj.HR: 1.85, 95%CI: 0.97–3.55, p = 0.06). Conclusion: PCI patients with PADs had a higher bleeding risk than PCI patients without PADs. In PADs patients, bleeding was associated with all-cause mortality, even after adjustment for potential confounders.

Non-contrast computed tomography (CT) scanning allows for reliable coronary calcium score (CCS) calculation at a low radiation dose and has been well established as marker to assess the future risk of coronary artery disease (CAD) events in asymptomatic individuals. However, the diagnostic and prognostic value in symptomatic patients remains a matter of debate. This narrative review focuses on the available evidence for CCS in patients with stable chest pain complaints.PubMed, Embase, and Web of Science were searched for literature using search terms related to three overarching categories: CT, symptomatic chest pain patients, and coronary calcium. The search resulted in 42 articles fulfilling the inclusion and exclusion criteria: 27 articles (n = 38 137 patients) focused on diagnostic value and 23 articles (n = 44 683 patients) on prognostic value of CCS. Of these, 10 articles (n = 21 208 patients) focused on both the diagnostic and prognostic value of CCS.Between 22 and 10 037 patients were included in the studies on the diagnostic and prognostic value of CCS, including 43 % and 51 % patients with CCS 0. The most evidence is available for patients with a low and intermediate pre-test probability (PTP) of CAD. Overall, the prevalence of obstructive CAD (OCAD, defined as a luminal stenosis of ≥ 50 % in any of the coronary arteries) as determined with CT coronary angiography in CCS 0 patients, was 4.4 % (n = 703/16 074) with a range of 0-26 % in individual studies. The event rate for major adverse cardiac events (MACE) ranged from 0 % to 2.1 % during a follow-up of 1.6 to 6.8 years, resulting in a high negative predictive value for MACE between 98 % and 100 % in CCS 0 patients. At increasing CCS, the OCAD probability and MACE risk increased. OCAD was present in 58.3 % (n = 617/1058) of CCS 400 patients with percentages ranging from 20 % to 94 % and MACE occurred in 16.7 % (n = 175/1048) of these patients with percentages ranging from 6.9 % to 50 %.Accumulating evidence shows that OCAD is unlikely and the MACE risk is very low in symptomatic patients with CCS 0, especially in those with low and intermediate PTPs. This suggests a role of CCS as a gatekeeper for additional diagnostic testing. Increasing CCS is related to an increasing probability of OCAD and risk of cardiac events. Additional research is needed to assess the value of CCS in women and patient management in a primary healthcare setting.· A CCS of zero makes OCAD in patients at low-intermediate PTP unlikely. · A CCS of zero is related to a very low risk of MACE. · Categories of increasing CCS are related to increasing rates of OCAD and MACE. · Future studies should focus on the diagnostic and prognostic value of CCS in symptomatic women and the role in primary care.· Koopman MY, Willemsen RT, van der Harst P et al. The Diagnostic and Prognostic Value of Coronary Calcium Scoring in Stable Chest Pain Patients: A Narrative Review. Fortschr Röntgenstr 2022; 194: 257 - 265.Die kontrastfreie Computertomografie (CT) ermöglicht eine zuverlässige Berechnung des koronaren Kalziumscores (KKS) bei niedriger Strahlendosis und hat sich als Marker zur Beurteilung des Risikos für koronare Herzkrankheiten (KHK) bei asymptomatischen Personen bewährt. Der diagnostische und prognostische Wert bei symptomatischen Patienten bleibt jedoch umstritten. Die vorliegende Übersichtsarbeit befasst sich mit der verfügbaren Evidenz des KKS bei Patienten mit stabilen Brustschmerzbeschwerden.In PubMed, Embase und Web of Science wurde eine Literaturrecherche mit Suchbegriffen zu drei übergeordneten Kategorien durchgeführt: CT, Patienten mit symptomatischen Brustschmerzen und Koronarkalk. Die Suche ergab 42 Artikel, die die Ein- und Ausschlusskriterien erfüllten: 27 Artikel (n = 38 137 Patienten) konzentrierten sich auf den diagnostischen Wert und 23 Artikel (n = 44 683 Patienten) auf den prognostischen Wert des KKS. Davon befassten sich 10 Artikel (n = 21 208 Patienten) mit dem diagnostischen und dem prognostischen Wert des KKS.In die Studien zum diagnostischen und prognostischen Wert des KKS wurden zwischen 22 und 10 037 Patienten eingeschlossen, darunter 43 % bzw. 51 % Patienten mit KKS0. Die meisten Erkenntnisse liegen für Patienten mit einer niedrigen und mittleren Prätestwahrscheinlichkeit (PTP) für KHK vor. Insgesamt lag die Prävalenz der obstruktiven KHK (OKHK, definiert als luminale Stenose von ≥ 50 % in einer der Koronararterien), die mittels CT-Koronarangiografie bei KKS0-Patienten bestimmt wurde, bei 4,4 % (n = 703/16 074) mit einem Bereich von 0–26 % in einzelnen Studien. Die Ereignisrate für schwerwiegende unerwünschte kardiale Ereignisse („major adverse cardiac events“ MACE) reichte von 0 % bis 2,1 % während einer Nachbeobachtungszeit von 1,6 bis 6,8 Jahren, was bei KKS 0-Patienten zu einem hohen negativen Vorhersagewert für MACE zwischen 98 % und 100 % führte. Mit zunehmendem KKS stiegen die OKHK-Wahrscheinlichkeit und das MACE-Risiko. Bei 58,3 % (n = 617/1058) der Patienten mit einem KKS 400 lag eine OKHK vor, wobei die Spanne von 20 % bis 94 % reichte. Bei 16,7 % (n = 175/1048) dieser Patienten trat ein MACE auf, mit einer Spanne von 6,9 % bis 50 %.Es gibt zunehmend mehr Hinweise darauf, dass bei symptomatischen Patienten mit KKS0 eine OKHK unwahrscheinlich und das MACE-Risiko sehr gering ist, insbesondere bei den Patienten mit niedriger und mittlerer PTP. Dies weist auf eine „Torwächter“-Rolle des KKS hinsichtlich zusätzlicher diagnostischer Tests hin. Mit zunehmendem KKS steigt sowohl die Wahrscheinlichkeit einer OKHK als das Risiko für kardiale Ereignisse. Weitere Forschungsarbeiten sind erforderlich, um den Wert des KKS bei Frauen und beim Patientenmanagement im Rahmen der medizinischen Grundversorgung zu bewerten.

Objective: Post-COVID syndrome leaves millions of people with severe fatigue, yet little is known about its nature in daily life. In this exploratory study, momentary associations between physical and mental fatigue, quality of sleep and behaviours over two weeks in patients with post-COVID syndrome were assessed. Method: Data on fatigue levels, quality of sleep and behaviours was collected for 14 consecutive days using the experience sampling method in ten ex-hospitalised patients with post-COVID syndrome. Results: Multilevel linear regression modelling showed strong associations between physical and mental fatigue (β = 0.61, p ≤0.001), significant both between and within individuals. Sleeping more hours at night was associated with less physical and mental fatigue the following day (β = −0.35, p = .001; β = −0.27, p = .008). Strenuous relaxation (B = 0.45, p ≤0.001; B = 0.28, p = .004) and social contacts (B = −0.33, p = .003; B = −0.22, p = .02) were associated with physical and mental fatigue at the same measurement point. Performing household chores decreased physical and mental fatigue (B = −0.29, p = .02; B = −0.30, p = .006) two hours later on the same day, whereas eating and drinking increased physical fatigue (B = 0.20, p = .05) two hours later on the same day. Conclusion: Physical fatigue and mental fatigue were strongly associated and revealed fluctuations in fatigue levels between individuals, which might suggest potentially different post-COVID subgroups. Indications for potential risk and beneficial behaviours for fatigue were found.

Background: At 1 year, the international randomized BIONYX trial (ClinicalTrials.gov:NCT02508714) established non-inferiority regarding safety and efficacy of the novel Resolute Onyx zotarolimus-eluting stent (RO-ZES) vs. the Orsiro sirolimus-eluting stent (O-SES). Although the RO-ZES is used in daily practice, no clinical results have been published beyond 2 years. Methods and Results: We assessed 3-year clinical outcomes of 2,488 all-comers after percutaneous coronary intervention (PCI) with RO-ZES vs. O-SES. The main endpoint was target vessel failure (TVF), a composite of cardiac death, target vessel myocardial infarction (MI), or target vessel revascularization. Time-to-endpoints was assessed by Kaplan-Meier methods and between-group comparisons by log-rank tests. Follow-up was available in 2,433/2,488 (97.8%) patients. There was no significant between-stent difference in TVF (RO-ZES 112/1,243 [9.2%] vs. O-SES 109/1,245 [8.9%], hazard ratio [HR]: 1.03, 95% confidence interval [CI] 0.79-1.34; Plog-rank=0.85) and its individual components. The all-cause mortality was significantly lower after PCI with RO-ZES (3.7% vs.5.4%, HR: 0.67, 95% CI 0.46-0.97; Plog-rank=0.034), but cardiac mortality did not differ significantly (1.1% vs.1.9%, HR: 0.56, 95% CI 0.28-1.11; Plog-rank=0.09). Definite-or-probable stent thrombosis rates were low for both groups (0.6% vs.1.2%, HR: 0.46, 95% CI 0.19-1.14; Plog-rank=0.09). Conclusions: This first 3-year randomized assessment of the RO-ZES showed a favorable rate of TVF that matched the outcomes of patients treated with O-SES. We observed a lower rate of all-cause death in the RO-ZES group, but long-term clinical follow-up is of interest. Biotronik; Medtronic

Background Diabetes is associated with adverse outcomes after percutaneous coronary intervention with drug-eluting stents (DES), but for prediabetes this association has not been definitely established. Furthermore, in patients with prediabetes treated with contemporary stents, bleeding data are lacking. We assessed 3-year ischemic and bleeding outcomes following treatment with new-generation DES in patients with prediabetes and diabetes as compared to normoglycemia. Methods For this post-hoc analysis, we pooled patient-level data of the BIO-RESORT and BIONYX stent trials which both stratified for diabetes at randomization. Both trials were multicenter studies performed in tertiary cardiac centers. Study participants were patients of whom glycemic state was known based on hemoglobin A1c, fasting plasma glucose, or medically treated diabetes. Three-year follow-up was available in 4212/4330 (97.3 %) patients. The main endpoint was target vessel failure, a composite of cardiac death, target vessel myocardial infarction, or target vessel revascularization. Results Baseline cardiovascular risk profiles were progressively abnormal in patients with normoglycemia, prediabetes, and diabetes. The main endpoint occurred in 54/489 patients with prediabetes (11.2 %) and 197/1488 with diabetes (13.7 %), as compared to 142/2,353 with normoglycemia (6.1 %) (HR: 1.89, 95 %-CI 1.38–2.58, p Conclusions Not only patients with diabetes but also patients with prediabetes represent a high-risk population. After treatment with new-generation DES, both patient groups had higher risks of ischemic and bleeding events. Differences in major bleeding were mainly attributable to dissimilarities in baseline characteristics. Routine assessment of glycemic state may help to identify patients with prediabetes for intensified management of cardiovascular risk factors. Trial registration: BIO-RESORT ClinicalTrials.gov: NCT01674803, registered 29-08-2012; BIONYX ClinicalTrials.gov: NCT02508714, registered 27-7-2015.

Objectives Knowledge of possible drug-laboratory test interactions (DLTIs) is important for the interpretation of laboratory test results. Failure to recognize these interactions may lead to misinterpretation, a delayed or erroneous diagnosis, or unnecessary extra diagnostic tests or therapy, which may harm patients. The aim of this multicentre survey was to evaluate the clinical value of DLTI alerts. Methods A survey was designed with six predefined clinical cases selected from the clinical laboratory practice with a potential DLTI. Physicians from several departments, including internal medicine, cardiology, intensive care, surgery and geriatrics in six participating hospitals were recruited to fill in the survey. The survey addressed their knowledge of DLTIs, motivation to receive an alert and opinion on the potential influence on medical decision making. Results A total of 210 physicians completed the survey. Of these respondents 93% had a positive attitude towards receiving DLTI alerts; however, the reported value differed per case and per respondent’s background. In each clinical case, medical decision making was influenced as a consequence of the reported DLTI message (ranging from 3 to 45% of respondents per case). Conclusions In this multicentre survey, most physicians stated DLTI messages to be useful in laboratory test interpretation. Medical decision making was influenced by reporting DLTI alerts in each case. Alerts should be adjusted according to the needs and preferences of the receiving physicians.

Contains fulltext : 249975.pdf (Publisher’s version ) (Open Access) BACKGROUND: Coronary artery disease (CAD) burden for society is expected to steeply increase over the next decade. Improved feasibility and efficiency of preventive strategies is necessary to flatten the curve. Acute myocardial infarction (AMI) is the main determinant of CAD-related mortality and morbidity, and predominantly occurs in individuals with more advanced stages of CAD causing subclinical myocardial ischemia (obstructive CAD; OCAD). Unfortunately, OCAD can remain subclinical until its destructive presentation with AMI or sudden death. Current primary preventive strategies are not designed to differentiate between non-OCAD and OCAD and the opportunity is missed to treat individuals with OCAD more aggressively. METHODS: EARLY-SYNERGY is a multicenter, randomized-controlled clinical trial in individuals with coronary artery calcium (CAC) presence to study (1.) the yield of cardiac magnetic resonance stress myocardial perfusion imaging (CMR-MPI) for early OCAD diagnosis and (2) whether early OCAD diagnosis improves outcomes. Individuals with CAC score ≥300 objectified in 2 population-based trials (ROBINSCA; ImaLife) are recruited for study participation. Eligible candidates are randomized 1:1 to cardiac magnetic resonance stress myocardial perfusion imaging (CMR-MPI) or no additional functional imaging. In the CMR-MPI arm, feedback on imaging results is provided to primary care provider and participant in case of guideline-based actionable findings. Participants are followed-up for clinical events, healthcare utilization and quality of life. CONCLUSIONS: EARLY-SYNERGY is the first randomized-controlled clinical trial designed to test the hypothesis that subclinical OCAD is widely present in the general at-risk population and that early differentiation of OCAD from non-OCAD followed by guideline-recommended treatment improves outcomes.

Objectives: Stroke patients should be treated as soon as possible since the benefit of reperfusion therapies is highly time-dependent. The proportion of patients eligible for reperfusion therapy is still limited, as many patients do not immediately alarm healthcare providers. The choice of healthcare system entrance influences the time of arrival in the hospital. Therefore, we assessed differences in these choices to obtain insight for strategies to reduce time delays in acute stroke patients. Materials and Methods: Patients with suspected acute stroke admitted to the participating hospitals received a questionnaire. We assessed differences between patients who initially alarmed the general practitioner (GP) and patients who directly alarmed the emergency medical services (EMS). Additionally, we assessed regional differences and patient trajectories after medical help was sought. Results: We included 163 patients. Most patients alarmed the GP as primary healthcare provider (n = 104; 64%), and median onset-to-door times were longer in these patients (466 minutes [IQR 149–1586]) compared to patients directly alarming the EMS (n = 59; 36%) (90 minutes [IQR 45–286]). This was even more pronounced in less densely populated areas. Patients who alarmed the GP first, more often had patient delay >15 minutes, hesitated to burden healthcare providers and underestimated symptomatology. Conclusions: Our results showed that patients who alarmed the GP first instead of the EMS differed in several factors that are potentially modifiable. Strategies to achieve reduction of vital prehospital time delays and to improve patient outcome are optimizing public awareness campaigns and GP triage along with adjusting current guidelines by enabling and focusing on immediate involvement of the EMS once acute stroke is suspected.

Background Patients with coronary disease may have unknown diabetes or prediabetes. We evaluated 3‐year outcomes after percutaneous coronary intervention (PCI) with contemporary drug‐eluting stents (DES) in patients with silent diabetes, prediabetes, and normoglycemia. Methods All BIO‐RESORT trial (NCT01674803) participants without known diabetes, enrolled at our center, were invited for oral glucose tolerance testing (OGTT) and measurements of fasting plasma glucose and glycated hemoglobin (HbA1c). Results OGTT detected silent diabetes in 68 (6.9%), prediabetes in 132 (13.4%), and normoglycemia in 788 (79.8%) of all 988 study participants. Follow‐up was available in 986 (99.8%) patients. The main endpoint target vessel failure (TVF: cardiac death, target vessel‐related myocardial infarction [MI], or target vessel revascularization) differed between groups (14.8, 9.9, and 5.6%; p = .002), driven by MI during the first 48 hr and by cardiac death (p

Objectives The aim of this study was to assess 2-year safety and efficacy of the current-generation thin composite-wire-strut durable-polymer Resolute Onyx zotarolimus-eluting stent (ZES), compared with the ultrathin-strut biodegradable-polymer Orsiro sirolimus-eluting stent (SES) in all-comers and a pre-specified small-vessel subgroup analysis. Background The Resolute Onyx ZES is widely used in clinical practice, but no follow-up data beyond 1 year have been published. The randomized BIONYX (Bioresorbable Polymer-Coated Orsiro Versus Durable Polymer-Coated Resolute Onyx Stents) trial (NCT02508714) established the noninferiority of ZES versus SES regarding target vessel failure (TVF) rates. Methods A total of 2,488 all-comer patients were treated at 7 coronary intervention centers in Belgium, Israel, and the Netherlands. The main endpoint, TVF, was a composite of safety (cardiac death or target vessel–related myocardial infarction) and efficacy (clinically indicated target vessel revascularization). Two-year follow-up data were analyzed using Kaplan-Meier methods. Results Two-year follow-up data were available for 2,460 of 2,488 patients (98.9%). TVF occurred in 93 of 1,243 patients (7.6%) assigned to ZES versus 87 of 1,245 patients (7.1%) assigned to SES (log-rank p = 0.66). There was no significant between-stent difference in individual components of this endpoint. The incidence of definite-or-probable stent thrombosis was low for both treatment arms (0.4% vs. 1.1%; log-rank p = 0.057). In patients stented in small vessels, there was no between-stent difference (TVF 8.2% vs. 8.7% [log-rank p = 0.75], target lesion revascularization 4.0% vs. 4.4% [log-rank p = 0.77]). Conclusions At 2-year follow-up, the novel thin composite-wire-strut durable-polymer Resolute Onyx ZES showed in all-comers similar safety and efficacy compared with the ultrathin cobalt-chromium-strut biodegradable-polymer Orsiro SES. The analysis of patients who were treated in small vessels also suggested no advantage for either stent.

Objectives The aim of this study was to determine 1-year safety and efficacy after treatment with the COMBO and Orsiro stents. Background The COMBO stainless-steel stent has an anti-CD34+ antibody coating to capture endothelial progenitor cells, thereby promoting faster endothelialization. The Orsiro is an ultrathin-strut cobalt-chromium stent, covered by an extremely thin layer of amorphous silicon carbide to minimize ion leakage. Both devices elute sirolimus from biodegradable polymers. Methods For this analysis we included European patients from the COMBO collaboration, a patient-level pooling of 2 prospective all-comers registries of COMBO stent implantation (n = 2,775), and all patients randomized to the Orsiro stent (n = 1,169) from the Dutch BIO-RESORT (Comparison of Biodegradable Polymer and Durable Polymer Drug-Eluting Stents in an All Comers Population) randomized trial. The main outcome of interest was 1-year target lesion failure, a composite of cardiac death, target vessel myocardial infarction, and clinically driven target lesion revascularization evaluated using propensity score–matched analysis. Results At baseline, COMBO patients were older and had more insulin-treated diabetes, renal insufficiency, and other comorbidities. However, Orsiro patients included more current smokers and more acute coronary syndrome presentations. Orsiro patients also received longer stents and had more complex target lesions. After propensity score–matched analysis (n = 862/arm), 1-year target lesion failure occurred in 4.1% of COMBO-treated and 2.7% of Orsiro-treated patients (hazard ratio: 1.55; 95% confidence interval: 0.92 to 2.62; p = 0.10). Definite stent thrombosis occurred in 0.5% of COMBO-treated and 0.5% of Orsiro-treated patients (p = 0.99). Conclusions A propensity score–matched comparison of all comers treated with the COMBO or Orsiro stent showed no statistically significant differences. Stent thrombosis risk was low and similar between the stents. (Comparison of Biodegradable Polymer and Durable Polymer Drug-Eluting Stents in an All Comers Population [BIO-RESORT], NCT01674803; MASCOT–Post Marketing Registry [MASCOT], NCT02183454; Prospective Registry to Assess the Long-term Safety and Performance of the Combo Stent [REMEDEE Reg], NCT01874002)

Objectives This study sought to assess 2-year clinical outcome following percutaneous coronary intervention (PCI) with thin-strut new-generation drug-eluting stents (DES) in patients treat...

Objectives For the correct interpretation of test results, it is important to be aware of drug-laboratory test interactions (DLTIs). If DLTIs are not taken into account by clinicians, erroneous interpretation of test results may lead to a delayed or incorrect diagnosis, unnecessary diagnostic testing or therapy with possible harm for patients. A DLTI alert accompanying a laboratory test result could be a solution. The aim of this study was to test a multicentre proof of concept of an electronic clinical decision support system (CDSS) for real-time monitoring of DLTIs. Methods CDSS was implemented in three Dutch hospitals. So-called ‘clinical rules’ were programmed to alert medical specialists for possible DLTIs based on laboratory test results outside the reference range in combination with prescribed drugs. A selection of interactions from the DLTI database of the Dutch society of clinical chemistry and laboratory medicine were integrated in 43 clinical rules, including 24 tests and 25 drugs. During the period of one month all generated DTLI alerts were registered in the laboratory information system. Results Approximately 65 DLTI alerts per day were detected in each hospital. Most DLTI alerts were generated in patients from the internal medicine and intensive care departments. The most frequently reported DLTI alerts were potassium-proton pump inhibitors (16%), potassium-beta blockers (11%) and creatine kinase-statins (11%). Conclusions This study shows that it is possible to alert for potential DLTIs in real-time with a CDSS. The CDSS was successfully implemented in three hospitals. Further research must reveal its usefulness in clinical practice.

Background Telehealth interventions, that is, health care provided over a distance using information and communication technology, are suggested as a solution to rising health care costs by reducing hospital service use. However, the extent to which this is possible is unclear. Objective The aim of this study is to evaluate the effect of telehealth on the use of hospital services, that is, (duration of) hospitalizations, and to compare the effects between telehealth types and health conditions. Methods We searched PubMed, Scopus, and the Cochrane Library from inception until April 2019. Peer-reviewed randomized controlled trials (RCTs) reporting the effect of telehealth interventions on hospital service use compared with usual care were included. Risk of bias was assessed using the Cochrane Risk of Bias 2 tool and quality of evidence according to the Grading of Recommendations Assessment, Development and Evaluation guidelines. Results We included 127 RCTs in the meta-analysis. Of these RCTs, 82.7% (105/127) had a low risk of bias or some concerns overall. High-quality evidence shows that telehealth reduces the risk of all-cause or condition-related hospitalization by 18 (95% CI 0-30) and 37 (95% CI 20-60) per 1000 patients, respectively. We found high-quality evidence that telehealth leads to reductions in the mean all-cause and condition-related hospitalizations, with 50 and 110 fewer hospitalizations per 1000 patients, respectively. Overall, the all-cause hospital days decreased by 1.07 (95% CI −1.76 to −0.39) days per patient. For hospitalized patients, the mean hospital stay for condition-related hospitalizations decreased by 0.89 (95% CI −1.42 to −0.36) days. The effects were similar between telehealth types and health conditions. A trend was observed for studies with longer follow-up periods yielding larger effects. Conclusions Small to moderate reductions in hospital service use can be achieved using telehealth. It should be noted that, despite the large number of included studies, uncertainties around the magnitude of effects remain, and not all effects are statistically significant.

AimTo determine the risk of myocardial infarction (MI) associated with pattern, frequency, and intensity of alcohol consumption, type of alcoholic beverage, and the combined effect of alcohol and smoking on risk of MI, inflammation, and lipid profile.MethodA total of 423 cases with a first MI and 465 controls from the Maltese Acute Myocardial Infarction (MAMI) Study were analysed. Data was collected through an extensive interviewer-led questionnaire, along with measurements of various blood parameters. Medians and the Mann–Whitney test were used to assess effect of different drinking patterns, frequency, intensity, and smoking and drinking combinations on hs-CRP and lipid profile. Odds ratios, adjusted for the conventional risk factors of MI (AdjORs), were calculated as an estimate of the relative risk of MI.ResultsRegular alcohol consumption protected against MI [AdjOR 0.6 (95% CI 0.4–0.9)] while daily binge drinking increased risk [AdjOR 5.0 (95% CI 1.6–15.0)] relative to regular drinkers who did not binge drink. Whereas moderate weekly consumption of wine protected against MI, high weekly consumption of beer conveyed a deleterious effect. Alcohol consumption decreased risk of MI independent of smoking status. Frequent alcohol consumption was associated with higher HDL-, non-HDL-, total cholesterol and triglycerides, and lower hs-CRP. Total and HDL-cholesterol increased and BMI decreased with increasing quantity of weekly alcohol consumption relative to the non-regular drinkers. The effect of smoking on lipid profile and hs-CRP was less pronounced in current drinkers than in those who were non-regular drinkers.ConclusionThe protective effect of alcohol consumption was dependent on the pattern, frequency, type, and intensity of alcohol consumed. Alcohol modified the effects of smoking on the lipid profile. Regular drinking attenuated the effect of smoking on hs-CRP and lipid profile.

Objectives The aim of this study was to assess the 3-year safety and efficacy of treating all-comer patients with 3 contemporary drug-eluting stents (DES). Background The BIO-RESORT (Comparison of Biodegradable Polymer and Durable Polymer Drug-Eluting Stents in an All Comers Population) (TWENTE III) randomized trial (NCT01674803) found similar 1-year safety and efficacy for the 2 biodegradable-polymer DES (i.e., ultrathin-strut cobalt-chromium Orsiro sirolimus-eluting stent [SES] and very-thin-strut platinum-chromium Synergy everolimus-eluting stent) compared with the durable-polymer thin-strut cobalt-chromium Resolute Integrity zotarolimus-eluting stent (ZES). Two-year follow-up suggested that the SES might reduce repeat revascularizations beyond 1 year compared with the ZES. Methods A total of 3,514 all-comer patients were treated at 4 centers for coronary intervention. The main clinical endpoint, target vessel failure, was a composite of safety (cardiac death or target vessel–related myocardial infarction) and efficacy (target vessel revascularization). Secondary endpoints included the individual components of target vessel failure and stent thrombosis. Results Three-year follow-up data were available for 3,393 of 3,514 patients (96.6%). Target vessel failure occurred in 8.5% with SES and 10.0% with ZES (plog rank = 0.22) and in 8.8% with everolimus-eluting stents (vs. ZES, plog rank = 0.32). Rates of cardiac death, target vessel myocardial infarction, and target vessel revascularization were similar between stent groups. Landmark analyses found no statistically significant between-stent difference in repeat revascularization between 1 and 3 years. Definite or probable stent thrombosis rates were low (SES, 1.1%; everolimus-eluting stent, 1.1%; ZES, 0.9%) and similar with all 3 DES. Conclusions Despite substantial differences in stent backbone and polymer coating, all 3 DES showed favorable 3-year safety and efficacy in all comers, without significant between-stent differences. Further follow-up is required to definitely answer the question of whether one stent might improve clinical outcomes at a later stage.

Objectives To compare 2-year outcome following treatment with drug-eluting stents (DES) for acute myocardial infarction (MI) versus non-MI clinical syndromes. In acute MI patients, a stent-level comparison was performed, comparing Resolute Onyx versus Orsiro stents.Background In patients presenting with acute MI, higher adverse event rates have been reported. So far, no clinical results >1 year have been published of acute MI patients treated with Resolute Onyx.Methods This post-hoc analysis of the randomized BIONYX trial(NCT02508714) assessed the main outcome target vessel failure (TVF: cardiac death, target vessel MI, or target vessel revascularization) with Kaplan-Meier methods.Results Of all 2,488 trial participants, acute MI patients (n = 1,275[51.2%]) were significantly younger and had less comorbidities than non-MI patients (n = 1,213[48.8%]). TVF rates were lower in acute MI patients (77/1,275[6.1%] vs. 103/1,213[8.6%], HR:0.70, 95%-CI 0.52-0.94; p(log-rank) = 0.02), mainly driven by target vessel revascularization (4.1 vs. 6.1%, p(log-rank) = 0.03). Multivariate analysis showed no independent association of clinical syndrome with TVF (adjusted-HR: 0.81, 95%-CI 0.60-1.10; p = .17). In MI patients treated with Resolute Onyx (n = 626) versus Orsiro (n = 649), there was no difference in TVF (6.2 vs. 6.1%; p(log-rank) = 0.97) and its components. There was only 1(0.2%) definite-or-probable stent thrombosis in RO-ZES and 8(1.2%) in O-SES (p = .053).Conclusions Two years after treatment with thin-strut DES in this randomized trial, patients treated for acute MI had lower adverse event rates than non-MI patients. Yet, these findings were mainly attributable to between-group differences in patient and lesion characteristics. In patients who underwent PCI for acute MI, both Resolute Onyx and Orsiro showed favorable and similar 2-year outcomes. Biotronik; Medtronic

BACKGROUND Treatment of a coronary bifurcation lesion is often required in routine clinical practice, but data on the performance of very thin-strut biodegradable polymer drug-eluting stents are scarce. METHODS Comparison of biodegradable polymer and durable polymer drug-eluting stents in an all comers population (BIO-RESORT) is a prospective, multicenter randomized clinical trial that included 3514 all-comer patients, who were randomized to very thin-strut biodegradable polymer-coated sirolimus- or everolimus-eluting stents, versus thin-strut durable polymer-coated zotarolimus-eluting stents. The approach of bifurcation stenting was left at the operator's discretion, and provisional stenting was generally preferred. This prespecified analysis assessed 3-year clinical outcome of all patients in whom treatment involved at least one bifurcation with a side-branch diameter ≥1.5 mm. RESULTS Of all BIO-RESORT trial participants, 1236 patients were treated in bifurcation lesions and analyzed. Single- and two-stent techniques were used in 85.8% and 14.2%, respectively. 'True' bifurcation lesions (main vessel and side-branch obstructed) were treated in 31.1%. Three-year follow-up was available in 1200/1236 (97.1%) patients. The main endpoint target vessel failure (composite of cardiac death, target vessel-related myocardial infarction, or target vessel revascularization) occurred in sirolimus-eluting stents in 42/412 (10.3%) and in zotarolimus-eluting stents in 49/409 (12.1%) patients (P-logrank = 0.40). In everolimus-eluting stents, target vessel failure occurred in 40/415 (9.8%) patients (vs. zotarolimus-eluting stents: P-logrank = 0.26). There was no between-stent difference in individual components of target vessel failure. Findings were consistent in patients with single-vessel treatment and patients treated with a single-stent technique. CONCLUSIONS Three years after stenting all-comers with bifurcation lesions, clinical outcome was similar with the sirolimus-eluting and everolimus-eluting stents versus the zotarolimus-eluting stent.

Background Patients with diabetes have more extensive coronary disease, resulting in higher risks of adverse clinical events following stenting. In all-comer patients, contemporary DES have shown excellent safety and efficacy, but data on diabetic patients are scarce. Separately for the BIO-RESORT and BIONYX trials, we assessed the 2-year clinical outcomes of diabetic patients, treated with various contemporary drug-eluting stents (DES). Methods We performed two prespecified secondary analyses of two randomized DES trials, which both stratified for diabetes. The main endpoint was target vessel failure (TVF), a composite of cardiac death, target vessel myocardial infarction, or target vessel revascularization. Follow-up was finished before the COVID-19 pandemic. Results In BIO-RESORT, 624/3514 (17.8%) had diabetes: 211 received Orsiro sirolimus-eluting stents (SES), 203 Synergy everolimus-eluting stents (EES), and 210 Resolute Integrity zotarolimus-eluting stents (RI-ZES). TVF did not differ between SES (10.2%) and EES (10.0%) versus RI-ZES (12.7%) (SES vs. RI-ZES HR:0.78, 95%-CI [0.44–1.40]; p = 0.40, EES vs. RI-ZES HR:0.79, 95%-CI [0.44–1.40]; p = 0.42). In BIONYX, 510/2488 (20.5%) patients had diabetes: 250 received SES and 260 Resolute Onyx zotarolimus-eluting stents (RO-ZES). There was no difference in TVF between SES (10.7%) versus RO-ZES (12.2%) (HR:0.88, 95%-CI [0.52–1.48]; p = 0.63). Conclusions There was no difference in 2-year clinical outcome among patients with diabetes, who were treated with SES, or EES, versus RI-ZES. In addition there was no difference in clinical outcome in diabetic patients, who were treated with SES versus RO-ZES. These findings may be considered as a signal of safety and efficacy of the studied DES in patients with diabetes., Graphical abstract Unlabelled Image, Highlights • This is the first report of diabetic patient outcome after PCI with Resolute Onyx. • Resolute Onyx versus Orsiro stents were similarly safe and efficacious at 2 years. • Diabetic patient outcome with Orsiro, Synergy, and Resolute Integrity was similar. • 2-year stent thrombosis rate was low for each device, yet lowest for Resolute Onyx. • Medical therapy and risk factor management may have greater impact than DES choice.

Objective The objective was to assess the 2‐year clinical performance of three drug‐eluting stents in all‐comer patients with severely calcified coronary lesions. Background Severe lesion calcification increases cardiovascular event risk after coronary stenting, but there is a lack of data on the clinical outcome of all‐comers with severely calcified lesions who were treated with more recently introduced drug‐eluting stents. Methods The BIO‐RESORT trial (clinicaltrials.gov: NCT01674803) randomly assigned 3,514 all‐comer patients to biodegradable polymer Synergy everolimus‐eluting stents (EES) or Orsiro sirolimus‐eluting stents (SES), versus durable polymer Resolute Integrity zotarolimus‐eluting stents (ZES). In a post hoc analysis, we assessed 783 patients (22.3%) with at least one severely calcified target lesion. Results At 2‐year follow‐up (available in 99% of patients), the main composite endpoint target vessel failure occurred in 19/252 (7.6%) of the EES and in 33/265 (12.6%) of the ZES‐treated patients (p = .07). Target vessel failure occurred in 24/266 (9.1%) of the SES‐treated patients (vs. ZES: p = .21). There was a difference in target vessel revascularization, which was required in EES in 6/252 (2.4%) patients and in ZES in 20/265 (7.7%) patients (p = .01); the target vessel revascularization rate in SES was 9/266 (3.4%, vs. ZES: p = .04). Multivariate analysis showed that implantation of EES, but not SES, was independently associated with lower target vessel revascularization rates than in ZES. Conclusions In BIO‐RESORT participants with severely calcified target lesions, treatment with EES was associated with a lower 2‐year target vessel revascularization rate than treatment with ZES.

Aims: It is unclear whether detection of prediabetes (pre-DM) by routine assessment of glycated haemoglobin A1c (HbA1c) and fasting plasma glucose (FPG) among patients undergoing percutaneous coronary intervention (PCI) with contemporary drug-eluting stents (DES) may help identify subjects with increased event risk. We assessed the relation between glycaemia status and one-year outcome after PCI. Methods and results: Glycaemia status was determined in 2,362 non-diabetic BIO-RESORT participants, treated at all four study sites, to identify pre-DM (HbA1c 42-47 mmol/mol; FPG 6.1-6.9 mmol/L) and unknown diabetes mellitus (DM) (HbA1c ≥48 mmol/mol; FPG ≥7.0 mmol/L). Another 624 patients had medically treated DM. The main composite endpoint consisted of death, myocardial infarction, or revascularisation. Glycaemic state was known in 2,986 participants: 324 (11%) patients had pre-DM, 793 (27%) had DM (known or new), and 1,869 (63%) patients had normoglycaemia. Pre-DM and DM patients differed from normoglycaemic patients in cardiovascular risk factors. The composite endpoint occurred in 11.1% in pre-DM, 10.5% in DM, and 5.7% in normoglycaemia (p

Meta-analyses have reported a 2- to 3-fold increased risk of venous thrombosis (VT) in individuals with hyperhomocysteinemia. However, confounding factors were generally not considered. In contrast, randomized trials of homocysteine-lowering therapy and VT risk have been negative. We investigated whether hyperhomocysteinemia was associated with VT in the Multiple Environmental and Genetic Assessment of Risk Factors for Venous Thrombosis (MEGA) case-control study (1999-2004) from the Netherlands (1,689 cases and 1,726 controls), taking into account measured and unmeasured confounders. We compared patients with population controls to estimate odds ratios using unconditional logistic regression and adjusted for various potential confounders. We matched patients to their partners to additionally adjust for unmeasured confounders (e.g., lifestyle factors) using conditional logistic regression. We found that elevated homocysteine concentrations were not associated with an increased risk for VT when comparing patients with population controls, either as a continuous variable (odds ratio = 1.00, 95% confidence interval: 0.99, 1.01), in terms of 0.7-mg/L increase (odds ratio = 0.99, 95% confidence interval: 0.93, 1.05), or within different homocysteine categories. We obtained similar results when patients were compared with their partners. Stratification by sex, deep vein thrombosis, pulmonary embolism, provoked VT, and unprovoked VT also provided no evidence of an association. In conclusion, after extensive adjustments for confounding, hyperhomocysteinemia was not associated with an increased risk of venous thrombosis in this study.

Inleiding: Patiënten met symptomen van een acuut coronair syndroom (ACS) hebben zo snel mogelijk de juiste behandeling nodig om schade aan het hart te voorkomen of te beperken. Hoewel er veel onderzoek is gedaan naar prehospitale vertraging en de oorzaken daarvan, is er weinig bekend over de motivatie van de patiënt voor het kiezen van een keteningang. Het doel van dit onderzoek is het vinden van factoren die invloed hebben op deze keuze. Methode: We deden een explorerend dwarsdoorsnedeonderzoek, waarbij we met een vragenlijst gegevens verzamelden van 67 ACS-patiënten. Resultaten: Patiënten kregen toegang tot de acute zorgketen via vier verschillende ingangen: de huisarts (43%), de huisartsenpost (28%), de meldkamer ambulancezorg (112) (21%) of de spoedeisende hulp (7%). De overtuiging van patiënten dat hun huisarts het beste weet wat ze nodig hebben maakte dat ze vaker contact zochten met hun eigen huisarts. Dit deden ook de patiënten die alleen waren toen de symptomen ontstonden. Patiënten met een fast onset van de klachten en acute pijn belden vaker 112, net als patiënten die hun klachten als ernstig inschatten. Conclusie: Niet de kennis over alarmsymptomen, maar vooral subjectieve factoren, zoals de interpretatie van de ernst van de klachten, de overtuigingen van de patiënt over wie de juiste zorgverlener is, en de manier (plotseling, pijn) waarop de klachten zich voordoen zijn bepalend voor de keuze van de keteningang bij patiënten met ACS-klachten. Voor het reduceren van prehospitale vertraging kunnen huisartsen een rol spelen door patiënten de juiste voorlichting te geven.

Knowledge about the changes in endothelial function after ST-elevation myocardial infarction (STEMI) is of substantial interest, but serial data are scarce. The aim of the present study was to noninvasively evaluate whether endothelial function, as assessed shortly after primary percutaneous coronary intervention (PPCI) for STEMI, may improve until 12-month follow-up. This prospective observational cohort study was performed in patients in the RESPONSE randomized trial who participated in a substudy and underwent noninvasive assessment of endothelial function at 1 (baseline), 6, and 12-month follow-up after treatment of a STEMI by PPCI. The reactive hyperemia peripheral artery tonometry (RH-PAT) method was used to assess endothelial function (higher RH-PAT index signifies better function). Of the 70 study participants, who were 57.4 ± 9.7 years of age, 55 (78.6%) were male and 9 (13%) had diabetes. The endothelial function deteriorated significantly during follow-up: the RH-PAT index at baseline, 6, and 12-month follow-up was 1.90 ± 0.58, 1.81 ± 0.57, and 1.69 ± 0.49, respectively (p = 0.04). Although patients were carefully treated in outpatient clinics and adequate pharmacological therapy was prescribed, we noted an increase in total cholesterol (p = 0.001), LDL cholesterol (p = 0.002), HbA1C (p = 0.054), and diastolic blood pressure (p = 0.047) However, multivariate analysis revealed that this increase in cardiovascular risk factors could not explain the observed deterioration in endothelial function. In patients with STEMI, we observed a significant deterioration in endothelial function during 12 months after PPCI that could not be explained by changes in the traditional cardiovascular risk profile.

Objectives The study sought to evaluate for the first time the 5-year outcomes after treating an all-comers population with newer-generation cobalt chromium-based Resolute Integrity zotarolimus-eluting stents (ZES) (Medtronic, Santa Rosa, California) versus platinum chromium-based PROMUS Element everolimus eluting stents (EES) (Boston Scientific, Natick, Massachusetts). Background The DUTCH PEERS (TWENTE II) (DUrable polymer-based sTent CHallenge of Promus ElemEnt versus ReSolute integrity: TWENTE II) trial is a randomized, multicenter, single-blinded, investigator-initiated all-comers trial that found at its main analysis similar 1-year safety and efficacy for both drug-eluting stents. It is the first randomized trial ever to investigate the Resolute Integrity ZES and the first trial to compare both devices. Methods In total, 1,811 patients were 1:1 randomized to ZES versus EES. We performed a pre-specified assessment of the 5-year clinical outcomes in terms of safety and efficacy. The main endpoint target vessel failure (TVF) is a composite of cardiac death, target vessel–related myocardial infarction, or target vessel revascularization. Secondary endpoints included the individual components of TVF, and stent thrombosis. The study was independently monitored, and adverse clinical events were independently adjudicated. Results Five-year clinical follow-up data was available in 1,798 (99.3%) patients. The ZES and EES groups showed favorable outcomes, with similar 5-year incidence of TVF (13.2% vs. 14.2%; plog-rank = 0.62) and its individual components: cardiac death (4.5% vs. 4.9%; plog-rank = 0.69), target vessel–related myocardial infarction (3.1% vs. 2.6%; plog-rank = 0.47), and target vessel revascularization (7.6% vs. 8.6%; plog-rank = 0.46). The 5-year incidence of definite or probable stent thrombosis was similar (1.5% vs. 1.3%; plog-rank = 0.83). Conclusions At 5-year follow-up, the Resolute Integrity ZES and PROMUS Element EES showed similar and sustained results in terms of safety and efficacy for treating a broad population of all-comers.

Objectives This study sought to assess the prevalence and clinical impact of silent diabetes and pre-diabetes in “nondiabetic” percutaneous coronary intervention (PCI) all-comers. Background Patients with undetected and thus untreated (silent) diabetes may have higher event risks after PCI with contemporary drug-eluting stents (DES). Methods The BIO-RESORT Silent Diabetes study, performed at Thoraxcentrum Twente, is a substudy of the randomized multicenter BIO-RESORT (BIOdegradable Polymer and DuRable Polymer Drug-eluting Stents in an All COmeRs PopulaTion) trial (NCT01674803). Patients underwent oral glucose tolerance testing (OGTT), and assessment of glycosylated hemoglobin with fasting plasma glucose. Primary endpoint was a composite of cardiac death, target vessel–related myocardial infarction, or target vessel revascularization at 1 year. Results Of the 988 participants, OGTT detected silent diabetes in 68 (6.9%), pre-diabetes in 133 (13.3%), and normal glucose metabolism in 788 (79.8%). Patients with silent diabetes had higher primary endpoint rates (13.2% vs. 7.6% vs. 4.8%; p Conclusions Abnormal glucose metabolism was detected in 1 of 3 “nondiabetic” PCI patients and was independently associated with up to 4-fold higher event risks. Future intervention trials should determine whether meaningful benefits accrue from routine glycemia testing in such patients.

Introduction Unrelieved acute musculoskeletal pain continues to be a reality of major clinical importance, despite advancements in pain management. Accurate pain assessment by nurses is crucial for effective pain management. Yet inaccurate pain assessment is a consistent finding worldwide in various clinical settings, including the emergency department. In this study, pain assessments between nurses and patients with acute musculoskeletal pain after extremity injury will be compared to assess discrepancies. A second aim is to identify patients at high risk for underassessment by emergency nurses. Methods The prospective PROTACT study included 539 adult patients who were admitted to the emergency department with musculoskeletal pain. Data on pain assessment and characteristics of patients including demographics, pain, and injury, psychosocial, and clinical factors were collected using questionnaires and hospital registry. Results Nurses significantly underestimated patients' pain with a mean difference of 2.4 and a 95% confidence interval of 2.2-2.6 on an 11-points numerical rating scale. Agreement between nurses' documented and patients' self-reported pain was only 27%, and 63% of the pain was underassessed. Pain was particularly underassessed in women, in persons with a lower educational level, in patients who used prehospital analgesics, in smokers, in patients with injury to the lower extremities, in anxious patients, and in patients with a lower urgency level. Discussion Underassessment of pain by emergency nurses is still a major problem and might result in undertreatment of pain if the emergency nurses rely on their assessment to provide further pain treatment. Strategies that focus on awareness among nurses of which patients are at high risk of underassessment of pain are needed.

Background: The combination of high levels of high-sensitive C-reactive protein (hs-CRP) and lipoprotein-associated phospholipase-A2 (Lp-PLA2) was recently shown to correlate with increased cardiovascular risk. Endothelial dysfunction is also known to be a risk factor for cardiovascular events. Aim: To test among patients with previous ST-elevation myocardial infarction (STEMI) the hypothesis that high levels of both hs-CRP and Lp-PLA2 may be associated with impaired endothelium-dependent vasodilatation. Methods: In this substudy of the RESPONSE randomized trial, we used reactive hyperemia peripheral artery tonometry (RH-PAT) 4 to 6 weeks after STEMI and primary percutaneous coronary intervention (PPCI) to non-invasively assess endothelial function (RH-PAT index 239 μg/L, respectively). Results: Patients were 57.4 ± 9.7 years and 53 (77.9%) were men. 11 (16%) patients were classified as high-risk and 57 (84%) as low-to-intermediate-risk. The RH-PAT index was 1.68 ± 0.22 in high-risk and 1.95 ± 0.63 in low-to-intermediate-risk patients (p = 0.17). Endothelial dysfunction was present in 8 (72.7%) high-risk and 26 (45.6%) low-to-intermediate-risk patients (p = 0.09). Framingham risk score, NT-proBNP and fibrinogen levels were higher in high-risk patients (p ≤ 0.03). Conclusion: In this population of patients with recent STEMI and PPCI, we observed between patients with high hs-CRP and Lp-PLA levels and all other patients no more than numerical differences in endothelial function that did not reach a statistical significance. Nevertheless, further research in larger study populations may be warranted.

Background Data on medium-term outcome of patients with acute coronary syndrome (ACS), treated with newer-generation durable polymer drug-eluting stents (DES) in severely calcified coronary lesions, are scarce. We aimed to assess the impact of severe coronary lesion calcification on clinical outcome of patients with ACS, treated with newer-generation DES. Methods The TWENTE and DUTCH PEERS randomized trials comprise 1779 ACS patients, who were categorized into patients with versus without severe target lesion calcification. We performed a patient-level pooled analysis to assess 2-year outcome, including target vessel failure (TVF), a composite of cardiac death, target vessel-related myocardial infarction (MI), or target vessel revascularization (TVR). Results Patients with severe target lesion calcification (n = 340, 19.1%) were older (66.8 ± 10.6 years vs. 62.8 ± 11.5 years, p < 0.001) and had more often diabetes (22.1% vs. 16.8%, p = 0.02) and hypercholesterolemia (51.5% vs. 42.9%, p = 0.005) than other patients (n = 1439, 79.9%). In addition they showed a higher TVF rate (12.4% vs.7.0%, p = 0.001), mainly related to a difference in TVR (6.8% vs. 3.3%, p = 0.003). There was a borderline significant between-group difference in cardiac death (3.6% vs. 1.8%, p = 0.05), but not in target vessel MI (3.8% vs.2.6%, p = 0.23) and definite stent thrombosis (0.9% vs. 0.6%, p = 0.71). Multivariate analysis demonstrated that severe lesion calcification was an independent risk factor of TVF (adjusted HR; 1.58, 95% CI: 1.23–2.03; p < 0.001). Conclusions In patients with ACS, treatment of severely calcified lesions with newer-generation DES was associated with an overall higher clinical event risk – related in particular to a higher TVR rate, while the risk of MI was low.

Importance: Stenting small-vessel lesions has an increased adverse cardiovascular event risk. Very thin-strut or ultrathin-strut drug-eluting stents might reduce this risk, but data are scarce. Objective: To assess the outcome of all-comer patients with small coronary vessel lesions treated with 3 dissimilar types of drug-eluting stents. Design: This is a prespecified substudy of the Comparison of Biodegradable Polymer and Durable Polymer Drug-eluting Stents in an All Comers Population (BIO-RESORT) trial, an investigator-initiated, randomized, patient-blinded comparative clinical drug-eluting stent trial. Patients treated with ultrathin-strut sirolimus-eluting stents, very thin-strut everolimus-eluting stents, or previous-generation thin-strut zotarolimus-eluting stents were enrolled from December 2012 to August 2015. This multicenter trial was conducted in 4 Dutch centers for cardiac intervention. Of all 3514 all-comer BIO-RESORT participants, 1506 patients with treatment in at least 1 small-vessel lesion (reference vessel

Purpose Patients with high bleeding risk (HBR) who undergo percutaneous coronary intervention also have an increased risk of ischemic events and represent an overall high-risk population. The coating of durable polymer drug-eluting stents (DP-DES) may induce inflammation and delay arterial healing, which might be reduced by novel biodegradable polymer DES (BP-DES). We aimed to evaluate the safety and efficacy of treating HBR patients with very thin-strut BP-DES versus thin-strut DP-DES. Methods Participants in BIO-RESORT (NCT01674803), an investigator-initiated multicenter, randomized all-comers trial, were treated with very thin-strut BP-DES (Synergy or Orsiro) or thin-strut DP-DES (Resolute Integrity). For the present analysis, patients were classified following HBR criteria based on previous trials. The primary endpoint was target vessel failure: a composite of cardiac death, target vessel-related myocardial infarction, or target vessel revascularization at 1 year. Results Of all 3514 patients, 1009 (28.7%) had HBR. HBR patients were older (p

Background This study assessed the association between heart failure (HF) medication (angiotensin-converting-enzyme inhibitors (ACEI)/angiotensin-receptor blockers (ARB), beta-blockers (BB), mineralocorticoid-receptor antagonists (MRA) and diuretics) and HF readmissions in a real-world unselected group of patients after a first hospital admission for HF. Furthermore we analysed readmission rates for ACEI versus ARB and for carvedilol versus β1-selective BB and we investigated the effect of HF medication in relation to time since discharge. Methods and findings Medication at discharge was determined with dispensing data from the Dutch PHARMO Database Network including 22,476 patients with HF between 2001 and 2015. After adjustment for age, gender, number of medications and year of admission no associations were found for users versus non-users of ACEI/ARB (hazard ratio, HR = 1.01; 95%CI 0.96–1.06), BB (HR = 1.00; 95%CI 0.95–1.05) and readmissions. The risk of readmission for patients prescribed MRA (HR = 1.11; 95%CI 1.05–1.16) or diuretics (HR = 1.17; 95%CI 1.09–1.25) was higher than for non-users. The HR for ARB relative to ACEI was 1.04 (95%CI 0.97–1.12) and for carvedilol relative to β1-selective BB 1.33 (95%CI 1.20–1.46). Post-hoc analyses showed a protective effect shortly after discharge for most medications. For example one month post discharge the HR for ACEI/ARB was 0.77 (95%CI 0.69–0.86). Although we did try to adjust for confounding by indication, probably residual confounding is still present. Conclusions Patients who were prescribed carvedilol have a higher or at least a similar risk of HF readmission compared to β1-selective BB. This study showed that all groups of HF medication -some more pronounced than others- were more effective immediately following discharge.

Background: In patients with coronary artery disease, treated with durable polymer-coated drug-eluting stents, the life-long presence of the polymer might delay arterial healing. Novel very thin strut biodegradable polymer stents, which leave only a bare metal stent after polymer resorption, might improve long-term outcome. We investigated in allcomers the safety and efficacy of three stents eluting either everolimus, sirolimus, or zotarolimus, often clinically used but never compared, of which the biodegradable polymer everolimus-eluting stent was never before assessed in allcomers. Methods: The large-scale, investigator-initiated, multicentre, assessor and patient blinded, three-arm, randomised, BIO-RESORT non-inferiority trial was done at four clinical sites in the Netherlands. All-comer patients were aged 18 years or older, capable of providing informed consent, and required a percutaneous coronary intervention with drug-eluting stent implantation according to clinical guidelines or the operators' judgment. Exclusion criteria were: participation in another randomised drug or device study before reaching the primary endpoint of that study; planned surgery necessitating interruption of dual antiplatelet therapy within the first 6 months; known intolerance to components of the investigational product or medication required; uncertainty about the adherence to follow-up procedures or an assumed life expectancy of less than 1 year; or known pregnancy. Web-based computer-generated allocation sequences randomly assigned patients (1:1:1) to treatment with very thin strut biodegradable polymer everolimus-eluting or sirolimus-eluting stents (which differ substantially in type, amount, distribution, and resorption speed of their respective coating), or thin strut durable polymer zotarolimus-eluting stents. The primary endpoint was a composite of safety (cardiac death or target vessel-related myocardial infarction) and efficacy (target vessel revascularisation) at 12 months of follow up with a very thin strut biodegradable polymer of either everolimus-eluting or sirolimus-eluting stents, compared with durable polymer zotarolimus-eluting stents, analysed by intention to treat (non-inferiority margin 3·5%). This trial was registered with ClinicalTrials.gov, number NCT01674803. Findings: From Dec 21, 2012, to Aug 24, 2015, 3514 patients were enrolled and analysed, of whom 2449 (70%) had acute coronary syndromes, which included 1073 (31%) ST-elevation myocardial infarctions. 12 month follow-up of 3490 (99%) patients (three lost to follow-up; 21 withdrawals) was available. The primary endpoint was met by 55 (5%) of 1172 patients assigned to everolimus-eluting stents, 55 (5%) of 1169 assigned to sirolimus-eluting stents and 63 (5%) of 1173 assigned to zotarolimus-eluting stents. Non-inferiority of the everolimus-eluting stents and sirolimus-eluting stents compared with zotarolimus-eluting stents was confirmed (both −0·7% absolute risk difference, 95% CI −2·4 to 1·1; upper limit of one sided 95% CI 0·8%, pnon-inferiority

Aims: To keep patients in long-term clinical follow-up programmes after percutaneous coronary intervention (PCI), knowledge of the patient-preferred mode for follow-up assessment is crucial. We systematically assessed patient preference, and explored potential relationships with age and gender. Methods and results: In the prospective, observational PAPAYA study (ClinicalTrials.gov: NCT02189070), 2,566 patients, treated by PCI between June 2008 and May 2012, were invited to participate in a postal survey on the patient-preferred mode (postal questionnaire, telephone or e-mail consultation) and frequency of follow-up assessment. A total of 1,797 (70.0%) patients responded. The vast majority preferred completing postal questionnaires (1,248 [69.9%]) as compared to telephone (240 [13.4%]) or e-mail-based approaches (227 [12.7%]) (p

Background: The Absorb bioresorbable vascular scaffold (BVS) was developed to address long-term safety issues of metallic drug-eluting stents. However, it may be associated with an increased event risk during the first year. Methods: A systematic literature search was performed (in MEDLINE/PubMed, Cochrane CENTRAL, EMBASE, and scientific meeting abstracts) to identify studies that compared BVS and cobalt-chromium durable polymer everolimus-eluting stents (EES). For randomized clinical trials and non-randomized propensity score matched studies that reported 1-year outcome data, fixed/random-effects models were used to generate pooled estimates of outcomes, presented as odds ratios (OR) with 95%-confidence intervals (CI). Results: The 1-year follow-up data of 6 trials with 5588 patients were analyzed. A device-oriented composite endpoint (DOCE – cardiac death, target vessel myocardial infarction (MI), or target lesion revascularization (TLR)) was reached by 308 BVS or EES patients (195/3253 vs. 113/2315). Meta-analysis showed that patients who received BVS had an increased risk of MI (4.3% vs. 2.3%; OR:1.63, 95%-CI: 1.18–2.25, p < 0.01) and definite-or-probable scaffold thrombosis (1.3% vs. 0.6%; OR:2.10, 95%-CI: 1.13–3.87, p = 0.02). However, there was no significant between-group difference in risk of DOCE (6.0% vs. 4.9%; OR:1.19, 95%-CI: 0.94–1.52, p = 0.16), cardiac death (0.8% vs. 0.7%; OR:1.14, 95%-CI: 0.54–2.39, p = 0.73), or TLR (2.5% vs. 2.5%; OR: 0.98, 95%-CI:0.69–1.40, p = 0.92). Conclusions: During the first year of follow-up, patients treated with BVS had a higher incidence of MI and scaffold thrombosis. The risk of DOCE was not significantly different. As BVS may pay off later, future robust data on long-term clinical outcome will be of paramount importance.

Resumen Introduccion y objetivos Escasean datos a largo plazo sobre la relacion entre disfuncion endotelial tras infarto agudo de miocardio con elevacion del segmento ST y futuros eventos clinicos adversos. El objetivo de este estudio es evaluar de manera no invasiva si la disfuncion endotelial 4–6 semanas tras una intervencion coronaria percutanea primaria por infarto agudo de miocardio con elevacion del segmento ST predice la aparicion futura de eventos clinicos. Metodos Este estudio prospectivo de cohortes se llevo a cabo en 70 pacientes del ensayo aleatorizado RESPONSE, a los que se evaluo de manera no invasiva la funcion endotelial 4–6 semanas despues de la intervencion coronaria percutanea primaria. Se determino la funcion endotelial por el metodo de tonometria arterial periferica con hiperemia reactiva; la disfuncion endotelial se identifico por un indice Resultados El indice de tonometria arterial periferica con hiperemia reactiva fue en promedio 1,90 ± 0,58. Un total de 35 (50%) pacientes presentaban disfuncion endotelial y 35 (50%) tenian funcion endotelial normal. Las «complicaciones» periintervencion (como shock cardiogenico o bloqueo auriculoventricular completo) fueron mas frecuentes entre los pacientes con disfuncion endotelial que entre quienes no la presentaban (el 25,7 frente al 2,9%; p Conclusiones En esta serie de pacientes que habian sobrevivido a un infarto agudo de miocardio con elevacion del segmento ST, la disfuncion endotelial evaluada mediante tonometria arterial periferica con hiperemia reactiva 4–6 semanas tras el infarto de miocardio, no predijo los eventos clinicos futuros en una media de seguimiento de 4 anos.

Background The outcome of percutaneous coronary intervention with newer generation permanent polymer-coated drug-eluting stents (DES) in patients with severely calcified lesions is greatly unknown. We assessed the impact of severe lesion calcification on clinical outcome in patients with stable angina who underwent percutaneous coronary intervention with newer generation DES. Methods TWENTE and DUTCH PEERS randomized trials enrolled 1423 patients with stable angina, who were categorized into patients with versus without severe target lesion calcification. A patient-level pooled analysis assessed clinical outcome, including target vessel failure (TVF), a composite of cardiac death, target vessel-related myocardial infarction, or target vessel revascularization (TVR). Results Patients with severe calcification (n = 342) were older (66.6 ± 9.1 vs 64.2 ± 9.8 years, P < .001) and had more diabetes (25.7% vs 20.4%, P = .04) than other patients (n = 1081). Patients with calcified lesions had higher rates of TVF (16.4% vs 9.8%, pLogrank = .001), cardiac death (4.4% vs 1.5%, P = .03), target vessel myocardial infarction (7.6% vs 3.4%, P = .001), and definite stent thrombosis (1.8% vs 0.4%, P = .02). Multivariate analysis demonstrated that severe calcification was an independent risk factor of 2-year TVF (HR 1.42, 95% CI: 1.02-1.99, pLogrank = .04); landmark analysis showed that this was based on a difference during the first year (periprocedural: 5.8% vs. 3.1%, pLogrank = .02; first year: 7.5% vs. 3.8%, pLogrank = .007; second year: 4.1% vs. 3.3%, pLogrank = .54). Conclusion In patients with stable angina, severe target lesion calcification is associated with an increased risk of adverse cardiovascular events following treatment with newer generation permanent polymer-coated DES. This increase in risk is restricted to the first year of follow-up, which is an encouraging finding.

Summary Background During the past decade, many patients had zotarolimus-eluting stents implanted, which had circular shape cobalt–chromium struts with limited radiographic visibility. The Resolute Onyx stent was developed to improve visibility while reducing strut thickness, which was achieved by using a novel composite wire with a dense platinum–iridium core and an outer cobalt–chromium layer. We did the first randomised clinical trial to assess the safety and efficacy of this often-used stent compared with the Orsiro stent, which consists of ultrathin cobalt–chromium struts. Methods We did an investigator-initiated, assessor-blinded and patient-blinded, randomised non-inferiority trial in an allcomers population at seven independently monitored centres in Belgium, Israel, and the Netherlands. Eligible participants were aged 18 years or older and required percutaneous coronary intervention with drug-eluting stents. After guide wire passage with or without predilation, members of the catheterisation laboratory team used web-based computer-generated allocation sequences to randomly assign patients (1:1) to either the Resolute Onyx or the Orsiro stent. Randomisation was stratified by sex and diabetes status. Patients and assessors were masked to allocated stents, but treating clinicians were not. The primary endpoint was target vessel failure at 1 year, a composite of cardiac death, target-vessel-related myocardial infarction, and target vessel revascularisation, and was assessed by intention to treat (non-inferiority margin 2·5%) on the basis of outcomes adjudicated by an independent event committee. This trial is registered with ClinicalTrials.gov , number NCT02508714 . Findings Between Oct 7, 2015, and Dec 23, 2016, 2516 patients were enrolled, 2488 of whom were included in the intention-to-treat analysis (28 withdrawals or screening failures). 1243 participants were assigned to the Resolute Onyx group, and 1245 to the Orsiro group. Overall, 1765 (70·9%) participants presented with acute coronary syndromes and 1275 (51·2%) had myocardial infarctions. 1-year follow-up was available for 2478 (99·6%) patients. The primary endpoint was met by 55 (4·5%) patients in the Resolute Onyx group and 58 (4·7%) in the Orsiro group. Non-inferiority of Resolute Onyx to Orsiro was thus established (absolute risk difference −0·2% [95% CI −1·9 to 1·4]; upper limit of the one-sided 95% CI 1·1%; p non-inferiority =0·0005). Definite or probable stent thrombosis occurred in one (0·1%) participant in the Resolute Onyx group and nine (0·7%) in the Orsiro group (hazard ratio 0·11 [95% CI 0·01–0·87]; p=0·0112). Interpretation The Resolute Onyx stent was non-inferior to Orsiro for a combined safety and efficacy endpoint at 1-year follow-up in allcomers. The low event rate in both groups suggests that both stents are safe, and the very low rate of stent thrombosis in the Resolute Onyx group warrants further clinical investigation. Funding Biotronik and Medtronic.

Background The prospective observational CHANGE DAPT study compared clopidogrel versus ticagrelor-based dual antiplatelet (DAPT) regimens in consecutive patients with acute coronary syndrome (ACS), treated with percutaneous coronary intervention (PCI) with contemporary drug-eluting stents (DES). During the ticagrelor period (TP, May 2014–August 2015) there were more major bleedings than during the clopidogrel period (CP, December 2012–April 2014). Methods and results To evaluate whether the excess of major bleedings during TP may be limited to high bleeding risk (HBR) patients, we performed an explorative analysis of all 2062 CHANGE DAPT participants, of whom 547(26.5%) were classified as HBR (CP, n = 245; TP, n = 302). In HBR and non-HBR patients, we assessed the impact of CP versus TP on propensity score-adjusted rates of major bleeding and a pre-defined ischemic endpoint (composite of cardiac death, myocardial infarction, or stroke) at 1-year follow-up. Among HBR patients, the rate of major bleeding was significantly higher during TP (1.7% vs. 5.0%; HRadjusted 3.70 [95% CI 1.18–11.67], p = 0.03), while there was no significant difference in the ischemic endpoint (6.6% vs. 8.0%, HRadjusted 1.23 [95% CI 0.63–2.42], p = 0.54). In non-HBR patients, the rates of major bleeding (1.1% vs. 1.7%; HRadjusted 2.13 [95% CI 0.84–5.43], p = 0.11) and the ischemic endpoint (2.8% vs. 3.4%, HRadjusted 1.38 [95% CI 0.74–2.57], p = 0.32) were similar between both periods. Conclusions Among consecutive ACS patients, the increased risk of major bleeding during ticagrelor-based DAPT was limited to HBR patients. In both HBR and non-HBR patients, ticagrelor-based DAPT did not reduce ischemic outcomes following treatment with contemporary DES implantation.

Background Methotrexate (MTX) is widely used as disease modifying treatment for psoriasis and psoriatic arthritis (PsA). Rheumatological and dermatological guidelines to prevent MTX-induced adverse events diverge in the number and frequency of blood tests. These differences are not based on evidence indicating a higher risk for patients with psoriasis compared to PsA or rheumatic arthritis (RA). This raises the question if multiple testing increases safety, or results in false positive signals potentially leading to early withdrawal of an effective treatment. Objective Compare the effects of MTX monitoring strategies by rheumatologists and dermatologists regarding drug survival, reasons for withdrawal and safety. Methods Retrospective follow-up of all patients diagnosed with psoriasis by dermatologists or PsA by rheumatologists. Included were consecutive patients who started methotrexate (MTX) between 2006 and 2012 and had a scheduled follow-up by dermatologist or rheumatologist. Exclusions were: drug not started after the first prescription or incomplete availability of lab data. Data were extracted from electronic records: start and stop dates and dosing of MTX; treatment with folic acid and dose; reasons for withdrawal of MTX; numbers of blood sampling and types of laboratory tests performed for MTX safety; number of abnormal tests; occurrence of any serious adverse event (SAE). Results 190 Psoriasis and 196 PsA patients starting methotrexate (MTX) were included. Age and sex were comparable. PsA patients used higher initial and maximum doses of MTX and folic acid, but psoriasis patients had a higher frequency of abnormal laboratory results (0.14 vs 0.03 per treatment month, p

Background Percutaneous coronary intervention ( PCI ) in patients with previous coronary artery bypass grafting ( CABG ) is associated with adverse clinical events. Although newer generation drug‐eluting stents showed favorable short‐term safety profiles, there is a lack of long‐term outcome data. We evaluated the impact of previous CABG on 5‐year clinical outcomes of patients treated with PCI using newer‐generation drug‐eluting stents. Methods and Results In this patient‐level pooled analysis of the prospective TWENTE (The Real‐World Endeavor Resolute versus Xience V Drug‐Eluting Stent Study in Twente) trial and nonenrolled TWENTE registry, we assessed a consecutive series of patients who underwent PCI with newer‐generation drug‐eluting stents for non– ST ‐segment–elevation acute coronary syndromes or stable angina. Of all 1709 patients, 202 (11.8%) had a history of CABG . Patients with previous CABG had significantly higher 5‐year rates of cardiac death (10.4% versus 4.3%; P P P P CABG . Among patients with a history of CABG , PCI of an obstructed vein graft was associated with a higher rate of 5‐year target vessel revascularization ( P =0.003). Conclusions At 5‐year follow‐up after PCI with newer‐generation drug‐eluting stents, the risk of cardiac death and target vessel revascularization was significantly higher in patients with previous CABG . The target vessel revascularization rate was highest in patients who underwent PCI of obstructed vein grafts.

Aim The aim was to compare in a noninferiority trial the efficacy and safety of 2 contemporary drug-eluting stents (DESs): a novel, durable polymer-coated stent versus an established bioabsorbable polymer-coated stent. Methods and results The BIONYX trial (ClinicalTrials.gov-no.NCT02508714) is an investigator-initiated, prospective, randomized, patient- and assessor-blinded, international, multicenter study in all-comer patients with all types of clinical syndromes and lesions who require percutaneous coronary interventions with DES. Patients at 7 study sites in the Netherlands, Belgium, and Israel were randomly assigned (1:1, stratified for gender and diabetes mellitus) to treatment with the novel, zotarolimus-eluting, durable polymer-coated Resolute Onyx stent that has a radiopaque, thin-strut, CoreWire stent platform versus the sirolimus-eluting, bioresorbable polymer-coated Orsiro stent (reference device) that has a very thin-strut, cobalt-chromium stent backbone. The primary end point is the 1-year incidence of the composite clinical end point target vessel failure consisting of cardiac death, target vessel-related myocardial infarction, or clinically indicated target vessel revascularization. A power calculation, assuming a target vessel failure rate of 6.0% (noninferiority margin 2.5%), revealed that 2,470 study patients would give the study 80% power (a level 5%), allowing for up to 3% loss to follow-up. The first patient was enrolled on October 7, 2015; on December 23, 2016, the last patient entered the study. Conclusions BIONYX is a large-scale, prospective, randomized, international, multicenter trial comparing a novel DES with durable coating versus a reference DES with biodegradable coating in all-corners. The study is the first randomized assessment of the Resolute Onyx stent, which is an often-used DES outside the United States. Biotronik; Medtronic

Objectives This study assessed clinical events and patient-reported chest pain 2 years after treatment of all-comers with Resolute Integrity zotarolimus-eluting stents (Medtronic Vascular, Santa Rosa, California) and Promus Element everolimus-eluting stents (Boston Scientific, Natick, Massachusetts). Background For both drug-eluting stents (DES), no all-comer outcome data from >12 months of follow-up have been published. Although there is increasing interest in patient-reported chest pain following stenting, data with novel DES are scarce. Methods The DUTCH PEERS multicenter trial (TWENTE II) (DUrable Polymer-Based STent CHallenge of Promus ElemEnt Versus ReSolute Integrity) Randomized Trial [TWENTE II]) randomized 1,811 all-comer patients to treatment with 1 type of DES. Monitoring and event adjudication were performed by independent contract research organizations. Results The 2-year follow-up of 1,810 patients (99.9%) was available. The primary composite endpoint target vessel failure occurred in 8.6% and 7.8% of patients treated with zotarolimus- and everolimus-eluting stents, respectively (p = 0.55). Rates of components of target vessel failure were: cardiac death (2.4% vs. 1.9%, p = 0.42); target vessel–related myocardial infarction (2.4% vs. 1.8%, p = 0.33); clinically-indicated target vessel revascularization (4.6% vs. 4.9%, p = 0.83). At 1- and 2-year follow-up, >80% of patients were free from chest pain (no between-stent difference). In addition, >87% of patients were either free from chest pain or experienced pain only at maximal physical exertion, but not during normal daily activities. Patients with chest pain after 12 months at no more than moderate physical effort had a higher risk of target vessel revascularization during the following year (hazard ratio: 1.89 [95% confidence interval: 1.05 to 3.39], p = 0.03). Conclusions During the second year of follow-up, the incidence of adverse clinical endpoints remained similar and low for both DES. The vast majority of patients were free from chest pain

BACKGROUND: Patients with abnormal glucose metabolism, including patients with undetected and thus untreated diabetes, may have higher event risks after percutaneous coronary intervention (PCI) with contemporary drug-eluting stents (DES). We assessed the prevalence and clinical impact of abnormal glucose metabolism in allcomer patients without previously known diabetes undergoing PCI. METHODS: The BIO-RESORT Silent Diabetes study, performed at Thoraxcentrum Twente, is a substudy of the randomized BIO-RESORT trial (NCT01674803). We performed an additional analysis identifying patients with an abnormal glucose metabolism by means of oral glucose tolerance testing (OGTT), and assessment of glycated hemoglobin A1c (HbA1c) with fasting plasma glucose (FPG) and clinical outcome at 12 months. RESULTS: Assessment of glucose metabolism revealed that of the 988 participants a total 330 (33.4%) patients had an abnormal metabolism, while 658 (66.6%) patients had a normal metabolism. Patients with abnormal glucose metabolism showed higher rates of the primary endpoint Target Vessel Failure (6.4% vs. 2.7%; p0.01), a composite of cardiac death, target vessel-related myocardial infarction, or target vessel revascularization. Multivariate analysis demonstrated that an abnormal glucose metabolism independently predicted adverse event risk (HR 2.2, 95%-CI:1.2-4.2). CONCLUSION: Abnormal glucose metabolism was detected in one out of three PCI all-comer patients and independently associated with a more than 2-fold higher event risk. Future intervention studies should determine whether meaningful benefits may accrue from routine glycaemia testing in such patients.

Background: The DUTCH PEERS (TWENTE II) trial (clinicaltrials.gov NCT01331707) is a randomised, multicenter, single-blinded, investigator initiated all-comers trial. All coronary syndromes were permitted with no limit for lesion length, reference size, or number of lesions or diseased vessels to be treated. In total, 1811 patients were 1:1 randomised to cobalt chromium-based zotarolimuseluting stents (ZES) versus platinum chromium-based everolimus-eluting stents (EES). These durable polymer-based drug-eluting stents (DES) were developed to facilitate device deliverability and to improve stent apposition to the vessel wall. Purpose: We assessed the 4-year clinical outcome of the DUTCH PEERS trial in terms of safety and efficacy. Methods: Clinical outcome was assessed by means of follow-up data of the trial participants. The primary endpoint target vessel failure (TVF) is a composite of cardiac death, target vessel-related myocardial infarction (MI) or target vessel revascularization. Secondary endpoints included the individual components of the TVF and the incidence of definite-or-probable stent thrombosis. Endpoints were analyzed by the logrank test by comparing the time to the endpoint, using the Kaplan-Meier method. Independent contract research organizations performed the study monitoring and clinical event adjudication. Results: The 4-year clinical follow-up data were available in 1802 patients (99.5%; 4 patients were lost to follow-up and 5 withdrew consent). The ZES and EES groups showed favourable outcomes with a similar incidence of TVF (12.1% vs. 12.1%; Logrank p=0.95). The rates of the individual components of TVF were also similar for both stent arms: cardiac death (3.9% vs. 3.7%; Logrank p=0.78); target vessel-related MI (3.2% vs. 2.5%; Logrank p=0.38); and target vessel revascularization (6.8% vs. 7.5%; Logrank p=0.55), respectively. In addition, the incidence of definite-or-probable stent thrombosis was similar for patients treated with ZES versus EES (1.5% vs. 1.2%; Logrank p=0.67). Conclusion: At 4-year follow-up, ZES and EES showed similar and sustained results in terms of safety and efficacy for treating all-comer patients.

Objective: Limited data is available on the long-term outcome of patients with increased cardiovascular event risk, treated with newer-generation durable polymer drug-eluting stents (DES). Methods: We therefore assessed 3-year follow-up data of high-risk versus low- to intermediate-risk patients of the randomized DUTCH PEERS trial (NCT01331707). In both risk groups we also compared patients treated with Resolute Integrity versus Promus Element DES. Patients were categorized as “high-risk” if they met ≥1 of the following criteria: (1) diabetes (17.9%); (2) previous myocardial infarction (21.9%); (3) previous coronary revascularization (25.8%); (4) chronic renal failure (3.5%); (5) left ventricular ejection fraction ≤30% (1.5%); and (6) age ≥75 years (17.3%). Results: At the 3-year follow-up, the incidence of the composite endpoint target vessel failure (TVF) (13.2 vs. 7.5%; logrank p < 0.001) and 2 of its components - cardiac death (4.7 vs. 1.5%; logrank p < 0.001) and target vessel revascularization (7.3 vs. 4.7%; logrank p = 0.03) - was higher in high-risk (n = 957) versus low- to intermediate-risk patients (n = 854). Among high-risk patients, treatment with Resolute Integrity (n = 481) and Promus Element stents (n = 476) was similarly safe and efficacious (TVF: 13.3 vs. 13.1%; logrank p = 0.95; definite-or-probable stent thrombosis: 1.7 vs. 1.7%; logrank p = 1.00). Conclusions: The newer-generation Resolute Integrity and Promus Element stents showed similar results in terms of safety and efficacy for treating high-risk patients, who had significantly higher event rates than patients with low-to-intermediate risk.

Background Methotrexate (MTX) is widely used in the treatment of psoriasis and psoriatic arthritis (PsA). To prevent MTX-induced adverse events dermatological MTX guidelines advise a higher number and frequency of blood tests than rheumatological guidelines (1,2). These differences are not based on evidence indicating a higher risk for patients with psoriasis compared to PsA. Objectives Compare the effects of MTX monitoring strategies by rheumatologists and dermatologists. Methods Patients with psoriasis or PsA in a Dutch teaching hospital. Inclusion criteria: start methotrexate (MTX) between 2006 and 2012 and scheduled follow-up by dermatologist or rheumatologist. Exclusions: incomplete availability of lab data. Start and stop dates and dosing of MTX and folic acid, reasons for withdrawal of MTX, numbers and results of laboratory tests performed for MTX safety, occurrence of any serious adverse event (SAE) were retrieved from electronic records. Results PsA patients used higher initial and maximum doses of MTX and folic acid, but psoriasis patients had a higher frequency of abnormal liver function tests, resulting in a striking difference in withdrawal of MTX (Table). In PsA MTX was more often withdrawn for remission, and less frequently for ineffectiveness leading to longer drug survival in the first course of treatment. There were no differences in the occurrence of SAE or death between these groups. Hospital admissions related to infection were recorded in 6 (3.1%) PsA vs 4 (2.1%) psoriasis patients. Conclusions Monitoring by dermatologists resulted in more abnormal liver function tests and shorter drug survival of MTX. The monitoring strategy by rheumatologists was not associated with increased SAEs. This supports the safety of current rheumatological guidelines and suggests reconsideration of a higher number of liver function tests in dermatological guidelines. References Menter A, Korman NJ, Elmets C et al. Guidelines of care for the management of psoriasis and psoriatic arthritis. J Am Acad Dermatol. http://dx.doi.org/10.1016/j.jaad.2009.03.027. Barker J, Horn EJ, Lebwohl M et al. Assessment and management of methotrexate hepatotoxicity in psoriasis patients: Report from a consensus conference to evaluate current practice and identify key questions toward optimizing methotrexate use in the clinic. J Eur Acad Dermatol Venereol 2011;25:758–64. Disclosure of Interest None declared