VINCI Study Research Articles

Optimal implementation of the 2019 ESC/EAS dyslipidaemia guidelines in patients with and without atherosclerotic cardiovascular disease across Europe: a simulation based on the DA VINCI study.

The impact of the stepwise implementation of the 2019 European Society of Cardiology (ESC)/European Atherosclerosis Society (EAS) treatment algorithm on low-density lipoprotein cholesterol (LDL-C) goal attainment was simulated in patients from the DA VINCI study. Monte Carlo simulation was used to evaluate treatment optimisation scenarios, based on a patient's risk category: statin intensification (step 1), addition of ezetimibe (step 2), and addition of a proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor (step 3). Residual cardiovascular risk and predicted relative and absolute risk reduction (RRR and ARR) in cardiovascular events were assessed. In DA VINCI, 2482 patients did not achieve their 2019 ESC/EAS LDL-C goals and were included in the simulation. In patients without atherosclerotic cardiovascular disease (ASCVD) (n=962), 27.0% (n=259) and 57.0% (n=548) are likely to achieve their LDL-C goals at step 1 and step 2, respectively. Of those at very high risk without ASCVD (n=74), 88.1% (n=65) are likely to achieve their LDL-C goals at step 3. In patients with ASCVD (n=1520), 12.0% (n=183), 42.1% (n=641) and 93.2% (n=1416) are likely to achieve their LDL-C goals at steps 1, 2 and 3, respectively. In patients with and without ASCVD, treatment optimisation may result in mean simulated RRR of 24.0% and 17.7%, respectively, and ARR of 8.1% and 2.6%, respectively. Most patients at high cardiovascular risk are unlikely to achieve LDL-C goals through statin optimisation and ezetimibe, and will require a PCSK9 inhibitor, leading to greater reduction in cardiovascular risk. Amgen.

Underutilization of combination therapy in lipid lowering: a missed opportunity.

Atherosclerotic cardiovascular disease (ASCVD) is the leading cause of morbidity and mortality worldwide. LDL cholesterol (LDL-C) is the key driving force in the atherosclerotic process, and LDL-C lowering can change the trajectory of ASCVD and decrease cardiovascular (CV) events. In the light of new evidence, LDL-C goals have become more stringent in the ESC guidelines, especially for high-risk patients.1 Unfortunately, these goals are rarely reached in real life as shown in registries such as EUROASPIRE documenting a large implementation gap.2 The reasons for underimplementation are multiple, but underutilization of therapies is a major cause. Statins are the first line of treatment in lipid-lowering therapy (LLT) but may not get the patient to the guideline-recommended goals, and combination therapy may be necessary. The recent ESC guidelines recommend adding ezetimibe first, followed by proprotein convertase subtilisin/kexin type 9 (PCSK9) monoclonal antibody inhibitors to the treatment regimen, since both agents have been documented to decrease CV events further on top of a statin.3 However, combination therapy with non-statin drugs is widely underutilized. A recent pan-European observational study (the DA VINCI study) reported that a majority of patients under both primary and secondary prevention were receiving moderate-intensity statin therapy. Only 28% were receiving high-intensity statins, 9% ezetimibe combination therapy, and 1% PCSK9 inhibitors.4 As a result, only a third of the patients achieved their LDL-C goal as recommended in the recent guidelines.

Low-density lipoprotein cholesterol goal attainment in Germany: Results from the DA VINCI study

Background and aimsCardiovascular mortality is high in Germany. For patients with high or very high cardiovascular risk, the European Society of Cardiology (ESC)/European Atherosclerosis Society (EAS) guidelines recommend intensive lipid lowering therapy (LLT). This study aimed to assess dyslipidaemia management and achievement of the ESC/EAS guideline-recommended low-density lipoprotein cholesterol (LDL-C) goals. MethodsThis European 18-country, cross-sectional, observational DA VINCI study (EUPAS22075) collected data during a single visit between June 2017 and November 2018 and included LLT in the preceding 12 months and the patients' most recent LDL-C measurement. Achievement of the risk-based 2016 and 2019 ESC/EAS LDL-C goals while receiving stabilized LLT was assessed. Data from the German cohort are presented here. ResultsSeven German sites enrolled a total of 421 primary and secondary prevention patients, 327 were receiving stabilized LLT at the time of LDL-C measurement, i.e. statin monotherapy of high (16%; n = 53), moderate (49%; n = 160) or low (7%; n = 24) intensity, ezetimibe combination (18%; n = 58), proprotein convertase subtilisin/kexin type 9 antibody combination (3%; n = 9), and other LLT (7%; n = 23). The 2016 and 2019 risk-based LDL-C goals were attained by 46% (n = 149) and 28% (n = 92) of patients, respectively. ConclusionsThere is a large gap between ESC/EAS recommendations and LDL-C goal achievement in routine clinical practice in high and very high-risk patients in Germany. Low-to-moderate-intensity statin monotherapy was the most frequently used LLT; use of high-intensity statins and combination therapy was limited. In addition to optimizing statin intensity, combination with non-statin LLT may be needed in most of these patients.

LDL-cholesterol goal attainment through optimal implementation of the 2019 ESC/EAS dyslipidemia treatment algorithm in European patients with/without atherosclerotic cardiovascular disease: Simulation study from DA VINCI

Background and Aims : In the European-wide DA VINCI study, only 33% of patients attained their risk-based 2019 ESC/EAS guideline LDL-C goals. We aimed to simulate the impact of the step-wise implementation of the ESC/EAS lipid-lowering treatment (LLT) pathway on LDL-C goal attainment across risk categories.

The DA VINCI study: is Ireland achieving ESC/EAS guideline–directed LDL-C goals?

BackgroundThe EU-wide, cross-sectional observational study of lipid-lowering therapy (LLT) use in secondary and primary care (DA VINCI) assessed the proportion of patients achieving low-density lipoprotein cholesterol (LDL-C) goals recommended by the European Society of Cardiology (ESC)/European Atherosclerosis Society (EAS) guidelines and provided an insight into regional use of LLT in Europe, including Ireland.AimsThis analysis focuses on data from patients in Ireland who participated in the DA VINCI study.MethodsThe DA VINCI study enrolled patients receiving LLT at primary and secondary care sites across 18 European countries between June 2017 and November 2018. The study assessed the achievement of risk-based 2016 and 2019 ESC/EAS LDL-C goals. This subgroup analysis aimed to evaluate LDL-C goal attainment in an Irish cohort of primary and secondary care patients.ResultsIn total, 198 patients from Ireland were enrolled from three primary care and three secondary care centres. Most patients were White and male, and were receiving moderate- or high-intensity statin therapy (most frequently atorvastatin or rosuvastatin). Few patients (< 10%) were receiving combination therapy of statin and ezetimibe. Approximately 60% of patients achieved their 2016 ESC/EAC LDL-C goals while less than half the patients achieved their 2019 ESC/EAS goals. Approximately half of secondary prevention patients achieved their 2016 ESC/EAS goals and only 20% of secondary prevention patients achieved their 2019 ESC/EAS goals.ConclusionsThese results highlight the disparity between dyslipidaemia management in clinical practice in Ireland and guideline recommendations.Trial registrationENCePP; EU PAS 22,075; date registered 06 February 2018.

ACHIEVING THERAPEUTIC GOAL ON LDL IN HIGH AND VERY HIGH RISK PATIENTS IN A DEDICATED OUTPATIENT CLINIC

Objective: High LDL cholesterol levels represent an important risk factor for development of cardiovascular disease. The reduction of LDL reduces cardiovascular risk. Current guidelines (ESC 2019) recommend ambitious LDL levels for high and very high risk patients. But, in clinical practice, just a part of these patients achieve the ESC 2019 goals (DA VINCI Study). Design and method: We evaluated, in the first 152 patients, at high and very high cardiovascular risk, consecutively afferent to our dedicated clinic for hyperlipidaemia (Lipid Center CS), the achievement of the therapeutic goal of LDL according to ESC 2019 guidelines. All patients were on lipid-lowering drug treatment from at least twelve months and the last blood tests were no less recent than three months. Results: Of all patients, 82 were female. The mean age was 65.24 ± 10.33 years. Thirty patients were in secondary prevention. Of all patients, 70% reached the therapeutic goal (77% with very high risk and 68% with high risk). Fifty nine% were taking high-intensity lipid-lowering therapy. Seventy one% were taking combination therapy. Thirty four% were treated with PCSK9 inhibitors. Conclusions: Taking note of the limited number of the sample, our therapeutic achieved results are higher than that got in the DA VINCI study in which only 60% of patients, from west Europe, reached the therapeutic goal. A dedicated clinic for hyerlipidaemia and the high use of combination therapy with intensive drugs and extensive use of PCSK9 inhibitors may justify the results of our study. Our center did not participated in the DA VINCI study.

P359 ACHIEVING THERAPEUTIC GOAL ON LDL IN HIGH AND VERY HIGH RISK PATIENTS IN A DEDICATED OUTPATIENT CLINIC

Abstract Background High LDL cholesterol levels represent an important risk factor for development of cardiovascular disease. Reduction of LDL reduces cardiovascular risk. Current guidelines (ESC 2019) recommend ambitious LDL levels for high and very high risk patients. But, in clinical practice, just a part of these patients achieve the ESC 2019 goals (DA VINCI Study). Patients and Methods We evaluated, in the first 152 patients, at high and very high cardiovascular risk, consecutively afferent to our dedicated clinic for hyperlipidaemia (Lipid Center CS), the achievement of the therapeutic goal of LDL according to ESC 2019 guidelines. All patients were on lipid–lowering drug treatment from at least twelve months and the last blood tests were no less recent than three months. Results Of all patients, 82 were female. The mean age was 65.24±10.33 years. Thirty patients were in secondary prevention. Of all patients, 70% reached the therapeutic goal (77% with very high risk and 68% with high risk). Fifty nine% were taking high–intensity lipid–lowering therapy. Seventy one% were taking combination therapy. Thirty four% were treated with PCSK9 inhibitors. Discussion Taking note of the limited number of the sample, our therapeutic results achieved are higher than that achieved in the DA VINCI study in which only 60% of patients from west Europe reached the therapeutic goal. A dedicated clinic for hyerlipidaemia and the high use of combination therapy with intensive drugs and extensive use of PCSK9 inhibitors may justify the results of our study. Our center did not participated in the DA VINCI study.

Implications of ACC/AHA Versus ESC/EAS LDL-C Recommendations for Residual Risk Reduction in ASCVD: A Simulation Study From DA VINCI

PurposeLow-density lipoprotein cholesterol (LDL-C) recommendations differ between the 2018 American College of Cardiology/American Heart Association (ACC/AHA) and 2019 European Society of Cardiology/European Atherosclerosis Society (ESC/EAS) guidelines for patients with atherosclerotic cardiovascular disease (ASCVD) (< 70 vs. < 55 mg/dl, respectively). In the DA VINCI study, residual cardiovascular risk was predicted in ASCVD patients. The extent to which relative and absolute risk might be lowered by achieving ACC/AHA versus ESC/EAS LDL-C recommended approaches was simulated.MethodsDA VINCI was a cross-sectional observational study of patients prescribed lipid-lowering therapy (LLT) across 18 European countries. Ten-year cardiovascular risk (CVR) was predicted among ASCVD patients receiving stabilized LLT. For patients with LDL-C ≥ 70 mg/dl, the absolute LDL-C reduction required to achieve an LDL-C of < 70 or < 55 mg/dl (LDL-C of 69 or 54 mg/dl, respectively) was calculated. Relative and absolute risk reductions (RRRs and ARRs) were simulated.ResultsOf the 2039 patients, 61% did not achieve LDL-C < 70 mg/dl. For patients with LDL-C ≥ 70 mg/dl, median (interquartile range) baseline LDL-C and 10-year CVR were 93 (81–115) mg/dl and 32% (25–43%), respectively. Median LDL-C reductions of 24 (12–46) and 39 (27–91) mg/dl were needed to achieve an LDL-C of 69 and 54 mg/dl, respectively. Attaining ACC/AHA or ESC/EAS goals resulted in simulated RRRs of 14% (7–25%) and 22% (15–32%), respectively, and ARRs of 4% (2–7%) and 6% (4–9%), respectively.ConclusionIn ASCVD patients, achieving ESC/EAS LDL-C goals could result in a 2% additional ARR over 10 years versus the ACC/AHA approach.Graphical abstract

Lipid-lowering therapy and risk-based LDL-C goal attainment in Belgium: DA VINCI observational study

Background Cardiovascular disease (CVD) is one of the leading causes of death in Belgium. Current strategies for the prevention and management of CVD focus on reducing low-density lipoprotein cholesterol (LDL-C) levels. This analysis assessed whether LDL-C goals, recommended by the European Society of Cardiology (ESC)/European Atherosclerosis Society (EAS) guidelines, were being achieved in a Belgian study population. Methods The cross-sectional, observational, DA VINCI study enrolled patients prescribed lipid-lowering therapy (LLT) between 21 June 2017 and 20 November 2018. Data for patients from Belgium were extracted for this country-specific analysis. Primary endpoint was the proportion of patients who achieved 2016 ESC/EAS risk-based LDL-C goals; attainment of 2019 risk-based LDL-C goals was evaluated post hoc. Results Of 497 enrolled patients, 41% were female and mean age was 68 years. Among subjects with an LDL-C measurement on stabilised LLT, moderate-intensity statin monotherapy was the most prescribed LLT regimen (59%). Overall, 63% of patients achieved their risk-based LDL-C goals according to the 2016 ESC/EAS guidelines. Among patients with established ASCVD, risk-based LDL-C goal attainment was higher in patients with peripheral arterial disease (53%) than patients with coronary (37%) and cerebrovascular disease (42%). According to the updated 2019 ESC/EAS guidelines, less than half (41%) of patients achieved their risk-based LDL-C goal. The proportion of primary and secondary prevention patients who achieved 2019 risk-based LDL-C goals was 59% and 18%, respectively. Conclusion These findings reveal a large gap between the LDL-C goals advocated by the ESC/EAS and the levels achieved in routine clinical practice in Belgium.

Absent visitors: the wider implications of COVID-19 on cardiothoracic ICU staff: the VINCI Study

Patients are not lone entities; they are part of larger social networks containing their family and others. Before the COVID-19 pandemic, visiting policies varied globally1; many ICUs in the UK adopted a flexible approach to visiting. In March 2020 the rapidly progressing pandemic led the Scottish Government to stop non-essential visiting in hospitals. The impact of this policy on non-COVID-19 patients in cardiothoracic ICU, their relatives, and staff involved in their care is unknown. As one part of a mixed-method study, the experiences of staff caring for non-COVID-19 patients in a cardiothoracic ICU unit were explored.Participants were recruited using purposive sampling. Data were collected using semi-structured interviews, transcribed, and analysed using grounded theory.Twenty members of staff were recruited from a range of patient facing roles and experience. From initial coding a range of categories emerged. These were: isolation; delirium management; end-of-life issues; communication; and role and workload. Participants understood the necessity of the national visiting restrictions; however, they observed that the benefits came with notable negative effects on patients and their families.This study shows an increased burden experienced by participants, not solely in the delivery of clinical care, highlighting the possible exposure of clinical staff not involved in COVID-19 care to potentially morally injurious events at this time. Moral injury is associated with events that lead to internal moral conflict and has potential to develop into other psychological issues.2Further research is needed on identifying and supporting clinical staff with moral injury stemming from caring for ICU patients during COVID-19.This study provides some insight into the experiences of clinical staff in the cardiothoracic ICU during the pandemic and should be considered alongside the experiences of patients and their families.

Lipid-lowering therapy use in primary and secondary care in Central and Eastern Europe: DA VINCI observational study

Background and aimsCentral and Eastern Europe (CEE) is a largely understudied region, despite having the highest cardiovascular disease mortality in Europe. This analysis aimed to assess the proportion of patients in CEE who achieved their LDL-C goals based on individual cardiovascular risk recommended by the 2016 and 2019 European Society of Cardiology (ESC)/European Atherosclerosis Society (EAS) guidelines. MethodsThe DA VINCI study was a cross-sectional observational study of primary and secondary prevention patients receiving lipid-lowering therapy across Europe between June 2017 and November 2018. ResultsIn total, 2154 patients were enrolled from the Czech Republic (n = 509), Hungary (n = 319), Poland (n = 460), Romania (n = 259), Slovakia (n = 123) and Ukraine (n = 484). At LDL-C measurement, most patients were on either moderate- or high-intensity statin monotherapy (53% and 32%, respectively). Despite this, only 44% of patients achieved risk-based LDL-C goals recommended by the 2016 ESC/EAS guidelines, ranging from 21% in Ukraine to 50% in Hungary and Romania. Only 24% of patients overall achieved the risk-based LDL-C goals recommended by the 2019 ESC/EAS guidelines, ranging from 11% in Ukraine to 32% in Poland. ConclusionsAmong patients receiving lipid-lowering therapy, more than half did not achieve their 2016 LDL-C goals. In one of the first comparative analyses evaluating 2019 risk-based goal attainment among countries in CEE, three-quarters of patients did not meet their 2019 LDL-C goals, highlighting a significant gap between guidelines and clinical practice for lipid management in CEE.

Lipid lowering therapy in primary and secondary prevention across Europe: Are LDL-C goals achieved? Results from the da vinci study

Background and Aims: Describe lipid lowering therapy (LLT) and achievement of the LDL-C goals recommended in 2016 EAS/ESC dyslipidaemia guidelines.

Do European patients with peripeheral arterial disease receive optimal lipid lowering therapy and achieve LDL-C goals? Results from the DA VINCI study

Abstract Background 2016 and 2019 EAS/ESC dyslipidemia guidelines recommend lipid lowering therapy (LLT) to reduce LDL-C in patients with peripheral arterial disease (PAD) with or without established cardiovascular (CV) disease, and recommend target LDL-C goals based on individual CV risk. Data regarding the implementation of these guidelines in clinical practice across Europe is currently lacking. Purpose Describe LLT and achievement of the target LDL-C goals recommended in EAS/ESC dyslipidemia guidelines in patients with PAD. Methods The cross-sectional Da Vinci study enrolled consenting adults who had received LLT in the 12 months prior to the study visit and had at least one LDL-C measurement in the 14 months prior to the study visit, seen in a primary or secondary care setting across 18 European countries. Patients with coronary, peripheral and cerebral disease were enrolled at a ratio of 1:2:2. FH patients with prior CV events were excluded. Data were collected from medical records at a single visit between Jun '17–Nov '18, including LLT and most recent LDL-C. Primary outcome was LDL-C goal attainment ≥28 days after starting most recent LLT (treatment-stabilised LLT). Results Of 5888 patients enrolled, 2794 met our definition of atherosclerotic cardiovascular disease (ASCVD). Of these ASCVD patients, 1036 (37%) had PAD. 31% (323/1036) of PAD patients were female and mean (SD) age was 69 (9.4) years. Concomitant CV risk factors included diabetes mellitus (473/1036 patients [46%]), hypertension (809/1036 [78%]) and smoking (794/1036 [77%]). 26% (271/1036) of patients with PAD also had coronary vascular disease and 12% (122/1036) also had cerebrovascular disease. At the visit date, approximately half (497/1036 [48%]) of all PAD patients were receiving moderate intensity statins and 41% (421/1036) were receiving high intensity statins. 818 (73%) of the PAD patients had a treatment-stabilised LDL-C measurement (median, 2.20 mmol/L), of whom 40% (326/818) achieved the 2016 EAS/ESC LDL-C goal of 1.8 mmol/L and only 19% (159/818) achieved the 2019 goal of 1.4mmol/L. Conclusions European patients with PAD are not treated as per EAS/ESC recommendations, with a large proportion receiving suboptimal LLT and fewer than half achieving target LDL-C levels. Funding Acknowledgement Type of funding source: Private company. Main funding source(s): Amgen

DA VINCI study: Change in approach to cholesterol management will be needed to reduce the implementation gap between guidelines and clinical practice in Europe

DA VINCI study: Change in approach to cholesterol management will be needed to reduce the implementation gap between guidelines and clinical practice in Europe

Phenotype of definite familial hypercholesterolemia with negative genetic study in Argentina.

Familial hypercholesterolemia (FH) is a monogenic disease, associated with variants in the LDLR, APOB and PCSK9 genes. The initial diagnosis is based on clinical criteria like the DLCN criteria. A score > 8 points qualifies the patient as "definite" for FH diagnosis. The detection of the presence of a variant in these genes allows carrying out familial cascade screening and better characterizes the patient in terms of prognosis and treatment. In the context of the FH detection program in Argentina (Da Vinci Study) 246 hypercholesterolemic patients were evaluated, 21 with DLCN score > 8 (definite diagnosis).These patients were studied with next generation sequencing to detect genetic variants, with an extended panel of 23 genes; also they were adding the large rearrangements analysis and a polygenic score of 10 SNP (single nucleotide polymorphism) related to the increase in LDL-c. Of the 21 patients, 10 had variants in LDLR, 1 in APOB with APOE, 1 in LIPC plus elevated polygenic score, and 2 patients showed one deletion and one duplication in LDLR, the later with a variation in LIPA. It is highlighted that 6 of the 21 patients with a score > 8 did not show any genetic alteration. We can conclude that 28% of the patients with definite clinical diagnosis of FH did not show genetic alteration. The possible explanations for this result would be the presence of mutations in new genes, confusing effects of the environment over the genes, the gene-gene interactions, and finally the impossibility of detecting variants with the current available methods.

Fenotipo de hipercolesterolemia familiar definitivo con estudio genético negativo en Argentina.

Familial hypercholesterolemia (FH) is a monogenic disease, associated with variants in the LDLR, APOB and PCSK9 genes. The initial diagnosis is based on clinical criteria like the DLCN criteria. A score > 8 points qualifies the patient as "definite" for FH diagnosis. The detection of the presence of a variant in these genes allows carrying out familial cascade screening and better characterizes the patient in terms of prognosis and treatment. In the context of the FH detection program in Argentina (Da Vinci Study) 246 hypercholesterolemic patients were evaluated, 21 with DLCN score > 8 (definite diagnosis).These patients were studied with next generation sequencing to detect genetic variants, with an extended panel of 23 genes; also they were adding the large rearrangements analysis and a polygenic score of 10 SNP (single nucleotide polymorphism) related to the increase in LDL-c. Of the 21 patients, 10 had variants in LDLR, 1 in APOB with APOE, 1 in LIPC plus elevated polygenic score, and 2 patients showed one deletion and one duplication in LDLR, the later with a variation in LIPA. It is highlighted that 6 of the 21 patients with a score > 8 did not show any genetic alteration. We can conclude that 28% of the patients with definite clinical diagnosis of FH did not show genetic alteration. The possible explanations for this result would be the presence of mutations in new genes, confusing effects of the environment over the genes, the gene-gene interactions, and finally the impossibility of detecting variants with the current available methods.

One-Year Outcomes of the DA VINCI Study of VEGF Trap-Eye in Eyes with Diabetic Macular Edema

To compare different doses and dosing regimens of Vascular Endothelial Growth Factor (VEGF) Trap-Eye with laser photocoagulation in eyes with diabetic macular edema (DME). Randomized, double-masked, multicenter, phase 2 clinical trial. Diabetic patients (n = 221) with center-involved DME. Participants were assigned randomly to 1 of 5 treatment regimens: VEGF Trap-Eye 0.5 mg every 4 weeks (0.5q4); 2 mg every 4 weeks (2q4); 2 mg every 8 weeks after 3 initial monthly doses (2q8); or 2 mg dosing as needed after 3 initial monthly doses (2PRN), or macular laser photocoagulation. The change in best-corrected visual acuity (BCVA) at 24 weeks (the primary end point) and at 52 weeks, proportion of eyes that gained 15 letters or more in Early Treatment of Diabetic Retinopathy Study (ETDRS) BCVA, and mean changes in central retinal thickness (CRT) from baseline. As previously reported, mean improvements in BCVA in the VEGF Trap-Eye groups at week 24 were 8.6, 11.4, 8.5, and 10.3 letters for 0.5q4, 2q4, 2q8, and 2PRN regimens, respectively, versus 2.5 letters for the laser group (P ≤ 0.0085 versus laser). Mean improvements in BCVA in the VEGF Trap-Eye groups at week 52 were 11.0, 13.1, 9.7, and 12.0 letters for 0.5q4, 2q4, 2q8, and 2PRN regimens, respectively, versus -1.3 letters for the laser group (P ≤ 0.0001 versus laser). Proportions of eyes with gains in BCVA of 15 or more ETDRS letters at week 52 in the VEGF Trap-Eye groups were 40.9%, 45.5%, 23.8%, and 42.2% versus 11.4% for laser (P = 0.0031, P = 0.0007, P = 0.1608, and P = 0.0016, respectively, versus laser). Mean reductions in CRT in the VEGF Trap-Eye groups at week 52 were -165.4 μm, -227.4 μm, -187.8 μm, and -180.3 μm versus -58.4 μm for laser (P < 0.0001 versus laser). Vascular Endothelial Growth Factor Trap-Eye generally was well tolerated. The most frequent ocular adverse events with VEGF Trap-Eye were conjunctival hemorrhage, eye pain, ocular hyperemia, and increased intraocular pressure, whereas common systemic adverse events included hypertension, nausea, and congestive heart failure. Significant gains in BCVA from baseline achieved at week 24 were maintained or improved at week 52 in all VEGF Trap-Eye groups. Vascular Endothelial Growth Factor Trap-Eye warrants further investigation for the treatment of DME.

Healthcare professionals’ adoption and use of a clinical information system (CIS) in primary care: Insights from the Da Vinci study

Given the increasing prevalence of multimorbidity in primary care (PC), interdisciplinary PC teams supported by appropriate clinical information systems (CIS) are needed in order to deal with the complexity of multimorbid patients’ care. Our team has developed such a system, called the Da Vinci system. However, despite the expected benefits, evidence suggests generally low rates of CIS adoption. To optimize adoption in PC settings, a better understanding of the implementation process of such systems is crucial. Purpose To identify user profiles, investigate the drivers of and barriers to adoption and use of the Da Vinci system, a PC tailored CIS, and understand the dynamics of the CIS adoption for each profile. Methods Using a longitudinal approach, we conducted a qualitative study (individual interviews, documentation and observation) based on the Diffusion of Innovation theory. It included 31 participants (primary care physicians, staff or residents, nurses, pharmacists) from two Family Medicine Groups in Quebec (Canada). Results The different user profiles drawn from the dynamics of implementation are linked to different sets of perceived drivers and barriers that evolve over time. Certain factors favour the decision of adopting Da Vinci early on: e.g. user skills and the system's expected ease of use and usefulness. Certain concerns hinder its adoption: e.g. perceived negative impact on the doctor–patient relationship. Over time, 5 factors appear to be related to more advanced exploitation of the system's functionalities: user skills, ease of use, comfort using the system in front of patients, support from colleagues and, more importantly, perceived positive impacts. Conclusions A better understanding of the dynamics of CIS implementation provides insight into how best to encourage clinicians to adopt and make full use of such systems to improve the quality of care for multimorbid patients followed in PC settings.

The DA VINCI Study: Phase 2 Primary Results of VEGF Trap-Eye in Patients with Diabetic Macular Edema

To determine whether different doses and dosing regimens of intravitreal vascular endothelial growth factor (VEGF) Trap-Eye are superior to focal/grid photocoagulation in eyes with diabetic macular edema (DME). Multicenter, randomized, double-masked, phase 2 clinical trial. A total of 221 diabetic patients with clinically significant macular edema involving the central macula. Patients were assigned to 1 of 5 treatment regimens: 0.5 mg VEGF Trap-Eye every 4 weeks; 2 mg VEGF Trap-Eye every 4 weeks; 2 mg VEGF Trap-Eye for 3 initial monthly doses and then every 8 weeks; 2 mg VEGF Trap-Eye for 3 initial monthly doses and then on an as-needed (PRN) basis; or macular laser photocoagulation. Assessments were completed at baseline and every 4 weeks thereafter. Mean change in visual acuity and central retinal thickness (CRT) at 24 weeks. Patients in the 4 VEGF Trap-Eye groups experienced mean visual acuity benefits ranging from +8.5 to +11.4 Early Treatment of Diabetic Retinopathy Study (ETDRS) letters versus only +2.5 letters in the laser group (P ≤ 0.0085 for each VEGF Trap-Eye group vs. laser). Gains from baseline of 0+, 10+, and 15+ letters were seen in up to 93%, 64%, and 34% of VEGF Trap-Eye groups versus up to 68%, 32%, and 21% in the laser group, respectively. Mean reductions in CRT in the 4 VEGF Trap-Eye groups ranged from -127.3 to -194.5 μm compared with only -67.9 μm in the laser group (P = 0.0066 for each VEGF Trap-Eye group vs. laser). VEGF Trap-Eye was generally well tolerated. Ocular adverse events in patients treated with VEGF Trap-Eye were generally consistent with those seen with other intravitreal anti-VEGF agents. Intravitreal VEGF Trap-Eye produced a statistically significant and clinically relevant improvement in visual acuity when compared with macular laser photocoagulation in patients with DME.