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Implementation of dyslipidaemia management protocols in Spanish cardiology departments: Results from the CONTROL+T project
Implementación de protocolos para el abordaje de dislipemia en los servicios de cardiología españoles: resultados del proyecto CONTROL+T
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Ana Viana-Tejedora,b, Rosa Fernández-Olmoc, Román Freixa-Pamiasd, Luis Rodríguez-Padiale, Juan Cosín-Salesf,g,
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jcosinsales@gmail.com

Corresponding author.
a Servicio de Cardiología, Hospital Clínico San Carlos, Madrid, Spain
b Instituto de Investigación Sanitaria del Hospital Clínico San Carlos (IdISSC), Madrid, Spain
c Servicio de Cardiología, Hospital Universitario Virgen del Rocío, Seville, Spain
d Servicio de Cardiología Complex Hospitalari Universitari Moisès Broggi, Barcelona, Spain
e Servicio de Cardiología, Complejo Hospitalario de Toledo, Toledo, Spain
f Servicio de Cardiología, Hospital Universitario Arnau de Vilanova, Valencia, Spain
g Universidad CEU-Cardenal Herrera, Alfara del Patriarca, Valencia, Spain
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Table 1. Use of PSCK9 inhibitors and complexity of cardiology departments per autonomous community.
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To the Editor,

Since their publication, the implementation of the 2019 ESC/EAS guidelines for the management of dyslipidaemias to reduce cardiovascular risk1 has been suboptimal. Data on adherence are scarce, but the few national studies conducted reported a limited application of guideline-based protocols in Spanish cardiology departments (CDs).2,3 The CONTROL+T project is a pioneering initiative designed to promote both the evaluation of internal clinical care processes, collecting information on the implementation of guideline-based protocols and ongoing professional education, providing support for CDs with lower implementation levels. In this article, we present the findings from the self-evaluation of internal clinical care processes of the CONTROL+T project, designed to assess the integration of the 2019 ESC/EAS guidelines into the Spanish CDs's internal clinical protocols, to achieve an early low-density lipoprotein cholesterol (LDL-C) control following an acute coronary syndrome. The CONTROL+T project seeks to identify areas for improvement and to promote harmonisation of healthcare across the Spanish National Healthcare System (SNS), and it was endorsed by the Associations of Ischemic Heart Disease and Acute Cardiac Care, Clinical Cardiology, Preventive Cardiology, and the Research Agency of the Spanish Society of Cardiology (SEC).

All CDs in the SNS were invited to participate, with an expected participation rate ranging from 40% to 60%. The primary objective was to assess the degree of implementation of clinical protocols applying the recommendations of the 2019 ESC/EAS guidelines. The primary endpoint was the proportion of CDs demonstrating an adequate level of protocol implementation, assessed through an ad-hoc 18-item questionnaire. A satisfactory level of implementation was defined as achieving >83.3% of the total score (minimum of 15 items with an affirmative [“Yes”] response).

As a secondary endpoint, the degree of implementation of these protocols in the following individual stages defined ad hoc were evaluated: (a) event occurrence (myocardial infarction); (b) acute cardiovascular care; (c) hospitalization, (d) clinical cardiology care, (e) general practice/primary care.

Descriptive statistics (frequencies, percentages, and dispersion measures) were used to summarize the data and were analysed using R statistical software (version 4.2.0).

Throughout 2024 and 2025, 81 CDs voluntarily participated. All autonomous communities (ACs) (geopolitical organization of regions in Spain) were represented, except for La Rioja and the Canary Islands. The regions with the highest number of participating CDs were Andalusia (14), Madrid (12), Catalonia (11), and the Valencian Community (10). Post-hoc analysis revealed that 38.3% of CDs belonged to high-level assistance hospitals, while 61.7% were associated with hospitals offering a lower level of care.

Our data revealed that 37.0% of participating CDs were considered compliant. By region, Navarra and Andalusia showed the highest compliance rates (100% and 71.4%, respectively). The overall mean score was 11.7±5.8, while compliant CDs achieved a mean score of 16.5±1.0. The descriptive regional performance analysis showed heterogeneous results among the participating ACs.

A total of 8 (9.9%) CDs were considered fully compliant, achieving the maximum score of 18 points. In contrast, 14 (17.3%) services obtained a global score of 0 points. Responses by item are summarised in Fig. 1.

Fig. 1.

Percentage of positive responses to the 18-item self-evaluation questionnaire. ApoB, apolipoprotein B; GP, general practitioner; HDL, high-density lipoprotein; LDL-C, low density lipoprotein cholesterol; Lp(a), lipoprotein a; MI, myocardial infarction; PCSK9, proprotein convertase subtilisin/kexin type 9.

Finally, the analysis of the individual stages of the clinical care process revealed that 63.0% of services were compliant with phase 1. Event occurrence (myocardial infarction), 42.0% with acute cardiovascular care, 52.4% with hospitalization, 76.5% with clinical cardiology care, and 67.1% with general practice/primary care.

Regional differences in the use of proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitors therapy during hospitalization and in structural characteristics of cardiology departments are presented in Table 1.

Table 1.

Use of PSCK9 inhibitors and complexity of cardiology departments per autonomous community.

Autonomous community(N=15)  Use of PCSK9 inhibitors therapy during hospitalization  Use of combined therapy (statins+PCSK9 inhibitors) during hospitalization  CD or heart-attack service providing 24h care  Coordination with other units 
Andalusia  4 (28.6)  10 (76.9)  7 (50.0)  2 (100.0) 
Aragon  0 (0.0)  2 (66.7)  1 (33.3)  1 (100.0) 
Asturias  1 (20.0)  2 (40.0)  2 (40.0)  3 (100.0) 
Balearic Islands  0 (0.0)  1 (50.0)  0 (0.0)  2 (100.0) 
Cantabria  0 (0.0)  1 (33.3)  1 (33.3)  2 (100.0) 
Castile-La Mancha  0 (0.0)  1 (20.0)  3 (60.0)  2 (100.0) 
Castile and León  1 (33.3)  1 (33.3)  2 (66.7)  1 (100.0) 
Catalonia  1 (9.1)  4 (36.4)  5 (45.5)  4 (100.0) 
Valencian Community  0 (0.0)  3 (30.0)  5 (50.0)  2 (100.0) 
Extremadura  0 (0.0)  2 (100.0)  1 (50.0)  2 (100.0) 
Galicia  2 (40.0)  3 (60.0)  3 (60.0)  2 (100.0) 
Madrid  3 (27.3)  8 (72.7)  4 (36.4)  2 (100.0) 
Region of Murcia  0 (0.0)  0 (0.0)  0 (0.0)  1 (100.0) 
Navarre  1 (100.0)  1 (100.0)  1 (100.0)  3 (100.0) 
Basque Country  0 (0.0)  0 (0.0)  1 (50.0)  2 (100.0) 

PCSK9: proprotein convertase subtilisin/kexin type 9.

Data are expressed as no. of cardiology departments (CDs) and percentage (%) within each autonomous community. The table summarizes the reported use of PCSK9 inhibitors therapy and combined lipid-lowering therapy during hospitalization, as well as indicators of structural complexity, including availability of 24-h cardiology or infarction unit care and coordination with other healthcare units.

In addition to the 18 core items of the questionnaire, supplementary questions were included to address alternative practices used instead of guideline recommendations. A total of 55% of departments reported that, despite not having a 24-h coronary unit, they maintained close coordination with external units. Among CDs where cardiac rehabilitation was not routinely scheduled (57.7%), 32.0% of them indicated that patients were at least provided with a description of the patient follow-up program. The recommendation for the first follow-up visits at 4–6 weeks was met in 45.0% of cases, whereas the remaining departments (55.0%) reported a mean follow-up interval of 8.4±4.2 weeks. In summary, 49.9% of respondents believed that the existence of standardized protocols improves LDL-C target achievements. Additionally, according to their experience, 60.3% of patients reached LDL-C goals as a result of the implementation of these protocols.

The pilot initiative within the CONTROL+T project revealed a limited percentage (37.0%) of compliant CDs with established protocols that fully reflected the 2019 ESC/EAS guidelines for the management of dyslipidaemias for an early LDL-C control. Beyond the fact that less than half of the CDs achieved compliance, the overall mean questionnaire score (11.7±5.8) fell below the minimum threshold of 15 points. This finding highlights the need for greater guideline adherence across a substantial proportion of CDs. Even among compliant CDs, the mean score was only slightly above the required threshold (16.5±1.0), suggesting that, although these departments have implemented structured processes, there continues to be considerable room for improvement in achieving full compliance with guideline recommendations.

Interestingly, 8 (9.9%) CDs achieved full compliance, making them outstanding reference services for best practices and protocol implementation. In contrast, the percentage of CDs achieving 0 points in the self-evaluation questionnaire is surprisingly elevated (17.3%). Improvement measures should be addressed by these departments, nevertheless; this situation led us to consider operational issues occurring during the answer-recording process.

No linear pattern of adherence was observed by stages of the clinical care process; rather, compliance varied considerably between stages. The lowest adherence rates were recorded in 2 consecutive phases: acute cardiovascular care (42.0%) and hospitalization (52.4%). This likely reflects the fact that, in many hospitals, coronary or critical care units are not directly managed by CDs. In contrast, adherence improved substantially in the subsequent stages of care, with over 65% of services achieving compliance in clinical cardiology care (76.5%) and general practice/primary care follow-up (67.1%). This indicates better continuity of care and coordination in post-hospitalization phases.

We observed heterogeneity across ACs in the organizational and clinical approaches reported, particularly regarding the intended use of PCSK9 inhibitors therapy during hospitalization. These findings suggest that differences observed among cardiology departments may be partly explained by variations in how each AC implements the national therapeutic positioning reports.

In the work of Anguita et al.,4 only 20% of CDs referred patients to outpatient Cardiology follow-up, and merely 15% to GP/primary care. In contrast, our findings reveal much higher rates of continuity, with 42.5% of CDs scheduling cardiac rehabilitation and 67.1% ensuring primary care follow-up. These figures are closer to those reported in the IKIGAI study,5 which documented a 77% rate of cardiology-primary care coordination. Similarly, our data show modest improvement in the quality of information provided at discharge. The percentage of discharge reports including LDL-C targets and laboratory results (97.5% vs 80.0%) was comparable to previous data, but lipid-lowering therapy appeared less frequently (56.2% vs 92.0%).

Underuse of PCSK9 inhibitors has been previously shown, even in patients who remain above LDL-C targets despite guideline recommendations. For instance, only 37.5% of eligible patients were prescribed PCSK9 inhibitors in the IKIGAI cohort5 whilst the intention to prescribe PCSK9 inhibitors at hospital admission was even lower according to our data – 16.2% in monotherapy and 49.4% in combination with statins. This limited use likely contributed to the low adherence observed in the acute cardiovascular care stage.

According to the DaVinci study (ENCePP registration EUPAS22075) only 18% of patients reach the recommended LDL-C target (< 55mg/dL), and this rate falls to nearly half in Spain.6 In this regard and according to the participants’ opinion, approximately 60.3% of patients achieve LDL-C goals due to the implementation of local protocols, suggesting progress but also highlighting the need for wider adoption and continuous improvement.

This analysis entails some limitations. Data correspond to 81 CDs that voluntarily participated in the pilot launch, not the entire preselected cohort; therefore, selection bias should not be ruled out. The survey did not include currently relevant therapies such as inclisiran or bempedoic acid, as these drugs had not yet received reimbursement approval by the time of the project design. As the CONTROL+T project evaluates perceived service performance rather than patient-level outcomes, comparisons with clinical studies should be interpreted cautiously. Despite these limitations, the findings provide an updated national overview of protocol implementation in Spanish CDs. They highlight key areas for improvement, especially in acute cardiovascular care and the use of advanced lipid-lowering therapies such as PCSK9 inhibitors. The observed variability reinforces the need for stronger adherent and harmonised protocols, while establishing a foundation for future outcome-based research.

Funding

This project was sponsored by the Spanish Society of Cardiology Research Agency (Agencia de Investigación de laSociedad Española de Cardiología [AISEC]) and received funds from Amgen S.A. Data analysis and medical writing activities were funded by Amgen.

Ethical considerations

This study did not involve human participants, patient data, or animal experimentation. Therefore, approval from an institutional ethics committee and informed consent were not required in accordance with current regulations and journal guidelines. The study was conducted following the principles of good scientific practice.

Statement on the use of artificial intelligence

During the preparation of this work, the authors used generative AI tools to assist with language editing, including improvements in grammar, spelling, and style. The AI tools were not used to generate scientific content or interpret results. All outputs were carefully reviewed and edited by the authors, who take full responsibility for the final content of the manuscript.

Authors’ contributions

All authors substantially contributed to the study conception, design, conceptualization and methodology, literature review and data collection. A. Viana-Tejedor and J. Cosín-Sales drafted the first version of the manuscript. All authors critically revised the manuscript for important intellectual content, approved the final version for publication, and agree to be accountable for all aspects of the work.

Conflicts of interest

A. Viana-Tejedor: payment or honoraria for lectures, presentations or educational events from Amgen, Novartis, Astra Zeneca, Novo Nordisk, Pzifer, Palex, and Abiomed. R. Fernández-Olmo: consulting fees and honoraria from Amgen, Sanofi, Novartis, Daichii Sankyo, AstraZeneca, Organon Amarin, Bayer, Novo Nordisk, MSD and Menarini. R. Freixa-Pamias: payment or honoraria for lectures, presentations, speaker bureaus, manuscript writing or educational events from Almirall, Novartis, Sanofi, Daiichi Sankyo. Payment for expert testimony: Sanofi, Novartis, Daiichi Sankyo. L. Rodríguez-Padial: none. J. Cosín-Sales: payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing or educational events from Almirall, Amgen, Novartis, Sanofi, Daiichi Sankyo. Payment for expert testimony: Amgen, Sanofi.

Acknowledgements

The authors wish to thank all the participating Cardiology Services for their collaboration and commitment to the CONTROL+T Project. We also acknowledge Reyes Prieto from Evidenze Health España S.L.U. for her contribution to the medical writing and editorial support.

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