Title : Optimal adoption of the CNIC-polypill strategy (acetyl salicylic acid, atorvastatin and ramipril) in routine clinical practice: Global expert consensus and endorsement for enhanced cardiovascular outcomes
Abstract:
Background: The incidence of recurrent cardiovascular (CV) events (CVe) and all-cause mortality is high among patients in secondary prevention. The SECURE trial demonstrated that the CNIC-Polypill Strategy combining acetylsalicylic acid [ASA], atorvastatin and ramipril into a single pill, reduces CV mortality by 33% in patients with an acute myocardial infarction (AMI) over 3-year (median) follow-up, as compared to standard of care. Based on these findings, the 2023 ESC Guidelines for the Management of Acute Coronary Syndromes recommend the CNIC-Polypill Strategy to improve outcomes and adherence.
Objective: To reach consensus among medical experts worldwide on the optimal adoption of the CNIC-Polypill Strategy (ASA+atorvastatin+ramipril) as baseline treatment to prevent recurrent CVe in routine clinical practice.
Methods: A two-round, modified Delphi method was used. A questionnaire with 30 evidence-based statements was created and validated by 8 renowned cardiologists. Fifty clinicians from 19 countries in Europe, Latin America, and Asia formed the Delphi panel. Panellists ranked their responses using a three-point Likert scale for agreement and importance. Consensus was reached when ≥80% agreed or deemed questions 'very important' or 'important'. Statements without consensus in the first round were refined based on evidence and participant feedback in the second round. Any remaining disagreements were resolved in a face-to-face meeting with the experts. Descriptive statistics were applied.
Results: Response rates for the two rounds were 76% (38/50) and 74% (37/50) respectively. Among panelists, 82% practiced cardiology, 13% internal medicine; 74% frequently prescribed the CNIC-polypill. Consensus was achieved on 93.3% statements. Nearly all panellists (97.4%) agreed that the CNIC-Polypill Strategy (ASA+atorvastatin+ramipril) is safe and could replicate research findings showing a 24% relative risk reduction in major cardiovascular events over 3 years post-coronary heart disease event. A high percentage supported early initiation (81.1%) and concurred on the prospect of achieving guideline-recommended targets for blood pressure and LDL-cholesterol (89.5%) using the CNIC- Polypill Strategy. Participants (100%) unanimously endorsed the initiation of the CNIC-Polypill Strategy upon hospital discharge or first follow-up visits as baseline therapy. Consensus was reached on using algorithms to start (97.3%) or switch (97.4%) to the CNIC-Polypill Strategy from multiple cardioprotective drugs, considering patient preferences (97.4%). There was agreement on the effectiveness and safety of the CNIC-Polypill Strategy (ASA+atorvastatin+ramipril) for various patient groups beyond AMI patients: previous stroke (94.7%), peripheral artery disease (92.1%), type 2 diabetes mellitus (81.6%), in women and men alike (84.2%). There was agreement on patient satisfaction being determined by the simplified treatment regimen (100%) and convenience (94.7%) offered by the CNIC-Polypill Strategy. There was agreement (89.5%) on that the CNIC-Polypill Strategy prevents recurrent AMI and strokes at an affordable cost, leading to significant cost savings over a patient's lifetime through reduced CVe, hospitalizations, and decreased productivity losses.
Conclusions:
This Delphi consensus underscores the strong endorsement of experienced cardiologists and internal medicine doctors in Europe, Latin America, and Asia for the early implementation of the CNIC-Polypill Strategy
Audience Take Away:
- Clinical Practice: Healthcare professionals can initiate the CNIC-Polypill Strategy early after a cardiovascular event, using agreed-upon algorithms and considering patient preferences
- Treatment Decision-Making: Physicians can confidently use the CNIC-Polypill Strategy across various patient groups beyond coronary heart disease cases
- Guideline Adherence: The consensus aligns with ESC Guidelines, supporting its integration into routine clinical practice
- Enhancing Patient Satisfaction and Adherence: Emphasizing the CNIC-Polypill Strategy’s simplicity and benefits can improve patient outcomes
- Policy Consideration: Policymakers can consider these findings for healthcare policies, given the CNIC-Polypill Strategy’s cost-effectiveness and potential to reduce societal burdens
- Future Research Implications: Encouragement for further research and development on the positive outcomes observed with the CNIC-Polypill Strategy
- Improving Treatment Decision- Making: Providing clear guidelines for adopting the CNIC-Polypill Strategy early after cardiovascular events, enhancing patient care and prognosis
- Standardizing Treatment Protocols: Offering defined algorithms ensures consistency and efficiency in implementing the CNIC- Polypill Strategy, streamlining patient management
- Expanding Treatment Scope: Confirming its effectiveness across diverse patient groups allows for broader treatment options beyond ischemic coronary heart disease
- Enhancing Guideline Compliance: Supporting established ESC Guidelines aids professionals in adhering to standardized protocols for managing cardiovascular events
- Boosting Patient Outcomes and Satisfaction
- Emphasizing the CNIC-Polypill Strategy’s simplicity and positive outcomes can potentially improve patient adherence and satisfaction
- Advocating for Cost-Effective Strategies, understanding the CNIC-Polypill Strategy’s cost-effectiveness enables professionals to advocate for its adoption, benefiting both patients and healthcare systems
- Research opportunities, Further investigations explore long-term effects, Teaching and education, Curriculum Enhancement, Integrate findings into teaching materials for practical application, Case Studies Use research as a case study for engaging discussions
- Clinical practice implementation, Guideline integration consider incorporating consensus recommendations into clinical guidelines, Interdisciplinary collaboration, Collaborative projects spark collaborations across disciplines for related research, Continued investigation, Longitudinal Studies Initiate studies to assess real-world outcomes in diverse settings
- Streamlining Treatment Approaches, Providing clear guidelines and structured algorithms for initiating or transitioning to combined therapies, aiding in efficient decision-making for healthcare providers, Enhancing Patient Adherence Designing convenient and simplified therapies could improve patient compliance with prescribed treatments, Improved Design Accuracy, Structured Protocols, Guidelines and algorithms established by the consensus could aid in designing treatment protocols that are more accurate and efficient, minimizing variability in clinical decision- making, Addressing Design Challenges, Cost-Effectiveness Information on the cost-effectiveness of the strategy may assist designers in formulating medications that provide efficient healthcare solutions at reasonable costs
- Reduced Polypharmacy Issues: By combining multiple medications into a single pill, the CNIC-Polypill Strategy may mitigate issues related to polypharmacy, such as drug interactions, medication adherence challenges, and patient confusion, leading to more streamlined and manageable treatment regimens
- Preventive Approach: The CNIC-Polypill Strategy’s emphasis on early initiation and consensus agreement on its efficacy in preventing recurrent cardiovascular events could inspire a preventive approach in designing medications for chronic conditions, potentially reducing disease progression and associated complications.
- Patient-Centric Care: Understanding the importance of patient satisfaction and convenience with the CNIC- Polypill Strategy might prompt clinicians to prioritize patient-centric care, focusing on user experience and adherence-enhancing features in treatment plan development.
- Support for Personalized Medicine: The consensus-driven guidelines for using the CNIC-Polypill Strategy considering patient preferences could support the advancement of personalized medicine, encouraging tailored treatments based on individual patient needs and preferences.
- Data-Driven Innovation: The research provides empirical evidence supporting the effectiveness and safety of combined medications. This data-driven approach could encourage innovation in adopting novel drug combinations, utilizing evidence-based strategies to recommend more effective therapies.
- Healthcare System Efficiency: Implementing the CNIC-Polypill Strategy and similar approaches might contribute to a more efficient healthcare system by reducing healthcare costs associated with multiple medications, hospitalizations, and adverse cardiovascular events.
- Global Health Impact: Given the multi-country participation in the consensus, the findings may encourage global collaboration and adoption of similar combined strategies, potentially impacting global health outcomes by providing accessible and effective treatments.
- (ASA+atorvastatin+ramipril) as the baseline treatment for patients to reduce recurrence, improve prognosis, lower CVDs costs and decrease CV mortality after a CVe.
