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External Validation of the FREEDOM Score for Individualized Decision Making Between CABG and PCI
Kuniaki Takahashi1, Patrick W Serruys2, Valentin Fuster3
1Department of Cardiology, Amsterdam Universities Medical Centers, Location Academic Medical Center, University of Amsterdam, Amsterdam, the Netherlands.
Insights
The FREEDOM score helps identify differing treatment benefits between coronary artery bypass grafting (CABG) and percutaneous coronary intervention (PCI) for patients with diabetes and multivessel disease (MVD). This score aids in personalizing revascularization strategies for better major adverse cardiovascular event (MACE) outcomes.
Area of Science:
- Cardiology
- Interventional Cardiology
- Clinical Trials
Background:
- Randomized trials show coronary artery bypass grafting (CABG) is superior to percutaneous coronary intervention (PCI) for diabetes with multivessel disease (MVD).
- Individual patient characteristics influence treatment outcomes, necessitating personalized risk assessment.
- The FREEDOM score was developed to predict outcomes based on patient factors and smoking status.
Purpose of the Study:
- To evaluate the 5-year major adverse cardiovascular event (MACE) prediction model's ability to assess treatment benefit differences between CABG and PCI.
- To validate the FREEDOM score's predictive capability in the SYNTAX and BEST trial populations.
Main Methods:
- Analyzed 702 patients with diabetes and MVD from SYNTAX and BEST trials, mirroring FREEDOM participants.
- Assessed model discrimination using C-index and calibration via calibration plots for both PCI and CABG arms.
- Evaluated the FREEDOM score's capacity to predict differential treatment benefits.
Main Results:
- CABG showed a significantly lower 5-year MACE rate (12.4%) compared to PCI (20.3%) (P=0.021).
- The FREEDOM score demonstrated moderate discrimination in the CABG arm (C-index=0.61) and helpful discrimination in the PCI arm (C-index=0.69).
- The FREEDOM score indicated some heterogeneity in treatment benefit between CABG and PCI.
Conclusions:
- The FREEDOM score can identify some variations in treatment benefit for 5-year MACE between CABG and PCI in patients with diabetes and MVD.
- Further prospective validation is recommended before widespread clinical adoption of the FREEDOM score.
- Results should be considered when applying the FREEDOM score for treatment decisions in this patient cohort.
Background:
Although randomized trials have established that coronary artery bypass grafting (CABG) is, on average, the most effective revascularization strategy compared with percutaneous coronary intervention (PCI) in patients with diabetes and multivessel disease (MVD), individual patients differ in many characteristics that can affect the benefits and harms of treatment. The FREEDOM (Future Revascularization Evaluation in Patients with Diabetes Mellitus) score was developed to predict different outcomes with CABG vs PCI on the basis of 8 patient characteristics and the smoking-treatment interaction.
Objectives:
This study aimed to assess the ability of the 5-year major adverse cardiovascular event (MACE) model to predict treatment benefit of CABG vs PCI in the SYNTAX (Synergy Between Percutaneous Coronary Intervention With Taxus and Cardiac Surgery) and BEST (Bypass Surgery and Everolimus-Eluting Stent Implantation in the Treatment of Patients with Multivessel Coronary Artery Disease) trials.
Methods:
This study identified 702 patients with diabetes and MVD to mirror the FREEDOM participants. Discrimination was assessed by C-index, and calibration was assessed by calibration plots in the PCI and CABG arms, respectively. The ability of the FREEDOM score to predict treatment benefit of CABG vs PCI was assessed.
Results:
Overall, CABG was associated with a lower rate of 5-year MACE compared with PCI (12.4% vs 20.3%; log-rank P = 0.021) irrespective of a history of smoking (Pinteraction = 0.975). Both discrimination and calibration were helpful in the PCI arm (C-index: 0.69; slope: 0.96, intercept: -0.24), but moderate in the CABG arm (C-index: 0.61; slope: 0.61; intercept: -0.53). The FREEDOM score showed some heterogeneity of treatment benefit.
Conclusions:
The FREEDOM score could identify some heterogeneity of treatment benefit of CABG vs PCI for 5-year MACE. Until further prospective validations are performed, these results should be taken into consideration when using the FREEDOM score in patients with diabetes and MVD. (Synergy Between Percutaneous Coronary Intervention With Taxus and Cardiac Surgery [SYNTAX]; NCT00114972) (Bypass Surgery and Everolimus-Eluting Stent Implantation in the Treatment of Patients with Multivessel Coronary Artery Disease [BEST]; NCT00997828) (Future Revascularization Evaluation in Patients with Diabetes Mellitus [FREEDOM]; NCT00086450).
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