Key result
CABG cuts 5-year MACE vs. PCI in diabetic multivessel CAD, yielding ~5.5-point absolute reduction.
Why the study?
Although CABG was shown to be superior to PCI for MACE and angina reduction in diabetic patients with multivessel CAD in the FREEDOM trial, multivessel PCI remains commonly used in practice, necessitating individualized risk models to guide treatment decisions.
Does individualized risk prediction modeling identify heterogeneity of treatment benefit between CABG and multivessel PCI for 5-year MACE and 1-year angina in patients with diabetes and multivessel coronary artery disease?
RCT (n=1,900)
1:1 basis
Yes
Does individualized risk prediction modeling identify heterogeneity of treatment benefit between CABG and multivessel PCI for 5-year MACE and 1-year angina in patients with diabetes and multivessel coronary artery disease?
Answers are grounded in this paper and cite their sources.
Personalized risk prediction models derived from the FREEDOM trial demonstrate that CABG is superior to PCI for 5-year MACE in over half of diabetic patients with multivessel CAD (and all smokers) while identifying a subset with similar predicted risks to support shared decision-making.
BACKGROUND: In patients with diabetes and multivessel coronary artery disease (CAD), the FREEDOM (Future Revascularization Evaluation in Patients with Diabetes Mellitus: Optimal Management of Multivessel Disease) trial demonstrated that, on average, coronary artery bypass grafting (CABG) was superior to percutaneous coronary intervention (PCI) for major acute cardiovascular events (MACE) and angina reduction. Nonetheless, multivessel PCI remains a common revascularization strategy in the real world. OBJECTIVES: To translate the results of FREEDOM to individual patients in clinical practice, risk models of the heterogeneity of treatment benefit were built. METHODS: Using patient-level data from 1,900 FREEDOM patients, the authors developed models to predict 5-year MACE (all-cause mortality, nonfatal myocardial infarction, and nonfatal stroke) and 1-year angina after CABG and PCI using baseline covariates and treatment interactions. Parsimonious models were created to support clinical use. The models were internally validated using bootstrap resampling, and the MACE model was externally validated in a large real-world registry. RESULTS: The 5-year MACE occurred in 346 (18.2%) patients, and 310 (16.3%) had angina at 1 year. The MACE model included 8 variables and treatment interactions with smoking status (c = 0.67). External validation in stable CAD (c = 0.65) and ACS (c = 0.68) demonstrated comparable performance. The 6-variable angina model included a treatment interaction with SYNTAX score (c = 0.67). PCI was never superior to CABG, and CABG was superior to PCI for MACE in 54.5% of patients and in 100% of patients with history of smoking. CONCLUSIONS: To help disseminate the results of FREEDOM, the authors created a personalized risk prediction tool for patients with diabetes and multivessel CAD that could be used in shared decision-making for CABG versus PCI by estimating each patient's personal outcomes with both treatments.
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Qintar et al. (2019) conducted an RCT in Diabetes mellitus and angiographically confirmed multivessel coronary artery disease (n=1,900). Coronary artery bypass grafting (CABG) vs. Multivessel percutaneous coronary intervention (PCI) with first-generation drug-eluting stents was evaluated on 5-year major acute cardiovascular events (MACE: composite of all-cause mortality, nonfatal myocardial infarction, and nonfatal stroke). CABG resulted in lower 5-year MACE than PCI (15.4% vs 20.9%) and was predicted to be superior for MACE in 54.5% of diabetic multivessel CAD patients and 100% of smokers (model c=0.67).
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