Daily Cardiology Research Analysis
Three high-impact cardiology studies advance practice across revascularization, device strategy, and risk stratification. An economic analysis from the FAME 3 randomized trial shows FFR-guided PCI delivers comparable quality-adjusted survival to CABG at substantially lower 5-year costs. The REC-CAGEFREE I randomized trial reports higher 3-year device-oriented events with a drug-coated balloon strategy versus upfront DES, while a nationwide JACC registry demonstrates the Clinical Frailty Scale in
Summary
Three high-impact cardiology studies advance practice across revascularization, device strategy, and risk stratification. An economic analysis from the FAME 3 randomized trial shows FFR-guided PCI delivers comparable quality-adjusted survival to CABG at substantially lower 5-year costs. The REC-CAGEFREE I randomized trial reports higher 3-year device-oriented events with a drug-coated balloon strategy versus upfront DES, while a nationwide JACC registry demonstrates the Clinical Frailty Scale independently predicts 2-year mortality in heart failure and improves prognostic discrimination.
Research Themes
- Cost-effectiveness of PCI versus CABG in multivessel CAD
- Device strategy for de novo coronary lesions: DCB versus DES
- Frailty-based prognostication in heart failure
Selected Articles
1. Economic Outcomes and Quality of Life After CABG or PCI for Multivessel Disease: The FAME 3 Trial.
In the FAME 3 randomized trial of 1,500 patients with 3-vessel CAD, FFR-guided PCI using zotarolimus-eluting stents achieved similar 5-year QALYs to CABG at substantially lower cumulative costs. PCI yielded faster early quality-of-life gains and higher 5-year employment in patients <65, and offered superior economic value in most bootstrap replications.
Impact: This head-to-head randomized comparison provides contemporary, long-horizon economic and QOL evidence directly informing revascularization strategy selection in multivessel CAD. It challenges the assumption of default CABG cost-effectiveness by demonstrating superior value of FFR-guided PCI.
Clinical Implications: For eligible multivessel CAD patients, FFR-guided PCI can deliver comparable patient-centered outcomes at lower 5-year costs than CABG, supporting PCI as a high-value option when anatomy and clinical factors permit. Shared decision-making should incorporate economic and recovery considerations alongside clinical outcomes.
Key Findings
- Five-year cumulative costs were 30% higher with CABG; QALYs were similar between PCI (4.05) and CABG (4.03).
- Early EQ-5D improvement was faster after PCI; among patients <65 years, employment at 5 years favored PCI (56% vs 47%).
- Bootstrapping showed PCI had lower costs and higher QALYs in 66% of replications; CABG’s ICER exceeded $150,000/QALY in 98%.
Methodological Strengths
- Randomized, multicenter design with 5-year follow-up and prespecified economic endpoints
- Use of standardized EQ-5D utilities and rigorous cost modeling with extensive bootstrap uncertainty analysis
Limitations
- Open-label design; costs based on Medicare reimbursement may limit generalizability across health systems
- Device and strategy reflect zotarolimus DES with FFR guidance; results may not generalize to all stent types or non-FFR strategies
Future Directions: Assess cost-effectiveness across diverse payers and countries, evaluate alternative DES/polymers and physiology-guided strategies, and extend lifetime modeling with real-world data.
2. Drug-Coated Balloon Angioplasty vs Up-Front Stenting for De Novo CAD: 3-Year Follow-Up of REC-CAGEFREE I Trial.
In 2,272 patients with de novo CAD randomized to DCB with provisional stenting vs upfront DES, the 3-year device-oriented composite endpoint was higher with the DCB strategy (8.2% vs 5.0%). Landmark analyses suggest the excess accrued early and persisted, challenging generalized use of a DCB-first approach for de novo lesions.
Impact: This large randomized comparison directly informs device selection for de novo lesions, showing clinically relevant inferiority of a DCB-first strategy over modern thin-strut DES at mid-term follow-up.
Clinical Implications: For de novo CAD, upfront implantation of second-generation sirolimus-eluting stents remains the preferred strategy given lower 3-year device-oriented events. DCB use may be best reserved for specific scenarios (e.g., ISR, small vessels) pending further evidence.
Key Findings
- At 3 years, DOCE was higher with DCB strategy vs DES (8.2% vs 5.0%; absolute difference 3.21%; P=0.002).
- Provisional rescue DES was required in 9.4% of DCB-assigned patients, indicating frequent need for crossover.
- Landmark analyses indicated most of the difference accrued in the first year, with persistence through year 3.
Methodological Strengths
- Large, multicenter randomized design with 3-year follow-up and intention-to-treat analysis
- Broad inclusion across vessel diameters with standardized device strategies
Limitations
- Open-label design; trial conducted in China may limit generalizability to other populations
- Use of paclitaxel-coated balloons versus sirolimus DES may confound class comparisons
Future Directions: Define patient subsets where DCB provides equivalent outcomes (e.g., small vessels) and test newer-generation DCBs against contemporary DES in global populations with longer follow-up.
3. Frailty Scale Captures Multidimensional Vulnerability and Predicts Mortality in Heart Failure.
In 3,905 hospitalized HF patients from a nationwide prospective registry, higher CFS categories were associated with progressively worse physical and cognitive performance and stepwise increases in 2-year all-cause mortality. Incorporating CFS into prognostic models improved discrimination over models using SPPB and Mini-Cog alone.
Impact: The study validates a simple, clinically intuitive frailty scale as an independent, integrative predictor of mortality in HF, supporting its routine use to enhance risk stratification beyond performance tests.
Clinical Implications: Integrate CFS into discharge planning and ambulatory HF care to identify high-risk patients for tailored interventions (e.g., multidisciplinary rehab, nutrition, cognitive support) and to refine shared decision-making.
Key Findings
- CFS severity correlated with worse gait speed, chair-stand, SPPB, grip strength, 6MWD, and Mini-Cog scores.
- Two-year all-cause mortality was 18.6% overall and increased stepwise with higher CFS categories.
- Adding CFS to prognostic models significantly improved discrimination beyond SPPB and Mini-Cog.
Methodological Strengths
- Prospective nationwide multicenter registry with large sample size
- Comprehensive assessment across physical and cognitive domains with standardized tools
Limitations
- Observational design with potential residual confounding
- CFS assessment may be subject to interrater variability; generalizability primarily to hospitalized HF population
Future Directions: Test CFS-guided intervention pathways to reduce mortality and rehospitalization; evaluate integration with biomarkers and imaging for multidimensional risk staging.