Transcatheter Valve and Vessels - TCW
Contribution To Literature:
The TCW trial showed that in patients with severe aortic stenosis and complex CAD, FFR-guided PCI plus TAVI resulted in fewer deaths and major bleeding events compared with combined SAVR plus CABG at 12 months.
Description:
The goal of the trial was to test the noninferiority and, if positive, superiority, of percutaneous coronary intervention (PCI) with transcatheter aortic valve implantation (TAVI) compared with surgical aortic valve replacement (SAVR) and coronary artery bypass grafting (CABG) in severe aortic stenosis (AS) with comorbid coronary artery disease (CAD).
Study Design
- International (Europe)
- Multicenter
- Open-label
- Noninferiority
- Randomized
Patients with symptomatic severe AS and complex CAD were randomized in 1:1 fashion to fractional flow reserve (FFR)-guided PCI plus TAVI (n = 91) or SAVR plus CABG (n = 81). In the FFR-PCI/TAVI arm, PCI was performed in lesions with an FFR ≤0.80 followed by TAVI with a Medtronic CoreValve Evolut R or PRO, either simultaneously or within 40 days of PCI. SAVR was performed using a bioprosthetic aortic valve, and CABG could be performed with or without prior FFR information.
- Total number of enrollees: 172
- Duration of follow-up: 12 months
- Mean patient age: 77 years
- Percentage female: 31%
Inclusion criteria:
- Age ≥70 years
- Symptomatic severe AS with ≥1 of: aortic valve area ≤1 cm2, mean pressure gradient ≥40 mm Hg, peak jet velocity ≥4 m/s, or dimensionless valve index ≤0.25
- ≥2 de novo coronary artery lesions with ≥50% angiographic stenosis in any main epicardial arteries or side branches ≥2 mm in diameter, or a single left anterior descending artery bifurcation lesion ≥20 mm in length
- Suitable candidate for both PCI/TAVI and SAVR/CABG per local Heart Team
Exclusion criteria:
- Cardiogenic shock or acute heart failure <48 hours prior
- Left ventricular ejection fraction <30%
- Bicuspid or unicuspid aortic valve
- Left main bifurcation disease
- Myocardial infarction (MI) <2 weeks prior
- Disabling stroke or transient ischemic attack <6 months prior
Other salient features/characteristics:
- Angina Pectoris Canadian Cardiovascular Society class I: 54%
- New York Heart Association class ≥III: 32%
- Median European System for Cardiac Operative Risk Evaluation (EuroSCORE) II: 2.4%
- Median Society of Thoracic Surgeons-Predicted Risk of Mortality (STS-PROM) score: 2.4
- Median Synergy between PCI with Taxus and Cardiac Surgery (SYNTAX) score: 12.0
- SYNTAX score ≥22: 10%
- Multivessel coronary disease: 74%
Principal Findings:
Primary outcome, composite of all-cause mortality, MI, disabling stroke (90-day modified Rankin scale score ≥2 and ≥1-point increase from baseline), clinically driven target vessel revascularization, valve reintervention, and life-threatening or disabling bleeding (Bleeding Academic Research Consortium type 3b, 3c, or 5) at 1 year, for FFR-PCI/TAVI vs. SAVR/CABG: 4% vs. 23%, risk difference -18.5 (90% confidence interval [CI] -27.8 to -9.7), p for noninferiority < 0.001; hazard ratio (HR) 0.17 (95% CI 0.06-0.51), p for superiority < 0.001
Primary outcome components at 1 year for FFR-PCI/TAVI vs. SAVR/CABG:
- All-cause mortality: 0% vs. 10%, p = 0.0025
- MI: 2% vs. 1%, HR 1.58 (95% CI 0.14-17.48), p = 0.71
- Disabling stroke: 1% vs. 3%, HR 0.38 (95% CI 0.03-4.22), p = 0.42
- Clinically driven target vessel revascularization: 0% vs. 1%, p = 0.28
- Valve reintervention: 0% vs. 1%, p = 0.28
- Life-threatening or disabling bleeding: 2% vs. 12%, HR 0.17 (95% CI 0.04-0.80), p = 0.01
Secondary outcomes for FFR-PCI/TAVI vs. SAVR/CABG:
- Cardiovascular mortality, all stroke, MI, unscheduled coronary events, or valve reintervention: 3% vs. 14%, HR 0.23 (95% CI 0.06-0.83), p = 0.014
- All-cause mortality and stroke: 1% vs. 12%, HR 0.08 (95% CI 0.01-0.66), p = 0.0027
Procedural characteristics of FFR-PCI/TAVI vs. SAVR/CABG:
- Time from randomization to procedure: 19 vs. 53 days
- Mean lesions treated/vessels grafted: 1.5 vs. 1.6
- FFR-guided revascularization: 82% vs. 30%
- Complete revascularization: 81% vs. 64%
- Mean prosthetic valve diameter: 29.7 vs. 23.5 mm
- Artery-only bypass grafts (in CABG): 42%
Interpretation:
These data represent the first randomized comparison of PCI with TAVI versus combined SAVR and CABG in patients with severe AS and comorbid CAD. The trial was terminated after enrolling just over half the intended sample due to disproportionately higher primary event rates in the SAVR/CABG arm on interim analyses. This difference was driven almost entirely by a reduction in all-cause mortality and life-threatening or disabling bleeding in the FFR-PCI/TAVI arm. Although only the bleeding endpoint was positive at 30 days, over half of the deaths between 30 and 90 days were also attributed to postoperative complications of SAVR/CABG.
Combined SAVR/CABG is known to carry increased morbidity and mortality than either surgery alone. However, the current data do not answer whether that risk is outweighed in patients with a SYNTAX score ≥22, who comprised a minority of this cohort and derived greater long-term benefit with isolated CABG in the FAME 3 trial. Further, although simultaneous CABG with SAVR may be preferable to avoid the risks of a future redo sternotomy, there persists uncertainty regarding the role and timing of coronary revascularization in TAVI, even when guided by physiologic assessment. Future investigation, including the COMPLETE TAVR trial of revascularization in TAVI, as well as larger, confirmatory studies of CABG/SAVR vs. PCI/TAVI including both self-expanding and balloon-expandable valves, is warranted.
References:
Kedhi E, Hermanides RS, Dambrink JH, et al., on behalf of the TCW Study Group. TransCatheter aortic valve implantation and fractional flow reserve-guided percutaneous coronary intervention versus conventional surgical aortic valve replacement and coronary bypass grafting for treatment of patients with aortic valve stenosis and complex or multivessel coronary disease (TCW): an international, multicenter, prospective, open-label, non-inferiority, randomized controlled trial. Lancet 2024;Dec 4:[Epub ahead of print].
Clinical Topics: Cardiac Surgery, Invasive Cardiovascular Angiography and Intervention, Valvular Heart Disease, Aortic Surgery, Cardiac Surgery and VHD, Interventions and Structural Heart Disease
Keywords: Aortic Valve Stenosis, Coronary Artery Bypass, Percutaneous Coronary Intervention, Transcatheter Aortic Valve Replacement
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