Giuseppe Biondi-Zoccai
@gbiondizoccai
“In the 986-patient TAVI PCI RCT, a strategy of TAVI before PCI yielded similar outcome to a strategy of PCI before TAVI at 1 year in patients with both aortic stenosis and CAD (25% MVD)”
X ↗ESC 2026View all trials
Timing of PCI in Patients Undergoing Transcatheter Aortic-Valve Implantation
Barbara Elisabeth StähliFrank RuschitzkaDirk WestermannAxel LinkeNorman MangnerNicolas M. Van MieghemRahel KesterkeLaura OberholzerJürgen RotheConstantin von zur MühlenTobias ZeusWon‐Keun KimPhilipp LautenNikos WernerChristof BurgdorfHannes AlberP. Christian SchulzeMichael JonerJonathan MichelAlessandro CandrevaPhilipp JakobMichael WürdingerJulia StehliAlexander GotschyChristian TemplinOmer DzemaliLuise GaedeSteffen MaßbergAlexander LautenFrank van der KleyAydan EwersThomas NestelbergerMohamed Abdel‐WahabGiuseppe MusumeciSebastian BarthMichael HansenAndreas MüggeMoritz SeiffertD L David Manuel LeistnerThomas CuissetSteffen SchneiderAdnan KastratiIan FordMarkus A. Kasel
What happened
A TAVI-first strategy was noninferior to a PCI-first strategy in severe aortic stenosis with concomitant coronary artery disease: the primary composite endpoint occurred in at 1 year among 986 patients.
- 105 (22.2%) vs 112 (24.2%) at 1 year
Key points
- Context & question: Many patients undergoing TAVI have concomitant coronary artery disease, yet whether PCI should be performed before or after the valve procedure had never been randomised, leaving the sequencing decision to local practice.
- Methods & population: International, open-label, randomized noninferiority trial (48 European centres); 986 patients with severe aortic stenosis and coronary artery disease; TAVI-first vs PCI-first treatment sequence; 1 year follow-up.
- Finding & limits: A TAVI-first strategy was noninferior to a PCI-first strategy in severe aortic stenosis with concomitant coronary artery disease: the primary composite endpoint occurred in at 1 year among 986 patients. Safety: Serious adverse events occurred in 264 vs 273 patients (of 498 vs 488 randomized).
Discussion
Expert perspectives 3
Edgardo Alania
Endpoint critiqueHeart Failure / Cardiomyopathy · Hospital de Dénia
TAVI-first is a new sequencing option, not proof of superiority, and it was tested in simple coronary disease.
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Stefano Garzon
Practice takeInterventional / Structural Cardiology · Hospital Israelita Albert Einstein
No need for upfront PCI in TAVI patients. Do PCI after TAVI and only when clinically indicated.
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Full evidence
Why the trial, tables, limitations, PICO, abstract, media & sources
Full evidence
Why the trial, tables, limitations, PICO, abstract, media & sources
Why the trial?
Many patients undergoing TAVI have concomitant coronary artery disease, yet whether PCI should be performed before or after the valve procedure had never been randomised, leaving the sequencing decision to local practice.
Does a strategy of TAVI before PCI reduce adverse clinical events in patients with severe aortic stenosis and coronary artery disease compared to PCI before TAVI?
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Evidence details
What drove the result?
| Outcome | TAVI first | PCI first |
|---|---|---|
| Death, MI, revascularization, rehospitalization, or major bleeding Primary composite · RD −2.0 pp (95% CI −7.4 to 3.4); noninferior (margin 6.6 pp; p<0.001) | TAVI first 105 (22.2%) | PCI first 112 (24.2%) |
Limitations & tradeoffs
- Safety
- Serious adverse events occurred in 264 vs 273 patients (of 498 vs 488 randomized).
- Design limitations
- The trial was open-label, and individual components of the composite are not reported in the abstract.
- Statistical certainty
- Noninferiority was defined against a wide 6.6-percentage-point margin, and reported percentages do not match crude counts over the randomized Ns, implying an analysis population not detailed in the abstract.
Structured PICO
Does a strategy of TAVI before PCI reduce adverse clinical events in patients with severe aortic stenosis and coronary artery disease compared to PCI before TAVI?
Population
986 patients with severe aortic stenosis and coronary artery disease followed for 1 year.
Intervention
Transcatheter aortic-valve implantation (TAVI) performed before percutaneous coronary intervention (PCI) (TAVI-first strategy)
Comparator
Percutaneous coronary intervention (PCI) performed before TAVI (PCI-first strategy)
Outcome
Composite of death from any cause; nonfatal myocardial infarction; ischemia-driven revascularization; rehospitalization related to the valve, procedure, or heart failure; or life-threatening, disabling, or major bleeding at 1 year after randomizationcomposite endpoint
Main Result
Effect estimaterisk difference -2.0 percentage points (95% CI -7.4 to 3.4)
Absolute Event Rate22.2% vs 24.2%
Absolute Risk Reduction2%
p-valuep=<0.001 for noninferiority
Where experts stand
Transcatheter aortic valve replacement evidence still formingExperts read TAVI PCI as making valve-first a reasonable option for patients who need both a valve and a stent, though not a better one, and caution that it was tested mostly in simpler coronary disease.
Clinicians agree that doing the valve first was no worse than stenting first at one year. One structural cardiologist goes further and would defer the stent until after the valve and only when clinically needed. Another treats it as a flexible option and points out that the patients enrolled had mostly simple coronary disease, so the live question is whether the result holds for complex disease and other valve types.
1 take classified by contention axis so far — the map appears as more land.
Still unclear
The trial enrolled patients with a low SYNTAX score, no complex CAD, and almost all balloon-expandable valves, so it is not clear whether TAVI-first applies beyond that group. PCI was also skipped more often after TAVI, and experts have not settled whether that is a benefit or a gap.
Implication
In patients with severe aortic stenosis and concomitant coronary artery disease, a strategy of performing TAVI before PCI is noninferior to PCI before TAVI regarding a 1-year composite clinical endpoint.
Abstract
BackgroundApproximately one half of patients undergoing transcatheter aortic-valve implantation (TAVI) have concomitant coronary artery disease. Although percutaneous coronary intervention (PCI) is often performed before TAVI, the preferred treatment strategy has not been established. MethodsWe conducted an international, open-label, randomized, noninferiority trial at 48 centers in Europe. Patients with severe aortic stenosis and coronary artery disease were randomly assigned in a 1:1 ratio to a strategy of either TAVI before PCI (TAVI-first group) or PCI before TAVI (PCI-first group). The primary end point was a composite of death from any cause; nonfatal myocardial infarction; ischemia-driven revascularization; rehospitalization related to the valve, procedure, or heart failure; or life-threatening, disabling, or major bleeding at 1 year after randomization. The noninferiority margin was 6.6 percentage points, with testing for noninferiority of TAVI first as compared with PCI first. ResultsA total of 986 patients underwent randomization: 498 were assigned to the TAVI-first group and 488 to the PCI-first group. A primary end-point event occurred in 105 patients (22.2%) in the TAVI-first group and in 112 patients (24.2%) in the PCI-first group (risk difference, −2.0 percentage points; 95% confidence interval, −7.4 to 3.4; P<0.001 for noninferiority). Serious adverse events occurred in 264 patients in the TAVI-first group and in 273 patients in the PCI-first group. ConclusionsAmong patients with severe aortic stenosis and coronary artery disease, a strategy of TAVI before PCI was noninferior to a strategy of PCI before TAVI with respect to the primary end point at 1 year. (Funded by University Hospital Zurich and others; TAVI PCI ClinicalTrials.gov number, NCT04310046.)
Coverage & sources
Journal, society, and media accounts. Useful signal, not independent expert judgment.
Cite This Study
Stähli et al. (2026) conducted an RCT in Severe aortic stenosis and coronary artery disease (n=986). TAVI before PCI (TAVI-first) vs. PCI before TAVI (PCI-first) was evaluated on Composite of death from any cause; nonfatal myocardial infarction; ischemia-driven revascularization; rehospitalization related to the valve, procedure, or heart failure; or life-threatening, disabling, or major bleeding at 1 year (risk difference -2.0 percentage points, 95% CI -7.4 to 3.4, p=<0.001 for noninferiority).