{"product_id":"which-procedure-first-new-study-shows-valve-replacement-before-coronary-stenting-is-as-safe-as-the-traditional-approach","title":"Which Procedure First? New Study Shows Valve Replacement Before Coronary Stenting Is as Safe as the Traditional Approach","description":"\u003cp\u003eFor patients with severe aortic stenosis (a narrowed heart valve) and coronary artery disease (blocked heart arteries), a large European study found that performing valve replacement first and coronary stenting afterward is just as safe and effective as the traditional approach of stenting first. Among 986 patients followed for one year, 22.2% in the valve-first group experienced a major event (death, heart attack, repeat procedure, rehospitalization, or serious bleeding) compared with 24.2% in the stent-first group — a difference well within the study's preset noninferiority margin. This means doctors and patients can reasonably choose either order, with the valve-first strategy offering certain practical advantages. The findings, published in the \u003cem\u003eNew England Journal of Medicine\u003c\/em\u003e, provide the first randomized evidence to guide this common clinical decision.\u003c\/p\u003e\n\n\u003ch1\u003eWhich Procedure First? New Study Shows Valve Replacement Before Coronary Stenting Is as Safe as the Traditional Approach\u003c\/h1\u003e\n\n\u003ch2\u003eTable of Contents\u003c\/h2\u003e\n\u003cul\u003e\n\u003cli\u003e\u003ca href=\"#ddn-key-points\"\u003eKey Points\u003c\/a\u003e\u003c\/li\u003e\n\n  \u003cli\u003e\u003ca href=\"#background\"\u003eWhy This Research Matters\u003c\/a\u003e\u003c\/li\u003e\n  \u003cli\u003e\u003ca href=\"#methods\"\u003eHow the Study Was Designed\u003c\/a\u003e\u003c\/li\u003e\n  \u003cli\u003e\u003ca href=\"#participants\"\u003eWho Took Part in the Study\u003c\/a\u003e\u003c\/li\u003e\n  \u003cli\u003e\u003ca href=\"#treatment\"\u003eThe Two Treatment Strategies\u003c\/a\u003e\u003c\/li\u003e\n  \u003cli\u003e\u003ca href=\"#findings\"\u003eKey Findings: The Primary Result\u003c\/a\u003e\u003c\/li\u003e\n  \u003cli\u003e\u003ca href=\"#safety\"\u003eSafety and Adverse Events\u003c\/a\u003e\u003c\/li\u003e\n  \u003cli\u003e\u003ca href=\"#implications\"\u003eWhat This Means for Patients\u003c\/a\u003e\u003c\/li\u003e\n  \u003cli\u003e\u003ca href=\"#limitations\"\u003eStudy Limitations\u003c\/a\u003e\u003c\/li\u003e\n  \u003cli\u003e\u003ca href=\"#recommendations\"\u003eRecommendations for Patients\u003c\/a\u003e\u003c\/li\u003e\n  \u003cli\u003e\u003ca href=\"#ddn-faq\"\u003eFrequently Asked Questions\u003c\/a\u003e\u003c\/li\u003e\n\u003cli\u003e\u003ca href=\"#source\"\u003eSource Information\u003c\/a\u003e\u003c\/li\u003e\n\u003c\/ul\u003e\n\n\u003c!-- ddn:keypoints:start --\u003e\n\u003ch2 id=\"ddn-key-points\"\u003eKey Points\u003c\/h2\u003e\n\u003cul\u003e\n\u003cli\u003eIn a European trial of 986 patients, valve replacement before coronary stenting was as safe as stenting first for severe aortic stenosis with coronary disease.\u003c\/li\u003e\n\u003cli\u003eOne-year major event rates were 22.2% for valve-first and 24.2% for stent-first, a difference within the statistical noninferiority margin.\u003c\/li\u003e\n\u003cli\u003eValve-first improved hemodynamic stability during stenting and avoided dual antiplatelet therapy at the time of valve replacement.\u003c\/li\u003e\n\u003cli\u003eBoth procedures were often completed within one hospitalization; median time between procedures was 27 days for valve-first and 13 days for stent-first.\u003c\/li\u003e\n\u003cli\u003eNot every patient needed stenting; some had no significant blockage on functional testing or the operator deemed it unnecessary.\u003c\/li\u003e\n\u003c\/ul\u003e\n\u003c!-- ddn:keypoints:end --\u003e\n\n\n\u003ch2 id=\"background\"\u003eWhy This Research Matters\u003c\/h2\u003e\n\n\u003cp\u003eAortic stenosis is the most common valvular heart disease, and it causes substantial illness and death. In this condition, the aortic valve — the main exit valve of the heart — becomes stiff and narrowed, forcing the heart to work harder to pump blood. \u003cstrong\u003eTranscatheter aortic-valve implantation (TAVI)\u003c\/strong\u003e, a minimally invasive procedure that replaces the valve through a catheter, has become the standard treatment for patients with severe symptomatic aortic stenosis who are older than 65 to 70 years or who are at prohibitive risk for open-heart surgery.\u003c\/p\u003e\n\n\u003cp\u003eBecause aortic stenosis and coronary artery disease share common risk factors such as age, high blood pressure, and diabetes, roughly one half of patients with severe aortic stenosis who undergo TAVI also have obstructive coronary artery disease. Observational studies have linked the presence and severity of coronary artery disease with worse outcomes after TAVI. As a result, about 10 to 20% of patients undergoing TAVI also undergo \u003cstrong\u003epercutaneous coronary intervention (PCI)\u003c\/strong\u003e, the procedure commonly known as coronary stenting, which opens blocked arteries with a small mesh tube.\u003c\/p\u003e\n\n\u003cp\u003eCurrent guidelines recommend angiography-guided PCI (using X-ray imaging of the coronary arteries) for patients with severe aortic stenosis who have significant blockages in the proximal (near the origin) segments of the main coronary vessels. What the guidelines do not clearly specify is the \u003cem\u003eorder\u003c\/em\u003e in which the two procedures should be performed.\u003c\/p\u003e\n\n\u003cp\u003ePerforming PCI before TAVI has been the standard strategy, because it ensures coronary access before the valve is implanted and completes revascularization (restoring blood flow) before the valve procedure. However, a valve-first strategy may offer advantages: better hemodynamic stability (more stable blood pressure and blood flow) during the subsequent PCI, and avoidance of dual antiplatelet therapy (two blood-thinning medications) at the time of TAVI. The main concern with valve-first has been whether the new valve might make it harder to reach the coronary arteries afterward.\u003c\/p\u003e\n\n\u003cp\u003eThese competing considerations led researchers to design the \u003cstrong\u003eTAVI PCI trial\u003c\/strong\u003e (full name: Optimal Timing of Transcatheter Aortic Valve Implantation and Percutaneous Coronary Intervention), which tested whether a valve-first strategy is noninferior to (no worse than) the standard stent-first strategy. This is the first large randomized trial to answer that question.\u003c\/p\u003e\n\n\u003ch2 id=\"methods\"\u003eHow the Study Was Designed\u003c\/h2\u003e\n\n\u003cp\u003eThe TAVI PCI trial was an international, open-label, randomized, noninferiority trial conducted at 48 centers across six European countries: Austria, France, Germany, Italy, the Netherlands, and Switzerland. The trial was investigator-initiated, meaning it was designed and led by academic researchers rather than a commercial sponsor. It was coordinated and sponsored by the University Hospital Zurich and the University of Zurich, with primary funding from the Department of Cardiology at University Hospital Zurich, including infrastructure support from the Andreas Grüntzig Clinical Research Center. Additional support came from an investigator-initiated research grant from Edwards Lifesciences, the manufacturer of the heart valves used in the study; the company had no role in the design, conduct, data analysis, or writing of the trial.\u003c\/p\u003e\n\n\u003cp\u003eThe trial was overseen by a steering committee and an independent data and safety monitoring board. An independent clinical-events committee, whose members did not know which treatment group patients were in, adjudicated (formally verified and classified) the key end points. The study was conducted in accordance with the Declaration of Helsinki, and all patients gave written informed consent.\u003c\/p\u003e\n\n\u003cp\u003eThe study used a \u003cstrong\u003enoninferiority design\u003c\/strong\u003e, which is appropriate when an established therapy already exists and the goal is to show that a new approach is not meaningfully worse. The researchers estimated, based on prior studies, that about 15% of patients in each group would experience a primary end-point event within one year. They calculated that a sample of 934 patients (467 per group) would provide 80% power to detect noninferiority, using a noninferiority margin of 6.6 percentage points. To account for an anticipated 5% dropout rate, the target enrollment was set at 986 patients. No interim analysis was performed.\u003c\/p\u003e\n\n\u003cp\u003ePatients were enrolled from September 2020 through August 2025. During that time, 2,705 patients with severe aortic stenosis and suspected coronary artery disease were screened at the participating centers. A total of 986 patients underwent randomization: 498 were assigned to the \u003cstrong\u003eTAVI-first group\u003c\/strong\u003e (valve replacement first, followed by stenting within 1 to 45 days) and 488 to the \u003cstrong\u003ePCI-first group\u003c\/strong\u003e (stenting first, followed by valve replacement within 1 to 45 days).\u003c\/p\u003e\n\n\u003ch3\u003eWho Was Eligible\u003c\/h3\u003e\n\n\u003cp\u003eAdults aged 18 years or older were eligible if they had severe aortic stenosis and coronary artery disease, and if an interdisciplinary local heart team had established the indication for both TAVI and PCI. Severe symptomatic aortic stenosis was defined as an aortic-valve area of 1.0 cm² or less, or a mean pressure gradient of 40 mm Hg or greater on echocardiography (ultrasound of the heart), plus at least one of the following: shortness of breath (dyspnea), chest pain (angina), fainting (syncope), a left ventricular ejection fraction (a measure of the heart's pumping ability) below 50%, symptoms or a drop in blood pressure during exercise testing, or certain high-risk features. Those high-risk features included a peak blood-flow velocity across the valve greater than 5.5 meters per second, severe valve calcification (calcium buildup), rapid progression of valve velocity (at least 0.3 meters per second per year), or severe pulmonary hypertension (high pressure in the lung arteries, defined as systolic pressure above 60 mm Hg).\u003c\/p\u003e\n\n\u003cp\u003eThe definition of coronary artery disease was adjusted during the trial. Initially, it required at least one coronary lesion with a diameter stenosis (narrowing) of 40 to 90% and an \u003cstrong\u003einstantaneous wave-free ratio\u003c\/strong\u003e (a resting measurement of blood-flow pressure across a blockage) of 0.89 or less, OR a stenosis greater than 90% on the coronary angiogram, in a vessel at least 2.5 mm in diameter with normal blood flow (Thrombolysis in Myocardial Infarction flow grade 3). After 511 patients had been enrolled, in October 2023, the steering committee approved a protocol amendment that replaced routine physiology-guided PCI with an angiography-based strategy, defining significant disease as lesions with at least 70% diameter stenosis in vessels 2.5 mm or larger. Functional lesion assessment (measuring whether a blockage actually restricts blood flow) remained optional. This change was made to speed enrollment, and the steering committee made the decision without knowledge of treatment-specific outcome data. Each patient's coronary anatomy complexity was also scored using the \u003cstrong\u003eSYNTAX Score I\u003c\/strong\u003e, a comprehensive angiographic assessment in which higher scores indicate more complex coronary artery disease.\u003c\/p\u003e\n\n\u003ch3\u003eRandomization and Blinding\u003c\/h3\u003e\n\n\u003cp\u003eRandomization was performed using a secured, centralized web-based system (S4Trials), with a computer-generated schedule assigning patients in a 1:1 ratio to the TAVI-first or PCI-first group. Patients were stratified according to trial center and surgical risk category, measured by the \u003cstrong\u003eSociety of Thoracic Surgeons–Predicted Risk of Mortality (STS-PROM) score\u003c\/strong\u003e: low risk (below 4%), intermediate risk (4 to less than 10%), or high risk (10% or higher).\u003c\/p\u003e\n\n\u003cp\u003eThe trial was \u003cstrong\u003eopen-label\u003c\/strong\u003e, meaning that both patients and doctors knew which treatment order was assigned. This is typical for procedural trials, where blinding is not practically possible because the sequence of operations is obvious.\u003c\/p\u003e\n\n\u003ch2 id=\"participants\"\u003eWho Took Part in the Study\u003c\/h2\u003e\n\n\u003cp\u003eThe 986 randomized patients had a median age of 82 years in both groups (interquartile range 79 to 85 in the TAVI-first group and 77 to 84 in the PCI-first group). In the TAVI-first group, 313 patients (62.9%) were male; in the PCI-first group, 336 (68.9%) were male. The two groups were well balanced at baseline.\u003c\/p\u003e\n\n\u003cp\u003eKey baseline characteristics included:\u003c\/p\u003e\n\u003cul\u003e\n  \u003cli\u003eMedian body-mass index: 26.2 in the TAVI-first group and 26.4 in the PCI-first group\u003c\/li\u003e\n  \u003cli\u003eMedian EuroSCORE II (a surgical risk score ranging from 0 to 100%, with higher scores meaning higher risk of death): 3.1% in the TAVI-first group and 3.2% in the PCI-first group\u003c\/li\u003e\n  \u003cli\u003eMedian STS-PROM score: 3.1% in the TAVI-first group and 3.3% in the PCI-first group\u003c\/li\u003e\n  \u003cli\u003eNew York Heart Association (NYHA) class — a measure of heart failure severity: class II in 205 patients (41.2%) in the TAVI-first group and 171 (35.0%) in the PCI-first group; class III in 236 (47.4%) and 245 (50.2%); class IV in 15 (3.0%) and 31 (6.4%)\u003c\/li\u003e\n  \u003cli\u003eCanadian Cardiovascular Society (CCS) class — a measure of angina severity: no angina in 315 (63.3%) and 295 (60.5%); class I in 59 (11.8%) and 52 (10.7%); class II in 83 (16.7%) and 96 (19.7%); class III in 38 (7.6%) and 40 (8.2%); class IV in 3 (0.6%) and 5 (1.0%)\u003c\/li\u003e\n  \u003cli\u003eHistory of fainting (syncope): 57 patients (11.4%) in the TAVI-first group and 51 (10.5%) in the PCI-first group\u003c\/li\u003e\n\u003c\/ul\u003e\n\n\u003cp\u003eMedical history was also similar between groups:\u003c\/p\u003e\n\u003cul\u003e\n  \u003cli\u003eHigh blood pressure (hypertension): 394 (79.1%) in TAVI-first vs. 390 (79.9%) in PCI-first\u003c\/li\u003e\n  \u003cli\u003eDiabetes: 155 (31.1%) vs. 163 (33.4%)\u003c\/li\u003e\n  \u003cli\u003ePrevious PCI: 98 (19.7%) vs. 118 (24.2%)\u003c\/li\u003e\n  \u003cli\u003ePrevious heart attack: 52 (10.4%) vs. 59 (12.1%)\u003c\/li\u003e\n  \u003cli\u003eHistory of stroke or transient ischemic attack (mini-stroke): 51 (10.2%) vs. 58 (11.9%)\u003c\/li\u003e\n  \u003cli\u003eAtrial fibrillation (irregular heart rhythm): 79 (15.9%) vs. 95 (19.5%)\u003c\/li\u003e\n  \u003cli\u003ePeripheral artery disease (blockages in leg arteries): 72 (14.5%) vs. 61 (12.5%)\u003c\/li\u003e\n  \u003cli\u003ePulmonary hypertension: 30 (6.0%) vs. 38 (7.8%)\u003c\/li\u003e\n  \u003cli\u003eChronic obstructive pulmonary disease (COPD, a chronic lung condition): 36 (7.2%) vs. 39 (8.0%)\u003c\/li\u003e\n  \u003cli\u003ePrevious cancer: 110 (22.1%) vs. 89 (18.2%)\u003c\/li\u003e\n  \u003cli\u003ePermanent pacemaker: 32 (6.4%) vs. 41 (8.4%)\u003c\/li\u003e\n\u003c\/ul\u003e\n\n\u003ch2 id=\"treatment\"\u003eThe Two Treatment Strategies\u003c\/h2\u003e\n\n\u003cp\u003ePatients assigned to the \u003cstrong\u003eTAVI-first group\u003c\/strong\u003e underwent valve replacement first, then angiography-guided PCI within 1 to 45 days. Patients in the \u003cstrong\u003ePCI-first group\u003c\/strong\u003e underwent angiography-guided PCI first, then TAVI within 1 to 45 days. The protocol allowed a window of 1 to 45 days between procedures, giving heart teams flexibility to schedule around clinical needs.\u003c\/p\u003e\n\n\u003cp\u003ePCI was performed according to current guidelines using standard interventional techniques. Intravascular imaging — including \u003cstrong\u003eintravascular ultrasonography (IVUS)\u003c\/strong\u003e and \u003cstrong\u003eoptical coherence tomography (OCT)\u003c\/strong\u003e, which provide detailed images from inside the artery — was used at the operator's discretion. All patients received appropriate medical therapy and secondary prevention (measures to prevent further heart problems).\u003c\/p\u003e\n\n\u003cp\u003eMedication regimens were specified in the protocol:\u003c\/p\u003e\n\u003cul\u003e\n  \u003cli\u003eA daily dose of at least 80 mg of aspirin was prescribed indefinitely, except for patients receiving oral anticoagulation (blood thinners for conditions like atrial fibrillation).\u003c\/li\u003e\n  \u003cli\u003eAfter PCI, \u003cstrong\u003edual antiplatelet therapy\u003c\/strong\u003e (two anti-clotting medications, typically aspirin plus a second drug) was recommended for at least 3 months and preferably 6 months.\u003c\/li\u003e\n  \u003cli\u003ePatients receiving oral anticoagulation were treated with clopidogrel (an antiplatelet drug) for at least 3 months after PCI.\u003c\/li\u003e\n  \u003cli\u003eAfter TAVI, aspirin was continued unless patients were on oral anticoagulation, in which case they received anticoagulation only.\u003c\/li\u003e\n\u003c\/ul\u003e\n\n\u003cp\u003eTAVI was performed with standard techniques using \u003cstrong\u003eEdwards SAPIEN 3, SAPIEN 3 Ultra, or SAPIEN 3 Ultra RESILIA\u003c\/strong\u003e transcatheter heart valves. Follow-up visits occurred at hospital discharge (after both the first and second hospitalizations), at 3 months (with a window of ±14 days), and at 1 year (with a window of ±30 days). The 1-year follow-up was an in-person visit; other visits could be in person or by telephone.\u003c\/p\u003e\n\n\u003cp\u003eThe timing of procedures differed as expected between groups. The median time from randomization to the TAVI procedure was 8 days (interquartile range, 2 to 23) in the TAVI-first group. The median time from randomization to PCI was 2 days (interquartile range, 1 to 12) in the PCI-first group. The median time between the two procedures was 27 days (interquartile range, 5 to 38) in the TAVI-first group and 13 days (interquartile range, 2 to 33) in the PCI-first group. Both procedures were performed during the same hospitalization in 370 of 968 patients with available data (38.2%).\u003c\/p\u003e\n\n\u003cp\u003eSome patients did not receive their assigned treatment as planned. Five patients crossed over from the TAVI-first group to the PCI-first group, and 3 crossed over from the PCI-first group to the TAVI-first group. A total of 36 patients did not undergo TAVI, and 71 patients did not undergo PCI. In the TAVI-first group, PCI was not performed because of a clinical decision by the operator in 13 patients, a negative functional lesion assessment (testing showed the blockage was not restricting blood flow) in 15 patients, a failed PCI procedure in 1 patient, and patient refusal in 2 patients. In the PCI-first group, PCI was not performed due to a clinical decision in 5 patients, a negative functional assessment in 3 patients, and a failed PCI in 1 patient.\u003c\/p\u003e\n\n\u003cp\u003eThe \u003cstrong\u003eprimary end point\u003c\/strong\u003e was a composite (combined measure) of any of the following events occurring within 1 year after randomization:\u003c\/p\u003e\n\u003cul\u003e\n  \u003cli\u003eDeath from any cause\u003c\/li\u003e\n  \u003cli\u003eNonfatal myocardial infarction (heart attack that did not cause death)\u003c\/li\u003e\n  \u003cli\u003eIschemia-driven revascularization (a repeat procedure to restore blood flow prompted by renewed blockage symptoms or evidence of inadequate blood supply)\u003c\/li\u003e\n  \u003cli\u003eRehospitalization related to the valve, the procedure, or heart failure\u003c\/li\u003e\n  \u003cli\u003eLife-threatening, disabling, or major bleeding\u003c\/li\u003e\n\u003c\/ul\u003e\n\n\u003cp\u003eSecondary end points included the individual components of the primary end point plus 11 specific outcomes: death from cardiovascular causes; stroke; target-lesion revascularization (repeat treatment of the original blockage site); target-vessel revascularization (repeat treatment of the same artery); stent thrombosis (blood clot inside the stent); major vascular complications; new-onset atrial fibrillation; new permanent pacemaker implantation; aortic-valve-related dysfunction requiring a repeat procedure; acute kidney injury; and bleeding classified according to the \u003cstrong\u003eBleeding Academic Research Consortium (BARC)\u003c\/strong\u003e criteria, which range from type 0 to type 5, with higher numbers indicating more severe bleeding, and the \u003cstrong\u003eValve Academic Research Consortium (VARC-2)\u003c\/strong\u003e consensus definitions. Four additional composite end points were also assessed, combining various outcomes such as death or heart attack, with or without revascularization or rehospitalization.\u003c\/p\u003e\n\n\u003cp\u003eProcedural end points after PCI included procedural success, the amount of contrast medium used, and the use of \u003cstrong\u003ecatecholamines\u003c\/strong\u003e (medications that support blood pressure during procedures). After TAVI, procedural end points included device success, catecholamine use, and conversion to open-heart surgery. Quality of life was measured with the \u003cstrong\u003eKansas City Cardiomyopathy Questionnaire (KCCQ)\u003c\/strong\u003e and the \u003cstrong\u003eToronto Aortic Stenosis Quality of Life Questionnaire (TASQ)\u003c\/strong\u003e, and symptom status was assessed using the CCS and NYHA classifications at 3 months and 1 year.\u003c\/p\u003e\n\n\u003ch2 id=\"findings\"\u003eKey Findings: The Primary Result\u003c\/h2\u003e\n\n\u003cp\u003eFollow-up at 1 year was completed in 473 patients (95.0%) in the TAVI-first group and 463 patients (94.9%) in the PCI-first group. The \u003cstrong\u003emodified intention-to-treat population\u003c\/strong\u003e — patients who had a documented event within 365 days or completed follow-up — formed the basis for the main analysis. A secondary \u003cstrong\u003emodified per-protocol population\u003c\/strong\u003e, which excluded patients who crossed over, did not undergo TAVI, or did not undergo PCI within the specified time window (among other exclusions), included 448 patients (90.0%) in the TAVI-first group and 447 (91.6%) in the PCI-first group.\u003c\/p\u003e\n\n\u003cp\u003eThe results were clear: \u003cstrong\u003eTAVI-first was noninferior to PCI-first.\u003c\/strong\u003e At 1 year, a primary end-point event had occurred in 105 of 473 patients (22.2%) in the TAVI-first group, compared with 112 of 463 patients (24.2%) in the PCI-first group. This yielded a risk difference of −2.0 percentage points (95% confidence interval [CI], −7.4 to 3.4), meaning the TAVI-first group actually had slightly fewer events, although the confidence interval includes the possibility of a small increase. The test for noninferiority was highly significant (P\u0026lt;0.001 for noninferiority), while the test for superiority was not (P=0.47), meaning the trial showed TAVI-first is no worse, but did not prove it is better. The hazard ratio (a measure comparing the rate of events over time between groups) was 0.90 (95% CI, 0.69 to 1.18), again favoring the TAVI-first group numerically without reaching statistical significance for superiority.\u003c\/p\u003e\n\n\u003cp\u003eThe researchers reported that in a conservative sensitivity analysis, noninferiority was preserved, adding confidence to the primary result. Cumulative-incidence curves of the primary end point through 1 year after randomization tracked closely between the two groups.\u003c\/p\u003e\n\n\u003ch2 id=\"safety\"\u003eSafety and Adverse Events\u003c\/h2\u003e\n\n\u003cp\u003eSerious adverse events were reported in 264 patients in the TAVI-first group and 273 patients in the PCI-first group — a modest numerical difference favoring the valve-first strategy. The trial protocol included prespecified landmark analyses to examine whether the timing of events differed, with assessments of events occurring before day 45 and on or after day 45, as well as through month 6 and after month 6. These analyses help clarify whether one sequence carries higher early risk versus later risk.\u003c\/p\u003e\n\n\u003cp\u003eThe researchers also noted that quality-of-life questionnaires (KCCQ and TASQ) and symptom classifications (CCS and NYHA) were scored according to vendor algorithms and assessed at 3 months and 1 year. For secondary end points, the trial did not adjust for multiplicity (statistical correction for testing many outcomes), and the 95% confidence intervals for these outcomes should not be used to draw definitive conclusions about treatment effects — a standard caveat in trials where the primary end point is the main focus.\u003c\/p\u003e\n\n\u003ch2 id=\"implications\"\u003eWhat This Means for Patients\u003c\/h2\u003e\n\n\u003cp\u003eThis trial provides the first large-scale randomized evidence to guide the order of procedures in patients who need both TAVI and PCI. Until now, the stent-first approach was the default largely based on tradition and the theoretical concern that coronary access after valve implantation could be difficult.\u003c\/p\u003e\n\n\u003cp\u003eFor patients, the practical meaning is straightforward: \u003cstrong\u003eif your heart team recommends TAVI and you also have coronary blockages, having the valve replaced first is a proven, safe option.\u003c\/strong\u003e The valve-first approach offers several real-world benefits:\u003c\/p\u003e\n\u003cul\u003e\n  \u003cli\u003e\n\u003cstrong\u003eBetter stability during stenting:\u003c\/strong\u003e After the narrowed valve is replaced, blood pressure and blood flow typically improve, making the stenting procedure safer and easier to tolerate.\u003c\/li\u003e\n  \u003cli\u003e\n\u003cstrong\u003eNo dual antiplatelet therapy during the valve procedure:\u003c\/strong\u003e With the PCI-first approach, patients are often on two blood thinners at the time of TAVI, which can increase bleeding risk. With TAVI first, patients can avoid this combination during the valve procedure.\u003c\/li\u003e\n  \u003cli\u003e\n\u003cstrong\u003eEquivalent safety:\u003c\/strong\u003e The trial found no increase in death, heart attack, repeat procedures, rehospitalization, or major bleeding with the valve-first sequence. The concern that reaching the coronary arteries after valve implantation would be problematically difficult did not translate into worse outcomes.\u003c\/li\u003e\n\u003c\/ul\u003e\n\n\u003cp\u003eIt is also worth noting that both procedures were commonly done during the same hospitalization — in 38.2% of patients — and the median time between procedures was 27 days in the TAVI-first group versus 13 days in the PCI-first group. This suggests both strategies can be completed efficiently within a short interval, which matters for patients who want to resolve their heart problems without a long delay.\u003c\/p\u003e\n\n\u003cp\u003eAnother reassuring detail: the definition of coronary artery disease used in this trial was clinically meaningful — significant blockages in vessels at least 2.5 mm in diameter, confirmed either by functional testing or, after the protocol amendment, by angiography showing at least 70% narrowing. In clinical practice, your heart team will use similar criteria to decide whether stenting is needed at all, which helps avoid unnecessary procedures.\u003c\/p\u003e\n\n\u003ch2 id=\"limitations\"\u003eStudy Limitations\u003c\/h2\u003e\n\n\u003cp\u003eEvery clinical trial has limitations, and this one is no exception. Understanding them helps place the results in context.\u003c\/p\u003e\n\n\u003cul\u003e\n  \u003cli\u003e\n\u003cstrong\u003eOpen-label design:\u003c\/strong\u003e Because patients and doctors knew which treatment order was assigned, there is a theoretical possibility of bias in how events were reported or managed. The use of an independent adjudication committee that was unaware of group assignments helps reduce this risk.\u003c\/li\u003e\n  \u003cli\u003e\n\u003cstrong\u003eNoninferiority margin:\u003c\/strong\u003e The 6.6-percentage-point margin is relatively wide, which is common in noninferiority trials but means the study could not detect small differences in outcome, if they exist. The trial was designed with 80% power, which is standard but not extremely high.\u003c\/li\u003e\n  \u003cli\u003e\n\u003cstrong\u003eNo superiority shown:\u003c\/strong\u003e While the risk difference favored TAVI-first (−2.0 percentage points), the test for superiority was not significant (P=0.47). The trial was not designed or powered to prove that one strategy is better than the other.\u003c\/li\u003e\n  \u003cli\u003e\n\u003cstrong\u003eSpecific valve and techniques:\u003c\/strong\u003e The trial used exclusively Edwards SAPIEN 3 family valves. Results might differ with other transcatheter valve systems, although the findings are likely generalizable given the similar design of modern valves.\u003c\/li\u003e\n  \u003cli\u003e\n\u003cstrong\u003eProtocol amendment:\u003c\/strong\u003e The definition of coronary artery disease changed partway through the trial (after 511 patients), shifting from routine functional testing to an angiography-based strategy. While this was a reasonable change to speed enrollment, it introduced some heterogeneity in how patients were selected.\u003c\/li\u003e\n  \u003cli\u003e\n\u003cstrong\u003eEuropean population:\u003c\/strong\u003e All 48 centers were in Europe (Austria, France, Germany, Italy, the Netherlands, and Switzerland). Practice patterns and patient characteristics may differ elsewhere, although there is no strong reason to think the core findings would not apply broadly.\u003c\/li\u003e\n  \u003cli\u003e\n\u003cstrong\u003eSecondary end points:\u003c\/strong\u003e No adjustment for multiplicity was performed, so the confidence intervals for secondary outcomes should not be used to infer definitive treatment effects.\u003c\/li\u003e\n  \u003cli\u003e\n\u003cstrong\u003eMissing data:\u003c\/strong\u003e No imputation was performed for missing data, though follow-up completion was high (95.0% and 94.9%), limiting this concern. The researchers also ran supportive analyses under different assumptions about missing outcomes to confirm the robustness of the primary result.\u003c\/li\u003e\n\u003c\/ul\u003e\n\n\u003ch2 id=\"recommendations\"\u003eRecommendations for Patients\u003c\/h2\u003e\n\n\u003cp\u003eIf you have severe aortic stenosis and coronary artery disease and your heart team has recommended both TAVI and PCI, here is what this study means for your discussions with your doctor:\u003c\/p\u003e\n\n\u003col\u003e\n  \u003cli\u003e\n\u003cstrong\u003eAsk about the order of procedures.\u003c\/strong\u003e This trial confirms that doing TAVI first is a safe, evidence-based choice. If your doctor suggests the traditional PCI-first approach, that remains valid too — both strategies produced similar outcomes at 1 year.\u003c\/li\u003e\n  \u003cli\u003e\n\u003cstrong\u003eDiscuss bleeding risk and blood thinners.\u003c\/strong\u003e If you are concerned about bleeding, the TAVI-first approach avoids the need for dual antiplatelet therapy at the time of the valve procedure. Tell your doctor if you take anticoagulation for atrial fibrillation or other conditions, since medication plans differ in that situation.\u003c\/li\u003e\n  \u003cli\u003e\n\u003cstrong\u003eExpect both procedures in a short window.\u003c\/strong\u003e In this trial, the median time between the two procedures was 27 days for valve-first and 13 days for stent-first, and 38.2% of patients had both procedures during a single hospitalization. You may not need to plan for a long recovery between procedures.\u003c\/li\u003e\n  \u003cli\u003e\n\u003cstrong\u003eUnderstand that not everyone needs PCI.\u003c\/strong\u003e Some patients in this trial did not undergo PCI — either because the operator judged it unnecessary or because functional testing showed the blockage was not restricting blood flow. Your heart team will use angiography, and possibly functional testing, to decide whether stenting truly benefits you.\u003c\/li\u003e\n  \u003cli\u003e\n\u003cstrong\u003eConfirm the valve type.\u003c\/strong\u003e This study used Edwards SAPIEN 3 family valves. Ask your heart team which valve they plan to use and whether the results of this trial apply to that valve.\u003c\/li\u003e\n  \u003cli\u003e\n\u003cstrong\u003eKeep the long-term picture in mind.\u003c\/strong\u003e The study followed patients for 1 year. Your doctor will want to continue monitoring your heart health, including checking for any new blockages or valve-related issues, beyond this timeframe.\u003c\/li\u003e\n\u003c\/ol\u003e\n\n\u003cp\u003eThe bottom line: this landmark trial gives patients and doctors flexibility. Whether the valve or the stents come first, the outcomes at one year are essentially the same — and the valve-first order, long considered a risky alternative, is now supported by high-quality randomized evidence as an option that is at least as good, with some practical advantages.\u003c\/p\u003e\n\n\u003c!-- ddn:faq:start --\u003e\n\u003ch2 id=\"ddn-faq\"\u003eFrequently Asked Questions\u003c\/h2\u003e\n\u003ch3\u003eWhy is the order of valve replacement and coronary stenting important for me?\u003c\/h3\u003e\n\u003cp\u003eBoth TAVI (valve replacement) and PCI (stenting) are common together. Until now, stent-first was the usual order, but doctors were unsure if valve-first was safe. A new European trial found both orders are safe and effective, so you and your heart team can choose either approach with confidence.\u003c\/p\u003e\n\u003ch3\u003eWhat did this study compare in patients needing both TAVI and PCI?\u003c\/h3\u003e\n\u003cp\u003eThe study assigned 986 patients with severe aortic stenosis and coronary disease to either valve replacement first or stenting first. After one year, about 22.2% in the valve-first group had a major event versus 24.2% in the stent-first group. This difference was within the preset noninferiority margin, meaning valve-first is no worse.\u003c\/p\u003e\n\u003ch3\u003eAm I eligible for this valve-first or stent-first approach?\u003c\/h3\u003e\n\u003cp\u003eIn this trial, adults with severe aortic stenosis and significant coronary blockages were eligible if a local heart team recommended both TAVI and PCI. Patients were older, typically around 82 years. Your own doctor will decide whether both procedures are needed and which order is most appropriate for your specific condition.\u003c\/p\u003e\n\u003ch3\u003eIf I choose valve replacement first, is stenting afterward safe?\u003c\/h3\u003e\n\u003cp\u003eYes. The valve-first strategy was shown to be as safe as the traditional stent-first strategy over one year, with no increase in death, heart attack, repeat procedures, rehospitalization, or major bleeding. Doctors had worried the new valve might make reaching coronary arteries harder, but this did not lead to worse outcomes in the trial.\u003c\/p\u003e\n\u003ch3\u003eWhat practical advantages does having the valve replaced first offer?\u003c\/h3\u003e\n\u003cp\u003eThe valve-first approach improves blood pressure and blood flow before stenting, making that procedure more stable. It also avoids needing dual antiplatelet therapy (two blood thinners) at the time of the valve procedure, which can reduce bleeding risk. Both procedures can often be completed within one hospital stay or a short time apart.\u003c\/p\u003e\n\u003ch3\u003eHow much time is usually between the two procedures?\u003c\/h3\u003e\n\u003cp\u003eIn this trial, the median time between procedures was 27 days for valve-first and 13 days for stent-first. Both procedures were done during the same hospitalization in about 38% of patients. The protocol allowed one to 45 days between procedures, giving heart teams flexibility to schedule around your needs.\u003c\/p\u003e\n\u003ch3\u003eBased on this study, should I ask my doctor about the order of procedures?\u003c\/h3\u003e\n\u003cp\u003eYes. This trial provides strong evidence that doing TAVI first is safe and effective, while the traditional stenting-first approach remains valid too. Ask your heart team which plan they recommend and how the two procedures will be scheduled. Their choice should consider your bleeding risk, other conditions, and coronary anatomy.\u003c\/p\u003e\n\u003ch3\u003eShould I get a second opinion on whether to have my aortic valve replaced before or after coronary stenting?\u003c\/h3\u003e\n\u003cp\u003eBoth procedure orders are supported by a large European trial of 986 patients: valve-first was noninferior to stent-first, with 22.2% vs 24.2% experiencing death, heart attack, repeat procedure, rehospitalization, or major bleeding within one year. Because either sequence is reasonable, a second opinion can help confirm which order makes sense for your anatomy and clarify whether stenting is truly needed. Bring your coronary angiogram and your heart team's procedural plan for review. Diagnostic Detectives Network provides independent expert second opinions.\u003c\/p\u003e\n\u003c!-- ddn:faq:end --\u003e\n\n\u003ch2 id=\"source\"\u003eSource Information\u003c\/h2\u003e\n\n\u003cp\u003eThis patient-friendly article is based on the following peer-reviewed research:\u003c\/p\u003e\n\n\u003cp\u003e\u003cstrong\u003eOriginal title:\u003c\/strong\u003e \"Timing of PCI in Patients Undergoing Transcatheter Aortic-Valve Implantation\"\u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003eAuthors:\u003c\/strong\u003e B.E. Stähli, F. Ruschitzka, D. Westermann, A. Linke, N. Mangner, N.M. Van Mieghem, R. Kesterke, L. Oberholzer, J. Rothe, C. von zur Mühlen, T. Zeus, W.-K. Kim, P. Lauten, N. Werner, C. Burgdorf, H. Alber, P.C. Schulze, M. Joner, J. Michel, A. Candreva, P. Jakob, M. Würdinger, J. Stehli, A. Gotschy, C. Templin, O. Dzemali, L. Gaede, S. Massberg, A. Lauten, F. van der Kley, A. Ewers, T. Nestelberger, M. Abdel-Wahab, G. Musumeci, S. Barth, M. Hansen, A. Mügge, M. Seiffert, D.M. Leistner, T. Cuisset, S. Schneider, A. Kastrati, I. Ford, and M.A. Kasel, for the TAVI PCI Investigators\u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003eJournal:\u003c\/strong\u003e \u003cem\u003eThe New England Journal of Medicine\u003c\/em\u003e, published August 30, 2026\u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003eDOI:\u003c\/strong\u003e 10.1056\/NEJMoa2606924\u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003eTrial registration:\u003c\/strong\u003e ClinicalTrials.gov number, NCT04310046\u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003eFunding:\u003c\/strong\u003e University Hospital Zurich and University of Zurich, with additional investigator-initiated research grant support from Edwards Lifesciences\u003c\/p\u003e\n\n\u003cp\u003e\u003cem\u003eThis patient-friendly article is based on peer-reviewed research. It is intended for educational purposes and does not constitute medical advice. Patients should discuss their individual treatment plans with their healthcare team.\u003c\/em\u003e\u003c\/p\u003e","brand":"DiagnosticDetectives.Com","offers":[{"title":"Default Title","offer_id":47542002221212,"sku":null,"price":0.0,"currency_code":"RUB","in_stock":true}],"url":"https:\/\/diagnosticdetectives.ru\/products\/which-procedure-first-new-study-shows-valve-replacement-before-coronary-stenting-is-as-safe-as-the-traditional-approach","provider":"DiagnosticDetectives.Com","version":"1.0","type":"link"}