Obstructive Coronary Artery Disease Does Not Diminish Long-Term Health Status or Clinical Efficacy After TAVR: 3-Year Insights from SCOPE I

Introduction

The management of coronary artery disease (CAD) in the context of transcatheter aortic valve replacement (TAVR) remains one of the most debated frontiers in interventional cardiology. As the prevalence of aortic stenosis (AS) increases with age, so too does the likelihood of concomitant CAD, which is estimated to occur in up to 50% of TAVR candidates. For years, clinicians have grappled with whether obstructive CAD necessitates revascularization prior to or during TAVR and how its presence influences long-term patient-reported outcomes. A recent post hoc analysis of the SCOPE I randomized clinical trial, published in JAMA Network Open, provides essential data on these questions, suggesting that obstructive CAD may not be the prognostic deterrent it was once considered to be in the TAVR population.

Highlights

The study yielded several high-impact findings for the clinical community:

1. Long-Term Parity in Survival and Health Status

At the 3-year follow-up, there were no statistically significant differences in all-cause mortality, cardiovascular mortality, or patient-reported health status (measured by KCCQ scores) between patients with and without obstructive CAD.

2. Routine PCI May Not Confer Additional Benefit

Among patients with obstructive CAD, those who underwent elective percutaneous coronary intervention (PCI) did not show improved clinical outcomes or quality of life compared to those managed conservatively.

3. Potential MI Risk Signal

While survival was similar, patients with obstructive CAD exhibited a numerically higher, though not statistically significant, risk of myocardial infarction (MI) over three years.

Background and Clinical Context

Aortic stenosis and CAD share common risk factors, including age, hypertension, and dyslipidemia. Historically, the presence of CAD in patients undergoing surgical aortic valve replacement (SAVR) was associated with worse outcomes, leading to the routine practice of combined SAVR and coronary artery bypass grafting (CABG). However, the TAVR population is generally older and more comorbid, making the risks of additional procedures like PCI a significant concern. The fundamental question remains: is the obstructive lesion in the coronary artery contributing to the patient’s symptoms and risk, or is the stenotic valve the primary driver of the clinical presentation?

Study Design and Methodology

This study was a post hoc analysis of the SCOPE I (Safety and Efficacy of the Symetis ACURATE Neo/TF Compared to the Edwards SAPIEN 3 Bioprosthesis for Transcatheter Aortic Valve Implantation by Transfemoral Approach) trial. The analysis included 732 patients with symptomatic severe AS across 20 tertiary heart centers in Europe.The researchers defined obstructive CAD as greater than 50% stenosis in at least one major epicardial coronary vessel. The primary focus was on clinical efficacy—defined by the Valve Academic Research Consortium (VARC)-3 standards—and disease-specific health status, quantified using the Kansas City Cardiomyopathy Questionnaire (KCCQ). The KCCQ scores range from 0 to 100, where higher scores represent better health status and fewer symptoms.

Detailed Findings

The analysis provided a robust dataset covering three years of patient follow-up.

Patient Characteristics

Of the 732 patients (mean age 82 years; 56.8% female), 51.0% (n=373) were identified as having obstructive CAD. Within this CAD cohort, 38.6% (n=144) underwent periprocedural PCI.

Health Status and Quality of Life

Both groups—those with and without CAD—showed significant and comparable improvements in health status following TAVR. At baseline, the median KCCQ overall summary score was 54.2 for the CAD group and 55.2 for the no-CAD group. By the 3-year mark, these scores rose to 79.7 and 82.3, respectively. The lack of a statistically significant difference between these groups suggests that the relief of the valvular obstruction is the dominant factor in improving quality of life, regardless of coronary anatomy.

Survival and Clinical Efficacy

The 3-year mortality data further reinforced the neutrality of CAD status:All-cause death: 24.7% (CAD) vs. 22.3% (No CAD) [Adjusted HR 0.97; 95% CI, 0.66-1.43].Cardiovascular death: 17.6% (CAD) vs. 15.5% (No CAD) [Adjusted HR 0.87; 95% CI, 0.54-1.42].Clinical efficacy, a composite endpoint including survival and valve performance, was nearly identical at 52.1% for CAD patients and 53.4% for those without.

The Impact of PCI

Perhaps the most striking finding was that periprocedural PCI did not move the needle. Patients with CAD who received PCI had no significant improvement in clinical outcomes or KCCQ scores compared to those with CAD who did not receive PCI. This suggests that the physiological impact of many 50% coronary lesions may not be severe enough to warrant the procedural risks of PCI in an elderly TAVR population.

Myocardial Infarction Trends

One area of potential concern was the rate of MI. The CAD group had an MI rate of 5.5% compared to 1.1% in the no-CAD group. Although the adjusted hazard ratio was 3.83, the 95% confidence interval (0.96-15.31) crossed the line of unity, meaning the result was not statistically significant. However, this trend suggests that while CAD does not drive mortality in the short-to-medium term, it does leave patients more vulnerable to ischemic events.

Expert Commentary and Clinical Implications

The SCOPE I post hoc analysis contributes to a growing body of evidence suggesting that a conservative approach to CAD in TAVR patients may be appropriate. The findings align with the concept that in many elderly patients, the hemodynamic burden of AS is so severe that it overshadows the impact of moderate coronary stenoses.

The Tailored Approach

The authors conclude that a tailored approach is essential. Rather than a blanket policy of revascularizing all lesions >50%, the Heart Team should consider:1. The physiological significance of the lesion (e.g., using FFR or iFR where appropriate).2. The location of the lesion (proximal vs. distal).3. The patient’s overall frailty and risk of bleeding associated with dual antiplatelet therapy (DAPT) required after PCI.

Limitations

As a post hoc analysis, the study is subject to inherent limitations, including the lack of prospective randomization for the PCI intervention. Additionally, the 50% stenosis threshold is an anatomical rather than functional definition, which may include lesions that do not cause significant ischemia.

Conclusion

For clinicians managing patients with severe aortic stenosis, the SCOPE I post hoc analysis provides reassurance that the presence of obstructive CAD should not necessarily complicate the TAVR decision-making process or dampen expectations for quality-of-life improvements. While CAD patients may face a slightly higher risk of MI, their 3-year survival and health status trajectories remain largely indistinguishable from those without CAD. This study supports a shift away from routine revascularization and toward a more nuanced, patient-centric strategy in the TAVR era.

Funding and Trial Registration

The SCOPE I trial was investigator-initiated and supported by research grants from Boston Scientific. ClinicalTrials.gov Identifier: NCT03011346.

References

1. Tomii D, Lanz J, Thiele H, et al. Obstructive Coronary Artery Disease and Health Status in Transcatheter Aortic Valve Replacement: A Post Hoc Analysis of the SCOPE I Randomized Clinical Trial. JAMA Netw Open. 2025;8(12):e2547111. 2. VARC-3 Writing Committee. Valve Academic Research Consortium 3: Updated Endpoint Definitions for Aortic Valve Clinical Research. J Am Coll Cardiol. 2021. 3. Kim WK, et al. Safety and Efficacy of the Symetis ACURATE neo/TF Compared With the Edwards SAPIEN 3 Bioprosthesis (SCOPE I): A Randomized Clinical Trial. Lancet. 2019.