PCI vs Medical Management for Aortic Stenosis

(COMPLETE TAVR Trial)

Recruiting at 78 trial locations

Overseen By Charles Resor, MD

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: University of British Columbia

Disqualifiers: Prior CABG, Severe mitral regurgitation, Severe LV dysfunction, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 1-45 days

4000 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the best way to manage heart patients undergoing TAVR, a less invasive heart valve replacement. It tests whether treating additional heart artery blockages with PCI (Percutaneous Coronary Intervention, which uses tiny tubes called stents to open arteries) is more effective than using standard heart medications alone. This is crucial for individuals with severe aortic stenosis (narrowing of the heart valve) and significant coronary artery disease (blockages in the heart arteries). Suitable candidates experience troublesome heart symptoms like shortness of breath, require TAVR, and have artery blockages that could be treated with PCI. The goal is to determine if adding PCI to medication improves heart health and survival. As an unphased trial, this study allows patients to contribute to important research that could enhance treatment strategies for heart conditions.

Do I need to stop my current medications for this trial?

The trial does not specify if you need to stop your current medications. However, all participants will receive guideline-directed medical therapy, which includes risk factor modification and evidence-based therapies.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that percutaneous coronary intervention (PCI), a procedure that opens blocked heart arteries, is generally safe but carries some risks. One study found that 28% of patients who underwent PCI experienced bleeding, compared to 20% of those who opted for more conservative treatment. Notably, undergoing PCI after a TAVR procedure can increase the risk of major heart problems compared to those who have not had TAVR. However, the specific outcomes of PCI for patients with severe narrowing of the aortic valve and coronary artery disease remain unclear. While PCI has been successfully used for other heart issues, participants should discuss potential risks and benefits with their healthcare provider. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using Percutaneous Coronary Intervention (PCI) for treating aortic stenosis because it offers a unique approach compared to standard medical management, which typically involves medication and lifestyle changes without revascularization. Unlike traditional methods that focus on managing symptoms, PCI actively targets coronary artery blockages by inserting a catheter to open narrowed arteries, potentially improving blood flow more directly and effectively. This could lead to better outcomes for patients with significant coronary artery stenoses, offering a more immediate and mechanical solution to improving heart function.

What evidence suggests that this trial's treatments could be effective for aortic stenosis?

This trial will compare Percutaneous Coronary Intervention (PCI) with medical therapy alone for patients with aortic stenosis. Research has shown that combining PCI, a procedure to open blocked heart arteries, with TAVR, a method to replace a heart valve without open surgery, may reduce the risk of death and heart problems in patients with both aortic valve narrowing and coronary artery disease. One study found that using PCI with TAVR leads to better results than using TAVR alone, although the difference in death rates within 30 days was not significant. The study also showed that PCI was successful in many patients, with some having all their blocked arteries treated. However, uncertainty remains about the best timing for PCI and its long-term benefits. Overall, PCI might help improve heart function and reduce complications for patients undergoing TAVR. ^{6 7 8 9 10}

Who Is on the Research Team?

David A Wood, MD

Principal Investigator

CCI-CIC, University of British Columbia

Are You a Good Fit for This Trial?

This trial is for men and women with severe symptomatic aortic valve stenosis who have undergone successful TAVR within the past 96 hours. They must have at least one treatable coronary artery lesion and be deemed suitable for elective transfemoral TAVR by a heart team. Exclusions include recent heart attacks or strokes, severe mitral regurgitation, life expectancy under 5 years, prior bypass surgery or valve replacement, among others.

Inclusion Criteria

My heart team agrees I can have a specific heart valve replacement through my thigh and would get a bypass if I had surgery.

I had a successful heart valve replacement via catheter within the last 4 days without major issues.

I have a significant blockage in one of my heart's arteries that can be treated without surgery.

Exclusion Criteria

I had or will have a PCI procedure close to my TAVR surgery date.

I am scheduled for a procedure to open blocked arteries in my heart.

You have something that would prevent you from being followed up for 5 years.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants undergo elective transfemoral TAVR and are randomized to either staged PCI with drug eluting stents or medical therapy alone

1-45 days

Multiple visits for TAVR and PCI procedures

Follow-up

Participants are monitored for safety and effectiveness, including cardiovascular outcomes and quality of life assessments

3.5 years

Regular follow-up visits, including annual assessments

What Are the Treatments Tested in This Trial?

Interventions

• Percutaneous Coronary Intervention (PCI)

Trial Overview

The study tests if complete revascularization using drug eluting stents after TAVR (staged PCI) is better than just medical therapy alone in reducing cardiovascular death and other complications. Patients are randomly assigned to either undergo staged PCI post-TAVR or receive only medical management without further revascularization.

How Is the Trial Designed?

Group I: Complete Revascularization Experimental Treatment 1 Intervention

Routine PCI (percutaneous coronary intervention) of all suitable coronary artery stenoses of ≥70% in vessels ≥2.5mm in diameter.

Group II: Medical Therapy Alone Active Control 1 Intervention

No revascularization of coronary artery lesions.

Percutaneous Coronary Intervention (PCI) is already approved in European Union, United States, Canada, Japan for the following indications:

Approved in European Union as Percutaneous Coronary Intervention for:

• Stable angina
• Unstable angina
• Myocardial infarction
• Ischemic heart disease

Approved in United States as Percutaneous Coronary Intervention for:

• Stable angina
• Unstable angina
• Myocardial infarction
• Ischemic heart disease

Approved in Canada as Percutaneous Coronary Intervention for:

• Stable angina
• Unstable angina
• Myocardial infarction
• Ischemic heart disease

Approved in Japan as Percutaneous Coronary Intervention for:

• Stable angina
• Unstable angina
• Myocardial infarction
• Ischemic heart disease

Who Is Running the Clinical Trial?

University of British Columbia

Lead Sponsor

Trials

1,506

Recruited

2,528,000+

Published Research Related to This Trial

A study of 45,420 patients with aortic stenosis (AS) showed that PCI procedures, including those with atherectomy, increased significantly from 2016 to 2019, indicating a growing trend in treating AS patients with coronary artery disease.

Using intravascular ultrasound (IVUS) during atherectomy and PCI was associated with lower odds of major adverse cardiovascular events (MACE), suggesting that this approach is both safe and effective for patients with AS.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Percutaneous Coronary Intervention and Discretionary Atherectomy in Patients with Aortic Stenosis: 2016-2019 National Inpatient Sample. Vedantam, K., Torres, CA., Martinsen, BJ., et al.[2023]

Percutaneous coronary intervention (PCI) is a safe and effective treatment for patients with severe aortic stenosis (AS) and significant coronary artery disease (CAD), with 92.1% of patients reporting symptomatic improvement after the procedure.

The study, which analyzed 38 patients aged around 71 years, found that good functional class and single-vessel coronary disease were significant predictors of long-term survival, suggesting that PCI may be particularly beneficial for patients with these characteristics.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The value of percutaneous coronary intervention in aortic valve stenosis with coronary artery disease. Alcalai, R., Viola, N., Mosseri, M., et al.[2010]

In a study of 593 patients undergoing transapical TAVI, those with severe aortic stenosis and significant coronary artery disease (CAD) who received combined TAVI and PCI showed similar survival rates up to 3 years compared to patients without CAD who only received TAVI.

The combined treatment significantly reduced the complexity of coronary lesions, as indicated by a decrease in the mean SYNTAX score from 8.0 to 3.0, while not increasing the risk of acute kidney injury despite higher radiation exposure and contrast use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcatheter aortic valve implantation combined with elective coronary artery stenting: a simultaneous approach†. Penkalla, A., Pasic, M., Drews, T., et al.[2015]

A study involving 51 cardiologists and 54 cardiac surgeons revealed significant differences in how these two groups assess the risks and benefits of percutaneous aortic valve replacement (PAVR), with cardiologists generally viewing the procedure more favorably.

Both groups acknowledged risks associated with PAVR, such as impaired hemodynamic outcomes and embolic events, but cardiologists rated these risks significantly lower than surgeons, suggesting a need for more evidence-based information to align perspectives.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Job matters: differences in risk assessment of percutaneous aortic valve replacement between cardiologists and cardiac surgeons. Grebel, T., Schumm, J.[2015]

Percutaneous aortic valvuloplasty (PAV) can effectively increase aortic valve area and improve heart function in patients with critical aortic stenosis, even in life-threatening situations like cardiogenic shock.

While PAV can be life-saving, especially after complications like a myocardial infarction, it is associated with high rates of morbidity and mortality, highlighting the need for careful patient selection and management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Combined PTCA and aortic valvuloplasty for acute myocardial infarction complicated by severe aortic stenosis and cardiogenic shock. Whisenant, B., Sweeney, J., Ports, TA.[2019]

Percutaneous coronary intervention (PCI) in patients with severe aortic stenosis (AS) does not increase the risk of 30-day mortality compared to patients without AS, based on a study of 254 AS patients matched with 508 non-AS patients.

However, patients with severe AS who also have a low ejection fraction (≤30%) or a high Society of Thoracic Surgeons score (≥10) face a significantly higher risk of 30-day mortality after PCI, highlighting the need for careful risk assessment in these high-risk groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Percutaneous coronary intervention in patients with severe aortic stenosis: implications for transcatheter aortic valve replacement. Goel, SS., Agarwal, S., Tuzcu, EM., et al.[2012]

In patients with severe aortic stenosis undergoing transcatheter aortic valve implantation (TAVI), the necessity of pre-TAVI revascularization through percutaneous coronary intervention (PCI) is being questioned, suggesting it may not always be required.

Current data indicates that the management of coronary artery disease in TAVI patients can be approached differently, impacting clinical decision-making and potentially reducing unnecessary procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Coronary artery disease in patients undergoing TAVI--why not to treat. Khawaja, MZ., Redwood, SR., Thomas, M.[2022]

In patients with severe aortic stenosis and significant coronary artery disease, performing percutaneous coronary intervention (PCI) followed immediately by percutaneous aortic valve implantation (PAVI) can be a viable treatment strategy.

The study highlights the complexity of treating these frail patients and proposes an algorithm to guide treatment decisions, emphasizing the need to differentiate between symptoms of ischemic heart disease and severe aortic stenosis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Percutaneous aortic valve implantation in patients with coronary artery disease: review of therapeutic strategies. Dvir, D., Assali, A., Spargias, K., et al.[2010]

In a study of 409 patients with severe aortic stenosis, combining balloon aortic valvuloplasty (BAV) with percutaneous coronary intervention (PCI) was found to be safe, with similar rates of serious adverse events compared to BAV alone (13.7% vs. 17.3%).

The combined procedure did not significantly increase mortality rates, with 40% in the BAV/PCI group and 48.6% in the BAV alone group, suggesting that the combination may provide additional protection against myocardial ischemia without increasing risks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Outcomes of concomitant percutaneous coronary intervention and balloon aortic valvuloplasty. Ben-Dor, I., Maluenda, G., Looser, PM., et al.[2015]

A meta-analysis evaluating patients undergoing transcatheter aortic valve replacement (TAVR) found that adding percutaneous coronary intervention (PCI) for coronary artery disease (CAD) does not increase the risk of 30-day mortality compared to TAVR alone.

The study also showed no significant differences in major complications such as myocardial infarction, stroke, or life-threatening bleeding between patients receiving TAVR with PCI and those receiving TAVR alone, indicating that PCI is a safe and feasible option for these patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and feasibility of PCI in patients undergoing TAVR: A systematic review and meta-analysis. Bajaj, A., Pancholy, S., Sethi, A., et al.[2018]

In patients with severe aortic stenosis and coronary artery disease, the combined percutaneous approach of TAVI and PCI showed significantly lower risks of major adverse cardiovascular events (MACE) and all-cause mortality during the initial hospitalization compared to the surgical approach of SAVR and CABG.

However, the TAVI+PCI group experienced a higher incidence of complications and mortality within 30 days post-procedure, indicating a trade-off between immediate benefits and short-term risks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Trends and outcomes of combined percutaneous (TAVI+PCI) and surgical approach (SAVR+CABG) for patients with aortic valve and coronary artery disease: A National Readmission Database (NRD) analysis. Ullah, W., Sarvepalli, D., Kumar, A., et al.[2023]

Citations

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Clinical outcomes of percutaneous coronary interventions ...

Successful PCI in the prior TAVR occurred in 96.9% of the patients and complete revascularization in 69.2%. Figure 1. Figure 1 · Open in a new ...

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ahajournals.org/doi/10.1161/circulationaha.111.039180

Percutaneous Coronary Intervention in Patients With ...

It was indeed sobering to find a 30-day mortality rate of 4.3% after PCI in patients with severe AS, which is similar to that in the highest-risk patients such ...

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jscai.org

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This systematic review and meta-analysis assesses the efficacy and safety of percutaneous coronary intervention (PCI) prior to TAVI in aortic stenosis (AS) ...

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nejm.org

nejm.org/doi/abs/10.1056/NEJMoa2401513

PCI in Patients Undergoing Transcatheter Aortic-Valve ...

Among patients with coronary artery disease who were undergoing TAVI, PCI was associated with a lower risk of a composite of death from any ...

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sciencedirect.com

sciencedirect.com/science/article/abs/pii/S0146280623003973

Clinical Outcomes of Transcatheter Aortic Valve ...

Compared to patients undergoing TAVR alone, the TAVR+PCI group showed no significant difference in 30-day all-cause mortality (RR 0.90, CI 0.66, 1.22, P = 0.49) ...

6.

jacc.org

jacc.org/doi/full/10.1016/S0735-1097(25)01376-2

SAFETY AND EFFICACY OF PERCUTANEOUS ...

The outcomes of interest were major adverse cardiovascular events (MACE), all deaths, cardiovascular (CV) deaths, major bleeding, myocardial infarction (MI), ...

7.

ahajournals.org

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Percutaneous Coronary Intervention in Patients With ...

Outcomes of percutaneous coronary intervention (PCI) in patients with severe AS and coronary artery disease remain unknown.

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academic.oup.com

academic.oup.com/ehjopen/article/5/5/oeaf095/8255918

Clinical outcomes of percutaneous coronary interventions ...

Patients undergoing PCI after TAVR face a higher incidence of MACE compared to those without prior TAVR. These findings highlight the importance ...

9.

pubmed.ncbi.nlm.nih.gov

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PCI in Patients Undergoing Transcatheter Aortic-Valve ...

A bleeding event occurred in 64 patients (28%) in the PCI group and in 45 (20%) in the conservative-treatment group (hazard ratio, 1.51; 95% CI, ...

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eurointervention.pcronline.com

eurointervention.pcronline.com/article/impact-of-coronary-artery-disease-and-percutaneous-coronary-intervention-on-outcomes-in-patients-with-severe-aortic-stenosis-undergoing-transcatheter-aortic-valve-implantation

Impact of coronary artery disease and percutaneous ...

This study investigated the impact of percutaneous coronary intervention in patients with severe aortic stenosis undergoing transcatheter aortic valve ...