Staged Complete Revascularization for Coronary Artery Disease vs Medical Management Alone in Patients With AS Undergoing Transcatheter Aortic Valve Replacement

NCT04634240 | Recruiting DMC

• 1 other identifier: H20-00968
• Study Type: interventional
• Target: 4,000
• Locations: 2 countries
• Sites: 72

Brief Summary

Patients undergoing transcatheter aortic valve replacement (TAVR) often have concomitant coronary artery disease (CAD) which may adversely affect prognosis. There is uncertainty about the benefits and the optimal timing of revascularization for such patients. There is currently clinical equipoise regarding the management of concomitant CAD in patients undergoing TAVR. Some centers perform routine revascularization with percutaneous coronary intervention (PCI) (either before or after TAVR), while others follow an alternative strategy of medical management. The potential benefits and optimal timing of PCI in these patients are unknown. As TAVR expands to lower risk patients, and potentially becomes the preferred therapy for the majority of patients with severe aortic stenosis, the optimal management of concomitant coronary artery disease will be of increasing importance. The COMPLETE TAVR study will determine whether, on a background of guideline-directed medical therapy, a strategy of complete revascularization involving staged PCI using drug eluting stents to treat all suitable coronary artery lesions is superior to a strategy of medical therapy alone in reducing the composite outcome of Cardiovascular Death, new Myocardial Infarction, Ischemia-driven Revascularization or Hospitalization for Unstable Angina or Heart Failure. The study will be a randomized, multicenter, open-label trial with blinded adjudication of outcomes. Patients will be screened and consented for elective transfemoral TAVR and randomized within 96 hours of successful balloon expandable TAVR. Complete Revascularization: Staged PCI using third generation drug eluting stents to treat all suitable coronary artery lesions in vessels that are at least 2.5 mm in diameter and that are amenable to treatment with PCI and have a ≥70% visual angiographic diameter stenosis. Staged PCI can occur any time from 1 to 45 days post successful transfemoral TAVR. Vs. Medical Therapy Alone: No further revascularization of coronary artery lesions. All patients, regardless of randomized treatment allocation, will receive guideline-directed medical therapy consisting of risk factor modification and use of evidence-based therapies. The COMPLETE TAVR study will help address the current lack of evidence in this area. It will likely impact both the global delivery of health care and the management and clinical outcomes of all patients undergoing TAVR with concomitant CAD.

Conditions

Aortic Stenosis; Coronary Artery Disease; Coronary Stenosis

Keywords

Transcatheter Aortic Valve Replacement; Percutaneous Coronary Intervention; Coronary Artery Disease; Aortic Stenosis

Outcome Measures

Primary Outcomes (1)

• Composite of Cardiovascular Death or New Myocardial Infarction or Ischemia-Driven Revascularization or Hospitalization for Unstable Angina or Heart Failure

  Median follow-up of 3.5 years

Secondary Outcomes (20)

• Cardiovascular Death or New Myocardial Infarction

  Median follow-up of 3.5 years

• Transaortic gradient immediately post-TAVR (echocardiographically-derived vs. direct invasive measurement)

  Immediately post-TAVR

• Transaortic Gradient Reclassification

  Median follow-up of 3.5 years

• VARC-3 Hemodynamic Valve Deterioration Reclassification

  Median follow-up of 3.5 years

• Severe Patient Prosthesis Mismatch (PPM) Reclassification

  Median follow-up of 3.5 years

Study Arms (2)

Complete Revascularization

EXPERIMENTAL

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

Procedure: Percutaneous Coronary Intervention (PCI)

Medical Therapy Alone

NO INTERVENTION

No revascularization of coronary artery lesions.

Interventions

Percutaneous Coronary Intervention (PCI) PROCEDURE

PCI of all qualifying lesions.

Complete Revascularization

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• \- Symptomatic aortic valve stenosis prior to TAVR (NYHA Functional Class ≥ 2 OR Abnormal exercise test with severe SOB, abnormal BP response, or arrhythmia)
• AND
• \- CAD defined as: at least 1 coronary artery lesion of ≥70% visual angiographic diameter stenosis in a native segment ≥2.5 mm in diameter that is not a CTO and is amenable to treatment with PCI
• AND
• \- Consensus by the Local Multidisciplinary Heart Team that the patient is suitable for elective transfemoral TAVR with a balloon expandable transcatheter heart valve AND would receive a bypass with an anastomosis distal to the coronary artery lesion(s) if they were undergoing SAVR.
• Local Multidisciplinary Heart Teams are expected to follow current clinical guidelines for selection of patients for TAVR with an eligible patient generally expected to have:
• \[AVA ≤ 1.0 cm2 OR AVA index ≤ 0.6 cm2/m2\]
• \[Jet velocity ≥ 4.0 m/s OR mean gradient ≥ 40 mmHg\]
• patients without these criteria may undergo TAVR if the Local Multidisciplinary Heart Team concludes it is appropriate.
• AND
• \- Successful transfemoral TAVR, defined as the implantation of a single transcatheter aortic valve within the past 96 hours with freedom from more than minimal aortic insufficiency, stroke, or major vascular complications.

You may not qualify if:

• PCI already performed within 90 days prior to TAVR or at the same time as the index transfemoral TAVR procedure
• Planned PCI of coronary artery lesion(s)
• Planned surgical revascularization of coronary artery lesion(s)
• Non-cardiovascular co-morbidity reducing life expectancy to \< 5 years
• Any factor precluding 5-year follow-up
• Prior coronary artery bypass grafting surgery or surgical valve replacement
• Severe mitral regurgitation (\> 3+)
• Severe left ventricular dysfunction (LVEF \< 30%)
• Low coronary takeoff (high risk for coronary obstruction)
• Acute myocardial infarction within 90 days
• Stroke or transient ischemic attack within 90 days
• Renal insufficiency (eGFR \< 30 ml/min) and/or renal replacement Rx
• Hemodynamic or respiratory instability

Sponsors & Collaborators

• University of British Columbia: lead

Study Sites (72)

Huntsville Heart Center

Huntsville, Alabama, 35801, United States

RECRUITING

Arizona Cardiovascular Research

Phoenix, Arizona, 85027, United States

RECRUITING

Veteran Affairs Palo Alto Health Care System

Palo Alto, California, 94304, United States

RECRUITING

Loma Linda University

Redlands, California, 92373, United States

RECRUITING

Santa Barbara Cottage Hospital

Santa Barbara, California, 93105, United States

RECRUITING

Torrance Memorial Medical Center

Torrance, California, 90505, United States

RECRUITING

JFK Medical Center

Atlantis, Florida, 33462, United States

RECRUITING

Baptist Health Jacksonville

Jacksonville, Florida, 32207, United States

RECRUITING

Miami Cardiac and Vascular/Baptist Hospital

Miami, Florida, 33139, United States

RECRUITING

Piedmont

Atlanta, Georgia, 30309, United States

RECRUITING

Northeast Georgia Health System

Gainesville, Georgia, 30501, United States

RECRUITING

St. Alphonsus Regional Medical Center

Boise, Idaho, 83709, United States

RECRUITING

Ascension Alexian Brothers

Chicago, Illinois, 60007, United States

RECRUITING

Midwest Cardiovascular Research and Education Foundation

Elkhart, Indiana, 46514, United States

RECRUITING

Parkview Research Center

Fort Wayne, Indiana, 46845, United States

RECRUITING

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

RECRUITING

Midwest Heart and Vascular

Overland Park, Kansas, 66211, United States

RECRUITING

Cardiovascular Research Institute of Kansas

Wichita, Kansas, 64131, United States

RECRUITING

Tufts Medical

Boston, Massachusetts, 02111, United States

RECRUITING

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

RECRUITING

Sparrow Clinical Research Institute

Lansing, Michigan, 48912, United States

RECRUITING

William Beaumont Hospital

Royal Oak, Michigan, 48073, United States

RECRUITING

Ascension St. Mary's

Saginaw, Michigan, 48197, United States

RECRUITING

St. Joseph Mercy Health System

Ypsilanti, Michigan, 48197, United States

RECRUITING

University of Minnesota Medical Center

Minneapolis, Minnesota, 55455, United States

RECRUITING

CentraCare Heart and Vascular Center

Saint Cloud, Minnesota, 56303, United States

RECRUITING

Boone Hospital

Columbia, Missouri, 65201, United States

RECRUITING

St. Louis University

St Louis, Missouri, 63103, United States

RECRUITING

Missouri Baptist

St Louis, Missouri, 63131, United States

RECRUITING

Bryan Heart

Lincoln, Nebraska, 68506, United States

RECRUITING

Dartmouth Hitchcock Medical Center

Lebanon, New Hampshire, 03765, United States

RECRUITING

Our Lady of Lourdes

Camden, New Jersey, 08103, United States

RECRUITING

Valley Hospital

Ridgewood, New Jersey, 07450, United States

RECRUITING

University at Buffalo

Buffalo, New York, 14203, United States

RECRUITING

NYU Langone Hospital - Long Island

Mineola, New York, 11501, United States

RECRUITING

Mount Sinai

New York, New York, 10029, United States

RECRUITING

Columbia University Medical Center

New York, New York, 10552, United States

RECRUITING

St. Joseph's Hospital

Syracuse, New York, 13088, United States

RECRUITING

Montefiore Medical Center

The Bronx, New York, 10467, United States

RECRUITING

Novant Health Heart and Vascular Institute

Charlotte, North Carolina, 28204, United States

RECRUITING

Summa Health System

Akron, Ohio, 44304, United States

RECRUITING

Mount Carmel

Columbus, Ohio, 43213, United States

RECRUITING

Oklahoma Heart

Oklahoma City, Oklahoma, 73110, United States

RECRUITING

Kaiser Permanente Northwest

Clackamas, Oregon, 97015, United States

RECRUITING

Rhode Island Hospital

Providence, Rhode Island, 02903, United States

RECRUITING

Methodist Le Bonheur Healthcare

Germantown, Tennessee, 38138, United States

RECRUITING

Ballad Health CVA Heart Institute

Kingsport, Tennessee, 37660, United States

RECRUITING

Parkwest Medical Center

Knoxville, Tennessee, 37923, United States

RECRUITING

Cardiovascular Surgery Clinic/Baptist Memorial

Memphis, Tennessee, 38671, United States

RECRUITING

HCA Houston Healthcare Medical Center

Houston, Texas, 77004, United States

RECRUITING

Baylor Scott & White Plano

Plano, Texas, 75093, United States

RECRUITING

Baylor Scott & White Round Rock

Round Rock, Texas, 78665, United States

RECRUITING

University of Vermont Medical Center

Burlington, Vermont, 05401, United States

RECRUITING

Bellin Health System

Green Bay, Wisconsin, 54301, United States

RECRUITING

Ascension Columbia St. Mary's

Milwaukee, Wisconsin, 53211, United States

RECRUITING

University of Alberta, Mazankowski Heart Institute

Edmonton, Alberta, T6G 2B7, Canada

RECRUITING

Royal Columbian Hospital

New Westminster, British Columbia, V3L 3W7, Canada

RECRUITING

Vancouver General Hospital

Vancouver, British Columbia, V5Z 1M9, Canada

RECRUITING

Centre for Cardiovascular Innovation-Centre d'Innovation Cardiovasculaire (CCI-CIC)

Vancouver, British Columbia, V5Z1M9, Canada

NOT YET RECRUITING

St. Paul's Hospital

Vancouver, British Columbia, V6Z 1Y6, Canada

RECRUITING

Saint Boniface

Winnipeg, Manitoba, R2H 2A6, Canada

RECRUITING

New Brunswick Heart

Saint John, New Brunswick, E2L 4L2, Canada

RECRUITING

Queen Elizabeth II Health Sciences Centre

Halifax, Nova Scotia, B3H 3A7, Canada

RECRUITING

Hamilton Health Sciences

Hamilton, Ontario, L8L 2X2, Canada

RECRUITING

Ottawa Heart

Ottawa, Ontario, K1Y 4W7, Canada

RECRUITING

Sunnybrook Hospital

Toronto, Ontario, M4N 3M5, Canada

RECRUITING

St. Michael's Hospital

Toronto, Ontario, M5B 1W8, Canada

RECRUITING

Montréal Heart

Montreal, Quebec, H1T 1C8, Canada

RECRUITING

Centre Hospitalier de l'Université de Montréal

Montreal, Quebec, H2X 3E4, Canada

RECRUITING

Sacré-Coeur

Montreal, Quebec, H4J 1C4, Canada

RECRUITING

CIUSSS de l'Estrie-CHUS

Sherbrooke, Quebec, J1H 5H3, Canada

RECRUITING

Prairie Vascular

Regina, Saskatchewan, S4P 0W5, Canada

RECRUITING

MeSH Terms

Conditions

Aortic Valve Stenosis; Coronary Artery Disease; Coronary Stenosis

Interventions

Percutaneous Coronary Intervention

Condition Hierarchy (Ancestors)

Aortic Valve Disease; Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases; Ventricular Outflow Obstruction; Coronary Disease; Myocardial Ischemia; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Endovascular Procedures; Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Study Officials

• David A Wood, MD

  CCI-CIC, University of British Columbia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Brady J Robinson, CCRP

CONTACT

604-875-4111; brobinson@cci-cic.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 16, 2020
• First Posted: November 18, 2020
• Study Start: December 19, 2020
• Primary Completion: April 1, 2026
• Study Completion: April 1, 2026
• Last Updated: July 24, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

CA (17); US (55)