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

A Randomized, Comparative Effectiveness Study of Staged Complete Revascularization With Percutaneous Coronary Intervention to Treat Coronary Artery Disease vs Medical Management Alone in Patients With Symptomatic Aortic Valve Stenosis Undergoing Elective Transfemoral Transcatheter Aortic Valve Replacement: The COMPLETE TAVR Study

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.

Study Overview

• Status: Recruiting
• Conditions: Coronary Artery Disease; Aortic Stenosis; Coronary Stenosis
• Intervention / Treatment: Procedure: Percutaneous Coronary Intervention (PCI)

• Study Type: Interventional
• Enrollment (Estimated): 4000
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Brady J Robinson, CCRP; Phone Number: 22936 604-875-4111; Email: brobinson@cci-cic.org

Study Locations

• Canada
  • Alberta
    • Edmonton, Alberta, Canada, T6G 2B7
      • Recruiting
      • University of Alberta, Mazankowski Heart Institute
      • Contact: Robert Welsh, MD
  • British Columbia
    • New Westminster, British Columbia, Canada, V3L 3W7
      • Recruiting
      • Royal Columbian Hospital
      • Contact: Albert Chan, MD
    • Vancouver, British Columbia, Canada, V6Z 1Y6
      • Recruiting
      • St. Paul's Hospital
      • Contact: Elizabeth Grieve; Phone Number: 64980 604-682-2344
    • Vancouver, British Columbia, Canada, V5Z 1M9
      • Recruiting
      • Vancouver General Hospital
      • Contact: Jackie Chow; Phone Number: 604-875-5324
    • Vancouver, British Columbia, Canada, V5Z1M9
      • Not yet recruiting
      • Centre for Cardiovascular Innovation-Centre d'Innovation Cardiovasculaire (CCI-CIC)
      • Contact: Brady J Robinson, CCRP; Phone Number: 22936 604-875-4111; Email: brobinson@cci-cic.org
      • Principal Investigator: David A Wood, MD
  • Manitoba
    • Winnipeg, Manitoba, Canada, R2H 2A6
      • Recruiting
      • Saint Boniface
      • Contact: Malek Kass, MD
  • New Brunswick
    • Saint John, New Brunswick, Canada, E2L 4L2
      • Recruiting
      • New Brunswick Heart
      • Contact: Brent McGrath, MD
  • Nova Scotia
    • Halifax, Nova Scotia, Canada, B3H 3A7
      • Recruiting
      • Queen Elizabeth II Health Sciences Centre
      • Contact: Osama Elkhateeb, MD
  • Ontario
    • Hamilton, Ontario, Canada, L8L 2X2
      • Recruiting
      • Hamilton Health Sciences
      • Contact: Tej Sheth, MD
    • Ottawa, Ontario, Canada, K1Y 4W7
      • Recruiting
      • Ottawa Heart
      • Contact: Sandy Dick, MD
    • Toronto, Ontario, Canada, M5B 1W8
      • Recruiting
      • St. Michael's Hospital
      • Contact: Neil Fam, MD
    • Toronto, Ontario, Canada, M4N 3M5
      • Recruiting
      • Sunnybrook Hospital
      • Contact: Sam Radhakrishnan
  • Quebec
    • Montréal, Quebec, Canada, H2X 3E4
      • Recruiting
      • Centre hospitalier de l'Université de Montréal
      • Contact: Jean Bernard Masson
    • Montréal, Quebec, Canada, H1T 1C8
      • Recruiting
      • Montreal Heart
      • Contact: Anita Asgar, MD
    • Montréal, Quebec, Canada, H4J 1C4
      • Recruiting
      • Sacré-Coeur
      • Contact: Rémi Kouz, MD
    • Sherbrooke, Quebec, Canada, J1H 5H3
      • Recruiting
      • CIUSSS de l'Estrie-CHUS
      • Contact: Benoit Daneault, MD
  • Saskatchewan
    • Regina, Saskatchewan, Canada, S4P 0W5
      • Recruiting
      • Prairie Vascular
      • Contact: Payam Dehghani, MD
• United States
  • Alabama
    • Huntsville, Alabama, United States, 35801
      • Recruiting
      • Huntsville Heart Center
      • Contact: Alex Vasquez, MD
  • Arizona
    • Phoenix, Arizona, United States, 85027
      • Recruiting
      • Arizona Cardiovascular Research
      • Contact: Hursh Naik, MD
  • California
    • Palo Alto, California, United States, 94304
      • Recruiting
      • Veteran Affairs Palo Alto Health Care System
      • Contact: Celina Yong, MD
    • Redlands, California, United States, 92373
      • Recruiting
      • Loma Linda University
      • Contact: Ken Jutzy, MD
    • Santa Barbara, California, United States, 93105
      • Recruiting
      • Santa Barbara Cottage Hospital
      • Contact: Michael Shenoda, MD
    • Torrance, California, United States, 90505
      • Recruiting
      • Torrance Memorial Medical Center
      • Contact: Salman Azam, MD
  • Florida
    • Atlantis, Florida, United States, 33462
      • Recruiting
      • JFK Medical Center
      • Contact: Mark Rothenberg, MD
    • Jacksonville, Florida, United States, 32207
      • Recruiting
      • Baptist Health Jacksonville
      • Contact: Sidd Wayangankar, MD
    • Miami, Florida, United States, 33139
      • Recruiting
      • Miami Cardiac and Vascular/Baptist Hospital
      • Contact: Ramon Quesada
  • Georgia
    • Atlanta, Georgia, United States, 30309
      • Recruiting
      • Piedmont
      • Contact: Pradeep Yadav, MD
    • Gainesville, Georgia, United States, 30501
      • Recruiting
      • Northeast Georgia Health System
      • Contact: Ronnie Ramadan
  • Idaho
    • Boise, Idaho, United States, 83709
      • Recruiting
      • St. Alphonsus Regional Medical Center
      • Contact: Joseph Walsh, MD
  • Illinois
    • Chicago, Illinois, United States, 60007
      • Recruiting
      • Ascension Alexian Brothers
      • Contact: Andrei Pop, MD
  • Indiana
    • Elkhart, Indiana, United States, 46514
      • Recruiting
      • Midwest Cardiovascular Research and Education Foundation
      • Contact: Troy Weirick, MD
    • Fort Wayne, Indiana, United States, 46845
      • Recruiting
      • Parkview Research Center
      • Contact: Roy W Robertson, MD
  • Kansas
    • Kansas City, Kansas, United States, 66160
      • Recruiting
      • University Of Kansas Medical Center
      • Contact: Peter Tadros, MD
    • Overland Park, Kansas, United States, 66211
      • Recruiting
      • Midwest Heart and Vascular
      • Contact: Bangalore Deepak, MD
    • Wichita, Kansas, United States, 64131
      • Recruiting
      • Cardiovascular Research Institute of Kansas
      • Contact: Bassem Chehab, MD
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Recruiting
      • Massachusetts General Hospital
      • Contact: Nilay Patel, MD
    • Boston, Massachusetts, United States, 02111
      • Recruiting
      • Tufts Medical
      • Contact: Charles Resor, MD
  • Michigan
    • Lansing, Michigan, United States, 48912
      • Recruiting
      • Sparrow Clinical Research Institute
      • Contact: Mohammad Qintar, MD
    • Royal Oak, Michigan, United States, 48073
      • Recruiting
      • William Beaumont Hospital
      • Contact: Amr Abbas, MD
    • Saginaw, Michigan, United States, 48197
      • Recruiting
      • Ascension St. Mary's
      • Contact: Safwan Kassas, MD
    • Ypsilanti, Michigan, United States, 48197
      • Recruiting
      • St. Joseph Mercy Health System
      • Contact: Mansoor A Qureshi, MD
  • Minnesota
    • Minneapolis, Minnesota, United States, 55455
      • Recruiting
      • University of Minnesota Medical Center
      • Contact: Gregory Helmer, MD
    • Saint Cloud, Minnesota, United States, 56303
      • Recruiting
      • Centracare Heart and Vascular Center
      • Contact: Thom Dahle, MD
  • Missouri
    • Columbia, Missouri, United States, 65201
      • Recruiting
      • Boone Hospital
      • Contact: Joss Fernandez, MD
    • Saint Louis, Missouri, United States, 63103
      • Recruiting
      • St. Louis University
      • Contact: Kishore Harjai, MD
    • Saint Louis, Missouri, United States, 63131
      • Recruiting
      • Missouri Baptist
      • Contact: Gus Theodos, MD
  • Nebraska
    • Lincoln, Nebraska, United States, 68506
      • Recruiting
      • Bryan Heart
      • Contact: Matthew Johnson, MD
  • New Hampshire
    • Lebanon, New Hampshire, United States, 03765
      • Recruiting
      • Dartmouth Hitchcock Medical Center
      • Contact: James DeVries, MD
  • New Jersey
    • Camden, New Jersey, United States, 08103
      • Recruiting
      • Our Lady of Lourdes
      • Contact: Ibrahim Moussa, MD
    • Ridgewood, New Jersey, United States, 07450
      • Recruiting
      • Valley Hospital
      • Contact: Raj Tayal, MD
  • New York
    • Bronx, New York, United States, 10467
      • Recruiting
      • Montefiore Medical Center
      • Contact: Mark Menegus, MD
    • Buffalo, New York, United States, 14203
      • Recruiting
      • University at Buffalo
      • Contact: Vijay Iyer, MD
    • Mineola, New York, United States, 11501
      • Recruiting
      • NYU Langone Hospital - Long Island
      • Contact: Richard Schwartz, DO
    • New York, New York, United States, 10029
      • Recruiting
      • Mount Sinai
      • Contact: Samin Sharma, MD
    • New York, New York, United States, 10552
      • Recruiting
      • Columbia University Medical Center
      • Contact: Vivian Ng, MD
    • Syracuse, New York, United States, 13088
      • Recruiting
      • St. Joseph's Hospital
      • Contact: Ayman Iskander, MD
  • North Carolina
    • Charlotte, North Carolina, United States, 28204
      • Recruiting
      • Novant Health Heart and Vascular Institute
      • Contact: Oluseun Alli, MD
  • Ohio
    • Akron, Ohio, United States, 44304
      • Recruiting
      • Summa Health System
      • Contact: Peter Bittenbender, MD
    • Columbus, Ohio, United States, 43213
      • Recruiting
      • Mount Carmel
      • Contact: Noah Jones, MD
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73110
      • Recruiting
      • Oklahoma Heart
      • Contact: Mohammad Ghani, MD
  • Oregon
    • Clackamas, Oregon, United States, 97015
      • Recruiting
      • Kaiser Permanente Northwest
      • Contact: Abhimanyu Uberoi
  • Rhode Island
    • Providence, Rhode Island, United States, 02903
      • Recruiting
      • Rhode Island Hospital
      • Contact: Paul Gordon, MD
  • Tennessee
    • Germantown, Tennessee, United States, 38138
      • Recruiting
      • Methodist Le Bonheur Healthcare
      • Contact: Mehul Patel, MD
    • Kingsport, Tennessee, United States, 37660
      • Recruiting
      • Ballad Health CVA Heart Institute
      • Contact: Mark Aziz, MD
    • Knoxville, Tennessee, United States, 37923
      • Recruiting
      • Parkwest Medical Center
      • Contact: Ayaz Rahman, MD
    • Memphis, Tennessee, United States, 38671
      • Recruiting
      • Cardiovascular Surgery Clinic/Baptist Memorial
      • Contact: Basil Paulus, MD
  • Texas
    • Houston, Texas, United States, 77004
      • Recruiting
      • HCA Houston Healthcare Medical Center
      • Contact: Pranav Loyalka, MD
    • Plano, Texas, United States, 75093
      • Recruiting
      • Baylor Scott & White Plano
      • Contact: Srini Potluri, MD
    • Round Rock, Texas, United States, 78665
      • Recruiting
      • Baylor Scott & White Round Rock
      • Contact: Jose Condado, MD
  • Vermont
    • Burlington, Vermont, United States, 05401
      • Recruiting
      • University of Vermont Medical Center
      • Contact: Tanush Gupta, MD
  • Wisconsin
    • Green Bay, Wisconsin, United States, 54301
      • Recruiting
      • Bellin Health System
      • Contact: Jason Ricci
    • Milwaukee, Wisconsin, United States, 53211
      • Recruiting
      • Ascension Columbia St. Mary's
      • Contact: Brad Stair, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

- 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]

OR

[Jet velocity ≥ 4.0 m/s OR mean gradient ≥ 40 mmHg]

OR

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.

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Complete Revascularization; Routine PCI (percutaneous coronary intervention) of all suitable coronary artery stenoses of ≥70% in vessels ≥2.5mm in diameter.	Procedure: Percutaneous Coronary Intervention (PCI); PCI of all qualifying lesions.
No Intervention: Medical Therapy Alone; No revascularization of coronary artery lesions.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cardiovascular Death or New Myocardial Infarction	Deaths will be classified as cardiovascular or non-cardiovascular. All deaths with a clear cardiovascular or unknown cause, will be classified as cardiovascular. However, within cardiovascular deaths, hemorrhagic deaths will be clearly identified. Only deaths due to a documented non-cardiovascular cause (e.g., cancer) will be classified as non-cardiovascular. Myocardial Infarction will be defined according to the 4th Universal Definition of Myocardial Infarction, with modification for Type 4a (PCI-related) and Type 5 (CABG-related) as defined for the ISCHEMIA trial and as used in the COMPLETE trial.	Median follow-up of 3.5 years
Transaortic gradient immediately post-TAVR (echocardiographically-derived vs. direct invasive measurement)		Immediately post-TAVR
Transaortic Gradient Reclassification	Proportion of patients developing echocardiographic aortic gradient ≥20 mmHg who are found to have a gradient < 20 mmHg on direct hemodynamic assessment.	Median follow-up of 3.5 years
VARC-3 Hemodynamic Valve Deterioration Reclassification	Proportion of patients developing ≥ moderate echocardiographic VARC-3 valve deterioration reclassified to < moderate VARC-3 valve deterioration using direct invasive methods, including mean gradient and valve area.	Median follow-up of 3.5 years
Severe Patient Prosthesis Mismatch (PPM) Reclassification	Proportion of patients with echocardiographic severe PPM immediately post-TAVR, reclassified as non-severe PPM using direct invasive methods.	Median follow-up of 3.5 years
Composite of CV Death, New MI, IDR or Hospitalization for UA or for HF in patients with PPM and elevated gradients vs those without	Deaths: will be classified as cardiovascular or non-cardiovascular. All deaths with a clear cardiovascular or unknown cause, will be classified as cardiovascular. However, within cardiovascular deaths, hemorrhagic deaths will be clearly identified. Only deaths due to a documented non-cardiovascular cause (e.g., cancer) will be classified as non-cardiovascular. Myocardial Infarction: will be defined according to the 4th Universal Definition of Myocardial Infarction, with modification for Type 4a (PCI-related) and Type 5 (CABG-related) as defined for the ISCHEMIA trial and as used in the COMPLETE trial. Hospital admission: for protocol-defined unstable angina, new/worsening NYHA Class IV heart failure, or for protocol-defined Ischemia-driven revascularization, among patients with patient prosthesis mismatch (PPM), elevated echocardiography-derived transaortic gradients and elevated direct invasive transaortic gradient vs those without.	Median follow-up of 3.5 years
Composite outcome of mean echocardiographic gradient ≥ 20mmHg, severe PPM, ≥ moderate AR, thrombosis, endocarditis, and aortic valve re-intervention		Median follow-up of 3.5 years
Cardiovascular Death		Median follow-up of 3.5 years
New Myocardial Infarction		Median follow-up of 3.5 years
Ischemia-Driven Revascularization		Median follow-up of 3.5 years
Hospitalization for Unstable Angina or Heart Failure		Median follow-up of 3.5 years
All-cause Mortality	Includes deaths from both cardiac and non-cardiac causes	Median follow-up of 3.5 years
Stroke	Defined as the presence of a new focal neurologic deficit thought to be vascular in origin, with signs or symptoms lasting more than 24 hours. It is strongly recommended (but not required) that an imaging procedure such as CT scan or MRI be performed. Stroke will be further classified as ischemic, hemorrhagic or type uncertain.	Median follow-up of 3.5 years
Bleeding	Clinically overt, symptomatic bleeding with at least one of the following criteria: Fatal, or; Symptomatic intracranial hemorrhage, or; Retroperitoneal hemorrhage, or; Intraocular hemorrhage leading to significant vision loss, or; Decrease in hemoglobin of 3.0 g/dL (with each blood transfusion unit counting for 1.0 g/dL of Hb) or requiring transfusion of two or more units of red blood cells or equivalent of whole blood.; Requiring surgical intervention to stop the bleeding	Median follow-up of 3.5 years
Angina status	As evaluated by the Seattle Angina Questionnaire	Median follow-up of 3.5 years
Economic evaluation	Includes health resource utilization, costs, and cost-effectiveness	Median follow-up of 3.5 years
Patient-reported outcomes	Health-related quality of life as evaluated by the Kansas City Cardiomyopathy Questionnaire at baseline, 30 days, 6 months, 1 year, and annually thereafter.	Median follow-up of 3.5 years
Contrast-associated acute kidney injury	An absolute rise in serum creatinine of greater than or equal to 44 μmol/L from baseline and/or a relative rise in serum creatinine of ≥25% compared to baseline at any time between 48hrs and 96hrs post-procedure.	Median follow-up of 3.5 years
Fluoroscopic time for Staged PCI procedure	Total time under fluoroscopy	During PCI procedure
Contrast Utilization for Stages PCI Procedure		During PCI procedure

Collaborators and Investigators

• Sponsor: University of British Columbia
• Investigators: Principal Investigator: David A Wood, MD, CCI-CIC, University of British Columbia

Study record dates

Study Major Dates

• Study Start (Actual): December 19, 2020
• Primary Completion (Estimated): April 1, 2026
• Study Completion (Estimated): April 1, 2026

Study Registration Dates

• First Submitted: November 16, 2020
• First Submitted That Met QC Criteria: November 17, 2020
• First Posted (Actual): November 18, 2020

Study Record Updates

• Last Update Posted (Actual): July 24, 2025
• Last Update Submitted That Met QC Criteria: July 22, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Keywords: Coronary Artery Disease; Percutaneous Coronary Intervention; Aortic Stenosis; Transcatheter Aortic Valve Replacement
• Additional Relevant MeSH Terms: Aortic Valve Disease; Vascular Diseases; Cardiovascular Diseases; Pathological Conditions, Anatomical; Heart Diseases; Heart Valve Diseases; Ventricular Outflow Obstruction; Arteriosclerosis; Arterial Occlusive Diseases; Aortic Valve Stenosis; Constriction, Pathologic; Coronary Artery Disease; Coronary Stenosis; Myocardial Ischemia; Coronary Disease
• Other Study ID Numbers: H20-00968

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No