COMPASS Clinical Trial First Prospective Study to Compare Efficacy and Outcomes of Shunt Versus Stent for Neonates with Cyanotic Congenital Heart Disease
October 24, 2022
The Heart Institute at UPMC Children’s Hospital of Pittsburgh has completed site activation and is now recruiting patients in the multicenter COMPASS Trial, sponsored by the National Heart Lung and Blood Institute and Pediatric Heart Network. The COMPASS Trial – Comparison of Methods of Pulmonary Blood Flow Augmentation in Neonates: Shunt Versus Stent, is the first prospective, randomized clinical study designed to assess and characterize safety, efficacy, and outcomes in the use of either systemic-to-pulmonary artery shunt or ductal artery stent in neonates with ductal-dependent pulmonary blood flow.
Leading the trial in the Heart Institute at UPMC Children’s is Bryan H. Goldstein, MD, director of the Cardiac Catheterization Laboratory and site principal investigator for the study; surgical lead, Luciana Da Fonseca Da Silva, MD; CICU lead, Rod Ghassemzadeh, MD, and lead study coordinator, Niklas Gerhart.
Study participants who meet inclusion criteria and agree to randomization will be treated with either a transcatheter ductal artery stent or a systemic-to-pulmonary artery shunt. Patient care provided during the interventional or surgical procedure, and thereafter, will not be protocolized by the clinical trial but, rather, will be routine care as dictated by the UPMC Children’s clinical services and providers.
The primary outcome measures defined for this study are morbidity and mortality rates during the first year of life, comparing outcomes between shunt and stent participants.
“This study will provide a tremendous amount of information on the outcomes of shunt versus stent as initial palliation for neonates with cyanotic CHD,” says Dr. Goldstein. “Ultimately, findings from the COMPASS Trial will help us make more informed decisions and develop personalized plans of care – using gold-standard evidence – for patients based on many factors, such as birth weight, congenital heart lesion, vascular anatomy, and countless other parameters. I don’t think we’ll find that one therapy (a shunt or stent) is better across the board in all patients, but rather that in certain cases with certain variables, we can achieve the best possible outcome for a particular patient using a specific therapy.”
Participating centers will evaluate individual patients with ductal-dependent blood flow. This process will begin during fetal cardiac care, with counseling provided to potentially eligible patients to include a discussion regarding the COMPASS Trial. Postnatally, if a patient is eligible and the care team determines that either a transcatheter stent or surgical shunt procedure are equally viable, and if the patient's family agrees to participate in the study, then the patient will be randomized to receive either a stent or shunt. The treating center will then manage the care pathway for the study patient using their own standards of care and clinical guidelines.
As Dr. Goldstein explains, because of the design of the study and participating centers enrolling patients, numerous clinical outcomes and comparative findings will be generated by this study.
“We’ll be able to see patterns in the outcomes overall, but possibly also at the level of an individual center,” says Dr. Goldstein. “The study has such power that we’ll likely be exploring and following up on the initial data with further analyses and possibly additional investigations for years to come. It’s the kind of study that is quite difficult to perform for many reasons – we’ve been discussing the concepts behind this trial for at least 6 years now – but it is crucial to cementing the evidence behind the care using these two distinct interventions – which treatment strategy is best, and when, and under what circumstances, and the like."
Dr. Goldstein goes on to emphasize that the centers involved and the study teams conducting and controlling the trial are making an extra effort to partner with families and their young infants to thoroughly prepare them for participating in the trial.
“One of the ways in which we will do this is to closely partner with our fetal cardiology teams such that when a developing fetus is found to have congenital heart disease with probable ductal-dependent pulmonary blood flow, we can begin the evaluation and discussions of the trial with the family well in advance of birth. To the extent possible, we don't want families to have to make such difficult and critical decisions involving treatment options with information provided only after birth, let alone trying to consent them into a randomized clinical trial at the last minute," says Dr. Goldstein. "Our study coordinator, Niklas comes from a pediatric cardiology nursing background, so he has the skill set, knowledge base, and communication acumen to help families understand the clinical care and trial processes.”
Dr. Goldstein also credits pediatric cardiology Division Chief and Heart Institute co-director Jacqueline Kreutzer, MD, FACC, FSCAI, and Victor Morell, MD, Heart Institute co-director and Chief of Pediatric Cardiothoracic Surgery, with understanding the pivotal nature of this study and providing the necessary support to make UPMC Children’s one of the participating centers. “It is critical for our top-ranked Heart Institute at UPMC Children’s to participate in multicenter PHN-sponsored clinical trials,” says Drs. Kreutzer and Morell. “We are thrilled to be one of the first centers enrolling patients in the COMPASS trial. This is a major component of our strategy to lead the field in research and discovery here in Pittsburgh.”
Learn more about the study protocol and prior research by Dr. Goldstein and his colleagues at UPMC Children's and with the Congenital Cardiac Research Collaborative that provide much of the basis for this new randomized study, using the references and links below.
Study Reference and Further Reading
- Glatz AC, Petit CJ, Goldstein BH, Kelleman MS, McCracken CE, McDonnell A, Mascio C, Shashidharan S, Ligon RA, Ao J, Whiteside W, Wallen WJ, Metcalf CM, Aggarwal V, Agrawal H, Heinle JS, Qureshi AM. A Comparison Between Patent Ductus Arteriosus Stent and Modified Blalock-Taussig Shunt as Palliation for Infants With Ductal-Dependent Pulmonary Blood Flow: Insights From the Congenital Catheterization Research Collaborative. Circulation. 2018 Feb 6; 137(6): 589-601.
- Goldstein BH, Petit CJ, Qureshi AM, Dai D, Griffis HM, France A, Kelleman MS, McCracken CE, O’Byrne ML, Mascio CE, Shashidaran S, Ligon RA, Whiteside W, Wallen WJ, Agrawal H, Aggarwal V, Glatz AC. Differences in Cost of Care by Palliation Strategy for Infants With Ductal-Dependent Pulmonary Blood Flow: Results From a Multicenter Study of Patent Ductus Arteriosus Stent and Modified Blalock-Taussig Shunt. Circ Cardiovasc Interv. 2019 Apr; 12(4): e007232.
- Nasef MA, Shahbah DA, Batlivala SP, Darwich R, Qureshi AM, Breatnach CR, Linnane N, Walsh KP, Oslizlok P, McCrossan B, Momenah T, Alshahri A, Abdulhamed J, Arafat A, Tamimi OA, Diraneyya OM, Goldstein BH, Kenny D. Short- and Medium-term Outcomes for Patent Ductus Arteriosus Stenting in Neonates ≤ 2.5 kg With Duct-dependent Pulmonary Circulation. Catheter Cardiovasc Interv. 2022 Jul 29.
- Shahanavaz S, Qureshi AM, Petit CJ, Goldstein BH, Glatz AC, Bauser-Heaton HD, McCracken CE, Kelleman MS, Law MA, Nicholson GT, Zampi JD, Pettus J, Meadows J. Factors Influencing Reintervention Following Ductal Artery Stent Implantation for Ductal-Dependent Pulmonary Blood Flow: Results From the Congenital Cardiac Research Collaborative. Circ Cardiovasc Interv. 2021 Dec; 14(12): e010086.
- Qureshi AM,Goldstein BH, Glatz AC, Agrawal H, Aggarwal V, Ligon RA, McCracken C, McDonnell A, Buckey TM, Whiteside W, Metcalf CM, Petit CJ. Classification Scheme for Ductal Morphology in Cyanotic Patients With Ductal Dependent Pulmonary Blood Flow and Association With Outcomes of Patent Ductus Arteriosus Stenting. Catheter Cardiovasc Interv. 2019 Apr 1; 93(5): 933-943.
- Bauser-Heaton H, Qureshi AM, Goldstein BH, Glatz AC, Ligon RA, Gartenberg A, Aggarwal V, Shashidharan S, McCracken CE, Kelleman MS, Petit CJ Comparison of Patent Ductus Arteriosus Stent and Blalock-Taussig Shunt as Palliation for Neonates With Sole Source Ductal-Dependent Pulmonary Blood Flow: Results From the Congenital Catheterization Research Collaborative.Pediatr Cardiol. 2022 Jan; 43(1): 121-131.
