Optimal timing of staged percutaneous coronary intervention after subintimal tracking and re-entry: Rationale and design of the subintimal tracking and re-entry with deferred stenting study.
chronic total occlusion
percutaneous coronary intervention
quality of life
subintimal tracking and re‐entry
Journal
Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions
ISSN: 1522-726X
Titre abrégé: Catheter Cardiovasc Interv
Pays: United States
ID NLM: 100884139
Informations de publication
Date de publication:
24 Jul 2024
24 Jul 2024
Historique:
revised:
19
06
2024
received:
20
04
2024
accepted:
15
07
2024
medline:
24
7
2024
pubmed:
24
7
2024
entrez:
24
7
2024
Statut:
aheadofprint
Résumé
Ten to fifteen percent of chronic total occlusion (CTO) percutaneous coronary interventions (PCIs) are unsuccessful in contemporary practice. Subintimal tracking and re-entry (STAR) (one form of "investment procedure") with staged reattempt and stenting may further increase the ultimate success and safety of CTO as a bailout strategy. The optimal timing for staged stenting after STAR is unknown. We designed a six-center, prospective randomized trial with a planned enrollment of 150 patients where STAR is utilized in case of impending failure. The primary aim is to evaluate the optimal timing of the staged PCI after STAR by randomizing the timing to earlier (5-7 weeks) versus later (12-14 weeks) staged PCI. The primary endpoint of the study is the technical success rate of the staged procedure. The secondary endpoints include: (1) the rate of thrombolysis in myocardial infarction 3 flow at the start of staged intervention, (2) rate of partial technical and procedural success of the staged procedure, (3) rate of in-hospital and 12-month major cardiac and cerebrovascular adverse events, and (4) change in patient-reported quality at 30 days, 6 months, and 12 months assessed by Seattle Angina Questionnaire. This study will ascertain the optimal timing of staged stenting after bail-out STAR approach in contemporary CTO PCI (ClinicalTrials.gov NCT05089864).
Sections du résumé
BACKGROUND
BACKGROUND
Ten to fifteen percent of chronic total occlusion (CTO) percutaneous coronary interventions (PCIs) are unsuccessful in contemporary practice. Subintimal tracking and re-entry (STAR) (one form of "investment procedure") with staged reattempt and stenting may further increase the ultimate success and safety of CTO as a bailout strategy. The optimal timing for staged stenting after STAR is unknown.
METHODS AND RESULTS
RESULTS
We designed a six-center, prospective randomized trial with a planned enrollment of 150 patients where STAR is utilized in case of impending failure. The primary aim is to evaluate the optimal timing of the staged PCI after STAR by randomizing the timing to earlier (5-7 weeks) versus later (12-14 weeks) staged PCI. The primary endpoint of the study is the technical success rate of the staged procedure. The secondary endpoints include: (1) the rate of thrombolysis in myocardial infarction 3 flow at the start of staged intervention, (2) rate of partial technical and procedural success of the staged procedure, (3) rate of in-hospital and 12-month major cardiac and cerebrovascular adverse events, and (4) change in patient-reported quality at 30 days, 6 months, and 12 months assessed by Seattle Angina Questionnaire.
CONCLUSION
CONCLUSIONS
This study will ascertain the optimal timing of staged stenting after bail-out STAR approach in contemporary CTO PCI (ClinicalTrials.gov NCT05089864).
Banques de données
ClinicalTrials.gov
['NCT05089864']
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Subventions
Organisme : Asahi Intecc
Informations de copyright
© 2024 Wiley Periodicals LLC.
Références
Grantham JA, Marso SP, Spertus J, House J, Holmes Jr. DR, Rutherford BD. Chronic total occlusion angioplasty in the United States. JACC Cardiovasc Interv. 2009;2:479‐486.
Ybarra LF, Rinfret S, Brilakis ES, et al. Definitions and clinical trial design principles for coronary artery chronic total occlusion therapies: CTO‐ARC consensus recommendations. Circulation. 2021;143:479‐500.
Patel MR, Calhoon JH, Dehmer GJ, et al. ACC/AATS/AHA/ASE/ASNC/SCAI/SCCT/STS 2017 appropriate use criteria for coronary revascularization in patients with stable ischemic heart disease: a report of the American College of Cardiology Appropriate Use Criteria Task Force,Cardiology Appropriate Use Criteria Task Force, American Association for Thoracic Surgery, American Heart Association, American Society of Echocardiography, American Society of Nuclear Cardiology, Society for Cardiovascular Angiography and Interventions, Society of Cardiovascular Computed Tomography, and Society of Thoracic Surgeons. J Am Coll Cardiol. 2017;69:2212‐2241.
Sapontis J, Hirai T, Patterson C, et al. Intermediate procedural and health status outcomes and the clinical care pathways after chronic total occlusion angioplasty: a report from the OPEN‐CTO (outcomes, patient health status, and efficiency in chronic total occlusion hybrid procedures) study. Catheter Cardiovasc Interv. 2021;98:626‐635.
Hirai T, Nicholson WJ, Sapontis J, et al. A detailed analysis of perforations during chronic total occlusion angioplasty. JACC Cardiovasc Interv. 2019;12:1902‐1912.
Brilakis ES, Grantham JA, Rinfret S, et al. A percutaneous treatment algorithm for crossing coronary chronic total occlusions. JACC Cardiovasc Interv. 2012;5:367‐379.
Hirai T, Grantham JA, Sapontis J, et al. Impact of subintimal plaque modification procedures on health status after unsuccessful chronic total occlusion angioplasty. Catheter Cardiovasc Interv. 2018;91:1035‐1042.
Hall AB, Brilakis ES. Hybrid 2.0: Subintimal plaque modification for facilitation of future success in chronic total occlusion percutaneous coronary intervention. Catheter Cardiovasc Interv. 2019;93:199‐201.
Hirai T, Grantham JA, Gosch KL, et al. Impact of subintimal or plaque modification on repeat chronic total occlusion angioplasty following an unsuccessful attempt. JACC Cardiovasc Interv. 2020;13:1010‐1012.
Colombo A, Mikhail GW, Michev I, et al. Treating chronic total occlusions using subintimal tracking and reentry: the STAR technique. Catheter Cardiovasc Interv. 2005;64:407‐411
discussion 412.
Galassi AR, Tomasello SD, Costanzo L, et al. Mini‐STAR as bail‐out strategy for percutaneous coronary intervention of chronic total occlusion. Catheter Cardiovasc Interv. 2012;79:30‐40.
Azzalini L, Carlino M, Brilakis ES, et al. Subadventitial techniques for chronic total occlusion percutaneous coronary intervention: the concept of “vessel architecture”. Catheter Cardiovasc Interv. 2018;91:725‐734.
Visconti G, Focaccio A, Donahue M, Briguori C. Elective versus deferred stenting following subintimal recanalization of coronary chronic total occlusions. Catheter Cardiovasc Interv. 2015;85:382‐390.
Azzalini L, Karmpaliotis D, Santiago R, et al. Contemporary issues in chronic total occlusion percutaneous coronary intervention. JACC: Cardiovascular Interventions. 2022;15:1‐21.
Goleski PJ, Nakamura K, Liebeskind E, et al. Revascularization of coronary chronic total occlusions with subintimal tracking and reentry followed by deferred stenting: experience from a high‐volume referral center. Catheter Cardiovasc Interv. 2019;93:191‐198.
Chan PS, Jones PG, Arnold SA, Spertus JA. Development and validation of a short version of the Seattle angina questionnaire. Circ Cardiovasc Qual Outcomes. 2014;7:640‐647.
Spertus JA, Winder JA, Dewhurst TA, et al. Development and evaluation of the Seattle Angina Questionnaire: a new functional status measure for coronary artery disease. J Am Coll Cardiol. 1995;25:333‐341.
Spertus JA, Winder JA, Dewhurst TA, Deyo RA, Fihn SD. Monitoring the quality of life in patients with coronary artery disease. Am J Cardiol. 1994;74:1240‐1244.
Mozaffarian D, Bryson CL, Spertus JA, McDonell MB, Fihn SD. Anginal symptoms consistently predict total mortality among outpatients with coronary artery disease. Am Heart J. 2003;146:1015‐1022.
Spertus JA, Jones P, McDonell M, Fan V, Fihn SD. Health status predicts long‐term outcome in outpatients with coronary disease. Circulation. 2002;106:43‐49.
Arnold SV, Kosiborod M, Li Y, et al. Comparison of the Seattle Angina Questionnaire with daily angina diary in the TERISA Clinical Trial. Circ Cardiovasc Qual Outcomes. 2014;7:844‐850.
Xenogiannis I, Choi JW, Alaswad K, et al. Outcomes of subintimal plaque modification in chronic total occlusion percutaneous coronary intervention. Catheter Cardiovasc Interv. 2019;96(5):1029‐1035.
Øksnes A, Skaar E, Engan B, et al. Effectiveness, safety, and patient reported outcomes of a planned investment procedure in higher‐risk chronic total occlusion percutaneous coronary intervention: Rationale and design of the invest‐CTO study. Catheter Cardiovasc Interv. 2023;102:71‐79.