TY - JOUR
T1 - Definitions and Clinical Trial Design Principles for Coronary Artery Chronic Total Occlusion Therapies
T2 - CTO-ARC Consensus Recommendations
AU - Ybarra, Luiz F.
AU - Rinfret, Stéphane
AU - Brilakis, Emmanouil S.
AU - Karmpaliotis, Dimitri
AU - Azzalini, Lorenzo
AU - Grantham, J. Aaron
AU - Kandzari, David E.
AU - Mashayekhi, Kambis
AU - Spratt, James C.
AU - Wijeysundera, Harindra C.
AU - Ali, Ziad A.
AU - Buller, Christopher E.
AU - Carlino, Mauro
AU - Cohen, David J.
AU - Cutlip, Donald E.
AU - De Martini, Tony
AU - Di Mario, Carlo
AU - Farb, Andrew
AU - Finn, Aloke V.
AU - Galassi, Alfredo R.
AU - Gibson, C. Michael
AU - Hanratty, Colm
AU - Hill, Jonathan M.
AU - Jaffer, Farouc A.
AU - Krucoff, Mitchell W.
AU - Lombardi, William L.
AU - Maehara, Akiko
AU - Magee, P. F.Adrian
AU - Mehran, Roxana
AU - Moses, Jeffrey W.
AU - Nicholson, William J.
AU - Onuma, Yoshinobu
AU - Sianos, Georgios
AU - Sumitsuji, Satoru
AU - Tsuchikane, Etsuo
AU - Virmani, Renu
AU - Walsh, Simon J.
AU - Werner, Gerald S.
AU - Yamane, Masahisa
AU - Stone, Gregg W.
AU - Rinfret, Stéphane
AU - Stone, Gregg W.
N1 - Publisher Copyright:
© 2021 Lippincott Williams and Wilkins. All rights reserved.
PY - 2021/2/2
Y1 - 2021/2/2
N2 - Over the past 2 decades, chronic total occlusion (CTO) percutaneous coronary intervention has developed into its own subspecialty of interventional cardiology. Dedicated terminology, techniques, devices, courses, and training programs have enabled progressive advancements. However, only a few randomized trials have been performed to evaluate the safety and efficacy of CTO percutaneous coronary intervention. Moreover, several published observational studies have shown conflicting data. Part of the paucity of clinical data stems from the fact that prior studies have been suboptimally designed and performed. The absence of standardized end points and the discrepancy in definitions also prevent consistency and uniform interpretability of reported results in CTO intervention. To standardize the field, we therefore assembled a broad consortium comprising academicians, practicing physicians, researchers, medical society representatives, and regulators (US Food and Drug Administration) to develop methods, end points, biomarkers, parameters, data, materials, processes, procedures, evaluations, tools, and techniques for CTO interventions. This article summarizes the effort and is organized into 3 sections: key elements and procedural definitions, end point definitions, and clinical trial design principles. The Chronic Total Occlusion Academic Research Consortium is a first step toward improved comparability and interpretability of study results, supplying an increasingly growing body of CTO percutaneous coronary intervention evidence.
AB - Over the past 2 decades, chronic total occlusion (CTO) percutaneous coronary intervention has developed into its own subspecialty of interventional cardiology. Dedicated terminology, techniques, devices, courses, and training programs have enabled progressive advancements. However, only a few randomized trials have been performed to evaluate the safety and efficacy of CTO percutaneous coronary intervention. Moreover, several published observational studies have shown conflicting data. Part of the paucity of clinical data stems from the fact that prior studies have been suboptimally designed and performed. The absence of standardized end points and the discrepancy in definitions also prevent consistency and uniform interpretability of reported results in CTO intervention. To standardize the field, we therefore assembled a broad consortium comprising academicians, practicing physicians, researchers, medical society representatives, and regulators (US Food and Drug Administration) to develop methods, end points, biomarkers, parameters, data, materials, processes, procedures, evaluations, tools, and techniques for CTO interventions. This article summarizes the effort and is organized into 3 sections: key elements and procedural definitions, end point definitions, and clinical trial design principles. The Chronic Total Occlusion Academic Research Consortium is a first step toward improved comparability and interpretability of study results, supplying an increasingly growing body of CTO percutaneous coronary intervention evidence.
KW - clinical trial protocols as topic
KW - clinical trials as topic
KW - coronary occlusion
KW - endpoint determination
KW - myocardial revascularization
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U2 - 10.1161/CIRCULATIONAHA.120.046754
DO - 10.1161/CIRCULATIONAHA.120.046754
M3 - Article
C2 - 33523728
AN - SCOPUS:85099872643
SN - 0009-7322
VL - 143
SP - 479
EP - 500
JO - Circulation
JF - Circulation
IS - 5
ER -