TY - JOUR
T1 - Randomized Comparison of a CrossBoss First Versus Standard Wire Escalation Strategy for Crossing Coronary Chronic Total Occlusions
T2 - The CrossBoss First Trial
AU - Karacsonyi, Judit
AU - Tajti, Peter
AU - Rangan, Bavana V.
AU - Halligan, Sean C.
AU - Allen, Raymond H.
AU - Nicholson, William J.
AU - Harvey, James E.
AU - Spaedy, Anthony J.
AU - Jaffer, Farouc A.
AU - Grantham, J. Aaron
AU - Salisbury, Adam
AU - Hart, Anthony J.
AU - Safley, David M.
AU - Lombardi, William L.
AU - Hira, Ravi
AU - Don, Creighton
AU - McCabe, James M.
AU - Burke, M. Nicholas
AU - Alaswad, Khaldoon
AU - Koenig, Gerald C.
AU - Sanghvi, Kintur A.
AU - Ice, Daniel
AU - Kovach, Richard C.
AU - Varghese, Vincent
AU - Murad, Bilal
AU - Baran, Kenneth W.
AU - Resendes, Erica
AU - Martinez-Parachini, Jose R.
AU - Karatasakis, Aris
AU - Danek, Barbara A.
AU - Iwnetu, Rahel
AU - Roesle, Michele
AU - Khalili, Houman
AU - Banerjee, Subhash
AU - Brilakis, Emmanouil S.
N1 - Funding Information:
The CrossBoss First trial was a multicenter, randomized trial conducted at 11 centers. The trial was funded by Boston Scientific. All authors vouch for the accuracy and completeness of the data and the analyses, as well as for the fidelity of this report to the trial protocol. The trial was approved by the institutional review board of each participating site and all patients provided written informed consent. An independent Data Safety Monitoring Board provided additional trial oversight.
Funding Information:
This work was supported by a research grant from Boston Scientific. Dr. Rangan has received research grant support from InfraReDx and Spectranetics. Dr. Halligan has received consulting fees from Abbott Vascular and Boston Scientific. Dr. Nicholson has served on the advisory board and Speakers Bureau as well as a proctor for Abbott Vascular, Boston Scientific, Asahi Intecc, and Medtronic; and has served as a proctor and consultant for and owns intellectual property in Vascular Solutions. Dr. Harvey has served as a consultant and on the advisory board for Boston Scientific. Dr. Spaedy has served as a consultant for Abbott Vascular, Medtronic, and Boston Scientific. Dr. Jaffer has served as a consultant for Abbott Vascular and Boston Scientific; and has received research grant support from Canon, Siemens, and the National Institutes of Health. Dr. Grantham has received research grant support from and served on the advisory board for Boston Scientific; has received speaking fees and honoraria from Boston Scientific and Abbott Vascular; and is a part-time employee of and owns equity in Corindus. Dr. Salisbury has received research grant support from Boston Scientific and Gilead. Dr. Hira has served as a consultant for Abbott Vascular. Dr. Lombardi owns equity in BridgePoint Medical. Dr. Alaswad has received consulting fees from Terumo and Boston Scientific; and has served as a consultant for Abbott Laboratories. Dr. Murad has served as a proctor for CTO PCI for Boston Scientific. Dr. Banerjee has received research grant support from Gilead and The Medicines Company; has received institutional research grants from Boston Scientific and Merck; has received consultant and speaker honoraria from Covidien, Gore, Janssen, AstraZeneca, Cardiovascular Systems, Inc., and Medtronic; and has ownership in MDCARE Global (spouse) and intellectual property in HygeiaTel. Dr. Brilakis has received consulting and speaker honoraria from Abbott Vascular, Amgen, Asahi, Cardiovascular Systems, Inc., Elsevier, GE Healthcare, and Medicure; has received research grant support from Boston Scientific and Osprey; and his spouse was an employee of Medtronic. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
Publisher Copyright:
© 2018 American College of Cardiology Foundation
PY - 2018/2/12
Y1 - 2018/2/12
N2 - Objectives: The authors performed a multicenter, randomized-controlled, clinical trial comparing upfront use of the CrossBoss catheter versus antegrade wire escalation for antegrade crossing of coronary chronic total occlusions. Background: There is equipoise about the optimal initial strategy for crossing coronary chronic total occlusions. Methods: The primary endpoints were the time required to cross the chronic total occlusion or abort the procedure and the frequency of procedural major adverse cardiovascular events. The secondary endpoints were technical and procedural success, total procedure time, fluoroscopy time required to cross and total fluoroscopy time, total air kerma radiation dose, total contrast volume, and equipment use. Results: Between 2015 and 2017, 246 patients were randomized to the CrossBoss catheter (n = 122) or wire escalation (n = 124) at 11 U.S. centers. The baseline clinical and angiographic characteristics of the study groups were similar. Technical and procedural success were 87.8% and 84.1%, respectively, and were similar in the 2 groups. Crossing time was similar: 56 min (interquartile range: 33 to 93 min) in the CrossBoss group and 66 min (interquartile range: 36 to 105 min) in the wire escalation group (p = 0.323), as was as the incidence of procedural major adverse cardiovascular events (3.28% vs. 4.03%; p = 1.000). There were no significant differences in the secondary study endpoints. Conclusions: As compared with wire escalation, upfront use of the CrossBoss catheter for antegrade crossing of coronary chronic total occlusions was associated with similar crossing time, similar success and complication rates, and similar equipment use and cost.
AB - Objectives: The authors performed a multicenter, randomized-controlled, clinical trial comparing upfront use of the CrossBoss catheter versus antegrade wire escalation for antegrade crossing of coronary chronic total occlusions. Background: There is equipoise about the optimal initial strategy for crossing coronary chronic total occlusions. Methods: The primary endpoints were the time required to cross the chronic total occlusion or abort the procedure and the frequency of procedural major adverse cardiovascular events. The secondary endpoints were technical and procedural success, total procedure time, fluoroscopy time required to cross and total fluoroscopy time, total air kerma radiation dose, total contrast volume, and equipment use. Results: Between 2015 and 2017, 246 patients were randomized to the CrossBoss catheter (n = 122) or wire escalation (n = 124) at 11 U.S. centers. The baseline clinical and angiographic characteristics of the study groups were similar. Technical and procedural success were 87.8% and 84.1%, respectively, and were similar in the 2 groups. Crossing time was similar: 56 min (interquartile range: 33 to 93 min) in the CrossBoss group and 66 min (interquartile range: 36 to 105 min) in the wire escalation group (p = 0.323), as was as the incidence of procedural major adverse cardiovascular events (3.28% vs. 4.03%; p = 1.000). There were no significant differences in the secondary study endpoints. Conclusions: As compared with wire escalation, upfront use of the CrossBoss catheter for antegrade crossing of coronary chronic total occlusions was associated with similar crossing time, similar success and complication rates, and similar equipment use and cost.
KW - CrossBoss
KW - antegrade dissection/re-entry
KW - antegrade wire escalation
KW - chronic total occlusion
KW - percutaneous coronary intervention
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U2 - 10.1016/j.jcin.2017.10.023
DO - 10.1016/j.jcin.2017.10.023
M3 - Article
C2 - 29413236
AN - SCOPUS:85041909022
SN - 1936-8798
VL - 11
SP - 225
EP - 233
JO - JACC: Cardiovascular Interventions
JF - JACC: Cardiovascular Interventions
IS - 3
ER -