Safety and Effectiveness of Everolimus-Eluting Stents in Chronic Total Coronary Occlusion Revascularization: Results From the EXPERT CTO Multicenter Trial (Evaluation of the XIENCE Coronary Stent, Performance, and Technique in Chronic Total Occlusions).
OBJECTIVE
This study sought to evaluate procedural and clinical outcomes among patients undergoing chronic total occlusion (CTO) percutaneous coronary intervention (PCI) using contemporary methods and everolimus-eluting stents (EES).


BACKGROUND
Limited studies have detailed the procedural and late-term safety and efficacy of CTO revascularization among multiple centers applying modern techniques and with newer-generation drug-eluting stents.


METHODS
Among 20 centers, 250 consecutive patients were enrolled for attempted CTO PCI. Procedural and in-hospital clinical outcomes were examined in addition to the 1-year primary endpoint of death, myocardial infarction, and target lesion revascularization (major adverse cardiac events [MACE]).


RESULTS
Demographic, lesion, and procedural characteristics included prior bypass surgery: 9.9%; diabetes: 40.1%; lesion length: 36.1 ± 18.5 mm; and stent length: 51.7 ± 27.2 mm. Procedural success, defined as guidewire recanalization with no in-hospital MACE, was 96.4%. Success with antegrade-only methods was 97.9% and 86.2% by retrograde/combined methods, respectively. Compared with a pre-specified performance goal derived from 6 prior CTO drug-eluting stent trials (1-year MACE: 24.4%), treatment with EES was associated with significantly lower composite adverse events for both intent-to-treat (18.5%, 1-sided upper confidence interval: 23.4%, p = 0.025) and per-protocol populations (8.2%, 1-sided upper confidence interval: 12.3%, p < 0.0001). Target lesion revascularization at 1 year was 6.3%. Dual antiplatelet therapy adherence was 53.9% at 1 year, yet subacute definite stent thrombosis occurred in only 2 patients (0.9%), and late probable stent thrombosis occurred in 1 patient (0.5%).


CONCLUSIONS
In a multicenter registration trial representing contemporary technique and EES, favorable procedural success and late-term clinical outcomes support CTO PCI in a patient population with high lesion complexity. (EXPERT CTO: Evaluation of the XIENCE PRIME LL and XIENCE Nano Everolimus Eluting Coronary Stent Coronary Stents, Performance, and Technique in Chronic Total Occlusions; NCT01435031).
Piedmont Heart Institute, Atlanta, Georgia. Electronic address: david.kandzari@piedmont.org.
David E
DE
Kandzari
Mount Sinai Medical Center, New York, New York.
Annapoorna S
AS
Kini
Columbia University Medical Center and the Cardiovascular Research Foundation, New York, New York.
Dimitri
D
Karmpaliotis
Columbia University Medical Center and the Cardiovascular Research Foundation, New York, New York.
Jeffrey W
JW
Moses
Northeast Georgia Heart Center, Gainesville, Georgia.
Pradyumna E
PE
Tummala
St. Luke's Mid-America Heart Institute, Kansas City, Missouri.
J Aaron
JA
Grantham
St. Vincent's Heart Center, Indianapolis, Indiana.
Charles
C
Orr
PeaceHealth St. Joseph Medical Center, Cardiovascular Center, North Cascade Cardiology, Bellingham, Washington.
William
W
Lombardi
York Hospital, York, Pennsylvania.
William J
WJ
Nicholson
Piedmont Heart Institute, Atlanta, Georgia.
Nicholas J
NJ
Lembo
Beth Israel Deaconess Medical Center, Boston, Massachusetts.
Jeffrey J
JJ
Popma
Abbott Vascular, Inc., Santa Clara, California.
Jin
J
Wang
Abbott Vascular, Inc., Santa Clara, California.
Cristina
C
Larracas
Abbott Vascular, Inc., Santa Clara, California.
David R
DR
Rutledge
D000368:Aged; D002317:Cardiovascular Agents / Q000008:administration & dosage*; D002908:Chronic Disease; D054059:Coronary Occlusion / Q000175:diagnosis / Q000401:mortality / Q000628:therapy*; D003328:Coronary Thrombosis / Q000209:etiology; D054855:Drug-Eluting Stents; D000068338:Everolimus / Q000008:administration & dosage*; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009203:Myocardial Infarction / Q000209:etiology; D062645:Percutaneous Coronary Intervention / Q000009:adverse effects / Q000295:instrumentation* / Q000401:mortality; D011446:Prospective Studies; D011474:Prosthesis Design; D012307:Risk Factors; D013997:Time Factors; D016896:Treatment Outcome; D014481:United States
D002317:Cardiovascular Agents; D000068338:Everolimus
chronic total occlusion; drug-eluting stent; everolimus; percutaneous coronary intervention