Author + information
- David Kandzari1,
- Annapoorna Kini2,
- Dimitri Karmpaliotis3,
- Jeffrey Moses3,
- Pradyumna Tummala4,
- J. Aaron Grantham5,
- William Lombardi6,
- William Nicholson7 and
- Nicholas Lembo8
- 1Piedmont Heart Institute, Atlanta, Georgia, United States
- 2Mount Sinai Health System, New York, New York, United States
- 3NewYork-Presbyterian Hospital/Columbia University Medical Center, New York, New York, United States
- 4The Heart Center of Northeast Georgia Medical Center, Gainesville, Georgia, United States
- 5University of Missouri Kansas City and Mid America Heart Institute, Kansas City, Missouri, United States
- 6University of Washington Medical Center, Seattle, Washington, United States
- 7York Hospital - Wellspan Health, York, Pennsylvania, United States
- 8Columbia University, New York, New York, United States
Limited long term data exists regarding chronic total occlusion (CTO) revascularization with modern techniques and new-generation drug-eluting stents. EXPERT CTO (NCT01435031) is a prospective, multicenter registration trial examining the safety and effectiveness of XIENCE everolimus eluting stents (EES) in CTO percutaneous coronary intervention (PCI) with dedicated long-term follow-up.
Among patients undergoing attempted CTO PCI and stent revascularization with Xience everolimus eluting stents (EES), the primary endpoint of major adverse cardiac events (MACE: death, ARC-defined myocardial infarction (MI), or clinically-driven target lesion revascularization [CD-TLR)] at 1 year was compared with a pre-specified performance goal derived from prior CTO studies. Additional key outcomes included target lesion failure (TLF: cardiac death, ARC-defined target vessel myocardial infarction [TV-MI], or CD-TLR) and individual component endpoints. Annual follow-up through 4 years was protocol mandated.
Among 222 patients undergoing successful CTO PCI, treatment with EES was associated with significantly lower 1-year MACE for both intent-to-treat (ITT; 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) compared with a pre-specified performance goal derived from 6 prior CTO drug-eluting stent trials (1-year MACE: 24.4%). Through 4 years, rates of MACE and TLF by ITT analysis were 31.6% and 24.1%, respectively. Four year TV-MI was 15.5%, and CD-TLR was 11.3%. There was no occurrence of definite/probable stent thrombosis (ST) after 1 year.
Late follow-up of the EXPERT CTO trial demonstrates durable outcomes related to the CTO target lesion with modest interval progression in TLR and no very late ST. These results confirm sustained long-term safety and efficacy of EES for CTO revascularization.
CORONARY: Complex and Higher Risk Procedures for Indicated Patients (CHIP)