Chronic total occlusion PCI was associated with a significant reduction in major adverse outcomes in a cohort of patients with complex lesions, according to results of the EXPERT CTO study.
In the perspective, nonrandomized trial, researchers enrolled 250 consecutive patients at 20 centers. Eligible participants underwent CTO PCI with everolimus-eluting stents (EES).
The primary endpoint was 1-year incidence of MACE, a composite of all-cause death, MI and target lesion revascularization. Secondary endpoints included individual MACE components; procedural success, defined as guidewire recanalization with no in-hospital MACE; and device success, defined as less than 50% diameter stenosis achieved with the assigned stent.
Successful guidewire recanalization of the occlusion occurred in 222 patients. In this population, prior bypass surgery was reported in 9.9% of patients and 40.1% had diabetes. Mean lesion length was 36.1 ± 18.5 mm and mean stent length was 51.7 ± 27.2 mm.
Overall, the procedural success rate was 89.6% according to the Academic Research Consortium definition of MI and 96.4% according to the protocol definition. Clinicians used antegrade-only guidewire methods in approximately 80% of patients, with a success rate of 97.9% compared with 86.2% using retrograde or combined methods.
A 1-year performance goal of 24.4% MACE was culled from the results of six previous CTO PCI trials. Compared with this goal, EES was associated with significantly lower adverse event rates in the intent-to-treat (ITT) population (18.5%; 1-sided upper CI, 23.4%). A similar outcome was reported in the per-protocol population (8.2%; 1-sided upper CI, 12.3%). The researchers wrote that the assessment and definition of MI caused the difference in event rates (13.9% by ITT and 3.4% for the per-protocol group).
The 1-year TLR rate was 6.3%, and 1.9% experienced cardiac death. Dual antiplatelet therapy adherence at that time point was 53.9%; however, subacute definite stent thrombosis occurred in 0.9% of the cohort, and one patient (0.5%) experienced late probable stent thrombosis. All stent thromboses occurred among patients adhering to prescribed DAPT regimens.
“In a multicenter registration trial representing contemporary technique, broad operator experience and newer-generation DES, favorable procedural success and late-term clinical outcomes support CTO PCI in a patient population with high lesion complexity,” the researchers concluded. “The results suggest that treatment with EES should be favored for percutaneous revascularization in chronically occluded native coronary arteries.” – by Rob Volansky
Disclosure: The researchers report associations with a number of device and pharmaceutical companies. Please see the full study for a list of all authors’ relevant financial disclosures.