Predictors of target lesion failure after treatment of left main, bifurcation, or chronic total occlusion lesions with ultrathin‐strut drug‐eluting coronary stents in the ULTRA registry
Ovidio De Filippo, Francesco Bruno, Tineke H. Pinxterhuis, Mariusz Gąsior, Leor Perl, Luca Gaido, Domenico Tuttolomondo, Antonio Greco, Roberto Verardi, Gianluca Lo Martire, Mario Iannaccone, Attilio Leone, Gaetano Liccardo, Serena Caglioni, Rocío González-Ferreiro, Giulio Rodinò, Giuseppe Musumeci, Giuseppe Patti, Irene Borzillo, Giuseppe Tarantini, Wojciech Wańha, Bruno Casella, Eline H. Ploumen, Łukasz Pyka, Ran Kornowski, Andrea Gagnor, Raffaele Piccolo, Sergio Raposeiras‐Roubín, Davide Capodanno, Paolo Zocca, Federico De Marco, Gaetano Maria De Ferrari, Clemens von Birgelen, Fabrizio D’Ascenzo, ULTRA Collaborators
Abstract
BACKGROUND: Data about the long-term performance of new-generation ultrathin-strut drug-eluting stents (DES) in challenging coronary lesions, such as left main (LM), bifurcation, and chronic total occlusion (CTO) lesions are scant. METHODS: The international multicenter retrospective observational ULTRA study included consecutive patients treated from September 2016 to August 2021 with ultrathin-strut (<70 µm) DES in challenging de novo lesions. Primary endpoint was target lesion failure (TLF): composite of cardiac death, target-lesion revascularization (TLR), target-vessel myocardial infarction (TVMI), or definite stent thrombosis (ST). Secondary endpoints included all-cause death, acute myocardial infarction (AMI), target vessel revascularization, and TLF components. TLF predictors were assessed with Cox multivariable analysis. RESULTS: Of 1801 patients (age: 66.6 ± 11.2 years; male: 1410 [78.3%]), 170 (9.4%) experienced TLF during follow-up of 3.1 ± 1.4 years. In patients with LM, CTO, and bifurcation lesions, TLF rates were 13.5%, 9.9%, and 8.9%, respectively. Overall, 160 (8.9%) patients died (74 [4.1%] from cardiac causes). AMI and TVMI rates were 6.0% and 3.2%, respectively. ST occurred in 11 (1.1%) patients while 77 (4.3%) underwent TLR. Multivariable analysis identified the following predictors of TLF: age, STEMI with cardiogenic shock, impaired left ventricular ejection fraction, diabetes, and renal dysfunction. Among the procedural variables, total stent length increased TLF risk (HR: 1.01, 95% CI: 1-1.02 per mm increase), while intracoronary imaging reduced the risk substantially (HR: 0.35, 95% CI: 0.12-0.82). CONCLUSIONS: Ultrathin-strut DES showed high efficacy and satisfactory safety, even in patients with challenging coronary lesions. Yet, despite using contemporary gold-standard DES, the association persisted between established patient- and procedure-related features of risk and impaired 3-year clinical outcome.