Clinical outcomes of the Resolute zotarolimus-eluting stent in patients with in-stent restenosis: 2-year results from a pooled analysis
Gert Richardt, Matthias Leschke, Mohamed Abdel-Wahab, Ralph Toelg, Mohamed El-Mawardy, Patrick W Serruys, Sigmund Silber, Stephan Windecker, Jorge A Belardi, Franz-Josef Neumann, Petr Widimsky, RESOLUTE All Comers, RESOLUTE International Investigators, Gert Richardt, Matthias Leschke, Mohamed Abdel-Wahab, Ralph Toelg, Mohamed El-Mawardy, Patrick W Serruys, Sigmund Silber, Stephan Windecker, Jorge A Belardi, Franz-Josef Neumann, Petr Widimsky, RESOLUTE All Comers, RESOLUTE International Investigators
Abstract
Objectives: This study sought to assess the clinical safety and effectiveness of the Resolute zotarolimus-eluting stent (R-ZES) in patients with in-stent restenosis (ISR) from 2 large trials.
Background: ISR treatment is associated with higher rates of subsequent cardiac events compared with treatment of de novo lesions. Although drug-eluting stents (DES) are an option, second-generation DES are largely untested in the treatment of ISR.
Methods: A total of 3,489 patients were pooled from the RAC (RESOLUTE All Comers) trial and the RESOLUTE International (RINT) registry. Two-year clinical endpoints included clinically driven target lesion revascularization (TLR), target lesion failure (TLF), cardiac death (CD), target vessel myocardial infarction (TVMI), combined CD or TVMI (CD/TVMI), and Academic Research Consortium definite and probable stent thrombosis (ST).
Results: Overall, 281 patients (8.1%) received an R-ZES for ISR. Two-year TLR and TLF rates were significantly higher in ISR patients than in non-ISR patients (TLR: 12.7% vs. 4.3%, p = 0.003; TLF: 17.4% vs. 9.4%, p = 0.007); however, the CD/TVMI rate was not (6.9% vs. 6.1%, p = 0.711). Seven ISR patients had ST. Two-year outcomes by ISR stent type were similar: bare-metal stent (BMS)-ISR TLR was 12.5% and TLF was 17.2%; DES-ISR TLR was 13.0% and TLF was 18.8%. CD/TVMI was 7.3% and 7.2% for BMS-ISR and DES-ISR, respectively.
Conclusions: Using R-ZES to treat ISR appears equally safe in BMS-ISR and DES-ISR, with CD/TVMI rates comparable to 2-year outcomes in other clinical trials. Although revascularization rates are still higher in ISR lesions, the R-ZES offers an effective alternative for treatment of BMS-ISR and DES-ISR. (Randomized, Two-Arm, Non-inferiority Study Comparing Endeavor-Resolute Stent With Abbot Xience-V Stent [RESOLUTE-AC]; NCT00617084; and RESOLUTE International Registry: Evaluation of the Resolute Zotarolimus-Eluting Stent System in a 'Real-World' Patient Population [RINT]; NCT00752128).
Keywords: BMS; CD; DES; ISR; MI; PCI; R-ZES; Resolute zotarolimus-eluting stent(s); ST; TLF; TLR; TVMI; TVR; bare-metal stent(s); cardiac death; clinical outcome; drug-eluting stent(s); in-stent restenosis; myocardial infarction; percutaneous coronary intervention; stent thrombosis; target lesion failure; target lesion revascularization; target vessel myocardial infarction; target vessel revascularization; zotarolimus-eluting stent.
Copyright © 2013 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.
Source: PubMed