Medtronic's Resolute Zotarolimus-Eluting Stent Studied in Patients With In-Stent Restenosis

August 14, 2013—Gert Richardt, MD, et al published 2-year results from a pooled analysis that sought to assess the clinical safety and effectiveness of the Resolute zotarolimus-eluting stent (R-ZES, Medtronic, Inc., Minneapolis, MN) in patients with in-stent restenosis (ISR) from two large trials. The study is available online ahead of print in Journal of the American College of Cardiology: Cardiovascular Interventions (JACC: CI).

The investigators stated that the background of the study is that ISR treatment is associated with higher rates of subsequent cardiac events compared with treatment of de novo lesions. Drug-eluting stents (DES) are an option, but second-generation DES are largely untested in the treatment of ISR.

As summarized in JACC: CI, the analysis pooled 3,489 patients from the RESOLUTE All Comers trial and the RESOLUTE International registry. The 2-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 MI (CD/TVMI), and Academic Research Consortium definite and probable stent thrombosis.

The investigator reported that 281 patients (8.1%) received an R-ZES for ISR. The 2-year TLR and TLF rates were significantly higher in ISR patients than in non-ISR patients (TLR: 12.7% vs 4.3%; P = .003; TLF: 17.4% vs 9.4%; P = .007); however, the CD/TVMI rate was not (6.9% vs 6.1%; P = .711). Seven ISR patients had stent thrombosis.

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% and TLF was 18.8%. CD/TVMI was 7.3% and 7.2% for BMS-ISR and DES-ISR, respectively.

The investigators concluded that 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, stated the investigators in JACC: CI.