1. Three-Year Patient-Related and Stent-Related Outcomes of Second-Generation Everolimus-Eluting Xience V Stents Versus Zotarolimus-Eluting Resolute Stents in Real-World Practice (from the Multicenter Prospective EXCELLENT and RESOLUTE-Korea Registries)
- Author
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Jang Whan Bae, Jin Sik Park, Do Sun Lim, Han Mo Yang, Jong Seon Park, Dong Woon Jeon, Seok Kyu Oh, Doo Il Kim, Jin Ho Kang, Hui Kyung Jeon, Dong Kyu Jin, Bon Kwon Koo, Sang-Hyun Kim, Myeong Gon Kim, Hyo-Soo Kim, Min Su Hyon, Joo Myung Lee, Jin Yong Hwang, Hyun Jae Kang, Kyung Woo Park, Jung-Kyu Han, Keon Woong Moon, Seung-Woon Rha, Young Jin Choi, Sung Il Woo, Sung Ho Her, and Yangsoo Jang
- Subjects
Male ,medicine.medical_specialty ,Time Factors ,medicine.medical_treatment ,Antineoplastic Agents ,Coronary Artery Disease ,Coronary Angiography ,Prosthesis Design ,law.invention ,Electrocardiography ,Percutaneous Coronary Intervention ,Randomized controlled trial ,law ,Republic of Korea ,medicine ,Humans ,Zotarolimus ,Everolimus ,Prospective Studies ,Registries ,Prospective cohort study ,Sirolimus ,business.industry ,Hazard ratio ,Percutaneous coronary intervention ,Stent ,Drug-Eluting Stents ,Middle Aged ,Confidence interval ,Surgery ,Survival Rate ,Treatment Outcome ,Female ,Cardiology and Cardiovascular Medicine ,business ,Immunosuppressive Agents ,Follow-Up Studies ,medicine.drug - Abstract
Long-term outcomes are imperative to confirm safety of drug-eluting stents. There have been 2 randomized controlled trials comparing everolimus-eluting stents (EESs) and Resolute zotarolimus-eluting stents (ZES-Rs). To date, long-term clinical outcomes of these stents were limited to only 1 report, which has recently reported 4-year comparisons of these stents. Therefore, more evidence is needed regarding long-term clinical outcomes of the second-generation stents. This study compared the long-term clinical outcomes of EES with ZES-R in "all-comer" cohorts up to 3-year follow-up. The EXCELLENT and RESOLUTE-Korea registries prospectively enrolled 3,056 patients treated with EES and 1,998 with ZES-R, respectively, without exclusions. Stent-related composite outcomes (target lesion failure) and patient-related composite events up to 3-year follow-up were compared in crude and propensity score-matched analyses. Of 5,054 patients, 3,830 patients (75.8%) had off-label indication (2,217 treated with EES and 1,613 treated with ZES-R). The stent-related outcome (189 [6.2%] vs 127 [6.4%], p = 0.812) and the patient-related outcome (420 [13.7%] vs 250 [12.5%], p = 0.581) did not differ between EES and ZES-R, respectively, at 3 years, which was corroborated by similar results from the propensity score-matched cohort (hazard ratio [HR] 0.92, 95% confidence interval [CI] 0.70 to 1.20, p = 0.523 and 0.85, 95% CI 0.70 to 1.02, p = 0.081, for stent- and patient-related outcomes, respectively). The rate of definite or probable stent thrombosis up to 3 years (22 [0.7%] vs 10 [0.5%], p = 0.370) was also similar. The rate of very late definite or probable stent thrombosis was very low and comparable between the 2 stents (3 [0.1%] vs 1 [0.1%], p = 0.657). In multivariate analysis, chronic renal failure (adjusted HR 3.615, 95% CI 2.440 to 5.354, p 0.001) and off-label indication (adjusted HR 1.782, 95% CI 1.169 to 2.718, p = 0.007) were the strongest predictors of target lesion failure at 3 years. In conclusion, both stents showed comparable safety and efficacy at 3-year follow-up in this robust real-world registry with unrestricted use of EES and ZES-R. Overall incidences of target lesion failure and definite stent thrombosis, including very late stent thrombosis, were low, even in the patients with off-label indications, suggesting excellent long-term safety and sustained efficacy of both types of second-generation drug-eluting stents.
- Published
- 2014