Koji Nishida1, Kenji Nakatsuma2, Hiroki Shiomi2, Masahiro Natsuaki3, Kazuya Kawai1, Takeshi Morimoto4, Ken Kozuma5, Keiichi Igarashi6, Kazushige Kadota7, Kengo Tanabe8, Yoshihiro Morino9, Kiyoshi Hibi10, Takashi Akasaka11, Mitsuru Abe12, Satoru Suwa13, Toshiya Muramatsu14, Masakazu Kobayashi15, Kazuoki Dai16, Koichi Nakao17, Yasuhiro Tarutani18, Kenshi Fujii19, Takeshi Kimura2. 1. Division of Cardiology, Chikamori Hospital. 2. Department of Cardiovascular Medicine, Kyoto University Graduate School of Medicine. 3. Department of Cardiovascular Medicine, Saga University. 4. Division of General Medicine, Department of Internal Medicine, Hyogo College of Medicine. 5. Department of Cardiology, Teikyo University Hospital. 6. Department of Cardiology, Hokkaido Social Insurance Hospital. 7. Department of Cardiology, Kurashiki Central Hospital. 8. Department of Cardiology, Mitsui Memorial Hospital. 9. Department of Cardiology, Iwate University Hospital. 10. Department of Cardiology, Yokohama City University Medical Center. 11. Department of Cardiovascular Medicine, Wakayama Medical University Hospital. 12. Department of Cardiology, National Hospital Organization, Kyoto Medical Center. 13. Department of Cardiology, Juntendo University Shizuoka Hospital. 14. Department of Cardiology, Saiseikai Yokohama-city Eastern Hospital. 15. Department of Cardiology, Hamamatsu Medical Center. 16. Department of Cardiology, Hiroshima City Hospital. 17. Department of Cardiology, Saiseikai Kumamoto Hospital Cardiovascular Center. 18. Department of Cardiology, Okamura Memorial Hospital. 19. Department of Cardiology, Sakurabashi Watanabe Hospital.
Abstract
BACKGROUND: The comparative efficacy of second-generation (G2) vs. first-generation (G1) drug-eluting stents (DES) for calcified coronary lesions is unknown.Methods and Results: We compared the 3-year clinical outcomes of patients withG1- or G2-DES according to the presence or absence of calcified coronary lesions as assessed in an angiographic core laboratory using data from 2 large-scale prospective multicenter randomized trials, RESET and NEXT. G1-DES and G2-DES were implanted in 299 and 1,033 patients, respectively, in the Calc stratum (≥1 lesion with moderate/severe calcification), and 1,208 and 3,550 patients, respectively, in the Non-calc stratum (no/mild calcification). The patients in the Calc stratum had a significantly higher adjusted risk for the primary outcome measure (any target-lesion revascularization (TLR)) than those in the Non-calc stratum (HR: 1.38, 95% CI: 1.11-1.71, P=0.004). The cumulative 3-year incidence of any TLR was not significantly different between the G1-DES and G2-DES groups in both the Calc and Non-calc strata (12.1% vs. 9.7%, P=0.22, and 6.8% vs. 6.1%, P=0.44, respectively). After adjusting for confounders, the effect of G2DES relative to G1-DES for any TLR remained insignificant in both the Calc and Non-calc strata (HR: 0.78, 95% CI: 0.48-1.25, P=0.3, and HR: 0.84, 95% CI: 0.61-1.17, P=0.31, respectively, P interaction=0.55). CONCLUSIONS: The effect of G2-DES relative to G1-DES for TLR was not significantly different regardless of the presence or absence of lesion calcification.
RCT Entities:
BACKGROUND: The comparative efficacy of second-generation (G2) vs. first-generation (G1) drug-eluting stents (DES) for calcified coronary lesions is unknown.Methods and Results: We compared the 3-year clinical outcomes of patients with G1- or G2-DES according to the presence or absence of calcified coronary lesions as assessed in an angiographic core laboratory using data from 2 large-scale prospective multicenter randomized trials, RESET and NEXT. G1-DES and G2-DES were implanted in 299 and 1,033 patients, respectively, in the Calc stratum (≥1 lesion with moderate/severe calcification), and 1,208 and 3,550 patients, respectively, in the Non-calc stratum (no/mild calcification). The patients in the Calc stratum had a significantly higher adjusted risk for the primary outcome measure (any target-lesion revascularization (TLR)) than those in the Non-calc stratum (HR: 1.38, 95% CI: 1.11-1.71, P=0.004). The cumulative 3-year incidence of any TLR was not significantly different between the G1-DES and G2-DES groups in both the Calc and Non-calc strata (12.1% vs. 9.7%, P=0.22, and 6.8% vs. 6.1%, P=0.44, respectively). After adjusting for confounders, the effect of G2DES relative to G1-DES for any TLR remained insignificant in both the Calc and Non-calc strata (HR: 0.78, 95% CI: 0.48-1.25, P=0.3, and HR: 0.84, 95% CI: 0.61-1.17, P=0.31, respectively, P interaction=0.55). CONCLUSIONS: The effect of G2-DES relative to G1-DES for TLR was not significantly different regardless of the presence or absence of lesion calcification.