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Second-Generation vs. First-Generation Drug-Eluting Stents in Patients With Calcified Coronary Lesions - Pooled Analysis From the RESET and NEXT Trials.

Second-Generation vs. First-Generation Drug-Eluting Stents in Patients With Calcified Coronary Lesions - Pooled Analysis From the RESET and NEXT Trials.
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Nishida K, Nakatsuma K, Shiomi H, Natsuaki M, Kawai K, Morimoto T, Kozuma K, Igarashi K, Kadota K, Tanabe K, Morino Y, Hibi K, Akasaka T, Abe M, Suwa S, Muramatsu T, Kobayashi M, Dai K, Nakao K, Tarutani Y, Fujii K, Kimura T, ,


Nishida K, Nakatsuma K, Shiomi H, Natsuaki M, Kawai K, Morimoto T, Kozuma K, Igarashi K, Kadota K, Tanabe K, Morino Y, Hibi K, Akasaka T, Abe M, Suwa S, Muramatsu T, Kobayashi M, Dai K, Nakao K, Tarutani Y, Fujii K, Kimura T, , (click to view)

Nishida K, Nakatsuma K, Shiomi H, Natsuaki M, Kawai K, Morimoto T, Kozuma K, Igarashi K, Kadota K, Tanabe K, Morino Y, Hibi K, Akasaka T, Abe M, Suwa S, Muramatsu T, Kobayashi M, Dai K, Nakao K, Tarutani Y, Fujii K, Kimura T, ,

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Circulation journal : official journal of the Japanese Circulation Society 2017 10 05() doi 10.1253/circj.CJ-17-0746
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 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.

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