BACKGROUND: No randomized studies have been conducted to investigate serial changes in optical coherence tomography (OCT) analyses following implantation of biolimus-A9-eluting stents (BES) and sirolimus-eluting stents (SES). METHODS: A total of 60 patients fulfilling the study criteria were randomly assigned into BES (n=30) and SES (n=30) implantation groups. Serial OCT evaluation at post-procedure, 3- and 12-month follow-up was performed in 46 patients [BES (n=22) and SES (n=24)]. OCT analyses were compared according to the type of stents and the follow-up time intervals. The percentage of uncovered struts was defined as the ratio of uncovered struts to total struts in all cross-sections. The primary endpoint was the percentage change (Δ) of uncovered struts in the 3- and 12-month follow-up samples. RESULTS: The percentage of uncovered struts at the 3-month time period was not significantly different in the BES and SES groups; the median value (interquartile range) was 14.7% (0.0-23.4) versus 8.6% (0.7-21.5) (p=0.98), respectively. However, OCT at the 12-month follow-up showed a significantly lower percentage of uncovered struts [2.6% (0.8-5.6) versus 6.2% (1.7-14.7), (p=0.028), respectively] without significant difference of neointimal thickness. BES showed a greater reduction of percentage Δ of uncovered struts from 3-12 months than that of SES [-17.2±14.5% versus -7.7±16.3%, respectively (p=0.043)]. CONCLUSIONS: Both drug-eluting stents showed a high percentage of incomplete strut coverage at 3 months. However, BES showed a significantly lower percentage of uncovered struts at 12 months compared to that of SES. This was achieved by superior strut coverage from 3 to 12 months.
RCT Entities:
BACKGROUND: No randomized studies have been conducted to investigate serial changes in optical coherence tomography (OCT) analyses following implantation of biolimus-A9-eluting stents (BES) and sirolimus-eluting stents (SES). METHODS: A total of 60 patients fulfilling the study criteria were randomly assigned into BES (n=30) and SES (n=30) implantation groups. Serial OCT evaluation at post-procedure, 3- and 12-month follow-up was performed in 46 patients [BES (n=22) and SES (n=24)]. OCT analyses were compared according to the type of stents and the follow-up time intervals. The percentage of uncovered struts was defined as the ratio of uncovered struts to total struts in all cross-sections. The primary endpoint was the percentage change (Δ) of uncovered struts in the 3- and 12-month follow-up samples. RESULTS: The percentage of uncovered struts at the 3-month time period was not significantly different in the BES and SES groups; the median value (interquartile range) was 14.7% (0.0-23.4) versus 8.6% (0.7-21.5) (p=0.98), respectively. However, OCT at the 12-month follow-up showed a significantly lower percentage of uncovered struts [2.6% (0.8-5.6) versus 6.2% (1.7-14.7), (p=0.028), respectively] without significant difference of neointimal thickness. BES showed a greater reduction of percentage Δ of uncovered struts from 3-12 months than that of SES [-17.2±14.5% versus -7.7±16.3%, respectively (p=0.043)]. CONCLUSIONS: Both drug-eluting stents showed a high percentage of incomplete strut coverage at 3 months. However, BES showed a significantly lower percentage of uncovered struts at 12 months compared to that of SES. This was achieved by superior strut coverage from 3 to 12 months.
Authors: Keun Ho Park; Myung Ho Jeong; Young Joon Hong; Youngkeun Ahn; Hyun Kuk Kim; Young Yub Koh; Doo Il Kim; Sang Wook Kim; Weon Kim; Seung Woon Rha; Jay Young Rhew; Jong Seon Park; Hun Sik Park; Jang Ho Bae; Jang Whan Bae; Seok Kyu Oh; Sung Yun Lee; Seung Wook Lee; Jae Hwan Lee; Sang Yeob Lim; Jang Hyun Cho; Kwang Soo Cha; Jai Keon Chae; Seung Ho Hur; Sun Ho Hwang; Jin Yong Hwang Journal: Yonsei Med J Date: 2018-01 Impact factor: 2.759