Abstract
Coronary stent fracture (SF) is recognized as a risk of restenosis or stent thrombosis. However, the actual incidence is unclear in real world clinical settings in Japan. This study aims to estimate the incidence of SF in Japan by surveying peer-reviewed journals, and to elucidate the actual situation of adverse event reports. We conducted literature analysis regarding the incidence of SF using PubMed and ICHUSHI on April 1 2014. For PubMed, the term “stent fracture” was used. For ICHUSHI, “coronary artery” (in Japanese), “stent” (in Japanese), “fracture” (in English), “fracture” (in Japanese), and “damage” (in Japanese) were used. PubMed search initially yielded 895 papers. Of these, 792 studies had been conducted in countries outside of Japan, 45 studies were related to non-coronary artery, 17 studies did not deal with incidences of SF, and 11 studies targeted duplicated cases during the same implantation period. After these studies were excluded, we analyzed 30 remaining papers comprising 14 observational studies and 16 case reports. There were 643 SF cases in the scientific papers and 105 SF cases in the adverse event reports. Through the 14 observational studies, the SF incidence was estimated as 5.4% (595/10,927 lesions). We found a significant difference in SF incidences between the paper and adverse event report (6.1-hold). These data indicated that the adverse event report showed a partial picture of the real situation.
