ollowing the development of drug-eluting stents (DES) the interventional cardiologist seems to have overcome the nemesis of restenosis. The First-InMan study and a randomized comparison of a sirolimuseluting stent (SES) with a standard stent for coronary revascularization reported complete inhibition of restenosis in simple discrete lesions at 6 months. 1,2 However, recent randomized clinical trials using DES for lesions with lowor intermediate restenosis risk reported restenosis rates ranging from 2.3% to 16.7%. [3][4][5][6][7][8][9][10][11][12] Furthermore, the number of DES used and the stent length required for each lesion are both substantially increasing based on the recent recommended policy of full lesion coverage to avoid any potential injury at the stent edges. popularity of DES technologies worldwide, the precise mechanisms responsible for DES restenosis remain unclear. Several case reports have highlighted the occurrence of stent fracture (absence or deformity of a stent strut inside the stent) at follow-up, especially in patients experiencing restenosis with SES, however, the incidence of fracture and its impact on restenosis are poorly understood. [12][13][14][15][16][17][18] The purpose of this study was to investigate the predictors of restenosis following SES implantation and to determine the incidence and impact of stent fracture. We prospectively performed the SES implantation under intravascular ultrasound (IVUS) Guidance in Native coronary Artery Lesions (SIGNAL) study at the Fujita Health University hospital.
Methods
Study Design and EndpointsThe SIGNAL study was designed as a prospective, single-center, angiographic and IVUS follow-up study to evaluate the acute and late efficacy, as well as safety of deployment, of SES. The primary endpoint was angiographic restenosis. The principal clinical endpoint was a composite Circ J 2007; 71: 1669 -1677 (Received September 19, 2006 revised manuscript received July 5, 2007; accepted July 19, 2007 Although multivariate logistic regression analysis revealed that minimal lumen area (min-LA) post (p=0.027), total stent length (p=0.003) and diabetes (p=0.032) were significant independent predictors of restenosis, univariate analysis showed that stent fracture was more common in the restenosis than in the non-restenosis groups (p=0.001).Conclusions Although min-LA post by IVUS, total stent length by QCA and diabetes are independent predictors for angiographic restenosis, stent fracture occurred in 4 lesions (2.4%) and all of them resulted in restenosis (31% of the restenosis). The impact of stent fracture and its potential role in the development of restenosis deserves further study. (Circ J 2007; 71: 1669 -1677)