Circ J 2009; 73: 508 -511 lthough drug-eluting stents (DES) have significantly decreased the incidence of restenosis and the need for repeat revascularization, restenosis still occurs. 1-10 Large-scale randomized trials 1-3 have demonstrated a high proportion of focal restenosis after DES implantation, but on the other hand, recent real-world registries have shown that a significant proportion of restenosis is non-focal when DES are used in unselected lesions. [4][5][6][7][8] The present study evaluated angiographic patterns of restenosis after sirolimuseluting stent (SES) implantation in real-world practice in Japan.
Methods
PatientsA total of 1,693 lesions underwent SES implantation in 3 Japanese hospitals (Chiba University Hospital, Fukuyama Cardiovascular Hospital, and Chiba Cardiovascular Center) between August 2004 and April 2007. PCI was performed after written informed consent was given by the patients. All lesions underwent SES implantation according to current guidelines. 10 Angiographic follow-up was performed in 1,312 lesions (78%) at 6-9 months or earlier if noninvasive evaluation or clinical presentation suggested ischemia. Restenosis occurred in 124 lesions (9.5%) in 122 patients.Using a validated edge detection system (CMS, MEDIS, The Netherlands), quantitative coronary angiography was performed by an experienced cardiologist (H.K.). Standard qualitative and quantitative definitions and measurements were used. The outer diameter of the contrast-filled catheter was used as the calibration and the minimal lumen diameter was obtained from the single "worst" view. Angiographic restenosis was defined as diameter stenosis >50% within a previously stented segment (stent and 5 mm proximal and distal) on follow-up angiography. Cases of stent thrombosis were not considered as restenosis. The angiographic pattern of restenosis was classified as focal (≤10 mm in length), diffuse (restenosis >10 mm within the stent), proliferative (restenosis >10 mm in length extending outside the stent) or occlusive. 11 Focal restenosis was further categorized according to its position as proximal edge, intrastent, distal edge, or multi-focal. This study was approved by the local council on human research.
Statistical AnalysisStatistical analysis was performed using StatView 5.0 (SAS Institute, Cary, NC, USA). Continuous variables are expressed as mean ± SD and categorical variables as frequency (%). Continuous variables were compared using Student's t-test. Categorical variables were compared with chi-square statistics; P<0.05 was considered significant.Multivariate logistic regression was used to identify independent predictors of non-focal restenosis. At this stage, the diffuse, proliferative, and occlusive restenosis patterns were combined into a single non-focal group in order to simplify and strengthen subsequent analysis. This was done (Received July 23, 2008; revised manuscript received September 30, 2008; accepted October 20, 2008; released online January 16, 2009
Angiographic Patterns of Restenosis After Sirol...