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January 2, 2012

Classification and Clinical Impact of Restenosis After Femoropopliteal Stenting Studied

January 3, 2012—In the Journal of the American College of Cardiology, Atsushi Tosaka, MD, et al published findings from a study that sought to investigate the relationship between angiographic patterns of in-stent restenosis (ISR) after femoropopliteal stenting and the frequency of refractory ISR (2012;59:16–23). The background of the study is that ISR after femoropopliteal stenting is an unresolved problem and that the incidence and predictors of refractory restenosis remain unclear.

From their findings, the investigators concluded that restenotic patterns after femoropopliteal stenting are important predictors of recurrent ISR and occlusion. John R. Laird, MD, and Khung Keong Yeo, MD, provide an editorial commentary, “The Treatment of Femoropopliteal In-Stent Restenosis: Back to the Future,” on the study in the Journal of the American College of Cardiology (2012;59:24–25).

As detailed in the Journal of the American College of Cardiology, the investigators conducted a multicenter, retrospective observational study. From September 2000 to December 2009, 133 restenotic lesions after femoropopliteal artery stenting were classified by angiographic pattern: class I included focal lesions (50 mm in length), class II included diffuse lesions (> 50 mm in length), and class III included totally occluded ISR. All patients were treated by balloon angioplasty for at least 60 seconds. Recurrent ISR or occlusion was defined as ISR or occlusion after target lesion revascularization. Restenosis was defined as > 2.4 of the peak systolic velocity ratio by duplex scan or > 50% stenosis by angiography.

In the study population, 64% of patients were men, 67% had diabetes mellitus, and 24% underwent hemodialysis. Class I pattern was found in 29% of the limbs, class II in 38%, and class III in 33%. The mean follow-up period was 24 ± 17 months.

The investigators reported that all-cause death occurred in 14 patients, bypass surgery was performed in 11 limbs, and major amputation was performed on one limb during the follow-up. Kaplan-Meier survival curves showed that the rate of recurrent ISR at 2 years was 84.8% in class III patients compared with 49.9% in class I patients (P < .0001) and 53.3% in class II patients (P = .0003). The rate of recurrent occlusion at 2 years was 64.6% in class III patients compared with 15.9% in class I patients (P < .0001) and 18.9% in class II patients (P < .0001).

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January 3, 2012

FDA Issues Three Draft Guidances on Medical Devices

January 3, 2012

FDA Issues Three Draft Guidances on Medical Devices