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5% (95% confidence interval, 69.9-87.1). Proportional TLR was 21.2% (18/85 limbs). The performance goal of TLR (bailout stent included as TLR) was set at 37.9% at 6 months with balloon angioplasty alone. TLR rate derived from the meta-analysis was significantly lower than the TLR rate set for the historic control accounting for the 95% confidence interval lower bound (P.01). There was no device-stent interaction and no amputation. Distal embolization occurred in 11/92 (12.0%) (filters used in 76.1% of all cases) and

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