A journal article was submitted detailing a study which investigated the outcomes of atherectomy plus dcb (a+dcb) compared with dcb alone for the treatment of femoropopliteal artery disease.In the a+dcb group, two types of atherectomy devices were used, directional devices (59.8%) and rotational devices (40.2%).Embolization protection filters were used in 65.9% of the a+dcb group.311 patients (348 limbs) were included in the study.Of these, 82 limbs were treated with a+dcb and 266 limbs with dcb alone.Medtronic¿s spiderfx and in.Pact admiral devices were used during the study.The in.Pact admiral dcb was used in approximately 70% of cases.In lesions requiring more than one dcb, a minimal overlap of 10 mm was obtained.If residual stenosis exceeded 30%, post-dilation was performed with an additional uncoated non-compliant balloon.Stenting was considered only as a last resort in the presence of flow-limiting dissection or when residual stenosis exceeded 30% despite post-dilation.Technical success is reported in 80.15% of the a+dcb group and 69.2% in the dcb alone group.Procedural related minor complications of arterial dissection, distal embolization, and vascular perforation are reported.Patients were clinically followed for a mean duration of 24.8±14.3 months.The 2-year primary clinical patency did not differ significantly between the a+dcb and the dcb group.Similarly, 2-year tlr-free survival was also not different between the two groups.The rates of mortality and the male at 2 years showed no difference between the two groups.There is no established or suspected causal relationship between the device(s) and the death events.
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Title: clinical outcomes of atherectomy plus drug-coated balloon versus drug-coated balloon alone in the treatment of femoropopliteal artery disease author: jung-joon cha, jae-hwan lee, young-guk ko journal: korean circulation journal year: 2021.Vol/issue: 52:e1 ref: doi: 10.4070/kcj.2021.0246.Date of publication journal reported death but there is no information to suggest the device caused or contributed to the death events.Deaths are common occurrences in clinical studies, however the cause(s) of death are often not characterized or clearly associated with a particular product.Therefore, deaths will not be considered reportable unless clearly stated as being associated with a medtronic device.If information is provided in the future, a supplemental report will be issued.
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