Sample size 3 SRs with RCTs: 5 SRs with 3 SRs with RCTs: 2 SRs with RCTs: total SR 2014:xlv n=259 SR 2010:xlvii 2 RCTs of (range) for total enrolled = RCTs: total enrolled = enrolled = 1,594 to patients in device 129 and 400 patients included 4,796 to 7,572 enrolled = 627 to 1,387 3,194 patients group; n=551 in control (division between arms studies patients 6,298 to patients group NR) 1 SR with RCTs & 14,740 3 SRs with 1 SR with SRs registries; enrolled Primary study:xlvi SR 2014:xlviii n=432 in patients various study and RCTs; = 52,220 patients Level III-2 filter groups; n=4160 in designs: total 1 SR with enrolled = retrospective cohort historical control 1 SR with RCTs, enrolled = up to RCTs and unclear with concurrent groups observational studies & 575,556 observational controls; n=51 in 1 SR with RCTs registries: total RCT 2012:xlix total studies: total device group; n=130 in and case series: enrolled = 72,114 n=141 (70 in device enrolled = control group total enrolled = group, 71 in control Primary study: total 10,447 1,628 group) enrolled = 2,198 Reported Carotid artery 4 assessed DES Balloon Primarily EVAR versus Implanted device IVC filter versus no comparisons stenting vs. versus BMS; 2 angioplasty with open repair; also EVAR versus surgical closure filter endarterectomy assessed DES stents (BMS or versus watchful (one study also versus BMS or DES) versus waiting in candidates included medical another type balloon deemed not fit for therapy) of DES angioplasty alone surgery (one compared BMS versus DES)
Sample size (range) for included studies 3 SRs with RCTs: total enrolled = 4,796 to 7,572 patients 3 SRs with various study designs: total enrolled = up to 575,556 5 SRs with RCTs: total enrolled = 6,298 to 14,740 patients 1 SR with RCTs and observational studies: total enrolled = 10,447 3 SRs with RCTs: enrolled = 627 to 1,387 patients 1 SR with SRs and RCTs; enrolled = unclear 1 SR with RCTs and case series: total enrolled = 1,628 2 SRs with RCTs: total enrolled = 1,594 to 3,194 patients 1 SR with RCTs & registries; enrolled = 52,220 patients 1 SR with RCTs, observational studies & registries: total enrolled = 72,114 Primary study: total enrolled = 2,198 SR 2014:xlv n=259 patients in device group; n=551 in control group Primary study:xlvi Level III-2 retrospective cohort with concurrent controls; n=51 in device group; n=130 in control group SR 2010:xlvii 2 RCTs of 129 and 400 patients (division between arms NR) SR 2014:xlviii n=432 in filter groups; n=4160 in historical control groups RCT 2012:xlix total n=141 (70 in device group, 71 in control group) Reported comparisons Carotid artery stenting vs. endarterectomy (one study also included medical therapy) 4 assessed DES versus BMS; 2 assessed DES versus BMS or another type of DES Balloon angioplasty with stents (BMS or DES) versus balloon angioplasty alone (one compared BMS versus DES) Primarily EVAR versus open repair; also EVAR versus watchful waiting in candidates deemed not fit for surgery Implanted device versus surgical closure IVC filter versus no filter
consult-draft-clinical-evidence-guidelines-medical-devices.docx