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Methods prospect monster (prospective comparison of second-generation low-dose drug-coated balloon with high-dose drug-coated balloon) was a prospective, multicenter, nonrandomized trial that prospectively collected data from 581 patients who underwent endovascular therapy with the ld-dcb (n ¼ 370) or the hd-dcb (n ¼ 211) for symptomatic femoropopliteal artery disease (rutherford classes 2-5).The primary outcome was the 1-year primary patency of the ld-dcb in comparison with that of the hd-dcb, as evaluated using propensity score matching.The incidence of impaired flow after drug-coated balloon application was also evaluated.Results propensity score matching extracted 163 pairs (358 and 163 patients in the ld-dcb and hd-dcb groups, respectively), with no significant intergroup difference in baseline characteristics.The 1-year primary patency rates in the matched population were similar between the ld-dcb and hd-dcb groups (87.0% [82.5%-91.7%] vs 81.3% [74.8%- 88.5%]; hr: 0.93; 95% ci: 0.55-1.59; p ¼ 0.79), as was the incidence of impaired flow (13.6% vs 9.8%; or: 1.46; 95% ci: 0.78-2.73; p ¼ 0.24).No baseline characteristics had any significant interaction effects on the association of the ld-dcb vs the hd-dcb and 1-year restenosis risk studies of a first-generation high dose dcb (hd-dcb; in.Pact, medtronic), which carries a high dose (3.5 mg/mm2) of paclitaxel coated with urea as an excipient, have yielded a wealth of evidence and improved guideline recommendations.However, problems with the use of high dose paclitaxel, such as downstream effects of paclitaxel and its excipients, have been reported.Although high-dose dcbs showed stable and sustainable efficacy, they may carry an increased risk for a downstream effect.Instances of impaired flow after hd-dcb application have been observed.In the prospect monster study, intravascular ultrasound¿guided procedures were performed in approximately 70%, and preparation balloons were selected according to lesion morphology and characteristics (scoring balloons were used in approximately 35% and noncompliant balloons in approximately 65%).As a result, 1) insufficient lesion expansion (residual stenosis $30%) was <(><<)>10%; 2) severe dissection (grade d or more) was only approximately 3%; and 3) the rate of bailout stenting was 1.8% to 3.1%.Excellent results of lesion preparation were reported in the prospect monster study.In the compare trial, 25.6% to 30.0% had bailout stent, 35.8% to 39.1% showed incomplete lesion expansion (residual stenosis $30%), and more than 20% of patients had residual severe dissections (grade d or more).This high rate of residual stenosis and severe dissection may have affected the patency of the target lesion.Conversely, from the results of the prospect monster study, it may be possible to maximize the effect of dcb treatment by performing careful lesion preparation with ivus guidance the incidence of impaired flow, assessed as a safety indicator, was 12.1% for the ld-dcb and 8.6% for the hd-dcb (p ¼ 0.19).Although the difference was not significant, the ld-dcb demonstrated a slightly higher rate of downstream effects.No downstream effects leading to major amputation or worsening of clti were observed in either group.As there was no significant difference, we concluded that there was no difference in the occurrence of clinical downstream effects between the ld-dcb and the hd-dcb and that their safety profiles were equivalent.Contrary to our hypothesis and the results of a previous experimental study,7 the incidence of impaired flow was higher in the ld-dcb group, and the reason was unknown.A possible explanation for this unexpected result is selection bias.Before propensity score matching, the ld-dcb group included significantly more patients with clti and a slightly larger number of patients with severe below-the-knee runoff.In these patients with poor distal circulation, an intentional preference for using the ld-dcb over the hd-dcb may have been observed.Furthermore, because of the lack of information regarding below the-ankle outflow conditions, especially in the presence of small artery disease, the clinical risks for the impaired flow phenomenon may not have been fully adjusted for.
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Literature title: understanding and managing in-stent restenosis: a review of clinical data, from pathogenesis to treatment j thorac dis.2016 oct; 8(10): e1150¿e1162.Doi: 10.21037/jtd.2016.10.93 b3: date of publication.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
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