TCT: Zilver (Michael Dake, MD)

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Michael Dake, MD has financial interests in several medical device companies including W. L. Gore, Cook Medical, NovoStent, Vatrix, Amaranth, CVRx, Endoluminl Sciences, REVA Medical, and TriVascular. He also serves as an officer or director for VIVA Physicians Group. The document describes a prospective, randomized trial comparing the Zilver PTX drug-eluting stent to percutaneous transluminal angioplasty (PTA) and provisional bare metal stenting for treating symptomatic femoropopliteal peripheral artery disease. At 12 months, primary patency was significantly higher for patients receiving the Zilver PTX stent compared to

Health & Medicine

Michael Dake, MD Within the past 12 months, the presenter or their spouse/partner have had a financial interest/arrangement or affiliation with the organization listed below. ,[object Object]

The availability of real world (e.g., routinely collected) data has allowed researchers to generate massive amounts of evidence on epidemiology, natural history, disease burden, and drug efficacy. However, very few studies conducted with these data use validated code algorithms to identify the study cohort, exposure, or control variables. Even when algorithms are validated, their performance is often suboptimal. Several research groups and government agencies have offered recommendations for when and how algorithms should be validated and how the results should be reported. Key learning objectives: - The majority of studies performed with real world data lack adequate algorithm validation. - Exposures and outcomes algorithms are often more important to validate than population identification algorithms. - Positive predictive value, while the most often reported validation statistic, may not be the most useful or important one - Validation of algorithms for rare conditions requires a different approach than for common ones. - Medical record review remains the only reliable validation method in most cases and cannot be reliably performed with artificial intelligence techniques. - Validation of code algorithms using accepted methods improves study quality and increases chance of publication acceptance at higher impact journals.

September 10, 2019 Book Talk: Birth Rights and Wrongs: How Medicine and Technology are Remaking Reproduction and the Law Millions of Americans rely on the likes of birth control, IVF, and genetic testing to make plans as intimate and far-reaching as any over a lifetime. This is no less than the medicine of miracles. It fills empty cradles, frees families from terrible disease, and empowers them to fashion their lives on their own terms. But accidents happen. Pharmacists mix up pills. Lab techs misread tests. Obstetricians tell women their healthy fetuses would be stillborn. Political and economic forces conspire against regulation. And judges throw up their hands when professionals foist parenthood on people who didn't want it, or childlessness on those who did. Failed abortions, switched donors, and lost embryos may be first-world problems. But these aren't innocent lapses or harmless errors. They're wrongs in need of rights. At this event, author Dov Fox and an expert panel discussed his book Birth Rights and Wrongs: How Medicine and Technology are Remaking Reproduction and the Law (Oxford University Press, 2019). Panelists explored the ways in which the book seeks to lift the curtain on reproductive negligence, give voice to the lives it upends, and vindicate the interests that advances in medicine and technology bring to full expression. They also examined the book's effort to force citizens and courts to rethink the reproductive controversies of our time, and to equip us to meet the new challenges -- from womb transplants to gene editing -- that lie just over the horizon. Learn more: https://petrieflom.law.harvard.edu/events/details/book-talk-birth-rights-and-wrongs

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Hide glossary Glossary Study record managers: refer to the Data Element Definitions if submitting registration or results information. Search for terms x Accepts healthy volunteersA type of eligibility criteria that indicates whether people who do not have the condition/disease being studied can participate in that clinical study. Active comparator armAn arm type in which a group of participants receives an intervention/treatment considered to be effective (or active) by health care providers. Adverse eventAn unfavorable change in the health of a participant, including abnormal laboratory findings, that happens during a clinical study or within a certain amount of time after the study has ended. This change may or may not be caused by the intervention/treatment being studied. Age or age groupA type of eligibility criteria that indicates the age a person must be to participate in a clinical study. This may be indicated by a specific age or the following age groups: The age groups are: Child (birth-17)Adult (18-64)Older Adult (65+)AllocationA method used to assign participants to an arm of a clinical study. The types of allocation are randomized allocation and nonrandomized. ArmA group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol. Arm typeA general description of the clinical trial arm. It identifies the role of the intervention that participants receive. Types of arms include experimental arm, active comparator arm, placebo comparator arm, sham comparator arm, and no intervention arm. Baseline characteristicsData collected at the beginning of a clinical study for all participants and for each arm or comparison group. These data include demographics, such as age, sex/gender, race and ethnicity, and study-specific measures (for example, systolic blood pressure, prior antidepressant treatment). Canceled submissionIndicates that the study sponsor or investigator recalled a submission of study results before quality control (QC) review took place. If the submission was canceled on or after May 8, 2018, the date is shown. After submission of study results, a study record cannot be modified until QC review is completed, unless the submission is canceled. Certain agreementsInformation required by the Food and Drug Administration Amendments Act of 2007. In general, this is a description of any agreement between the sponsor of a clinical study and the principal investigator (PI) that does not allow the PI to discuss the results of the study or publish the study results in a scientific or academic journal after the study is completed. CertificationA sponsor or investigator may submit a certification to delay submission of results information if they are applying for FDA approval of a new drug or device, or new use of an already approved drug or device. A sponsor or investigator who submits a certification can.

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20. Effectiveness EndpointPrimary Patency (PSVR < 2.0) 83.1% 76.7% Zilver PTX 65.3% Optimal PTA (p < 0.01 vs. Zilver PTX) 60.0% 32.8% PTA (p < 0.01 vs. Zilver PTX) 29.8%

21. Patency (PSVR < 2.0) for Primary Zilver PTX vs. Standard Care (PTA with Provisional Bare Stenting) 83.1% 76.7% Zilver PTX 67.0% Standard Care (p < 0.01 vs. Zilver PTX) 61.0%

22. Patency (PSVR < 2.0) for Zilver PTX vs. BMSIs the drug effect significant? 89.9% 83.0% Zilver PTX 73.0% Bare Zilver (p = 0.01 vs. Zilver PTX) 65.9%

23. Conclusions Largest prospective, randomized trial for endovascular treatment of symptomatic femoropopliteal PAD (479 patients) Low Zilver stent fracture rate (0.9%) through 12 months Primary Zilver PTX stenting resulted in Significantly better 12-month patient safety compared to PTA Significantly higher 12-month patency compared to: PTA and optimal PTA Standard care (PTA with provisional BMS) Provisional Zilver PTX patency (89.9%) significantly higher than provisional BMS patency (73.0%) PTX coating reduced 12-month restenosis rate by 63%

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