Real-World Safety Analysis of Paclitaxel Devices Used for the Treatment of Peripheral Arterial Disease

NCT04647643 | Completed FDA Drug

• 2 other identifiers: 20203069FH6292-2020-2AS-1001-Phase1
• Study Type: observational
• Target: 8,000
• Locations: 1 country
• Sites: 1

Brief Summary

Treatment with paclitaxel-based endovascular devices (PED) has become a common treatment option for patients with peripheral artery disease (PAD) involving the femoral-popliteal artery. However, an aggregate level meta-analysis identified an association between the use of PED and increased all-cause mortality at both two and five-year follow-up intervals, though there are significant limitations of these analyses. Exploration of real-world data has been suggested as a means to further investigate the safety of PED. The current study explores the association of PED and mortality in real-world data using U.S. commercial claims from the FAIR Health data warehouse.

Conditions

Peripheral Arterial Disease

Outcome Measures

Primary Outcomes (1)

• Survival

  Freedom from death of any cause

  4 years post intervention

Secondary Outcomes (3)

• Survival

  2 years post intervention

• Retreatment

  2 years post intervention

• Amputation

  2 years post intervention

Other Outcomes (3)

• Survival for age groups

  4 years and 2 years post intervention

• Survival for demographics and special baseline variables

  4 years and 2 years post intervention

• Survival for special treatment category

  4 years and 2 years post intervention

Study Arms (2)

Paclitaxel Drug Coated Balloon

Patients treated with paclitaxel drug-coated balloon

Drug: Paclitaxel

Paclitaxel Drug Coated Stent

Patients treated with paclitaxel drug-coated stent

Drug: Paclitaxel

Interventions

Paclitaxel DRUG

Paclitaxel to treat peripheral arterial disease

Also known as: Taxol

Paclitaxel Drug Coated Balloon; Paclitaxel Drug Coated Stent

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Commercial claims of patients who underwent endovascular interventional treatment of the femoral or popliteal arteries for symptomatic PAD between 1/1/15 and 12/31/2019 will form the study population. Three separate safety analyses will be performed. 1. Paclitaxel Drug coated balloons (DCB) as compared with propensity-matched patients treated with plain transluminal balloon angioplasty (PTA). 2. Paclitaxel delivering Drug-Eluting Stents (DES) as compared with propensity-matched cases using bare-metal stents (BMS). 3. Patients treated with either paclitaxel DCB or paclitaxel DES (any PTX) compared with propensity-matched controls (non-PTX,with DCB patients, matched to patients treated with PTA, and DES patients matched to patients treated with BMS).

You may qualify if:

• All patients, age 18 or older, who had a health insurance claim for outpatient endovascular treatment of the femoral or popliteal arteries for symptomatic PAD will be included. The diagnosis and treatment of PAD in the femoral and popliteal arteries will be identified by CPT/HCPCS and ICD-9 and ICD-10 PCS codes.
• Presence of at least one additional outpatient or inpatient claims, at least 12 months following the index procedure, in order to demonstrate continued enrollment in health insurance coverage.

You may not qualify if:

• Age \<18 years
• No qualifying peripheral arterial endovascular procedure
• Inpatient procedure
• Patients without any linked claim record more than 12 months after the index procedure, not known to have died or entered hospice care within the first 12 months

Sponsors & Collaborators

• Lahey Clinic: lead
• National Evaluation System for health Technology Coordinating Center: collaborator
• Society for Vascular Surgery Patient Safety Organization: collaborator

Study Sites (1)

Lahey Clinic, Inc

Burlington, Massachusetts, 01805, United States

Location

Related Publications (13)

• Dake MD, Ansel GM, Jaff MR, Ohki T, Saxon RR, Smouse HB, Zeller T, Roubin GS, Burket MW, Khatib Y, Snyder SA, Ragheb AO, White JK, Machan LS; Zilver PTX Investigators. Paclitaxel-eluting stents show superiority to balloon angioplasty and bare metal stents in femoropopliteal disease: twelve-month Zilver PTX randomized study results. Circ Cardiovasc Interv. 2011 Oct 1;4(5):495-504. doi: 10.1161/CIRCINTERVENTIONS.111.962324. Epub 2011 Sep 27.

  PMID: 21953370 RESULT

• Dake MD, Ansel GM, Jaff MR, Ohki T, Saxon RR, Smouse HB, Snyder SA, O'Leary EE, Tepe G, Scheinert D, Zeller T; Zilver PTX Investigators. Sustained safety and effectiveness of paclitaxel-eluting stents for femoropopliteal lesions: 2-year follow-up from the Zilver PTX randomized and single-arm clinical studies. J Am Coll Cardiol. 2013 Jun 18;61(24):2417-2427. doi: 10.1016/j.jacc.2013.03.034. Epub 2013 Apr 10.

  PMID: 23583245 RESULT

• Katsanos K, Spiliopoulos S, Kitrou P, Krokidis M, Karnabatidis D. Risk of Death Following Application of Paclitaxel-Coated Balloons and Stents in the Femoropopliteal Artery of the Leg: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. J Am Heart Assoc. 2018 Dec 18;7(24):e011245. doi: 10.1161/JAHA.118.011245.

  PMID: 30561254 RESULT

• Rocha-Singh KJ, Duval S, Jaff MR, Schneider PA, Ansel GM, Lyden SP, Mullin CM, Ioannidis JPA, Misra S, Tzafriri AR, Edelman ER, Granada JF, White CJ, Beckman JA; VIVA Physicians, Inc. Mortality and Paclitaxel-Coated Devices: An Individual Patient Data Meta-Analysis. Circulation. 2020 Jun 9;141(23):1859-1869. doi: 10.1161/CIRCULATIONAHA.119.044697. Epub 2020 May 6.

  PMID: 32370548 RESULT

• Secemsky EA, Kundi H, Weinberg I, Jaff MR, Krawisz A, Parikh SA, Beckman JA, Mustapha J, Rosenfield K, Yeh RW. Association of Survival With Femoropopliteal Artery Revascularization With Drug-Coated Devices. JAMA Cardiol. 2019 Apr 1;4(4):332-340. doi: 10.1001/jamacardio.2019.0325.

  PMID: 30747949 RESULT

• Secemsky EA, Kundi H, Weinberg I, Schermerhorn M, Beckman JA, Parikh SA, Jaff MR, Mustapha J, Rosenfield K, Yeh RW. Drug-Eluting Stent Implantation and Long-Term Survival Following Peripheral Artery Revascularization. J Am Coll Cardiol. 2019 May 28;73(20):2636-2638. doi: 10.1016/j.jacc.2019.02.020. Epub 2019 Mar 1. No abstract available.

  PMID: 30831175 RESULT

• Behrendt CA, Sedrakyan A, Peters F, Kreutzburg T, Schermerhorn M, Bertges DJ, Larena-Avellaneda A, L'Hoest H, Kolbel T, Debus ES. Editor's Choice - Long Term Survival after Femoropopliteal Artery Revascularisation with Paclitaxel Coated Devices: A Propensity Score Matched Cohort Analysis. Eur J Vasc Endovasc Surg. 2020 Apr;59(4):587-596. doi: 10.1016/j.ejvs.2019.12.034. Epub 2020 Jan 8.

  PMID: 31926836 RESULT

• Resnic FS, Gross TP, Marinac-Dabic D, Loyo-Berrios N, Donnelly S, Normand SL, Matheny ME. Automated surveillance to detect postprocedure safety signals of approved cardiovascular devices. JAMA. 2010 Nov 10;304(18):2019-27. doi: 10.1001/jama.2010.1633.

  PMID: 21063011 RESULT

• Kumar A, Matheny ME, Ho KK, Yeh RW, Piemonte TC, Waldman H, Shah PB, Cope R, Normand SL, Donnelly S, Robbins S, Resnic FS. The data extraction and longitudinal trend analysis network study of distributed automated postmarket cardiovascular device safety surveillance. Circ Cardiovasc Qual Outcomes. 2015 Jan;8(1):38-46. doi: 10.1161/CIRCOUTCOMES.114.001123. Epub 2014 Dec 9.

  PMID: 25491915 RESULT

• Resnic FS, Majithia A. Registry-Based Surveillance of Medical-Device Safety. N Engl J Med. 2017 May 18;376(20):1995. doi: 10.1056/NEJMc1704006. No abstract available.

  PMID: 28514621 RESULT

• Hsieh FY, Lavori PW, Cohen HJ, Feussner JR. An overview of variance inflation factors for sample-size calculation. Eval Health Prof. 2003 Sep;26(3):239-57. doi: 10.1177/0163278703255230.

  PMID: 12971199 RESULT

• Vidi VD, Matheny ME, Resnic FS. Post-marketing device safety surveillance. Contemp Clin Trials. 2011 May;32(3):307-8. doi: 10.1016/j.cct.2011.02.002. Epub 2011 Feb 28. No abstract available.

  PMID: 21371573 RESULT

• Austin PC. Optimal caliper widths for propensity-score matching when estimating differences in means and differences in proportions in observational studies. Pharm Stat. 2011 Mar-Apr;10(2):150-61. doi: 10.1002/pst.433.

  PMID: 20925139 RESULT

Related Links

• McKeown L. Two trials halted in wake of study linking paclitaxel-coated devices to deaths in PAD

MeSH Terms

Conditions

Peripheral Arterial Disease

Interventions

Paclitaxel

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Study Officials

• Sourbha S Dani, MD, MSc

  Lahey Hospital & Medical Center

  PRINCIPAL INVESTIGATOR

• Frederic S Resnic, MD, MSc

  Lahey Hospital & Medical Center

  STUDY DIRECTOR

• Robbert Zusterzeel, MD, MPH, PhD

  NESTcc

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Staff Cardiologist

Study Record Dates

• First Submitted: November 23, 2020
• First Posted: December 1, 2020
• Study Start: November 20, 2020
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2021
• Last Updated: February 14, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)