Paclitaxel-coated balloons (pcb) and paclitaxel-eluting stents (pes) for the treatment of peripheral arterial disease (pad) and the potential risk of long-term all-cause mortality

UPDATED INFORMATION – February 20, 2024 Health Canada worked with manufacturers, clinicians, and other international health regulatory agencies to further assess the risk of increased mortality associated with the use of paclitaxel-coated devices used to treat peripheral arterial disease (PAD). Based on all available clinical evidence, Health Canada did not identify an increased risk of mortality associated with the use of these devices when used in accordance with the licensed indications. This information aligns with the U.S. Food and Drug Administration (US FDA) recommendations of July 11, 2023 and recommendations made by Health Canada’s Scientific Advisory Committee on Medical Devices Used in the Cardiovascular System (SAC-MDUCS) in November 2023. This update applies to all paclitaxel-coated device models. Please note that the communication issued on May 6, 2019 (see below), is no longer reflective of the current Health Canada findings. Healthcare professionals are advised to use the paclitaxel-coated devices in accordance with the licensed indications outlined in the labeling material. May 6, 2019 A potential increased risk of long-term, all-cause mortality (at 2 years to 5 years) after the use of PCB and PES for the treatment of PAD was identified in a meta-analysis, which was published in the Journal of the American Heart Association (JAHA) in December 2018.1 The reason for the potential increased risk of death is not yet known. Health Canada is currently evaluating this safety concern to determine if there is an increased long-term mortality risk associated with paclitaxel‐containing devices used for PAD treatment. Audience Healthcare professionals in hospitals, including hospital chiefs of medical staff, department of vascular surgery, interventional radiologists, and other relevant departments. Key Messages A study published in the Journal of the American Heart Association has identified a possible increased risk of death after the use of paclitaxel‐coated balloons (PCB) and paclitaxel-eluting stents (PES) to treat peripheral arterial disease (PAD).1 The reason for this possible increased risk of death is not yet known. Health Canada is currently evaluating recently-published information on this risk. As a precautionary measure, healthcare professionals are advised to: Continue surveillance of patients who have been treated with paclitaxel-containing devices for treatment of PAD according to current standards of care. Weigh the risks and benefits for each patient when considering the use of PCB and PES in patients with PAD. Consider alternative treatment options rather than PCB and PES until additional analysis of the safety concern has been done. Consider limiting the use of PCB and PES to patients with critical limb ischemia (CLI). Inform patients of the possible additional risks associated with the use of paclitaxel-containing devices. Health Canada has also requested that manufacturers update the labelling of paclitaxel-containing devices to include details about this potential risk. Products affected Medical Device Name Manufacturer Device Licence Number Paclitaxel-containing devices used to treat PAD LUTONIX 035 DRUG COATED BALLOON PTA CATHETER Lutonix Inc. 96031 IN.PACT ADMIRAL PACLITAXEL-COATED PTA BALLOON CATHETER Medtronic Inc. 98019 LUTONIX 014 DRUG COATED PTA DILATATION CATHETER Lutonix Inc. 91277 RANGER OTW PACLITAXEL-COATED PTA BALLOON CATHETER Hemoteq AG 97627 RANGER SL OTW PACLITAXEL-COATED PTA BALLOON CATHETER Hemoteq AG 97627 IVASCULAR LUMINOR 14M, PACLITAXEL ELUTING PTA BALLOON DILATATION CATHETER Life Vascular Devices Biotech S.L. 97387 ZILVER PTX DRUG-ELUTING PERIPHERAL STENT (6FR) Cook Ireland LTD. 90774 ZILVER PTX DRUG-ELUTING PERIPHERAL STENT (7FR) * Cook, Inc. 90773 Other paclitaxel-containing devices ** PANTERA LUX PACLITAXEL RELEASING PTCA BALLOON CATHETER Biotronik AG 95407 OPTILUME URETHRAL DRUG COATED BALLOON CATHETER Urotronic Inc. 101026 LUTONIX 035 DRUG COATED BALLOON PTA CATHETER Lutonix Inc. 100575 * Device no longer licensed in Canada as of October 2018. **Other paclitaxel-containing devices are licensed for treatment of different diseases than PAD. These devices were not evaluated in the recently-published meta-analysis, but they could also potentially be associated with the increased risk of long-term mortality due to paclitaxel content.1 Background PCB and PES are intended to treat de novo or restenotic lesions in the leg, including the superficial femoral and femoropopliteal arteries to mechanically open obstructed vessels. The release of paclitaxel from these devices is intended to reduce restenosis in the artery that can reduce blood flow. Paclitaxel-containing devices have also been licensed for the treatment of coronary artery disease, stenotic lesions in dysfunctional arteriovenous dialysis fistulae, and other diseases. A recent meta-analysis of randomized controlled trials published in the Journal of the American Heart Association (JAHA) in December 2018 identified an increase in all-cause mortality at two years in PAD patients treated with PCB and PES compared to patients treated with non-coated balloons or bare metal stents.1 This increase persisted for five years. The reason for the potential increased risk of death is not yet known. This issue was discussed at the March 1, 2019, meeting of Health Canada’s Scientific Advisory Committee on Medical Devices Used in the Cardiovascular System (SAC-MDUCS), which is made up of medical experts.2 The committee felt the benefits of the use of devices containing paclitaxel continue to outweigh the potential increased risk for patients with CLI. However, the potential impact of this issue remains unclear in patients treated for claudication. Health Canada is currently evaluating the recently published meta-analysis and other information to assess the risk/benefit profile of paclitaxel-containing devices indicated for PAD treatment. As an interim measure, while Health Canada and other global stakeholders continue to assess data, the department has requested additional information from manufacturers for PCB and PES licensed in Canada. Health Canada has also requested that manufacturers update the labelling of paclitaxel-containing devices to include details about this potential risk. Information for consumers Paclitaxel-coated balloons are devices inserted into narrowed or blocked blood vessels to restore blood flow. After the balloon is removed, a drug called paclitaxel remains on the blood vessel to prevent scar tissue formation and recurrence of the vessel blockage. Paclitaxel-eluting stents are devices placed to hold a blood vessel open and slowly release the drug to prevent scar tissue and blockage. The drug from paclitaxel-coated balloons and in paclitaxel-eluting stents is released over days to months. A recently-published study showed a higher risk of death in the long term in patients treated with paclitaxel-containing devices in blood vessels in the leg compared to patients treated with balloons and stents that do not contain the drug. The reason for the potential increased risk of death is not known at this time. Patients who have been treated with paclitaxel-containing devices should continue to consult their health care provider for regular follow-up. Patients who are potentially going to be treated with these devices should discuss all known risks with their health care provider. Information for healthcare professionals Until additional information is available, healthcare professionals are advised to: Continue surveillance of patients who have been treated for PAD with PCB and PES according to current standards of care. Determine whether the benefits of using these devices outweigh the risks for each patient. Consider limiting the use of PCB and PES indicated for the treatment of PAD to CLI patients. Make the patient aware of the potential additional risks associated with these products. Action taken by Health Canada Health Canada discussed this potential safety issue at the recent SAC-MDUCS meeting.2 Additional information was requested from the Canadian PCB and PES manufacturers in order to further assess the potential risk. Health Canada continues to actively engage with the manufacturers, clinicians, and other international regulatory agencies to better understand the safety issue. This important safety information is being communicated to Canadians via the Recalls and Safety Alerts Database on the Healthy Canadians website. This communication will be further distributed through the MedEffect™ e-Notice email notification system as well as social media channels including LinkedIn and Twitter. Health Canada will also continue to monitor safety information involving PCB and PES, as it does for all health products on the Canadian market, to better understand this potential risk and identify and assess other potential harms. Appropriate and timely action will be taken if and when any new health risks are identified. Report health or safety concerns Health Canada’s ability to monitor the safety of marketed health products depends on healthcare providers and consumers reporting adverse reactions and medical device incidents. Any cases of death or serious or unexpected side effects in patients receiving PCB and PES should be reported to the device manufacturer or Health Canada. Any suspected adverse incident can be reported to: Regulatory Operations and Enforcement Branch HEALTH CANADA Address Locator: 2003D Ottawa, Ontario K1A 0K9 Telephone: Regulatory Operations and Regions Branch Hotline: 1-800-267-9675 The Health Product Complaint Form (FRM-0317) can be found on the Health Canada Web site. For other health product inquiries related to this communication, contact Health Canada at: Marketed Health Products Directorate (MHPD) E-mail: mhpd-dpsc@canada.ca Telephone: 613-954-6522 Fax: 613-952-7738 References Katsanos, K., Spiliopoulos, et al. 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. Journal of the American Heart Association, 2018;7(24). Health Canada. Medical Devices Used in the Cardiovascular System - Canada.ca. Https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/activities/scientific-expert-advisory-committees/medical-devices-used-cardiovascular-system.html. Published 2019. Accessed April 17, 2019.

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Brand: Paclitaxel-coated Balloons And Paclitaxel-eluting Stents.