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
- Starting date:
- May 6, 2019
- Posting date:
- May 6, 2019
- Type of communication:
- Dear Healthcare Professional Letter
- Subcategory:
- Medical Device
- Source of recall:
- Health Canada
- Issue:
- Important Safety Information
- Audience:
- Healthcare Professionals
- Identification number:
- RA-69848
Last updated:
Audiences
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).Footnote 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.
Issue
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.Footnote 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.
| Medical Device Name | Manufacturer | Device Licence Number |
|---|---|---|
* Device no longer licensed in Canada as of October 2018
**Other paclitaxel-containing devices are licensed for treatment of differentFootnote 1 | ||
| 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 |
Background information
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.Footnote 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.Footnote 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.
Who is affected
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
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
E-mail: mhpd-dpsc@canada.ca
Telephone: 613-954-6522
Fax: 613-952-7738
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