Article Type
Changed
Fri, 03/15/2019 - 16:49

 

“Alternative treatment options should generally be used for most patients,” rather than paclitaxel-coated balloons and stents for peripheral arterial disease (PAD), pending an ongoing safety review, according to the Food and Drug Administration.

FDA icon

The FDA conducted a preliminary analysis of long-term follow-up data (up to 5 years in some studies) of the pivotal premarket randomized trials for paclitaxel-coated products indicated for peripheral arterial disease (PAD). In a Letter to Healthcare providers issued March 15, the FDA reported that their preliminary review of these data found “a potentially concerning signal of increased long-term mortality in study subjects treated with paclitaxel-coated products, compared to patients treated with uncoated devices.”

The three trials (totaling 975 patients) that had 5-year follow-up data demonstrated an approximately 50% increased risk of mortality in subjects treated with paclitaxel-coated devices vs. those treated with control devices (20.1% vs. 13.4% crude risk of death at 5 years), according to the agency.

The FDA indicated that these data “should be interpreted with caution for several reasons.” They cited a large variability in the risk estimate of mortality because of the limited amount of long-term data and pointed out that the studies were not designed to be pooled. In addition, the specific cause and mechanism of the increased mortality was unknown.

The FDA also announced that they are planning on convening an Advisory Committee meeting of the Circulatory System Devices Panel to address this issue, including plausible mechanisms for this mortality effect, a re-examination of the benefit-risk profile, modifications of current and future clinical trials regarding these devices, and guidance to any regulatory action, as needed. The timing of this meeting is to be announced within the upcoming weeks.

The FDA letter further stated that the agency intends to conduct additional analyses “to determine whether the benefits continue to outweigh the risks for approved paclitaxel-coated balloons and paclitaxel-eluting stents when used in accordance with their indications for use.”

mlesney@mdedge.com

SOURCE: Food and Drug Administration Letter to Healthcare Providers. 2019 Mar 15.

Publications
Topics
Sections

 

“Alternative treatment options should generally be used for most patients,” rather than paclitaxel-coated balloons and stents for peripheral arterial disease (PAD), pending an ongoing safety review, according to the Food and Drug Administration.

FDA icon

The FDA conducted a preliminary analysis of long-term follow-up data (up to 5 years in some studies) of the pivotal premarket randomized trials for paclitaxel-coated products indicated for peripheral arterial disease (PAD). In a Letter to Healthcare providers issued March 15, the FDA reported that their preliminary review of these data found “a potentially concerning signal of increased long-term mortality in study subjects treated with paclitaxel-coated products, compared to patients treated with uncoated devices.”

The three trials (totaling 975 patients) that had 5-year follow-up data demonstrated an approximately 50% increased risk of mortality in subjects treated with paclitaxel-coated devices vs. those treated with control devices (20.1% vs. 13.4% crude risk of death at 5 years), according to the agency.

The FDA indicated that these data “should be interpreted with caution for several reasons.” They cited a large variability in the risk estimate of mortality because of the limited amount of long-term data and pointed out that the studies were not designed to be pooled. In addition, the specific cause and mechanism of the increased mortality was unknown.

The FDA also announced that they are planning on convening an Advisory Committee meeting of the Circulatory System Devices Panel to address this issue, including plausible mechanisms for this mortality effect, a re-examination of the benefit-risk profile, modifications of current and future clinical trials regarding these devices, and guidance to any regulatory action, as needed. The timing of this meeting is to be announced within the upcoming weeks.

The FDA letter further stated that the agency intends to conduct additional analyses “to determine whether the benefits continue to outweigh the risks for approved paclitaxel-coated balloons and paclitaxel-eluting stents when used in accordance with their indications for use.”

mlesney@mdedge.com

SOURCE: Food and Drug Administration Letter to Healthcare Providers. 2019 Mar 15.

 

“Alternative treatment options should generally be used for most patients,” rather than paclitaxel-coated balloons and stents for peripheral arterial disease (PAD), pending an ongoing safety review, according to the Food and Drug Administration.

FDA icon

The FDA conducted a preliminary analysis of long-term follow-up data (up to 5 years in some studies) of the pivotal premarket randomized trials for paclitaxel-coated products indicated for peripheral arterial disease (PAD). In a Letter to Healthcare providers issued March 15, the FDA reported that their preliminary review of these data found “a potentially concerning signal of increased long-term mortality in study subjects treated with paclitaxel-coated products, compared to patients treated with uncoated devices.”

The three trials (totaling 975 patients) that had 5-year follow-up data demonstrated an approximately 50% increased risk of mortality in subjects treated with paclitaxel-coated devices vs. those treated with control devices (20.1% vs. 13.4% crude risk of death at 5 years), according to the agency.

The FDA indicated that these data “should be interpreted with caution for several reasons.” They cited a large variability in the risk estimate of mortality because of the limited amount of long-term data and pointed out that the studies were not designed to be pooled. In addition, the specific cause and mechanism of the increased mortality was unknown.

The FDA also announced that they are planning on convening an Advisory Committee meeting of the Circulatory System Devices Panel to address this issue, including plausible mechanisms for this mortality effect, a re-examination of the benefit-risk profile, modifications of current and future clinical trials regarding these devices, and guidance to any regulatory action, as needed. The timing of this meeting is to be announced within the upcoming weeks.

The FDA letter further stated that the agency intends to conduct additional analyses “to determine whether the benefits continue to outweigh the risks for approved paclitaxel-coated balloons and paclitaxel-eluting stents when used in accordance with their indications for use.”

mlesney@mdedge.com

SOURCE: Food and Drug Administration Letter to Healthcare Providers. 2019 Mar 15.

Publications
Publications
Topics
Article Type
Sections
Disallow All Ads
Content Gating
No Gating (article Unlocked/Free)
Alternative CME
Vitals

 

Key clinical point: FDA advises that alternatives to paclitaxel-coated devices for PAD should be used for most patients.

Major finding: Five-year data demonstrated an approximately 50% increased risk of mortality in patients with paclitaxel-coated devices, compared with uncoated ones.

Study details: Preliminary FDA review of three trials with 975 patients.

Disclosures: Study is funded and performed by the FDA.

Source: Food and Drug Administration. Letter to Healthcare Providers. 2019 Mar 15.

Disqus Comments
Default
Use ProPublica
Hide sidebar & use full width
render the right sidebar.