User login
SAN DIEGO – In the first randomized, head-to-head trial of drug-releasing stents for above-the-knee femoropopliteal peripheral artery disease (PAD), Boston Scientific’s polymer-coated, paclitaxel-eluting stent outperformed Cook Medical’s polymer-free, paclitaxel-coated stent.
At 12 months, primary patency was 86.8% (231/266) in the Eluvia group, versus 81.5% (106/130) among those randomized to Zilver PTX. About 5% of Eluvia patients (14/273) and 9% of patients in the Zilver PTX arm (12/133) had a major adverse event, defined as death within a month or target limb amputation or revascularization through 12 months. Both outcomes were statistically significant at P less than .0001. Overall, 4.5% of Eluvia patients (13/287) required target lesion revascularization, compared with 9% of Zilver PTX patients (13/145).
“These data suggest the Boston Scientific product is superior. Unless there are big differences in cost or technical aspects of the procedure, I would foresee a fairly substantial shift to” Eluvia if it’s approved, which seems likely, said interventional cardiologist David Cohen, MD, of Saint Luke’s Mid America Heart Institute, Kansas City, Mo., who comoderated the study presentation at the Transcatheter Cardiovascular Therapeutics annual meeting.
There were six cases of aneurysmal degeneration with Eluvia, but none with Zilver PTX. All six patients were patent at 1 year, without revascularization or stent thrombosis. It’s too early to know what to make of the finding. The planned 5-year follow-up should shed some light on the issue, Dr. Gray said.
At present, there’s no clear algorithm for above-the-knee PAD. Balloons and stents – both drug-releasing and bare – are all in play, and new devices are on the way. “With a head-to-head trial like this, we are staring to pare down all the noise in the market place. I think for long complicated lesions, I would be very surprised if we don’t start seeing more drug-eluting stents, because the results are so good. Drug-coated balloons are useful, but they take a little bit longer and a little more nuance,” especially when stent are used to touch up the results, he said.
“If [Boston Scientific] prices this at a premium and my doctors come to me and say ‘You’ve got to let us buy this,’ it’s going to be a hard sell for me,” said Dr. Jaff, a professor of medicine at Harvard Medical School, Boston, and president of the nearby Newton-Wellesley Hospital in Newton, Mass.
As for shifting away from drug-coated balloons, which are an increasingly popular option, a head-to-head trial is in order. If it turns out Eluvia doesn’t “have a huge advantage, I’d start off with a drug-coated balloon. You leave yourself every option going down the road if it fails. If you have a stent that fails, it’s harder to work with,” he said.
About two-thirds of the subjects were men, and the mean age was about 68 years. Most patients in both arms had marked improvements in symptoms and walking ability after stent placement. Rates of stent thrombosis were low, at about 2% with Eluvia versus 4% with Zilver PTX, a statistically nonsignificant difference.
The IMPERIAL results were published online simultaneously with Dr. Gray’s presentation (Lancet. 2018 Sep 22. doi: 10.1016/S0140-6736[18]32262-1).
The work was funded and conducted by Boston Scientific. Dr. Gray and Dr. Jaffe are advisors to the company. Most of the other investigators disclosed financial ties to company, and one was an employee. Dr. Cohen wasn’t involved in the work. The TCT meeting was sponsored by the Cardiovascular Research Foundation.
SAN DIEGO – In the first randomized, head-to-head trial of drug-releasing stents for above-the-knee femoropopliteal peripheral artery disease (PAD), Boston Scientific’s polymer-coated, paclitaxel-eluting stent outperformed Cook Medical’s polymer-free, paclitaxel-coated stent.
At 12 months, primary patency was 86.8% (231/266) in the Eluvia group, versus 81.5% (106/130) among those randomized to Zilver PTX. About 5% of Eluvia patients (14/273) and 9% of patients in the Zilver PTX arm (12/133) had a major adverse event, defined as death within a month or target limb amputation or revascularization through 12 months. Both outcomes were statistically significant at P less than .0001. Overall, 4.5% of Eluvia patients (13/287) required target lesion revascularization, compared with 9% of Zilver PTX patients (13/145).
“These data suggest the Boston Scientific product is superior. Unless there are big differences in cost or technical aspects of the procedure, I would foresee a fairly substantial shift to” Eluvia if it’s approved, which seems likely, said interventional cardiologist David Cohen, MD, of Saint Luke’s Mid America Heart Institute, Kansas City, Mo., who comoderated the study presentation at the Transcatheter Cardiovascular Therapeutics annual meeting.
There were six cases of aneurysmal degeneration with Eluvia, but none with Zilver PTX. All six patients were patent at 1 year, without revascularization or stent thrombosis. It’s too early to know what to make of the finding. The planned 5-year follow-up should shed some light on the issue, Dr. Gray said.
At present, there’s no clear algorithm for above-the-knee PAD. Balloons and stents – both drug-releasing and bare – are all in play, and new devices are on the way. “With a head-to-head trial like this, we are staring to pare down all the noise in the market place. I think for long complicated lesions, I would be very surprised if we don’t start seeing more drug-eluting stents, because the results are so good. Drug-coated balloons are useful, but they take a little bit longer and a little more nuance,” especially when stent are used to touch up the results, he said.
“If [Boston Scientific] prices this at a premium and my doctors come to me and say ‘You’ve got to let us buy this,’ it’s going to be a hard sell for me,” said Dr. Jaff, a professor of medicine at Harvard Medical School, Boston, and president of the nearby Newton-Wellesley Hospital in Newton, Mass.
As for shifting away from drug-coated balloons, which are an increasingly popular option, a head-to-head trial is in order. If it turns out Eluvia doesn’t “have a huge advantage, I’d start off with a drug-coated balloon. You leave yourself every option going down the road if it fails. If you have a stent that fails, it’s harder to work with,” he said.
About two-thirds of the subjects were men, and the mean age was about 68 years. Most patients in both arms had marked improvements in symptoms and walking ability after stent placement. Rates of stent thrombosis were low, at about 2% with Eluvia versus 4% with Zilver PTX, a statistically nonsignificant difference.
The IMPERIAL results were published online simultaneously with Dr. Gray’s presentation (Lancet. 2018 Sep 22. doi: 10.1016/S0140-6736[18]32262-1).
The work was funded and conducted by Boston Scientific. Dr. Gray and Dr. Jaffe are advisors to the company. Most of the other investigators disclosed financial ties to company, and one was an employee. Dr. Cohen wasn’t involved in the work. The TCT meeting was sponsored by the Cardiovascular Research Foundation.
SAN DIEGO – In the first randomized, head-to-head trial of drug-releasing stents for above-the-knee femoropopliteal peripheral artery disease (PAD), Boston Scientific’s polymer-coated, paclitaxel-eluting stent outperformed Cook Medical’s polymer-free, paclitaxel-coated stent.
At 12 months, primary patency was 86.8% (231/266) in the Eluvia group, versus 81.5% (106/130) among those randomized to Zilver PTX. About 5% of Eluvia patients (14/273) and 9% of patients in the Zilver PTX arm (12/133) had a major adverse event, defined as death within a month or target limb amputation or revascularization through 12 months. Both outcomes were statistically significant at P less than .0001. Overall, 4.5% of Eluvia patients (13/287) required target lesion revascularization, compared with 9% of Zilver PTX patients (13/145).
“These data suggest the Boston Scientific product is superior. Unless there are big differences in cost or technical aspects of the procedure, I would foresee a fairly substantial shift to” Eluvia if it’s approved, which seems likely, said interventional cardiologist David Cohen, MD, of Saint Luke’s Mid America Heart Institute, Kansas City, Mo., who comoderated the study presentation at the Transcatheter Cardiovascular Therapeutics annual meeting.
There were six cases of aneurysmal degeneration with Eluvia, but none with Zilver PTX. All six patients were patent at 1 year, without revascularization or stent thrombosis. It’s too early to know what to make of the finding. The planned 5-year follow-up should shed some light on the issue, Dr. Gray said.
At present, there’s no clear algorithm for above-the-knee PAD. Balloons and stents – both drug-releasing and bare – are all in play, and new devices are on the way. “With a head-to-head trial like this, we are staring to pare down all the noise in the market place. I think for long complicated lesions, I would be very surprised if we don’t start seeing more drug-eluting stents, because the results are so good. Drug-coated balloons are useful, but they take a little bit longer and a little more nuance,” especially when stent are used to touch up the results, he said.
“If [Boston Scientific] prices this at a premium and my doctors come to me and say ‘You’ve got to let us buy this,’ it’s going to be a hard sell for me,” said Dr. Jaff, a professor of medicine at Harvard Medical School, Boston, and president of the nearby Newton-Wellesley Hospital in Newton, Mass.
As for shifting away from drug-coated balloons, which are an increasingly popular option, a head-to-head trial is in order. If it turns out Eluvia doesn’t “have a huge advantage, I’d start off with a drug-coated balloon. You leave yourself every option going down the road if it fails. If you have a stent that fails, it’s harder to work with,” he said.
About two-thirds of the subjects were men, and the mean age was about 68 years. Most patients in both arms had marked improvements in symptoms and walking ability after stent placement. Rates of stent thrombosis were low, at about 2% with Eluvia versus 4% with Zilver PTX, a statistically nonsignificant difference.
The IMPERIAL results were published online simultaneously with Dr. Gray’s presentation (Lancet. 2018 Sep 22. doi: 10.1016/S0140-6736[18]32262-1).
The work was funded and conducted by Boston Scientific. Dr. Gray and Dr. Jaffe are advisors to the company. Most of the other investigators disclosed financial ties to company, and one was an employee. Dr. Cohen wasn’t involved in the work. The TCT meeting was sponsored by the Cardiovascular Research Foundation.
REPORTING FROM TCT 2018
Key clinical point: A drug-eluting stent under development for peripheral artery disease outperformed the only one currently on the market in the United States.
Major finding: At 12 months, primary patency was 86.8% in the Eluvia group versus 81.5% among those randomized to Zilver PTX.
Study details: IMPERIAL was a head-to-head randomized trial with 465 subjects comparing two stents for femoropopliteal PAD.
Disclosures: The work was funded and conducted by Boston Scientific. Most of the investigators disclosed financial ties to company; one was an employee.