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PARIS – The Xience everolimus-eluting coronary stent is widely considered the current standard treatment, implanted by interventional cardiologists far more often than any other drug-eluting stent (DES). But judging from the results of the TARGET All Comers trial, some serious competition may be headed Xience’s way in the form of the new Firehawk rapamycin-eluting, thin-strut stent featuring a biodegradable polymer drug delivery system.
What’s more, the Firehawk offers a theoretical advantage in that the rapamycin is delivered via a polymer that’s fully absorbed by 9 months, leaving behind a bare metal stent made of cobalt chromium. This structure is believed to be less proinflammatory, atherogenic, and thrombogenic over the long haul, compared with a permanent durable polymer, such as that employed in the Xience stent. This should translate into less late restenosis and in-stent thrombosis.
Also, the Firehawk features thin, 86-mcm struts and the rapamycin, also known as sirolimus, is contained in abluminal grooves directed specifically to the vessel wall. As a result, this DES exposes patients to only one-third as much active drug as other DESs. Ninety percent of the rapamycin is released within 90 days after implantation, according to Dr. Baumbach, director of interventional research at Barts Heart Centre in London and president of the European Association of Percutaneous Cardiovascular Interventions.
The TARGET All Comers trial is a prospective, open-label, noninferiority trial comparing the safety and efficacy of the Firehawk with those of Xience stents in 1,656 DES-eligible patients with symptomatic coronary artery disease randomized at 21 centers.
The primary endpoint was the 12-month composite of target lesion failure, comprising rates of cardiac death, target vessel MI, or ischemia-driven target lesion revascularization. In an intention-to-treat analysis, the rate was 6.1% in the Firehawk patients and 5.9% in the Xience recipients. Results for each of the three components of the composite endpoint were similar in the two groups as well.
A secondary endpoint was in-stent late loss as measured by quantitative coronary angiography at 13 months in a 137-patient subgroup. The rate was 0.17 mm in the Firehawk recipients and similar at 0.11 mm in those receiving the Xience stent, again, which provided solid evidence of noninferiority.
The rate of definite stent thrombosis at 1 year was 1.2% in both study arms.
Discussant Giulio Guagliumi, MD, an interventional cardiologist at Pope Giovanni XXIII Hospital in Bergamo, Italy, pronounced the results “quite reassuring.” But where, he asked, is the evidence of late benefit for the completely biodegradable polymer utilized in the Firehawk?
“We would expect to see such an effect later on, after the stent in question becomes a simple bare metal stent as opposed to a stent with a durable polymer. But we don’t have the ultimate answer yet. In this trial we will have an extended follow-up out to 5 years to see whether there is any translation of these differences into clinical benefit,” Dr. Baumbach replied.
Discussion panelist Julinda Mehilli, MD, inquired how this new stent, which has been approved for the European market, will fit into everyday clinical practice.
“We have many biodegradable polymer DES already. We have the Ultimaster, we have Synergy – and now, the Firehawk. What kind of special features does it have? Is it for use in routine practice or in special populations?” asked Dr. Mehilli, director of interventional cardiology at the German Heart Center at the University of Munich.
“That’s of course the question: What’s the unique point of this stent? I think that the unique point is that there is really no unique point. This is a classic workhorse stent. This is a stent with good radial force and all the other features for everyday use,” according to Dr. Baumbach.
Indeed, he and his Barts colleagues did more than 100 cases in TARGET All Comers and found one of the Firehawk’s strengths was its versatility. It performed well in challenging cases, including left main interventions, as well as in more straightforward cases in this all comers trial.
The Firehawk was developed by MicroPort in China, where its safety and efficacy was established in clinical trials totaling more than 1,000 patients. It then moved to Europe, where it has earned regulatory approval. A pivotal U.S. trial is being planned with the Food and Drug Administration, which has indicated that the European TARGET All Comers data can be incorporated in the study.
Dr. Baumbach reported receiving research grants from Abbott and consultation fees from Keystone Heart, MicroPort, Sinomed, and Stentys.
PARIS – The Xience everolimus-eluting coronary stent is widely considered the current standard treatment, implanted by interventional cardiologists far more often than any other drug-eluting stent (DES). But judging from the results of the TARGET All Comers trial, some serious competition may be headed Xience’s way in the form of the new Firehawk rapamycin-eluting, thin-strut stent featuring a biodegradable polymer drug delivery system.
What’s more, the Firehawk offers a theoretical advantage in that the rapamycin is delivered via a polymer that’s fully absorbed by 9 months, leaving behind a bare metal stent made of cobalt chromium. This structure is believed to be less proinflammatory, atherogenic, and thrombogenic over the long haul, compared with a permanent durable polymer, such as that employed in the Xience stent. This should translate into less late restenosis and in-stent thrombosis.
Also, the Firehawk features thin, 86-mcm struts and the rapamycin, also known as sirolimus, is contained in abluminal grooves directed specifically to the vessel wall. As a result, this DES exposes patients to only one-third as much active drug as other DESs. Ninety percent of the rapamycin is released within 90 days after implantation, according to Dr. Baumbach, director of interventional research at Barts Heart Centre in London and president of the European Association of Percutaneous Cardiovascular Interventions.
The TARGET All Comers trial is a prospective, open-label, noninferiority trial comparing the safety and efficacy of the Firehawk with those of Xience stents in 1,656 DES-eligible patients with symptomatic coronary artery disease randomized at 21 centers.
The primary endpoint was the 12-month composite of target lesion failure, comprising rates of cardiac death, target vessel MI, or ischemia-driven target lesion revascularization. In an intention-to-treat analysis, the rate was 6.1% in the Firehawk patients and 5.9% in the Xience recipients. Results for each of the three components of the composite endpoint were similar in the two groups as well.
A secondary endpoint was in-stent late loss as measured by quantitative coronary angiography at 13 months in a 137-patient subgroup. The rate was 0.17 mm in the Firehawk recipients and similar at 0.11 mm in those receiving the Xience stent, again, which provided solid evidence of noninferiority.
The rate of definite stent thrombosis at 1 year was 1.2% in both study arms.
Discussant Giulio Guagliumi, MD, an interventional cardiologist at Pope Giovanni XXIII Hospital in Bergamo, Italy, pronounced the results “quite reassuring.” But where, he asked, is the evidence of late benefit for the completely biodegradable polymer utilized in the Firehawk?
“We would expect to see such an effect later on, after the stent in question becomes a simple bare metal stent as opposed to a stent with a durable polymer. But we don’t have the ultimate answer yet. In this trial we will have an extended follow-up out to 5 years to see whether there is any translation of these differences into clinical benefit,” Dr. Baumbach replied.
Discussion panelist Julinda Mehilli, MD, inquired how this new stent, which has been approved for the European market, will fit into everyday clinical practice.
“We have many biodegradable polymer DES already. We have the Ultimaster, we have Synergy – and now, the Firehawk. What kind of special features does it have? Is it for use in routine practice or in special populations?” asked Dr. Mehilli, director of interventional cardiology at the German Heart Center at the University of Munich.
“That’s of course the question: What’s the unique point of this stent? I think that the unique point is that there is really no unique point. This is a classic workhorse stent. This is a stent with good radial force and all the other features for everyday use,” according to Dr. Baumbach.
Indeed, he and his Barts colleagues did more than 100 cases in TARGET All Comers and found one of the Firehawk’s strengths was its versatility. It performed well in challenging cases, including left main interventions, as well as in more straightforward cases in this all comers trial.
The Firehawk was developed by MicroPort in China, where its safety and efficacy was established in clinical trials totaling more than 1,000 patients. It then moved to Europe, where it has earned regulatory approval. A pivotal U.S. trial is being planned with the Food and Drug Administration, which has indicated that the European TARGET All Comers data can be incorporated in the study.
Dr. Baumbach reported receiving research grants from Abbott and consultation fees from Keystone Heart, MicroPort, Sinomed, and Stentys.
PARIS – The Xience everolimus-eluting coronary stent is widely considered the current standard treatment, implanted by interventional cardiologists far more often than any other drug-eluting stent (DES). But judging from the results of the TARGET All Comers trial, some serious competition may be headed Xience’s way in the form of the new Firehawk rapamycin-eluting, thin-strut stent featuring a biodegradable polymer drug delivery system.
What’s more, the Firehawk offers a theoretical advantage in that the rapamycin is delivered via a polymer that’s fully absorbed by 9 months, leaving behind a bare metal stent made of cobalt chromium. This structure is believed to be less proinflammatory, atherogenic, and thrombogenic over the long haul, compared with a permanent durable polymer, such as that employed in the Xience stent. This should translate into less late restenosis and in-stent thrombosis.
Also, the Firehawk features thin, 86-mcm struts and the rapamycin, also known as sirolimus, is contained in abluminal grooves directed specifically to the vessel wall. As a result, this DES exposes patients to only one-third as much active drug as other DESs. Ninety percent of the rapamycin is released within 90 days after implantation, according to Dr. Baumbach, director of interventional research at Barts Heart Centre in London and president of the European Association of Percutaneous Cardiovascular Interventions.
The TARGET All Comers trial is a prospective, open-label, noninferiority trial comparing the safety and efficacy of the Firehawk with those of Xience stents in 1,656 DES-eligible patients with symptomatic coronary artery disease randomized at 21 centers.
The primary endpoint was the 12-month composite of target lesion failure, comprising rates of cardiac death, target vessel MI, or ischemia-driven target lesion revascularization. In an intention-to-treat analysis, the rate was 6.1% in the Firehawk patients and 5.9% in the Xience recipients. Results for each of the three components of the composite endpoint were similar in the two groups as well.
A secondary endpoint was in-stent late loss as measured by quantitative coronary angiography at 13 months in a 137-patient subgroup. The rate was 0.17 mm in the Firehawk recipients and similar at 0.11 mm in those receiving the Xience stent, again, which provided solid evidence of noninferiority.
The rate of definite stent thrombosis at 1 year was 1.2% in both study arms.
Discussant Giulio Guagliumi, MD, an interventional cardiologist at Pope Giovanni XXIII Hospital in Bergamo, Italy, pronounced the results “quite reassuring.” But where, he asked, is the evidence of late benefit for the completely biodegradable polymer utilized in the Firehawk?
“We would expect to see such an effect later on, after the stent in question becomes a simple bare metal stent as opposed to a stent with a durable polymer. But we don’t have the ultimate answer yet. In this trial we will have an extended follow-up out to 5 years to see whether there is any translation of these differences into clinical benefit,” Dr. Baumbach replied.
Discussion panelist Julinda Mehilli, MD, inquired how this new stent, which has been approved for the European market, will fit into everyday clinical practice.
“We have many biodegradable polymer DES already. We have the Ultimaster, we have Synergy – and now, the Firehawk. What kind of special features does it have? Is it for use in routine practice or in special populations?” asked Dr. Mehilli, director of interventional cardiology at the German Heart Center at the University of Munich.
“That’s of course the question: What’s the unique point of this stent? I think that the unique point is that there is really no unique point. This is a classic workhorse stent. This is a stent with good radial force and all the other features for everyday use,” according to Dr. Baumbach.
Indeed, he and his Barts colleagues did more than 100 cases in TARGET All Comers and found one of the Firehawk’s strengths was its versatility. It performed well in challenging cases, including left main interventions, as well as in more straightforward cases in this all comers trial.
The Firehawk was developed by MicroPort in China, where its safety and efficacy was established in clinical trials totaling more than 1,000 patients. It then moved to Europe, where it has earned regulatory approval. A pivotal U.S. trial is being planned with the Food and Drug Administration, which has indicated that the European TARGET All Comers data can be incorporated in the study.
Dr. Baumbach reported receiving research grants from Abbott and consultation fees from Keystone Heart, MicroPort, Sinomed, and Stentys.
REPORTING FROM EUROPCR 2018
Key clinical point: The Firehawk has established itself as a versatile workhorse coronary stent.
Major finding:
Study details: This open-label international study randomized 1,656 patients with symptomatic CAD to one of two drug-eluting stents.
Disclosures: The TARGET All Comers trial was sponsored by MicroPort. The presenter reported serving as a consultant to MicroPort and other companies.