FDA News

FDA approves stent platform to treat chronic total occlusions

David E. Kandzari
David E. Kandzari

Medtronic announced that the FDA has approved its drug-eluting stent platform for treatment of de novo chronic total occlusion lesions in patients with CAD.

The platform, which includes the Resolute Onyx and Resolute Integrity stents, were previously approved for use in PCI, but not for CTO procedures, according to a press release from the company.

“While many contemporary drug-eluting stents are used for CTO procedures, we have limited information in a rigorous, detailed clinical trial to document the results with regard to stent thrombosis, MI and repeat revascularization,” David E. Kandzari, MD, director of interventional cardiology and chief scientific officer at the Piedmont Heart Institute in Atlanta, told Cardiology Today’s Intervention.

Therefore, he said, researchers conducted the PERSPECTIVE single-arm observational study of 183 patients with CTOs, on which the new indication was based. The patients were treated with the Resolute Integrity; the Resolute Onyx is a newer generation with thinner struts.

Medtronic announced the FDA has approved its drug-eluting stent platform for treatment of de novo chronic total occlusion lesions in patients with CAD.
Source: Shutterstock

“The salient results of this trial are that we demonstrated with the Resolute drug-eluting stent platform, one of the most commonly used drug-eluting stents worldwide in clinical practice, that we have achieved 1-year results in chronic total occlusion that are similar to that of less complex, non-occlusive disease,” Kandzari, who was principal investigator for PERSPECTIVE, said in an interview.

According to the release, at 1 year, 1.1% of the cohort had repeat revascularization, 2.2% died from cardiac causes and 0.6% had stent thrombosis. Kandzari noted that while the study was nonrandomized and from a single center, it was rigorously conducted enough to lead to an expanded indication.

“While these data alone are not going to create a frame shift alone in the number of procedures being performed, in some ways they will inform both operators and patients with regard to the success that we can achieve with these procedures,” Kandzari said in an interview. “That would endorse considering CTO PCI for patients when we think about not only improving their clinical outcomes, but also improving their patient-reported health status and quality of life. The new indication also opens up more opportunities for physician training in and education about chronic total occlusions and the potential benefits of this procedure.” – by Erik Swain

Disclosure: Kandzari reports he received institutional research/grant support from Biotronik, Boston Scientific, Medinol, Medtronic and OrbusNeich and personal consultant honoraria from Boston Scientific, Cardiovascular Systems Inc. and Medtronic.

David E. Kandzari
David E. Kandzari

Medtronic announced that the FDA has approved its drug-eluting stent platform for treatment of de novo chronic total occlusion lesions in patients with CAD.

The platform, which includes the Resolute Onyx and Resolute Integrity stents, were previously approved for use in PCI, but not for CTO procedures, according to a press release from the company.

“While many contemporary drug-eluting stents are used for CTO procedures, we have limited information in a rigorous, detailed clinical trial to document the results with regard to stent thrombosis, MI and repeat revascularization,” David E. Kandzari, MD, director of interventional cardiology and chief scientific officer at the Piedmont Heart Institute in Atlanta, told Cardiology Today’s Intervention.

Therefore, he said, researchers conducted the PERSPECTIVE single-arm observational study of 183 patients with CTOs, on which the new indication was based. The patients were treated with the Resolute Integrity; the Resolute Onyx is a newer generation with thinner struts.

Medtronic announced the FDA has approved its drug-eluting stent platform for treatment of de novo chronic total occlusion lesions in patients with CAD.
Source: Shutterstock

“The salient results of this trial are that we demonstrated with the Resolute drug-eluting stent platform, one of the most commonly used drug-eluting stents worldwide in clinical practice, that we have achieved 1-year results in chronic total occlusion that are similar to that of less complex, non-occlusive disease,” Kandzari, who was principal investigator for PERSPECTIVE, said in an interview.

According to the release, at 1 year, 1.1% of the cohort had repeat revascularization, 2.2% died from cardiac causes and 0.6% had stent thrombosis. Kandzari noted that while the study was nonrandomized and from a single center, it was rigorously conducted enough to lead to an expanded indication.

“While these data alone are not going to create a frame shift alone in the number of procedures being performed, in some ways they will inform both operators and patients with regard to the success that we can achieve with these procedures,” Kandzari said in an interview. “That would endorse considering CTO PCI for patients when we think about not only improving their clinical outcomes, but also improving their patient-reported health status and quality of life. The new indication also opens up more opportunities for physician training in and education about chronic total occlusions and the potential benefits of this procedure.” – by Erik Swain

Disclosure: Kandzari reports he received institutional research/grant support from Biotronik, Boston Scientific, Medinol, Medtronic and OrbusNeich and personal consultant honoraria from Boston Scientific, Cardiovascular Systems Inc. and Medtronic.