Novel stent for long coronary lesions linked with low rate of target lesion failure
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Key takeaways:
- A novel stent for treating long coronary lesions met its primary performance goal at 1 year.
- The 48-mm stent was deliverable in 97.2% of patients.
A novel 48-mm stent for the treatment of diffuse de novo coronary artery lesions was found to be safe and effective at 1 year, with a high level of device deliverability, a speaker reported.
The results of the prospective, single-arm, open-label, multicenter global SPIRIT 48 trial were presented at the Society for Cardiovascular Angiography and Interventions Scientific Sessions and simultaneously published in the Journal of the Society of Cardiovascular Angiography and Interventions.
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“The purpose of this study was to look at the efficacy and safety of a longer-platform 48 mm stent in patients with diffuse coronary disease. We know that this is a challenging population to treat,” Ki Park, MD, MS, FACC, FSCAI, associate professor of medicine in the division of cardiovascular medicine at the University of Florida, said during a press conference.
At 25 sites globally, Park and colleagues enrolled 105 patients to undergo PCI for the treatment of diffuse de novo coronary artery lesions using the 48-mm stent (Xience Skypoint 48, Abbott). Participants had a reference vessel diameter of between 2.5 and 4.25 mm and a lesion length between 32 and 44 mm.
The primary endpoint was target lesion failure, defined as cardiac death, target vessel MI or clinically indicated target lesion revascularization, at 1 year compared with a prespecified performance goal of 20%.
The device success rate was 97.2%.
Park reported that the primary endpoint occurred in approximately 5.7% of patients, with an upper bound of the 95% CI of 9.5% (P < .0001) — significantly lower than the prespecified performance goal of 20%.
At 1 year, cardiac death and clinically indicated target lesion revascularization occurred in approximately 1% the cohort; target vessel MI occurred in 4.8%; and a composite endpoint of all death, MI and revascularization occurred in 5.8% to 6.7% of participants, based on either the SCAI, Academic Research Consortium 2 or Fourth Universal definition.
One patient (1%) had definite acute or subacute stent thrombosis by the Academic Research Consortium at 1 year, according to the researchers.
“SPIRIT 48 met its primary endpoint of target lesion failure at 1 year,” Park said during the press conference. “The device success rate, which I think is also an important point ... was very high at 97%. Our data supports the efficacy and safety of the Xience Skypoint 48 in treating diffuse de novo coronary artery lesions.”
Reference:
Perspective
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Srihari S. Naidu, MD, FACC, FAHA, FSCAI
This trial goes in the same vein as the EVOLVE 48 trial for the Synergy stent (Boston Scientific). There is certainly a need for longer stents from an ergonomic standpoint — in terms of wanting to be able to implant a stent in the least amount of procedural, contrast and fluoroscopy time. These are all good benefits for the physician and the patient. Longer stents allow you to do that by right-fitting a lesion and lesion length to one stent.
In addition, there are clinical benefits to having one long stent. We have known for a long time that when you overlap stents, there is more stent fracture, it straightens your artery more and it increases target lesion failure, stent thrombosis and in-stent restenosis.
The first time we saw these stents was Abbott’s Xpedition 48 stent about 10 years ago, which had some good results. But obviously the next generation is Skypoint, and in the meantime we’ve had the Synergy stent that was also a 48 mm. That stent was approved based on the similar EVOLVE 48 trial. It was a single-arm study to look at TLF and target lesion revascularization, and in both studies, including SPIRIT 48, TLR occurred in one patient out of 100 and TLF was about 4%. This stent is very similar to the Synergy stent and allows us to have two different options from two different companies showing very similar safety and efficacy results. Obviously, these are not head-to-head studies of these two stents, nor are they head-to-head studies of these longer stents compared with multiple overlapping stents. But we’ve known historically that multiple overlapping stents increase overall procedural time and have greater risk for stent thrombosis.
In addition, these stents now have a shorter DAPT indication. You can do 1 month of DAPT and presume to have good outcomes that you see in these single-arm studies.
I do think that SPIRIT 48 will allow the Abbott-designed Skypoint to be approved by the FDA and on the market as another option for patients and for physicians to implant in long lesions. We are doing more complex lesions these days. There are more chronic total occlusions, there are more high-risk PCIs, there is more calcification and patients are getting older, so there is more opportunity to have diffuse disease that is better treated with longer stents. This does usher in a new era in terms of being able to right-size the patient and lesion with the type of devices that we have.
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Park KE, et al. Late-Breaking Presentation III. Presented at: Society for Cardiovascular Angiography and Interventions Scientific Sessions; May 18-20, 2023; Phoenix.
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