Coronary Artery Aneurysms: A Review of the Epidemiology, Pathophysiology, Diagnosis, and Treatment
Paclitaxel Or Sirolimus: New PAD Studies Shed Light On Choices
LONDON, England—While it's not clear sirolimus-based devices will ever overtake the old workhorse paclitaxel, data from several studies presented here at the 2025 Charing Cross International Symposium show these technologies may have their place in the armamentarium of operators performing interventions for peripheral vascular disease.
In multiple presentations featuring patients with a wide range of disease complexities, there were hints for how sirolimus may differ therapeutically from paclitaxel and what role it may have once long-term efficacy and durability are known.
In the SUCCESS PTA trial, for instance, the sirolimus-eluting Selution SLR (Cordis) DCB was on par with established paclitaxel-coated balloons, including Ranger (Boston Scientific), In.Pact Admiral (Medtronic), and Passeo-18 (Biotronik), when it came to freedom from clinically driven TLR.
"These data continue to demonstrate the consistency of positive results across this new technology," primary investigator Michael Lichtenberg, MD (Arnsberg Clinic, Germany), said in his presentation. "This study is proof that sirolimus works from a clinical context."
SUCCESS PTA and SIRONA
SUCCESS PTA enrolled 723 patients from 27 sites in Europe, Asia, and South America. Nearly 40% had diabetes, 17% had renal failure/impairment, and 26% had chronic limb-threatening ischemia (CLTI; Rutherford class 4, 5, or 6). Mean lesion length was 128.4 mm, and 16% had a calcium grade of 4. Overall, 8% of patients had a below-the-knee (BTK) lesion.
The device success rate was 99%, and the procedural success rate was 98%. At 1 year, rates of freedom from clinically driven TLR were 91.1% in the full cohort (91.3% in claudication and 90.3% in CLTI).
In terms of safety, target lesion amputation rates were low at 2.2% (0.2% for claudication and 9.4% for CLTI).
Improvements in ankle-brachial index seen at 6 months were maintained at 12 months, Lichtenberg noted. The same was true for quality of life as measured by the EuroQol-5D. Follow-up is planned out to 5 years.
Commenting from the audience, George Adams, MD (University of North Carolina at Chapel Hill, Raleigh), said he was struck by the freedom from clinically driven TLR in the CLTI patients, noting they are "some of the highest numbers I have ever seen."
Lichtenberg said while more research is needed to inform these results, they provide some inspiration for investigators to "put our efforts in" to understand if there is perhaps an enhanced response to sirolimus in the CLTI population. Currently, he is heading the SELUTION4BTK trial, which should help add more needed insights.
"This book chapter is definitely not closed, it is just opened and I think it's important to learn here," he said. According to Lichtenberg, the answer to understanding the role of sirolimus and paclitaxel may be combinations of strategies such as vessel preparation combined with the balloon and the most appropriate antiproliferative therapy for the patient being treated.
Last year, Ulf Teichgräber, MD, (University Hospital Jena, Germany), showed that another sirolimus balloon (MagicTouch; Concept Medical) was noninferior to paclitaxel drug-coated balloons (DCBs) in the SIRONA trial. Here, Teichgräber presented updated results from a deep dive into the clinical improvement (≥ 1 Rutherford category) at 12 months, demonstrating that the paclitaxel group fared better (P = 0.043). Conversely, pain-free walking distance was slightly better in the sirolimus group, but was not statistically significant.
HOPE Registry
More data from a CTLI population came from a presentation of HOPE registry data by Edward Choke, MBBS, PhD (Northern Heart Hospital, Penang, Malaysia). At 3 years, sirolimus-based DCB (MagicTouch) was associated with fewer BTK reinterventions compared with plain balloon angioplasty (P = 0.033).
"We think that this is because sirolimus is effectively inhibiting the neointimal hyperplasia that starts to occur from about 5 months on," Choke said. The sirolimus-treated patients also saw better amputation-free survival and better overall survival in this highly comorbid real-world population.
With evidence at this stage that both drugs work, moderator Andrew Holden, MBChB (Auckland Hospital, New Zealand), wondered how clinicians will eventually choose which to use in their PAD interventions.
If you have free choice, then you can differentiate lesion characteristics [and] outflow characteristics regarding device selection. Thomas Zeller
Panelist Thomas Zeller, MD, PhD (Universitäts-Herzzentrum Freiburg-Bad Krozingen, Germany), said as with most things, it may come down to cost and what is available to the operator at their institution.
"Of course, if you have free choice, then you can differentiate lesion characteristics [and] outflow characteristics regarding device selection," he said. "For example, if you have a bad outflow situation, you should probably not use long paclitaxel crystalline-coated devices. You should use a limus-coated balloon. If it's a simple [lesion], then you can go with paclitaxel."
Lichtenberg noted that paclitaxel DCBs have progressed with each generation and have fewer issues like cracking or flaking of the drug on the balloon than were seen in the past.
"This is bringing us to a new level as we have more safety data now for modern [devices], including of course paclitaxel and sirolimus," he said. "I think this should drive how we do the interventions."
Paclitaxel Mortality No Longer the Main Question
After years of being the standard drug for DCBs in PAD treatment, a safety signal for paclitaxel emerged in 2018 from a meta-analysis that led to a period where paclitaxel-based devices for peripheral interventions were taken out of use around the world. Ultimately, the mortality signal was refuted by numerous datasets and the US Food and Drug Administration removed black box warnings from paclitaxel DCBs in 2023.
While there was intense interest in sirolimus devices as alternatives during the paclitaxel moratorium, Brian DeRubertis, MD (NewYorkPresbyterian/Weill Cornell Medical Center and Cornell University Medical College, New York, NY), asked from the audience if researchers have finally put the paclitaxel safety questions behind them.
In response, Teichgräber said the question that remains now when considering sirolimus versus paclitaxel is no longer one of mortality, noting there are concerns about things such as vessel wall degradation from paclitaxel use. It's uncertain yet if sirolimus is a less aggressive drug that yields similar treatment effects, he said.
What Steps Can Be Taken To Prevent Infections After Surgeries To Fix The Aortic Or The Aortoiliac Segment (the Largest Arteries In The Body)?
Key messages
• Antibiotics seem to reduce surgical site infections in people undergoing aortic or aortoiliac surgery.
• Other interventions assessed appear to make little or no difference in reducing the incidence of surgical site infections.
• Other outcomes evaluated were minimally or not affected by the interventions studied.
What are peripheral arterial disease and aortic aneurysms?
Peripheral arterial disease happens when arteries narrow, and blood flow is reduced. Aortic aneurysms—abnormal bulges in the aorta wall—are also a serious concern. When severe, these conditions may require arterial reconstruction surgery. Often, this involves using a graft—a piece of biological or synthetic material moved from another body part or source to replace or support the damaged artery. A graft lacks its own blood supply and depends on nearby tissue to heal. Infections at the surgical site, especially involving the graft, are a major concern due to the risk of severe illness or death. These infections also burden healthcare systems globally. That is why it is crucial to assess whether our current infection-prevention strategies are effective.
What did we want to find out?
We wanted to find out how medicines such as antibiotics, other treatments, cleaning methods, different surgical techniques, and wound care affect the risk of infection in people who have surgery to repair their aorta or aortoiliac arteries, which are important blood vessels.
What did we do?
We looked at all types of randomised studies that tested different treatments to prevent infections after surgery of the aorta or aortoiliac arteries. We only included studies where people were randomly assigned to different treatments. We also looked at whether different treatments had an impact on other important outcomes, such as overall mortality, the rate of failed arterial reconstructions, the need for additional surgeries, the rate of amputations, the level of pain resulting from infection-prevention treatments, and any adverse events caused by these treatments. We assessed how well the studies were conducted and collected, and combined the data for analysis whenever we could, examined the quality of the evidence, and described the results we found.
What did we find?
We included a total of 21 studies involving 4952 participants in this review. Fifteen studies were found to have a high risk of bias in at least one area, and 19 studies had an unclear risk of bias in at least one area. We looked at 10 different comparisons for eight different outcomes. These comparisons included: antibiotics versus placebo or no treatment; short-duration antibiotics (≤ 24 hours) versus long-duration antibiotics (> 24 hours); different types of systemic antibiotics (one versus another); antibiotic-bonded implants versus standard implants; Dacron grafts versus polytetrafluoroethylene grafts; prophylactic closed suction drainage versus undrained wound; individualised goal-directed therapy versus fluid therapy based on losses, standard haemodynamic parameters, and arterial blood gas values; comprehensive geriatric assessment versus standard preoperative care; percutaneous versus open-access technique; and negative pressure wound therapy (NPWT) versus standard dressings. The main outcomes of interest were the rates of graft infections and surgical site infections (SSIs). We also looked at other outcomes, like overall mortality, how often the arterial reconstruction failed, the need for re-intervention, the amputation rate, pain, and any adverse events related to the treatments to prevent infections. We could not assess all the outcomes in each comparison and, due to the absence of available data, we could not measure or analyse many other outcomes quantitatively. Here is a summary of the main findings:
Antibiotics versus placebo (five studies): Antibiotics seem to reduce SSIs with very low-confidence evidence. There was no difference between the groups in the other outcomes that we could assess (all-cause mortality, re-intervention rate, and amputation rate), with very low- to low-confidence evidence.
Short-duration versus long-duration antibiotics (three studies): With very low-confidence evidence, we found no difference between short- or long-duration antibiotics to prevent graft infections or SSIs.
Different types of antibiotics (seven studies): With very low-confidence evidence, we did not find differences between the different types of antibiotics when compared with each other for graft infection rate, SSI rate, or all-cause mortality. The comparisons included beta-lactams versus cephalosporins, glycopeptides versus cephalosporins, and one cephalosporin versus another.
What are the limitations of the evidence?
There are not many studies that have focused on people having surgery on their aortic or aortoiliac segments. The few available studies involve small numbers of patients and not many events, which makes it hard to compare different treatments. Some studies included different types of people, and not all of them provided specific data for the groups of people of interest for this review. The length of time patients were followed up after surgery varied a lot between the studies. We also noticed that some studies had methodological problems that could lead to biased results. We listed these challenges when we looked at the results and took them into account before making our conclusions.
How up-to-date is this evidence?
The evidence is current as of November 2024.
If you found this evidence helpful, please consider donating to Cochrane. We are a charity that produces accessible evidence to help people make health and care decisions.Peripheral Vascular Devices Market To Reach USD 8.…
The global peripheral vascular devices market, valued at USD 4.7 billion in 2022, is projected to expand at a robust CAGR of 6.6%, reaching USD 8.9 billion by 2032, according to Future Market Insights. The surge in market growth is being driven by the rising prevalence of peripheral arterial disease (PAD), an increase in the aging population, and the steady pace of innovation in vascular intervention technologies.
Peripheral Vascular Stents Dominate the Market
Among the various product categories, peripheral vascular stents lead the global market, capturing an impressive 78.5% share in 2021. These stents, including self-expanding, balloon-expanding, covered, and drug-eluting variants, are widely adopted due to their ability to restore blood flow in narrowed or blocked arteries. Their efficacy in reducing the risks of severe cardiovascular events makes them essential in the treatment of PAD, especially in high-risk patient populations such as diabetics, smokers, and elderly individuals.
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PAD, primarily caused by plaque buildup in arteries, is both a standalone medical challenge and an indicator of systemic atherosclerosis. Despite nearly half of PAD patients being asymptomatic, the condition significantly increases the likelihood of heart disease and stroke.
Technological Advancements and Minimally Invasive Interventions Fuel Growth
The market is witnessing a wave of technological innovation, with new and improved devices now available for endovascular, minimally invasive procedures. These devices are critical for managing PAD with reduced hospital stays, fewer complications, and improved patient outcomes.
One key milestone in this regard is Cook Medical's breakthrough drug-eluting stent, which received the FDA's Breakthrough Device designation in January 2022. Designed specifically for treating chronic limb-threatening ischemia (CLTI) in below-the-knee applications, this device reflects the growing trend toward patient-specific, targeted solutions in vascular healthcare.
Challenges: Device Recalls and Cost Barriers
Despite the optimistic growth outlook, the market faces several headwinds. Notably, device recalls and limitations pose a serious concern. For instance, Medtronic's HawkOne system, used for clearing blocked arteries, was subjected to a Class I recall—the most serious category issued by the FDA—following multiple reports of patient injuries. The recall impacted nearly 95,000 devices sold in the U.S. Since 2018, signaling the critical importance of safety and regulatory compliance in this competitive space.
Additionally, the high material and acquisition costs of peripheral vascular devices—particularly in institutional settings—continue to hinder widespread adoption. While innovations improve clinical outcomes, their financial burden on healthcare providers and systems in emerging markets can restrain growth.
Restenosis risks, especially following procedures with drug-eluting balloons, further emphasize the need for ongoing product refinement and improved clinical protocols.
Key Takeaways: Peripheral Vascular Devices Market
The U.S. Held a commanding 94.5% share of the North American peripheral vascular devices market in 2021, driven by a high prevalence of cardiovascular disorders and strong product adoption.
China accounted for 56.5% of the East Asian market in 2021 and is projected to grow at a robust CAGR of 8.5%, supported by promising outcomes from the FREEWAY-CHINA clinical trial for paclitaxel-coated balloons.
Germany is expected to grow at a CAGR of nearly 6.0%, owing to its aging population, cutting-edge medical technology, and a high burden of chronic diseases.
Peripheral vascular stents are anticipated to grow at a CAGR of 6.0%, as they are widely used in angioplasty procedures to treat calcified arterial lesions.
Holding a 30.3% market share in 2021, peripheral arterial disease remains a key focus, driven by lifestyle factors such as smoking and alcohol consumption.
With a 48.1% revenue share, the iliac artery is the most targeted artery segment globally, due to its association with prevalent conditions like claudication and critical limb ischemia.
Hospitals captured 60.4% of the market share in 2021, attributed to the high volume of surgical procedures and the increasing prevalence of chronic conditions.
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Competitive Landscape: Consolidation and Innovation
The peripheral vascular devices market is highly fragmented, with major players continuously engaging in mergers and acquisitions, strategic collaborations, and product launches to expand their footprint and meet the growing demand for advanced vascular care.
Key players driving innovation and competition include:
These firms are not only investing in cutting-edge product development but also targeting underserved markets with tailored therapeutic solutions.
Market Segmentation Snapshot
By Product:
By Indication:
By Artery:
By End User:
By Region:
Future Outlook
As the global burden of cardiovascular diseases continues to rise, the peripheral vascular devices market is set to play a pivotal role in reshaping patient outcomes. The push towards less invasive therapies, the availability of next-generation stents and scaffolds, and strategic partnerships among medical device giants will continue to propel the market forward.
However, ensuring cost-effectiveness, addressing safety concerns, and expanding accessibility in low- and middle-income regions will be critical for sustained growth.
In conclusion, the global peripheral vascular devices market stands at the intersection of urgent medical need and transformative innovation. As players address the existing barriers and invest in future-ready solutions, the market is poised for a dynamic decade of progress and impact.
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