In patients with severe artery blockage in the lower leg, an artery-supporting device called a resorbable scaffold is superior to angioplasty, according to the results of a large international clinical trial co-led by researchers at Weill Cornell Medicine and NewYork-Presbyterian.
根一，由美威康奈院及老院研究人，共同的大型床果，於罹患小腿重阻塞的病患中，一被可吸收支架的支置，於血管成形。
Angioplasty, which has been the standard treatment, involves the widening of a narrowed artery with a small, balloon-like mechanism. A resorbable scaffold is a stent-like structure that props the artery open but is biodegradable and dissolves within a few years, avoiding some of the potential complications of a permanent stent.
一直是法的血管成形，涉及使用小型、似球的制，窄。可吸收支架是一，可生物降解，且在年溶解，避免永久性支架一些在症的似支架物。
In the clinical trial, reported Oct. 25 in the New England Journal of Medicine, the researchers compared the insertion of a resorbable scaffold – imbued with a drug to reduce the chance of re-blockage – to standard angioplasty in 261 patients with severe artery disease below the knee.
在(2023年) 10月25日，表於《新英格》的床中，此些研究人，在261名罹患膝以下重疾病的患者中，行了插入可吸收支架(被灌物以少再阻塞的)血管成形的比。
They found that nearly three-quarters of the patients who received the resorbable scaffold avoided bad outcomes in the year after the procedure, compared with less than half of patients who underwent angioplasty.
他，接受可吸收支架的患者中，於手後一年，近四分之三避了不良後果。相下，接受血管成形的患者，不到一半。
“If approved, this device has the potential to change clinical practice and save many patients’ limbs,” said study co-senior author Dr. Brian DeRubertis, M.D. ’97, chief of vascular and endovascular surgery at Weill Cornell Medicine and NewYork-Presbyterian/Weill Cornell Medical Center.
研究共同深撰文人，威康奈院及老院/威康奈中心，血管暨血管的外科主任，Brian DeRubertis 博士宣：「倘若得批准，此置具有改床，及挽救多患者肢的力。」
The other leaders of the study were Dr. Sahil Parikh, associate professor of medicine at the Columbia University Vagelos College of Physicians and Surgeons, and director of endovascular services at NewYork-Presbyterian/Columbia University Irving Medical Center; and Dr. Ramon Varcoe, associate professor at the University of New South Wales and director of the Vascular Institute at the Prince of Wales Hospital in Sydney, Australia.
研究的其他人包括，哥比大瓦格洛斯、外科院的副教授，兼老院/哥比大文中心血管部主任 Sahil Parikh博士，及澳洲新南威斯大副教授，兼澳洲雪梨威斯王院，血管研究所所Ramon Varcoe博士。
Peripheral artery disease is similar to coronary artery disease but involves the narrowing or blockage of arteries in the limbs, usually the legs. It has the same major risk factors as other forms of vascular disease – namely smoking, aging, diabetes, high blood cholesterol levels and lack of exercise. The condition is also very common, affecting an estimated 7 million to 12 million people in the United States alone.
周疾病冠疾病相似，不涉及四肢(通常是腿部)的窄或阻塞。它具有其他形式之血管疾病相同的主要危因素，即吸、老化、糖尿病、高血液固醇水平及缺乏。疾病也很普遍，在美估，侵7百至1千2百人。
The most severe form of peripheral artery disease, known as chronic limb-threatening ischemia (CLTI), involves such an insufficiency of blood flow that patients feel pain in the affected limb even when at rest. Patients with CLTI often develop non-healing wounds and ulcerations, which can require amputation or cause fatal infection.
被通慢性迫肢的局部缺血(CLTI)之周疾病最重的型涉及，即使在休息，於遭侵的肢，病患亦感疼痛的此血流不足。罹患CLTI的病患通常，需要截肢或致致命感染之法治的口及。
CLTI has been particularly hard to treat successfully when the affected arteries are below the knee. In recent years, multiple clinical trials of stents and other proposed new interventions for below-knee CTLI have failed to show a benefit over angioplasty.
遭侵的是在膝以下，CLTI一直很成功治。於最近年，供膝以下之CTLI使用的支架，及其他被提出之新干措施的多床，一直未能示出，於血管成形的益。
“Apart from angioplasty, which is a more than 40-year-old technology, we haven’t had a lot of treatment options for CLTI below the knee,” DeRubertis said.
DeRubertis宣：「除了血管成形，40多年史的技外。我一直有多，供膝以下之CLTI使用的治。」
Resorbable scaffolds that slowly release inflammation-suppressing compounds are already used to treat coronary artery blockages, and some initial studies have suggested that they might be more effective than angioplasty for lower-leg artery disease.
慢放抑制炎之化合物的可吸收支架，已被用治冠阻塞，且一些初步研究已暗示，就小腿疾病而言，它可能比血管成形更有效。
Scaffolds provide direct mechanical support to diseased arteries for much longer, compared to angioplasty. They also dissolve eventually, unlike permanent stents which can accelerate artery re-blockage by their long-term contact with artery walls and can complicate future interventions.
相於血管成形，可吸收支架不健全之，提供更的直接械支。不像由於壁期接，加速再阻塞且使未之干的永久性支架。最，它溶解。
The new trial, sponsored by Abbott Vascular, compared the company’s resorbable, drug-releasing scaffold with standard angioplasty at 50 vascular surgery centers, including NewYork-Presbyterian/Weill Cornell Medical Center, in the United States, Australia, New Zealand, Hong Kong, Singapore and Taiwan.
由Abbott Vascular助的新行了，公司可吸收、放物的支架，在美、澳洲、西、香港、新加坡及台，包括老院/威康奈中心等，50血管手中心之血管成形的比。
Of the 173 CLTI patients randomly assigned to receive the scaffold, 135 were able to avoid amputation, new total blockage of the affected artery and other pre-defined adverse events in the year after the procedure, compared with 48 of the 88 angioplasty patients.
被分配接受此支架的173名CLTI病患中，135名能在此做法後一年，避免截肢、新遭侵的完全阻塞及其他的不利展事。相下，88名血管成形病患中，有48名。
A standard statistical analysis accounting for differences in event times suggested that the scaffold group had a 74% chance of avoiding these adverse events for the first year, whereas the angioplasty group had a 44% chance. “That’s a very big difference for this type of trial,” said DeRubertis, who was recruited as professor of surgery at Weill Cornell Medicine.
明展事上差的分析暗示了，就第一年而言，此支架群有74%，避免此些不利之展事的，而血管成形群有44%的。被聘威康奈院，外科教授的DeRubertis宣：「就此而言，那是一很大的差。」
Scaffold insertion also appeared to be as safe as angioplasty, in terms of procedure-related complications. DeRubertis said that, unlike some clinical trials, this one enrolled patients from a relatively diverse set of ethnic backgrounds, making it more likely that its results are broadly applicable.
手相的症看，支架插入似乎也血管成形一安全。DeRubertis表示，不像某些床，此招募了一群，自相上不同族背景的病患。使其果，更可能泛可用。
As the researchers noted in their paper, the study had some limitations including the fact that patients on average had shorter areas of arterial blockage than the typical patient with below-the-knee CTLI. Nevertheless, DeRubertis said that he expects the findings to lead to Food and Drug Administration approval of the scaffold device.
如同此些研究人，於其文中特指出那，研究有些局限，包括病患平均具有，比罹患膝以下之CTLI典型病患短的阻塞域。管如此，DeRubertis表示，他期盼此些研究，能致美食品暨物管理局，批准此支架置。
址：https://news.cornell.edu/stories/2023/11/absorbable-scaffold-beats-angioplasty-lower-leg-artery-disease
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