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.
根據一項，由美國威爾康奈爾醫學院及紐約長老會醫院研究人員們，共同領導的大型國際臨床試驗結果，於罹患小腿嚴重動脈阻塞的病患中，一種被稱為可吸收支架的動脈支撐裝置，優於血管成形術。
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.
一直是標準療法的血管成形術，涉及使用小型、類似氣球的機制，來擴張狹窄動脈。可吸收支架是一種，撐開動脈卻可生物降解，且在幾年內溶解，避免永久性支架一些潛在併發症的類似支架結構物。
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，該發表於《新英格蘭醫學雜誌》的臨床試驗中，此些研究人員，在261名罹患膝蓋以下嚴重動脈疾病的患者中，進行了插入可吸收支架(被灌輸藥物以減少再阻塞的機會)與標準血管成形術的比較。
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.
他們發現，接受可吸收支架的患者中，於該種手術後一年內，近四分之三避開了不良後果。相較下，接受血管成形術的患者，僅不到一半。
“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.
該項研究共同資深撰文人，威爾康奈爾醫學院及紐約長老會醫院/威爾康奈爾醫療中心，血管暨血管內的外科主任，Brian DeRubertis 博士宣稱：「倘若獲得批准，此裝置具有改變臨床實務，及挽救許多患者肢體的潛力。」
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.
該項研究的其他領導人包括，哥倫比亞大學瓦格洛斯內、外科醫師學院的醫學副教授，兼紐約長老會醫院/哥倫比亞大學歐文醫學中心血管內部門主任 Sahil Parikh博士，及澳洲新南威爾斯大學副教授，兼澳洲雪梨威爾斯親王醫院，血管研究所所長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.
周邊動脈疾病與冠狀動脈疾病相似，不過涉及四肢(通常是腿部)的動脈狹窄或阻塞。它具有與其他形式之血管疾病相同的主要危險因素，即吸煙、老化、糖尿病、高血液膽固醇水平及缺乏運動。這種疾病也很普遍，僅在美國據估，侵襲7百萬至1千2百萬人。
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.
被通稱為慢性脅迫肢體的局部缺血(CLTI)之周邊動脈疾病最嚴重的類型涉及，即使在休息時，於遭侵襲的肢體，病患亦感疼痛的此類血流不足。罹患CLTI的病患通常顯現，會需要截肢或導致致命感染之無法治癒的傷口及潰瘍。
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.
當遭侵襲的動脈是在膝蓋以下時，CLTI一直很難成功治療。於最近幾年，供膝蓋以下之CTLI使用的支架，及其他被提出之新干預措施的多項臨床試驗，一直未能顯示出，優於血管成形術的益處。
“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宣稱：「除了血管成形術，該項40多年歷史的技術外。我們一直沒有諸多，供膝蓋以下之CLTI使用的治療選擇。」
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.
緩慢釋放抑制發炎之化合物的可吸收支架，已經被用來治療冠狀動脈阻塞，且一些初步研究已經暗示，就小腿動脈疾病而言，它們可能比血管成形術更有效。
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.
相較於血管成形術，可吸收支架對不健全之動脈，提供達更長時間的直接機械支撐。不像由於與動脈壁長期接觸，會加速動脈再阻塞且會使未來之干預變複雜的永久性支架。最終，它們會溶解。
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.
該項由Abbott Vascular贊助的新試驗進行了，該公司可吸收、釋放藥物的支架與，在美國、澳洲、紐西蘭、香港、新加坡及台灣，包括紐約長老會醫院/威爾康奈爾醫療中心等，50個血管手術中心之標準血管成形術的比較。
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.
隨機被分配接受此種支架的173名CLTI病患中，135名能在此做法後一年內，避免截肢、新遭侵襲動脈的完全阻塞及其他預計的不利發展事態。相較下，88名血管成形術病患中，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.
說明發展事態時間上差異的標準統計分析暗示了，就第一年而言，此種支架群有74%，避免此些不利之發展事態的機會，而血管成形術群有44%的機會。被聘為威爾康奈爾醫學院，外科醫學教授的DeRubertis宣稱：「就此類試驗而言，那是一項很大的差異。」
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.
從手術相關的併發症來看，支架插入似乎也與血管成形術一樣安全。DeRubertis表示，不像某些臨床試驗，此試驗招募了一群，來自相對上不同種族背景的病患。這使其結果，更可能廣泛可適用。
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.
如同此些研究人員，於其論文中特別指出那樣，該項研究有些局限，包括病患平均具有，比罹患膝蓋以下之CTLI典型病患較短的動脈阻塞區域。儘管如此，DeRubertis表示，他期盼此些研究發現，能導致美國食品暨藥物管理局，批准此種支架裝置。
網址：https://news.cornell.edu/stories/2023/11/absorbable-scaffold-beats-angioplasty-lower-leg-artery-disease
翻譯：許東榮
文章定位：
