Journal of vascular surgery · 2003
A multicenter controlled clinical trial of open versus endovascular treatment of abdominal aortic aneurysm.
Клиническое исследованиеКлиническое исследование II фазыКонтролируемое клиническое исследованиеСтатьяМногоцентровое исследованиеПоддержка исследования: вне правительства СШАНазвание и аннотация: Перевод пока не подготовлен
Обработка статьи · этапы, ошибки и управление
Загрузка состояния…
Ошибки и ограничения
История · было → стало
Состояние обновляется каждые 5 секунд, пока блок открыт. Процент показывается только там, где известен объём работы. Пауза останавливает продолжение этапа; текущий запрос к источнику может завершиться.
Matsumura Jon S, Brewster David C, Makaroun Michel S, Naftel David C
Аннотация
OBJECTIVE: The purpose of this study was to evaluate the safety and efficacy of a novel endovascular graft for elective treatment of infrarenal abdominal aortic aneurysm. The device is a modular bifurcated system with nitinol/expanded polytetrafluoroethylene components and a smaller profile than currently approved devices.
METHODS: In a multicenter, concurrent controlled phase II trial, 334 patients underwent treatment with the Excluder bifurcated endoprosthesis (test, n = 235; W. L. Gore & Associates, Inc, Sunnyvale, Calif) or with standard open repair (control, n = 99). Preoperative characteristics, perioperative variables, follow-up clinical evaluations, and radiographic examination results through the first 2 years were analyzed with univariable and multivariable statistics.
RESULTS: Patients in the test group had less blood loss (310 +/- 19 mL versus 1590 +/- 124 mL; P <.0001), fewer homologous transfusions (6% versus 32%; P <.0001), and shorter lengths of stay (2.0 +/- 0.1 days versus 9.8 +/- 1.4 days; P <.0001). Early major adverse events were markedly reduced in the test group (14% versus 57%; P <.0001), and this difference persisted at 2 years. No difference was seen in survival rate (P =.13). In the first 2 years, no deployment failure, early conversion, or aneurysm rupture occurred. At the 2-year timepoint, core laboratory read trunk migration in 1%, limb migration in 1%, limb narrowing in 1%, endoleak in 20%, and aneurysm growth in 14%. One wire discontinuity (0.6%) was identified in a discharge film. A 7% annual reintervention rate was seen in the test group in the first 2 years.
SUMMARY: The test device is a safe and effective treatment compared with open surgical repair for infrarenal abdominal aortic aneurysm. The most striking benefits are reduced blood loss, fewer complications, and faster recovery. Two-year survival rate was similar.
METHODS: In a multicenter, concurrent controlled phase II trial, 334 patients underwent treatment with the Excluder bifurcated endoprosthesis (test, n = 235; W. L. Gore & Associates, Inc, Sunnyvale, Calif) or with standard open repair (control, n = 99). Preoperative characteristics, perioperative variables, follow-up clinical evaluations, and radiographic examination results through the first 2 years were analyzed with univariable and multivariable statistics.
RESULTS: Patients in the test group had less blood loss (310 +/- 19 mL versus 1590 +/- 124 mL; P <.0001), fewer homologous transfusions (6% versus 32%; P <.0001), and shorter lengths of stay (2.0 +/- 0.1 days versus 9.8 +/- 1.4 days; P <.0001). Early major adverse events were markedly reduced in the test group (14% versus 57%; P <.0001), and this difference persisted at 2 years. No difference was seen in survival rate (P =.13). In the first 2 years, no deployment failure, early conversion, or aneurysm rupture occurred. At the 2-year timepoint, core laboratory read trunk migration in 1%, limb migration in 1%, limb narrowing in 1%, endoleak in 20%, and aneurysm growth in 14%. One wire discontinuity (0.6%) was identified in a discharge film. A 7% annual reintervention rate was seen in the test group in the first 2 years.
SUMMARY: The test device is a safe and effective treatment compared with open surgical repair for infrarenal abdominal aortic aneurysm. The most striking benefits are reduced blood loss, fewer complications, and faster recovery. Two-year survival rate was similar.