INvestigation of STEnt grafts in patients with type B Aortic Dissection: design of the INSTEAD trial--a prospective, multicenter, European randomized trial.
OBJECTIVE
This study describes the design of an ongoing randomized trial initiated to compare the 2-year outcome of uncomplicated type B aortic dissection when treated by endovascular implantation of a Medtronic Talent stent graft adjunctive to best medical treatment versus best medical treatment alone.


METHODS
Patients older than 18 years with type B aortic dissection as diagnosed by computed tomography or magnetic resonance angiography are randomized to either a thoracic aortic endoprosthesis and antihypertensive treatment, called "stent grafting," or a tailored antihypertensive treatment, called "medical treatment." Only patients in a clinically stable condition and without spontaneous thrombosis of the false lumen after 14 days of the index dissection are considered eligible for study inclusion.


RESULTS
Primary outcome measure is all-cause mortality. Secondary outcome variables include conversion to stent and/or surgery, induced thrombosis of the false lumen, cardiovascular morbidity, aortic expansion (>5 mm/y of maximum diameter including true and false lumina), quality of life, and length of intensive care unit and hospital stay. The study design calls for 136 patients to be randomized and monitored for 24 months.


CONCLUSIONS
The INSTEAD trial is the first randomized trial investigating the role of endoluminal treatment of uncomplicated type B aortic dissection. By the end of December 2004, 125 patients were randomized, accounting for 92% of the target. Final results of the INSTEAD trial should be available in 2006.
Nienaber
Christoph A
CA
Division of Cardiology and Internal Medicine Department, Rostock University, Germany. christoph.nienaber@med.uni-rostock.de
Zannetti
Simona
S
Barbieri
Barbara
B
Kische
Stephan
S
Schareck
Wolfgang
W
Rehders
Tim C
TC
D000368:Aged; D000784:Aortic Dissection / Q000188:drug therapy / Q000601:surgery*; D000959:Antihypertensive Agents / Q000627:therapeutic use; D017545:Aortic Aneurysm, Thoracic / Q000188:drug therapy / Q000601:surgery*; D003131:Combined Modality Therapy; D005060:Europe; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007362:Intensive Care Units / Q000706:statistics & numerical data; D007902:Length of Stay / Q000706:statistics & numerical data; D015993:Life Tables; D008297:Male; D008875:Middle Aged; D009026:Mortality; D018579:Patient Selection; D011183:Postoperative Complications / Q000453:epidemiology; D011446:Prospective Studies; D011788:Quality of Life; D012107:Research Design; D018401:Sample Size; D015607:Stents; D016019:Survival Analysis; D013927:Thrombosis / Q000453:epidemiology; D016896:Treatment Outcome
D000959:Antihypertensive Agents