title: Strategies for subacute/chronic type B aortic dissection: the Investigation Of Stent Grafts in Patients with type B Aortic Dissection (INSTEAD) trial 1-year outcome.
abstract: OBJECTIVE
  Endovascular stent grafting represents a novel concept for type B aortic dissection both in the acute and subacute/chronic setting, with an unknown effect on outcomes.
  
  
  METHODS
  In a prospective trial 140 patients with stable type B dissection were randomly subjected to elective stent-graft placement in addition to optimal medical therapy (n = 72) or to optimal medical therapy (n = 68) with surveillance (arterial pressure according to World Health Organization guidelines ≤ 120/80 mm Hg). The primary end point was 1-year all-cause mortality, whereas aorta-related mortality, progression (with need for conversion or additional endovascular or open surgical intervention), and aortic remodeling were secondary end points.
  
  
  RESULTS
  There was no difference in all-cause mortality: cumulative survival was 97.0% ± 3.4% with optimal medical therapy versus 91.3% ± 2.1% with thoracic endovascular aortic repair (P = .16). Moreover, aorta-related mortality was not different (P = .42), and the risk for the combined end point of aorta-related death (rupture) and progression (including conversion or additional endovascular or open surgical intervention) was similar (P = .86). Three neurologic adverse events occurred in the thoracic endovascular aortic repair group (1 paraplegia, 1 stroke, and 1 transient paraparesis) versus 1 episode of paraparesis with medical treatment. Finally, aortic remodeling (with true-lumen recovery and thoracic false-lumen thrombosis) occurred in 91.3% with thoracic endovascular aortic repair versus 19.4% with medical treatment (P < .001), which is suggestive of continued remodeling.
  
  
  CONCLUSIONS
  In survivors of uncomplicated type B aortic dissection, elective stent-graft placement does not improve 1-year survival and adverse events, despite favorable aortic remodeling.
authors.affiliation: Divisions of Cardiology and Biomedical Statistics, University of Rostock, Rostock, Germany. christoph.nienaber@med.uni-rostock.de
authors.forename: Christoph A
authors.initials: CA
authors.lastname: Nienaber
authors.forename: Stephan
authors.initials: S
authors.lastname: Kische
authors.forename: Ibrahim
authors.initials: I
authors.lastname: Akin
authors.forename: Hervé
authors.initials: H
authors.lastname: Rousseau
authors.forename: Holger
authors.initials: H
authors.lastname: Eggebrecht
authors.forename: Rossella
authors.initials: R
authors.lastname: Fattori
authors.forename: Tim C
authors.initials: TC
authors.lastname: Rehders
authors.forename: Guenther
authors.initials: G
authors.lastname: Kundt
authors.forename: Dierk
authors.initials: D
authors.lastname: Scheinert
authors.forename: Martin
authors.initials: M
authors.lastname: Czerny
authors.forename: Tilo
authors.initials: T
authors.lastname: Kleinfeldt
authors.forename: Burkhart
authors.initials: B
authors.lastname: Zipfel
authors.forename: Louis
authors.initials: L
authors.lastname: Labrousse
authors.forename: Hüseyin
authors.initials: H
authors.lastname: Ince
mesh_terms: D000368:Aged; D000784:Aortic Dissection / Q000175:diagnosis / Q000188:drug therapy / Q000401:mortality / Q000503:physiopathology / Q000601:surgery*; D001014:Aortic Aneurysm / Q000175:diagnosis / Q000188:drug therapy / Q000401:mortality / Q000503:physiopathology / Q000601:surgery*; D001027:Aortography / Q000379:methods; D001794:Blood Pressure; D001807:Blood Vessel Prosthesis; D019917:Blood Vessel Prosthesis Implantation / Q000009:adverse effects / Q000295:instrumentation* / Q000401:mortality; D002317:Cardiovascular Agents / Q000627:therapeutic use*; D016009:Chi-Square Distribution; D002908:Chronic Disease; D003131:Combined Modality Therapy; D017558:Elective Surgical Procedures; D005060:Europe; D005260:Female; D006801:Humans; D053208:Kaplan-Meier Estimate; D018810:Magnetic Resonance Angiography; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D018570:Risk Assessment; D012307:Risk Factors; D015607:Stents; D015996:Survival Rate; D013997:Time Factors; D014057:Tomography, X-Ray Computed; D016896:Treatment Outcome
chemical_list: D002317:Cardiovascular Agents