title: One-year results of the INSPIRE trial with the novel MGuard stent: serial analysis with QCA and IVUS.
abstract: BACKGROUND
  The newly developed balloon-expandable Mguard stent system, a combination of an ultra-thin polymer mesh sleeve attached to the external surface of a BMS, was conceived to provide embolic protection during PCI of SVG and thrombus-containing lesions. Although the acute results (<30 days) have pointed to the efficacy of this novel device, few is known about its long-term performance.
  
  
  METHODS
  The present article address the 1-year clinical results of a cohort of 30 patients enrolled in the INSPIRE trial. Inclusion critiria was de novo lesions in SVG or native vessels with angiographic evidence of instability with potential to provoke flow disturbances and/or distal embolization. The primary endpoint (incidence of MACE-composite of cardiac death, nonfatal MI, and TLR) up to 30 days of the procedure has already been published. Secondary endpoints here presented included in-stent late lumen loss (QCA), % of stent obstruction (IVUS) at 6 months and combined MACE at 1 year. QCA and IVUS were performed by independent corelabs.
  
  
  RESULTS
  Mean population age was 63 years with 38% of diabetics. Overall, 55% presented with ACS and 57% of lesions were located in SVG. Most lesions had complex morphology including the presence of thrombus (26%) and ulceration (20%). Distal/proximal protection devices were not used. Preprocedural QCA data showed lesion length and reference vessel diameter of 12.0 ± 4.5 mm and 3.0 ± 0.5 mm. The MGuard stent was successfully delivered in all cases and final TIMI-3 was achieved in 100% with no MACE up to 30 days. At 6 months, in-stent late loss and % of stent obstruction were 1.0 ± 0.4 mm and 28.5 ± 15.6%. Up to 1 year there was no case of cardiac death, two MI (one Q-wave and one non-Q-wave) and six cases of ischemia-driven TLR. Of note, there was no case of definite/probable stent thorombosis.
  
  
  CONCLUSIONS
  In this series of patients treated with MGuard stent, the novel device showed no midterm efficacy and safety concerns.
authors.affiliation: Department of Invasive Cardiology, Instituto Dante Pazzanese de Cardiologia, São Paulo, Brazil.
authors.forename: J Ribamar
authors.initials: JR
authors.lastname: Costa
authors.forename: Alexandre
authors.initials: A
authors.lastname: Abizaid
authors.forename: Fausto
authors.initials: F
authors.lastname: Feres
authors.forename: Ricardo
authors.initials: R
authors.lastname: Costa
authors.forename: Rodolfo
authors.initials: R
authors.lastname: Staico
authors.forename: Dimytri
authors.initials: D
authors.lastname: Siqueira
authors.forename: Marinella
authors.initials: M
authors.lastname: Centemero
authors.forename: Luiz Fernando
authors.initials: LF
authors.lastname: Tanajura
authors.forename: Amanda
authors.initials: A
authors.lastname: Sousa
authors.forename: J Eduardo
authors.initials: JE
authors.lastname: Sousa
mesh_terms: D000368:Aged; D015906:Angioplasty, Balloon, Coronary / Q000009:adverse effects / Q000295:instrumentation* / Q000401:mortality; D001938:Brazil; D002318:Cardiovascular Diseases / Q000000981:diagnostic imaging* / Q000209:etiology / Q000401:mortality; D017023:Coronary Angiography; D003324:Coronary Artery Disease / Q000000981:diagnostic imaging / Q000401:mortality / Q000628:therapy*; D023903:Coronary Restenosis / Q000000981:diagnostic imaging; D057505:Embolic Protection Devices; D005260:Female; D006801:Humans; D053208:Kaplan-Meier Estimate; D008297:Male; D008670:Metals; D008875:Middle Aged; D009203:Myocardial Infarction / Q000000981:diagnostic imaging; D011237:Predictive Value of Tests; D011474:Prosthesis Design; D015607:Stents; D013927:Thrombosis / Q000000981:diagnostic imaging; D013997:Time Factors; D016896:Treatment Outcome; D018084:Ultrasonography, Interventional
chemical_list: D008670:Metals