title: Direct drug-eluting stenting to reduce stent restenosis: a randomized comparison of direct stent implantation to conventional stenting with pre-dilation or provisional stenting in elective PCI patients.
abstract: OBJECTIVE
  The aim was to investigate whether a strategy of direct drug-eluting stent (DES) implantation without pre-dilation is associated with a reduced incidence of restenosis compared with CS with pre-dilation or provisional stenting (PS).
  
  
  BACKGROUND
  Previous studies were performed comparing direct stenting (DS) with conventional stenting (CS) after pre-dilation; however, none of these in the DES era. Therefore, the STRESSED (direct Stenting To reduce REStenosis in Stent Era with Drug elution) study was designed and carried out.
  
  
  METHODS
  A total of 600 patients with angina pectoris or recent myocardial infarction were randomized to a DS, CS, or PS strategy. The primary endpoint was the mean minimal lumen diameter at 9-month follow-up angiography. Secondary endpoints were clinical procedural success defined as angiographic success without in-hospital major adverse cardiac events (MACE), and MACE at 9-month and 2-year follow-up.
  
  
  RESULTS
  Stent implantation in the DS group was 98%, 99% in the CS group, and 77% in the PS group. Percutaneous coronary intervention success was 99% in all groups. The minimal lumen diameter at 9-month follow-up was 2.12 ± 0.58 mm (DS), 2.17 ± 0.67 mm (CS), and 1.99 ± 0.69 mm (PS), p = 0.556 for comparison of DS with CS, p = 0.073 for comparison of DS with PS. The absolute difference was -0.05 (DS to CS), 95% confidence interval: -0.19 to -0.09, p = 0.48 and 0.13 (DS to PS), confidence interval: -0.02 to -0.27, p = 0.087. Restenosis was found in 3.4% (DS), 6.7% (CS), and 11.5% (PS), p = 0.025. At 9-month and 2-year follow-up, MACE occurred in 6.8% and 11.5% (DS), 4.6% and 10.3% (CS), and 7.6% and 13.8% (PS) (p = 0.439 and 0.536), respectively.
  
  
  CONCLUSIONS
  Direct DES implantation compared with conventional DES implantation did not reduce restenosis. Provisional stenting, however, was associated with a higher rate of restenosis. This did not translate into a difference in the rate of MACE. (STRESSED study: direct Stenting To reduce REStenosis in Stent Era with Drug elution; ISRCTN41213536).
authors: Isala Klinieken, Zwolle, the Netherlands.
authors: Wouter S
authors: WS
authors: Remkes
authors: Isala Klinieken, Zwolle, the Netherlands.
authors: Samer
authors: S
authors: Somi
authors: Isala Klinieken, Zwolle, the Netherlands.
authors: Vincent
authors: V
authors: Roolvink
authors: Isala Klinieken, Zwolle, the Netherlands.
authors: Saman
authors: S
authors: Rasoul
authors: Isala Klinieken, Zwolle, the Netherlands.
authors: Jan Paul
authors: JP
authors: Ottervanger
authors: Isala Klinieken, Zwolle, the Netherlands.
authors: A T Marcel
authors: AT
authors: Gosselink
authors: Isala Klinieken, Zwolle, the Netherlands.
authors: Jan C A
authors: JC
authors: Hoorntje
authors: Isala Klinieken, Zwolle, the Netherlands.
authors: Jan-Henk E
authors: JH
authors: Dambrink
authors: Isala Klinieken, Zwolle, the Netherlands.
authors: Menko-Jan
authors: MJ
authors: de Boer
authors: Isala Klinieken, Zwolle, the Netherlands.
authors: Harry
authors: H
authors: Suryapranata
authors: Isala Klinieken, Zwolle, the Netherlands. Electronic address: v.r.c.derks@isala.nl.
authors: Arnoud W J
authors: AW
authors: van 't Hof
mesh_terms: D000368:Aged; D000787:Angina Pectoris / Q000175:diagnosis / Q000401:mortality / Q000628:therapy*; D015906:Angioplasty, Balloon, Coronary / Q000009:adverse effects / Q000295:instrumentation* / Q000401:mortality; D017023:Coronary Angiography; D023903:Coronary Restenosis / Q000175:diagnosis / Q000209:etiology / Q000401:mortality / Q000517:prevention & control*; D018572:Disease-Free Survival; D054855:Drug-Eluting Stents; D005260:Female; D006801:Humans; D053208:Kaplan-Meier Estimate; D008297:Male; D008875:Middle Aged; D009203:Myocardial Infarction / Q000175:diagnosis / Q000401:mortality / Q000628:therapy*; D009426:Netherlands; D062645:Percutaneous Coronary Intervention / Q000009:adverse effects / Q000295:instrumentation* / Q000379:methods / Q000401:mortality; D011237:Predictive Value of Tests; D011474:Prosthesis Design; D012307:Risk Factors; D013997:Time Factors; D016896:Treatment Outcome
keywords: direct stenting; late lumen loss; percutaneous coronary intervention; pre-dilation; provisional stenting; restenosis