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

Wouter S Remkes, Samer Somi, Vincent Roolvink, Saman Rasoul, Jan Paul Ottervanger, A T Marcel Gosselink, Jan C A Hoorntje, Jan-Henk E Dambrink, Menko-Jan de Boer, Harry Suryapranata, Arnoud W J van 't Hof, Acute Myocardial Infarction Study Group

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Abstract

OBJECTIVES: 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).

Original languageEnglish
Pages (from-to)751-8
Number of pages8
JournalJacc-Cardiovascular Interventions
Volume7
Issue number7
DOIs
Publication statusPublished - Jul 2014

Keywords

  • Aged
  • Angina Pectoris
  • Angioplasty, Balloon, Coronary
  • Coronary Angiography
  • Coronary Restenosis
  • Disease-Free Survival
  • Drug-Eluting Stents
  • Female
  • Humans
  • Kaplan-Meier Estimate
  • Male
  • Middle Aged
  • Myocardial Infarction
  • Netherlands
  • Percutaneous Coronary Intervention
  • Predictive Value of Tests
  • Prosthesis Design
  • Risk Factors
  • Time Factors
  • Treatment Outcome

Cite this

Remkes, W. S., Somi, S., Roolvink, V., Rasoul, S., Ottervanger, J. P., Gosselink, A. T. M., Hoorntje, J. C. A., Dambrink, J-H. E., de Boer, M-J., Suryapranata, H., van 't Hof, A. W. J., & Acute Myocardial Infarction Study Group (2014). 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. Jacc-Cardiovascular Interventions, 7(7), 751-8. https://doi.org/10.1016/j.jcin.2014.02.012