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 |
Author(s): | Remkes, W.S.; Somi, S.; Roolvink, V. ; Rasoul, S.; Ottervanger, J.P.; Gosselink, A.T.M.; Hoorntje, J.C.A.; Dambrink, J.H.; Boer, M.J. de ; Suryapranata, H. ; Hof, A.W. van 't |
Publication year: | 2014 |
Source: | Jacc. Cardiovascular Interventions, vol. 7, iss. 7, (2014), pp. 751-758 |
ISSN: | 1936-8798 |
DOI: | https://doi.org/10.1016/j.jcin.2014.02.012 |
Publication type: | Article / Letter to editor |
Please use this identifier to cite or link to this item : https://hdl.handle.net/2066/134030 ![]() |
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Subject: | Radboudumc 16: Vascular damage RIHS: Radboud Institute for Health Sciences |
Organization: | Cardiology Radboudumc Extern |
Journal title: |
Jacc. Cardiovascular Interventions
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Volume: | vol. 7 |
Issue: | iss. 7 |
Page start: | p. 751 |
Page end: | p. 758 |
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).
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