TY - JOUR
T1 - Direct drug-eluting stenting to reduce stent restenosis
T2 - a randomized comparison of direct stent implantation to conventional stenting with pre-dilation or provisional stenting in elective PCI patients
AU - Remkes, Wouter S
AU - Somi, Samer
AU - Roolvink, Vincent
AU - Rasoul, Saman
AU - Ottervanger, Jan Paul
AU - Gosselink, A T Marcel
AU - Hoorntje, Jan C A
AU - Dambrink, Jan-Henk E
AU - de Boer, Menko-Jan
AU - Suryapranata, Harry
AU - van 't Hof, Arnoud W J
AU - Acute Myocardial Infarction Study Group
N1 - Copyright © 2014 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.
PY - 2014/7
Y1 - 2014/7
N2 - 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).
AB - 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).
KW - Aged
KW - Angina Pectoris
KW - Angioplasty, Balloon, Coronary
KW - Coronary Angiography
KW - Coronary Restenosis
KW - Disease-Free Survival
KW - Drug-Eluting Stents
KW - Female
KW - Humans
KW - Kaplan-Meier Estimate
KW - Male
KW - Middle Aged
KW - Myocardial Infarction
KW - Netherlands
KW - Percutaneous Coronary Intervention
KW - Predictive Value of Tests
KW - Prosthesis Design
KW - Risk Factors
KW - Time Factors
KW - Treatment Outcome
U2 - 10.1016/j.jcin.2014.02.012
DO - 10.1016/j.jcin.2014.02.012
M3 - Article
C2 - 25060017
SN - 1936-8798
VL - 7
SP - 751
EP - 758
JO - Jacc-Cardiovascular Interventions
JF - Jacc-Cardiovascular Interventions
IS - 7
ER -