Intra-individual head-to-head comparison of Sirolimus®- and Paclitaxel®-eluting stents for coronary revascularization. A randomized, multi-center trial
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Intra-individual head-to-head comparison of Sirolimus®- and Paclitaxel®-eluting stents for coronary revascularization. A randomized, multi-center trial. / Kollum, M; Heitzer, T; Schmoor, C; Brunner, M; Witzenbichler, B; Wiemer, M; Hoffmann, R; Gutleben, K J; Schultheiss, H P; Horstkotte, D; Brachmann, J; Meinertz, T; Bode, Ch; Zehender, M; FreRace Trial Investigators.
in: INT J CARDIOL, Jahrgang 167, Nr. 4, 20.08.2013, S. 1552-1559.Publikationen: SCORING: Beitrag in Fachzeitschrift/Zeitung › SCORING: Zeitschriftenaufsatz › Forschung › Begutachtung
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TY - JOUR
T1 - Intra-individual head-to-head comparison of Sirolimus®- and Paclitaxel®-eluting stents for coronary revascularization. A randomized, multi-center trial
AU - Kollum, M
AU - Heitzer, T
AU - Schmoor, C
AU - Brunner, M
AU - Witzenbichler, B
AU - Wiemer, M
AU - Hoffmann, R
AU - Gutleben, K J
AU - Schultheiss, H P
AU - Horstkotte, D
AU - Brachmann, J
AU - Meinertz, T
AU - Bode, Ch
AU - Zehender, M
AU - FreRace Trial Investigators
N1 - Copyright © 2012 Elsevier Ireland Ltd. All rights reserved.
PY - 2013/8/20
Y1 - 2013/8/20
N2 - BACKGROUND: Despite the known effects of drug-eluting stents (DES), other cofactors attributed to patient characteristics affect their success. Interest focused on designing a study minimizing these factors to answer continuing concerns on the heterogeneity of response to different DESs. The study's aim was to investigate the feasibility and impact of an intra-individual comparison design in patients (pts) with two coronary artery stenosis treated with a Sirolimus- (SES) and a Paclitaxel- (PES) eluting stent.METHODS AND RESULTS: The study was conducted as a prospective, randomized, multi-center trial in 112 pts who consented to treatment with a SES and a PES. Pts were eligible if they suffered from the presence of two single primary target lesions in two different native coronary arteries. Lesions were randomized to either SES or PES treatment. The primary endpoint was in-stent luminal late loss (LLL), as determined by quantitative angiography at 8 months; clinical follow up was obtained at 1, 8, and 12 months additionally. The LLL (0.13 ± 0.28 mm SES vs. 0.26 ± 0.35 mm PES, p=0.011) showed less neointima in SES. With a predefined cut-off criterion of 0.2mm difference in LLL, 53/87 pts SES and PES were similar effective. 34/87 pts had a divergent result, 26 pts had greater benefit from SES while 8 pts had greater benefit from PES. Overall, MACE (MI, TLR, and death) occurred in 19 (17%) pts. Based on lesion analysis of 108 lesions treated with SES and 110 lesions treated with PES, 5 (4.6%) lesions with SES and 3 (2.7%) lesions with PES required repeated TLR.CONCLUSION: An intra-individual comparison design to assess differences in efficacy of different DESs is feasible, safe and achieves similar results to inter-individual studies. This study is among the first to show that failure of one DES does not necessarily implicate failure of another DES and vice versa.
AB - BACKGROUND: Despite the known effects of drug-eluting stents (DES), other cofactors attributed to patient characteristics affect their success. Interest focused on designing a study minimizing these factors to answer continuing concerns on the heterogeneity of response to different DESs. The study's aim was to investigate the feasibility and impact of an intra-individual comparison design in patients (pts) with two coronary artery stenosis treated with a Sirolimus- (SES) and a Paclitaxel- (PES) eluting stent.METHODS AND RESULTS: The study was conducted as a prospective, randomized, multi-center trial in 112 pts who consented to treatment with a SES and a PES. Pts were eligible if they suffered from the presence of two single primary target lesions in two different native coronary arteries. Lesions were randomized to either SES or PES treatment. The primary endpoint was in-stent luminal late loss (LLL), as determined by quantitative angiography at 8 months; clinical follow up was obtained at 1, 8, and 12 months additionally. The LLL (0.13 ± 0.28 mm SES vs. 0.26 ± 0.35 mm PES, p=0.011) showed less neointima in SES. With a predefined cut-off criterion of 0.2mm difference in LLL, 53/87 pts SES and PES were similar effective. 34/87 pts had a divergent result, 26 pts had greater benefit from SES while 8 pts had greater benefit from PES. Overall, MACE (MI, TLR, and death) occurred in 19 (17%) pts. Based on lesion analysis of 108 lesions treated with SES and 110 lesions treated with PES, 5 (4.6%) lesions with SES and 3 (2.7%) lesions with PES required repeated TLR.CONCLUSION: An intra-individual comparison design to assess differences in efficacy of different DESs is feasible, safe and achieves similar results to inter-individual studies. This study is among the first to show that failure of one DES does not necessarily implicate failure of another DES and vice versa.
KW - Adult
KW - Aged
KW - Aged, 80 and over
KW - Coronary Stenosis/diagnosis
KW - Drug-Eluting Stents
KW - Female
KW - Follow-Up Studies
KW - Humans
KW - Male
KW - Middle Aged
KW - Observer Variation
KW - Paclitaxel/administration & dosage
KW - Percutaneous Coronary Intervention/methods
KW - Prospective Studies
KW - Sirolimus/administration & dosage
U2 - 10.1016/j.ijcard.2012.04.095
DO - 10.1016/j.ijcard.2012.04.095
M3 - SCORING: Journal article
C2 - 22575624
VL - 167
SP - 1552
EP - 1559
JO - INT J CARDIOL
JF - INT J CARDIOL
SN - 0167-5273
IS - 4
ER -
