TY - JOUR
T1 - Randomized Multicenter Trial Investigating Angiographic Outcomes of Hybrid Sirolimus-Eluting Stents With Biodegradable Polymer Compared With Everolimus-Eluting Stents With Durable Polymer in Chronic Total Occlusions The PRISON IV Trial
AU - Teeuwen, Koen
AU - van der Schaaf, Rene J.
AU - Adriaenssens, T
AU - Koolen, Jacques J.
AU - Smits, Pieter C.
AU - Henriques, Jose P. S.
AU - Vermeersch, Paul H. M. J.
AU - Gin, R. Melvyn Tjon Joe
AU - Scholzel, Bastiaan E.
AU - Kelder, Johannes C.
AU - Tijssen, Jan G. P.
AU - Agostoni, Pierfrancesco
AU - Suttorp, Maarten J.
PY - 2017/1/23
Y1 - 2017/1/23
N2 - OBJECTIVES The aim of this study was to investigate the efficacy and safety of the hybrid ultrathin-strut sirolimuseluting stent (SES) with biodegradable polymer compared with the thin-strut everolimus-eluting stent (EES) with durable polymer in successfully recanalized chronic total occlusions (CTOs).
BACKGROUND The introduction of drug-eluting stents revolutionized the treatment of CTOs. However, limited data are available on new-generation drug-eluting stents with biodegradable polymer in CTOs.
METHODS In this multicenter trial, patients were randomized, after successful CTO recanalization, to either SES or EES. The primary noninferiority endpoint was in-segment late lumen loss (noninferiority margin 0.2 mm). Secondary endpoints included in-stent late lumen loss and clinical endpoints.
RESULTS Overall, 330 patients were included. At 9 months, angiography was available in 281 patients (85%). Duration of occlusion >= 3 months was 92.5%, with mean stent length of 52.4 +/- 28.1 mm versus 52.3 +/- 26.5 mm in the SES and EES groups. The primary noninferiority endpoint, in-segment late lumen loss, was not met for SES versus EES (0.13 +/- 0.63 mm vs. 0.02 +/- 0.47 mm; p = 0.08, 2-sided; difference 0.11 mm; 95% confidence interval: -0.01 to 0.25 mm; pnoninferiority = 0.11, 1-sided). In-stent late lumen loss was comparable between SES and EES (0.12 + 0.59 mm vs. 0.07 +/- 0.46 mm; p = 0.52). The incidence of in-stent and in-segment binary restenosis was significantly higher with SES compared with EES (8.0% vs. 2.1%; p = 0.028), with comparable rates of reocclusions (2.2% vs. 1.4%; p = 0.68). Clinically indicated target lesion and target vessel revascularization (9.2% vs. 4.0% [ p = 0.08] and 9.2% vs. 6.0% [ p = 0.33]), target vessel failure (9.9% vs. 6.6%; p = 0.35), and definite or probable stent thrombosis (0.7% vs. 0.7%; p = 1.00) were comparable between the SES and EES groups.
CONCLUSIONS This randomized trial failed to show noninferiority of hybrid SES relative to EES in terms of in-segment late lumen loss in successfully recanalized CTOs. Furthermore, a statistically significantly higher rate of binary restenosis was found with SES. (C) 2017 by the American College of Cardiology Foundation.
AB - OBJECTIVES The aim of this study was to investigate the efficacy and safety of the hybrid ultrathin-strut sirolimuseluting stent (SES) with biodegradable polymer compared with the thin-strut everolimus-eluting stent (EES) with durable polymer in successfully recanalized chronic total occlusions (CTOs).
BACKGROUND The introduction of drug-eluting stents revolutionized the treatment of CTOs. However, limited data are available on new-generation drug-eluting stents with biodegradable polymer in CTOs.
METHODS In this multicenter trial, patients were randomized, after successful CTO recanalization, to either SES or EES. The primary noninferiority endpoint was in-segment late lumen loss (noninferiority margin 0.2 mm). Secondary endpoints included in-stent late lumen loss and clinical endpoints.
RESULTS Overall, 330 patients were included. At 9 months, angiography was available in 281 patients (85%). Duration of occlusion >= 3 months was 92.5%, with mean stent length of 52.4 +/- 28.1 mm versus 52.3 +/- 26.5 mm in the SES and EES groups. The primary noninferiority endpoint, in-segment late lumen loss, was not met for SES versus EES (0.13 +/- 0.63 mm vs. 0.02 +/- 0.47 mm; p = 0.08, 2-sided; difference 0.11 mm; 95% confidence interval: -0.01 to 0.25 mm; pnoninferiority = 0.11, 1-sided). In-stent late lumen loss was comparable between SES and EES (0.12 + 0.59 mm vs. 0.07 +/- 0.46 mm; p = 0.52). The incidence of in-stent and in-segment binary restenosis was significantly higher with SES compared with EES (8.0% vs. 2.1%; p = 0.028), with comparable rates of reocclusions (2.2% vs. 1.4%; p = 0.68). Clinically indicated target lesion and target vessel revascularization (9.2% vs. 4.0% [ p = 0.08] and 9.2% vs. 6.0% [ p = 0.33]), target vessel failure (9.9% vs. 6.6%; p = 0.35), and definite or probable stent thrombosis (0.7% vs. 0.7%; p = 1.00) were comparable between the SES and EES groups.
CONCLUSIONS This randomized trial failed to show noninferiority of hybrid SES relative to EES in terms of in-segment late lumen loss in successfully recanalized CTOs. Furthermore, a statistically significantly higher rate of binary restenosis was found with SES. (C) 2017 by the American College of Cardiology Foundation.
KW - biodegradable polymer
KW - chronic total occlusion
KW - drug-eluting stent(s)
KW - percutaneous coronary intervention
UR - http://www.scopus.com/inward/record.url?scp=85010212059&partnerID=8YFLogxK
U2 - 10.1016/j.jcin.2016.10.017
DO - 10.1016/j.jcin.2016.10.017
M3 - Article
VL - 10
SP - 133
EP - 143
JO - JACC: Cardiovascular Interventions
JF - JACC: Cardiovascular Interventions
SN - 1936-8798
IS - 2
ER -