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. 2023 May 18;2(4):100971. doi: 10.1016/j.jscai.2023.100971

Table 5.

Selected Trials Evaluating Management Strategies for In-stent Restenosis

Trial, publication year Investigation
Time		 No. of lesions centers, region Design Drug-coated balloon, carrier agent, commercial name Control device Restenotic stent Endpoint(s) Follow-up (mo) Principal findings P-value
PCB vs Uncoated balloon
 PACCOCATH ISR I&II, 201275 Dec 2003 - Dec 2005 54/54
Multicenter, Germany		 Core lab, CEC Paclitaxel, iopromide 3 μg/mm2, PACCOCATH Uncoated balloon BMS, DES LLL (mm) 6 0.11 ± 0.44 vs 0.80 ± 0.79 .001
TLR (%) 12/60 4 vs 37 / 9 vs 39 .001/.004
MACE (%) 12/60 9 vs 44 / 28 vs 59 .001/.009
 Habara et al, 201186 Sep 2008 - Nov 2009 25/25
1, Japan		 — Paclitaxel, iopromide 3 μg/mm2, SeQuent Please Uncoated balloon SES LLL (mm) 6 0.18 ± 0.45 vs 0.72 ± 0.55 <.01
TLR (%) 6 4 vs 42 <.01
MACE (%) 6 4 vs 40 <.01
 PEPCAD-DES, 201272,76 Nov 2009 - Apr 2011 72/38
Multicenter, Germany		 Core lab Paclitaxel, iopromide 3 μg/mm2, SeQuent Please Uncoated balloon DES LLL (mm) 6 0.43 ± 0.61 vs. 1.03 ± 0.77 <.01
TLR (%) 6/36 15 vs 37 / 19 vs 37 <.01/<.01
MACE (%) 6/36 17 vs 50.0 / 21 vs 53 <.01/<.01
PCB vs DES
 PEPCAD II, 200970,77 Jan 2006 - Dec 2006 66/65
10, Germany		 Core lab, CEC Paclitaxel, iopromide 3 μg/mm2, SeQuent Please PES, durable polymer, stainless steel (132 μm) BMS LLL (mm) 6 0.17 ± 0.42 vs 0.38 ± 0.6 .03
TLR (%) 12 6 vs 15 .15
MACE (%) 12/36 9 vs 22 / 35 vs 42 .08/–
 SEDUCE, 201474 Jun 2009 - Oct 2011 24/25
2, Belgium		 Core lab, CEC Paclitaxel, iopromide 3 μg/mm2, SeQuent Please EES, durable polymer, CoCr (81 μm) BMS LLL (mm) 9 0.28 vs 0.07 .1
TLR (%) 12 4.2 vs 8 .576
 RIBS V, 201473 Jan 2010 - Jan 2012 95/94
25, Spain		 Core lab, CEC Paclitaxel, iopromide 3 μg/mm2, SeQuent Please EES, durable polymer, CoCr (81 μm) BMS LLL (mm) 6 to 9 0.14 ± 0.5 vs 0.04 ± 0.5 .14
TLR (%) 12/36 6 vs 1 / 8 vs. 2 .09/.04
MACE (%) 12/36 8 vs 6 / 12 vs 10 .60/.64
 TIS, 201678 Jan 2012 - Aug 2014 74/74
1, Czech Rep.		 Core lab, CEC Paclitaxel, iopromide 3 μg/mm2, SeQuent Please EES, durable polymer, CoCr (81 μm) BMS LLL (mm) 12 0.02 vs 0.19 <.01
TVR (%) 12 7.4 vs 16.2 .110
MACE (%) 12 10.3 vs 19.1 .213
 ISAR-DESIRE3, 201371,79 Aug 2009 - Oct 2011 137/131/134
3, Germany		 Core lab, CEC Paclitaxel, iopromide 3 μg/mm2, SeQuent Please
  • 1)

    PES, durable polymer, stainless steel (132 μm)

  • 2)

    Common balloon

 DES ISR diameter (%) 6 to 8 38% vs 37.4% vs 54.1% <.01a
TLR (%) 12/36 22 vs 14 vs 44 / 33 vs 24 vs 51 .09/.11b
MACE (%) 12/36 24 vs 19 vs 46 / 38 vs 38 vs 56 .5/.91b
 PEPCAD China ISR, 201480 Mar 2011 - Apr 2012 113/108
17, China		 Core lab, CEC Paclitaxel, iopromide 3 μg/mm2, SeQuent Please PES, durable polymer, stainless steel (132 μm) DES LLL (mm) 9 0.46 ± 0.51 vs 0.55 ± 0.61 .0005a
TLR (%) 12/24 15.6 vs 12.3 / 15.9 vs 13.7 .48/.66
TLF (%) 12/24 16.5 vs 16 / 16.8 vs 18.6 .92/.73
 RIBS IV, 201844 Jan 2010 - Aug 2013 154/155
23, Spain		 Core lab, CEC Paclitaxel, iopromide 3 μg/mm2, SeQuent Please EES, durable polymer, CoCr (81 μm) DES Binary restenosis 6 to 9 19% vs 11% .27
TLR (%) 12 16.2 vs 21.8 .26
MACE (%) 12 18.4 vs 23.3 .35
 RESTORE, 201881 Apr 2013 - Oct 2016 86/86
10, South Korea		 Core lab, CEC Paclitaxel, iopromide 3 μg/mm2 EES, durable polymer, CoCr (81 μm) DES LLL (mm) 9 0.15 ± 0.49 vs 0.19 ± 0.41 .54
TLR (%) 12 7 vs 5 .51
MACE (%) 12 6 vs 1 .10
 DARE, 201847 May 2010 - Jun 2015 137/141
8, Netherlands		 Core lab, CEC Paclitaxel, iopromide 3 μg/mm2, SeQuent Please EES, durable polymer, CoCr (81 μm) BMS, DES MLD (mm) 6 1.71 ± 0.51 vs 1.74 ± 0.61 <.01a
TVR (%) 12 7.1 vs 8.8 .65
MACE (%) 12 10.9 vs 9.2 .66
 BIOLUX-RCT, 201882 Aug 2012 - Jan 2015 163/80
14, Germany, Latvia		 Core lab, CEC Paclitaxel, BTHC 3 μg/mm2, Pantera Lux DES, bioresorbable polymer, CoCr (60–80 μm) BMS, DES LLL (mm) 6 0.03 ± 0.40 vs 0.20 ± 0.70 .40
TLR (%) 12 12.5 vs 10.1 .82
TLF (%) 12 16.9 vs 14.2 .65
 DAEDALUS, 202083 Pooled analysis of 10 RCTc Core lab, CEC Paclitaxel, iopromide/BTHC 3 μg/mm2 DES BMS, DES TLR (%) 36 16 vs 12, HR 1.27 (0.90-1.79) .17
Safety endpointd 36 9 vs 11, HR 0.79 (0.58-1.10) .16
SCB vs PCB
 FIM LIMUS DCB, 201984 Dec 2015 - Jan 2017 25/25
5, Malaysia		 Core lab, CEC Sirolimus, crystalline coating 4 μg/mm2, SeQuent SCB Paclitaxel, iopromide 3 μg/mm2, SeQuent Please DES LLL (mm) 6 0.21 ± 0.54 vs 0.17 ± 0.55 .794
TLR (%) 12 16 vs 12 >.99
MACE (%) 12 16 vs 12 >.99
 Scheller et al. 202285 Dec 2015 - Feb 2020 50/51
10, Malaysia, Germany, Switzerland		 Core lab, CEC Sirolimus, crystalline coating 4 μg/mm2, SeQuent SCB Paclitaxel, iopromide 3 μg/mm2, SeQuent Please DES LLL (mm) 6 0.25 ± 0.57 vs 0.26 ± 0.60 <.35a
TLR (%) 12 16 vs 10 .39
MACE (%) 12 18 vs 14 .60

BMS, bare metal stent; BTHC, butyryl-tri-hexyl citrate; CEC, clinical events committee; CoCr, cobalt-chromium; DES, drug-eluting stent; EES, everolimus-eluting stent; ISR, in-stent restenosis; LLL, late lumen loss; MACE, major adverse cardiovascular events; MLD, minimal lumen diameter; PCB, paclitaxel-cboated balloon; PES, paclitaxel-eluting stent; SCB, sirolimus-coated balloon; TLF, target lesion failure; TLR, target lesion revascularization; TVR, target vessel revascularization;

a

Non-inferiority.

b

PCB vs PES.

c

PEPCAD II, ISAR-DESIRE 3, PEPCAD China ISR, RIBS V, SEDUCE, RIBS IV, TIS, DARE, RESTORE, BIOLUX-RCT.

d

All-cause death, myocardial infarction, or target lesion thrombosis.