Cardiology Research and Practice

Review Article

In-Stent Restenosis and a Drug-Coated Balloon: Insights from a Clinical Therapeutic Strategy on Coronary Artery Diseases

Table 1

The clinical trial of the drug-coated balloon in the treatment of in-stent restenosis.


	Trial name	Balloon and groups	Principal findings	Ref.

Scheller et al., 2006	PACCOCATH ISR I	PACCOCATH® DEB (26 cases) vs. Uncoated balloon (26 cases)	At 6-month follow-up, LLL: (0.03 ± 0.48) mm vs. (0.74 ± 0.86) mm (); TLR 23% vs. 0%	[30]

Scheller et al., 2008; Scheller et al., 2012	PACCOCATH ISR II	PACCOCATH® DEB (54 cases) vs. uncoated balloon (54 cases)	6 or 12 months, LLL: (0.81 ± 0.79) mm vs. (0.11 ± 0.46) mm (); 37% vs. 4%	[31, 32]

Unverdorben et al, 2009	PEPCAD II	SeQuent Please (66 cases)/TAXUS stents (65 cases)	6 months, LLL: (0.17 ± 0.42) mm vs. (0.38 ± 0.61) mm (); 6.3% vs. 15.4%	[33]

Byrne et al. 2013	ISAR-DESIRE3	SeQuent Please (137 cases)/TAXUS stent (131 cases)/common balloon (134 cases)	9 months, in-stent restenosis diameter: 38%:37.4% vs. 54.1% (noninferiority )	[34]

Rittger et al., 2012	PEPCAD-DES	SeQuent Please (72 cases)/common balloon (38 cases)	6 months, LLL: (0.43 ± 0.61) mm vs. (1.03 ± 0. 77) mm ()	[35]

Xu et al., 2014	PEPCAD China ISR	SeQuent Please (110cases)/TAXUS (110 cases)	9 months, LLL: (0.46 ± 0.51) mm vs. (0.55 ± 0.61) mm (P noninferiority = 0.0005)	[36]

Toelg et al., 2014	DELUX registry	Pantera Lux DCB (1064 cases)	6, 12 months, MACE: 8.5%, 15.1%	[37]

Habara et al., 2011	Habara et al.	SeQuent Please (25 cases)/common balloon (25 cases)	6 months, LLL: (0.18 ± 0.45) mm vs. (0.72 ± 0.55) mm ()	[38]

Wöhrle et al., 2012	SeQuent Please World Wide Registry	SeQuent Please (DES-ISR (464 cases)/BMS-ISR (763 cases))	9 months, TLR: 9.6% vs. 3.8% ()	[39]

Stella et al., 2011	Valentines I	DIOR II DCB (paclitaxel DES-ISR (34 cases)/everolimus DES-ISR (42 cases))	8 months, MACE: 0 : 23.8% ()	[40]

Hehrlein et al., 2012	PEPPER	Pantera Lux DES (BMS-ISR (43 cases)/DES-ISR (38 cases))	6 months, LLL: (0.05 ± 0.28) mm vs. (0.19 ± 0.29) mm ()	[41]

Alfonso et al., 2018	RIBS IV	DCB (154 cases)/EES (155 cases)	3-yr follow-up, MLD: (2.03 ± 0.7) mm vs. (1.8 ± 0.6) mm	[42]

Note. DCB, drug-coated balloon; DES, drug-eluting stent; MACE, major adverse cardiac event; LLL, late lumen loss; MLD, minimal lumen diameter; TLR, target lesion revascularization.