Table 2.

Five‐Year Outcome

	Events (KM, %)			Unadjusted HR (95% CI); P value		Adjusted HR (95% CI)*
	DCB	DES	POBA	DCB vs DES	DCB vs POBA	DCB vs DES	DCB vs POBA
TLR	416 (21.9)	548 (15.5)	165 (21.7)	1.45 (1.29–1.64); <0.001	0.77 (0.64–0.92); 0.005	1.20 (1.06–1.37); 0.005	0.69 (0.57–0.82); <0.001
All‐cause death	423 (22.0)	900 (22.3)	235 (33.8)	0.94 (0.84–1.06); 0.305	0.51 (0.44–0.60); <0.001	0.92 (0.81–1.04); 0.193	0.72 (0.59–0.88)†; 0.001
Cardiovascular death	198 (11.5)	451 (12.3)	139 (22.0)	0.88 (0.75–1.04); 0.141	0.41 (0.33–0.51); <0.001	0.84 (0.70–1.01); 0.062	0.59 (0.44–0.77); 0.003
Myocardial infarction	535 (26.6)	950 (23.9)	171 (27.1)	1.13 (1.01–1.25); 0.026	0.85 (0.72–1.01); 0.068	1.06 (0.95–1.19); 0.317	1.04 (0.85–1.27)†; 0.728
Any PCI	691 (34.0)	1290 (30.9)	223 (33.5)	1.07 (0.97–1.17); 0.164	0.83 (0.71–0.96); 0.013	0.97 (0.88–1.07); 0.486	0.85 (0.72–1.01)†; 0.058

ACC/AHA indicates American College of Cardiology/American Heart Association; DCB, drug‐coated balloon; DES, drug‐eluting stent; HR, hazard ratio; ISR, in‐stent restenosis; IVUS, intravascular ultrasound; KM, Kaplan–Meier estimates; OCT, optic coherence tomography; PCI, percutaneous coronary intervention; POBA, plain old balloon angioplasty; and TLR, target‐lesion revascularization.

^*Adjusted for inclusion year, age, sex, smoking status, diabetes, hypertension, hyperlipidemia, previous heart failure, renal failure, previous myocardial infarction, previous coronary artery bypass graft surgery, indication, number of lesions with ISR, lesion location, use of IVUS or OCT, ACC/AHA lesion classification, ISR type (DES‐ISR vs BMS‐ISR), number of previous stents in target lesion (single vs multiple) and time to ISR (early ISR [<31 days] vs late ISR [31–365 days] vs very late ISR [>365 days]).

^† Outcome was assessed using Poisson regression, as the proportional hazard assumption was not met. Results are presented as risk ratios along with 95% CI.