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Table 3 Clinical outcomes at 12-month follow-up stratified according to diabetic status and type of lesion (de-novo lesions vs. ISR)

From: Sirolimus-coated balloon in all-comer population of coronary artery disease patients: the EASTBOURNE DIABETES prospective registry

 

Overall population

(N = 2,083)

Patents with de-novo lesions

(N = 1,173)

Patients with ISR

(N = 910)

 

Patients with DM (N = 864)

Patients without DM (N = 1,219)

HR (95% CI)

Patients with DM (N = 452)

Patients without DM (N = 721)

HR (95% CI)

Patients with DM (N = 412)

Patients without DM (N = 498)

HR (95% CI)

Death, n (%)

33 (3.8)

32 (2.6)

1.81 (0.95–3.46)

10 (2.2)

14 (1.9)

1.80 (0.58–5.64)

23 (5.6)

18 (3.6)

1.74 (0.79–3.81)

MI, n (%)

29 (3.4)

18 (1.5)

2.15 (1.09–4.25)

8 (1.8)

3 (0.4)

2.44 (0.57–10.46)

21 (5.1)

15 (3.0)

1.90 (0.88–4.09)

Bleeding, n (%)

9 (1.0)

4 (0.3)

2.65 (0.75–9.31)

3 (0.7)

3 (0.4)

1.49 (0.29–7.60)

6 (1.5)

1 (0.2)

7.26 (0.71–74.20)

MACE, n (%)

105 (12.2)

109 (8.9)

1.26 (0.92–1.74)

27 (6.0)

40 (5.5)

1.05 (0.59–1.85)

78 (18.9)

69 (13.9)

1.39 (0.94–2.04)

TLR, n (%), per-patient

52 (6.0)

61 (5.0)

1.15 (0.73–1.81)

9 (2.0)

13 (1.8)

1.00 (0.39–2.59)

43 (10.4)

48 (9.6)

1.13 (0.67–1.90)

TLR, n/lesion number (%), per lesion

63/968 (6.5)

64/1371 (4.7)

1.38 (0.91–2.08)

11/486 (2.3)

13/798 (1.6)

1.35 (0.56–3.26)

52/482 (10.8)

51/573 (8.9)

1.36 (0.85–2.16)

  1. DM: diabetes mellitus; ISR: in-stent restenosis; MI: myocardial infarction; MACE: major adverse cardiovascular event; TLR: target lesion revascularization; Cox model HR (95% CI) are shown; adjusted for patient age, hypercolesterolemia, hypertension, MVD and predilatation