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Table 3 Safety and efficacy outcomes at follow-up

From: Everolimus-eluting bioresorbable scaffolds for treatment of coronary artery disease in patients with diabetes mellitus: the midterm follow-up of the prospective ABSORB DM Benelux study

Endpoints and clinical events

% (n)

Lower 95% CI

Higher 95% CI

Event rate per 100 PY

Lower 95% CI

Higher 95% CI

MACEa

15.2 (20)

0.77

0.90

8.8

5.38

13.61

 All-cause death

3.4 (5)

0.92

0.99

2.1

0.67

4.82

 Any MI

4.9 (7)

0.90

0.98

3.0

1.21

6.21

 Ischemic-driven TVR

9.3 (11)

0.83

0.95

4.8

2.37

8.49

TLFb

11.7 (16)

0.82

0.93

7.0

3.97

11.29

 CD

3.4 (5)

0.92

0.99

2.1

0.67

4.82

 Target vessel MI

3.6 (5)

0.92

0.99

2.1

0.69

4.97

 Ischemic-driven TLR

5.5 (7)

0.89

0.97

3.0

1.19

6.12

ScT

1.4 (2)

0.95

1.00

0.8

0.10

3.01

 Early: 0–30 days

1.4 (2)

     

  Acute: ≤ 24 h

0

     

  Subacute: > 24 h–30 days

1.4 (2)

     

 Late: 31 days: ≤ 1-year

0

     

 Very late: > 1-year

0

     

 Definite

0.7 (1)

     

 Probable

0.7 (1)

     
  1. Clinical outcomes represented as endpoints and clinical events at midterm follow-up. Endpoints and clinical events are presented by Kaplan–Meier estimates at 2-years and in event rates per 100 patient years both given with 95% confidence intervals. Three patients were lost to follow-up
  2. CI confidence interval, PY patient years, MACE major adverse cardiac events, MI myocardial infarction, TVR target vessel revascularization, TLF target lesion failure, CD cardiac death, TLR target lesion revascularization, ScT scaffold thrombosis
  3. aMajor adverse cardiac event was defined as a composite of all-cause death, any myocardial infarction and ischemic-driven target vessel revascularization
  4. bTarget lesion failure was defined as a composite of cardiac death, target vessel myocardial infarction and ischemic-driven target lesion revascularization