Skip to main content

Table 2 Assessment of harm described in reports of randomized controlled trials assessing stent treatment for coronary diseases by type of stent

From: Reporting of harm in randomized controlled trials evaluating stents for percutaneous coronary intervention

  All reports Drug-eluting stent Polymer-coating stent Bare metal stent
  N = 132 N = 64 N = 19 N = 41
  N (%) N (%) N (%) N (%)
Assessment of harm     
   - Nature of adverse events systematically collected when considering     
- All adverse events 110 (83) 50 (78) 16 (84) 39 (95)
- Events other than MAC(C)E1 63 (48) 22 (34) 8 (42) 16 (39)
   - Mode of data collection provided when considering     
- All adverse events 29 (22) 17 (27) 5 (26) 6 (15)
- Events other than MAC(C)E1 13 (10)    
Definition of expected adverse event 47 (36) 27 (42) 2 (11) 14 (34)
Assessment by an adjudication committee 46 (35) 35 (55) 4 (21) 7 (17)
Length of follow-up specified 95 (72) 52 (81) 11 (58) 32 (78)
   - < 1 month 3 (2) 1 (2) 0 2 (5)
   - 6 months 32 (24) 14 (22) 7 (37) 11 (27)
   - 7–11 months 27 (20) 21 (33) 1 (5) 5 (12)
   - 12 months 28 (21) 14 (22) 1 (5) 13 (32)
   - > 12 months 5 (4) 2 (3) 2 (11) 1 (2)
No duration specified 29 (22) 12 (19) 8 (42) 9 (22)
  1. 1MAC(C)E: Major Adverse Cardiac (Cerebrovascular) Event