Benefits and harms of extended dual antiplatelet therapy (DAPT) compared with DAPT for 6–12 months among participants with or without diabetes*
| Outcome† | Diabetes | No diabetes | ||||||
|---|---|---|---|---|---|---|---|---|
| RCTs | No. events (no. participants) | RR (95% CI)‡; I2 | RCTs | No. events (no. participants) | RR (95% CI)‡; I2 | |||
| > 12 mo | 6–12 mo | > 12 mo | 6–12 mo | |||||
| All-cause death | ITALIC; (7) DAPT (11) | 56 (2086) | 42 (1990) | 1.27 (0.86–1.89); 0% | DAPT | 62 (4125) | 50 (4132) | 1.24 (0.86–1.80); NA |
| Cardiovascular death | ITALIC; (7) DAPT (11) | 30 (2086) | 28/1990 | 1.02 (0.61–1.71); 0% | – | – | – | – |
| Noncardiovascular death | DAPT (11) | 18 (1737) | 10/1654 | 1.71 (0.79–3.70); NA | – | – | – | – |
| Myocardial infarction | ITALIC; (7) DAPT (11) | 63 (2086) | 81/1990 | 0.74 (0.54–1.02); 0% | DAPT | 66 (4125) | 149 (4132) | 0.44 (0.33–0.59); NA |
| Stroke | DAPT (11) | 18 (1737) | 17/1654 | 1.01 (0.52–1.95); NA | – | – | – | – |
| Definite ST | DAPT (11) | 6 (1737) | 14/1654 | 0.41 (0.16–1.06); NA | – | – | – | – |
| Probable or definite ST | DAPT (11) | 9 (1737) | 18/1654 | 0.48 (0.21–1.06) | DAPT | 17 (4125) | 58 (4132) | 0.29 (0.17–0.50); NA |
| Urgent revascularization | ITALIC (7) | 3 (349) | 3/336 | 0.96 (0.20–4.74) | – | – | – | – |
| MACCE§ | DAPT; (11) PRODIGY (10) | DAPT: 111 (1737) | DAPT: 113 (1654) | PRODIGY: HR 0.85 (0.53–1.38); NA DAPT: 0.94 (0.73–1.20); NA | DAPT, PRODIGY | DAPT: 136 (4125) | DAPT: 215 (4132) | PRODIGY: HR 1.06 (0.76–1.50); NA DAPT: 0.63 (0.51–0.78); NA |
| Gastrointestinal bleeding | – | – | – | – | – | – | – | – |
| TIMI major bleeding | – | – | – | – | – | – | – | – |
| TIMI minor bleeding | ITALIC (7) | 2 (349) | 3 (336) | 0.64 (0.11–3.82); NA | – | – | – | – |
| GUSTO moderate bleeding | DAPT (11) | 32 (1737) | 20 (1654) | 1.52 (0.87–2.65); NA | – | – | – | – |
| GUSTO severe bleeding | DAPT (11) | 9 (1737) | 6 (1654) | 1.43 (0.51–4.00); NA | – | – | – | – |
| GUSTO moderate or severe bleeding | DAPT (11) | 41 (1737) | 26 (1654) | 1.50 (0.92–2.44); NA | DAPT | 99 (4125) | 58 (4132) | 1.71 (1.24–2.36); NA |
| BARC type 3 bleeding | DAPT (11) | 44 (1737) | 24 (1654) | 1.75 (1.07–2.86); NA | – | – | – | – |
| BARC type 5 bleeding | DAPT (11) | 1 (1737) | 2 (1654) | 0.48 (0.04–5.25); NA | – | – | – | – |
| BARC type 2, 3, 5 bleeding | DAPT (11) | 95 (1737) | 57 (1654) | 1.59 (1.15–2.19); NA | – | – | – | – |
Note: BARC = Bleeding Academic Research Consortium, CI = confidence interval, GUSTO = Global Use of Strategies to Open Occluded Coronary Arteries, HR = hazard ratio, MACCE = major adverse cardiovascular and cerebrovascular event, NA = not applicable, RCT = randomized controlled trial, RR = relative risk, ST = stent thrombosis, TIMI = Thrombolysis In Myocardial Infarction.
↵* Corresponding forest plots are presented in Appendix 1 and Figure 2. See Table 2 for bleeding outcome definitions.
↵† No outcome data available: gastrointestinal bleeding, TIMI major bleeding.
↵‡ Unless otherwise stated.
↵§ Composite outcome: all-cause death, myocardial infarction or stroke.