Table 1.
Patient and Study Characteristics
| ITALIC (18) | SECURITY (17) | RESET (12) | PRODIGY (13) | OPTIMIZE (15) | ISAR-SAFE (16) | EXCELLENT (14) | ||
|---|---|---|---|---|---|---|---|---|
| PATIENT CHARACTERISTICS | ||||||||
| Number of Patients | 2031 | 1399 | 2117 | 2013 | 3119 | 4005 | 1443 | |
| Mean Age (years) | Abbreviated DAPT | 61.7 | 65.5 | 62.4 | 67.9 | 61.3 | 67.2 | 63.0 |
| Standard DAPT | 61.5 | 64.9 | 62.4 | 67.8 | 61.9 | 67.2 | 62.4 | |
| Female (%) | Abbreviated DAPT | 19.2 | 22.4 | 35.6 | 24.0 | 36.5 | 19.3 | 34.9 |
| Standard DAPT | 20.8 | 23.2 | 36.1 | 22.6 | 36.9 | 19.5 | 36.1 | |
| Diabetes (%) | Abbreviated DAPT | 36.3 | 31.1 | 29.8 | 23.7 | 35.4 | 24.8 | 37.7 |
| Standard DAPT | 37.8 | 31.4 | 28.8 | 24.7 | 35.3 | 24.2 | 38.6 | |
| PCI for ACS/UA (%) | Abbreviated DAPT | 58.9 | 38.4* | 55.5 | 74.6 | 40.2* | 39.8 | 51.1 |
| Standard DAPT | 58.5 | 38.4* | 53.7 | 74.2 | 41.4* | 40.3 | 52.0 | |
| Primary PCI for STEMI | Excluded | Excluded | Excluded | Included | Excluded | Excluded | Excluded | |
| STUDY CHARACTERISTICS | ||||||||
| Primary composite endpoint | All-cause mortality MI Stroke Major Bleeding TVR |
Cardiac mortality MI Stroke Major bleeding ST |
Cardiac mortality MI Stroke ST TVR |
All-cause mortality MI Stroke |
All-cause mortality MI Stroke Major Bleeding |
All-cause mortality MI Stroke Major Bleeding ST |
Cardiac mortality MI TVR |
|
| DAPT Regimen | ASA + Clopidogrel (98.5%) | ASA + Clopidogrel (99%) | ASA + Clopidogrel (100%) | ASA + Clopidogrel (100%) | ASA + Clopidogrel (100%) | ASA + Clopidogrel (100%) | ASA + Clopidogrel (100%) | |
| Duration of DAPT (months) | Abbreviated DAPT | 6 | 6 | 3 | 6 | 3 | 6 | 6 |
| Standard DAPT | 24 | 12 | 12 | 24 | 12 | 12 | 12 | |
| Timing of Randomization | At time of index stenting | At time of index stenting | At time of index stenting | 1 month after index stenting | 3 months after index stenting | 6 months after index stenting | At time of index stenting | |
| Follow up (months) | 36 | 24 | 12 | 24 | 12 | 15 | 12 | |
| BMS/1st Gen DES/2nd Gen DES (%) | Abbreviated DAPT | 0/0/100 | 0/0/100 | 0/0/100 | 25/25/50 | 0/0/100 | 0.4/11/88 | 0/25/75 |
| Standard DAPT | 0/0/100 | 0/0/100 | 0/28/72 | 25/25/50 | 0/0/100 | 0.3/10/89 | 0/25/75 | |
| NOTABLE ANGIOGRAPHIC CHARACTERISTICS | ||||||||
| 3 Vessel Disease (%) | Abbreviated DAPT | 19.5 | 11.3 | 15.6 | 30.4 | 25.3 | 30.8 | 20.6 |
| Standard DAPT | 18 | 11.4 | 15.3 | 29.6 | 26.4 | 31 | 19.8 | |
| Left Main Disease (%) | Abbreviated DAPT | 1.5 | 0 | 0 | 5.7 | 1.2 | 0.5 | 0 |
| Standard DAPT | 0.9 | 0 | 0 | 5.6 | 1.5 | 0.2 | 0 | |
| Saphenous Vein Graft (%) | Abbreviated DAPT | 6.5 | 0 | N/A | 1.7 | 0 | 1.5 | N/A |
| Standard DAPT | 4.3 | 0 | N/A | 2.3 | 0 | 1.3 | N/A | |
ACS, acute coronary syndrome; ASA; aspirin; BMS, bare metal stent; DAPT, dual antiplatelet therapy; DES, drug eluting stent; MI, myocardial infarction; TVR, target vessel revascularization; UA, unstable angina.