Table 4.
Trial | Year | Randomization of DAPT Duration (Months) | Number of Patients (Group 1; Group 2) |
Placebo Control | ACS (%) | DM (%) | 1G DES (%) |
2G DES (%) |
Primary Endpoint | Event Rate (Intervention vs. Control) |
---|---|---|---|---|---|---|---|---|---|---|
PRODIGY | 2012 | 6 vs. 24 (superiority of 24 months) 25% BMS |
1970 | No | 75 | 24 | 25 | 50 | Death, MI, stroke | 10% vs. 10.1% p = 0.91 |
ITALIC | 2015 | 6 vs. 24 (noninferiority of 6 months) |
1822 | No | 24 | 37 | - | 100 | Death, MI, stroke, TVR, major bleeding | 1.6% vs. 1.5% pni = 0.0002 |
NIPPON | 2017 | 6 vs. 18 (noninferiority of 6 months) |
3773 | No | 28 | 33 | - | 100 | Death, MI, stroke, major bleeding | 2.1% vs. 1.5% |
ACS = acute coronary syndrome; DM = diabetes mellitus; 1G = first generation; 2G = second generation; MI = myocardial infarction; TVR = target vessel revascularization; pni = p value for noninferiority. PRODIGY [48] = The PROlonging Dual AntIplatelet Treatment After Grading Stent-Induced Intimal Hyperplasia Study; short-versus long-term duration of dual-antiplatelet therapy after coronary stenting: a randomized multicenter trial; ITALIC [49] = Is There A Life for DES after DIscontinuation of Clopidogrel, 6- versus 24-month dual antiplatelet therapy after implantation of drug-eluting stents in patients nonresistant to aspirin; NIPPON [50] = Dual Antiplatelet Therapy for 6 Versus 18 Months After Biodegradable Polymer Drug-Eluting Stent Implantation.