Table 3.
Comparative features of randomized controlled trials (RCTs) for short DAPT (S-DAPT) vs. standard DAPT.
| 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 (Noninferiority Margin) |
|---|---|---|---|---|---|---|---|---|---|---|
| EXCELLENT | 2012 | 6 vs. 12 (noninferiority) |
1443 (722; 721) |
No | 52 | 38 | 25 | 75 | Cardiac death, MI, TVR | 4.8% vs. 4.3% pni = 0.001 (4%) |
| RESET | 2012 | 3 vs. 12 (noninferiority) |
2117 (1059; 1058) |
No | 54 | 29 | 21 | 85 | Cardiac death, MI, TVR, ST, TIMI major or minor bleeding | 4.7% vs. 4.7% pni < 0.001 |
| OPTIMIZE | 2013 | 3 vs. 12 (noninferiority) |
3119 (1563;1556) |
No | 32 | 35 | - | 100 | Death, MI, stroke, major bleeding | 6% vs. 5.8% pni = 0.002 |
| SECURITY | 2014 | 6 vs. 12 (noninferiority) |
1399 (682; 717) |
No | 38 | 31 | - | 100 | Cardiac death, MI, ST, stroke, BARC 3/5 bleeding | 4.5% vs. 3.7% pni < 0.05 (2%) |
| ISAR-SAFE | 2015 | 6 vs. 12 (noninferiority) |
4000 (1997; 2003) |
Yes | 40 | 25 | 10 | 89 | Death, MI, ST, stroke, TIMI major bleeding | 1.5% vs. 1.6% pni <0.001 (2%) |
| I LOVE IT | 2016 | 6 vs. 12 (noninferiority) |
1829 | No | 82 | - | - | - | Cardiac death, MI, TLR | 6.8% vs. 5.9% pni < 0.05 (3.7%) |
| IVUS XPL | 2016 | 6 vs. 12 (comparability) |
1400 | No | 49 | - | - | - | Cardiac death, MI, stroke, TIMI major bleeding | 2.2% vs. 2.1% p = 0.85 |
| DAPT-STEMI | 2017 | 6 vs. 12 (noninferiority) |
1100 | No | 100 | 14 | - | 100 | All cause mortality, MI, revascularization, stroke, and TIMI major bleeding | 4.8% vs. 6.6% pni = 0.004 |
| REDUCE | 2017 | 3 vs. 12 (noninferiority |
1496 | No | 100 | - | - | 100 | Death, MI, stroke and bleeding | 8.2% vs. 8.4% pni < 0.01 |
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; ST = stent thrombosis; TIMI = thrombolysis in myocardial infarction; BARC = bleeding academic research consortium; TLR = target lesion revascularization. EXCELLENT [39] = Six-month versus 12-month dual antiplatelet therapy after implantation of drug-eluting stents: the Efficacy of Xience/Promus versus Cypher to REduce Late Loss After Stenting randomized, multicenter study; RESET [40] = REal Safety and Efficacy of 3-month dual antiplatelet Therapy following Endeavor zotarolimus-eluting stent implantation; OPTIMIZE [41] = Three vs. twelve months of dual antiplatelet therapy after zotarolimus-eluting stents; SECURITY [42] = Second-generation drug-eluting stent implantation followed by 6- versus 12-month dual antiplatelet therapy; ISAR-SAFE [43] = Intracoronary Stenting and Antithrombotic Regimen: Safety and Efficacy of 6 months’ DAPT after DES; I LOVE IT [44] = a randomized, double-blind, placebo-controlled trial of 6 vs. 12 months of clopidogrel therapy after drug-eluting stenting; IVUS XPL [45] = 6-Month Versus 12-Month Dual-Antiplatelet Therapy Following Long Everolimus-Eluting Stent Implantation; DAPT-STEMI [46] = A prospective, randomized, open-label trial of 6-month versus 12-month dual antiplatelet therapy after drug-eluting stent implantation in ST-elevation myocardial infarction; REDUCE [47] = Randomized evaluation of short-term dual antiplatelet therapy in patients with acute coronary syndrome treated with the COMBO dual therapy stent.