Table 1.
Study (year) | Randomisation | Sample size | Primary endpoint | Design and randomisation | % ACS | Proportion with Newer-Generation DES (%) | Primary endpoint (short vs. long DAPT) |
---|---|---|---|---|---|---|---|
RESET (2012) [13] | 3 vs. 12 months DAPT | 2,117 | Cardiac death, MI, ST, revasc. or bleeding | Non-inferiority Randomisation at time of PCI |
55 | 85 | 4.7% in both arms (pNI <0.001) |
OPTIMIZE (2014) [14] | 3 vs. 12 months DAPT | 3,119 | NACCE—death, MI, stroke, or bleed | Non-inferiority Randomisation at time of PCI |
32 | 100 | 6.0% with 3 months DAPT vs. 5.8% with 1‑year DAPT (pNI = 0.002) |
EXCELLENT (2011) [15] | 6 vs. 12 months DAPT | 1,443 | Cardiac Death, MI, or ischemia driven TVR | Non-inferiority Randomisation at time of PCI |
51 | 75 | 4.8% with 6‑months vs. 4.3% with 1‑year DAPT (pNI = 0.001) |
ISAR-SAFE (2014) [16] | 6 vs. 12 months DAPT | 4,000* (planned: 6,000) |
Death, MI, stroke, or TIMI major bleed | Non-inferiority Randomisation at DAPT discontinuation |
40 | 72 | 1.5% with 6 months DAPT vs. 1.6% with 1‑year DAPT (pNI < 0.001) |
SECURITY (2014) [17] | 6 vs. 12 months DAPT | 1,399* (planned: 2,740) | Cardiac death, MI, ST, or stroke | Non-inferiority Randomisation at time of PCI |
38 | 100 | 4.5% with 6‑months DAPT vs. 5.7% with 1‑year DAPT (pNI ≤ 0.05) |
PRODIGY (2012) [20] | 6 vs. 24 months DAPT | 1,970 | Death, MI, stroke | Superiority Randomisation 1 month after PCI |
75 | 50 | 10.0% with 6 months DAPT vs. 10.1% with 2‑year DAPT (p = 0.91) |
ITALIC (2014) [21] | 6 vs. 24 months DAPT | 1,822* (planned: 2,475) |
Death, MI, urgent TVR, stroke or bleeding | Non-inferiority Randomisation at time of PCI |
24 | 100 | 1.6% with 6 months DAPT vs. 1.5% with 2‑year DAPT |
ARCTIC Interruption (2014) [22] | 12 vs. 18–24 months | 1,259 | Death/MI/ST/CVA/TVR | Superiority Randomisation at DAPT discontinuation |
26 | 63 | 4.0% in both arms (median 17 months FU) (p = 0.58) |
DAPT (2015) [23] | 12 vs. 30 months | 9,961 | 1 ST 2 MACE |
Superiority Randomisation at DAPT discontinuation |
43 | 59 | ST: 1.4% vs. 0.4% and MACE 4.1 vs. 2.1% (p < 0.001) |
DES-LATE (2010) [24] | 12 vs. 36 months | 5,045 | Cardiac death/MI/ CVA |
Superiority Randomisation at DAPT discontinuation |
61 | 30 | 2.4% SAPT vs. 2.7% DAPT (p = 0.75) |
OPTIDUAL (2015) [25] | 12 vs. 48 months | 1,385* (planned: 1,966) | Death/MI/ CVA/bleeding |
Superiority Randomisation at DAPT discontinuation |
36 | 59 | 7.5% SAPT vs. 5.8% DAPT (p = 0.17) |
* Inclusion of patients terminated prematurely
RESET REal Safety and Efficacy of 3‑month dual antiplatelet Therapy following Endeavor zotarolimus-eluting stent implantation, NI non-inferior, OPTIMIZE Optimized Duration of Clopidogrel Therapy Following Treatment With the Zotarolimus-Eluting Stent in Real-World Clinical Practice, EXCELLENT Efficacy of Xience/Promus Versus Cypher to Reduce Late Loss After Stenting, ISAR-SAFE Intracoronary Stenting and Antithrombotic Regimen: Safety And EFficacy of 6 Months Dual Antiplatelet Therapy After Drug-Eluting Stenting, SECURITY Second-Generation Drug-Eluting Stent Implantation Followed By Six- Versus Twelve-Month Dual Antiplatelet Therapy, PRODIGY Prolonging Dual Antiplatelet Treatment After Grading Stent-Induced Intimal Hyperplasia Study, ITALIC Is There a Life for DES After Discontinuation of Clopidogrel, ARCTIC Assessment with a double Randomization of (1) a fixed dose versus a monitoring-guided dose of aspirin and Clopidogrel after DES implantation, and (2) Treatment Interruption versus Continuation, 1 year after stenting, DAPT Dual AntiPlatelet Therapy, DES-LATE Optimal Duration of Clopidogrel Therapy With DES to Reduce Late Coronary Arterial Thrombotic Event, OPTIDUAL OPTImal DUAL antiplatelet therapy, CVA cerebrovascular accident, DAPT dual antiplatelet therapy, DES drug-eluting stent, MACE major adverse cardiac event, MI myocardial infarction, NACCE Net Adverse clinical and cerebral event, PCI percutaneous coronary intervention, SAPT single antiplatelet therapy, ST stent thrombosis. TVR target vessel revascularisation