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. 2018 Apr 30;26(6):321–333. doi: 10.1007/s12471-018-1113-5

Table 1.

Studies comparing different durations of dual antiplatelet therapy after PCI

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