1. ARCTIC-INTERRUPTION
2-year- Versus 1year Duration of Dual-Antiplatelet Therapy After DES implantation
The randomized ARCTIC-Interruption Study
JP Collet and G Montalescot for the ARCTIC
investigators
ARCTIC: Assessment by a double Randomization of a Conventional antiplatelet strategy versus a monitoring-guided strategy for drug-eluting stent implantation and,of Treatment Interruption versus Continuation one year after stenting – ARCTIC-INTERRUPTION (NCT )
COI Disclosure for Dr. Montalescot: Gilles Montalescot reports: research grants to the institution or consulting/lecture fees from Abbott Vascular, Accumetrics, AstraZeneca, Bayer, Biotronik, BMS, Boehringer-Ingelheim, Daiichi-Sankyo, Duke Institute, Eli Lilly and Company, Europa, Fédération Française de Cardiologie, Fondation de France, GSK, INSERM, Institut de France, Iroko, Lead-up, Menarini, Medtronic, Nanospheres, Novartis, Pfizer, ReCor Medical, Roche, Sanofi-Aventis, Stentys, Société Française de Cardiologie, Springer, The Medicines Company, The TIMI group, WebMD, and Wolters. 1

2. ARCTIC-INTERRUPTION design
Rd #2
DAPT
SAPT
6-18 more months of FU
1° EP: Death, MI, stroke, stent thrombosis, urg. revasc.

3. Randomized vs. Non-Randomized
Age - median 63 64
Diabetes - % 33
40*
Prior PAD- % 10
14*
Prior PCI - % 41 45
Prior CABG - % 7
Proton pump inhibitors - % 31
Drug-eluting stent implanted - % 99
95*
* p<0.05

4. DAPT vs. SAPT: Baseline characteristics
Age - median 64
Diabetes - % 36 37
Prior MI - % 31 30
Prior PCI - % 43 40
Prior CABG - % 7 6
Clopidogrel - % 90
Clopidogrel 150 mg - % 10 14
Prasugrel - %
8.5
Proton pump inhibitors - % 33 29
Drug-eluting stent implanted - % 98 99

5. Death, MI, stroke, stent thrombosis, urgent revascularization
Primary Endpoint up to 18 months
Death, MI, stroke, stent thrombosis, urgent revascularization
Event Probability
N at risks
DAPT
SAPT
Follow-up (days)
HR = 1.17 [ ] p=
DAPT
SAPT
3.8%
4.3%

6. All ischemic Endpoints
DAPT
SAPT
HR [95%CI] P
Primary End Point*
3.8
4.3
1.17 [0.68; 2.03]
0.57
Stent thrombosis or Urgent Revasc
1.3
1.6
1.30 [0.51;3.30]
0.58
Death or myocardial Infarction - %
2.2
2.7
1.26 [0.62 ;2.55]
0.52
Any death - %
1.1
1.4
1.32 [0.49 ;3.55]
Myocardial infarction - %
1.04 [0.41 ;2.62]
0.94
Stent thrombosis - %
0.5
Stroke or TIA- %
0.9
0.6
0.69 [0.19;2.44]
0.56
Urgent revascularization - %
1.17 [0.45 ;3.04]
0.74
*Any death, Myocardial infarction, stent thrombosis, stroke or transient ischemic attack, urgent revascularization

7. Key Safety Outcome Whole population DAPT SAPT 1.1 0.2 0.8 0.3 1.9 0.5
DAPT
SAPT
HR [95%CI] P
Major bleeding - %
1.1
0.2
0.15 [0.02; 1.20]
0.073
Minor bleeding - %
0.8
0.3
0.41 [0.08 ;2.13]
0.29
Major or minor bleeding - %
1.9
0.5
0.26 [0.07 ;0.91]
0.035
BARC III and V
0.15 [0.02 ;1.20] =
STEEPLE definitions - Montalescot G, et al. N Engl J Med 2006; 355:1006–17

8. ARCTIC-INTERRUPTION
Half of the patients could not be randomized 1 year after stenting
The randomized patients were at lower risk
No ischemic benefit of DAPT continuation beyond one year
Significant more major or minor bleedings with DAPT continuation
Findings consistent across pre-specified subgroups and prior studies