Pooled RESOLUTE Clinical Program

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1 The Relationship Between Short and Long-term Antiplatelet Therapy Use and Stent Thrombosis Following Percutaneous Coronary Intervention With the Resolute Zotarolimus-eluting Stent Pooled RESOLUTE Clinical Program Ajay J. Kirtane New York-Presbyterian Hospital/Columbia University Medical Center, New York, NY, USA Sigmund Silber, Franz-Josef Neumann, Patrick Serruys, Laura Mauri, Ian Meredith, Stephan Windecker, Jorge Belardi, Petr Widimsky, Alan Yeung, Shigeru Saito, Martin B. Leon

2 Author Disclosures Nothing to disclose

3 Background Continuation of dual antiplatelet therapy (DAPT), consisting of aspirin plus a P2Y12 receptor antagonist, is currently recommended for 12 months following drug-eluting stent (DES) implantation. Observational data suggest that a significant proportion of patients either interrupt or are unable to tolerate DAPT in this period. It is unclear if earlier interruption and/or discontinuation of DAPT is associated with a higher risk of stent thrombosis (ST), particularly with newer generation DES.

4 Methods One-year ST data from 4896 patients treated with a Resolute Zotarolimus-eluting stent (R-ZES) in the global RESOLUTE Clinical Program were analyzed according to DAPT status. ST was assessed based on the timing of first DAPT interruption (0-3 vs >3-12 months; 0-1 vs >1-12 months), and was further categorized by the type of interruption (permanent, all interruptions >1 day and interruptions >14 days).

5 Patient Flow and Stent Thrombosis Through 1 Year 4991 Assessed for Eligibility Included Trials*: 1140 RAC; 2349 RINTL; 100 RJ; 1402 RUS 95 Excluded 61 incomplete data or not verified to have started DAPT 33 DAPT start date more than 1 day post-procedure 1 stent thrombosis event prior to DAPT start date 4896 Eligible for DAPT Analysis 3827 DAPT Never Interrupted Within 1 Year 1069 DAPT Interrupted Within 1 Year 166 First Interruptions Within 0-1 Month 903 First Interruptions Within 1-12 Months 258 First Interruptions Within 0-3 Months 811 First Interruptions Within 3-12 Months *All trials within the Pooled RESOLUTE Program were included in this analysis with the exception of RESOLUTE FIM. The RESOLUTE FIM protocol did not require DAPT data collection.

6 Baseline Patient and Lesion Characteristics From the Pooled RESOLUTE Program Baseline Characteristics (%) All Patients Included in the Analysis N = 4896 Age (years) Mean ± SD (N) 63.9 ± 11.0 History of Smoking 58.7 Prior Percutaneous Coronary Revascularization 31.0 Diabetes Mellitus 30.1 Insulin Dependent 8.9 Prior MI 25.8 ACS 41.9 STEMI 8.2 NSTEMI 7.9 Unstable Angina 25.8 Lesion Class ACC/AHA - B2/C 66.6 Pre-procedure RVD (mm) Mean ± SD (N) 2.78 ± 0.51 Lesion Length (mm) Mean ± SD (N) ± 9.50 No. of stents per patient 1.5 ± 0.9 Total Length of stents per patient 29.0 ±19.5 Implanted stent diameter per lesion 3.0 ± 0.4

7 Number of Events Timing of Stent Thrombosis N = 4896 Resolute ZES Patients 29 of 39 Events (74.4%) Occurred Within 30 Days Timing of ST (days post-index procedure)

8 Number of Events Timing of Stent Thrombosis N = 4896 Resolute ZES Patients Early ST Events (<30 days): 29 of 39 (74.4%) Late ST Events ( days): 10 of 39 (25.6%) Off DAPT On DAPT Timing of ST (days post-index procedure)

9 Reasons Given for DAPT Temporary Interruption and Permanent Discontinuation Reasons Given for DAPT Temporary Interruption Reasons Given for DAPT Permanent Discontinuation Not Categorizable 14.7% Not Available 6,7% Not Available 21,6% Procedural 4,6% Clinical 18,3% Completed Script 8,0% Procedural 42,2% Not Categorizable 2.9% Patient related 6,6% Patient related 15,5% Clinical 12,8% Completed Script 46,0%

10 Baseline Demographic and Lesion Characteristics Never Interrupted vs All Interruptions Baseline Characteristics (%) Never Interrupted N = 3827 Patients All Interruptions N = 1069 Patients P-value Age (years) Mean ± SD (N) 63.4 ± ± 11.4 <0.001 History of Smoking Prior Percutaneous Coronary Revascularization Diabetes Mellitus Insulin Dependent Prior MI ACS STEMI NSTEMI Unstable Angina Lesion Class ACC/AHA B2/C Pre-procedure RVD (mm) Mean ± SD (N) 2.79 ± ± Lesion Length (mm) Mean ± SD (N) ± ±

11 Subsequent ST (ARC Def/Prob) (%) Pooled RESOLUTE: 3 Months All Interruptions Timing of First DAPT Interruption and ST Through 1 Year 5% 4% 3% P = P = P ,71% 2% 1% 0% 0,84% 0,00% Never Interrupted Interrupted 0-3 Mo Interrupted 3-12 Mo # of pts at risk at baseline # of events # of days to interruption (median) NA % CI (0.57, 1.18) (1.10, 5.51) (0.00, 0.37)

12 Baseline Demographic and Lesion Characteristics Temporary Interruptions and Interruptions >14 Days Baseline Characteristics (%) Temporary Interruptions N = 374 Patients Interruptions >14 Days N = 874 Patients Age (years) Mean ± SD (N) 65.9 ± ± 11.3 History of Smoking Prior Percutaneous Coronary Revascularization Diabetes Mellitus Insulin Dependent Prior MI ACS STEMI NSTEMI Unstable Angina Lesion Class ACC/AHA B2/C Pre-procedure RVD (mm) Mean ± SD (N) 2.66 ± ± 0.53 Lesion Length (mm) Mean ± SD (N) ± ± 8.78

13 Pooled RESOLUTE: 3 Months Subsequent ST (ARC Def/Prob) (%) >14 Days Of Interruption Or Discontinuation Only Interruption duration >14 days, chosen to define compliance in the Dual Antiplatelet Therapy (DAPT) Study. Timing of First DAPT Interruption (>14 Days) and ST Through 1 Year 5% P = % 3% 2% 1% 0% P = P ,08% 0,82% 0,00% Never Interrupted Interrupted 0-3 Mo Interrupted 3-12 Mo # of pts at risk at baseline # of events # of days to interruption (median) NA % CI (0.57, 1.15) (1.14, 6.58) (0.00, 0.44)

14 Baseline Demographic and Lesion Characteristics Baseline Characteristics (%) Interrupted 0-1 Month N = 166 Patients Interrupted 1-12 Months N = 903 Patients P-value Age (years) Mean ± SD (N) 66.6 ± ± History of Smoking Prior Percutaneous Coronary Revascularization Diabetes Mellitus Insulin Dependent Prior MI ACS STEMI NSTEMI Unstable Angina Lesion Class ACC/AHA Interrupted 0-1 Month vs Interrupted 1-12 Months B2/C Pre-procedure RVD (mm) Mean ± SD (N) 2.70 ± ± Lesion Length (mm) Mean ± SD (N) ± ±

15 Subsequent ST (ARC Def/Prob) (%) Pooled RESOLUTE: 1 Month All Interruptions Timing of First DAPT Interruption and ST Through 1 Year 5% 4% P = P = P ,61% 3% 2% 1% 0% 0,84% 0,11% Never Interrupted Interrupted 0-1 Mo Interrupted 1-12 Mo # of pts at risk at baseline # of events # of days to interruption (median) NA % CI (0.57, 1.18) (1.34, 7.70) (0.00, 0.62)

16 Subsequent ST (ARC Def/Prob) (%) Pooled RESOLUTE: 1 Month >14 Days of Interruption or Discontinuation Only Interruption duration >14 days, chosen to define compliance in the Dual Antiplatelet Therapy (DAPT) Study. Timing of First DAPT Interruption (>14 Days) and ST Through 1 Year P = P = P ,92% 5% 4% 3% 2% 1% 0% 0,82% 0,00% Never Interrupted Interrupted 0-1 Mo Interrupted 1-12 Mo # of pts at risk at baseline # of events # of days to interruption (median) NA % CI (0.57, 1.15) (1.83, 10.40) (0.00, 1.12)

17 Subsequent ST (ARC Def/Prob) (%) Pooled RESOLUTE: 1 Month 1ST Interruption Was Permanent Discontinuation Timing of DAPT Permanent Discontinuation and ST Through 1 Year 10% 8% 6% P = P = ,80% P # of pts at risk at baseline 4% 2% 0% 0,83% Never Permanently Discontinued* Discontinued 0-1 Mo *Including patients with no DAPT interruption except for ST while on DAPT through 12 months. 0,00% Discontinued 1-12 Mo # of events # of days to interruption (median) NA % CI (0.58, 1.16) (1.60, 14.18) (0.00, 0.48)

18 Event Rates (%) RESOLUTE Pooled Risk of Cardiac Death/Target Vessel MI Categorized by Timing of Interruption 5,03% 4,28% 4,12% 1,17% 1,04% No Interruption Through 1 Year n = Mo 1-12 Mo 0-3 Mo 3-12 Mo n = 159 n = 856 n = 243 n = 772 Risk of CD/TVMI during the first year after with and without DAPT interruption.

19 Conclusions One-year data from the RESOLUTE Clinical Program indicate low stent thrombosis rates for those that interrupted or discontinued DAPT any time after 1 month. While physicians should adhere to current ESC or ACC/AHA/SCAI Guidelines for PCI, in the event a patient interrupts or discontinues DAPT medication 1 month or more after stent implantation, the incremental risk of stent thrombosis appears to be low with the Resolute stent, as used in these included trials.

20 Strengths and Limitations Strengths: All data were collected from regulatory trials with 100% monitoring (except for RESOLUTE International with 25% randomly assigned monitoring) and high rates of follow-up. Limitations: This is a post-hoc analysis of pooled datasets, the generalized application of these results to the entire population demands careful attention given that a larger sample size might be required to provide a definite answer regarding low frequency events such as ST.

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