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Two-Year Outcomes in Real-World Patients Treated With a Thin-Strut, Platinum-Chromium, Everolimus-Eluting Stent in the PROMUS Element Plus US Post-Approval Study (PE Plus PAS) David E. Kandzari, A. Thomas Siachos, Luis Tami, Bruce Watt, Randall Goodroe, Thomas Pow, Roger Hill, Amir Haghighat, Thomas Christen, Dominic J. Allocco, and Keith D. Dawkins, for the PE Plus PAS Investigators
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FOR INTERNAL USE ONLY David Kandzari: Research/grant support: Abbott Vascular, Biotronik, Boston Scientific, Medtronic, Medinol, Thoratec Consulting honoraria: Boston Scientific, Medtronic Equity/ownership/other: None Disclosure
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FOR INTERNAL USE ONLYIntroduction The PROMUS Element Plus US Post-Approval Surveillance Study (PE Plus PAS) is a prospective, open-label, multicenter observational study with patients enrolled at 52 US sites Study Objectives – Evaluate ‘real-world’ clinical outcomes following PROMUS Element implantation in routine clinical practice – Compare clinical outcomes following Promus Element PCI among ‘PLATINUM-like’ * patients from 3 studies with a prespecified performance goal * Patients without acute MI, graft stenting, chronic total occlusion, in-stent restenosis, failed brachytherapy, bifurcation, ostial lesion, severe tortuosity, moderate/severe calcification in target lesion or target vessel proximal to target lesion, 3-vessel stenting, cardiogenic shock, left main disease, or acute or chronic renal dysfunction (serum creatinine >2.0 mg/dl or patient on dialysis); lesion length ≤28 mm and ≥2.25 mm RVD <2.5 mm –OR– lesion length ≤24 mm and ≥2.5 mm RVD ≤4.25 mm.
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FOR INTERNAL USE ONLY PLATINUMWH/SVN=786/94PLATINUMWH/SVN=786/94 PE Prove N=1010 N=1010 N=862N=862 * * The PE Plus PAS 2-year follow-up included 1 additional patient classified as ‘PLATINUM-like’ (n=777). Pooled Study Endpoints N=269N=269 N=776 * PE Plus PAS N=2681 N=2681 PLATINUM-like patients (N=1907) PE Plus PAS Primary Endpoint: 12-month cardiac death/MI in PLATINUM-like patients Secondary Endpoint: Increase in stent thrombosis rate, Year 1 to Year 2
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FOR INTERNAL USE ONLY Baseline Clinical Characteristics * Renal disease defined as subject on dialysis or with baseline serum creatinine level >2.0 mg/dL (177 μ mol/L) PE Plus PAS N=2681 Patients
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FOR INTERNAL USE ONLY Angiographic Characteristics * Site reported. PE Plus PAS N=2681 Patients N=3605 Lesions
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FOR INTERNAL USE ONLY Procedural Characteristics * Lesion-based. † Per stent, site-reported and core laboratory confirmed. First case: compression of distal stent end upon retrieval of a distal protection device; resolved using post- dilation balloon. Second case: compression of proximal end upon post-dilation; resolved by deployment of an additional stent. There were no associated adverse events in either case. PE Plus PAS N=2681 Patients N=2712 Procedures N=3605 Lesions N=3070 Vessels N=4021 Stents
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FOR INTERNAL USE ONLY PE Plus PAS Primary Endpoint PE Plus PAS Primary Endpoint 12-month Cardiac Death/MI in PLATINUM-like Patients Performance goal 3.2% P < 0.001 * * The PE Plus PAS 2-year follow-up included 1 additional patient classified as ‘PLATINUM-like’ (n=777). *
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FOR INTERNAL USE ONLY Patient Disposition at 2 Years PE Plus PAS 2683 patients enrolled at 52 clinical sites in the US PE Plus PAS 2683 patients enrolled at 52 clinical sites in the US 2681 patients were eligible for analysis * (3602 lesions) 2-Year clinical follow-up or death: 2445/2681 patients (91.2%) 2-Year clinical follow-up or death: 2445/2681 patients (91.2%) 74 patients discontinued prematurely Withdrew consent, n=44 Lost to Follow-up, n=18 Investigator discretion, n=6 Death >730 days, n=4 Other, n=2 151 patients did not have a 2-year follow-up visit 74 patients discontinued prematurely Withdrew consent, n=44 Lost to Follow-up, n=18 Investigator discretion, n=6 Death >730 days, n=4 Other, n=2 151 patients did not have a 2-year follow-up visit * 2 patients not eligible for analysis due to Implant failure (reason: could not cross lesion). 777 PLATINUM-like patients (932 lesions) 777 PLATINUM-like patients (932 lesions) 723 PLATINUM-like patients (93.1%) had 2-Year follow-up available
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FOR INTERNAL USE ONLY Antiplatelet Medications Overall Patients Patients, % ASA=acetyl salicylic acid; DAPT=dual antiplatelet therapy, consisting of ASA + thienopyridine (eg, Clopidogrel, Prasugrel, Ticagrelor, Ticlopidine).
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FOR INTERNAL USE ONLY Key Clinical Endpoints at 1 and 2 Years Overall Patients TVFCardiac Death or MI Cardiac Death MITVRARC ST (Def/Prob) N=2681 patients enrolled; N=2477 at 2-year follow-up * Binary analysis ARC ST (Def/Prob)=Academic Research Consortium definite/probable stent thrombosis. Time Period 0-1 days (n=2681) 2-30 days (n=2664) 31-365 days (n=2625) 366-730 days (n=2459) ST Rate * 0.1%0.3%0.4%0.7%
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FOR INTERNAL USE ONLY Key Clinical Endpoints at 2 Years Medically-treated Diabetes Subset TVFCardiac Death or MI Cardiac Death MITVRARC ST (Def/Prob) P-values by log-rand test ARC ST (Def/Prob)=Academic Research Consortium definite/probable stent thrombosis. P<0.0001 P=0.010 P=0.030 P=0.067 P=0.001
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FOR INTERNAL USE ONLY Key Clinical Endpoints at 2 Years Long Lesion Subset TVFCardiac Death or MI Cardiac Death MITVRARC ST (Def/Prob) P=0.004 P=0.027 P=0.151 P=0.444 P=0.402 P=0.175 Patients with at least one 32mm or 38mm study stent P-values by log-rand test ARC ST (Def/Prob)=Academic Research Consortium definite/probable stent thrombosis.
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FOR INTERNAL USE ONLY Key Clinical Endpoints at 2 Years Small Vessel Subset TVFCardiac Death or MI Cardiac Death MITVRARC ST (Def/Prob) P=0.015 P=0.009 P=0.008 P=0.089P=0.017 P=0.225 Patients with at least one target lesion diameter ≥2.25mm and <2.5mm P-values by log-rand test ARC ST (Def/Prob)=Academic Research Consortium definite/probable stent thrombosis.
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FOR INTERNAL USE ONLY Stent Thrombosis, Year 1 to Year 2 Performance Goal Analysis Performance Goal: 1.0% P < 0.001 ARC ST (Def/Prob)=Academic Research Consortium definite/probable stent thrombosis. PLATINUM-like patients, N=1908
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FOR INTERNAL USE ONLY PE Plus PAS Leading Enrolling Centers Based on current enrolment as of October 1, 2015
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FOR INTERNAL USE ONLY In a large, real-world patient US post-approval study, coronary artery revascularization with the PROMUS Element Plus everolimus-eluting stent provides favorable results Low event rates were maintained through 2 years – 2.5% cardiac death – 2.0% MI – 5.6% target vessel revascularization – 1.4% ARC definite/probable stent thrombosis – 2 cases of longitudinal stent deformation (0.05% of cases) Conclusions
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