Biodegradable Polymer coated Drug Eluting Stents Versus Durable Polymer coated Drug Eluting Stents for Percutaneous Coronary Intervention

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1 Biodegradable Polymer coated Drug Eluting Stents Versus Durable Polymer coated Drug Eluting Stents for Percutaneous Coronary Intervention Amos Levi, MD, Tamir Bental, MD, Abid R Assali, MD, Hanna Vaknin-Assa, MD, Eli I. Lev, MD, and Ran Kornowski, MD Cardiology Department of the Rabin Medical Center, Petah Tikva Israel & Sackler school of medicine Tel Aviv University Tel Aviv Israel.

2 We have no conflict of interests to disclose

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4 Otsuka et al. Circulation 2014; 129:

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6 Contemporary DES Platforms Strut and Coating Thickness In Perspective Durable Polymer Coated Bioabsorbable Polymer Coated Xience CoCr-EES Promus PtCr-EES Resolute Biomatrix Nobori SYNERGY BioMime MiStent Orsiro CoNi-ZES 316L-BES 316L-BES PtCr-EES CoCr-SES CoCr-SES CoCr-SES Strut thickness 81µm µm µm µm µm µm µm µm Polymer PVDF BioLINX PLA PLA PLGA PLLA + PLGA PLGA PLLA Probio* Distribution / thickness Conformal 7-8µm / side Conformal 6µm / side Abluminal 10µm Abluminal 20µm Abluminal 4µm Conformal 2µ / 2µ Conformal 5µm / 15µm Conformal 3.5µm / 7.5µm

7 Background Mean follow up = 26 months Only 6 RCTs studied outcomes > 1 year El-Hayek et al. JACC CV interv. March 13, 2017:

8 Aim To preform a real life evaluation of the long term performance of Biodegradable Polymer DES vs Durable Polymer DES PCIs in RMC between 2004 and mid 2016 n=18,641 Initial Interventions n=14,043 BMS, BVS, and 1 st gen DES excluded Biodegradable n= 1437 Biomatrix/Nobori 1043 Orsiro 394 End points: Death TVR ACS/MI Composite Stent thrombosis Durable polymer n = 3922 Resolute Onyx 1556 Xience / Promus 2366 Mean follow up = 33.4 ± 20.5 months Mean follow up = 52.7 ± 26.7 months

9 Results Baseline characteristics Durable polymer n=3922 Biodegradabe n=1437 p value Age ± ± Gender (female) 21.7% 0.9% Hg (g/dl) ± ± Creatinine (mg/dl) 1.08 ± ± egfr (ml/min/1.73m2) ± ± Diabetes mellitus 46.3% 4.3% Hypertension 73.7% 69.6% Smoking history 34.9% 33.5% Pre-existing CHF 6.1% 5.2% Dementia 1.8% 1.3% Prior CABG 13.2% 14.3% LVD moderate or greater 13.8% 15.2% Anticoagulation tx 4% 5.4% PCI Indication ACS / MI 55.7% 57.8% STEMI 11.3% 14.1% Cardiogenic shock 0.4% 0.9% Procedural characteristics Durable polymer n=3922 Biodegradable n=1437 p value Stent length (mm) Durable polymer n=3922 Biodegradable n= Longest Stent (mm) 32 ± ± Stent diameter (mm) ± ± 7.1 <0.001 Radial approach 2.94 ± ± 0.43 <0.001 Iib/IIIa 39.2% 60.8% <0.001 Proximal LAD 11.4% 7.9% <0.001 Unprotected LM 25.1% 20% CTO 4% 2.8% Bifurcation lesion 5.4% 3.7% Calcified lesion 12.1% 9.4% 0.1 Vessels diseased 10% 11.6% One Two 23.8% 26.1% Three 33.1% 36.2% <0.001 Territories treated 43.1% 37.7% One Two 81.9% 85% 0.012

10 Results Baseline characteristics Durable polymer n=3922 Biodegradabe n=1437 p value Age ± ± Gender (female) 21.7% 0.9% Hg (g/dl) ± ± Creatinine (mg/dl) 1.08 ± ± egfr (ml/min/1.73m2) ± ± Diabetes mellitus 46.3% 4.3% Hypertension 73.7% 69.6% Smoking history 34.9% 33.5% Pre-existing CHF 6.1% 5.2% Dementia 1.8% 1.3% Prior CABG 13.2% 14.3% LVD moderate or greater 13.8% 15.2% Anticoagulation tx 4% 5.4% PCI Indication ACS / MI 55.7% 57.8% STEMI 11.3% 14.1% Cardiogenic shock 0.4% 0.9% Procedural characteristics Durable polymer n=3922 Biodegradable n=1437 p value Stent length (mm) 32 ± ± Longest Stent (mm) ± ± Stent diameter (mm) 2.94 ± ± 0.43 <0.001 Radial approach 39.2% 60.8% <0.001 Iib/IIIa 11.4% 7.9% <0.001 Proximal LAD 25.1% 20% <0.001 Unprotected LM 4% 2.8% CTO 5.4% 3.7% Bifurcation lesion 12.1% 9.4% Calcified lesion 10% 11.6% 0.1 Vessels diseased One 23.8% 26.1% Two 33.1% 36.2% Three 43.1% 37.7% <0.001 Territories treated One 81.9% 85% Two 16.8 % 13.9% Three 1.2% 15 (1% 0.637

11 Results Baseline characteristics Durable polymer n=3922 Biodegradabe n=1437 p value Age ± ± Gender (female) 21.7% 0.9% Hg (g/dl) ± ± Creatinine (mg/dl) 1.08 ± ± egfr (ml/min/1.73m2) ± ± Diabetes mellitus 46.3% 4.3% Hypertension 73.7% 69.6% Smoking history 34.9% 33.5% Pre-existing CHF 6.1% 5.2% Dementia 1.8% 1.3% Prior CABG 13.2% 14.3% LVD moderate or greater 13.8% 15.2% Anticoagulation tx 4% 5.4% PCI Indication ACS / MI 55.7% 57.8% STEMI 11.3% 14.1% Cardiogenic shock 0.4% 0.9% Procedural characteristics Durable polymer n=3922 Biodegradable n=1437 p value Stent length (mm) 32 ± ± Longest Stent (mm) ± ± Stent diameter (mm) 2.94 ± ± 0.43 <0.001 Radial approach 39.2% 60.8% <0.001 IIb/IIIa inhibitors 11.4% 7.9% <0.001 Proximal LAD 25.1% 20% <0.001 Unprotected LM 4% 2.8% CTO 5.4% 3.7% Bifurcation lesion 12.1% 9.4% Calcified lesion 10% 11.6% 0.1 Vessels diseased One 23.8% 26.1% Two 33.1% 36.2% Three 43.1% 37.7% <0.001 Territories treated One 81.9% 85% Two 16.8 % 13.9% Three 1.2% 15 (1% 0.637

12 Results Univariate Cox: HR = 1.09 (95% CI ), p=0.37 Multivariate Cox: HR = 1.04 (95% CI ), p=0.27

13 Results Univariate Cox: HR = 0.49 (95% CI ), p < Multivariate Cox: HR = 0.56 (95% CI ), p = 0.003

14 Results Univariate Cox: HR = (95% CI ), p=0.051 Multivariate Cox: HR = 0.85 (95% CI ), p=0.18

15 Results Univariate Cox: HR = 0.96 (95% CI ) Multivariate Cox: HR = 0.96 (95% CI )

16 Results Univariate Cox: HR = 0.55 (95% CI )

17 PSM analysis

18 Summary BP DES compared to DP DES 43% relative risk reduction in long-term rehospitalization for acute coronary syndrome No differences between the groups in terms of Death, TVR, and the composite outcomes. Low overall rates of definite stent thrombosis mechanism of ACS?

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20 Critical appraisal Strengths: Large, unselected real life cohort Long term follow up Procedural data Rigorous comparison limitations: Some endpoints (TVR, rehospitalization) may be partially reported Limitations of single center, retrospective data

21 Background Durable polymer Control Biodegradable polymer [CATEGORY NAME][PERCE NTAGE] [CATEGORY NAME] [PERCENTAGE] BioMatrix Flex (EVERBIO II / SORT OUT IV ) 13% Others 13% Nobori (BASKET- PROVE II / COMPARE II / NEXT / LONG- DES V) 43% [CATEGORY NAME] [PERCENTAGE] Orsiro (BIOSENCE / BIOFLOW) 15% Mean follow up = 26 months Only 6 RCTs studied outcomes > 1 year Yukon choice PC (ISAR TEST IV) 16% El-Hayek et al. JACC CV interv. March 13, 2017:

22 Methods Resolute October 2007 Xience / Promus August 2007

23 Methods Resolute October 2007 Xience / Promus August 2007 Biomatrix / Nobori January 2008 Orsiro August 2013 Durable polymer Biodegradable Mean follow up = 52.7 ± 26.7 months Mean follow up = 33.4 ± 20.5 months