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
3
4 Otsuka et al. Circulation 2014; 129:
5
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?
19
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
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