TLR des Stents Actifs

TLR des Stents Actifs

No Conflict of Interest

Target Lesion Revascularization DES vs BMS Stettler C et al. Lancet 2007;370:937-48 N=18,023 58% 70% SES vs BMS: HR=0.30 (0.24-0.37), p<0.0001 PES vs BMS: HR=0.42 (0.33-0.53), p<0.0001 SES vs PES: HR=0.70 (0.56-0.84), p<0.0021

BMS PES SES Target Lesion Revascularization Network Meta-Analysis: DES vs BMS Stettler C et al. Brit Med J 2008 Diabetic Patients N=3,853 BMS PES SES Non-Diabetic Patients N=10,947 0 5 10 15 20 25 30 SES vs BMS: 0.29 (0.19,0.45) PES vs BMS: 0.38 (0.26,0.56) SES vs PES: 0.78 (0.50,1.14) 0 1 2 3 4 Years SES vs BMS: 0.29 (0.19,0.42) PES vs BMS: 0.46 (0.32,0.60) SES vs PES: 0.64 (0.49,0.84) 0 1 2 3 4 Years BMS 1228 1228 667 451 348 3384 3384 2128 1420 1195 PES 1161 1161 942 486 146 3466 3466 2776 1477 660 SES 1373 1373 947 606 219 3505 3505 2614 1512 753

Definitions and Classification of Restenosis

Ischemia Driven Repeat Revascularization Diameter stenosis 50-69% and one of the following: Recurrent angina pectoris Objective signs of ischemia at rest (ECG changes) or during exercise test (or equivalent), presumably related to target vessel Abnormal results of any invasive functional diagnostic test FFR 0.80) or IVUS minimum cross-sectional area 4 mm2 (and 6.0 mm2 for left main stem) TLR with diameter stenosis 70% even in absence of the above ischemic signs or symptoms Dangas GD et al. JACC 2010;56;1897-907

Mechanisms of DES Restenosis Biological Factors Drug Resistance Hypersensitivity Clinical presentation of DES ISR Usually recurrent angina Some patients present with ACS Mechanical Factors Stent Underexpansion Nonuniform Stent Strut Distribution Stent Fracture Nonuniform Drug Elution/Deposition Polymer Peeling Technical Factors Dangas GD et al. JACC 2010;56;1897-907 Barotrauma Outside Stented Segment Stent Gap Residual Uncovered Atherosclerotic Plaques

Predictors or ISR/TLR after DES Implantatuion Dangas GD et al. JACC 2010;56;1897-907

Morphologic Pattern of DES-Restenosis: Sirolimus Eluting Stent (Cypher) Majority of ISR focal Dangas GD et al. JACC 2010;56;1897-907

Morphologic Pattern of DES-Restenosis: Paclitaxel Eluting Stent (Taxus) ISR ½ focal ½ nonfocal Dangas GD et al. JACC 2010;56;1897-907

ISAR-DESIRE 2: SES vs. PES for DES Restenosis 450 pts with in-ses restenosis Randomized to SES vs. PES Primary endpoint LLL at 6-8 months Mehilli J et al. JACC 2010;55:2710-6

Outcomes After Percutaneous Treatment of DES Restenosis Dangas GD et al. JACC 2010;56;1897-907

Algorithm for the Treatment of DES Restenosis Consider IVUS DEB not tested for DES-ISR! Dangas GD et al. JACC 2010;56;1897-907

2010 ESC EACTS Revascularization Guidelines

Have Newer Genera+on DES Improved Clinical Outcome? Safety Efficacy

Comparison of Everolimus Elu+ng and Paclitaxel Elu+ng Stents Meta Analysis of SPIRIT II, III, IV and COMPARE Clinical Outcomes Up to 3 Years TLR Cardiac Death or MI Year 1 Year 2 Year 3 Overall 0.49 (0.38-0.64) 0.83 (0.32-2.18) 0.44 (0.14-1.39) 0.51 (0.40-0.65) Year 1 Year 2 Year 3 Overall 0.65 (0.50-0.84) 0.56 (0.10-3.09) 0.54 (0.11-2.56) 0.63 (0.49-0.81).1.15.2.25.5 1 2 4 6.1.15.2.25.5 1 2 4 6 Favors EES Favors PES Favors EES Favors PES 6,789 Patients Jüni, Windecker

Everolimus Elu+ng vs Zotarolimus Elu+ng Endeavor Resolute Stent Serruys PW et al. N Engl J Med 2010 Target Lesion Revasc @ 1 Year Cardiac Death or MI @ 1 Year

TLR/ISR Conclusions TLR reduced by 60-70% with DES vs. BMS. DES ISR 3%-20% depending on patient/lesion characteristics and DES type. TLR with newer vs. first generation DES further reduced. Clinical presentation of DES ISR is usually recurrent angina while some patients present with ACS. Mechanisms of DES ISR can be biological, mechanical, and technical, and its pattern is predominantly focal. Best treatment option for DES-restenosis remains to be determined (newer generation DES, DEB). CABG is reserved for diffuse and repetitive ISR, especially in multivessel disease.