Drug-Eluting Coronary Stents. Paul Montero PGY-II University of Colorado Health Sciences Center Surgical Grand Rounds Resident Debate

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1 Drug-Eluting Coronary Stents Paul Montero PGY-II University of Colorado Health Sciences Center Surgical Grand Rounds Resident Debate

2 Outline Coronary Artery Disease Evolution of Percutaneous Coronary Intervention Drug-Eluting Stents CABG vs PCI Current/Future Trials

3 Coronary Artery Disease Etiology Atherosclerosis Internal elastic membrane rupture and regeneration Endothelial proliferation with lipid deposits Formation of plaque Worldwide Incidence of Death 3.8 million men yearly 3.4 million women yearly worst episode ever

4 Treatments for CAD Medical Aspirin, beta blockers, statins,, ACE inhibitors, Ca Channel blockers, ARBs,, platelet inhibitors, heparinization, tpa Surgical CABG: Reversed Saphenous Vein, Internal Thoracic Arteries, Radial Artery, off pump, robotic Interventional IABP, balloon angioplasty, bare metal stents (BMS), drug-eluting stents (DES)

5 Percutaneous Coronary Intervention (PCI) Balloon dilation angioplasty successfully used in 1978 for single vessel, isolated lesions Improved technology Increasing experience

6 Stenting 1850s: Dentist Charles Stent created metal scaffolding for aligning teeth s: Charles Dotter described concept of stenting after dilation angioplasty 1980s: Sigwart et al introduce coronary stents 2

7 Stents Structure 3 Now over 40 designs Flexibility Trackability Radiopacity Scaffolding Corrugated vs Slotted Tube Materials Covered Stents Gold Stents/Coated Stents Silicon Carbide Heparin

8 Problems with Stents Thrombosis Acute, subacute,, late No difference between BMS and DES 4 Hypersensitivity Dyspnea, bronchospasm, urticaria, hypotension, asymptomatic bradycardia Restenosis the the achilles heel 5

9 Mechanism of Restenosis Elastic Recoil of Vessel immediate Negative Remodeling late constrictive process Vessel Injury Neo-Intimal Intimal Hyperplasia stress induced protein kinases growth factors and cytokines smooth muscle cell proliferation and migration to intima thrombus/platelet activation Formation of Matrix

10 Restenosis Risk Factors Diabetes Lesion Length Use of Multiple Stents Inadequate Stent Expansion Gaps Between Stents Luminal Cross-section section Area after Stenting

11 Restenosis Rates Balloon Angioplasty: 40% rate of angiographic restenosis 6 months after PTCA, with majority having recurrent symptoms % required clinically driven repeat target lesion revascularization Bare Metal Stents: Prevent Recoil and Negative Remodeling, but not Intimal Hyperplasia 20-30% 30% angiographic restenosis at one year 10-15% 15% target lesion revascularization

12 Preventing Restenosis 2 Brachytherapy Catheter based delivery of radiation to vessel Reduced rate of intimal hyperplasia/restenosis Too many late effects such as thrombosis Addition of Abciximab 7 Stone et al, NEJM 2002 N = 2082 PTCA with/without Stent, abciximab Death, CVA, MI, revascularization occurred least in group with stent and abciximab

13 Preventing Restenosis Is there any other way to reduce restenosis?

14 Drug-Eluting Stents Delivery Mechanism- Biostable or bioerodable polymer with controlled release of drug, usually over days Non-thrombogenic Inert Delivered Goods Lipophilic Medications Locally absorbed Less variable concentration Various Classes of Drugs Anti-inflammatory, inflammatory, antiproliferative, immunomodulators

15 Stents Eluting Drugs Sirolimus Everolimus Paclitaxel Beta-Estradiol Dexamethasone

16 Rapamycin 8 Produced by Streptomyces hygroscopicus,, a fungus discovered on Easter Island Macrolide antibiotic Antifungal Anti-tumor tumor Immunosuppressant Sirolimus

17 Sirolimus Arrests smooth muscle cells in G 1 phase via FK506 binding protein and p27 the Cypher Johnson and Johnson Inhibits proliferation and migration of vascular smooth muscle cells First DES approved by FDA in 2003

18 First In Man Study 9 Brazil and Netherlands Single de novo coronary lesions < 18mm length, mm diameter Tested fast and slow release Sirolimus stents Followed at intervals with Intravascular Ultrasound (IVUS) Found 0% restenosis at 24 months

19 More Sirolimus Trials RAVEL 10 Randomized Double Blind Study 238 patients with single coronary lesions, not including left main SIRIUS 11 O% in-stent restenosis (ISR) at 6 months O% revascularization at 2 years Multicenter Randomized Double Blind Study 1058 patients with de novo coronary artery lesions, including diabetes and multivessel disease 3.2% ISR at 8 months versus 35.4% in BMS 8.3% ISR with diabetics versus 48.5% in BMS Further benefit from those on GIIb/IIIa inhibitors

20 Paclitaxel Broad Spectrum Antineoplastic Agent Ovary Breast Lung Head and Neck Esophagus TAXUS stent,, Boston Scientific Pacific Yew Tree Taxus brevifolia Found in Northwestern US and Canada

21 Paclitaxel Mechanism Enhances and stabilizes microtubule assembly Prevents mitosis, migration, endocytosis,, and secretion Cell arrest at G 0 Lipophilic Cell remains viable Long lasting antiproliferative effect after short dosing

22 12 Paclitaxel Trials 12 ELUTES n = 304 n = 304 European Evaluation of Paclitaxel Eluting Stent At 6 months, DES restenosis rate was 3% vs 21% in BMS ASPECT ASPECT n = 117 Asian Paclitaxel Eluting Stent Clinical Trial At 6 months, DES restenosis rate was 4% vs 27% in BMS TAXUS II n = 1314 At 9 months, angiographic restenosis rate was 8% (versus 27% for BMS) and target revascularization rate was 3% (versus 11% for BMS). At one year, major adverse cardiac events were significantly less (10.8% versus 20% in BMS).

23 DES vs BMS Indolfi et al: Meta-analysis analysis 13 RAVEL, TAXUS, ASPECT, SIRIUS, ELUTES, DELIVER, SMART N = 3680 DM population ranged from 13 to 29% in studies MACEs occurred less frequently with DES (RR 0.40). Major Adverse Cardiac Events: MI, Death, Revasc Significant decrease in need for revascularization (RR 0.30) for DES vs BMS

24 DES vs BMS Kong et al 2005 Meta-analysis analysis 14 Eleven trials, N = 5140 Significant reduction in target lesion revascularization (4% vs 13%) and major adverse cardiac events (8% vs 16%) with DES.

25 How does CABG weigh in? CABG vs Balloon Angioplasty CABG vs Bare Metal Stents CABG vs Drug- Eluting Stents?

26 PTCA vs CABG 2 RITA-1 (Randomized Intervention Treatment of Angina) RITA N = 1011 No difference in mortality at 6.5 yr f/u Angina 3x more frequent in PTCA Similar costs after 5 years 26% of PTCA patients later underwent CABG

27 PTCA vs CABG 2 BARI BARI (Bypass Angioplasty Revasc.. Investigation) N = 1829 PTCA- more frequent revascularization (52% v 6%) 5 year survival better with CABG* for diabetics (94% v 80%). * required IMA graft Survival at 7 years better for CABG (76% v 56%) EAST EAST (Emory Angioplasty v Surgery Trial) N = 392 Non-significant late survival benefit in CABG for those with proximal LAD stenosis or diabetes

28 CABG vs PTCA Are results any better for PTCA with stents?

29 Stent vs CABG SoS SoS (Stent or Surgery) N = 988 Repeat revascularization 21% (stent( stent) vs 6% (surgery) at 2 yr In hospital events no different (CVA, death, MI) ERACI II (Argentina) 2001 N = 450 Repeat revascularization 14.8% (stent( stent) vs 4.8% (surgery) at 1 yr ARTS ARTS (Arterial Revascularization Therapies Study) 2002 N = 205 No difference in death, CVAs, MIs for multivessel disease Repeat revascularization 29.2% (stent( stent) vs 7.3% (surgery) at 3 yr

30 Stent vs CABG Serruys et al 2001 NEJM 16 N = 1205 Studied multivessel disease Rates of death, stroke, myocardial infarction were no different Revascularization occurred in 16.8% of stented patients vs 3.5% in CABG group

31 Stent vs. CABG New York Cardiac Registry, NEJM 2005 NEJM N = 37,212 Observational Study 3 yr survival rate favored Stenting 3 yr risk-adjusted survival rate favored CABG Revascularization rate BMS > CABG 7.8% vs 0.3% underwent subsequent CABG 27.3% vs 4.6% underwent subsequent PCI In hospital mortality rate CABG > BMS (650 vs 150 deaths)

32 Stent vs CABG Hoffman et al 2003 JACC 18 Meta-analysis analysis RITA, EAST, ERACI, CABRI BARI, SIMA, ARTS, SoS 13 randomized trials N = 7964 Revascularization Stents: : 15% more at 1,3 yrs Survival Same at 1,3 yrs 5 and 8 year data includes PTCA without Stents A. All Trials in Investigation B. Multivessel Disease Only

33 Stent vs CABG How about stents vs CABG in special scenarios?

34 Stent vs CABG in High Risk AWESOME trial 19 Angina With Extremely Serious Operative Mortality Evaluation VA Multicenter,, Randomized Trial N = 2431 At least one risk factor IABP MI within 7 days LVEF < 35% Age > 70 Prior heart surgery

35 Stent vs CABG in High Risk AWESOME trial 36 month survival rate CABG: 79% PCI: 80%

36 Stent vs CABG in Diabetes 20 BARI, EAST, CABRI- survival at 8 years CABG 76% PCI 60%* * before stent usage ARTS one year results in diabetics Similar death rates (3.1% vs 6.3%, p = 0.40) Similar MI rates (3.1% vs 6.3%, p = 0.40) Revascularization Rates CABG 3.1% Stent 22%

37 CABG vs Stent in Diabetics New Developments Drugs 2006 Clopidogrel: : ADP-induced aggregation inhibitor Ticlodipine: : ADP-induced aggregation inhibitor Abciximab: IIb/IIIa Platelet Inhibitor EPISTENT (12% reduction of TVR in diabetics) 21 DES in Diabetics RAVEL RAVEL (12.2% revascularization with CYPHER vs 27.1% with BMS)

38 CABG vs DES?? CARDia Trial UK UK Diabetics with multivessel disease Surgeon and Cardiologist in agreement about ability to be randomized Will include sirolimus stents,, bare metal stents,, and abciximab End Points Include Death/nonfatal MI/nonfatal stroke Revascularization Major Bleeding Complications

39 CABG vs DES?? FREEDOM Trial North America North America 23 Enrolling 2600 diabetics with multivessel disease Sirolimus Stents with abciximab vs CABG Primary End-Point: 5 year mortality

40 Summary Drug-Eluting Stents are yet another advancement in non-surgical technology for the treatment of CAD Mode of controlled, tissue-directed drug release Significant reduction in restenosis and revascularization Experience and technology advance faster than research that can support it

41 Summary Major limitation of PTCA with stenting is the need for target vessel revascularization DES reduce need for revascularization

42 References 1. Nelken et al. Advances in Stent Technology. Surg Clin N Am 2004; Townsend et al. Sabiston Textbook of Surgery, 17 edition Kean-Wah Wah et al. Clinical impact of Stent Construction and Design in Percutaneous Coronary Intervention. Curriculum in Cardiology 2003; Bavry et al. Risk of Thrombosis with the Use of Sirolimus-Eluting Stents for Percutaneous Coronary Intervention. Am J Cardiol 2005; 95: Leon et al. Drug-eluting eluting Stents and Glycoprotein IIb/IIIa inhibitors: Combination Therapy for the future. Am Heart J 2003; 146:S Cutlip et al. Drug-eluting eluting Intracoronary Stents to Prevent Stenosis. UpToDate (2006) 7. Stone et al. Comparison of Angioplasty with Stenting,, with or withour Abciximab,, in Acute Myocardial Infarction. NEJM 2002; 346: Vishnevetsky et al. Sirolimus-Eluting Eluting Coronary Stent.. Am J Health-Syst Pharm 2004; 61(5): Sousa et al. Sustained Suppression of Neo-intimal intimal Proliferation by Sirolimus- eluting Stents: : One-Year Angiographic and Intravascular Ultrasound Follow- Up. Circulation 2001; 104: Serruys et al. Intravascular Ultrasound Findings in the Multicenter, Randomized, Double-Blind Blind RAVEL (Randomized study with the sirolimus- eluting Velocity balloon-expandable stent in the treatment of patients with de novo coronary artery Lesions) trial. Circulation 2002; 106: 798

43 References 11. Moses et al. Sirolimus-eluting eluting Stents versus Standard Stents in Patients with Stenosis in a Native Coronary Artery. NEJM 2003; 349: Sonoda et al. Taxol-Based Based Eluting Stents From Theory to Human Validation: Clinical and Intravascular Ultrasound Observations. J Invasive Cardiol 2003; 15(3): Indolfi et al. Drug-Eluting Eluting Stents versus Bare Metal Stents in Percutaneous Coronary Interventions (A Meta-Analysis). Am J Cardiol 2005; 95: Kong et al. Drug-Eluting Eluting Stents Reduce Restenosis Rates and Major Adverse Cardiac Events, but Not Mortality, in Patients Undergoing Percutaneous Coronary Intervention. Evidence-Based Healthcare & Public Health 2005: 9: Zhang et al. The Impact of Acute Coronary Syndrome on Clinical, Economic, and Cardiac-Specific Specific Health Status After Coronary Bypass Surgery versus Stent-Assisted Percutaneous Coronary Intervention: 1-year 1 Results from the Stent or Surgery (SoS( SoS) ) Trial. 16. Serruys et al. Comparison of Coronary-Artery Bypass Surgery and Stenting for the Treatment of Multivessel Disease. NEJM 2001; 344:

44 References 17. Hannan et al. Long-Term Term Outcomes of Coronary-Artery Bypass Grafting versus Stent Implantation. NEJM 2005; 352: Hoffman et al. A Meta-Analysis Analysis of Randomized Controlled Trials Comparing Coronary Artery Bypass Graft with Percutaneous Transluminal Coronary Angioplasty: One- to Eight-Year Outcomes. J Am Coll Cariol 2003; 41: Morrison et al. Percutaneous Coronary Intervention versus Coronary Bypass Grafting Surgery for patients with Medially Refractory Myocardial Ischemia and Risk Factors for Adverse Outcomes with Bypass- The VA Multicenter Registry J Am Coll Cariol 2002: Mukherjee,, D. Percutaneous Coronary Intervention versus Coronary Artery Bypass Grafting in Diabetic Patients. Cardiol Clin 2005; 23: Marso et al. Optimizing the Percutaneous Interventional Outcomes for Patients with Diabetes Mellitus: Results of the EPISTENT Diabetic c Study. Cirulation 1999: 100: Kapur et al. The Coronary Artery Revascularization In Diabetes (CARDia( CARDia) Trial: Background, Aims, and Design. Am Heart J 2005; 149: 13-9

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