Introduction An Update on Angioplasty and Richard M. Ross Heart - PDF document

Introduction An Update on Angioplasty and • Richard M. Ross Heart Hospital Coronary Stents • The Ohio State University, Columbus, OH • Universal Bed Concept • 90 bed hospital Raymond D. Magorien, MD • 60 more beds open in 9/08 Director, Cardiac Catheterization Lab • Cardiology The Ohio State University, Columbus, Ohio • Cardiothoracic Surgery • Vascular Surgery Objectives Introduction • Outline the history and development of coronary angiography, coronary angioplasty, coronary stenting • Cath Lab Volumes 12 Month 24 Month • Discuss In-Stent-Restenosis and the impact it • Diagnostic 5,345 10,506 has on our patients and the medical community • Interventional 1,903 3,939 • Discuss the data behind Drug Eluting Stents • Discuss Stent Thrombosis and it’s impact on current standard of care • Discuss future concepts in the cardiac catheterization laboratory 1

Risks of Cardiac History of Angioplasty Catheterization 3000 B.C: Egyptians perform bladder catheterizations using metal pipes. • Diagnostic Catheterization: 1/1000 400 B.C.: Hollow reed catheters used in chance of the following: cadavers to study the function of cardiac valves. • Death 1711: Hales conducts the first cardiac cath on a horse using brass pipes, a glass • Stroke tube and a goose trachea. • Loss of Limb 1844: Bernard uses catheters to record intracardiac pressures and coins the term “cardiac catheterization.” • Myocardial Infarction 1929: First documented human cardiac • Major Bleed (1/500) catheterization is performed by Dr. Werner Forssmann in Eberswald, Germany…on himself. Downloaded from Angioplasty.org on February 17, 2007 Risks of Cardiac History of Angioplasty Catheterization 1941: Cardiac output measured by Cournand and Richards, first use of cardiac cath as • Coronary Intervention: 1-2% chance of diagnostic tool. the following 1956: Forssmann, Cournand and Richards • Significant myocardial infarction share the Nobel Prize. • Death 1958: Mason Sones performs first diagnostic coronary angiogram at the Cleveland • Major Bleed Clinic….by accident. 1964: Transluminal Angioplasty, the concept of “remodeling the artery”, is introduced by Charles Dotter Downloaded from Angioplasty.org on February 17, 2007. 2

History of Angioplasty History of Angioplasty 1977 Gruentzig 1985 Gruentzig 1967: Judkins technique introduced. performs first cath lab dies in plane PTCA on awake crash. 1974: Gruentzig performs the first human patient in Zurich. angioplasty….in a lower extremity 1977 1987 1976: Gruentzig presents results of animal studies at AHA meeting. 1982 Over-the-wire coaxial 1986 Coronary balloon systems atherectomy 1977: First human coronary balloon angioplasty performed intraoperatively introduced, brachial devices are by Gruentzig, Myler and Hanna in San guiding catheters and introduced. Francisco. steerable guide wires are developed. Downloaded from Angioplasty.org on February 17, 2007. History of Angioplasty History of Angioplasty 1987-1993 1977: Gruentzig performs first cath lab PTCA on awake patient in Zurich. Cardiothoracic surgery present for backup. 1997 Over one Lasers, rotational million atherectomy, IVUS angioplasties and stents introduced performed. into practice. 1987 1997 1994 Palmaz-Schatz stent is approved by the FDA for use in U.S. 3

History of Angioplasty 2001 Two million 2004 Taxus (Boston angioplasties and Sci.) approved by Presently, Stents are a stents performed. FDA. multi-billion dollar industry and 2004 1997 are by far the most common prosthetic device placed in man 2003 First drug-eluting stent (Cyper-J&J, Cordis) approved by FDA. History of Angioplasty Data and Clinical Practice 2006 European 2007 2 nd Generation DES • 1980’s: Plain Old Balloon Angioplasty Bioabsorbable (“POBA”) led to restenosis in 15-60% of Introduced to Market in Stent: First in patients Europe Man • 1990’s: Bare metal coronary stents significantly reduced overall target vessel 2005 Present revascularization. • Two important studies in the August 1994 2006 EPC (Endothelial Progenitor Cell) issue of NEJM looked at BMS vs. Coated Antibody Stent Introduced: angioplasty alone First in Man Fischman DL et al. NEJM August 25, 1994 (331): 496-501. Serruys PW et al. NEJM August 25, 1994 (331): 489-495. 4

BENESTENT Trial (1994) BENESTENT Trial Findings • 520 Patients w/ stable angina and a single coronary lesion • Favoring PTCA � 262 Stent vs 258 PTCA (“POBA”) � Less blood transfusions, peripheral � PEP: Death, CVA, MI, CABG, repeat PCI vascular complications (13.5% vs 3.1%, P<0.001) � Follow-up 7 months � Shorter hospitalizations (8.5 vs 3.1 days, � Primary Angiographic Endpoint: MLD 7 P<0.001) months • Non Significant difference in death, � Pt’s treated w/ ASA & Dipyridamole for 6 myocardial infarction months � Stent patients received Warfarin 3 months Serruys PW et al. N Engl J Med 1994:331;489-495 Serruys PW et al. N Engl J Med 1994:331;489-495 BENESTENT Trial Findings STRESS Study 1994 • Favoring Stents • 420 patients with symptomatic coronary disease � 207 Stent vs 203 PTCA � Decreased primary endpoint (20% v 30%, � PEP: Angiographic evidence of >50% P=0.02) restenosis on follow-up angiogram at 6 • Driven by less repeat PCI (13% vs 23%, months P=0.005) � Clinical Endpoints: Death, MI, CABG, repeat � Larger Lumen Diameter at 7 months (2.0 vs revascularization (in-hospital and 6 months) 2.5mm, P<0.001) � ASA, Dipyridamole started before procedure � Less Restenosis of > 50% (22% vs 32%, � Warfarin and dipyridamole for 1 month, ASA p=0.02) indefinitely Serruys PW et al. N Engl J Med 1994:331;489-495 Fischman DL et al. N Engl J Med 1994:331;496-501 5

STRESS Study Findings BMS Update 2002 • Favoring Stents • Meta-analysis of 29 randomized trials comparing BMS to PTCA up until 6/2002 � Higher procedural success (96% vs 89%, p=0.011) • Important things to remember: � Larger post procedural (1.7mm vs 1.2mm, � Every study included patients with stable p=0.001) and 6-month lumen diameters (1.7mm vs 1.5mm, p=0.007) angina � Lower restenosis at 6 months (31.2 vs 42.6%, � Very few of the studies included patients with p=0.046) unstable angina (varied definitions) � Less target lesion revascularization (10.2 vs � None of the studies included NSTEMI/STEMI 15.4%, p=0.06) patients Annals of Internal Medicine Fischman DL et al. N Engl J Med 1994:331;496-501 Brophy JM, Ann Int Med . 2003;138:777-786 STRESS Study Findings BMS Update 2002 “Trend” Towards improved Survival • Conclusions � No Difference between Stenting and PTCA in terms of Death and Myocardial Infarction � Stenting reduced restenosis rates and recurrent PCI Annals of Internal Medicine Brophy JM, Ann Int Med . 2003;138:777-786 Fischman DL et al. N Engl J Med 1994:331;496-501 6

Replacing One Problem for Restenosis after Bare Metal Stents Another: ISRS? Scope of the Problem • By 1999, Stenting comprised • PCI worldwide 2005 : 85% of Percutaneous • 2.4 million Coronary Interventions • ~ 50% performed in United States • However; • Angiographic restenosis: 600,000/yr � Increased risk of subacute thombosis in the stented • Clinical events: 300,000/yr segment (3.7% of all procedures) � Replacement of atherosclerotic • Recurrent clinical events: 120,000/yr coronary disease with the • Ultimate bypass surgery: 100,000/yr iatrogenic in-stent neointimal hyperplasia Top Picture courtesy of www.hkma.org/.../clinicalcase/200703a-fig2.jpg G. Guagliumi et al. Circulation 2003;107:1340 Economic Burden of Clinical Restenosis after Bare Metal Stenting: Multicenter Perspective Restenosis in U.S. Balloon angioplasty 1 million PCI procedures in US during in 2004 1 ~30 to 40% Restenosis >70% of PCIs used bare metal stents (conservative) 2 T V T F T V L R Estimated TVR frequency (Centers for Medicine & R Medicaid Services population) 14.4% in the BMS era 3 Mean cost for each TVR event $11,913 4 Est. annual economic burden in the US ~$1.2 billion 4 Thom T et al. Circulation 2006;113:e85-151 1 Cutlip DE, et al. JACC 2002;40:2082-9 3 JACC 2002 (40)12:2082-9 Laskey WK, et al. Am J Cardiol 2001; 87:964-9 2 Cohen DJ et al. Circulation 2001;104: I:386-7 4 7

Drug Eluting Stents: A New Is Restenosis a Benign Entity? Solution First Generation 2003 1186 Cases of single lesion Bare Metal In-Stent-Restenosis at the Cleveland Clinic Drug eluting stents promised to reduce the number of repeat revascularization procedures (ISRS) by inhibiting neointimal proliferation (AKA “delayed healing”) 64.1% Effort Angina • Cypher (J&J ,Cordis): Sirolimus (Rapamycin) coated stent. 26.4% Unstable TREATMENT Cytostatic with antiinflammatory and Angina 8 (0.7%) Procedural antiproliferative properties. 9.5% Acute MI Deaths 7.3% NSTEMI • Taxus (Boston Scientific) Paclitaxel (derived 2.2% STEMI from the Pacific yew tree, Taxus brevifolia) coated stent. Lipophilic, inhibits cellular division, motility, activation, secretory *106 cases (8.9%) totally processes and signal transduction. occluded Chen MS et al. AHJ 2006, 151:1260-1264 The First Available DES An Update on Angioplasty and TAXUS Coronary Stents Polyolefin Paclitaxel Express 2 Ernest L. Mazzaferri Jr, MD, FACC derivative Director, Regional STEMI Program Drug Polymer Stent The Richard M. Ross Heart Hospital Cypher The Ohio State University, Columbus, Ohio PEVA + PBMA Sirolimus BX Velocity blend Pictures Courtesy of Stone GW 8