糖尿病PCI治疗-英文课件

Click to edit Master title style,Click to edit Master text styles,Second level,Third level,Fourth level,Fifth level,*,Percutaneous Coronary Intervention In Diabetic Patients,S. Chiu Wong MD, FACCAssociate Professor of MedicineWeill Medical College of Cornell UniversityDirector, Cardiac Catheterization LaboratoriesThe New York Presbyterian Hospital-Cornell Campus,The ACC Symposium at the Great Wall Meeting, Beijing China,October 17, 2004,Percutaneous Coronary Interven,1,PCI in Diabetic Patients,Summary,Prevalence of Diabetes Mellitus and its Associated Cost?,What are the Distinctive Features About Diabetic Vessels?,What is the Impact of Drug Eluting Stent in Diabetic Patients with CAD?,How could we Optimize PCI Treatment Strategies in Diabetic Patients?,PCI in Diabetic Patients Summ,2,PCI in Diabetic Patients,Prevalence of Diabetes Mellitus and its Associated Costs?,What are the Distinctive Features About Diabetic Vessels?,What is the Impact of Drug Eluting Stent in Diabetic Patients with CAD?,How Should we Optimize PCI Treatment Strategies in Diabetic Patients?,PCI in Diabetic PatientsPreval,3,PCI in Diabetic Patients,Prevalence of Diabetes Mellitus and its Associated Costs?,What are the Distinctive Features About Diabetic Vessels?,What is the Impact of Drug Eluting Stent in Diabetic Patients with CAD?,How Should we Optimize PCI Treatment Strategies in Diabetic Patients?,PCI in Diabetic PatientsPreval,4,Accessed on Oct 2, 2004. www.diabetes.org/diabetes-statistics/national-diabetes-fact-sheet.jsp,Source: National Diabetes Fact Sheet (American Diabetes Association),National estimates on diabetes in the US in 2002,Total: 18.2 million people (6.3% of the population),Approximately 90% of patients with diabetes have the type 2 variety which is associated with excess body fat and physical inactivity.,PCI in Diabetic Patients,Prevalence of DM Among US Adults,Accessed on Oct 2, 2004. www.d,5,PCI in Diabetic Patients,Diabetes: A Genetic Legacy,Approximately 90% of patients with diabetes have the type 2 variety. The increasing prevalence of type 2 diabetes cannot be divorced from the rising incidence of obesity and physical inactivity in industrialized society. Both excess body fat and physical inactivity predispose to type 2 diabetes,PCI in Diabetic PatientsApprox,6,Mokdad, A. H. et al. JAMA 2001;286:1195-1200.,PCI in Diabetic Patients,Prevalence of DM Among US Adults: 1990 vs. 2000,Incidence of a self-report of diagnosed diabetes increased from 4.9% in 1990 to 7.3% (49% increase) in 2000.,Mokdad, A. H. et al. JAMA 2001,7,Saydah, S. H. et al. JAMA 2004;291:335-342.,PCI in Diabetic Patients,Percentages of Adults With Recommended Levels of Vascular Disease Risk Factors in NHANES III (1988-1994) and NHANES 1999-2000,Saydah, S. H. et al. JAMA 2004,8,PCI in Diabetic Patients,Levels of HbA,1c, blood pressure, and total cholesterol in NHANES Pts,Risk factor,NHANES 88-94,NHANES 99-2000,p,Mean HbA,1c,(%),7.6,7.8,0.30,% subjects HbA,1c,8.0%,36.5,37.2,0.87,Total mean cholesterol (mg/dL),222.8,208.9,200 mg/dL,66.1,51.8,0.001,Total mean systolic BP (mm Hg),137.9,134.8,0.04,Total mean diastolic BP(mm Hg),73.5,71.5,0.12,% subjects with normal BP,(SBP 130 and DBP ,140 or DBP,90),42.9,40.4,0.56,Saydah SH et al.,JAMA,2004; 291:335-342.,PCI in Diabetic Patients Leve,9,Estimated numbers of people with diabetes by region for 2000 and 2030 and summary of population changes,Region (all ages),# of people with DM in 2000,# of people with DM in 2030,% change in # of people with DM,*,% change in total population,*,% change in population 65,*,% change in urban population,*,Established market economies,44,268,68,156,54,9,80,N/A,Former socialist economies,11,665,13,960,20,14,42,N/A,India,31,705,79,441,151,40,168,101,China,20,757,42,321,104,16,168,115,Other Asia and Islands,22,328,58,109,148,42,198,91,Sub-Saharan Africa,7,146,18,645,161,97,147,192,Latin America and the Caribbean,13,307,32,959,148,40,194,56,Middle Eastern Crescent,20,051,52,794,163,67,194,94,World,171,228,366,212,114,37,134,61,*,A positive value indicates an increase, a negative value indicates a decrease.,Wild et al Diabetes Care 2004; 27:1047-53,Estimated numbers of people wi,10,Country,People with diabetes (millions),Country,People with diabetes (millions),1,India,31.7,India,79.4,2,China,20.8,China,42.3,3,U.S.,17.7,U.S.,30.3,4,Indonesia,8.4,Indonesia,21.3,5,Japan,6.8,Pakistan,13.9,6,Pakistan,5.2,Brazil,11.3,7,Russian Federation,4.6,Bangladesh,11.1,8,Brazil,4.6,Japan,8.9,9,Italy,4.3,Philippines,7.8,10,Bangladesh,3.2,Egypt,6.7,PCI in Diabetic Patients,Countries with the highest # of estimated cases of DM for 2000 and 2030,CountryPeople with diabetes (m,11,“,.estimate that there would be 754 thousand new diabetics per year in 25-74 years old Chinese if the total population were 1.3 billion in China in the 21st century”,Hu YH, Li GW, Pan XR , Zhonghua Nei Ke Za Zhi. 1993 Mar;32(3):173-5.,PCI in Patients with Diabetes Mellitus,Scope of the Problem,“.estimate that there would,12,糖尿病PCI治疗-英文课件,13,PCI in Diabetic Patients,Diabetes and Cardiovascular Complications,UKPDS Investigators Lancet 1998;352:837,PCI in Diabetic PatientsUKPDS,14,Khaw KT et al.,Ann Intern Med,2004; 141:413-420.,Population,Relative risk,95% CI,p,Men,1.24,1.14-1.34,0.001,Women,1.28,1.06-1.32,0.001,PCI in Diabetic Patients,EPIC-Norflk Study: Hemoglobin A1c and Mortality,Increase in all-cause mortality associated with 1 % increase in hemoglobin A1c by gender,Khaw KT et al. Ann Intern Med,15,Heart disease is the leading cause of diabetes-related deaths. Adults with diabetes have CV death rates 2 to 4 times higher than adults non-diabetics.,About 65% of deaths among people with diabetes are due to heart disease and stroke.,PCI in Diabetic Patients,Complications of Diabetes in US: Heart Disease and Stroke,Accessed on Oct 2, 2004. www.diabetes.org/diabetes-statistics,Source: National Diabetes Fact Sheet (American Diabetes Association),Heart disease is the leading c,16,Haffner, S. M. et al. N Engl J Med 1998;339:229-234,In 1059 Type 2 Diabetic and 1378 Nondiabetic patients with and without Prior MI,PCI in Diabetic Patients,Kaplan-Meier Estimates of the Probability of Death from CAD,Patients with diabetes have the same risk of death as non-diabetic patients who have had an previous MI,Haffner, S. M. et al. N Engl J,17,PCI in Patients with Diabetes Mellitus,Scope of the Problem,PCI in Patients with Diabetes,18,PCI in Patients with Diabetes Mellitus,Scope of the Problem,PCI in Patients with Diabetes,19,The total annual economic cost of diabetes in 2002 was estimated to be $132 billion, or one out of every 10 health care dollars spent in the US.,PCI in Diabetic Patients,Health Care Cost of the Diabetes Mellitus in US,The total annual economic cost,20,Differences in the Diabetic Artery:,Insights from Angiography and IVUS,Differences in the Diabetic Ar,21,PCI in Diabetic Patients,Prevalence of Diabetes Mellitus and its Associated Costs?,What are the Distinctive Features About Diabetic Vessels?,What is the Impact of Drug Eluting Stent in Diabetic Patients with CAD?,How Should we Optimize Treatment Strategies Following PCI in Diabetic Patients?,PCI in Diabetic PatientsPreval,22,0,10,20,30,40,50,60,Severity,Index,Extent,Index,Atheroma,Burden,Non-IDDM (n=57),Matched controls (n=57),Pajunen et al, Am J Cardiol 1997;80:550-556,0,10,20,30,40,50,60,Severity,Index,Extent,Index,Atheroma,Burden,Type I (all IDDM, n=64),Matched controls (n=64),Pajunen et al, Am J Cardiol 2000;86:1080-1085,p0.0001,p0.0001,p10yrs were insulin dependent compared to 19% of Diabetics 10yrs (p0.0001),p=0.02,p=0.1,p=0.02,p=0.003,p=0.004,PCI in Patients with Diabetes,26,PCI in Patients with Diabetes Mellitus,Pre-intervention IVUS Comparison of Insulin-Treated vs Non-Insulin Treated Diabetics,Reference,Lesion,Insulin use was the,only,independent (and,negative,) predictor of reference segment EEM, and P&M CSA and lesion EEM and P&M CSA.,p=0.015,p0.0001,p=0.0063,p0.0001,PCI in Patients with Diabetes,27,Reference Segments,Mintz et al, J Am Coll Cardiol 1995;25:1479-85,Positive remodeling,Intermediate remodeling,Negative remodeling,Nishioka et al. J Am Coll Cardiol 1996; 27:1571-76,Lesions,Reference SegmentsMintz et al,28,PCI in Patients with Diabetes Mellitus,Remodeling in Acute Coronary Syndromes,p,Stable,ACS,0.008,0.940.2,1.060.2,Remodeling Index,0.005,11.14.8,13.95.5,P&M CSA (mm,2,),0.3,1.90.4,2.31.1,Lumen CSA (mm,2,),0.004,13.04.8,16.16.2,EEM CSA (mm,2,),Lesion,0.9,6.23.5,6.12.6,P&M CSA (mm,2,),0.06,7.92.8,9.13.6,Lumen CSA (mm,2,),0.2,14.25.2,15.25,2,EEM CSA (mm,2,),Proximal reference,Schoenhagen et al. Circulation 2000;101:598-603,Remodeling,p0.0001,PCI in Patients with Diabetes,29,PCI in Patients with Diabetes Mellitus,Diabetes Modulates Remodeling in ACS and Stable Angina (n=927),DM,No DM,Acute Coronary Syndrome,59/183,(32.0%),225/469,(48.0%),Stable Angina,17/88,(19.6%),42/187,(22.3%),Abizaid, unpublished observations,Frequency of Positive Remodeling,PCI in Patients with Diabetes,30,PCI in Patients with Diabetes Mellitus,Interaction of Diabetes,Vessel Size, Final MLD, and Multiple Stents on Restenosis Post-stenting,0.6,0.4,0.2,0,2,3,4,5,Diabetics,Non-Diabetics,Probability of Restenosis,Vessel Size (mm),Elezi et al. J Am Coll Cardiol 1997;30:1428-36,Elezi et al. J Am Coll Cardiol 1998;32:1866-73,Probability& Predictors of Restenosis,PCI in Patients with Diabetes,31,PCI in Patients with Diabetes Mellitus,IVUS findings in diabetic vs non-diabetic pts in,non-stented,lesions,WHC,p=NS,OARS,p=0.072,p=0.19,p=0.0392,EEM CSA,(mm,2,),P&M CSA,(mm,2,),EEM CSA,(mm,2,),P&M CSA,(mm,2,),EEM CSA correlated with P&M in non-diabetics, but not in diabetics indicating that,diabetics lacked the ability to respond to the exaggerated intimal hyperplasia,that is also present,PCI in Patients with Diabetes,32,PCI in Patients with Diabetes Mellitus,IVUS Findings in Diabetic vs Nondiabetic Patients Post,Stent,Kornowski et al. Circulation 1997;95:1366-9,p=0.0009,p=0.0007,mm,2,PCI in Patients with Diabetes,33,PCI in Patients with Diabetes Mellitus,Influence of Diabetes on Early and Late Outcome After PTCA,Stein et al. Circulation 1995;91:979-989,5-year event rates,Independent predictors of 5-year survival in diabetic patients were younger age, absence of heart failure, preserved LV function, absence of multivessel disease, and non-insulin dependent,P0.001,P0.001,P0.001,P0.001,PCI in Patients with Diabetes,34,PCI in Patients with Diabetes Mellitus,NHLBI PTCA Registry: Diabetic Patients,Kip et al. Circulation 1996;94:1818-1825,9-year event rates,P0.001,P0.001,P0.001,P0.05,PCI in Patients with Diabetes,35,PCI in Diabetic Patients,Impact of restenosis and disease progression on clinical outcome 14 months after multivessel stenting,Loutfi et al. Cath Cardiovasc Intervent 2003;58:451-4,PCI in Diabetic PatientsImpac,36,PCI in Patients with Diabetes Mellitus,Role of vessel size as predictor for in-stent restenosis in diabetic patients,p=0.002,Suslbeck et al. Am J Cardiol 2001;88:243-7,Restenosis rates,PCI in Patients with Diabetes,37,PCI in Diabetic Patients,Summary on Diabetic Vessels,Diabetics have more diffuse atherosclerosis and (perhaps) smaller lumen dimensions,Increased plaque mass especially in non-insulin treated patients,Impaired remodeling responses, especially in insulin-treated patients,Diabetics have increased risk of restenosis post-PCI (both stent or non-stent),Smaller final lumen dimensions,More intimal hyperplasia in both stent and non-stent interventions,Impaired remodeling responses in non-stent interventions,Diabetics have increased risk of death/MI/PCI of new lesions,Increased plaque burden,?More unstable plaque morphologies,PCI in Diabetic Patients Summ,38,Small diameter lesions30-40%,Long lesions37-50%,Diabetes26-46%,Ostial lesions40-50%,Bifurcated lesions40-60%,Source: Kalan Ho, and PCR 2000 market research.,Coronary Stents,Restenosis Post Stent in Higher Risk Patient/Lesion Subsets,Stent is no panacea,Small diameter lesions30-40%,39,PCI in Diabetic Patients,Prevalence of Diabetes Mellitus and its Associated Costs?,What are the Distinctive Features About Diabetic Vessels?,What is the Impact of Drug Eluting Stent in Diabetic Patients with CAD?,How Should we Optimize Treatment Strategies Following PCI in Diabetic Patients?,PCI in Diabetic PatientsPreval,40,Cost-effectiveness (1,000s) can vary dramatically in patients taking lovastatin for primary prevention.,PCI in Diabetic Patients,Diabetic Subset in the 4S Study,Pyorala K et al. Diabetes Care 1997;20:614-20,Cost-effectiveness (1,000s) ca,41,PCI in Diabetic Patients,SIRIUS,: Multivariable Predictors for In-segment Restenosis,15mm,3.0mm,3.4,3.9,4.9,2.5-3.0mm,5.6,6.4,7.9,2.5mm,8.2,9.4,11.5,Lesion Length,15mm,3.0mm,7.8,8.9,10.9,2.5-3.0mm,12.4,14.0,17.0,2.5mm,17.7,19.8,23.7,Lesion Length,Ref,Diam,Ref,Diam,NonDiabetic,Diabetic,PCI in Diabetic Patients SIRI,42,PCI in Diabetic Patients,Studies included in the meta-analysis,Dawkins K. ESC Congress 2004; August 28-September 1, 2004.,Study,Overall patients,Diabetic patients,Insulin-treated patients,TAXUS II,slow release,266,30,7,TAXUS II moderate release,263,21,7,TAXUS IV slow release,1314,318,105,TAXUS VI moderate release,446,89,35,Overall,2289,458 (Controls=242; TAXUS=216),154 (Controls=83; TAXUS=71),PCI in Diabetic Patients Stu,43,p =,n,s,p = 0.000,1,p =,ns,*incl. CABG,e-CYPHER: DM Subgroup,MACE & TLR 6-month FU,N=2716 Pts,p = nsp = 0.0001p = ns*incl.,44,RAVEL - Diabetic Subgroup,Sirolimus Control,N=19N=25p,Lesion length (mm)9.749.42 NS,Ref. Vessel diameter (mm)2.522.51 NS,MLD (mm)Pre0.990.93 NS,Post2.372.36 NS,FU2.311.56 .0001,Late loss (mm)0.080.82 .0001,Late loss index 0.050.57 .0001,DS (%)FU 16 38 .0001,Restenosis rate (%) 0 42 .0001,TLR-PCI(%) 0 32.0 0.007,Total MACE(%) 10.5 48.0 0.01,RAVEL - Diabetic SubgroupSiro,45,SIRIUS: Clinical Outcomes in Diabetic Subgroup,Sirolimus (n=131),Control,(n=148),P-value,Late loss (mm),in-stent,0.29,1.20,0.001,in-segment,0.40,1.00,0.001,Restenosis (%),in-stent,8.3,48.5,0.001,in-segment,17.6,50.5,0.001,TLR (%),6.9,22.3,0.001,MACE (%),9.2,25.0,0.001,Lesion length = 14.5mm and Reference vessel size = 2.75mm,At 9 months,SIRIUS: Clinical Outcomes in D,46, 73%,p = 0.015, 83%,p 0.001,3/37,15/55,5/158,28/143,New SIRIUS,- Diabetic Subgroup 9-month TLR, 73% 83% 3/3715/555/15828/1,47,PCI in Diabetic Patients,Late loss observed in the meta-analysis,Dawkins K. ESC Congress 2004; August 28-September 1, 2004,Patient subgroup,In-stent late loss (mm),p,Nondiabetic patients,0.0001,Bare-metal stent (n=609),0.86,+,0.54,Paclitaxel-eluting stent (n=603),0.36,+,0.47,Oral-agents-only diabetic patients,0.0001,Bare-metal stent (n=79),1.03,+,0.58,Paclitaxel-eluting stent (n=91),0.36,+,0.51,Insulin-treated diabetic patients,0.0006,Bare-metal stent (n=48),1.01,+,0.53,Paclitaxel-eluting stent (n=44),0.33,+,0.50,PCI in Diabetic Patients Late,48,Review of Drug-eluting Stents in Diabetes: IDDM Patients,n=54,n=51,42.9,7.7,p=0.007,TAXUS IV,DIRECT,TAXUS IV diabetics,*,TAXUS: 9 month analysis; SIRIUS: 8 month analysis,Control BMS,TAXUS DES,CYPHER DES,Angiographic restenosis* (mm),70,60,50,40,30,20,10,0,In segment restenosis rates: insulin-req. diabetic patients,n=38,35.0,n=14,0.0,DIRECT Diabetic,Subgroup Analysis,Significant reduction in restenosis compared to historical,SIRIUS IDDM patients, attributed to improved operator technique,p=0.03,Bx Velocity,Review of Drug-eluting Stents,49,DIABETes and sirolimus Eluting Stent,The,DIABETES,Trial,DIABETes and sirolimus Eluting,50,DIABETES: Background,Diabetic patients exhibit a higher incidence of restenosis / MACE after PCI as compared to non-diabetic population.,Sirolimus eluting stents have demonstrated to be effective for the treatment of coronary stenoses of low-to-moderate risk.,Subgroup analyses from randomized trials (RAVEL, SIRIUS) have shown a beneficial effect of these stents in diabetic patients.,HYPOTHESIS:,Sirolimus eluting stent reduces the degree of neointimal hyperplasia after stenting in diabetics.,DIABETES: Background Diabetic,51,DIABETES Trial: Objective,To assess the efficacy of sirolimus eluting stent,following successful coronary stent implantation in diabetic patients with de novo coronary stenoses.,DIABETES Trial: Objective To a,52,DIABETES,(,DIABET,es and sirolimus,E,luting,S,tent trial),Multicenter, Prospective, Randomized.,1 - Madrid. H. S Carlos (Dr Sabat, PI),2 - Barcelona. H. Bellvitge (Dr Gmez-Hospital),3 - Valladolid. H.Clnico (Dr Fernndez-Avils),4 - Vigo. H do Meixoeiro (Dr Goicolea),.,.,.,.,2,1,3,4,No official sponsor: grant from Cordis-Spain,Spanish Society of Cardiology 2003 grant,DIABETES 1 - Madrid. H. S Carl,53,Type of study & Primary Endpoint,- Multi (4 German)-center, prospective, randomized (computer), placebo-controlled trial.,- Sub-randomization according to the type of diabetes.,PRIMARY ENDPOINT:,- In,-Stent + edges (in-segment),late lumen loss,as assessed by QCA at 9-month angiographic follow-up.,Type of study & Primary Endpoi,54,Secondary Endpoints & Sample size,SECONDARY ENDPOINTS,- Other,QCA parameters,(restenosis, MLD) at FU.,- Mean in-stent + edges neointimal hyperplasia and % volume obstruction,by,IVUS,at 9-month follow-up.,-,MACE,(cardiac death, MI and TLR) at 30 d, 9,12 and 24 months.,- Development of,complications,: aneurysm formation, late thrombosis, edge effect, late stent malapposition.,SAMPLE SIZE,- 160 patients (80 SES; 80 BMS).,(56% difference in late lumen loss: estimated for a LLL of 0.73 mm in BMS to 0.32 mm in SES; SD 0.70, alfa error of 0.05, beta error of 0.10 and 10% missing values).,Secondary Endpoints & Sample s,55,DIABETES: Inclusion criteria,Diabetic patient (non-insulin dependent or insulin dependent) according to WHO 1999 Report.,Coronary lesions in native coronary arteries and symptoms or objective evidence of ischemia.,Lesion favourable for PTCA + stent implantation.,Informed consent