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Diabetes And   Multivessel Disease             Dr. Dev Pahlajani              MD,FACC,FSCAIChief of Interventional Cardiol...
DIABETES EPIDEMIOLOGY         www.cardiositeindia.com
The Diabetes Epidemic•      About 150 million diabetic patients worldwide, expected       to double by 2025•      One mill...
WORLD CAPITAL OF DIABETESIndia was the expected world capital of DMChina has overtaken India to wrest the title of the‘d...
Global Burden of DiabetesTop 10 Countries With Diabetics (20-79 Years Of Age)Country                  2011               C...
Multivessel disease in DiabetesBalloon EraBMS EraDES Era               www.cardiositeindia.com
Bypass AngioplastyRevascularization Investigation         (BARI) Trial           www.cardiositeindia.com
BYPASS ANGIOPLASTY REVASCULARISATION         INVESTIGATION (BARI) New Engl Jour Of Med 1996 (335): 217-225 Comparison of...
BARI: 5 Year MortalityDiabetic vs. Non-Diabetic Patients                  Non-CV death      CV death                 40   ...
BARI study: Mortality in Diabetic Patientso Benefit only in CABG patients with internal mammary  arteryo Greatest differen...
BARI Registry: No Difference in Long-term Outcome inDiabetics Treated by PTCA or CABG                   “PTCA is a safe al...
Cumulative Number of Subsequent Revascularization  Procedures per 100 Patients by Randomization                           ...
Overall Survival by RandomizedTreatment Stratified by Diabetes Status                         The BARI Investigators, J Am...
Overall Survival and Survival Free of Q- Wave MI by Randomized Treatment            www.cardiositeindia.com   The BARI Inv...
Rates of Survival and Freedom from Major Cardiovascular        Events, According to PCI and CABG Strata.               www...
10-Year Survival Rates for Patients According  to Subgroups Based on Characteristics at                 Study Entry       ...
Percent of Surviving Patients With Stable or  Unstable Angina at Each Follow-Up by              Randomization             ...
Freedom From Cardiac Death and Freedom FromCardiac Death or Any MI by Randomized Treatment         www.cardiositeindia.com...
Diabetes is a Predictor of Late Loss                               %                    LL             DTrial             ...
Arterial RevascularizationTherapies Study (ARTS) Trial          www.cardiositeindia.com
ARTS I   The primary objective of ARTS I was to compare intra-    coronary stenting to bypass surgery in patients with   ...
ARTS I – Patient FlowSTENT                                                          CABG 600                   INTENTION T...
ARTS IMACCE (30 day follow-up)                              CABG                       Stent                              ...
The Stent Era: ARTS I Study• Less favorable long-term outcome with stenting in DM• 1-year mortality rate: 6.4% vs. 3.1%• R...
ARTS I DIABETICSDeath/CVA/MI/CABG/RE- PTCADIABETIC SUBGROUP Repeat revascularization was higher in diabetic patients  ran...
ARTS I DIABETICS    www.cardiositeindia.com
ARTS Trial (CABG v. PCI)                                    Three year follow-up                          100             ...
ARTS Trial (CABG v. PCI)                                       Three year Follow-up                          100Event Free...
ARTS Trial (CABG v. PCI)                                       Three year Follow-up                          100    95.7%E...
ARTS Trial (CABG v. PCI)Three year Follow-up (Diabetic subgroup)                           100                            ...
ARTS I DIABETICSDeath/CVA/MI/CABG/RE- PTCADIABETIC SUBGROUP• Repeat revascularization was higher in diabetic patients  ran...
ARTS IIPRIMARY OBJECTIVE   To compare the effectiveness of coronary stent    implantation using the Sirolimus drug elutin...
Sirolimus Coating Modulates neointima   in 30-Day Porcine Coronary Model   Control                         + Sirolimus    ...
ARTS II: Study Design   Single arm, multicenter trial   607 patients in 45 centers from 19 countries   Main goal of the...
ARTS-II Trial                                              Historical Controls from ARTS I: 1202607 patients with multives...
ARTS II – Diabetic population (MACCEat 1y)                                           ARTS II            ARTS I (CABG)     ...
ARTS II - MACCE up to 1 year*                                       ARTS II            ARTS I (CABG)           ARTS I (PCI...
ARTS II : Event free survivalAt one year, there was no difference in event-free survival between theARTS II SES group and ...
ARTS II study  www.cardiositeindia.com
ARTS II – Diabetic population                                      ARTS II            ARTS I (CABG)           ARTS I (PCI)...
ARTS – 5 Yrs Outcome Major Adverse Cardiac Events At 5 Years In Patients Without Diabetes Stratified               Accordi...
ARTS II : Summary• Among patients with multivessel coronary lesions, patients  treated with sirolimus eluting stents had s...
Short & Long Term Results AfterMultivessel Stenting In DiabeticPatients              www.cardiositeindia.com
Short & Long Term Results AfterMultivessel Stenting In Diabetic Patients•   Prospective data base of CRF 1993-1999•   689 ...
MULTISTENTING IN DIABETICSIN-HOSPITAL OUTCOMES OF PATIENTS /LESIONS NO DM    NIDDM   IDDM               (N= 560/1428)     ...
MULTIVESSEL STENTING IN DIABETICS           1.0           0.9           0.8           0.7SURVIVAL           0.6           ...
MULTIVESSEL STENTING IN DIABETICS                      1.0                      0.9                      0.8EVENT FREE SUR...
Comparison of Outcome Using Sirolimus- Eluting Stenting in Diabetic Versus Non   diabetic Patients With Comparisonof Insul...
Comparison of Sirolimus Stent in DM  Vs NDM - Insulin VS Non Insulin             Therapy•   297 pts. With DM•   115 on Ins...
CAD / Insulin TREATED & Siro Stent Outcome             Nine-month clinical events :        diabetic versus non diabetic pa...
CAD / Insulin Treated & Siro Stent OutcomeNine-month clinical events : insulin-treated patients versus                    ...
Influence of DM on Outcomes-ST in             Asian Patients 856 with DM 2295 no DM All received DES Death, Non fatal ...
40                                                                 4                                                      ...
Non-diabetics vs. insulin-treated diabetesA                                                               Adjusted HR (95 ...
Non-diabetics vs. Non insulin-treated diabetesB                                                                Adjusted HR...
ENDEAVOR IV - DM    www.cardiositeindia.com
ENDEAVOR IV: Diabetics                     Baseline Characteristics                              Endeavor               Ta...
ENDEAVOR IV - DM    www.cardiositeindia.com   JACC Intv. 2009, 2, 967
Endeavor Clinical program• Endeavor shows remarkable consistency in clinical outcomes   9 month    EI n=100   EII n=591   ...
www.cardiositeindia.com
www.cardiositeindia.com
ENDEAVOR IV: Diabetics vs Non-diabetics          Clinical Results to 12 months                                  Diabetes  ...
ENDEAVOR IV: Diabetics                   TVF and TLR at 12 months             477 diabetics (30.8% of E IV patients)      ...
DENDEAVOR IV:     Demographics: Diabetics vs Non Diabetics                            Diabetics              Non-Diabetics...
1. The Endeavor stent is safe and effective in diabetic   patients with “workhorse lesions” (i.e., moderate lesion   compl...
Thank You!! www.cardiositeindia.com
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Diabetes Mellitus & Multi vessel disease-part 1

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  • Point out the increasing number of diabetic patients. Endeavor trials also have less usage of IIbIIIa than other trials. Usage of IIbIIIa helps prevent acute and subacute stent thrombosis. Despite that Endeavor has less usage of IIbIIIa than other trials, the stent thrombosis rates are lower (total of only 4 patients to date in all trials).
  • The angio cohort of EII shows the same TLR results as the EIII trial. Remember EIII had 87% Angio FU in all patients (282/323)
  • Transcript of "Diabetes Mellitus & Multi vessel disease-part 1"

    1. 1. Diabetes And Multivessel Disease Dr. Dev Pahlajani MD,FACC,FSCAIChief of Interventional Cardiology, Breach Candy Hospital, Mumbai www.cardiositeindia.com
    2. 2. DIABETES EPIDEMIOLOGY www.cardiositeindia.com
    3. 3. The Diabetes Epidemic• About 150 million diabetic patients worldwide, expected to double by 2025• One million new patients diagnosed in the US each year• Prevalence in Europe ~5% to ~7%, expected to double in next 25 years. UK 3.1 Netherlands 3.6 Italy 7.1 Germany 4.2 France 4.0 Belgium 4.1 0.0 2.0 4.0 6.0 8.0 0-5% in Western Europe (%) 5-8% in Southern Europe Amos AF et al. Diabetic Medicine 1997; 17: S7-S85 Mak KH et al. European Heart Journal 2003; 24: 1087-1103 IDF (International Diabetes Federation - 2000) www.cardiositeindia.com
    4. 4. WORLD CAPITAL OF DIABETESIndia was the expected world capital of DMChina has overtaken India to wrest the title of the‘diabetes capital of the world, going by the latest figuresrevealed by the 5th edition of Diabetes AtlasAt 90.0 million, China today has the largest number ofpeople with diabetes.India follows with about 61.3 millionThe third on the list is far behind – United States at 23.7million. www.cardiositeindia.com
    5. 5. Global Burden of DiabetesTop 10 Countries With Diabetics (20-79 Years Of Age)Country 2011 Country 2031 [Millions] [Millions]China 90.0 China 129.7India 61.3 India 101.2USA 23.7 USA 29.6Russian Federation 12.6 Brazil 19.6Brazil 12.4 Bangladesh 16.8Japan 10.7 Mexico 16.4Mexico 10.3 Russian Federation 14.1Bangladesh 8.4 Egypt 12.4Egypt 7.3 Indonesia 11.8Indonesia 7.3 Pakistan 11.4 www.cardiositeindia.com
    6. 6. Multivessel disease in DiabetesBalloon EraBMS EraDES Era www.cardiositeindia.com
    7. 7. Bypass AngioplastyRevascularization Investigation (BARI) Trial www.cardiositeindia.com
    8. 8. BYPASS ANGIOPLASTY REVASCULARISATION INVESTIGATION (BARI) New Engl Jour Of Med 1996 (335): 217-225 Comparison of Coronary Bypass Surgery with Angioplasty in Patients with Multivessel Disease 914 assigned to CABG 915 assigned to PTCA Similar  Demographic Features  Angiography Findings  EF Equally Distributed Co morbid Features www.cardiositeindia.com
    9. 9. BARI: 5 Year MortalityDiabetic vs. Non-Diabetic Patients Non-CV death CV death 40 34 30 10 Mortality (%) 20 24 19 10 9 10 10 4 5 5 9 5 5 0 PTCA CABG PTCA CABG Diabetics Non-diabetics www.cardiositeindia.com Circulation 1997; 96: 1761-1769
    10. 10. BARI study: Mortality in Diabetic Patientso Benefit only in CABG patients with internal mammary arteryo Greatest difference seen in diabetics treated with insulino Difference due to a reduced mortality in patients with a subsequent AMI “Diabetics with multi-vessel disease should undergo CABG” www.cardiositeindia.com
    11. 11. BARI Registry: No Difference in Long-term Outcome inDiabetics Treated by PTCA or CABG “PTCA is a safe alternative to CABG in diabetics when they are properly selected”CABG Patients PTCA Patients 100 Registry (85.8) 100 Registry (86.1) 80 Randomized (84.4) 80 Randomized (80.9) Survival (%) Survival (%) 60 60 40 40 Unadjusted p=0.57 Unadjusted p<0.01 20 Adjusted p=0.66 20 Adjusted p=0.16 0 0 0 1 2 3 4 5 6 7 0 1 2 3 4 5 6 7 No. of patients No. of patients Registry 625 590 569 436 Registry 1189 1124 1091 769 Random. 914 860 814 590 Random. 915 842 790 579 www.cardiositeindia.comF et al, Circulation 2000;101:2795 Feit
    12. 12. Cumulative Number of Subsequent Revascularization Procedures per 100 Patients by Randomization PCI CABG PCI CABG www.cardiositeindia.com The BARI Investigators, J Am Coll Cardiol 2007;49:1600-1606
    13. 13. Overall Survival by RandomizedTreatment Stratified by Diabetes Status The BARI Investigators, J Am Coll Cardiol 2007;49:1600-1606 www.cardiositeindia.com
    14. 14. Overall Survival and Survival Free of Q- Wave MI by Randomized Treatment www.cardiositeindia.com The BARI Investigators, J Am Coll Cardiol 2007;49:1600-1606
    15. 15. Rates of Survival and Freedom from Major Cardiovascular Events, According to PCI and CABG Strata. www.cardiositeindia.com Source: The BARI 2D Study Group. N Engl J Med 2009;360:2503-2515 .
    16. 16. 10-Year Survival Rates for Patients According to Subgroups Based on Characteristics at Study Entry www.cardiositeindia.com The BARI Investigators, J Am Coll Cardiol 2007;49:1600-1606
    17. 17. Percent of Surviving Patients With Stable or Unstable Angina at Each Follow-Up by Randomization The BARI Investigators, J Am Coll Cardiol 2007;49:1600-1606 www.cardiositeindia.com
    18. 18. Freedom From Cardiac Death and Freedom FromCardiac Death or Any MI by Randomized Treatment www.cardiositeindia.com The BARI Investigators, J Am Coll Cardiol 2007;49:1600-1606
    19. 19. Diabetes is a Predictor of Late Loss % LL DTrial mm M Late Loss vs. % of Diabetics in Bare (non-DES)Sirius-Ctrl/8mo. 1 28.2 Stent StudyRavel-Ctrl/6mo. 0.8 21 30Venus-6mo 0.97 23.4 1 0.98 25Velvet-6mo 0.7 10.7 0.830.97 1.19 0.8 0.93 % of Diabetics in the studyVision-6mo 0.83 23 20 0.9Penta-6mo 0.9 18.5 15 Series1 0.6Multi-Link-ISAR2 0.54 10 0.7 -6mo 0.93 22BX ISAR2 1.19 22.2 5Bstent 0 Heprincoated 0.54 12.2 0 0.5 1 1.5Deliver Bare 0.98 26.8 Late Loss in mm.Orbit 0.6 13.3 www.cardiositeindia.com
    20. 20. Arterial RevascularizationTherapies Study (ARTS) Trial www.cardiositeindia.com
    21. 21. ARTS I The primary objective of ARTS I was to compare intra- coronary stenting to bypass surgery in patients with multivessel disease Effectiveness was measured in terms of Major Cardiac and Cerebrovascular Events (MACCE) – free survival at one year www.cardiositeindia.com
    22. 22. ARTS I – Patient FlowSTENT CABG 600 INTENTION TO TREAT 605 1 Medical Treatment only Medical Treatment only 3 Cross–over Cross-over 3 consent withdrawal 8 consent withdrawal 2 LM disease 8 exclusion criteria 6 19 1 inappropriate selection 1 miscommunication 1 QMI on waiting list 1 UAP on waiting list 3 urgent CABG 2 PTCA 13 10 elective CABG within hosp stay 2 within hosp stay 580 Successful treatment according to randomisation 581(97%) (96%) www.cardiositeindia.com
    23. 23. ARTS IMACCE (30 day follow-up) CABG Stent (605) (600)Death 8+3* 1.8% 9 1.5%CVA 7+1 * 1.3% 5 0.8%AMI (Q) 13+4* 2.8% 15+1* 2.7%Re-CABG 2 0.3% 12 2.0%Re-PTCA 3 0.5% 10 1.7%Total 41 6.8% 52 8.7%* Events prior to assigned treatment www.cardiositeindia.com
    24. 24. The Stent Era: ARTS I Study• Less favorable long-term outcome with stenting in DM• 1-year mortality rate: 6.4% vs. 3.1%• Reduced rate of revascularization compared to balloon PTCA 100 Event-free survival (%) 95 90 85 88.4% 84.4% 80 75 76.2% 70 65 63.4% 60 0 60 120 180 240 300 360 Days after randomizationCABG: Non Diabetes CABG: DiabetesStent: Non Diabetes Stent: Diabetes Abizaid A. Circulation 2001;104:533 www.cardiositeindia.com
    25. 25. ARTS I DIABETICSDeath/CVA/MI/CABG/RE- PTCADIABETIC SUBGROUP Repeat revascularization was higher in diabetic patients randomized to the stent arm vs. CABG(42.9% VS 10.9%) Compared to non diabetic patients(27.5% vs 8.4%) Based on the available evidence, surgery should continue to be viewed as the preferred therapy for diabetic patients with multivessel disease when using bare metal stents. www.cardiositeindia.com JACC, 2005, 46, 575-81
    26. 26. ARTS I DIABETICS www.cardiositeindia.com
    27. 27. ARTS Trial (CABG v. PCI) Three year follow-up 100 PCIEvent Free Survival (%) 80 99.5% 97.5% 97.2% CABG 96.3% 98.5% 97.2% 96.4% 95.5% 60 40 20 p=0.08 Log Rank Death p=0.09 Fisher 0 0 150 300 450 600 750 900 1050 1200 Days since randomization www.cardiositeindia.com
    28. 28. ARTS Trial (CABG v. PCI) Three year Follow-up 100Event Free Survival (%) CABG 80 PCI 60 96.0% 91.2% 89.8% 88.8% 40 95.5% 90.3% 89.2% 87.0% 20 Death AMI CVA p=0.58 Log Rank p=0.62 Fisher 0 0 150 300 450 600 750 900 1050 1200 Days since randomization www.cardiositeindia.com
    29. 29. ARTS Trial (CABG v. PCI) Three year Follow-up 100 95.7%Event Free Survival (%) 87.8% 90 85.0% 83.6% 91.8% CABG 80 73.5% 70 69.5% 65.7% 60 PCI p=0.005 Log Rank Death AMI CVA CABG Re-PCI p=0.006 Fisher 50 0 150 300 450 600 750 900 1050 1200 Days since randomization www.cardiositeindia.com
    30. 30. ARTS Trial (CABG v. PCI)Three year Follow-up (Diabetic subgroup) 100 CABG Event Free Survival (%) 90 92.7% 80 Death, AMI, CVA PCI = CABG 70 61.6% 60 PCI CABG Re-PCI p=0.0001 Log Rank 50 p<0.0001 Fisher 0 150 300 450 600 750 900 1050 1200 Days since randomization www.cardiositeindia.com
    31. 31. ARTS I DIABETICSDeath/CVA/MI/CABG/RE- PTCADIABETIC SUBGROUP• Repeat revascularization was higher in diabetic patients randomized to the stent arm vs. CABG(42.9% VS 10.9%)• Compared to non diabetic patients(27.5% vs 8.4%)• Based on the available evidence, surgery should continnue to be viewed as the preferred therapy for diabetic patients with multivessel disease when using bare metal stents. www.cardiositeindia.com JACC, 2005, 46, 575-81
    32. 32. ARTS IIPRIMARY OBJECTIVE To compare the effectiveness of coronary stent implantation using the Sirolimus drug eluting Bx Velocity™ stent with that of surgery as observed in ARTS I Effectiveness will be measured in terms of Major Cardiac and Cerebrovascular Events (MACCE) – free survival at 30 days and six months www.cardiositeindia.com
    33. 33. Sirolimus Coating Modulates neointima in 30-Day Porcine Coronary Model Control + Sirolimus www.cardiositeindia.com
    34. 34. ARTS II: Study Design Single arm, multicenter trial 607 patients in 45 centers from 19 countries Main goal of the ARTS II trial is to demonstrate non- inferiority in clinical effectiveness and cost-effectiveness with the CYPHER® stent compared to the previous results of the ARTS I trial ARTS II ARTS I Randomization CYPHER ® CABG CROWN™ & (n=607) (n=605) CrossFlex LC™ (n=600) Serruys P. et al., JACC 2005 (Sunday March 6th); Oral Presentation. www.cardiositeindia.com
    35. 35. ARTS-II Trial Historical Controls from ARTS I: 1202607 patients with multivessel patients with multivessel coronary coronary lesions lesions 26.2% diabetic 18.2% diabetic 28% 3 vessel disease 54% 3 vessel disease 7.5% type C lesions 13.9% type C lesions Bare Metal CABG Stent Sirolimus-eluting stent 2.8 stents per patient 3.7 stents per patient Avg total length: 48 Avg total length: 73 mm n = 602 mm n = 607 n = 600 Endpoints: Primary – Major adverse cardiac and cerebrovascular events (MACCE), including death, cerebrovascular event, myocardial infarction, and revascularization, at 1 year for the comparison of CABG treated patients in the ARTS I trial with sirolimus-eluting stent patients in the ARTS II trial Secondary – MACCE at 30 days, 6 months, 3 and 5 years. – Total cost at 30 days – Cost, cost effectiveness, quality of life at six mo, and 1, 3, and 5 years www.cardiositeindia.com ACC 2005
    36. 36. ARTS II – Diabetic population (MACCEat 1y) ARTS II ARTS I (CABG) ARTS I (PCI) Hierarchical MACCE up to 1 year (n=159) (n=96) (n=112) } }Death (%) 2.5 3.1 6.3CVA (%) 0.0 3.1 5.2 10.4 1.8MI (%) 0.6 2.1 6.3(re) CABG (%)(re) PCI (%) 3.1 9.4 } 12.5 1.0 3.1 } 4.1 8.0 14.3Any MACCE (%) 15.7 14.6 36.6 Significant difference in MACCE (p=<0.001) between ARTS II and ARTS I (PCI) No significant difference in MACCE (p=0.86) between ARTS II and ARTS I (CABG) www.cardiositeindia.com Morice M-C. EuroPCR 2005.
    37. 37. ARTS II - MACCE up to 1 year* ARTS II ARTS I (CABG) ARTS I (PCI) Hierarchical MACCE up to 1 year (n=607) (n=602) (n=600) } }Death (%) 1.0 2.7 2.7CVA (%) 0.8 3.0 1.8 8.0 1.8MI (%) 1.2 3.5 5.0(re) CABG (%)(re) PCI (%) 2.0 5.4 } 7.4 0.7 3.0 } 3.7 4.7 12.3Any MACCE (%) 10.4 11.6 26.5 More extensive disease in ARTS II (% diabetes, 3-vessel involvement, lesions/patients) than ARTS I www.cardiositeindia.com * Complete follow-up in 97% Morice M-C. EuroPCR 2005.
    38. 38. ARTS II : Event free survivalAt one year, there was no difference in event-free survival between theARTS II SES group and the ARTS I CABG group. However, the ARTS IIgroup showed significantly higher rates of survival free from cardiacdeath, MI, and reintervention than the ARTS I bare metal stent group. Thegroups were not significantly different in the primary endpoint of survivalfree from MACCE. ARTS II : DES ARTS I : BMS ARTS I : CABG100 80 P = < 0.001 60 P = 0.003 P = 0.46 91.5 90.7 92.0 96.9 78.1 40 95.9 73.7 89.5 88.5 20 0 Survival free from Survival free from Survival free from Death/CVE/MI reintervention MACE www.cardiositeindia.com
    39. 39. ARTS II study www.cardiositeindia.com
    40. 40. ARTS II – Diabetic population ARTS II ARTS I (CABG) ARTS I (PCI)Lesion characteristics patients (159) patients (96) patients (112)(main differences) lesions (568) lesions (290) lesions (309)Lesion length > 20mm (%) 15 6 6Calcified lesion (%) 33 15 13Type C lesions (%) 17 8 7# of lesions > 50% DS 3.6 ± 1.3 3.0 ± 1.1 2.9+1.2# of treated lesions 3.2 ± 1.2 2.8 ± 0.8 2.5+1.1Procedural characteristics# of stents implanted 3.6 ± 1.5 - 3.0 ± 1.5Total stent length (mm) 74 - 53Range 12-179 - 14-165 More extensive disease in ARTS II diabetic patients than ARTS I CABG www.cardiositeindia.com Morice M-C. EuroPCR 2005.
    41. 41. ARTS – 5 Yrs Outcome Major Adverse Cardiac Events At 5 Years In Patients Without Diabetes Stratified According To Treatment STENT BYPASS NON-DIABETIC NON-DIABETIC STENT VS N = 488 N = 509 RELATIVE RISK CABG N (%) N (%) (95% CI) p VALUE(RE) CABG 46 (9.4) 5 (1.0) 9.60 (3.85 – 23.95) < 0.001(RE) PTCA 105 (21.5) 41 (8.1) 2.67 (1.90 – 3.75) < 0.001ANY REVASC- 134 (27.5) 43 (8.4) 3.25 (2.36 – 4.48) < 0.001ULARISATIONANY MACCE 189 (38.7) 108 (21.2) 1.83 (1.49 – 2.23) < 0.001 P. W. SERRUYS www.cardiositeindia.com JACC 2005
    42. 42. ARTS II : Summary• Among patients with multivessel coronary lesions, patients treated with sirolimus eluting stents had significantly lower rates of MACCE compared with a historical registry of similar patients treated with bare metal stents and rates of MACCE statistically equivalent to patients from the same registry treated with CABG.• The majority of the differnce in MACCE between the ARTS II and ARTS I BMS groups was driven by the increased need for repeat revascularization in the bare metal stent group. The ARTS II group had equal rates of revascularization to the ARTS I CABG group, despite having increased length and complexity of lesions.• While this historical registry comparison is promising and statistical measures were used to adjust for co-founding variables, a randomized trial is needed to adequately determine the superiority of one therapy over another. www.cardiositeindia.com
    43. 43. Short & Long Term Results AfterMultivessel Stenting In DiabeticPatients www.cardiositeindia.com
    44. 44. Short & Long Term Results AfterMultivessel Stenting In Diabetic Patients• Prospective data base of CRF 1993-1999• 689 consecutive patients• 1639 stents• 501 (1200 lesions) – no DM• 102 (235 lesions) oral agents• 86 (204 lesions) insulin R. MEHRAN www.cardiositeindia.com JACC 2004
    45. 45. MULTISTENTING IN DIABETICSIN-HOSPITAL OUTCOMES OF PATIENTS /LESIONS NO DM NIDDM IDDM (N= 560/1428) (N = 114/284) (N = 81/213) p VALUEANGIOGRAPHICSUCCESS (%) 99.8 99.0 100 0.47ABRUPTCLOSURE (%) 1.3 0.4 0 0.13QMI (%) 0 0 0 NANON QMI (%) 27 28 21 0.51 R. MEHRAN www.cardiositeindia.com JACC 2004
    46. 46. MULTIVESSEL STENTING IN DIABETICS 1.0 0.9 0.8 0.7SURVIVAL 0.6 0.5 No DM P < 0.001 0.4 DM treated with oral agent 0.3 DM treated with Insulin 0.2 0.1 0 0 100 200 300 400 TIME IN DAYS R. MEHRAN ET AL www.cardiositeindia.com JACC 2004, 43, 1348
    47. 47. MULTIVESSEL STENTING IN DIABETICS 1.0 0.9 0.8EVENT FREE SURVIVAL 0.7 0.6 0.5 No DM P < 0.001 0.4 DM treated with oral agent 0.3 DM treated with Insulin 0.2 0.1 0 0 100 200 300 400 TIME IN DAYS R. MEHRAN ET AL www.cardiositeindia.com JACC 2004, 43, 1348
    48. 48. Comparison of Outcome Using Sirolimus- Eluting Stenting in Diabetic Versus Non diabetic Patients With Comparisonof Insulin Versus Non-Insulin Therapy in the Diabetic Patients Ramon Kumar, MDa, Tobias T. Lee, MDa, Allen Jeremias, MDa, Christopher P. Ruisi, MDa, Brett Sylvia, BSa, Jorge Magallon, MDa, Ajay J. Kirtane, MDa, Brian Bigelow, MDa, Martin Abrahamson, MDb, Duane S. Pinto, MDa, Kalon K.L. Ho, MD MSca, David J. Cohen, MD, MSca, Joseph P. Carrozza, Jr., MDa, and Donald E. Cutlip, MDa Am J. Cardiol 2007;100:1187 www.cardiositeindia.com
    49. 49. Comparison of Sirolimus Stent in DM Vs NDM - Insulin VS Non Insulin Therapy• 297 pts. With DM• 115 on Insulin• 541 Non DM• All received Sirolimus Stent www.cardiositeindia.com Am.J.Card.2007
    50. 50. CAD / Insulin TREATED & Siro Stent Outcome Nine-month clinical events : diabetic versus non diabetic patientsEvents Diabetes Mellitus P Value Yes No (n = 297) (n = 541)MACEs 33 (11.8 %) 28 (5.6 %) 0.002Cardiac death 5 (1.8 %) 6 (1.2 %) 0.80 www.cardiositeindia.com Am J. Cardiol 2007;100:1187
    51. 51. CAD / Insulin Treated & Siro Stent OutcomeNine-month clinical events : insulin-treated patients versus others Events Insulin Therapy P Value Yes No (n = 115) (n = 182) MACEs 19 (17.5 %) 14 (8.2 %) 0.001 Cardiac death 4 (3.7 %) 1 (0.6 %) 0.006 MI 9 (8.2 %) 8 (4.6 %) 0.06 Cardiac death or MI 11 (10.1 %) 9 (5.2 %) 0.01 TLR 14 (13.3 %) 12 (7.1 %) 0.04 Stent Thrombosis 3 (2.6 %) 3 (1.7 %) 0.57 www.cardiositeindia.com Am J. Cardiol 2007;100:1187
    52. 52. Influence of DM on Outcomes-ST in Asian Patients 856 with DM 2295 no DM All received DES Death, Non fatal MI,TVR Park et al Am.J.Card.2009,103,2079 www.cardiositeindia.com
    53. 53. 40 4 Diabetes Diabetes Non-diabetes Non-diabetes 30 Event rates (%) Event rates (%) 2 Log Rank P=0.34 Log Rank P=0.34 20 1 10 0 0 0 365 730 1095 0 365 730 1095No. at Risk Follow-up (days) No. at Risk Follow-up (days)Diabetes 865 730 457 195 Diabetes 865 842 560 247Non-diabetes 2295 2057 1339 561 Non-diabetes 2295 22487 1520 674 Kaplan-Meir survival curve of primary composite end point and stent thrombosis (definite or probable) www.cardiositeindia.com Park et al Am J. Cardiol 2009, 103;646
    54. 54. Non-diabetics vs. insulin-treated diabetesA Adjusted HR (95 % CI) P value Death 2.77 (1.55-4.95) 0.001 MI 1.01 (0.54-1.89) 0.97 TLR 1.36 (0.77-2.39) 0.29 TVR 1.72 (1.02-2.88) 0.04 Death or MI 1.66 (1.09-2.53) 0.02 Death, MI or TVR 1.65 (1.17-2.32) 0.004 ST (decline or probable 0.99 (0.20-4.92) 0.99 ST (any ARC criteria) 1.75 (0.77-3.96) 0.20 0.1 1 10 Adjusted Hazard Ratio (95 % CI) Adjusted hazard ratios for clinical outcomes and stent thrombosis in diabetic patients who do (A) and do not (B) require insulin therapy versus non-diabetic patients www.cardiositeindia.com Park et al Am j. Cardiol 2009, 103;646
    55. 55. Non-diabetics vs. Non insulin-treated diabetesB Adjusted HR (95 % CI) P value Death 0.66 (0.52-1.45) 0.58 MI 1.05 (0.74-1.49) 0.79 TLR 0.94 (0.67-1.32) 0.72 TVR 1.23 (0.91-1.67) 0.18 Death or MI 0.99 (0.74-1.31) 0.92 Death, MI or TVR 1.08 (0.87-1.35) 0.47 ST (decline or probable 0.62 (0.21-1.88) 0.40 ST (any ARC criteria) 0.74 (0.36-1.52) 0.41 0.1 1 10 Adjusted Hazard Ratio (95 % CI) Adjusted hazard ratios for clinical outcomes and stent thrombosis in diabetic patients who do (A) and do not (B) require insulin therapy versus non-diabetic patients www.cardiositeindia.com Park et al Am j. Cardiol 2009, 103;646
    56. 56. ENDEAVOR IV - DM www.cardiositeindia.com
    57. 57. ENDEAVOR IV: Diabetics Baseline Characteristics Endeavor Taxus P value (241) (236)Age (yrs) 64.2 63.8 0.679Male (%) 59.8 61.0 0.780History of Smoking (%) 54.4 53.8 0.926Family History CAD (%) 43.9 42.1 0.917Diabetes (%) 100.0 100.0 N/A IDDM (%) 33.2 27.1 0.163Hypertension (%) 90.5 90.7 1.000Hyperlipidemia (%) 83.8 90.3 0.041 www.cardiositeindia.com
    58. 58. ENDEAVOR IV - DM www.cardiositeindia.com JACC Intv. 2009, 2, 967
    59. 59. Endeavor Clinical program• Endeavor shows remarkable consistency in clinical outcomes 9 month EI n=100 EII n=591 EIICA EIII n= Combined results n=289 316 N=1296 MACE (%) 2.0 7.3 10.4 7.6 7.6 TLR (%) 2.0 4.6 4.8 6.3 4.9 TVF (%) 2.0 8.0 13.1 12.0 9.7 www.cardiositeindia.com
    60. 60. www.cardiositeindia.com
    61. 61. www.cardiositeindia.com
    62. 62. ENDEAVOR IV: Diabetics vs Non-diabetics Clinical Results to 12 months Diabetes Non Diabetes (477) (1071) P valueDeath (all) - % (#) 0.4% 1.4% 0.171 Cardiac 0.4% 0.6% 1.000MI (all) - % 0.9% 2.6% 0.030 Q Wave 0.0% 0.3% 0.557 Non Q Wave 0.9% 2.3% 0.063Cardiac Death + All MI, % 1.3% 3.2% 0.035Stent Thrombosis (all), % 0.7% 0.4% 0.444TLR - % 6.4% 2.8% 0.002TVR - % 9.0% 5.4% 0.012MACE - % 7.0% 6.4% 0.651TVF - % 9.6% 8.1% 0.367 www.cardiositeindia.com
    63. 63. ENDEAVOR IV: Diabetics TVF and TLR at 12 months 477 diabetics (30.8% of E IV patients) P =0.53 Endeavor 10.8% P =0.43 8.6% 8.9% Taxus P =0.70 7.4% 6.9% 5.8% P =0.19et a R 3.5% 2.1% 20/233 24/223 38/516 46/518 16/233 13/223 18/516 11/518 Diabetics Non-diabetics Diabetics Non-diabetics TVF TLR www.cardiositeindia.com
    64. 64. DENDEAVOR IV: Demographics: Diabetics vs Non Diabetics Diabetics Non-Diabetics P value (773) (775)Age (yrs) 64.0 63.3 0.225Male (%) 60.4 71.0 <0.001History of Smoking (%) 54.1 64.8 <0.001Family History CAD (%) 43.3 42.6 0.851Diabetes (%) 100.0 0.0 N/A IRDM (%) 30.2 0.0 <0.001Hypertension (%) 90.6 76.8 <0.001Hyperlipidemia (%) 87.0 81.3 0.007 www.cardiositeindia.com
    65. 65. 1. The Endeavor stent is safe and effective in diabetic patients with “workhorse lesions” (i.e., moderate lesion complexity) compared to patients treated with the TAXUS stent2. Very long term safety surveillance will determine whether very late stent thrombosis has been reduced with the use of the Endeavor www.cardiositeindia.com
    66. 66. Thank You!! www.cardiositeindia.com
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