Coronary Stent Choice in Patients With Diabetes Mellitus

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1 Rome Cardiology Forum 2014 Coronary Stent Choice in Patients With Diabetes Mellitus Stephan Windecker Department of Cardiology Swiss Cardiovascular Center and Clinical Trials Unit Bern Bern University Hospital, Switzerland

2 Scientific Advances and Cardiovascular Mortality Nabel and Braunwald. N Engl J Med 2012;366: Efficacy of drug-eluting vs. baremetal stents determined

3 Drug- Eluting Stents Stefanini G, Holmes D. N Engl J Med 2013; 368:254-65

4 Progress in Metallic DES Technology Stefanini, Taniwaki, Windecker. Heart 2013, online ahead of print

5 Vascular Biology Diabetes Mellitus Coronary Stent Choice Efficacy Safety

6 Pathological Healing Response to Implantation of Early Generation DES Inflammation and Vessel Remodeling Coronary Evaginations Cook et al. Circulation 2007 Cook et al. Circulation 2009 Uncovered Struts P< P< Räber et al. J Am Coll Card Intv 2012 Neoatherosclerosis P= Guagliumi et al. Circulation 2011 Nakazawa et al. J Am Coll Card 2011

7 Human Pathology of New Generation EES Compared With Early Generation SES and PES Otsuka F et al. Circulation 2014; 129: SES PES EES >30% Uncovered Struts

8 Arterial Healing After Coronary Stents Implantation Stefanini G, Holmes D. N Eng J Med 2013;368: BMS Early DES New DES

9 Vascular Biology Diabetes Mellitus Coronary Stent Choice Efficacy Safety

10 NNT Mortality and Repeat Revascularization with Early Generation DES versus Bare Metal Stents Stettler C et al. Lancet 2007;370: Mortality HR (95% CI) Repeat Revasc HR (95% CI) SES vs BMS 1.00 ( ) SES vs BMS 0.30 ( ) PES vs BMS 1.03 ( ) PES vs BMS 0.42 ( ) SES vs PES 0.96 ( ) SES vs PES 0.70 ( ) NNT=35 (CI 23-65) NNT=7 (CI 6-8) NNT=8 (CI 7-10) 0 SES vs BMS PES vs BMS SES vs PES

11 New Generation DES Improved Efficacy Target Lesion Revascularization Everolimus-Eluting Stents vs. Sirolimus-Eluting Stents Biodegradable Polymer DES vs. Sirolimus-Eluting Stents Stefanini, Windecker Stefanini G et al. Eur Heart J 2012; 33, Favors EES Favors SES Favors BP DES Favors SES N = 11,167 Updated Metaanalysis N = 4,062 IPD Pooled Analysis

12 Safety and Efficacy of DES vs BMS Stefanini G et al. Lancet 2013; 382(9908): Target Lesion Revascularization 18.6% Overall P<0.001 Early vs. Newer DES P= % 6.3% 11,557 Women enrolled into 26 Randomized Trials between 2000 and 2013

13 Vascular Biology Diabetes Mellitus Coronary Stent Choice Efficacy Safety

14 Early DES and Very Late ST SIRTAX LATE Räber L et al. Circulation 2011 Bavry A et al. Lancet 2008

15 Safety and Efficacy of DES vs BMS in Women Stefanini G et al. Lancet 2013; 382(9908): Definite/Probable Stent Thrombosis Overall P=0.01 Early vs. Newer DES P= % 1.3% 1.1% 11,557 Women enrolled into 26 Randomized Trials between 2000 and 2013

16 Stent Thrombosis With Everolimus-Eluting Stents and Bare Metal Stents A Network Meta-Analysis Palmerini T et al. Lancet 2012; 379:

17 DES vs. BMS in Large Coronary Arteries Kaiser C et al. N Eng J Med 2010; 363: Large Investigator-Driven Trial: BASKET-PROVE EES vs. SES vs. BMS DES Pooled vs. BMS Overall HR 0.60 ( ) P= Courtesy: C Kaiser for the BASKET-PROVE Investigators

18 Safety and Efficacy of DES vs BMS in Women Stefanini G et al. Lancet 2013 Death or Myocardial Infarction 12.8% 10.9% 9.2% Overall P=0.001 Early vs. Newer DES P= ,557 Women enrolled into 26 Randomized Trials between 2000 and 2013

19 Vascular Biology Diabetes Mellitus Coronary Stent Choice Efficacy Safety

20 Strategies for Multivessel Revascularization in Patients with Diabetes the FREEDOM Trial Farkouh ME et al. N Engl J Med 2012; 367: Death, MI, or Stroke Through 5 Years Median SYNTAX-Score = % 13.0% 11.9% 18.7%

21 FREEDOM TRIAL Farkouh ME et al. N Engl J Med ,966 patients assessed 1,900 patients randomized = 5.6% Generalisability? Anticipated difference in outcome between PCI and CABG - RR 23% 146 patients lost to follow-up/withdrew = 4.4%

22 FREEDOM TRIAL PATIENT FLOW Farkouh ME et al. N Engl J Med 2012; 367:

23 FREEDOM TRIAL MORTALITY Farkouh ME et al. N Engl J Med 2012; 367: N=118 N=86

24 Sensitivity Analysis - Mortality All non-evaluable patients having survived All non-evaluable patients having died PCI CABG

25 FREEDOM TRIAL STROKE OVER TIME Farkouh ME et al. N Engl J Med 2012; 367:

26 CABG VS PCI RISK OF STROKE Palmerini T et al. J Am Coll Cardiol 2012

27 Adverse Cerebral Outcomes After Coronary Artery Bypass Surgery Roach et al. N Engl J Med 1996;335: Type I neurologic deficit: stroke, TIA, coma Type II neurologic deficit: deterioration of intellect or seizures 10 8 Type I (Overall: 3.1%) Type II (Overall: 3.0%) ,5 4,5 1,9 2,2 2,2 1,8 1,7 1,2 0,1 0,1 < >80 (years)

28 Adverse Cerebral Outcomes After Coronary Artery Bypass Surgery Roach et al. N Engl J Med 1996;335: In-hospital Mortality Discharge to Home % % 30 Type I Type I Type II Type II No cerebral adverse event No cerebral adverse event

29 Target Lesion Revascularization Network Meta-Analysis: DES vs BMS Stettler C et al. BMJ 2008; 337:a1331 Diabetic Patients N=3,852 Non-Diabetic Patients N=10,947

30 Mortality in Diabetic vs Non-Diabetic Patients in Trials With At Least 6 Months Clopidogrel Stettler C et al. BMJ 2008; 337:1331 Diabetic Patients N=3,852 Non-Diabetic Patients N=10,947

31 Everolimus- Versus Paclitaxel-Eluting Stents Among Diabetic and Nondiabetic Patients Stone G et al. Circulation 2011; 124: Years P-inter = IPD of SPIRIT II, III, IV, and COMPARE Trials (N=6,789)

32 Drug-Eluting vs. Bare-Metal Stents in Women Stefanini G et al. Lancet 2013; 382(9908): Death or MI in Major Subgroups Early DES vs. BMS New DES vs. BMS 11,557 Women enrolled into 26 Randomized Trials between 2000 and 2013

33 DIFFUSE MULTIVESSEL CAD Jolicoeur EM et al. Can J Cardiol 2012

34 Coronary Scaffolds Compared With Coronary Stents Stents Scaffolding function and drug release Caged Vessel Scaffolds Scaffolding function and drug release Bioresorption Restoration of vascular physiology and lumen enlargement

35 Efficacy and Safety of DES, BMS, and CABG According to Clinical Indication Stefanini G, Holmes D. N Eng J Med 2013;368:254-65

36 Conclusions Advanced stent platforms with excellent deliverability, less arterial injury and improved biocompatibility The risk of repeat revascularization is further reduced The risk of ST is extremely low Diabetes remains the Achilles heel of current DES, particularly in patients with complex multivessel disease