Keynote Lecture Interventional Cardiology Unanswered Powerpoint Presentation

Keynote Lecture Interventional Cardiology Unanswered

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Slide 1 :

Interventional Cardiology – The Unanswered Questions Martin B. Leon, MD Columbia University Medical Center Cardiovascular Research Foundation New York City Advanced Angioplasty 2008 January 23-24, 2008; London, UK

Slide 2 :

Presenter Disclosure Information for AA BCIS 2008; January 23-5, 2008 Martin B. Leon, M.D. Consultant or Advisory Board: Abbott Vascular, Boston Scientific, Cordis-JNJ, Medtronic Vascular, Edwards Lifesciences, Volcano Stockholder or other Equity: Circulite, Sadra

Slide 3 :

Last Talk of the Day! (before the pubs open)

Slide 4 :

PCI 2008 Colliding Emotions

Slide 5 :

PCI 2008 Colliding Emotions Celebration of 30th anniversary of PCI

Slide 6 :

The Early Pioneers Forsmann Sones Dotter

Slide 7 :

Celebrating 30 Years! Andreas Gruentzig 1939 - 1985 His dream was the catheter-based percutaneous treatment of vascular disease in alert, awake patients!

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The Saga of Balloon Angioplasty Frequent dissections, recoil and poor angiographic outcomes Acute closure (surgical backup required) Ineffective in calcified (and other) lesions RESTENOSIS!!! Not Good Enough!

Slide 9 :

PCI 2008 We have achieved Andreas’ goal, to make PCI… Widely applicable (all patients) Predictable (consistent procedural results) Safe (complication-free) Definitive (no restenosis)

Slide 10 :

PCI 2008 Colliding Emotions Controversy, reappraisal, & debate

Slide 11 :

DES Penetration in the US BASKET LATE Trial ESC conference FDA Panel Meeting COURAGE Declines may not be leveling! DES Penetration 89.3% 89.0% 87.9% 87.8% 88.0% 87.7% 86.1% 72.8% 70.4% 70.2% 66.8% 65.2% 64.8% 67.9% 85.9% 83.9% 80.1% 76.9% 68.0% 60.0% 65.0% 70.0% 75.0% 80.0% 85.0% 90.0% 95.0% Jan-06 Feb-06 Mar-06 Apr-06 May-06 Jun-06 Jul-06 Aug-06 Sep-06 Oct-06 Nov-06 Dec-06 Jan-07 Feb-07 Mar-07 Apr-07 May-07 Jun-07 Jul-07 Source: Millenium Research Group 60.9% Nov 2007

Slide 12 :

Coronary Interventional Procedures Sept. 06 – Sept. 07 Normalized to 100 PCI Dx Only 86% 89% 75 80 85 90 95 100 105 110 Sep Oct Nov Dec Jan Feb Mar Apr May Jun Jul Aug Sep 2007 ACC FDA Panel ESC 2006 Source: BSC Bellwether Franchises ~10% decline

Slide 13 :

Exaggerated Trial Results Media Political and Regulatory Environment Territorial Subspecialties Too Little or Too Much Data Shrinking Markets Industry Pressures Reimbursement Concerns

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Slide 15 :

A “perfect storm” phenomenon – negative late outcomes (perhaps exaggerated) + challenged indications (COURAGE et al) + worldwide economic constraints have focused on the perceived overuse of procedural therapies. The impact of “medicine by media” has changed perceptions of referring MDs and patients. Many of our colleagues have fostered this siege mentality; interventionalists are fragmented and appear disengaged from mainstream cardiology. PCI 2008 Controversy and Reappraisal – Why?

Slide 16 :

PCI 2008 – Public Relations Counter-Offensive

Slide 17 :

Are DES Safe and (Cost) Effective? PCI – Unanswered Questions When Should PCI be Performed? What are the Next “Big Breakthroughs”? How Good is the “Evidence” in EBM?

Slide 18 :

Are DES Safe and (Cost) Effective? PCI – Unanswered Questions When Should PCI be Performed? What are the Next “Big Breakthroughs”? How Good is the “Evidence” in EBM?

Slide 19 :

“Seeing the Forest Through the Trees” “I’d like to thank my wife and the other astronauts for being here today” George W. Bush

Slide 20 :

Bare Metal Stents…. the good, the bad, and the ugly!

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Slide 22 :

Is BMS ISR a Benign Entity? 1186 cases of single lesion bare metal ISR at the Cleveland Clinic. Chen MS et al. AHJ 2006,151:1260-1264 Treatment 106 cases (8.9%) totally occluded

Slide 23 :

Patterns of In-Stent Restenosis 282 lesions; restenosis patterns classified by angiography and confirmed by IVUS % Frequency TLR @ 1 Year Predictors of TLR : diabetes, previous ISR and ISR patterns Mehran R et al. Circulation 1999;100:1872-78 DIFFUSE DIFFUSE

Slide 24 :

Economic Burden of Restenosis Est. annual economic burden in the US ~$1.2 billion Thom T et al. Circulation 2006;113:e85-1511 Cutlip DE, et al. JACC 2002;40:2082-93 Laskey WK, et al. Am J Cardiol 2001; 87:964-92 Cohen DJ et al. Circulation 2001;104: I:386-74

Slide 25 :

First Generation Drug-eluting Stents in the U.S.

Slide 26 :

SIRIUS – TLR Events @ 5 Years Sirolimus better Overall 9.4 24.3 6.7 Male 10.1 24.9 6.7 Female 7.5 22.8 6.5 Diabetes 13.7 33.1 5.2 No Diabetes 8.0 20.8 7.8 LAD 11.5 28.4 6.0 Non-LAD 7.7 21.4 7.3 Small Vessel (<2.75) 13.3 26.0 7.9 Large Vessel 5.6 22.6 5.9 Short Lesion 9.3 21.8 8.0 Long Lesion (>13.5) 9.7 26.8 5.9 Overlap 11.0 30.1 5.2 No Overlap 8.6 21.6 7.7 Odds Ratio 95% CI # pts needed to prevent 1 restenosis Sirolimus Control P-value 0.0 0.1 0.2 0.3 0.4 0.5 0.6 0.7 0.8 0.9 1.0 1.1 1.2 1.3 <0.001 <0.001 <0.001 <0.001 <0.001 <0.001 <0.001 <0.001 <0.001 <0.001 <0.001 <0.001 <0.001

Slide 27 :

Bare Stents October 24, 2002 April 24, 2003 282 pts with 311 lSR lesions one year FU Frequency of In-stent Restenosis - CRF

Slide 28 :

Network meta-analysis: 38 trials, 18,023 pts Stettler C et al. Lancet 2007;370:937-48 TLR Frequency

Slide 29 :

Medicare Database SAF Sampling (N=30,736) Demographics: 2004 vs. 2001 David J. Cohen. Presented at TCT2007

Slide 30 :

Medicare Database SAF Sampling* (N=30,736) Type of Revascularization: 2004 vs. 2001 0 10 20 30 40 50 60 70 80 Percent of patients 2001 2004 32.5% 24.8% 75.2% 67.5% 75.3% DES 24.7% Other ?7.7%** p<0.001 ?7.7%** p<0.001 * Standard Analytic File – 5%; **Absolute difference PCI CABG

Slide 31 :

Risk-Adjusted Clinical Outcomes in 2004 Compared to 2001 0.6 0.7 0.8 0.9 1.0 1.1 1.2 1.3 Odds Ratio Compared to 2001 Any Repeat Revascularization Repeat Revascularization Quarters 2-5 MI Death ~12% ? ~29% ? David J. Cohen. Presented at TCT2007

Slide 32 :

Risk-Adjusted Costs in 2004 Compared to 2001 -$3000 -$2500 -$2000 -$1500 -$1000 -$500 0 $500 $1000 $1500 CV-Related Non-CV-Related Total ? Cost Compared to 2001 ~$1500 savings/pt ~$2000 savings/pt David J. Cohen. Presented at TCT2007

Slide 33 :

ISR after BMS is NOT BENIGN; costly, assoc w clinical events, and problematic to treat (esp. diffuse pattern). DES (1st generation) are a highly effective anti-restenosis therapy over a broad spectrum of patient and lesion categories! Additional studies are required in AMI patients (vs. BMS), SVG lesions (vs. BMS), left main disease (vs. CABG), and complex multi-vessel disease (vs. CABG). The cost-effectiveness of DES (cw BMS) has been validated in most studies and in most patient/lesion subsets (the “NICE” furor is an aberration). PCI - Unanswered Questions DES (Cost) Effectiveness

Slide 34 :

Hypothesis: Use of the polymer-based slow-release paclitaxel-eluting TAXUS stent will safely reduce the 1-year rate of ischemia-driven TLR. 1? clinical endpoints at 12 mo; 2? angio endpoint at 13 mo; 5 year follow-up. Hypothesis: Bivalirudin compared to UFH + routine GP IIb/IIIa inhibition will reduce the composite rate of death, reinfarction, TVR, stroke and major bleeding at 30-days. HORIZONS AMI Trial 3600 Randomized Patients Undergoing Primary PCI UFH + GP IIb/IIIa Bivalirudin + bail-out GPI Anti-thrombotic therapy (n=3600) Randomize 1:1 TAXUS stent Express BMS Target vessel stenting (n=3000) Randomize 3:1 Sponsor: The Cardiovascular Research Foundation (PI: GW Stone) With unrestricted grant support from: Boston Scientific & The Medicines Company

Slide 35 :

SYNTAX Randomized Trial Left main disease (minimum 710) 3-vessel disease De novo disease acceptable for revascularization PIs: Patrick Serruys and Frederick Mohr and /or Primary NI endpoint – 1 year MACCE All cause death, MI, cerebrovascular events, repeat revascularization

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Slide 38 :

“An Epidemic of Madness!”

Slide 39 :

CYPHER vs. BMS: Mortality Days Number at risk BMS CYPHER 870 878 857 863 843 842 824 817 795 792 694 703 RAVEL, SIRIUS, E-SIRIUS, C-SIRIUS HR 1.10 [0.79,1.52] p=0.57 8.9% (76) 8.2% (69) Pooled Analyses of 4 RCTs Kirtane A. TCT 2007. Adapted from Stone GW et al. NEJM 2007;356:998–1008

Slide 40 :

Days BMS CYPHER 868 873 824 832 806 807 782 779 751 751 652 660 Number at risk RAVEL, SIRIUS, E-SIRIUS, C-SIRIUS HR 1.15 [0.81,1.63] p=0.44 7.9% (67) 6.8% (58) CYPHER vs. BMS: MI Pooled Analyses of 4 RCTs Kirtane A. TCT 2007. Adapted from Stone GW et al. NEJM 2007;356:998–1008

Slide 41 :

TAXUS vs. BMS: Mortality Pooled Analyses of 5 RCTs Days BMS TAXUS 1757 1754 1700 1695 1655 1647 1096 1081 852 838 291 277 Number at risk TAXUS I, TAXUS II, TAXUS IV, TAXUS V, TAXUS VI HR 0.98 [0.76,1.27] p=0.89 8.6% (119) 8.4% (116) Kirtane A. TCT 2007. Adapted from Stone GW et al. NEJM 2007;356:998–1008

Slide 42 :

Days BMS TAXUS 1731 1727 1626 1623 1576 1562 1035 1020 802 789 274 261 Number at risk TAXUS I, TAXUS II, TAXUS IV, TAXUS V, TAXUS VI HR 1.06 [0.82,1.37] p=0.66 7.4% (120) 7.1% (114) TAXUS vs. BMS: MI Pooled Analyses of 5 RCTs Kirtane A. TCT 2007. Adapted from Stone GW et al. NEJM 2007;356:998–1008

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Slide 44 :

BMS 4921 109/4904 48/3340 31/2264 44/1875 PES 6331 138/6283 78/4263 32/2187 15/869 SES 6771 139/6730 72/4041 38/2340 24/10810 Network meta-analysis: 38 trials, 18,023 pts 2 0 0 1 2 3 4 10 All cause death (%) SES vs. BMS: HR 1.00 (0.82-1.25), p=0.89 PES vs. BMS: HR 1.03 (0.84-1.22), p=0.75 SES vs. PES: HR 0.96 (0.83-1.24), p=0.80 8 4 Years after initial procedure 6 Stettler C et al. Lancet 2007;370:937-48

Slide 45 :

BMS 4891 210/4874 20/3174 17/2129 9/1745 PES 6300 249/6252 47/4057 15/2054 8/805 SES 6771 232/5730 25/3884 11/2236 7/1025 2 0 0 1 2 3 4 6 MI (%) SES vs. BMS: HR 0.81 (0.66-0.97), p=0.03 PES vs. BMS: HR 1.00 (0.81-1.23), p=0.99 SES vs. PES: HR 0.83 (0.71-1.00), p=0.045 Years after initial procedure 4 Network meta-analysis: 38 trials, 18,023 pts Stettler C et al. Lancet 2007;370:937-48

Slide 46 :

SCAAR — Swedish Coronary Angiography and Angioplasty Registry (www.ucr.uu.se) National registries with all procedures in Sweden between 1989-2007 In the database: 294,000 procedures, 123,000 PCI 118,000 stents (>37,000 DES) Complete long-term follow-up by merging with national registries of MI, CABG, hospital care, and death

Slide 47 :

SCAAR 2003-4: Death (Adjusted) BMS 12880 12473 12354 12213 9298 5960 DES 5770 5604 5541 5468 3434 1776 Cumulative risk 0.10 0.06 0.04 0.02 0.00 0.0 0.5 1.0 1.5 2.0 2.5 Time (years) RR: 1.32 (1.11,1.57) 0.08 RR: 1.03 (0.84,1.26) Lagerqvist B et al. NEJM;356:1009-19 BMS DES The SCAAR SCARE!

Slide 48 :

The lay press negative characterization of DES safety (a “million ticking time bombs”) has frightened both patients and referring physicians (unnecessarily), which has seriously affected the interventionalist’s ability to deliver optimal therapy for their patients.

Slide 49 :

What About SCAAR? SCAAR Expansion, ESC 2007 S. James. ESC 2007 *From the Swedish hospital d/c and Riks-HIA registries; ** From the Swedish population registry

Slide 50 :

SCAAR 2003-5: Death (Adjusted) 15,500 more pts and 1 extra year S. James. ESC 2007 Time (years) Cumulative incidence of death 0 1 2 3 4 0.00 0.05 0.10 0.15 BMS 18769 18136 17948 16109 13401 10326 7158 3970 1179 DES 12015 11705 11559 9020 6181 3844 2153 847 115 RR: 0.92 (0.78, 1.07) RR: 1.09 (0.96, 1.25) BMS DES The Oops from Uppsala!

Slide 51 :

2004 Time (years) Cumulative risk of death or MI 2003 2003 landmark 2005 Time (years) Cumulative risk of death or MI Why is SCAAR no longer scary? SCAAR Landmark Analyses Death/MI: Year by Year S. James. ESC 2007

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Slide 53 :

From all pts undergoing PCI in Ontario between 12/03 and 3/05, 7,502 propensity matched pts receiving DES or BMS were identified Mortality @ 3 yrs DES 5.5% BMS 7.8% P<0.001 Tu JV et al. NEJM 2007;357:1393-402 DES in Ontario: Mortality No. at Risk DES 3751 3671 3649 3618 2669 1418 BMS 3751 3651 3602 3568 2531 1197 Years after Index PCI Overall Survival (%) 100 96 92 88 84 80 0 0 0.5 1.0 1.5 2.0 2.5 3.0 Drug-eluting stent Bare-metal stent

Slide 54 :

What a Difference 6 Months Makes! SCAAR Registry March 8th, 2007 3 year mortality increased 18% with DES Ontario Registry October 4th, 2007 3 year mortality decreased 29% with DES

Slide 55 :

TCT2007 Late Breaking Registries: DES vs. BMS in >61,000 Pts with Long-term Follow-up ASAN data presented by SJ Park, TCT 2007. GHOST data presented by Harjai, TCT 2007. MIDAS data presented by Vagonescu, TCT 2007. NY State data presented by Hannan, TCT 2007. Ontario data presented by Ko, TCT 2007. STENT data presented by Brodie, TCT 2007. Western Denmark data presented by Jensen, TCT 2007. The safety and effectiveness of the TAXUS® Express® Stent have not been established in patients with a recent acute myocardial infarction where there is evidence of thrombus or poor flow.

Slide 56 :

DES vs. BMS Registries: Mortality p<0.001 All Cause Mortality (%) p=0.052 P<0.05 p<0.001 p<0.0001 p<0.001 p=0.004 N=4,061 3,160 N=871 N=483 N=5,399 N=5,719 N=6,384 N=7,834 N=3,751 N=3,751 N=5,996 N=1,359 N=3,548 N=8,847 3-year 3-year 2-year 2-year 3-year 2-year 2-year Presented at TCT2007

Slide 57 :

DES vs. BMS Registries Repeat Revascularization Revascularization (%) p<0.0001 (TVR) p<0.001 (TVR) P<<0.05 (TLR) p<0.0001 (TLR) N=871 N=483 N=6,384 N=7,834 N=3,751 N=3,751 N=5,996 N=1,359 N=3,548 N=8,847 3-year 2-year 3-year 2-year 2-year p<0.001 (TVR) Presented at TCT2007

Slide 58 :

NY State Database: 2 Year Adjusted Mortality Following PCI Edward L. Hannan. Presented at TCT2007 0 0.5 1 1.5 2 Years Rate of Death (%) 3.8 4.5 5.6 4.8 1.7 3.3 2.0 2.8 Adj. HR [95%CI] = 0.84 [0.72 – 0.97] 0% 1% 2% 3% 4% 5% 6% BMS (N=7.834) DES (N=6,384)

Slide 59 :

Edward L. Hannan. Presented at TCT2007 NY State Database: 2 Year Adjusted TLR Following PCI

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Log Rank p <0.00001 Adj. Cox HR 0.66 (0.59 - 0.74); p <0.0001 91.4% 1.00 0.95 0.90 0.85 0.80 0 100 200 300 400 500 600 700 800 Number at risk 1 year 2 years DES 5719 5341 5227 BMS 5399 4902 4704 87.1% Freedom from Death (%) BMS (N=5399) DES (N=5719) NJ MIDAS Database: 2-Year Survival from All Cause Death in AMI (N=11,118) Tudor D. Vagaonescu. Presented at TCT2007

Slide 61 :

Propensity Matched 2-Year Outcomes Mortality P < 0.0001 MI P = 0.11 P < 0.0001 Revascularization DES (n=514/5441) BMS (n=647/5441) DES (n=590/5441) BMS (n=643/5441) DES (n=1095/5441) BMS (n=1303/5441) ? = -2.4% [-3.6,-1.3] ? = -1.0% [-2.2,+0.2] ? = -3.8% [-5.4,-2.3] MASS PCI Registry Mauri et al; AHA 2007

Slide 62 :

2-Year Outcomes in Matched Patients Cumulative Incidence 0 0% 10% 20% 30% 180 365 730 DES n=5,441 Time after Initial Procedure (days) 11.9% 9.4% Mortality BMS n=5,441 MASS PCI Registry Mauri et al; AHA 2007

Slide 63 :

Meta-analysis – Adjusted All-Cause Mortality 10 registries, 118,959 total patients Overall (I2 = 83.3%, p<0.0001) REAL Western Denmark Asan Ontario NY State STENT Study SCAAR Wake Forest Massachusetts MIDAS 0.79 (0.70, 0.90) 0.90 (0.72, 1.13) 1.00 (0.86, 1.17) 0.60 (0.46, 0.79) 0.70 (0.59, 0.84) 0.84 (0.72, 0.97) 0.71 (0.56, 0.91) 1.03 (0.94, 1.14) 0.71 (0.54, 0.92) 0.79 (0.71, 0.89) 0.66 (0.59, 0.74) 100.00 8.95 10.67 % 7.90 10.13 10.79 8.54 Weight 11.88 7.99 11.57 11.56 1 .46 1 2.17 Random effects analysis OR (95% CI)

Slide 64 :

Drug-Eluting Stents…. the good, the bad, and the ugly! 40 mos BMS DES Incomplete apposition Late stent thrombosis Abn Vasomotion *P<0.001 vs. control Sirolimus Control * * Delayed Healing! Angioscopy BMS DES Late loss = 0 Eos Giant cells IVUS Inflammation

Slide 65 :

Bern-Rotterdam Experience 8146 pts. treated with SES (n=3823) or PES (n=4323) at 2 academic centers 0 3 6 9 13 18 24 31 46 85 146 192 224 260 336 356 381 441 464 491 Number of events Cumulative events (%) 20 15 10 5 2.0 1.5 1.0 0.5 0 0 Days after PCI 551 568 606 670 762 822 925 1074 Early stent thrombosis Late stent thrombosis Cumulative events (%) Daemen J, et al, Lancet 2007;369:667–78

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0 180 360 540 720 900 1080 30 5.3% 6.4% 3.3% - Definite (angiography pathological confirmation) - Definite & Probable (MI in stent area) - Definite, probable and possible (any unexplained death) % of Patients 0 1 2 3 4 5 6 7 8 9 10 ARTS II: Stent Thrombosis (up to 3 Years)

Slide 67 :

Death, MI, revasc before landmark excluded DES (N=1216 total) BMS (N=2393 total) Adj. 2 yr rates DES C+: 3.1% C-: 7.2% BMS C+: 5.5% C-: 6.0% P=0.70 P=0.02 Eisenstein EL et al. JAMA. 2007;297:159-168 Event-free Pts after DES (but not BMS) at 6m on Clopidogrel have Lower 2 yr Death/MI No. at Risk Drug-Eluting Stent With Clopidogrel 637 613 300 287 w/o Clopidogrel 579 526 262 238 Bare-Metal Stent With Clopidogrel 417 412 394 382 w/o Clopidogrel 1976 1941 1879 1825 With Clopidogrel Without Clopidogrel Bare-Metal Stent With Clopidogrel Without Clopidogrel Drug-Eluting Stent

Slide 68 :

No. of Patients Discontinued thienopyridine On thienopyridine 262 2759 439 2582 583 2438 1160 1861 1215 1806 1728 1293 2100 921 2207 814 2321 700 Days 0 60 120 180 300 360 420 480 540 Stent thrombosis rate 0.00 0.02 0.04 0.06 0.08 0.10 0.12 0.14 0.16 Patients without thienopyridine Patients with thienopyridine Cumulative incidence of ST = 58/3021 pts (1.9%) ST within 6 months 42 pts (1.4%) ST after 6 months 16 pts (0.5%) 34 patients 8 patients 7 patients 9 patients 240 3021 DES pts: Aalen-Nelson Estimate of the Cumulative Hazard Function Airoldi F et al. Circulation 2007;116:745-54

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Multivariate Predictors of Stent Thrombosis 0.01 0.1 1 10 100 0.01 0.1 1 10 100 No thieno* (0-6m) No thieno* (6-18m) LVEF* =30% Prior Brachytherapy RVD* Final atm Stent Length HR=13.74; 95%CI, 4.04-46.68, p<0.001 HR=0.94; 95%CI, 0.30-2.98, p=0.92 HR=3.72; 95%CI, 1.50-9.27, p=0.005 HR=9.70; 95%CI, 2.99-31.44, p<0.001 HR=0.27; 95%CI, 0.06-1.13, p=0.07 HR=0.39; 95%CI, 0.18-0.85, p=0.02 HR=2.75; 95%CI, 1.55-4.88, p<0.001 Airoldi F et al. Circulation 2007;166:In press

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Thrombosis and Thienopyridine Discontinuation Time (days) Individual 58 patients (each line bar is a patient) 2 54 3 113 270 6 29 30 81 126 38 196 549 485 540 420 336 279 270 249 240 240 240 210 180 176 150 139 128 108 60 38 19 15 15 18 15 10 7 6 6 5 4 4 3 3 2 2 2 2 2 1 1 10 3 557 553 0 60 120 180 240 320 360 420 480 540 58 thrombotic events (1.9%) at 18 month follow-up 7 without clopidogrel 42 (72%) 16 (28%) After 6-mo Before 6-mo 9 with clopidogrel Time from thienpyridine discontinuation to ST: Median 13.5 days Median 90 days

Slide 71 :

1st generation DES induce patho-biologic responses which may increase late/very late stent thrombosis (by 0.2-0.6% per year). The gravity of out-of-hospital late/very late stent thrombosis is disproportionate to the low event rate; this has created anxiety among patients and physicians (fueled by exaggerated press reports). For both on-label and off-label use indications, DES are not associated with increased death and MI, due to the offsetting effects of reduced restenosis. PCI - Unanswered Questions DES Safety

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Slide 73 :

Nevertheless, there are considerable logistic problems associated with obligatory long-term plavix use, including cost burdens, compliance issues, and premature discontinuation due to intercurrent co-morbid events (e.g. unplanned surgery) Two bothersome interrelated unanswered questions remain: (1) does DES late/very late thrombosis constitute a continuous hazard risk; (2) how long and in which patients should plavix therapy be sustained beyond 6-12 months. We need safer DES, better (more consistent) anti-platelet regimens, and improved platelet therapy monitoring techniques. PCI - Unanswered Questions DES Safety

Slide 74 :

Life is a Matter of “Balance” MI, Death, TLR Stent thrombosis Reduced restenosis The Scale Still Favors DES (in most, but not all patients)

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Are DES Safe and (Cost) Effective? PCI – Unanswered Questions When Should PCI be Performed? What are the Next “Big Breakthroughs”? How Good is the “Evidence” in EBM?

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PCI in Acute Coronary Syndromes Eur Heart J 2005;26:804-847

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23 Randomized Trials of PCI vs. Lysis p=0.0002 p=0.0003 N = 7,739 Keeley, Grines. Lancet 2003;361:13-20

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The RIKS-HIA Registry Consecutive pts admitted in 75 of 78 hospitals with CCUs in Sweden (N=26,206 STEMIs) Stenestrand U et al. JAMA 2006;296:1749-56 Unadjusted Cumulative Mortality Days Cumulative Mortality, % In-Hospital Thrombolysis Prehospital Thrombolysis Primary PCI # at Risk In Hospital TL 14260 12322 12100 11931 Prehospital TL 2736 2491 2460 2442 Primary PCI 6030 5661 5607 5555 15.9% 10.3% 7.6%

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TIMI IIIB 9 Randomized Trials N=10,412 Conservative (N=920) Invasive (N=6618) VANQWISH MATE FRISC II TACTICS- TIMI 18 VINO RITA-3 TRUCS Optimal Strategy for ACS 2007 N=2874 ICTUS c/o Chris Cannon

Slide 80 :

COURAGE: Clinical Outcomes Utilizing Revascularization and Aggressive Guideline-Driven Drug Evaluation Boden W et al. NEJM 2007;356:1503-16.

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Survival (median FU 4.6 yrs) Years 0 1 2 3 4 5 6 0.0 0.5 0.6 0.7 PCI + OMT 7 Hazard ratio: 0.87 95% CI (0.65-1.16) P = 0.38 Boden WE et al. NEJM 2007;356:1503-16 Freedom from Death (%) PCI would only be expected to reduce cardiac deaths! 0.8 0.9 OMT Death at 4.6 yrs 7.6% 8.3% 1.0 Of 180 total deaths (of 2287 enrolled pts): 48 (26.7%) were cardiac; 132 (73.3%) were non cardiac or unknown

Slide 82 :

What does it take to reduce mortality and change worldwide practice? GUSTO 41,021 pts in 15 countries and 1081 hospitals with AMI randomized to SK + SQ heparin, SK + IV heparin, accelerated t-PA and IV heparin, or SK/t-PA with IV heparin The GUSTO Investigators. N Engl J Med 1993;329:673-682 1? EP: 30 Day Mortality SK/SQ-H: 7.2% SK/IV-H: 7.4% Acc t-PA: 6.3% SK/t-PA : 7.0% RRR for t-PA vs. SK = 14% [5.9%, 21.3%] P=0.001

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5 Medical Therapies Proven to Reduce Death Adapted from Granger CB and McMurray JJV JACC 2006; 48:434 Reduction in deaths Conclusion: “Large clinical outcome trials must remain the basis for informing clinicians on which treatments improve clinical outcomes.”

Slide 84 :

Angina/QOL at 1 Year: Med Rx vs. PCI 8 prior randomized trials in stable CAD Refs in: Katritsis DG et al. Circulation 2005;111:2906-12.

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Angina free (%) P=NS Freedom from Angina During Long-term Follow-up Boden WE et al. NEJM 2007;356:1503-16 40%? P<0.001 <7% crossovers anticipated! P=NS

Slide 86 :

Was the Optimal Medical Therapy administered in COURAGE representative? LDL < 85 mg per deciliter in ~70% of pts SBP <130 mmHg in ~65% of pts DBP <85 mmHg in ~ 94% of pts HgBA1C <7.0% in ~45% of diabetic pts ? Boden WE et al. NEJM 2007;356:1503-16

Slide 87 :

PCI Outcomes 1149 patients total 46 (4%) procedure not attempted 27 (2%) no lesions crossed 1077 patients (94%) had PCI attempted 1577/1688 lesions had PCI success (93%) Few PCI pts received GPIIb/IIIa inhibitors or adequate clopidogrel pre-loading 787 patients (69%) had 2 or 3 vessel ds. 590 pts (59%) received 1 stent 416 pts (41%) received =2 stents At least 371 of 787 pts (47%) with multivessel disease had incomplete revascularization 14% PTCA only 86% stents 97% BMS 3% DES Really ~85% PCI success

Slide 88 :

A North American Trial 50 Hospitals 2,287 pts enrolled between 6/99-1/04 1 pt per hospital per month 19 US Non-VA Hospitals 387 pts (0.5 pts/mo/hosp) (17% of total) 15 VA Hospitals 968 pts (1.6 pts/mo/hosp) (42% of total) 16 Canadian Hospitals 932 pts (1.5 pts/mo/hosp) (41% of total) Boden WE et al. NEJM 2007;356:1503-16

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Does COURAGE Represent PCI in the United States? 962,732 (98.5%) 14,268 (1.5%) Canada US VA US non VA Boden WE et al. NEJM 2007;356:1503-16 *US data of file, Boston Scientific

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: COURAGE Projections: 3-year death/MI 21% (OMT) vs. 16.4% (PCI + OMT) (22%?) Death/MI (%) at 4.6 years 29%? 27%? ? P˜0.02 Boden WE et al. NEJM 2007;356:1503-16

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Nuclear Substudy (n=314/2,287) Hypothesis: Reduction in Ischemia will be greater for patients Randomized to PCI+OMT than for those Randomized to OMT Serial Rest/Stress Myocardial Perfusion SPECT (MPS) To Compare Patient Management Strategy for Ischemia Reduction Pre-Rx = Off Meds 6-18m = On Meds * Timing Chosen to Occur Beyond Window of In-Stent Restenosis & Delayed to Allow Effects of Medical Rx to be Observed Documented Pre-Rx Ischemia PCI + OMT (n=159) OMT (n=155) Repeat MPS* at 6-18m Repeat MPS* at 6-18m Mean = 374 ± 50 days Shaw, et al. J Nucl Cardiol. 2006;13:685-698.

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Survival Benefit With Revascularization According to Ischemic Risk (f/u 1.9 yr) % Total Myocardium Ischemic 0% 1- 5% 5-10% 11-20% >20% Cardiac Death Rate 7110 16 1331 56 718 109 545 243 252 267 P > .0001 Hachamovitch et al . Circulation 2003; 107:2900-2907

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Ischemia Predicts Prognosis: DEFER Study 5 year follow-up Pijls et al. JACC 2007;49:2105–11 FFR ? 0.75 FFR < 0.75 n=181 n=144 Cardiac Death or MI P=0.003

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Death or MI Rate (%) Rates of Death or MI by Residual Ischemia on 6-18m MPS p=0.002 0% (n=23) p=0.023 p=0.063 1%-4.9% (n=141) 5%-9.9% (n=88) >10% (n=62)

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Death or MI Rate (%) Rates of Death or MI by Ischemia Reduction (all pts) p=0.037 Ischemia Reduction =5% (n=82) RR=0.47 (95% CI=0.23-0.95) No Ischemia Reduction (n=232) Shaw LA. AHA 2007

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Ischemia reduction =5% Primary Endpoint: % with Ischemia Reduction =5% Myocardium (N=314) p=0.004 PCI + OMT (n=159) OMT (n=155) Shaw LA. AHA 2007

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Odds Ratio (95% Confidence Interval) Overall Trial Sievers et al. Dakik et al. ACIP ACME-1 TIME ALKK AVERT Bech et al. MASS ACME-2 RITA-2 Year of Publication 1993 1998 1997 1997 2004 2003 1999 2001 1999 1997 2003 271/3675 PCI 0/44 1/21 2/192 16/115 45/153 6/149 1/177 2/90 6/72 9/51 43/504 335/3838 Medical 1/44 1/23 20/366 15/112 40/148 17/151 1/164 4/91 6/72 10/50 43/514 Deaths/Total SWISSI II DANAMI COURAGE INSPIRE Hambrecht et al. MASS II 2007 2006 2007 2006 2004 2006 6/96 19/503 85/1149 2/104 28/205 22/105 24/505 95/1138 1/101 35/203 0/50 0/51 1 .1 10 Random effects model Fixed effects model Pheterogeneity=0.263; I2=17% PCI vs. Medical Rx – 17 RCTs, 7513 pts Primary End Point: All-Cause Death Kastrati et al; TCT 2007

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A Rational Approach to Stable Angina The results of COURAGE were important and reaffirmed… The value of aggressive medical Rx in the “modern era” The superior value of PCI in reducing angina symptoms and lowering ischemic burden The importance of optimal study design in pivotal strategy trials – NEED CONFIRMATORY STUDIES! PCI should be offered as Rx of 1st choice, or at least an alternative choice in most patients with stable angina! COURAGE DID NOT test whether optimal PCI compared to optimal medical therapy reduces death and MI in stable CAD

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A Rational Approach to Stable Angina Treatment decisions for stable angina pts require a sensible case-based individualized approach integrating… The severity of angina symptoms The presence and magnitude of inducible ischemia The presence, location and severity of angiographic coronary stenoses Optimal Medical Rx should be applied in all pts! Optimal PCI (complete revascularization - leave no ischemia untreated) is preferred (1st choice) in pts with mod/severe ischemic burden, poorly controlled Sx, and/or “high risk” anatomy

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A Rational Approach to Stable Angina CAVEATS… Coronary angiography is usually (not always) required as a component of the decision-making process Pts should actively participate in therapy decisions and PCI should be considered as an alternative to reduce angina if medical Rx is poorly tolerated or if lifestyle limitations remain The “art” of medicine requires the judicious application of EBM + clinical judgement for each case-based scenario!

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Are DES Safe and (Cost) Effective? PCI – Unanswered Questions When Should PCI be Performed? What are the Next “Big Breakthroughs”? How Good is the “Evidence” in EBM?

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Evidence-Based Medicine: What’s the Problem? “There is an unsettling truth about the practice of medicine… …study after study shows that few physicians systematically apply to everyday treatment the scientific evidence about what works best.” Millenson, ML. Demanding Medical Excellence: Doctors and Accountability in the Information Age. 1997

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Randomized Controlled Trials Observational Cohort Registries Meta- (or pooled) Analyses Treatment Strategy Studies PCI 2008 How Good is the Evidence? Adapted from Stuart Pocock

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Evidence-Based Preconceived Notions Distal embolization during primary PCI in AMI is associated with reduced survival. Thrombectomy and distal protection systems remove thrombus ± atheroma in >75% of pts. This will/”must” reduce infarct size and enhance survival!! ? 21 RCTs; 3,664 pts (and 3 more at TCT!) It doesn’t work!! (and no one can believe it!)

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Infarct Size after Microcirculatory Protection: 3 largest studies P=0.018 Stone GW et al. JAMA 2005 Distal protection (GuardWire Plus) Passive thrombus aspiration (Rescue) Active thrombectomy (AngioJet) Ali A et al. JACC 2006 Kaltoft A et al. JAMA 2005 P=0.26 P=0.018 P=0.004

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Mortality at 30 Days (N=3,470): 18 RCTs Favors Control Favors Adjunctive Devices 0.1 0.2 0.5 1 2 5 10 De Luca G, et al. Am Heart J. 2007;153:343–353. P=0.88

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“The tragedy of science is the slaying of a beautiful hypothesis by ugly facts” Thomas Huxley Evidence-Based Medicine

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Meta-analysis: Statistical Alchemy? There is a type of meta-analysis called network meta-analysis that is more subject to erroneous conclusions than a routine meta-analysis.* *Improving Medical Statistics and Interpretation of Clinical Trials www.improvingmedicalstatistics.com Meta-analysis can create artificial significance by combining small studies Meta-analyses have been proven wrong 35% of the time by large randomized trials! “We’ve just completed a meta analysis with very sophisticated technique which is called collaborative inferred meta-analysis. I am not even familiar with the details. But this seems to be the state-of-the-art” Dr. Meier, JSIC June 2007 J Clin Epidemiol Vol. 48, No. 1, pp. 71-79, 1995. N Engl J Med 1997;337:536-42. It is possible to “squeeze” the data too hard!

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Collaborative Network Meta-analysis 38 trials; 18,023 patients sirolimus-eluting, paclitaxel-eluting, bare metal stents SES PES BMS 17 trials 8 trials 15 trials Description of the methodology “An extension of multivariable Bayesian hierarchical random effects models for mixed multiple treatment comparisons” “A random-walk model based on piece-wise constant hazards” “Random effects at the level of trials, time periods and comparisons” Stettler C et al. Lancet 2007;370:937-48

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The Final 10-Year Mortality Results from the BARI Randomized Trial J Am Coll Cardiol. 2007;49:1600–1606 77.3 77.0 57.9 45.5 Interaction P value = 0.12 PTCA: 29.0% CABG: 26.5% P = 0.18 P = 0.59 P = 0.025 Overall

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Detre KM et al. Circulation 1999;99;633–640 BARI Randomized vs. Registry: Diabetics Rand: RR=3.10, p=0.0002 Reg: RR=1.07, p=0.86 Five-year Cardiac Mortality Rand PTCA vs CABG: 23.4% vs 8.2% Reg PTCA vs CABG: 7.5% vs 6.0% Rand: RR=1.87, p=0.002 Reg: RR=1.10, p=0.73 Five-year Mortality Rand PTCA vs CABG: 34.5% vs 19.4% Reg PTCA vs CABG: 14.4% vs 14.9%

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Meta Analysis of all Reported Results 5 Year Survival in Diabetics Bravata DM et al. Ann Intern Med. 2007;147:In press

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The word “randomized” doesn’t sanctify a study. RCTs apply only to patients meeting specific enrollment criteria, and if under-powered, are prone to false negative conclusions. Observational studies are useful to document “real-world” drug/device use patterns and to detect low frequency safety events; but when comparing different treatments, even the most sophisticated statistical adjustments cannot correct for marked differences in baseline characteristics and other unmeasured confounders. PCI 2008 How Good is the Evidence?

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Meta-analysis is often abused; dissimilar under-powered studies are pooled and robust statistical methodology is often not applied. 35% of Meta-Analyses are Wrong! Meta-analysis is no substitute for a single adequately powered RCT. “Meta-analysis is to analysis as meta-physics is to physics” (Eugene Braunwald). Due to their importance, treatment strategy studies must be held to the highest quality standards. Sweeping conclusions should not be drawn from a single underpowered study. Like all RCTs, the results must only be applied to the patient cohorts enrolled. PCI 2008 How Good is the Evidence?

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Clinical Decision Making Clinical Practice

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Clinical Decision Making Clinical Practice

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Socio-economic considerations – a complex interplay between what patients need, what the regulators will allow, and what a society can afford! more than ever, clinical decisions are affected by the cost of therapies, liability concerns, local regulatory environments, the media, competitive forces, and overt commercialism Somehow, we need to restore a “patient first” attitude as the driver of clinical care Clinical Decision Making Other Factors

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Medicine is the ART of “Balance” Optimal Patient Care Clinical Decision Making

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Are DES Safe and (Cost) Effective? PCI – Unanswered Questions When Should PCI be Performed? What are the Next “Big Breakthroughs”? How Good is the “Evidence” in EBM?

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Technology Innovation Stifled by Economic and Regulatory Constraints?

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Safer Drug-Eluting Stents Next Big Breakthroughs

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Endeavor DES System PC Technology Drug: Zotarolimus Stent Delivery System Driver Cobalt Alloy Stent Key Components

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Endeavor Program Overview 9m 2yr 3yr 4yr ENDEAVOR I ENDEAVOR II ENDEAVOR II CA ENDEAVOR III ENDEAVOR IV ENDEAVOR PK Single Arm First-in-Man (n=100) 4yr 1:1 RCT vs. BMS (E=598,D=599) PK (n=106) 3yr Continued Access Single Arm (n=296) 2yr 3:1 RCT vs. Cypher® (E=323,C=113) 2yr 1:1 RCT vs.Taxus® (E=773,T=775) 9mo Pharmacokinetic Study (n=43) 9mo Single Arm (n=99) 9mo ENDEAVOR Japan E-FIVE Open Label Single Arm (n=8000) US Post Approval PROTECT 1:1 RCT vs. Cypher (E=4400,C=4400) Open Label Single Arm Study (n=5000) Proposed Ongoing Premarket Safety and Efficacy Package 25,619 Patients

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Error bars represent 95% confidence intervals Clinical Event (%) Death Cardiac Death MI Cardiac Death/MI Protocol ST Definition ARC Def/Prob ST Definition 3.2% 1.0% 2.7% 3.5% 0.5% 0.7% 4.5% 2.4% 4.2% 6.6% 1.2% 1.5% n=2132 n=596 Endeavor Safety Analysis Cumulative Incidence of Safety Endpoints to 1080 Days Endeavor: Mauri et al. TCT. 2007

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0.0% 0.5% 1.0% 1.5% 2.0% 2.5% 3.0% 0 360 720 1080 1440 ARC ST % Days Mauri et al. N Engl J Med 2007;356:1020-9. Endeavor: Mauri et al. TCT. 2007 Xience: FDA Panel Meeting Nov. 29, 2007 *Represents “SPIRIT II and III 2-year Complete Analysis” from FDA Panel DES Comparison ARC Definite and Probable ST to 3 years

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Mauri et al. N Engl J Med 2007;356:1020-9. Endeavor: Mauri et al. TCT. 2007 Xience: FDA Panel Meeting Nov. 29, 2007 0% 3% 6% 9% 0 360 720 1080 1440 Cardiac Death and MI % Days DES Comparison Cardiac Death and MI to 3 years Mauri et al. N Engl J Med 2007;356:1020-9. Endeavor: Mauri et al. TCT. 2007 Xience: FDA Panel Meeting Nov. 29, 2007 *Represents “SPIRIT II and III 2-year Complete Analysis” from Panel

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Directional Drug Delivery (ablumenal preference) Selective coating on the outside surface of the stent Reduced drug/polymer Lumenal surface BMS Drug only where needed Labcoat JA™Coating Technology

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Biodegradable Drug/Carrier: Biolimus A9® / Poly (Lactic Acid) 50:50 mix abluminal surface only (contacts vessel wall) 15 µmeter coating thickness degrades in 9 months releasing CO2+ water Stent Platform: stainless steel (112 ?m) corrugated ring, quadrature-link™ design radius link enhances axial fatigue life Parylene Durable Primer Coating: 5 µmeter thick, encapsulates stent prevents surface metal ion migration biostable + athrombogenic* BioMatrix® II Stent Platform Design BIOFLEX™ I * Data per NHLBI sponsored study, available from BSI

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CoStar® Paclitaxel-Eluting Coronary Stent System A Stent Specifically Designed for Controlled Drug Delivery from a Bioresorbable PLGA Polymer Reservoir inlays with PLGA bioresorbable polymers; reduced tissue-polymer contact area

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Porous Hydroxyapatite Matrix for Polymer-free Drug Delivery

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Surfaces to Encourage Cell Growth Bioactive surfaces to accelerate functional endothelialization Orbus – EPC Capture Cell specific peptide linkers (Affinergy) Nanotextured Surfaces Example of IrOx

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Transcatheter Aortic Valve Replacement Next Big Breakthroughs

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“There is no treatment for aortic valve disease”

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Symptomatic patients with severe AS (Class I-B) Patients with severe AS undergoing CABG (Class I-C) Patients with severe AS undergoing Ao or other heart valve surgery (Class I-C) Patients with severe AS and LV systolic dysfunction - EF<50% (Class I-C) Patients with moderate AS undergoing CABG, or Ao, or other heart valve surgery (Class IIa-B) Transcatheter AVR Indications for Surgical AVR

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SEVERE AORTIC STENOSIS AORTIC VALVE REPLACEMENT SURGERY BALLOON AORTIC VALVULOPLASTY REFUSALS “MEDICAL THERAPY” “ASYMPTOMATIC” Potential Transcatheter Aortic Valve Therapy Patients HIGH-RISK PATIENTS There is an unmet clinical need!

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Day 8 post-implantation First successful percutaneous aortic valve replacement! Alain Cribier April 16, 2002

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Retrograde Trans-femoral Deployment Rapid pacing : 200/min

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Edwards THV Studies Transfemoral and Transapical 492 Patients * 2002-2007 Transfemoral (n=303) Transapical (n=191) Antegrade N=59 TRAVERCE n=125 Retrograde N=244 RECAST n = 24 iREVIVE n = 22 REVIVE I n = 4 REVIVAL I n = 7 REVIVE II n = 90 REVIVAL II n = 55 CANADIAN SPECIAL ACCESS n =99 REVIVAL II n =22 CANADIAN SPECIAL ACCESS n =44 US Compassionate n=2 US Compassionate n=2 * Excluding PARTNER EU and U.S. RCT

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Edwards THV Studies Transfemoral and Transapical 492 Patients * 2002-2007 Transfemoral (n=303) Retrograde N=244 REVIVE II n = 90 REVIVAL II n = 55 CANADIAN SPECIAL ACCESS n =99 * Excluding PARTNER EU and U.S. RCT

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Pooled Transfemoral tAVR All Cause Mortality (n=216) Canada 73 42 32 23 19 REVIVE 90 53 26 12 10 REVIVAL 55 47 39 35 19 Months Post Procedure Number at Risk 74.7% 73.8% 73.0%

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Transcatheter Valve Therapy Aortic Stenosis Cribier-Edwards >650 patients CoreValve >550 patients First Generation Devices

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PARTNER TRIAL Placement of AoRTic TraNscathetER Valves Trial Symptomatic High risk for AVR High Risk AVR tAVR Medical Rx N~350 pts N~250 pts tAVR Non-inferiority Superiority 1° endpoint: Mortality @ 1 yr PIs: M. Leon & C. Smith 1° endpoint: Mortality over duration of trial Severe AS High Surgical Risk Inoperable

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FUTURE Candidates for Transcatheter AVR AR patients Severe AS Normal and High Surgical Risk ACC/AHA Class I and IIa (Symp and Asymp) Failed AVR tAVR + PCI tAVR + MR Rx

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We are still learning how to fly….…

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Device-Based CHF Therapies Next Big Breakthroughs

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Maximum Cardiac Output Disease Severity Normal CGS NYHA III NYHA IV Big Gap due to: Normal QRS Not sick enough for LVAD Device-Based CHF Therapies

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Maximum Cardiac Output Disease Severity Normal CGS NYHA III NYHA IV Device-Based CHF Therapies

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A Permanent, Partial Support LVAD that could be Implanted Minimally Invasively Take Blood From LA Pump to the Subclavian Artery Subcutaneous pump, implanted like a pacemaker CircuLite

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First in Man: Surgical Implant Minimally Invasive Partial Suport LVAD

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CircuLite First-in-man Implant 46 year old male March 2007: AMI with cardiogenic shock May: listed for HTX June: hospitalized; IV diuretics unable to walk up stairs June 29: CircuLite device implantation Rapid post-op recovery July 3: transfered to the ward July 16: discharged from hospital Optimization of ACE and Beta-blocker Not tolerated prior to implant October 19: NYHA II Riding expercise bike 3 times/day Resumed daliy activities

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The interventional community must re-connect with mainstream cardiology Improve dialogue with referring MDs and expanded roles of societies (ACC/AHA, BCIS, SCAI, etc). Embrace new patient outcome initiatives; become patient care partners and not just procedure-oriented consultants. Heighten our sensitivity to economic forces and reimbursement concerns. Improve media and public relations to clearly explain the role and value of PCI. PCI 2008 Final Thoughts

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Redefine the evidence-based medicine process as it applies to interventional Rx Preach optimal study design methodology; studies should answer compelling clinical questions, with appropriate endpts and power. De-emphasize the value of any one study and demand a wider breadth of clinical studies extending to “real world” cohorts. The word “randomized” doesn’t sanctify a study and meta-analyses should be viewed with caution, and the trend of “mega-trials” to address patient outcomes is emerging. PCI 2008 Final Thoughts

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Oppose efforts to stifle innovation – a vital backbone of the interventional sub-specialty Find ways to stimulate and encourage innovation in interventional science. Engage regulatory agencies to help deconvolute the current device approval conondrum, such that industry can once more contemplate rational R&D programs. In the spirit of Andreas, encourage broad multi-disciplinary physician participation in this “innovation process”, including re-invigorating global clinical research. PCI 2008 Final Thoughts

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What Would Andreas Think? of What’s Become of Interventional Cardiology? We think he would be… Approving of the mandate to generate and utilize evidence-based medicine in clinical decision-making Enthralled with symposia such as Advanced Angioplasty 2008 which rely on live cases for education Ecstatic and overwhelmed with the technology explosion that has overcome many of the limitations of PTCA Distressed with the misinterpretation of data and the inappropriate use of devices, and concerned about operators who don’t practice with the highest standards of quality and ethics Appalled at the myriad external social, economic and political forces that are interfering with the practice of medicine

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