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2007, The Year in PCI Asad Pathan FACC FSCAI March 15 th, 2008.

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Presentation on theme: "2007, The Year in PCI Asad Pathan FACC FSCAI March 15 th, 2008."— Presentation transcript:

1 2007, The Year in PCI Asad Pathan FACC FSCAI March 15 th, 2008

2 2007, The Year in PCI DES DES –Registries –New stents Anticaogulants Anticaogulants –Bivalirudin Stable CAD Stable CAD –COURAGE trial AMI AMI –Technique/aspiration New Devices New Devices –Drug Eluting balloon

3 Drug Eluting Stents

4 DES vs BMS Recent Registry Data

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6 % of event Western Denmark Clinical endpoints to 2 years (unadjusted) NS P=0.004 NS P< DES ( N=8847) BMS (N=3548) Jensen TCT 2007

7 % of event DES ( N=8847) BMS (N=3548) Western Denmark Clinical endpoints >1 to 2 years P=0.02 P< P= P<0.001 *2 yr cumulative Adjusted P values Jensen TCT 2007

8 % of event Ontario Registry Clinical endpoints to 2 years in propensity matched cohort P=0.001 P=0.95 P<0.001 DES ( N=3751) BMS (N=3751) P=0.02 Tu et al. N Engl J Med 2007;357:

9 % of event Ontario Registry Clinical endpoints > 1 to 2 years in propensity matched cohort DES ( N=3751) BMS (N=3751) P values not available Tu et al N Engl J Med 2007;357:

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11 Mauri AHA 2007

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13 Stefan James, Jörg Carlsson, Johan Lindbäck, Tage Nilsson, Ulf Stenestrand, Lars Wallentin and Bo Lagerqvist for the SCAAR study group None of the authors have any conflicts of interest in relation to the presentation Long term outcome with drug eluting stents vs bare metal stents in Sweden – one additional year of follow-up

14 Restenosis one stent cohort UnadjustedAdjusted James ESC 2007

15 Adjusted death /MI Total cohort N = One stent cohort N = James ESC 2007

16 Death/MI-total cohort Year by year James ESC 2007

17 Stent thrombosis Time (years) 210 Cumulative risk of stent thrombosis % DES n= BMS n= Stent type Total cohort N = stents 0.5% per year Unadjusted James ESC 2007

18 P < All cause mortality rate (%) P = P = NR P < P < P < P = N = 3160 N = 4061 N = 483 N = 871 N = 5719N = 5399N = 6384N = 7834N = 3751 N = 5996 N = 1359 N = 3548 N = 8847 BMS DES 3-year 2-year 3-year2-year DES vs BMS registries at TCT 07 SJ ParkHarjaiVagonescuHannan Ko B BrodieJensen

19 DES vs. BMS Conclusions Over 35,000 patients with DES, 2-4 year follow-up with adjustment for differences in back ground characteristics: Over 35,000 patients with DES, 2-4 year follow-up with adjustment for differences in back ground characteristics: –No overall increase in mortality or risk of MI with DES use. Reduced mortality in some of the registries Reduced mortality in some of the registries –Sustained reduction in risk of TVR. –Slightly increased risk of ST and MI after initial 6 months, compensated by reduction of events in the first 6 months.

20 New DES Results Everolimus-Eluting XIENCE V chromium cobalt stent.

21 The SPIRIT of XIENCE The SPIRIT Family of Trials Post- CE Mark Approval International N = 2,000 Women only SPIRIT WOMEN Post- CE Mark Approval International N = 3,000 Diabetic study N = 300 Registry N = 2,700 SPIRIT V US Peri Approval US N = 3,690 SPIRIT IV Safety & Performance Europe N = 60 SPIRIT FIRST Clinical Support for CE Launch International N = 300 SPIRIT II US & Japan Approval US/ Japan N = 1,380 (1,292/88) SPIRIT III

22 2:1 Up to two de novo lesions, maximum of one lesion per epicardial vessel Main US RCT 2.5 – 3.75 mm* LL 28 mm N = 1,002 XIENCE V XIENCE V N = 669 TAXUS® Control TAXUS® Control N = 333 PI: Gregg Stone, MD PI: Gregg Stone, MD RCT: Prospective, single blind RCT: Prospective, single blind Primary end point: In-segment Late Loss at 8M Primary end point: In-segment Late Loss at 8M Stent Size: 2.5 – 3.5mm mm; Stent lengths: 8, 18, 28 mm Stent Size: 2.5 – 3.5mm mm; Stent lengths: 8, 18, 28 mm Angiographic and IVUS Follow-Up on 564 and 240 pts, respectively Angiographic and IVUS Follow-Up on 564 and 240 pts, respectively Clinical follow-up at 30, 180, 270d and 1, 2, 3, 4 and 5 years Clinical follow-up at 30, 180, 270d and 1, 2, 3, 4 and 5 years 6 Months clopidogrel for all arms 6 Months clopidogrel for all arms SPIRIT III SPIRIT III RCT Design

23 Baseline Demographics XIENCE V 669 pts TAXUS ® 333 pts P-value Age (in years) 63.2 ± ± Male (%) Hypertension (%) Hypercholesterolemia (%) Diabetes mellitus (%) Insulin requiring (%) Current smoker (%) Prior MI (%) Unstable angina (%) SOURCE: G.W. Stone, ACC 2007.

24 Baseline Angiography XIENCE V 767 lesions TAXUS ® 382 lesions P-value Lesion location LAD LAD41.3%42.9%0.61 LCX LCX27.6%28.3%0.83 RCA RCA31.0%28.5%0.41 LMCA LMCA0.1%0.3%0.55 QCA RVD (mm) RVD (mm) 2.77 ± ± MLD (mm) MLD (mm) 0.82 ± ± % DS % DS 70.0 ± ± Lesion length (mm) Lesion length (mm) 14.7 ± ± SOURCE: G.W. Stone, ACC 2007.

25 QCA at 8 Months (All Lesions) XIENCE V 344 lesions TAXUS ® 158 lesions P-value RVD (mm) 2.77 ± ± MLD (mm) In-segment In-segment 2.22 ± ± In-stent In-stent 2.56 ± ± Late Loss (mm) In-segment In-segment 0.14 ± ± In-stent In-stent 0.16 ± ± Diameter Stenosis (%) In-segment In-segment 18.8 ± ± In-stent In-stent 5.9 ± ± Binary Restenosis (%) In-segment In-segment In-stent In-stent SOURCE: G.W. Stone, ACC 2007.

26 SPIRIT III Clinical Results N = 658 N = 322 P = 0.55 P = 0.67 P = 0.64 P = % Reduction P = G.W. Stone, ACC 2007.

27 Meta-Analysis of Patient Level Data N = 1,302 SPIRIT II & III Pooled Meta- Analysis Similar inclusion and exclusion criteria: Up to two de novo lesions, maximum of one lesion per epicardial vessel 2.5 – 3.75 mm* LL 28 mm XIENCE V XIENCE V N = 892 TAXUS® Control TAXUS® Control N = 410 SPIRIT II + III Presented by Gregg Stone, MD at PCR, 5/22/07Presented by Gregg Stone, MD at PCR, 5/22/07 Independent Meta-Analysis done by CRFIndependent Meta-Analysis done by CRF SPIRIT II and SPIRIT III have similar inclusion and exclusion criteriaSPIRIT II and SPIRIT III have similar inclusion and exclusion criteria Pooled, patient level analysis of combined SPIRIT II and SPIRIT III dataPooled, patient level analysis of combined SPIRIT II and SPIRIT III data Pre-specified, Superiority Testing on all endpointsPre-specified, Superiority Testing on all endpoints *SPIRIT II was up to 4.0mm

28 SPIRIT II & III Meta-Analysis Late Loss Binary Restenosis mm 58% Reduction P < % Reduction P = % Reduction P = % Reduction P = N = 581 N = 244 SOURCE: G.W. Stone, PCR NOTE: This analysis was performed by the SPIRIT III investigator and is meant for descriptive purposes only. Please note that the data were from different patient populations (OUS vs. US) and had different angiographic follow-up time points (6 months vs. 8 months).

29 SPIRIT II & III Meta-Analysis N = 878 N = 398 9M Event Rate P = 0.59 P = 0.22 P = 0.32 P = 0.19 P = 0.87 P = 0.31 Safety Endpoints SOURCE: G.W. Stone, PCR 2007.

30 Number at risk XIENCE V TAXUS Ischemic TLR (%) Time in months HR [95% CI] 0.47 [0.26,0.87] p=0.01 XIENCE V TAXUS 5.1% 2.4% SPIRIT II & III TLR SOURCE: G.W. Stone, PCR 2007.

31 Number at risk XIENCE V TAXUS Ischemic MACE (%) Time in months HR [95% CI] 0.50 [0.31,0.81] p=0.004 XIENCE V XIENCE VTAXUS 8.0% 4.1% SPIRIT II & III MACE SOURCE: G.W. Stone, PCR 2007.

32 SPIRIT III Conclusions I In the large, multicenter, randomized SPIRIT III trial, the Everolimus-Eluting XIENCE V stent compared to the Paclitaxel-Eluting TAXUS ® stent: In the large, multicenter, randomized SPIRIT III trial, the Everolimus-Eluting XIENCE V stent compared to the Paclitaxel-Eluting TAXUS ® stent: –Was both non-inferior and superior in reducing in- segment late loss, the primary endpoint of the trial –Significantly reduced in-stent late loss at 8 months –Reduced angiographic FU diameter stenosis with a strong trend toward lower binary restenosis –Resulted in a significant reduction in in-stent volume obstruction without excess late acquired malapposition

33 SPIRIT III Conclusions II In the large, multicenter, randomized SPIRIT III trial, the Everolimus-Eluting XIENCE V stent compared to the Paclitaxel-Eluting TAXUS ® stent: In the large, multicenter, randomized SPIRIT III trial, the Everolimus-Eluting XIENCE V stent compared to the Paclitaxel-Eluting TAXUS ® stent: Demonstrated non-inferior rates of TVF at 9-months, with a significant 44% reduction in MACE Demonstrated non-inferior rates of TVF at 9-months, with a significant 44% reduction in MACE Showed a strong trend toward reduced ischemia-driven TLR, with a significant reduction in any TLR Showed a strong trend toward reduced ischemia-driven TLR, with a significant reduction in any TLR Had similar rates of death, MI and stent thrombosis Had similar rates of death, MI and stent thrombosis The primary and major secondary endpoints of the SPIRIT III trial were met The primary and major secondary endpoints of the SPIRIT III trial were met

34 Bivalirudin

35 Rationale for Use: Pharmacologic Intervention in Thrombosis UFH=unfractionated heparin. LMWH=low-molecular-weight heparin ADP=adenosine diphosphate. TFPI=tissue factor pathway inhibitor Selwyn A. Am J Cardiol. 2003;91:3H-11H. Coagulation cascadePlatelets LMWH Thienopyridines GP IIb/IIIa inhibitors Thrombolytics LMWH UFH LMWH UFH Direct thrombin inhibitors Tissue factor Factor Xa Prothrombin Thrombin Platelets A 2 vWF ADP Activated platelets Fibrinogen cross-linking Platelet aggregation Aspirin Fibrinogen Fibrin degradation Collagen Leukocytes TFPI Anti-thrombin Thromboxane Plasmin Thrombus

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48 Conclusion HORIZONS AMI Bivalirudin used during acute STEMI PCI as mono-therapy when compared to heparin + IIb/IIIa, Reduced bleeding complication. Reduced bleeding complication. Similar MACE Similar MACE Reduce cardiac death. Reduce cardiac death.

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

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52 Characteristic PCI + OMT (N=1149) OMT (N=1138)P Value Age – yr.62 ± ± Sex %0.95 Male85 % Female15 % Race or Ethnic group %0.64 White86 % Non-white14 % CLINICAL Angina (CCS – class) % and I42 %43 % II and III59 %56 % Median angina duration5 (1-15) months Median angina episodes/week3 (1-6) Baseline Clinical and Angiographic Characteristics 42 %43 % 3 (1-6) Boden W et al. NEJM. 2007;356:

53 Characteristic PCI + OMT (N=1149) OMT (N=1138)P Value CLINICAL Stress test0.84 Total patients – %85 %86 % Treadmill test57 % 0.84 Pharmacologic stress43 % Nuclear imaging – %70 %72 %0.59 Single reversible defect22 %23 %0.09 Multiple reversible defects65 %68 %0.09 ANGIOGRAPHIC Vessels with disease – %0.72 1, 2, 331, 39, 30 %30, 39, 31 % Disease in graft62 %69 %0.36 Proximal LAD disease31 %37 %0.01 Ejection fraction60.8 ± ± Baseline Clinical and Angiographic Characteristics 70% Multi-vessel Disease Boden W et al. NEJM. 2007;356:

54 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%) 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 Boden WE et al. NEJM. 2007;356: % BMS 3% DES

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56 COURAGE "Hard Outcomes" % of PatientsPCIOMTPCIOMTPCIOMTDeath Spontaneous MI Revascularization 9% 11% 33% with DES Moses, J. Data Analysis. April 2007

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61 COURAGE Nuclear Sub-study II Leslee J. Shaw, Daniel S. Berman, David J. Maron, G. B. John Mancini, Sean W. Hayes, Pamela M. Hartigan, William S. Weintraub, Robert A. ORourke, Marcin Dada, John A. Spertus, Bernard R. Chaitman, John Friedman, Piotr Slomka, Gary V. Heller, Guido Germano, Gilbert Gosselin, Peter Berger, William J. Kostuk, Ronald Schwartz, Merill Knudtson, Emir Veledar, Eric R. Bates, Benjamin McCallister, Koon K. Teo, William E. Boden for the COURAGE Investigators

62 Nuclear substudy (n=314 / 2287) Shaw et al. J Nucl Cardiol 2006;13: Documented pre-Rx ischemia PCI + OMT (n=159) OMT (n=155) Repeat MPS* at 6-18m Repeat MPS* at 6-18m 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) *timing chosen to occur beyond window of in-stent restenosis & delayed to allow effects of medical Rx to be observed pre-Rx = off meds to compare patient management strategy for ischemia reduction 6-18m = on meds Mean = 374 ±50 days

63 % ischemic myocardium: (stress TPD-rest TPD) (stress TPD-rest TPD) < 5%: minimal (no ischemia) < 5%: minimal (no ischemia) 5.0%-9.9%: mild 5.0%-9.9%: mild 10%: moderate-to-severe 10%: moderate-to-severe Significant reduction in ischemia: 5% reduction in ischemic myocardium* 5% reduction in ischemic myocardium* MPS ischemia based on total perfusion deficit (TPD) Slomka et al. J Nucl Cardiol 2005;12:66-77 Defect extent TPD Lower Nl limit Defect severity TPD: quantitative measure of defect extent & severity *threshold exceeds test repeatability

64 OMT (n=155) PCI + OMT (n=159) Mean = -2.7% (95% CI = -3.8% to -1.7%) 8.6% 8.1% (6.9%-9.4%) 8.2% 5.5% (4.7%-6.3%) MPS % ischemic myocardium (95% CI) pre-Rx & 6-18m Mean = -0.5% (95% CI = -1.6% to 0.6%) p <0.0001

65 Primary endpoint: % with ischemia reduction 5% myocardium (N=314) 19.8% p = % Ischemia reduction 5%

66 52.0% p = % Ischemia reduction 5% % with ischemia reduction 5% myocardium (n=105 moderate-to-severe pre-Rx ischemia)

67 RR=0.47 (95% CI= ) p =0.037 Rates of death or MI by ischemia reduction Death or MI rate (%) 24.7% 13.4% (n=82) (n=232)

68 p =0.001 Rates of death or MI by ischemia reduction in subset of 105 patients with moderate-to-severe pre-Rx ischemia (n=68) (n=37) 32.4% 16.2% Death or MI rate (%)

69 Rates of death or MI by residual ischemia on 6-18m MPS p =0.063 p =0.023 p =0.002 (n=23) (n=88) (n=141) (n=62) 22.3% 0.0% 39.3% 15.6% Death or MI rate (%)

70 Conclusions PCI added to OMT was more effective in reducing ischemia and improving angina than OMT, particularly in patients with moderate-to-severe pre-Rx ischemia Randomized trials of management strategies should evaluate quantitative measures of myocardial perfusion ischemia to guide clinical decisions regarding revascularization during long-term management

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84 Drug Eluting Balloon

85 Scheller Heart 2007, 93: DES vs. DEB (PACCOCATH) Hwang, Circulation 2001; 104: Instant and short term drug release from balloon ~ µg Paclitaxel No polymeres No permanent mechanical irritation Stenting optional Slow and continuous drug release from stent struts ~ µg Paclitaxel / Sirolimus Polymeres with associated reactions Implies stent deployment DES DEB

86 The Paclitaxel-Eluting PTCA-Balloon Catheter in Coronary Artery Disease PEPCAD I-SVD PEPCAD II-ISR

87 Outcome Comparison DEB ITT N=120 DEB Only N=82Taxus*BMS* Follow-up [mo] 6.4± ± ±1.299 Late loss [mm] 0.32± ± Restenosis (segment) 15.5%5.5%31.2%49.4% Total MACE 15%6.1%18.9%26.9%TLR11.7%4.9%10.4%21.5% Myocardial infarction 1.7%1.2%5.7%2.2% Cardiac death 0%0%1.9%1.1% *Stone, G JAMA 2005;294:

88 Summary PEPCAD I The paclitaxel-eluting balloon catheter Sequent Please (B.Braun Melsungen AG) … The paclitaxel-eluting balloon catheter Sequent Please (B.Braun Melsungen AG) … –was safe and associated with a high procedural success rate in de-novo lesions –exhibited low late lumen loss after 6 months in SVD –patients treated w/o additional stenting demonstrated a restenosis rate of 5.5%

89 The Paclitaxel-Eluting PTCA- Balloon Catheter in Coronary Artery Disease PEPCAD I-SVD PEPCAD II-ISR The Paclitaxel-Eluting PTCA- Balloon Catheter in Coronary Artery Disease PEPCAD I-SVD PEPCAD II-ISR

90 Event Free Survival (ITT/AsT) p=0.07 p=0.007 Months post PCI

91 Outcome (AsT: N=126) DEB (N=66) DES (N=60) P= Follow-up:clinical[months] 6.2 ± ± Follow-up: clinical [N] 64 (97.0%) 64 (97.0%) 60 (100%) 60 (100%)0.4 Follow-up: angiographic 58 (87.9%) 54 (90.0%) 54 (90.0%) Late lumen loss [mm] 0.19 ± ± ± Binary restenosis insegment 2/58 (3.4%) 11/54 (20.4%) 11/54 (20.4%) TLR 2/64 (3.1%) 2/64 (3.1%) 10/60 (16.7%) 0.02 Myocardial infarction 0/64 (0.0%) f 1/60 (1.7%) f 1/60 (1.7%)1 Death *2/64 (3.1%) **1/60 (1.7%) **1/60 (1.7%)1 Total MACE (w/o noncardiac death) 3/64 (4.7%) 11/60 (18.3%) 11/60 (18.3%)0.02 f NSTEMI due to side branch occlusion *1 cardiac, not lesion related 2 non cardiac ** non-cardiac death

92 The PEPCAD Program Paclitaxel-Eluting PTCA-Catheter in Coronary Artery Disease TitleDesignStatusPI PEPCAD I SVD Sequent in 2.8mm, 120px, multi-center, GER 6mo-FU 6mo-FU MU, CRI PEPCAD II ISR Sequent vs Taxus in ISR, 131px, multi-center, GER 6mo-FU 6mo-FU MU, CRI PEPCAD III Sequent + pre-loaded Coroflex Blue vs Cypher, 600 px, Europe Q2/07 active B.Scheller PEPCAD IV DM Sequent vs Taxus in DM, 160px, multi-center, Thailand, Malaysia Q2/07 active D.Rosli, MU, CRI PEPCAD V BIF Sequent, 25px, dual- center, GER Q3/ 07 active D.Mathey MU, CRI INDICOR Coroflex Blue+Sequent, Real World, 100px Planning U.Kaul, MU, CRI

93 2007, The year in PCI Conclusions DES DES –Multiple registries of real world DES usage showing that as compared to BMS DES improve outcome, and do so safely. Reduced mortality in some registries DES improve outcome, and do so safely. Reduced mortality in some registries Sustained reduction in TVR. Sustained reduction in TVR. Slight increase in ST beyond 6 months compensated by reduction in TVR. Slight increase in ST beyond 6 months compensated by reduction in TVR. –New DES, Everolimus-Eluting XIENCE V stent Similar rates of ST, MI and death Similar rates of ST, MI and death Favorable reduction in late loss and TVR. Favorable reduction in late loss and TVR. Bivalirudin Bivalirudin –When used during acute STEMI PCI as mono-therapy as compared to heparin + IIb/IIIa, Reduced bleeding complication. Reduced bleeding complication. Similar MACE Similar MACE Reduce cardiac death. Reduce cardiac death. PCI in stable CAD PCI in stable CAD –Courage trial, PCI with BMS for stable CAD vs. aggressive medical rx. only Similar mortality Similar mortality Similar outcome for composite death, MI, CVA, hospitalization for ACS. Similar outcome for composite death, MI, CVA, hospitalization for ACS. Reduced symptoms with decreased need for future revascularization. Reduced symptoms with decreased need for future revascularization. Nuclear sub study showed that patients with moderate to severe ischemia had nearly 50% reduction in death and MI. Nuclear sub study showed that patients with moderate to severe ischemia had nearly 50% reduction in death and MI. Residual ischemia is a predictor of increased mortality. Residual ischemia is a predictor of increased mortality.

94 2007, The year in PCI Conclusions Acute MI PCI Acute MI PCI –Use of thrombus aspiration catheter prior to stenting Improved myocardial blush grade Improved myocardial blush grade Improved ST resolution and reduced persistent ST deviation Improved ST resolution and reduced persistent ST deviation With improved myocardial perfusion, reduced mortality and MACE. With improved myocardial perfusion, reduced mortality and MACE. New Technology, DEB New Technology, DEB –Paclitaxel eluting DEB was safe and associated with a high procedural success rate in ISR was safe and associated with a high procedural success rate in ISR exhibited low late lumen loss after 6 months in ISR exhibited low late lumen loss after 6 months in ISR was superior to the paclitaxel-eluting Taxus stent in ISR after 6 months was superior to the paclitaxel-eluting Taxus stent in ISR after 6 months was not associated with late thrombosis in 250 patient years in ISR was not associated with late thrombosis in 250 patient years in ISR


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