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DR ALEX CHASE REGIONAL HEART CENTRE MORRISTON SWANSEA SLIDE MATERIAL:PERSONAL COMMUNICATION WITH AUTHORS ABBOTT, BOSTON SCIENTIFIC, CORDIS, MEDTRONIC TCT WEBSITE: www.tcdmd.com
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12 registries of DES use in 12 months DR ALEX CHASE REGIONAL HEART CENTRE MORRISTON SWANSEA do they work? are they safe?
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Swedish Coronary Angiography and Angioplasty Registry Adjusted Death 2003-04 N= 19 771 R.R. 1.32 95% CI (1.11 to 1.57) R.R. 1.09 95% CI (0.96 to 1.25) NEJM TCT 07 N= 35262 Adjusted Death 2003-05 2005 2006 % DES / month 2003- 21% DES R.R. 0.93 95% CI (0.76 to 1.13) 2005- 53.1% DES R.R. 1.31 95% CI (1.12 to 1.53) TCT 07 no difference in death or MI or both DES ‘on’ or ‘off’ all reproduced in single stent cohort tctmd.com
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2-yearMultiple Italy (13) 2002-2005 Real-world registry evaluating outcomes of DES and BMS 10,629 3,064 / 7,565 REAL 1-yearMultiple U.S. 2004 -2006 (3 waves) STEMI excluded Evaluation of DES used on and off-label and over time 3,323 (all DES) 1506 on / 1817 off EVENT 3 year MultipleSweden (26) 2003-04 Real-world registry evaluating outcomes of DES and BMS 19,771 6033 / 13738 SCAAR 2-yearMultiple Denmark (Multiple) 2002-05 Real-world registry evaluating outcomes of DES and BMS 12,395 3,548 / 8,247 Western Denmark 2-yearMultiple U.S. (MA) 2003-05 Propensity-matched analysis of DES vs. BMS outcomes 17,726 11,516 / 6,210 Massachusetts Evaluation of DES and BMS in an unrestricted patient population Landmark analysis comparing DES and BMS Case-matched propensity analysis of DES vs. BMS Real-world registry evaluating outcomes of DES and BMS Long-term evaluation of DES vs. BMS mortality in ST & NSTAMI patients Evaluation of DES and BMS used in all comers in off-label Real-world registry evaluating outcomes of DES and BMS Study Description 3,223 1460 / 1763 7,355 5,996 / 1,359 7,502 3751 / 3751 14,218 6,384 / 7,834 11,118 5719 / 5399 1,354 483 / 871 7,221 3,160 / 4,061 Number of Pts DES / BMS Multiple Single Number of Sites 1-year U.S. BMS 2001-02 DES 2004 NHLBI Dynamic Registry 2-yearU.S. (Southeast)STENT 2-3-year Canada Dec 03-Mar 05 Ontario 2-yearU.S. (NY)NY State Registry 2-year U.S. (NJ) did not report TVR MIDAS 2-3-year U.S. (PA) *(1)* 35% STEMI GHOST 3-year Korea *(1)* did not report TVR ASAN Years of Follow Up CountryRegistry
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do they work? revasc are they safe? mortality DES BMS
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are they safe? MI thrombosis DES BMS
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summary & any other business several studies (SCAAR, NHLBI, GHOST & EVENT demonstrated the safety and efficacy of DES off label (NHLBI :Greatest benefit TVR on label ( HR 0.44, 95% CI 0.28 ) vs off (HR 0.57, 95% CI 0.39 to 0.83) indications) GHOST: > 12 months dual anti-platelet was an advantage on sub-analysis several studies (MIDAS, ONTARIO, STENT & NY, ASAN & MASSACHUSETTS) demonstrated mortality benefit of DES vs BMS including STEMI and NSTEMI
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TCT 2007 Bifurcations Bad Krozingen M. Ferenc, H.J. Buettner, H.-P. Bestehorn, M. Gick, T. Comberg, K. Werner, J. Allgeier, J. Minners, R.-P. Kienzle F.-J. Neumann Heart Center Bad Krozingen / Germany ClinicalTrials.gov Identifier: NCT00288535 Cordis, Johnson & Johnson Company “The opposite of simple is not complicated, but wrong” “keep it simple stupid” “Avoid second stent at all costs” Systematic versus provisional T-stenting in the treatment of de novo coronary bifurcation lesions using sirolimus-eluting stents
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hypothesis In the treatment of coronary bifurcation lesions with sirolimus- eluting stents (CYPHER) systematic T-stenting of both main and the side branch reduces the restenosis in the side branch compared with provisional T-stenting TCTMD.com
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matched for lesion characteristics Medina A. Rev Esp Cardiol. 2006 Feb;59(2):183 1 3 2
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angiographic endpoints @ 9 months
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clinical endpoints @ 1 year
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conclusions Compared with provisional T-stenting, systematic T-stenting does not reduce in- segment percent diameter stenosis of the side branch. Provisional T-stenting yields a similar angiographic and clinical outcome as the more consumptive systematic T-stenting.
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Endeavor IV & Spirit III
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Taxus Endeavor colbalt alloy steel zotarolimus x 500 paclitaxel matched lesion characteristics matched post-procedural QCA 82.3% to 98.1% FU Endeavor IV- design & demographics *TVF = cardiac death, MI, or ischemia-driven TVR *
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8 month QCA 12 month clinical 1 o endpoint TVF @ 9 months non Q MI@ 30 days Endeavor 0.5%(4) vs Taxus 2.2%(17) diabetics risk TVF 9 months 7.7%(18) vs 8.4%(19) RR 0.91, p=0.99 Endeavor IV- the mesage -
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Endeavor IV - authors’ conclusions
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SPIRIT III - design & demographics PI: Gregg Stone, MD, 65 US sites RCT: Prospective, single blind Primary end point: In-segment Late Loss at 8M Stent Size: 2.5 – 3.5mm mm; Stent lengths: 8, 18, 28 mm 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 6 Months clopidogrel for all arms $$$ Abbott 2:12:1 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 N = 669 TAXUS ® Control N = 333 Stone ACC 2007 1002 pts everolimus paclitaxel
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% event @ 12 months SPIRIT III – the message Xience Taxus
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lunch
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