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AHA: BASKET-PROVE
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  • 1. BASKET-PROVE Late Cardiac Death and MI Associated With Late Stent Thrombosis in Large Vessel Stenting After 1st or 2nd Generation DES Compared to BMS - the BASKET PROspective Evaluation Examination - (BASKET-PROVE) C.Kaiser , M. Pfisterer on behalf of the BASKET-PROVE Investigators supported by the Basel Cardiovascular Research Foundation and the Swiss National Foundation for Research, no industry sponsorship/involvementRegister ISRCTN 72444640
  • 2. Presenter Disclosure InformationC. Kaiser, MDBASKET-PROVEFINANCIAL DISCLOSURE:Advisory Board: Eli Lilly Switzerland, Daiichi-SankyoSwitzerland, Astra Zeneca SwitzerlandSpeakers Bureau: Biotronik Switzerland, Abbott VascularSwitzerland, Eli Lilly Switzerland, Daiichi-Sankyo SwitzerlandM.Pfisterer, MDBASKET-PROVEFINANCIAL DISCLOSURE:Advisory Board: Hoffmann La Roche Switzerland, PfizerSwitzerland, Eli Lilly SwitzerlandSpeakers Bureau: Abbott, Biotronik, Boston Scientific, Cordis,Medtronic Eli Lilly, Daiichi-Sankyo, Sanofi Aventis, Switzerland,
  • 3. BASKET-PROVE Background Cardiac death /MI 0.14 0.14 Cumulative death / MI Cumulative death / MI 0.12 0.12 0.10 0.10 p=0.16 DES Overall 0.08 0.08 BMS BMS 0.06 0.06 p=0.009 0.04 0.04 0.02 DES 0.02 DES BMS p=0.30 0.00 0.00 0 3 6 9 12 15 18 21 24 27 30 33 36 0 3 6 9 12 15 18 21 24 27 30 33 36 Follow-up (months) Follow-up (months)•BASKET-Trial Small Vessels (n=268) 0.20 0.20 Cumulative death / MI Cumulative death / MI BMS 0.15 0.15 BMS - 2003-2004 0.10 0.10 DES - single center 0.05 0.05 p=0.005 BMS DES - n= 826 0.00 p=0.08 0.00 DES p=0.57 0 3 6 9 12 15 18 21 24 27 30 33 36 0 3 6 9 12 15 18 21 24 27 30 33 36 - DES vs. BMS Follow-up (months) Follow-up (months) - unselected patients Large vessels 0.14 0.14 - 3-year outcome Cumulative death / MI Cumulative death / MI (n=558) 0.12 0.12 0.10 0.10 p=0.70 DES DES 0.08 0.08 0.06 0.06 0.04 0.04 DES p=0.006 0.02 BMS 0.02 p=0.01 BMS 0.00 0.00 BMS 0 3 6 9 12 15 18 21 24 27 30 33 36 0 3 6 9 12 15 18 21 24 27 30 33 36 Follow-up (months) Follow-up (months) --> DES: LATE CARDIAC DEATH/MI INCREASED IN LARGE VESSELS Eur Heart J 2009; 30:16-24
  • 4. BASKET-PROVE Hypothesis ⇒ In large vessels, compared to BMS, 1st generation DES - provide only a small reduction in TVR - may increase late cadiac death/MI AIMS ⇒ First aim: to prove or refute this hypothesis in an adequately sized prospective multicenter trial ⇒ Second aim: to evaluate whether a similar risk- benefit relation would also be found for 2nd generation DES
  • 5. BASKET-PROVE Study Design I Prospective, randomized, 11-center, 4-country study Intention to-treat analysis Inclusion 2’314 patients in need of >3.0mm stents irrespective of indication for PCI (March 2007 until May 2008) Randomization 1:1:1 to 1st generation SES (Cypher select ®) vs Cobalt-Chromium BMS (Vision ®) vs 2nd generation EES (Xience V ®)
  • 6. BASKET-PROVE Study Design IIExclusions shock, In-stent restenosis, stent thrombosis, unprotected LM or SVG, planned surgery < 12 months, increased bleeding risk/oral anticoagulation, vessels >4mm, no complianceFollow-up - after 12 and 24 months - angio for clinical indication only - ASS and Clopidogrel for 12 months in all patientsEndpoints: - 1° EP: Cardiac death / MI up to 24 months a) SES vs BMS b) EES vs BMS [c) SES vs EES] - 2° EP: Late cardiac death / MI (7-24 months) =“safety” TVR (non-MI-related) =“efficacy” death, cardiac death, MI, stent thrombosis, MACE,
  • 7. BASKET-PROVE Patient Flow Chart Included into study (n) 2‘314 Randomization to stent used SES EES BMS Intention to-treat population 775 774 765 Protocol violators 7 4 7 Withdrew consent 7* 7* 7* Lost < 1 year visit 8* 5* 3* Lost >1<2 year visit 9* 7* 6* Died < 2 years 21 25 34 2 year complete FU (97%) 751 755 749 * Censored at time of last contact
  • 8. BASKET-PROVE Baseline Patient Characteristics SES EES BMS n 775 774 765 Male (%) 74 76 77 Age (years) 66±11 66±11 67±11 Diabetes (%) 18 15 14 Hypertension (%) 62 61 65 Hypercholesterol. (%) 61 64 75 Current Smoker (%) 30 34 34 Prior MI (%) 13 10 13 Prior PCI/CABG (%) 16 15 15 Stable Angina (%) 34 35 37 UA/NSTEMI (%) 32 34 32 STEMI (%) 34 31 31 (No significant between group differences)
  • 9. BASKET-PROVE Baseline Vessel Disease and Intervention SES EES BMS Patients (n) 775 774 765 MV- disease (%) 44 41 43 LAD treated (%) 52 53 52 Bifurcations treated (%) 8 7 9 CTO treated (%) 5 4 5 GP IIb/IIIa blockers (%) 26 28 25 # of stented lesions/pat. 1.4±0,7 1.4±0,6 1.5±0,8 # of stents/patient 1.6±0.9 1.7±1,1 1.7±1,1 total stent length/pat. (mm) 30±20 31±23 31±23 ≥ 1 stent ≤ 2,5mm (%) 3 6 6 „Off-label“ use (%) 78 75 75 Les. with ang. Success (%) 98 98 98 (No significant between group differences)
  • 10. BASKET-PROVE 1° EP (Cardiac death/MI) up to 24 MonthsSES vs BMS SES EESEES vs BMS BMSSES vs EES NOT adjusted for multiple comparisons, time-dependent p-values !!
  • 11. BASKET-PROVE 2° Endpoints up to 24 Months Cardiac Death Non fatal MI Definitive and probable Non-MI related TVR Stent Thrombosis Significant after adjustment for multiple comparisons SES EES NOT adjusted for multiple comparisons, time-dependent p-values !! BMS
  • 12. BASKET-PROVE Cumulative Clinical Events After 2 Years * p=0.005 SES vs BMS † p=0.009 SES vs BMS * p=0.002 EES vs BMS † p=0.005 EES vs BMS % 15 12.9† p=ns p=ns p=ns p=ns p=ns p=ns 10.3 * 10 7.9 7.6 4.8 4.4 4.3 5 3.7 3.6 3.2 2.9 3.2 2.6 2.6 1.7 1.7 1.7 0.9 0 all-cause cardiac MI Pts. with TVR Pts. with death death Cardiac death/ MACE MI P-values adjusted for multiple testing SES EES BMS
  • 13. BASKET-PROVE Conclusions In contemporary stenting of large coronary arteries > late safety problems of DES could no longer be confirmed (trend in opposite direction!) > both DES showed superior efficacy compared with BMS (TVR reduction >50%) > no difference in either safety or efficacy was found between 2nd generation EES and 1st generation SES (exploratory analysis)
  • 14. BASKET-PROVE Implications Findings of BASKET-PROVE imply that in patients in need of large coronary artery stenting > DES may be used without evidence of increased late cardiac events / late stent thrombosis > Since BMS and DES showed similar death / MI rates BMS may still be used - however, with a higher TVR-rate > Since the performance of 1st and 2nd generation DES (SES and EES) was similar both DES may be used in these patients
  • 15. BASKET-PROVE The BASKET-PROVE Centers (number of patients randomized) University Hospital Basel,Gentofte University Hospital, Switzerland (n=496) Cardiocentro Lugano,Copenhagen, Denmark (n=402) C. Kaiser Switzerland (n=154)S. Galatius G.PedrazziniState Hospital Lucerne, Clara Hospital Basel,Switzerland (n= 337) Switzerland (n=132)P. Erne B. HornigTriemli Hospital Zürich, Cardiovascular CenterSwitzerland (n= 264) Zürich, Switzerland (n=59)F. Eberli O. BertelUniversity Hospital Innsbruck, State Hospital Chur,Austria (n=199) Switzerland (n= 56)H. Alber P. BonettiState Hospital St. Gallen, Opedale Civile, Legnano,Switzerland (n=174) Italy (n=41)H. Rickli PI: M. Pfisterer S. De Servi Co-PI: C. Kaiser
  • 16. BASKET-PROVE Online Today !