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DES in Bifurcation Lesions: Insight from the ICPS Registry

DES in Bifurcation Lesions: Insight from the ICPS Registry. T. Lefèvre On Behalf the ICPS Team. Bifurcation Lesion ICPS Registry. Study Design. Prospective registry (2003-2005) All consecutive DES patients Provisonal SB T-stenting strategy Clinical follow-up at 6, 12 months and 2 years

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DES in Bifurcation Lesions: Insight from the ICPS Registry

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  1. DES in Bifurcation Lesions: Insight from the ICPS Registry T. Lefèvre On Behalf the ICPS Team

  2. Bifurcation Lesion ICPS Registry Study Design • Prospective registry (2003-2005) • All consecutive DES patients • Provisonal SB T-stenting strategy • Clinical follow-up at 6, 12 months and 2 years • Angiography in case of ischaemia • Aspirin ≥75 mg/d, indefinitely • Clopidogrel 75 to 150 mg/d > 2/6 months (Cypher/Taxus)

  3. Age (years) 64+12 Male (%) 81 Risk factors (%) Diabetes 32 Hypertension 51 Hypercholesterolemia 55 Current Smoker 37 Previous CABG (%) 1.6 Indication for intervention (%) Stable Angina 45 Unstable Angina 33 Acute STEMI 3.6 Post MI 9.8 Silent Ischemia 8.6 Bifurcation Lesion ICPS Registry Clinical Characteristics (n=477)

  4. Number of diseased vessels (n) 1.97+0.78 Multi-vessel disease (%) 68 LV Ejection Fraction (%) 60+12 Ejection Fraction < 50% (%) 9.2 Bifurcation Lesion ICPS Registry Angiographic Characteristics

  5. Lesion Location % LAD / Diagonal 66 Circumflex / obtuse marginal 21 PDA / PLV 8 Other 5 Restenosis 5.2 Lesion Type Type 1 73 Type 2 4.9 Type 3 3.6 Type 4 8.5 Type 4a 5.1 Type 4b 5.1 Bifurcation angle Y Type (70) 80 T Type (70) 20 Bifurcation Lesion ICPS Registry Angiographic Characteristics (cont..)

  6. Radial Approach (%) 73.1 6 French Guide (%) 99.0 Stenting Strategy (%) PTS 92.3 T stenting, SB stent first 6.7 Culotte stenting 0.63 V stenting 0.42 Stents deployed (%) Main branch 99.0 Side Branch 28.8 Both Branches 27.8 Final Kissing inflation (%) 95.4 Bifurcation Lesion ICPS Registry Procedural Characteristics

  7. Angiographic Success* (%) Both Branches 98.6 Main Branch 99.6 Side Branch 98.8 Other coronary lesion(s) treated (%) 52.4 Bifurcation Lesion ICPS Registry Procedural Characteristics (cont...) * MB Lesion < 30%, TIMI 3 flow)/ SB lesion < 50%, TIMI 3 flow

  8. Bifurcation Lesion ICPS Registry In-hospital Outcome n=291/291 (Follow-up completed 100%) % 2.5 1.1 0.8 (Q and non Q: CPK > 3 times normal value) * Non Hierarchical Ranking

  9. Bifurcation Lesion ICPS Registry 6-months Follow-up n=291/291 (Follow-up completed 100%) % Non cardiac 7.8 2.5 0.2 2.3 1.9 0.8 (Q and non Q: CPK > 3 times normal value) * Non Hierarchical Ranking

  10. Bifurcation Lesion ICPS Registry 12-months Follow-up n=291/291 (Follow-up completed 100%) % Non cardiac 3.0 10.7 0.4 3.9 3.0 1.0 (Q and non Q: CPK > 3 times normal value) * Non Hierarchical Ranking

  11. Bifurcation Lesion ICPS Registry 24-months Follow-up n=291/291 (Follow-up completed 100%) % Non cardiac 13.7 3.7 1.7 5.2 3.7 1.8 (Q and non Q: CPK > 3 times normal value) * Non Hierarchical Ranking

  12. HR 95% CI p Success MB 0.001 0.0001 – 0.006 0.0001 Non use of PTS Strategy 4.04 1.23 – 13.3 0.022 Age (per year increase) 1.05 1.01 – 1.10 0.022 Nb vessel disease (per extra vessel) 1.81 0.95 – 3.45 NS Type 4 Lesion 3.24 0.94 – 11.14 NS MV stent length (per mm) 1.04 0.98 – 1.11 NS Bifurcation Lesion ICPS Registry Predictors of 2-year Death (binary logistic regression analysis)

  13. Angiographic success MB Non TVR TVR P value OR 0.07 (0.05 – 0.11) 0.0001 Patients (n) 413 41 - Diabetes (%) 30 44 0.06 Lesion location (%) NS Lesion angulation (%) NS Lesion type (%) NS Provisional T stenting (%) 94 90 NS Angiographic success 2 br. (%) 99 95 0.095 Angiographic success MB (%) 100 98 0.09 Angiographic success SB (%) 99 95 0.095 Bifurcation Lesion ICPS Registry Predictors of 2-year TVR

  14. Definite ST (N=6, 1.26%) Probable ST (N=6, 1.26%) Possible ST (N=5, 1.05%) Subacute 0.63% Subacute 0.84% Late 0.42% Late 0.42% Very Late 0.63% Acute 0.63% 3 patients all re-PCI no deaths /MI 3 patients all re- PCI 2 deaths 4 patients SCD day 3 CCF day 8 LVF day 7 CCF day 30 5 patients Sudden death 9m, 13m, 23m Unexplained death 12m Probable MI 24m 2 patients CCF, VF 10m VF post TVR 7m Bifurcation Lesion ICPS Registry Stent Trombosis At 2 years

  15. Bifurcation Lesion ICPS Registry Predictors of ST(Univariate analysis) * T stenting with SB stent first

  16. Bifurcation Lesion ICPS Registry Predictors of Definite In-hospital ST * T stenting with SB stent first

  17. Bifurcation Lesion ICPS Registry Predictors of Later ST * T stenting with SB stent first

  18. Bifurcation Lesion ICPS Registry Conclusion In this large real world prospective multicenter study on bifurcation lesions stenting using a predefined strategy of provisional SB T-stenting, we found that this approach can be used in about 90% of cases. We found very promising results up to 2 years.

  19. Bifurcation Lesion ICPS Registry Conclusion The risk of stent thrombosis remains acceptable compared to non bifurcation lesions. The only independant procedural predictor of death is the non use of a provisional SB T-stenting strategy. However, there is probably confounding factors.

  20. PTS (n=440) No PTS N=37) P value Age (years) 64+12 66+12 NS Male gender (%) 81.1 81.1 NS High Blood pressure (%) 81.1 81.1 NS Diabetes (%) 51.8 45.9 NS Dyslipidemia (%) 31.1 40.5 NS Smoker (%) 54.3 64.9 NS Stable angina (%) 45.0 40.5 NS Unstable angina (%) 32.3 43.2 NS Silent ischaemia (%) 8.6 8.1 NS Restenosis (%) 5.0 10.8 NS Acue MI (%) 3.9 0.0 NS Multivessel disease (%) 67.5 75.7 0.560 Ejection Fraction (%) 60+12 57+11 NS

  21. PTS (n=440) No PTS N=37) P value LAD-Diagonal (%) 65.2 75.7 NS Circ.-Marginal (%) 20.7 21.6 NS PDA-PLA (%) 8.6 0.0 0.070 T-Shape (%) 19.1 16.2 NS Type 1 (%) 72.0 62.2 NS Type 2 (%) 5.2 0.0 0.160 Type 3 (%) 3.6 2.7 NS Type 4 (%) 8.0 13.5 NS Stent both branches (%) 23.0 83.8 NS Final Kissing (%) 95.5 94.6 NS Stent length MB (mm) 20.6+6.9 21.9+7.7 NS Stent diameter MB (mm) 2.98+0.33 3.04+0.37 NS Stent length SB (mm) 13+4.8 16+5.8 NS Stent diameter SB (mm) 2.57+0.27 2.63+0.23 NS Other lesion treated (%) 31.1 43.2 NS Stent outside Bifurcation (%) 27.5 35.1 NS Success both branches (%) 98.9 94.6 NS Success main branch (%) 99.8 97.3 NS Success side branch (%) 98.9 97.3 NS

  22. No Death Cardiac Death p Patients (n) 444 17 Age (years) 63.9 ± 11.7 69.2 ± 11.7 0.66 Diabetes (%) 31 53 0.055 Unstable angina (%) 32 53 0.058 Number of vessel disease (%) 1.94 ± 0.78 2.53 ± 0.72 0.003 EF (%) 60 ± 12 43 ± 15 0.0001 LAD-Diagonal (%) 66 71 NS Type 1 (%) 72 71 NS Both branches stented (%) 26 47 0.09 A strategy (%) 6 24 0.02 B strategy (%) 93 77 0.03 Non B strategy (%) 7 24 0.03 Stent SB Taxus (%) 24 63 0.03 Success MB (%) 100 94 0.04 Success SB (%) 99 100 NS Stent MB length (mm) 20.7 ± 6.9 19.5 ± 7.9 NS Other lesions treated (n) 0.76 ± 0.90 0.90 ± 0.94 NS Number stents hors bif (n) 0.92 ± 1.07 1.15 ± 1.11 NS

  23. OR 95% CI P value Diabetes 2.16 1.22-3.82 0.008 Success both branches 0.09 0.02-0.44 0.003 Current Smoker 0.51 0.27-0.97 0.039 Acute MI presentation 4.21 1.30-13.7 0.039 Nb vessels diseased (per extra vessel) 1.55 1.07-2.25 0.02 Stent in SB 1.67 0.87-3.21 0.12 Bifurcation Lesion ICPS Registry Multivariate predictors of 2-year MACE (binary logistic regression analysis)

  24. OR 95% CI p Non use of PTS Strategy 5.46 1.63 – 18.3 0.006 SB not stented 0.90 0.31- 2.57 NS Nb stents outside bif. (per ex. stent) 1.51 1.11 -2.07 NS Type 4 Lesion 2.78 0.90 -8.53 NS MV stent length (per mm) 1.51 0.99-1.11 NS Bifurcation Lesion ICPS Registry Procedural predictors of 2-year Death (binary logistic regression analysis)

  25. Bifurcation Lesion ICPS Registry Cardiac death Death TVR MACE

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