Rationale for Percutaneous Revascularization ESC 2011

Transcription

1 Rationale for Percutaneous Revascularization Marie Claude Morice, Massy FR MD, FESC, FACC ESC 2011 Paris Villepinte August, 2011 Massy, France

2 Potential conflicts of interest I have the following potential conflicts of interest to report: Research contracts Consulting Employment in industry Stockholder of a healthcare company Owner of a healthcare company X Other(s): Lecture Fees ( minor)

3 - Is Left main stenting a recent possibility? - Can LM stenting be considered as a safe alternative to CABG? - Are only «simple LM lesions «to be treated by PCI? -Are all stents equivalent? - Do we need more evidence?

4 5-year outcomes following percutaneous coronary intervention with drugeluting stent implantation versus coronary artery bypass graft for unprotected left main coronary artery lesions the Milan experience. Chieffo A, Magni V, Latib A, Maisano F, Ielasi A, Montorfano M, Carlino M, Godino C, Ferraro M, Calori G, Alfieri O, Colombo A We included 249 patients in the study: 107 were treated with PCI and DES implantation and 142 with CABG. At 5-year clinical follow-up, no difference was found between PCI and CABG in the occurrence of cardiac death (adjusted odds ratio [OR]: 0.502; 95% confidence interval [CI]: to 1.461; p = 0.24). The PCI group showed a trend toward a lower occurrence of the composite end point of cardiac death and MI (adjusted OR: 0.408; 95% CI: to 1.061; p = 0.06). Percutaneous coronary intervention was associated with a lower rate of the composite end point of death, MI, and/or stroke (OR: 0.399; 95% CI: to 0.989; p = 0.04). Indeed, CABG was correlated with lower target vessel revascularization (adjusted OR: 4.411; 95% CI: to ; p = ). No difference was detected in the occurrence of major adverse cardiac and cerebrovascular events (adjusted OR: 1.578; 95% CI: to 3.054; p = 0.18). JACC Cardiovasc Interv Jun;3(6):

5 . Incidence, predictors, treatment, and long-term prognosis of patients with restenosis after drug-eluting stent implantation for unprotected left main coronary artery disease. Lee JY, Park DW, Kim YH, Yun SC, Kim WJ, Kang SJ, Lee SW, Lee CW, Park SW, Park SJ. RESULTS: The overall incidence of angiographic ISR in LMCA lesions was 17.6% (71 of 402 patients, 57 with focal-type and 14 with diffuse-type ISR. Forty patients (56.3%) underwent repeated PCI, 10 (14.1%) underwent bypass surgery, and 21 (29.6%) were treated medically. During longterm follow-up (a median of 31.7 months), there were no deaths, 1 (2.2%) MI, and 6 (9.5%) repeated target-lesion revascularization cases. The incidence of major adverse cardiac event was 14.4% in the medical group, 13.6% in the repeated PCI group, and 10.0% in the bypass surgery group (p = 0.91). Multivariate analysis showed that the occurrence of DES-ISR did not affect the risk of death or MI. J Am Coll Cardiol Mar 22;57(12):

6 - Is Left main stenting a recent possibility? - Can LM stenting be considered as a safe alternative to CABG? - Are only «simple LM lesions «to be treated by PCI? -Are all stents équivalent? - Do we need more evidence?

7 Cumulative Event Rate (%) SYNTAX LM Subset All-Cause Death/CVA/MI to 3 Years CABG (N=348) TAXUS (N=357) P= Before 1 year * 9.2% vs 7.0% P= years * 2.8% vs 3.2% P= years * 2.6% vs 3.0% P= Months Since Allocation 14.3% 13.0% ITT population

8 Cumulative Event Rate (%) SYNTAX LM Subset Repeat Revascularization to 3 Years CABG (N=348) Before 1 year * 6.5% vs 11.8% P=0.02 P= years * 5.0% vs 8.2% P=0.10 TAXUS (N=357) 2-3 years * 2.6% vs 3.9% P= % 0 Repeat CABG: 1.7% vs 5.6%, P=0.01 Repeat PCI: 10.0% vs 16.2%, P= % Months Since Allocation ITT population

9 Cumulative Event Rate (%) SYNTAX LM Subset CVA to 3 Years 40 CABG (N=348) P=0.02 TAXUS (N=357) 20 Before 1 year * 2.7% vs 0.3% P= years * 0.9% vs 0.6% P= years * 0.3% vs 0.3% P= % 1.2% Months Since Allocation ITT population

10 SYNTAX PROTOCOL (2004)

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13 Comparison between DES and CABG for ULM CAD: Meta- Analysis of 2 RCT and 13 Observational Studies Zheng, Cardiology 2011;118:22 32

14 Zheng, Cardiology 2011;118:22 32 Comparison between DES and CABG for ULM CAD: Meta- Analysis of 2 RCT and 13 Observational Studies Comparison of DES versus CABG for the early outcomes (<30d)

15 Comparison between DES and CABG for ULM CAD: Meta- Analysis of 2 RCT and 13 Observational Studies Comparison of DES versus CABG for death from 1 year to 5 years Zheng, Cardiology 2011;118:22 32

16 Comparison between DES and CABG for ULM CAD: Meta- Analysis of 2 RCT and 13 Observational Studies DES vs CABG for composite endpoint of death, MI, CVA from 1 year to 5 years Zheng, Cardiology 2011;118:22 32

17 Comparison between DES and CABG for ULM CAD: Meta- Analysis of 2 RCT and 13 Observational Studies DES versus CABG for revascularization from 1 year to 5 years Zheng, Cardiology 2011;118:22 32

18 - Is Left main stenting a recent possibility? - Can LM stenting be considered as a safe alternative to CABG? - Are only «simple LM lesions «to be treated by PCI? -Are all stents equivalent? - Do we need more evidence?

19 Patients (%) Patients (%) SYNTAX LE MANS TAXUS Cohort Primary Endpoint: 18% (21/114) 134/145 <50% stenosis at 15 mo 47/48 87/97 LM Non-distal LM distal <50% stenosis at 15 mo Definitions: Diameter stenosis was assessed by QCA

20 Patients % MACCE to 3 Years in LM Subgroups Complexity of Disease (no p values as not powered for subanalysis) CABG TAXUS P=0.20 LM P=0.52 P=0.33 LM P=0.09 LM P=0.20 LM All LM Isolated + 1VD + 2VD + 3VD 22,3 26,8 17,0 11,9 26,7 19,4 21,2 31,7 31,1 22,8 0 n=

21 - Is Left main stenting a recent possibility? - Can LM stenting be considered as a safe alternative to CABG? - Are only «simple LM lesions «to be treated by PCI? -Are all stents equivalent? - Do we need more evidence?

22 Drug-eluting versus bare-metal stents in unprotected left main coronary artery stenosis a meta-analysis. Pandya SB, Of a total of 838 studies, 44 met inclusion criteria (n = 10,342). The co-primary end points were mortality, myocardial infarction (MI), target vessel/lesion revascularization (TVR/TLR), and major adverse cardiac events (MACE: mortality, MI, TVR/TLR). Results At 3 years, the OR for DES versus BMS were: mortality 0.70 (95% CI: 0.53 to 0.92; p = 0.01), MI 0.49 (95% CI: 0.26 to 0.92; p = 0.03), TVR/TLR 0.46 (95% CI: 0.30 to 0.69; p < 0.01), JACC Cardiovasc Interv Jun;3(6):

23 Impact of drug-eluting stent selection on long-term clinical outcomes in patients treated for unprotected left main coronary artery disease: the sirolimus vs paclitaxel drug-eluting stent for left main registry (SP-DELFT). Meliga E, Garcia-Garcia HM, Valgimigli M, Chieffo A, Biondi-Zoccai G, Maree AO, Gonzalo N, Cook S, Marra S, Moretti C, De Servi S, Palacios IF, Windecker S, van Domburg R, Colombo A, Sheiban I, Serruys PW From April 2002 to April 2004, 288 consecutive patients who underwent elective PCI with DES implantation for de novo lesions on ULMCA have been retrospectively selected and analyzed in seven European and US tertiary care centers. All patients had a minimum follow-up of 3 years. SES was used in 152 patients while 136 received PES. Isolated ostial-shaft disease was present in 27% of patients. Distal LM disease (73%) was treated with single and double stent approach in 29.5% and 43.4% of patients respectively. After 3 years, rates of survival free from any of the events investigated, were independent from lesion location and stenting approach and did not differ significantly between SES and PES groups. Freedom from MACE (SES vs. PES) was 76.3% vs. 83.1% in the ostial/shaft group, 80.3% vs. 72.8% in the distal-single stent group and 67.1% vs. 66.2% in the distaldouble stent group. Definite stent thrombosis occurred only in 1(0.3%) patient at 439 days. CONCLUSIONS: In elective patients who underwent PCI for de novo lesions in the ostium, shaft or distal ULMCA, long-term clinical outcomes with SES and PES use were similar independently of lesion location and stenting technique Int J Cardiol Sep 11;137(1):16-21

24 LEMAX and TAXUS LM registries

25 SUMMARY - Is Left main stenting a recent possibility? NO! - Can LM stenting be considered as a safe alternative to CABG? YES! - Are only «simple LM lesions «to be treated by PCI? NO! DIFFUSION OF DISEASE FAVOR CABG -Are all stents equivalent? NO! NEW DES BETTER? - Do we need more evidence? YES!!!!!

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