LM stenting - Cypher

Transcription

1 LM stenting - Cypher Left main stenting with BMS Since 1995

2 Issues in BMS era AMC Restenosis and TLR (%) 3 27 TLR P=.282 Restenosis P= Ostium 5 4 Shaft Bifurcation

3 Left main stenting with DES Not enough data, But promising

4 Published Data using DES Arampatzis CA, et al. Catheter Cardiovasc Interv. 24;62:292-6 Elective sirolimus-eluting stent implantation for left main coronary artery disease: six-month angiographic F/U and 1-year clinical outcome. Arampatzis CA, et al. Am J Cardiol. 23;92: Chieffo A, et al. Circulation 25;111:791-5 Park SJ, et al. J Am Coll Cardiol. 25;45: Effectiveness of sirolimus-eluting stent for treatment of left main coronary artery disease. Early and mid-term results of drug-eluting stent implantation in unprotected left main. Sirolimus-eluting stent implantation for unprotected left main coronary artery stenosis: comparison with bare metal stent implantation.

5 SES Implantation from RESEARCH 16 Elective (9 unprotected) LMCA Intervention In-hospital outcome Deaths MI TLR Overall MACE Late outcome at 1 year Deaths MI TLR Overall MACE 1 (6%) 1 (6%) 1 (6%) 1 (6%) Arampatzis CA et al. Catheter Cardiovasc Interv 24;62:292

6 DES vs. BMS in Milan Six-month clinical and angiographic follow-up 5 BMS (n=64) DES (n=85) Event rate (%) 2 1 P= P=.18 P=.11 P=.3 Cardiac death Restenosis TLR MACE Chieffo A et al. Circulation 25;111:791

7 Teirstein PS et al, TCT 24 29% TLR at 3 Months % % in side branch restenosis Cypher in 49 Pts Death MI TLR Stent thrombosis MACE

8 e - Cypher Registry, Barragan P et al, AHA 24 Very low clinical event rates at 6 months % 1 8 Cypher in 221 Pts Death MI TLR MACE

9 Summary DES for LMCA Stenosis Much improved early mortality : 4 % compared to that of BMS era Various TLR rates from % Stenting on the LM trunk would be good enough in real practice Left circumflex ostium is main TLR site LM bifurcation PCI should be needed appropriate treatment strategy

10 LM Cypher Study in AMC Comparison with BMS

11 Unprotected LMCA Cypher in AMC From Feb 23 till Dec 24 Total 178 patients Proximal involvement Ostium Shaft Distal involvement 47 (26 %) (74 %)

12 LMCA Intervention in AMC Matched Comparison with BMS BMS group SES group 121 patients 12 patients March 21 March 23 March 24 Park SJ et al, J Am Coll Cardiol 25;45:351

13 More LM Bifurcation stenting 149 pts with SES (Feb 23-Sep 24) 121 pts with BMS (Feb 21-Jan 23) BMS SES 48% 9% 43% 24% 6% 71% P<.1 Ostium Shaft Bifurcation % 5% 1% Park SJ et al, J Am Coll Cardiol 25;45:351

14 Multiple & Longer Stents SES BMS P Reference diameter, mm 3.46± ±.69 <.1 Stents per patient 2.1±1. 1.6±.7 <.1 Stents per lesion 1.6±.9 1.1±.4 <.1 Total stent length, mm 26.6± ±5.5 <.1 Final balloon size, mm 3.9± ±.55 <.1 Inflation pressure, mm 18.5± ±2.6 <.1 Balloon/Artery ratio 1.1±.3 1.1±.2.29 Park SJ et al, J Am Coll Cardiol 25;45:351

15 Fewer Debulking, More Direct Stenting SES BMS P Patients Multivessel PCI 63 (42.3) 42 (34.7).254 Direct stenting 67 (45.) 21 (17.4) <.1 Debulking atherectomy 3 (2.) 4 (33.1) <.1 IVUS guidance 129 (86.6) 91 (75.2).39 GP IIb/IIIa inhibitor 1 (6.7) 6 (5.).376 IABP support 6 (4.) 5 (4.1).782 Park SJ et al, J Am Coll Cardiol 25;45:351

16 In-Hospital Outcomes Procedure Success (%) Death Q MI Non-QMI SAT Emergent CABG Repeat PCI BMS N= (8.3%) * All procedure related, CK-MB 3 times normal value SES N= (7.4%) Park SJ et al, J Am Coll Cardiol 25;45:351

17 Overall Restenosis Rate : 7.9 % (%) 4 SES BMS P=.3 P=NS. P= /35 13/48 /5 2/9 1/86 15/42 Ostium Shaft Bifurcation Park SJ et al, J Am Coll Cardiol 25;45:351

18 Left main stenting with DES Ostial and Shaft lesions intervention

19 LM ostial or shaft lesions Total 47 patients Age 61 ± 13 Male 28 (6%) Hypertension 17 (36%) Diabetes 12 (26%) Smoking 11 (23%) Hypercholesterolemia 1 (21%) Previous PCI 1 (21%) Acute coronary syndrome 27 (57%) LV EF (%) 6 ± 1

20 Procedural Findings Used stent IVUS guidance Stent size 3. mm 3.5 mm Mean stent length, mm Maximal device diameter, mm Cutting balloon Use of reopro Debulking atherectomy Single in all pts 38 (81%) 1 (21%) 37 (79%) 13.6±5.3 4.±.4 1 (2.1%) 1 (2.1%) 1 (2.1%)

21 Angiographic Analysis Lesion length, mm Reference, mm Minimal lumen diameter, mm Before procedure After procedure At follow-up Acute gain, mm Late loss, mm Restenosis 9.3 ± ± ± ± ± ±.66.2 ±.23 (%)

22 Clinical Outcome Mean F/U duration, months Death Myocardial infarction Q-wave Non-Q-wave * Stent thrombosis Target lesion revascularization 13.1 ± (4.3%) * procedure-related, no event after discharge

23 DES for Ostial and Shaft LMCA stenosis No Mortality No Restenosis No TLR rate

24 Left main stenting with DES Bifurcation lesions intervention

25 13 patients with LMCA bifurcation lesions Demographic data Age, yr Male Hypertension Diabetes mellitus Hypercholesterolemia Current smoking Previous PCI Acute coronary syndrome Multivessel except LMCA Left ventricular ejection fraction, % 59.6± (78%) 48 (47%) 29 (28%) 23 (22%) 26 (25%) 15 (15%) 57 (55%) 55 (53%) 6.4±7.7

26 Different Treatment Strategy Unprotected Left Main Bifurcation Stenting Stenting Cross Over Kissing Stenting Stent Crushing T-stent technique

27 More Complex LM Bifurcation Stenting 13 pts with SES vs. 51 pts with BMS for bifurcation LM disease BMS SES 82% 2%16% P<.1 6% 21% 1% 19% Crossing LCX Kissing T-stenting Crushing % 5% 1% Park SJ et al, J Am Coll Cardiol 25;45:351

28 Restenosis Rate of Bifurcation Overall % 3 2 P= /86 3/52 3/18 4/25 Total Across LCX Kissing Crush

29 Restenosis Rate of Bifurcation % Main Vessel P= /86 /52 2/18 /16 Overall Across LCX Kissing Crush

30 Restenosis Rate of Bifurcation Circumflex Ositum % 3 2 P= /86 3/52 1/18 4/25 Total Across LCX Kissing Crush

31 Restenosis Rate of LM Bifucation DES vs BMS 86 pts with SES vs. 42 pts with BMS 5 SES BMS P= P=.1 P= Pts Overall Main vessel Side branch

32 TLR : 4.7% in LM Bifurcation PCI 4/ 86 patients % 2 1 2/18 (11.1%) 1/18 (5.6%) 2/25 (88 %) Cross- over Kissing Crush T stenting (n=52) 2 TLR 2 TLR (n=18) (n=25) (n=1) Side Branch Main Branch

33 Left main stenting with DES Over-all

34 6-months Clinical Outcomes Death Q MI Non-QMI SAT TLR * CABG PCI BMS N= (19.8%) SES N=126 4 (3.1%) 2 * p<.1 Park SJ et al, J Am Coll Cardiol 25;45:351

35 MACE free Survival at 1 year 1 SES group MACE free survival (%) P<.1 BMS group 96.2 ± 1.4% 81.4 ± 3.7% Months Park SJ et al, J Am Coll Cardiol 25;45:351

36 PCI for LMCA disease Simple technique, Acceptable overall restenosis and TLR rate (7.9% and 3.1%) PCI No restenosis may be in more ostialeffective and shaft alternative LM stenting to bypass For LM surgery bifurcation lesions, we could we do have appropriate to find more appropriate treatment strategy. However, Restenosis and treatment TLR rate with (11.6% DES and 4.7%) in AMC data were acceptable