PCI for Long Coronary Lesion

Transcription

1 PCI for Long Coronary Lesion Shift of a General Idea with the Introduction of DES

2 In the Bare Metal Stent Era

3 Higher Restenosis Rate With Increasing Stent Length and Decreasing Stent Area Restenosis Minimum in-stent area 6 35 Stent Length De Feyter. Circulation 1999; 1:

4 Spot Stenting vs. Long Stent 6 Months MACE Restenosis Rate Spot stenting Long stenting P<.5 P<.5 38 % 39 % 22 % 25 % Colombo A et al, J Am Coll Cardiol 21;38:

5 Single Stent vs. Multiple Stent Restenosis Rate % P = NS One stent (n=62) Two stents (n=62) Hoffmann R, et al. Am J Cardiol 22:9:46-464

6 Single Stent vs. Multiple Stent Contrast agent Cost-Effectiveness Intervention Cost ml Euros P =.56 P < One stent Two stent Hoffmann R, et al. Am J Cardiol 22:9:46-464

7 Stenting with Bare Metal Stent for Long Coronary Lesion It was suggested that Spot stenting Single stent

8 What is changing? In the Era of Drug Eluting Stent

9 No Increase of Restenosis with Increasing SES length SIRIUS : Sirolimus Eluting Stent % Control Sirolimus Stent Length (mm) TCT, Oct 22

10 TLR vs. Stent Length SIRIUS : Sirolimus Eluting Stent % Control Sirolimus Stent Length (mm) TCT, Sep 23

11 Relative Reduction of Restenosis Non-diabetic Ref Dia SIRIUS : Sirolimus Eluting Stent > 3.mm mm < 2.5mm < 12mm 81.7 % 79.8 % 77.6 % Lesion length mm 81.2 % 79.2 % 76.6 % 15mm 8.4 % 77.9 % 74.8 % Diabetic Ref Dia > 3.mm mm < 2.5mm < 12mm 78. % 74.1 % 69.6 % mm 77. % 72.7 % 67.8 % 15mm 75.3 % 7.2 % 64.5 % TCT, Oct 22

12 Restenosis in Lesions 1mm in stented segment TAXUS II : Paclitaxel Eluting Stent % P < Combined control (n=144).8 Combined TAXUS (n=133) Grube E, ACC, 23

13 Impact of Lesion Length in TAXUS IV Restenosis (analysis segment) 5 Control (n=652) TAXUS (n=662) P=.4 Restenosis P= P< N=9 N=9 N=124 N=153 N=53 N=47 <1 mm 1-2 mm >2 mm Lesion length (mm)

14 Full Metal Jacket in DES 71 patients (153 lesion, 29 SES) Lesion length : 52.1±23.1mm Reference vessel diameter: 2.59±.58mm Stented segment : 83.6±23.9mm Glycoprotein IIb/IIIa inhibitors: 65% Orlic D, ACC, 24

15 Full Metal Jacket in DES In-hospital events (postprocedure) Q-MI Non Q-MI (CK-MB>3 normal) 3 days outcomes Subacute stent thrombosis Death due to MI 6-month follow-up TLR Sirolimus (n=71) 1(1.4%) 15(21.1%) 1(1.4%) 1(1.4%) 7.2% Orlic D, ACC, 24

16 RESEARCH registry Stented length > 36 mm (de novo lesion) Study population Stented length Stents per lesion 6-month angiography 96 pts( 12 lesions) 62 ± 21mm( mm) 2.7 ±.9 (2-6) 67 patients (71%) Binary restenosis (DS > 5% ) : 11.9% Serruys PW ACC, 24

17 6-month Angiographic Follow-Up RESEARCH registry Proximal In-stent Reference vsl diameter Minimal lumen diameter % diameter stenosis Late lumen loss.2.13 In-lesion binary restenosis : 11.9% Distal Serruys PW ACC, 24

18 Clinical Follow-Up at 32 Days RESEARCH registry % 1 7% 5 5% 2% % Death MI TLR MACE Serruys PW ACC, 24

19 Comparison of Late Loss Stented length (mm) Late loss (mm) Kobayashi Tulip -angio guided Tulip -IVUS guided IMP ULSE-1 stent IM PULSE-2 stent ADVANCE RESEARCH Serruys PW ACC, 24

20 Long Cypher Multicenter Prospective non- Randomized Registry study for DES in Very Long Lesion ; -Preliminary Data- Coordinating center : Asan Medical Center, Collaborating centers Ajou University Medical Center, Catholic University of Korea, St Mary s Hospital, Chonnam Nat l University Hospital, Keimyung University Dongsan Medical Center, Korea University Kuro Hospital, Samsung Medical Center, Seoul National University Hospital, Yonsei University Severance Hospital, Yonsei University Wonju Christian Hospital, SJ Park SJ Tahk KB Seung MH Jeong KS Kim DJ Oh HC Gwon Lee MM, Koo BK YS Jang JH Yoon

21 Long Cypher Prospective, Non-randomized Multicenter, Registry Study in Korea From March 23 - February 24 De-novo Lesions ( 24mm) 487 patients, 597 lesions Cypher stent ( 28mm) 338 patients, 424 lesions Mean stent length : 41mm (28-92 mm) BMS stent ( 28mm) 149 patients, 173 lesions Mean stent length : 37mm (28 73 mm)

22 Long Cypher Lesion Characteristics Cypher Control P value (n=424) (n=173) Lesion length (mm) 33. ± ± Proximal reference (mm) 3.2 ± ±.55 <.1 Distal reference (mm) 2.63 ± ±.59 <.1 MLD (mm).72 ± ± Diameter stenosis (%) 74.2 ± ±

23 Stenting Procedure Long Cypher Cypher Control P value (n=424) (n=173) Used No of stents 1.55 ± ±.54 <.1 Overlapping 196 (46%) 44 (25%) <.1 Contiguous stent length (mm) 4.8 ± ± Maximal inflation pressure (atm) 15.4 ± ± 3.3 <.1 Maximal balloon size 3.31 ± ±.51.8 Balloon-to-artery ratio 1.11 ± ±.14 <.1 IVUS guidance 33 (72%) 71 (41%) <.1 Use of Abciximab 11 (3%) 7 (4%).492

24 Long Cypher Post-Procedure QCA Analysis Cypher Control P value (n=424) (n=173) Proximal reference (mm) 3.9 ± ±.55 <.1 Distal reference (mm) 2.56 ± ±.52 <.1 MLD (mm) 2.72 ± ±.54 <.1 Diameter stenosis (%) 2.7 ± ± Acute gain 2. ± ±.68.22

25 Angiographically normal reference vessels actually had 28-38% plaque burden when seen by IVUS N Proximal reference (mm 2 ) EEM CSA (mm 2 ) Lumen CSA (mm 2 ) Plaque burden (%) Distal reference EEM CSA (mm 2 ) Lumen CSA (mm 2 ) Plaque burden (%) ± ± ± ± ± ± 1.6

26 Postprocedural Stent CSA N 67 Stent (mm 2 ) EEM CSA Stent CSA 9.4 ± ± 2.5

27 In-Hospital Outcomes Long Cypher Procedural success * Death MI Q wave Non-Q wave *** Stent thrmbosis TLR TVR Cypher (n=338) 97.8% 29 (9%) 29 (9%) Control (n=149) 94.8% 1 (.7%) ** 18 (12%) 18 (12%) * Final TIMI flow 2 and residual diameter stenosis 3% ** No reflow after multivessel PCI *** CK-MB 3 times normal value P value

28 3-Day Outcomes Long Cypher Death Non-cardiac Cardiac MI Q wave Non-Q wave Sent thrombosis TLR TVR Cypher (n=338) 1 (.3%) * 1 (.3%) * Due to intracranial hemorrhage, 5 days after intervention Control (n=149) 1 (.7%) 1 (.7%) P value

29 6-Month Outcomes Long Cypher Death Non-cardiac Cardiac MI Q wave Non-Q wave Stent thrombosis TLR Repeat PCI CABG MACE Cypher (n=162) 1 (.6%) 1 (.6%) 1 (.6%) 1 2 (1.1%) Control (n=127) 1 (.8%) 1 (.8%) 18 (14.2%) (15.%) P value <.1 <.1

30 Long Cypher 6-Month QCA Analysis Cypher Control P value (n=117) (n=97) Proximal reference(mm) 3. ± ± Distal reference (mm) 2.6 ± ± MLD (mm) 2.54 ± ±.76 <.1 Diameter stenosis (%) 9.3 ± ± 22.2 <.1 Late loss (mm).31 ± ±.72 <.1 Restenosis 3 (2.6%) 42 (43.3%) <.1

31 Late Loss Long Cypher mm 2. SES (n=11) BMS (n=79) P<.1 P< P= P= In-segment Proximal edge In-stent Distal edge

32 Long Cypher Restenosis Rate % 5 SES (n=11) BMS (n=79) P<.1 P<.1 P=.2 P= In-segment Proximal edge In-stent Distal edge

33 Long Cypher Pattern of 3 Restenotic Cases % SES (n=3) 54.8 BMS (n=42) LAD 23 x 18, Focal, distal instent 54% LCX 28 x 23, Focal, distal instent 56% RCA, 33 x 23, Focal, overlapping area 82% Focal Diffuse Proliferative Total

34 Why not stent-overlap? Multiple Stent vs. Single Stent

35 Impact of Stent Overlapping SIRIUS : Sirolimus Eluting Stent Late loss (mm) In-stent In-segment Restenosis (%) In-stent In-segment Sirolimus (n=176) Control (n=168) P value <.1 <.1 <.1 <.1 TCT, Oct 22

36 Restenosis in > 1 Stent in stented segment TAXUS II : Paclitaxel Eluting Stent % P = Combined control (n=19). Combined TAXUS (n=14) Grube E, ACC, 23

37 Impact of Multiple Stents 6 5 Restenosis (analysis segment) TAXUS IV Control (n=267) TAXUS (n=291) 46.2 Restenosis P<.1 P= N=253 N=276 N=13 Single stent Multiple stents N=15

38 % 6 Restenosis Rate According to Multiple Stenting Long Cypher SES BMS P< Multiple stent 39.7 P<.1 Single stent N

39 Restenosis Rate According to % 5 4 Stent Overlap Long Cypher SES (n=56) BMS (n=2) P< Overlap site P< Non-overlap site

40 Area Change of Overlap Site Long Cypher mm Post-intervention Follow-Up P< Total 29 available lesions P<.1 P<.1 EEM P+M Lumen

41 Stent-overlap did not show any difference mm Area changes at 6 months F/U P=.68 Long Cypher Worst site in non-overlap Worst site in overlap P=.689 P= EEM P+M Lumen

42 Shift of an Idea for Long Lesion with DES the longer, the better Full lesion coverage Acceptance of stent-overlap

43 In Subgroups Does it applied to all patients and lesion subsets?

44 Long Cypher Restenosis Rate in DM % 6 SES (n=3) BMS (n=31) P< P<.1 P=.238 P= In-segment Proximal edge In-stent Distal edge

45 Long Cypher Restenosis Rate in LAD % 4 SES (n=73) BMS (n=39) P<.1 P= P<.1 P= In-segment Proximal edge In-stent Distal edge

46 Restenosis Rate in Long Cypher Acute Coronary Syndrome % SES (n=55) BMS (n=45) P<.1 P<.1 P=.88 P= In-segment Proximal edge In-stent Distal edge

47 Restenosis Rate in Long Cypher Small Vessel (<3.mm) % SES (n=76) BMS (n=5) P< P=.9 1 P< P=.1 In-segment Proximal edge In-stent Distal edge 14

48 Restenosis Rate According to Reference Diameter Long Cypher % 6 SES BMS P< P<.1 < > P=.544 N

49 Angiographic Restenosis SES BMS P-value Overall Male Female Diabetes No Diabetes LAD Non-LAD Small Vessel (<2.75) Large Vessel ACS Non ACS Overlap No Overlap < < < < < < < < < <.1 Hazards Ratio 95% CI Sirolimus better