1. Conventional Stenting Following Predilation and/or Debulking Is Better Than Direct Stenting Myeong-Ki Hong, MD, PhD Asan Medical Center, Seoul, Korea

2. Conventional stenting vs. Direct stenting - Safety & Feasibility -Procedural data & Costs -Procedure-related complications -Long-term outcome -Case selections

3. Safety & Feasibility Success rate No. of pts Type of stents Authors 80%61PS, NIR, JOFigulla HR, CCD 1998 92%39NIRNIR future trial (random), CCI 2000 96%123VariousBriguori c, JACC 1999 97%61NIR, Paragon Danzi GB (random), AJC 1999 86%173TenaxBET random study, AJC 2001

4. Several studies reported that most cases in the failure of direct stenting was successfully treated after predilation without stent dislodgement & stent damage. However, ……. Safety & Feasibility

5. Success rate No. of pts Type of stents Authors 80 % 61PS, NIR, JOFigulla HR, CCD 1998 86 % 173TenaxBET random study, AJC 2001 Failure rate: 14-20%

6. SuccessfulUnsuccessful Number of patients4912 Age (years) 61  1272  8* Lesion type(A/B1/B2/C)23/16/6/33/3/5/1 Lesion stenosis(%) 88  1081  11* Lesion length(mm) 8.9  7.47.3  3.8 Ang. calcification19%75%* Tortuous segment21%33% *p < 0.01. Safety & Feasibility Figulla HR, et al. Cathet Cardiovasc Diagn 1998; 43: 245-52

7. Stent dislocation Figulla HR, et al. ( Cathet Cardiovasc Diagn 1998; 43: 245-52) 3 of 61 cases, PS stents 2 calcified lesions & 1 extremely tortuous lesion Manually crimped bare slotted-tube stents on low-profile dilatation balloons Coil-type stents Safety & Feasibility

8. Case: Female, 67 years old Unstable angina IIIb EKG: ST-change in precordial leads Three vessel disease (culprit: LAD, LAD 70-85% tubular narrowing, LCX 70% diffuse narrowing, RCA 60-70% focal narrowing) DM for 10 years CABG was recommended. However, she refused to take bypass surgery. Very tortuous descending Aorta Intervention of LAD first, LCX for 1 and ½ hours, and then

9. Before StentingAfter Stenting

10. Before Stenting Direct stenting was initially tried. However, the stent delivery was not successfully performed. During the stent delivery, several resistances were noticed. Successful stenting was done after predilation.

11. Coil-type stents

12. Before Stenting After Stenting 조선일보 2002,2,8 진료실 엿보기 내과의사 박성진 Most cases in the failure of direct stenting was successfully treated after predilation without stent dislodgement & stent damage

13. Procedural Data Stent without Predilation Stent with predilation p value No. of balloons0.3 ± 0.71.4 ± 0.7<0.001 Procedural time (min) 41 ± 2059 ± 23<0.001 Fluoroscopic time (min) 7 ± 311 ± 7<0.001 Procedural data & costs Danzi GB, et al. Am J Cardiol 1999: 84; 1250-53

14. Resource UtilizationAverage Cost/Patient ($) Stent With Predilation Stent Without Predilation Unit Cost ($) Stent With Predilation Stent Without Predilatio n P Value Fixed procedure costs 11 295 1.0 Contrast medium(ml) 1421140.5 71 570.003 Guiding catheter 1.02 124 126 1.0 Guidewire1.051.00 146 153 146 0.08 Balloon 1.350.43 7761,048 334<0.001 Premounted stent 1.051.021,4121,4831,440 0.3 Total procedure costs 3,1762,398<0.001 Procedural data & costs Danzi GB, et al. Am J Cardiol 1999: 84; 1250-53

15. Procedure-related complications -Post-stent dissection -Additional stent implantation -Distal embolization -No reflow

16. Angiographic Complications Direct (216 lesions) Predilation (209 lesions) P Value Poststenting dissection 12(5.6%)16(7.7%)0.38 Mild11(5.1%)12(5.7%)0.77 Severe (types E-F)1(0.5%)4(1.9%)0.21 Distal embolization2(0.9%)2(1.0%)1.00 No-reflow4(1.9%)3(1.4%)0.96 Procedural complications DIRECT random study, Am J Cardiol 2002;89: 115-120

17. 52 세 남자 환자가 내원 3 시간 전 부터 안정시 발생한 흉통을 주소로 응급실에 내원하였다. 과거력상 2 년전에 운동시 발생하는 2 분간의 흉통으로 개인의원 에서 협심증으로 진단을 받았고, 그 후 지속적으로 항협심증 제제를 복용하였 다고 하였다.

18. 내원 당일 흉통은 안정시 발생하였으며, 3 시간 동안 지속되었다. 응급조치로서 sublingual NTG 를 3 회 반복 투여하였으 나 증상의 호전이 없어서 응급실에 내 원하였다. 내원 당시 혈압은 100/70mmHg 이었으며, 심전도 소견은 다음과 같았다.

20. Pre-stenting 1 stent2 stents Additional stenting

21. Pre-stenting 2 stents 하나 더 ! I will NEVER do direct stenting again. 조선일보 2002,3, 진료실 엿보기 내과의사 박성진 ?

22. Role of IVUS in Direct Stenting

23. Angiograpically Silent Disease In 884 native coronary arteries, the plaque burden in the anigographically “normal” reference segment was 51  13% Mintz GS, et al. Atherosclerosis in angiographically normal coronary artery reference segments. J am Coll Cardiol 1995;25:1479-1485

24. IVUS are of target lesion calcification Mintz et al. Patterns of calcification in coronary artery disease. Circulation 1995;91:1959-1965. Arc of lesion calcium 0o0o  90 o 91-180 o 181-270 o 271-360 o % of lesions 27 % 11% 26 % 25% 21 % 50% 15 % 60% 27 % 11%

25. IVUS eccentricity index Mintz et al. Limitations of angiography in the assessment of plaque distribution in coronary artery disease. Circulation 1996;93:924-931 Eccentricity index = max/min P + M thickness 1.0 – 3.0 3.1 – 5.0 5.1 – 7.0  7.1 57 % 53% 28 % 60% 8 % 61% 7 % 68% % of lesions

26. IVUS lumen-QCA (mm)IVUS midwall (mm)IVUS EEM-QCA (mm) -2 0 1 42 3 % -2 0 1 42 3 % -2 0 1 42 3 %

27. IVUS vs. QCA Assessment of Lesion Length IVUS lesion length (mm) QCA lesion length (mm) IVUS-QCA length = 0.6  7.2 mm +1 SD Mean -1 SD

28. DIRECT random study 0.5 0 0 3.8 3.5 1.0 3.8 P=NS % Am J Cardiol 2002 : 89 : 115 - 120 Long-term outcomes In-hospital events

29. 2.5 1.4 8.2 14.5 10.5 12.5 P = NS 5.3 5.0 % DIRECT random study Long-term outcomes Am J Cardiol 2002 : 89 : 115 - 120 6-month follow-up

30. BET random study In-hospitalPredilation (n=165) Direct (n=173) Crossover rate24 (13.9%) Subacute thrombosis01 Myocardial infarction20 Death10 Hematoma12 Clinical success (%)97.598.3 P=NS Long-term outcomes Am J Cardiol 2001; 87: 693-698

31. Eight month events (%) Predilation (n=165) Direct (n=173) Target lesion revascularization 5.53.5 Major adverse cardiac events 11.45.3 P=NS BET random study Long-term outcomes Am J Cardiol 2001; 87: 693-698

32. MACE During Follow-up Event Stent Without Predilation (n=61) Stent With Predilation (n=61) Death00 MI00 TLR11 (18%)9 (15%) CABG5 (8%)3 (5%) Repeat angioplasty6 (10%) Long-term outcomes Danzi GB, et al. Am J Cardiol 1999: 84; 1250-53

33. Case Selection Possible inappropriate lesions for direct stenting 1.Long lesion 2.Presence of severe calcium by fluoroscopy 3.Total occlusion 4.Inadequate positioning of the stent due to severe stenosis  impairment of distal coronary flow 5.Significant angulation(bend > 45°) 6.Bifurcation lesion 7.Severe tortuosity of the vessel proximal to the target segment 8.Poor guiding catheter beck-up support

34. Major disadvantage of direct stenting 1.Potential failure to cross the stenosis with stent 2.Potential risk of encountering an undilatable lesion Case selection

35. The case selection must be the most important factor for direct stenting Case selection

36. Critical narrowing at RCA ostium: Calcification Poor back-up support Case selection

37. Subtotal occlusion at distal RCA: Long journey to the target lesion site Case selection

38. Heavy calcification Case selection

39. Primary angioplasty due to evolving MI at 2:00 AM Total occlusion with heavy thrombi Unable to measure the lesion length Case selection

40. The lesion itself: very very simple Very very severe tortuosity of the vessel proximal to the target segment Case selection

41. Lesion with Intermediate or short length Stent length ? Case selection

42. 치료 전치료 후 Do you always want to perform the intervention only in such a simple lesion ?

43. Heart Liver spleen  간 빼고, 쓸개 빼고, 뺀 김에 심장도 빼고나면 남는 것은 ? Simple lesion Lipid Tx CABG ?

44. Therefore, conventional stenting following predilation is better than direct stenting.