REDUCE III Final Results

Transcription

1 REDUCE III Final Results Stenting after Cutting Balloon vs. Stenting after POBA Takahiko Suzuki, M.D. Toyohashi Japan

2 IVUS Findings for Cutting Balloon Angioplasty Dilatation Mechanism

3 IVUS Findings Plaque Reduction Vessel Expansion Pre Pre PA LA PA LA Post Post CB+Stent POBA+Stent Less Vessel Expansion More Plaque Reduction

4 Vessel Expansion Ratio Vessel Expansion Ratio (Post VA / Pre VA) 1.2 P< CB+Stent POBA+Stent Less Vessel Expansion

5 Dilatation Mechanism POBA Vessel stretch Vessel wall damage Plaque shift May lead to restenosis at follow-up

6 Dilatation Mechanism Cutting Balloon Less vessel stretch Less vessel wall damage More plaque compression May lead to a lower restenosis rate at follow-up

7 REDUCE III A prospective, randomized, multi-center trial run in Japan to answer the question: Is Cutting Balloon followed by stenting more effective than POBA stenting for reduction of restenosis?

8 REDUCE III p Prospective, multi-center, randomized study p 2 cohorts: CB + Stent vs. POBA + Stent p Target of 520 patients enrolled 260 patients randomized to each cohort p 38 Japanese centers participated as investigators p Primary Investigators: Tetsu Yamaguchi, M.D. Takahiko Suzuki, M.D. p Angiographic Core Laboratory: Aichi Medical University Angiographic Analysis Core Laboratory (AMAC) Yukio Ozaki, M.D. ; Tatsuya Yasukawa, M.D.

9 Current Analysis Status Enrollment: 523 patients Of the 523 patients 2 patients who were considered to be not suitable for the randomization were excluded from the study, because these two patients had already participated in another study. In the REDUCE III study 521 patients were randomly assigned to CB with stent arm (260 patients) or POBA with stent arm (261 patients). Of the 521 patients, 453 patients (87%) had angiographic follow-up.

10 Current Analysis Status Enrollment: Randomization: Overall: 523 patients Overall: 521 patients Follow-up: Angiographic F/U: 453 patients CB = 228 POBA = 225

11 Participating Centers Takahiko Suzuki, M.D. Kanazawa Medical University Hospital Michihiko Kitayama, M.D. Yamada Red Cross Hospital Hideo Nishikawa, M.D. Koshigaya Hospital - Dokkyo Univ. School of Medicine Teruo Inoue, M.D. Kikuna Memorial Hospital Fumihiko Usuba, M.D. Mitsui Memorial Hospital Kazuhiro Hara, M.D. Sekishinkai Sayama Hospital Masami Sakurada, M.D. Miki City Hospital Kojiro Awano, M.D. Osaka Medical Center for Cancer and Cardiovascular Disease Toru Kobayashi, M.D. Gifu Prefectural Hospital Hitoshi Matsuo, M.D.

12 Participating Centers Hoshi General Hospital; Keio University School of Medicine; Toranomon Hospital; Sakakibara Heart Institute; Dokkyo University School of Medicine; International Medical Center of Japan; Toho University Ohashi Hospital; Chiba Hokusoh Hospital; Meiho Itabashi Central Hospital; Toyooka Hospital; Tama Nambu Chiiki Hospital; Showa University School of Medicine; Mikihiro Kijima, M.D. Yasushi Asakura, M.D. Sugao Ishiwata, M.D. Tetsuya Sumiyoshi, M.D. Fumitsugu Oida, M.D. Mitsuo Kashida, M.D. Masato Nakamura, M.D. Kyoichi Mizuno, M.D. Tsutomu Tamura, M.D. Yoshinori Yasaka, M.D. Hiroyuki Takada, M.D. Mikitaka Murakami, M.D.

13 Participating Centers Ako City Hospital; Kawasaki Social Insurance Hospital; Komaki City Hospital; Tokyo Medical University Hachioji Medical Center; Nagoya Kyouritsu Hospital; Kyoto Katsura Hospital; National Toyohashi Higashi Hospital; Yokohama Sakae Kyosai Hospital; Aichi Prefectural Owari Hospital; Nagoya Dai-ni Red Cross Hospital; Himeji Cardiovascular Center; Osaka National Hospital; Masunori Mori, M.D. Toshiya Muramatsu, M.D. Taizo Kondo, M.D. Takashi Uchiyama, M.D. Tetsuo Matsubara, M.D. Osamu Kato, M.D. Hiroaki Hosokawa, M.D. Ichiro Michishita, M.D. Toyoaki Matsushita, M.D. Haruo Hirayama, M.D. Takatoshi Hayashi, M.D. Wakatomi Chin, M.D.

14 Study Flow 523 patients 521 patients Withdrawal 2 pt. CB+stent: 260 POBA+stent: pts. CB+Stent 1 pt. CB only pts. (87.7%) angiographic F/U Crossover 4 pts. POBA+Stent pts. (86.2%) angiographic F/U

15 Patient Characteristics CB POBA p (n=260) (n=261) Age Male Prior MI Prior CABG UAP LVEF 65±9 65±9 ns 78% 76% ns 33% 31% ns 0.4% 2.0% ns 26% 28% ns 60±12% 60±12% ns

16 Coronary Risk Factors CB POBA p (n=260) (n=261) Diabetes Mellitus Smoking Hypertension Hyperlipidemia 27% 34% ns 41% 45% ns 56% 60% ns 46% 43% ns

17 Lesion Characteristics CB POBA p (n=260) (n=261) Calcification Eccentricity Side branch Thrombus Restenosis lesion 20% 20% ns 57% 53% ns 28% 31% ns 3% 3% ns 9% 9% ns

18 Target Vessel RCA LAD LCx CB RCA LAD LCx POBA 21% 36% 19% 39% 43% 43% P = ns

19 Procedural Data Angiographic Success Procedural Success PCI procedures (n) CB and Stent CB only POBA and stent CB POBA p 260 (100%) 261 (100%) ns 258 (98.2%)* 261 (100%) ns ** 261 *Two MIs due to side branch occlusion and distal embolism **CB unable to cross the lesion

20 Minor Procedural Complications Perforation (transient, n) Distal Embolism (n) Side Branch Occlusion (n) Thrombus (temporary, n) Dissection (n) (> type C) CB POBA p (n=260) (n=261) 2 0 ns 4 4 ns 1 1 ns 1 2 ns 5 4 ns

21 Procedural and In-Hospital MACE CB POBA p (n=260) (n=261) Death (n) QMI (n) Emergent CABG (n) SAT (n) 0 0 ns 2* 0 ns 0 0 ns 0 0 ns * One patient had MI due to side branch occlusion and one had MI because of distal embolism

22 MACE at 6 month Follow-up CB POBA p (n=260) (n=261) Death (n) QMI (n) CABG (n) TLR (n,%) TVR (n,%) Overall (n,%) 1* 2** ns 2 1 ns 1 1 ns 27(10.4%) 39(14.9%) (10.8%) 40(15.3%) (12.3%) 42(16.1%) *= one cardiac death, **=one cardiac death and one noncardiac death

23 Stents Used Mul NIR S670 BX Velocity Other CB 111 Mul NIR S670 BX Velocity Other POBA p = ns

24 Acute QCA Data - 1 CB (n=260) POBA (n=261) p Lesion Length (mm) Pre Bal. Size (mm) Max. Pressure (atm) Number of Stents Implanted per lesion Stent/Artery Ratio 14.4± ±5.3 ns 3.33± ±0.40 ns 7.47± ± ± ±0.28 ns 1.22± ±0.18 ns

25 Acute QCA Data - 2 Pre RD (mm) Pre MLD (mm) %DS pre MLD post (mm) %DS post CB POBA p (n=260) (n=261) 2.82± ±0.47 ns 1.05± ±0.31 ns 63±9 63±9 ns 2.60± ± ±5 16±

26 Follow-up QCA Data CB POBA p (n=228) (n=225) RD (mm) MLD (mm) %DS Restenosis rate 2.73± ±0.47 ns 1.85± ±0.55 ns 32±15 35± % 19.1% Restenosis reduction 38.2%!

27 QCA Data Analysis Acute Gain (mm) Late Loss (mm) Relative Gain Relative Loss Net Gain (mm) Net Gain Index Loss Index CB (n=228) POBA(n=225) p 1.55± ±0.44 ns 0.74± ±0.51 ns 0.56± ±0.15 ns 0.27± ±0.19 ns 0.80± ±0.56 ns 0.28± ±0.20 ns 0.49± ±0.36 ns

28 %DS Cumulative Curve Restenosis rate CB : 11.8% POBA : 19.1% p = =CB =POBA % Diameter stenosis

29 Multivariate Analysis Variable Multiple Logistic Regression Analysis to Evaluate the Respective Contributions of Clinical, Angiographic & ICUS Variables to Categorical Restenosis (>50%DS) Regression Coefficient Standard Error of Regression Coeff. p CB use DM LAD location Vessel size by IVUS

30 Conclusions - 1 The high percentage of procedural success proved that Cutting Balloon (CB) angioplasty prior to stenting is a feasible and safe strategy for the treatment of coronary lesions. The similarity between CB stenting and POBA stenting in terms of procedural complications and cardiac events up to 6 months follow-up further supported the safety and efficacy of this strategy.

31 Conclusions - 2 This prospective multicenter randomized study indicated that CB stenting could convey a significantly lower restenosis rate than POBA stenting (11.8% versus 19.1%, p = 0.032), a 38.2% reduction of restenosis rate. CB stenting provided lower residual % diameter stenosis post-procedure than POBA stenting.

32 Conclusions - 3 Multivariate analysis indicated that not CB but POBA use, presence of DM, LAD lesion location and smaller vessel size assessed by IVUS were independent predictors for restenosis at follow-up. CB stenting could still have an impact on PCI practice even in the era of drug eluting stents.

33 Discussions in DES era Clinical Applications of Drug-Eluting Stents De novo ( mm) In-Stent Restenosis Diabetic Small vessel Bifurcation Others

34 Discussions in DES Era Mario, TCT 2003

35 Needs of plaque modification - Restenosis of side branch could not be improved by DES in bifurcation lesion - Therefore, plaque modification by predilatation is required in bifurcation so as to gain good long-term results after DES deployment - Cutting Balloon would be one of the most useful device for pre-dilatation which provides focal force and less vessel injury