Abstract Background: Methods: Results: Conclusions:

Transcription

1 Two-Year Clinical and Angiographic Outcomes of Overlapping Sirolimusversus Paclitaxel- Eluting Stents in the Treatment of Diffuse Long Coronary Lesions Kang-Yin Chen 1,2, Seung-Woon Rha 1, Yong-Jian Li 3, Guang-Ping Li 2, Ji-Young Park 1, Sureshkumar Ramasamy 1, Cheol Ung Choi 1, Chang Gyu Park 1, Hong Seog Seo 1, Dong Joo Oh 1 1: Cardiovascular Center, Korea University Guro Hospital, Seoul, Korea 2: Cardiology Department, the Second Hospital of Tianjin Medical University, Tianjin, China 3: Cardiology Department, Nankai Hospital, Tianjin Medical University, Tianjin, China

2 Abstract Background: The clinical and angiographic outcomes after sirolimus- and paclitaxel- eluting stents implantation in patients (pts) with coronary artery disease were not different in many studies. However, less has been known whether these two stents had similar efficacy in the treatment of diffuse long lesions with same overlapping stents strategy. Methods: A total of 174 pts who underwent percutaneous coronary intervention (PCI) with overlapping sirolimus- (SES group: Cypher, n=61 pts, 106 lesions) or paclitaxel- eluting stents (PES group: Taxus, n=122 pts, 276 lesions) were enrolled. Angiographic at 6 months and clinical outcomes at 2 years were evaluated. Results: Both groups had similar baseline clinical and procedural characteristics. Six-month angiographic results showed that PES group had more late loss, higher restenosis percentage and binary restenosis as compared with SES group. Two-year clinical outcomes showed that PES group had higher incidences of target lesion revascularization (TLR), target vessel revascularization (TVR), and major adverse cardiac events (MACE) as compared with SES group. The incidences of cardiac death, Q-wave myocardial infarction (MI), non-q-wave MI did not differ between the two groups. PES group had 3 cases of acute, 0 case of subacute, and 1 case of late stent thrombosis, while SES group didn t have any stent thrombosis throughout the follow-up period. Conclusions: The treatment for diffuse long lesions with overlapping SES had more favorable angiographic outcomes at 6 months which could be translated into superior clinical outcomes at 2 years as compared with overlapping PES, suggesting SES would be preferred for this subset of lesions.

3 Background 1. The clinical and angiographic outcomes after the implantation of sirolimus- and paclitaxeleluting stents in the patients with coronary artery disease were similar. 2. However, less has been known whether these two stents had similar efficacy in the treatment of diffuse long lesions with same overlapping stents strategy. J Am Coll Cardiol, 2006,48:21-31 Circulation, 2006,114: Am J Cardiol, 2006,98:

4 Purpose ; In the present study, we compared 6-month angiographic outcomes and 2-year clinical outcome of the sirolimus-eluting stent (SES) versus paclitaxel-eluting stent (PES) in the treatment for diffuse long lesions with same stents overlapping strategy.

5 Methods 1. Study Population A total of 197 consecutive pts with diffuse long lesions were assigned to receive: Sirolimus-eluting Stents (SES group; n=75 pts, 110 lesions) Paclitaxel-eluting Stents (PES group; n=122 pts, 177 lesions)

6 Methods 2. Definition Diffuse long lesion: the length of lesion> 20mm 3. Exclusion Criteria 1Cardiogenic shock 2Expected survival less than 1 year

7 Methods 4. Antiplatelet Regimen 1) All pts received Aspirin; 100 mg orally. 2) All pts received Clopidogrel (Plavix ) preloaded mg before PCI, followed by daily administration of 75 mg and encouraged to continue at least for 1 year. 3) In case of suspicious higher risk of stent thrombosis; Routine triple antiplatelets (Aspirin, Clopidogrel and Cilostazol) were administered for one month, then changed to dual antiplatelets.

8 Methods 5. Antithrombotic Regimen 1) Enoxaparin (Clexane ); 60mg bid before PCI and after PCI during the in-hospital stay (within 7 days). 2) Unfractionated Heparin; a bolus of 50 U/kg were administered during PCI. 3) GP IIbIIIa receptor blocker (Abxicimab, Reopro ); depend on physician s discretion.

9 Methods 6. PCI and Debulking Procedure A variety of atheroablative devices were not utilized except occasional Cutting Balloon or Rotablator and mostly simple predilation was performed to get an adequate luminal diameter which was necessary to accommodate the unexpanded DES and their delivery system. 7. Study End Points Angiographic outcomes at 6 months and Clinical outcomes at 2 years were compared.

10 Statistics (1) 1. All statistical analyses were performed using SPSS Continuous variables were expressed as means ± standard deviation and were compared using Student s t-test. 3. Categorical data were expressed as percentages and were compared using chi-square statistics or Fisher s exact test. 4. A p-value of <0.05 was considered statistically significant..

11 Statistics (2) 5. To rule out the confounding effects from the baseline biases, multivariable logistics analysis were performed. 6. Confounding factors included age, gender, conventional cardiovascular risk factors (hypertension, diabetes mellitus, hyperlipidemia, current smoking and family history of coronary heart disease), past history (prior myocardial infarction, prior heart failure), and major treatments (betablockers, angiotensin converting enzyme inhibitors, angiotensin II receptor blockers, calcium channel blockers, statins)

12 Results

13 Baseline Clinical Characteristics Variable, n (%) SES Group PES Group P value (n=75 patients) (n=122 patients) Male 49 (65.3) 82 (67.2) Age, years ± ± Current smoking 11 (15.1) 34 (28.6) Diabetes mellitus 7 (9.3) 23 (18.9) Hypertension 56 (74.7) 75 (61.5) Hyperlipidemia 6 (8.0) 19 (15.6) Chronic heart failure 11 (14.7) 20 (16.4) Prior myocardial infarction 8 (10.7) 18 (14.8) Diagnosis on admission AMI 21 (28.0) 46 (37.7) Unstable angina 31 (41.3) 41 (33.6) Stable angina 23 (30.7) 35 (28.7)

14 Baseline Angiographic and Procedural Characteristics Variable, n (%) SES Group PES Group P value (n=110 lesions) (n=177 lesions) Target vessel RCA 35 (32.1) 61 (34.3) LAD 45 (40.9) 76 (43.1) LCX 30 (27.0) 40 (22.6) Lesion length, mm ± ± Reference diameter, mm 3.06 ± ± CTO lesion 15 (13.5) 19 (10.8) Bifurcation lesion 35 (31.9) 56 (31.4) Small vessel ( 2.75 mm) 31 (27.8) 44 (24.8) Stent length, mm ± ± Stent diameter, mm 3.06 ± ± Stents number per pts 1.31 ± ±

15 Medical treatment Variable, n (%) SES Group PES Group P value (n=75 patients) (n=122 patients) Aspirin 70 (93.3) 115 (94.3) Clopidogrel 75 (0) 122 (0) -- Cilostazol 48 (64.0) 68 (55.7) Glycoprotein IIb/IIIa 21 (28.0) 33 (27.0) Low molecular weight 50 (66.7) 79 (64.8) heparins ACEIs 25 (33.3) 37 (30.3) Angiotensin II receptor 32 (42.7) 28 (23.0) blockers Beta-blockers 29 (38.7) 43 (35.2) Calcium channel blockers 11 (14.7) 31 (25.4) Statins 60 (80.0) 99 (81.1) 0.843

16 Angiographic Outcomes at 6 Months Variable, n (%) SES Group (n=75 patients, 110 lesions) PES Group (n=122 patients, 177 lesions) P value Binary restenosis 9 (12.0) 36 (29.5) MLD, mm 2.53 ± ± Restenosis percent, % ± ± Late loss, mm 0.64 ± ±

17 Clinical Outcomes at 2 Years Variable, n (%) SES Group (n=75 patients) PES Group (n=122 patients) P value Cardiac death 3 (4.0) 15 (12.3) Total death 4 (5.3) 18 (14.8) ST elevated myocardial infarction Non-ST elevated myocardial infarction 1 (1.3) 4 (3.3) (1.3) 1 (0.8) TLR 6 (8.0) 30 (24.6) TVR 10 (13.3) 39 (32.0) TVR-MACE 16 (21.3) 44 (36.1) Stent thrombosis 1 (1.3) 4 (3.3) 0.651

18 Multivariable Regression Analysis The use of SES (vs. PES) was an independent predictor of 2-year 1) Total Death (OR 0.20, 95% CI , P=0.027); 2) TLR (OR 0.26, 95% CI , P=0.010); 3) TVR-MACE (OR 0.38, 95% CI , P=0.014).

19 Conclusions 1. The treatment for diffuse long lesions with overlapping SES had more favorable angiographic outcomes which could be translated into superior clinical outcomes at 2 years as compared with overlapping PES. 2. This study suggests that SES would be preferred choice of DES for the patients with diffuse long lesions for better long-term angiographic and clinical outcomes.