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
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.
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, 2006,114:2148-2153 Am J Cardiol, 2006,98:1563-1566
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.
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)
Methods 2. Definition Diffuse long lesion: the length of lesion> 20mm 3. Exclusion Criteria 1Cardiogenic shock 2Expected survival less than 1 year
Methods 4. Antiplatelet Regimen 1) All pts received Aspirin; 100 mg orally. 2) All pts received Clopidogrel (Plavix ) preloaded 300-600 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.
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.
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.
Statistics (1) 1. All statistical analyses were performed using SPSS 13.0. 2. 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..
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)
Results
Baseline Clinical Characteristics Variable, n (%) SES Group PES Group P value (n=75 patients) (n=122 patients) Male 49 (65.3) 82 (67.2) 0.786 Age, years 64.22 ± 10.88 62.06 ± 11.38 0.190 Current smoking 11 (15.1) 34 (28.6) 0.033 Diabetes mellitus 7 (9.3) 23 (18.9) 0.071 Hypertension 56 (74.7) 75 (61.5) 0.057 Hyperlipidemia 6 (8.0) 19 (15.6) 0.121 Chronic heart failure 11 (14.7) 20 (16.4) 0.747 Prior myocardial infarction 8 (10.7) 18 (14.8) 0.410 Diagnosis on admission 0.349 AMI 21 (28.0) 46 (37.7) Unstable angina 31 (41.3) 41 (33.6) Stable angina 23 (30.7) 35 (28.7)
Baseline Angiographic and Procedural Characteristics Variable, n (%) SES Group PES Group P value (n=110 lesions) (n=177 lesions) Target vessel 0.642 RCA 35 (32.1) 61 (34.3) LAD 45 (40.9) 76 (43.1) LCX 30 (27.0) 40 (22.6) Lesion length, mm 28.35 ± 6.58 28.28 ± 6.03 0.943 Reference diameter, mm 3.06 ± 0.35 3.01 ± 0.45 0.460 CTO lesion 15 (13.5) 19 (10.8) 0.460 Bifurcation lesion 35 (31.9) 56 (31.4) 0.975 Small vessel ( 2.75 mm) 31 (27.8) 44 (24.8) 0.533 Stent length, mm 30.33 ± 6.35 30.21 ± 6.01 0.874 Stent diameter, mm 3.06 ± 0.35 3.01 ± 0.45 0.460 Stents number per pts 1.31 ± 0.32 1.36 ± 0.41 0.249
Medical treatment Variable, n (%) SES Group PES Group P value (n=75 patients) (n=122 patients) Aspirin 70 (93.3) 115 (94.3) 0.769 Clopidogrel 75 (0) 122 (0) -- Cilostazol 48 (64.0) 68 (55.7) 0.252 Glycoprotein IIb/IIIa 21 (28.0) 33 (27.0) 0.884 Low molecular weight 50 (66.7) 79 (64.8) 0.784 heparins ACEIs 25 (33.3) 37 (30.3) 0.659 Angiotensin II receptor 32 (42.7) 28 (23.0) 0.004 blockers Beta-blockers 29 (38.7) 43 (35.2) 0.628 Calcium channel blockers 11 (14.7) 31 (25.4) 0.074 Statins 60 (80.0) 99 (81.1) 0.843
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) 0.004 MLD, mm 2.53 ± 0.81 2.13 ± 0.89 0.013 Restenosis percent, % 25.22 ± 22.73 34.86 ± 24.95 0.048 Late loss, mm 0.64 ± 0.67 1.14 ± 0.85 0.003
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) 0.050 Total death 4 (5.3) 18 (14.8) 0.042 ST elevated myocardial infarction Non-ST elevated myocardial infarction 1 (1.3) 4 (3.3) 0.651 1 (1.3) 1 (0.8) 1.000 TLR 6 (8.0) 30 (24.6) 0.003 TVR 10 (13.3) 39 (32.0) 0.003 TVR-MACE 16 (21.3) 44 (36.1) 0.029 Stent thrombosis 1 (1.3) 4 (3.3) 0.651
Multivariable Regression Analysis The use of SES (vs. PES) was an independent predictor of 2-year 1) Total Death (OR 0.20, 95% CI 0.05-0.83, P=0.027); 2) TLR (OR 0.26, 95% CI 0.10-0.73, P=0.010); 3) TVR-MACE (OR 0.38, 95% CI 0.18-0.82, P=0.014).
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.