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Background: Studies have suggested that use of prolonged dual antiplatelet therapy (DAPT) following new generation drug-eluting stent implantation may increase costs and potential bleeding events. This study aimed to investigate the association of DAPT status with clinical safety in patients undergoing everolimus-eluting stent (EES) implantation in the SEEDS study (A Registry to Evaluate Safety and Effectiveness of Everolimus Drug-eluting Stent for Coronary Revascularization) at 2-year follow-up., Methods: The SEEDS study is a prospective, multicenter study, where patients (n = 1900) with small vessel, long lesion, or multi-vessel diseases underwent EES implantation. Detailed DAPT status was collected at baseline, 6-month, 1- and 2-year. DAPT interruption was defined as any interruption of aspirin and/or clopidogrel more than 14 days. The net adverse clinical events (NACE, a composite endpoint of all-cause death, all myocardial infarction (MI), stroke, definite/probable stent thrombosis (ST), and major bleeding (Bleeding Academic Research Consortium II-V)) were investigated according to the DAPT status at 2-year follow-up., Results: DAPT was used in 97.8% of patients at 6 months, 69.5% at 12 months and 35.4% at 2 years. It was observed that the incidence of NACE was low (8.1%) at 2 years follow-up, especially its components of all-cause death (0.9%), stroke (1.1%), and definite/probable ST (0.7%). DAPT was not an independent predictor of composite endpoint of all-cause death/MI/stroke (hazard ratio [HR]: 0.693, 95% confidence interval [CI]: 0.096-4.980, P = 0.715) and NACE (HR: 1.041, 95% CI: 0.145-7.454, P = 0.968). Of 73 patients who had DAPT interruption, no patient had ST at 12-month, and only 1 patient experienced ST between 1- and 2-year (1.4%). There was a high frequency of major bleeding events (53/65, 82.5%) occurred in patients receiving DAPT treatment., Conclusions: Prolonged DAPT use was not associated with improved clinical safety. The study emphasized that duration of DAPT needs to be shortened in Chinese patients following EES implantation (ClinicalTrials.gov identifier: NCT 01157455).

Aims: The SYNTAX score has been proposed as a valuable tool to characterise coronary anatomy prospectively based on its complexity. This study evaluated the prognostic value on adverse outcomes of the residual SYNTAX score (rSS) in patients with complex lesions treated with an everolimus-eluting stent (EES)., Methods and Results: One thousand eight hundred and fifty-one patients with small vessel (reference diameter <2.75 mm), long lesion (length >25 mm), or multivessel (>2 target vessels) disease who underwent percutaneous coronary intervention (PCI) with EES in the prospective SEEDS (A Registry To Evaluate Safety And Effectiveness Of Everolimus Drug Eluting Stent For Coronary Revascularization) trial were categorised into low (<6), mid (>6-<12) and high (>12) baseline SYNTAX score (bSS) groups, and into low (=0), mid (>0-<5) and high (>5) rSS groups. Mean bSS and rSS were 10.87±7.26 and 2.18±3.97, respectively; 64% of patients had complete revascularisation (rSS=0). At 12 months the primary outcome of ischaemia-driven target vessel failure (TVF, composite of cardiac death, target vessel myocardial infarction and ischaemia-driven target vessel revascularisation) was significantly higher in the high bSS and rSS groups than in the respective lower groups (p<0.01 for both). In multivariable analysis, rSS was an independent predictor of TVF (hazard ratio: 1.403, 95% confidence interval: 1.081 to 1.820, p=0.01)., Conclusions: Twelve-month TVF was significantly higher in the highest rSS group; rSS with a cut-off of 5 might therefore allow the risk stratification of patients with complex lesions treated with a second-generation drug-eluting stent (Clinical-Trials.gov identifier: NCT 01157455).

Objectives: The authors investigate whether the combination of anti-CD34 antibody with DES is win-win cooperation., Background: DES may reduce the risk of restenosis compared to bare-metal stents (BMS), but they were found to inhibit the healing process of intima., Methods: Fifteen BMS, 17 DES, and 16 combined anti-CD34 antibody and DES were randomly implanted in the coronary arteries of 22 minipigs. Ten minipigs were followed up to 2 weeks. The stenting coronary segments were examined by histological examination and scanning electron microscopy after in vivo coronary angiography and intracoronary optical coherence tomography (OCT) examinations. The other 12 minipigs were followed up to 3 months. Coronary angiography and intracoronary OCT examination were performed in vivo and histological examination was performed on the stenting coronary segments., Results: After 2 weeks, the neointimal covering level of the DES was lower than that in BMS, but the covering level of the combined stents was even better than the BMS. After 3 months, neointimal hyperplasia was significant in the BMS, but not in the other two types of stents. The in-stent late lumen loss of the combined stents even showed a decreasing tendency when compared with the DES., Conclusion: The combination of anti-CD34 antibody and DES can not only well offset the short-term inhibitory effect on re-endothelialization but also slightly enhance the long-term antiproliferative effect., (Copyright © 2011 Wiley Periodicals, Inc.)

Objective: This post-marketing surveillance registry is aimed at determining the safety and reliability of the CYPHER Select Sirolimus-eluting stent (SES) in routine clinical practice., Background: Little information and angiographic follow-up data in large-scale "real world" registry is available for the CYPHER Select SES, an advanced-generation SES., Methods: This was a prospective multicenter (20 centers) registry. 1189 consecutive patients who received at least 1 CYPHER Select SES during daily clinical practice were enrolled. Patients who underwent emergency stenting for acute myocardial infarction were excluded., Results: The procedure's success rate was 98.3% for CYPHER Select SES implantation, and follow-up rates were 98% with 100% data auditing. Target lesion revascularization (TLR) at 12 months occurred in 60 (5.14%) cases, cardiac death in 13 cases (1.11%), Q wave myocardial infarction (MI) in 5 cases (0.43%), non-Q-MI in 9 cases (0.77%), target vessel revascularization (TVR) in 67 cases (5.74%), and MACE defined as cardiac death, nonfatal MI and TLR in 76 cases (6.51%). MACE-free survival rate at 12 months was 93.7%. Angiographic follow-up at 9 months was performed in 418 (68.3%) lesions treated by CYPHER Select SES. The binary restenosis rate was 4.8% in-stent and 9.6% in-segment. Subgroup analysis showed diabetes, bifurcation lesion and combined use of different stents were independent risk factors of cumulative MACE. In-segment MLD

Drug-eluting stent (DES) now is the default selection for most of the interventional cardiologists. However, its benefits compromised by the stent-related thrombosis events. Given the catastrophic consequences, it is important to investigate possible mechanisms of stent thrombosis. The cause of stent thrombosis is multifactorial, and several stent-related and patient-related variables have been identified. The stent itself has components that may lead to thrombosis: the metal stent material, the polymer which houses the drug, and the actual cell-cycle inhibiting drugs. Most important the cell-cycle inhibitors (sirolimus and paclitaxel) reduce neointimal formation by impeding smooth muscle cells proliferation and migration, these drugs also impair the normal process of the injured arterial wall and cause delayed re-endothelialization [Tsimikas S. Drug-eluting stents and late adverse clinical outcomes. J Am Coll Cardiol 2006;47:2112-5; Colombo A, Drzewiecki J, Banning A, et al. Randomized study to assess the effectiveness of slow- and moderate-release polymer-based paclitaxel-eluting stent for coronary artery lesions. Circulation 2003;108:788-94; Kedia Gautam, Lee Michael S. Stent thrombosis with drug-eluting stents: a re-examination of the evidence. Catheter Cardiovasc Interv 2007;69:782-9] [1-3]. It has been proposed that bone marrow-derived endothelial progenitor cells may also be involved in re-endothelialization [Urao N, Okigaki M, Yamada H, et al. Erythropoietin-mobilized endothelial progenitors enhance reendothelialization via Akt-endothelial nitric oxide synthase activation and prevent neointimal hyperplasia. Circ Res 2006;98:1405-13; Griese DP, Ehsan A, Melo LG, et al. Isolation and transplantation of autologous circulating endothelial cells into denuded vessels and prosthetic grafts: implications for cell-based vascular therapy. Circulation 2003;108:2710-15] [4-5]. Interestingly, rapamycin inhibits proliferation, migration, and differentiation of human endothelial progenitor cells in vitro [Butzal M, Loges S, Schweizer M, et al. Rapamycin inhibits proliferation and differentiation of human endothelial progenitor cells in vitro. Exp Cell Res 2004;300:65-71; Chen TG, Chen JZ, Wang XX. Effects of rapamycin on number activity and eNOS of endothelial progenitor cells from peripheral blood. Cell Proliferat 2006;39:117-25]. We hypothesis that drugs loaded on DES may affect the number as well as the homing and proliferation of endothelial progenitor cells, thus further preventing proper endothelial healing, increasing platelet aggregation, which could lead to stent thrombosis.