OBJECTIVES: This registry study assessed the safety and efficacy of the 2 types of drug-eluting stents (DES), sirolimus-eluting stents (SES) and paclitaxel-eluting stents (PES), compared with bare-metal stents (BMS). BACKGROUND: Drug-eluting stents may increase the risk of stent thrombosis (ST), myocardial infarction (MI), and death. METHODS: A total of 12,395 consecutive patients with coronary intervention and stent implantation recorded in the Western Denmark Heart Registry from January 2002 through June 2005 were followed up for 2 years. Data on death and MI were ascertained from national medical databases. We used Cox regression analysis to control for confounding. RESULTS: The 2-year incidence of definite ST was 0.64% in BMS patients, 0.79% in DES patients (adjusted relative risk [RR]: 1.09; 95% confidence interval [CI]: 0.72 to 1.65), 0.50% in SES patients (adjusted RR: 0.63, 95% CI: 0.35 to 1.15), and 1.30% in PES patients (adjusted RR: 1.82, 95% CI: 1.13 to 2.94). The incidence of MI was 3.8% in BMS-treated patients, 4.5% in DES-treated patients (adjusted RR: 1.24, 95% CI: 1.02 to 1.51), 4.1% in SES-treated patients (adjusted RR: 1.15, 95% CI: 0.91 to 1.47), and 5.3% in PES-treated patients (adjusted RR: 1.38, 95% CI: 1.06 to 1.81). Whereas overall 2-year adjusted mortality was similar in the BMS and the 2 DES stent groups, 12- to 24-month mortality was higher in patients treated with PES (RR 1.46, 95% CI: 1.02 to 2.09). Target lesion revascularization was reduced in both DES groups. CONCLUSIONS: During 2 years of follow-up, patients treated with PES had an increased risk of ST and MI compared with those treated with BMS and SES. Mortality after 12 months was also increased in PES patients.
Comment In: J Am Coll Cardiol. 2009 Feb 24;53(8):665-619232898
There are limited head-to-head randomized data on patient-related versus stent-related outcomes for everolimus-eluting stents (EES) and sirolimus-eluting stents (SES).
In the SORT OUT IV (Scandinavian Organization for Randomized Trials With Clinical Outcome IV) trial, comparing the EES with the SES in patients with coronary artery disease, the EES was noninferior to the SES at 9 months.
The primary endpoint was a composite: cardiac death, myocardial infarction (MI), definite stent thrombosis, or target vessel revascularization. Safety and efficacy outcomes at 2 years were further assessed with specific focus on patient-related composite (all death, all MI, or any revascularization) and stent-related composite outcomes (cardiac death, target vessel MI, or symptom-driven target lesion revascularization). A total of 1,390 patients were assigned to receive the EES, and 1,384 patients were assigned to receive the SES.
At 2 years, the composite primary endpoint occurred in 8.3% in the EES group and in 8.7% in the SES group (hazard ratio [HR]: 0.94, 95% confidence interval [CI]: 0.73 to 1.22). The patient-related outcome: 15.0% in the EES group versus 15.6% in the SES group, (HR: 0.95, 95% CI: 0.78 to 1.15), and the stent-related outcome: 5.2% in the EES group versus 5.3% in the SES group (HR: 0.97, 95% CI: 0.70 to 1.35) did not differ between groups. Rate of definite stent thrombosis was lower in the EES group (0.2% vs. 0.9%, (HR: 0.23, 95% CI: 0.07 to 0.80).
At 2-year follow-up, the EES was found to be noninferior to the SES with regard to both patient-related and stent-related clinical outcomes.
We aimed to compare angiographic and clinical outcomes after the implantation of everolimus-eluting (EES) and sirolimus-eluting (SES) stents in patients with diabetes.
There are limited data on long-term outcome after EES vs SES implantation in diabetic patients.
We randomized 213 patients with diabetes and coronary artery disease to EES (n?=?108) or SES (n?=?105) implantation. Angiographic follow-up was performed 10 months after the index procedure and all patients were followed clinically for 4 years. The primary endpoint was angiographic in-stent late luminal loss at 10-month follow-up. Secondary endpoints included angiographic restenosis rate, the need for target lesion revascularization (TLR) and major adverse cardiac events (MACE; defined as cardiac death, myocardial infarction, definite stent thrombosis, or TLR) at 4-year follow-up.
At 10-month angiographic follow-up, in-stent late lumen loss was 0.20?±?0.53 mm and 0.11?±?0.49 mm (P?=?0.28), and angiographic restenosis rate was 3.8% and 5.2% (P?=?0.72) in the EES and SES groups, respectively. At 4-year clinical follow-up, MACE had occurred in 22 (20.4%) patients in the EES group and 25 (23.8%) patients in SES group (HR 0.84, 95% CI 0.47-1.49; P?=?0.55), with TLR performed in 6 (5.6%) and 10 (9.5%) patients in the two groups (HR 0.57, 95% CI 0.21-1-58; P?=?0.28).
EES and SES had comparable 10-month angiographic and 4-year clinical outcomes in patients with diabetes mellitus and coronary artery disease.
The proliferation of airway smooth muscle cells (ASMC) can cause airway hyperresponsiveness (AHR). It has been reported that platelet-derived growth factor (PDGF) can stimulate the proliferation of ASMC through phosphatidylinositol 3-kinase (PI3 K) signaling pathway, which can activate Akt protein. Activated-Akt can activate downstream signal protein [p70S6 K, nuclear factor (NF)-kappaB, and extracellular signal regulated kinase (ERK)], increasing the cyclin D1 level and suppressing the transcription of p27Kip1 to enable cell cycle entry. This investigation demonstrated that pentoxifylline (PTX) inhibited the PDGF-stimulated proliferation of ASMC by suppressing activation of the Akt/NF-kappaB pathway. ASMC were treated with PTX for 48 h, which attenuated the PDGF-stimulated proliferation of ASMC. PTX and wortmannin, a PI3 K inhibitor, not only inhibited the PDGF-activated phosphorylation of Akt but also suppressed p70S6 K expression and IkappaBalpha degradation, inhibiting nuclear translocation and the DNA binding activity of NF-kappaB. However, PTX did not influence the phosphorylation of ERK1/2. The suppression of p70S6 K by rapamycin did not influence cyclin D1 expression in PDGF-stimulated cells. These data reveal that the down-regulation of the Akt/NF-kappaB signaling pathway by PTX inhibited the proliferation of ASMC. PTX may provide information on the pathogenesis of asthma.
We assessed the safety and effectiveness of the sirolimus-eluting stent (SES) in treating single de novo long lesions in small native coronary arteries compared to an identical bare metal stent (BMS).
The SES was previously demonstrated to reduce restenosis significantly. However, patients with long lesions in small vessels have not been well studied and may define a group at very high risk.
The Canadian Study of the Sirolimus-Eluting Stent in the Treatment of Patients With Long De Novo Lesions in Small Native Coronary Arteries (C-SIRIUS) was a multicenter, randomized, double-blind trial comparing SES versus identical BMS. The primary end point was in-stent minimal lumen diameter (MLD) at eight months. Secondary end points included angiographic restenosis at 8 months, target lesion revascularization (TLR), and major adverse cardiac events (MACE) at 270 days.
A total of 100 patients were enrolled at eight Canadian sites. The in-stent MLD at eight months was 2.46 +/- 0.37 mm in the SES compared with 1.49 +/- 0.75 mm in the BMS (a 65% increase, p
Comment In: J Am Coll Cardiol. 2004 Mar 17;43(6):1116-715028376
Our aim was to compare the outcomes of a same versus different drug-eluting stent (DES) implantation strategy for the treatment of DES instent restenosis (ISR).
The absence of clear data renders the treatment of DES ISR one of the most challenging situations in interventional cardiology.
We identified all cases of DES ISR treated with a second DES between January 2004 and January 2009. The lesions were divided into those treated with the same DES as the initial one that restenosed and those treated with a different DES. The main end-point was repeat target lesion revascularization (TLR).
We included 116 patients with a total of 132 lesions. The patient population was highly complex: 55.5% with diabetes, 56% with type-C lesions, 15.9% with lesions previously stented with BMS and 18.2% with fluoroscopic evidence of stent fracture. A same and different stent strategy was conducted in 41 lesions (31%) and 91 lesions (69%), respectively. Overall TLR was 31.1% and occurred in 46.3% of patients treated with the same stent and 24.4% of those with a different stent (P = 0.012). Multivariable analysis found same stent strategy (OR 2.84, 95%CI 1.23-6.57;P = 0.014) and occurrence of stent fracture (OR 4.03, 95%CI 1.33-12.01;P = 0.012) to be the only independent predictors of TLR after a median follow-up of 20.4 [12.1-30.2] months.
In highly complex lesions, DES implantation for DES ISR is linked to a high need of future revascularization. An association between implanting a DES type other than the original and lower rate of TLR is suggested.
OBJECTIVES: To investigate the influence of drug-eluting stent (DES) implantation on clinical and angiographic restenosis. DESIGN: Registry study of data from the Swedish Coronary Angiography and Angioplasty Registry with a coronary angiographic substudy. SETTING: Multi-centre study. SUBJECTS: During October 2002 to May 2004 a total of 23 590 percutaneous coronary intervention (PCI) procedures were performed at 25 hospitals. After selection, to achieve comparable groups, a total of 5068 patients of whom 4111 had a bare metal stent (BMS) implanted and 957 had a DES implanted, remained. End-point in the registry follow-up was >50% diameter restenosis at clinically driven reangiography within 12 months after index PCI. The primary end-point in the angiographic substudy was late loss in patients' DES at 6-month angiographic follow-up. RESULTS: The rate of clinically driven restenosis, within 12 months, in patients receiving DES was less (3.9%) compared with those who received BMS (7.0%). In multivariate analysis the risk of clinical restenosis was one-third for DES compared with BMS (HR 0.36, 95% CI 0.25-0.52). In the angiographic substudy late loss was 0.07+/-0.53 mm (range -0.88 to 1.62). The amount of late loss was related to the presence of diabetes mellitus or not (0.19+/-0.45 mm vs. -0.12+/-0.58 mm), and lack of postdilatation of the stent or not (0.23+/-0.51 mm vs. -0.09+/-0.50 mm). CONCLUSIONS: The use of DES in the Swedish 'real world' is effective in reducing the clinically driven restenosis rate, when compared with patients with BMS treatment. In the angiographic follow-up the average late loss was as low as observed in recent randomized multi-centre trials.
Clinical impact of second-generation everolimus-eluting stent compared with first-generation drug-eluting stents in diabetes mellitus patients: insights from a nationwide coronary intervention register.
This study sought to study the second-generation everolimus-eluting stent (EES) as compared with first-generation sirolimus-eluting (SES) and paclitaxel-eluting stents (PES) in diabetes mellitus (DM) patients.
There are limited data available comparing clinical outcomes in this setting with EES and SES, whereas studies comparing EES with PES are not powered for low-frequency endpoints.
All DM patients treated with EES, PES, or SES from January 18, 2007, to July 29, 2011, from the SCAAR (Swedish Coronary Angiography and Angioplasty Registery) were included. The EES was compared with SES or PES for the primary composite endpoint of clinically driven detected restenosis, definite stent thrombosis (ST), and all-cause mortality.
In 4,751 percutaneous coronary intervention-treated DM patients, 8,134 stents were implanted (EES = 3,928, PES = 2,836, SES = 1,370). The EES was associated with significantly lower event rates compared with SES (SES vs. EES hazard ratio [HR]: 1.99; 95% confidence interval (CI): 1.19 to 3.08). The same was observed when compared with PES (PES vs. EES HR: 1.33; 95% CI: 0.93 to 1.91) but did not reach statistical significance. These results were mainly driven by lower incidence of ST (SES vs. EES HR: 2.87; 95% CI: 1.08 to 7.61; PES vs. EES HR: 1.74, 95% CI: 0.82 to 3.71) and mortality (SES vs. EES HR: 2.02; 95% CI: 1.03 to 3.98; PES vs. EES HR: 1.69; 95% CI: 1.06 to 2.72). No significant differences in restenosis rates were observed between EES and SES or PES (SES vs. EES HR: 1.26; 95% CI: 0.77 to 2.08; PES vs. EES HR: 1.05; 95% CI: 0.71 to 1.55).
In all-comer DM patients the use of EES was associated with improved outcomes compared with SES and PES mainly driven by lower rates of ST and mortality. These results suggest better safety rather than efficacy with EES when compared with SES or PES.
The aim of the study was to compare long-term follow-up results of crush versus culotte stent techniques in coronary bifurcation lesions.
The randomized Nordic Stent Technique Study showed similar 6-month clinical and 8-month angiographic results with the crush and culotte stent techniques of de novo coronary artery bifurcation lesions using sirolimus-eluting stents. Here, we report the 36-month efficacy and safety of the Nordic Stent Technique Study.
A total of 424 patients with a bifurcation lesion were randomized to stenting of both main vessel and side branch with the crush or the culotte technique and followed for 36 months. Major adverse cardiac events-the composite of cardiac death, myocardial infarction, stent thrombosis, or target vessel revascularization-were the primary endpoint.
Follow-up was complete for all patients. At 36 months, the rates of the primary endpoint were 20.6% versus 16.7% (p = 0.32), index lesion restenosis 11.5% versus 6.5% (p = 0.09), and definite stent thrombosis 1.4% versus 4.7% (p = 0.09) in the crush and the culotte groups, respectively.
At 36-month follow-up, the clinical outcomes were similar for patients with coronary bifurcation lesions treated with the culotte or the crush stent technique. (Nordic Bifurcation Study. How to Use Drug Eluting Stents [DES] in Bifurcation Lesions? NCT00376571).
BACKGROUND: In selected patient cohorts the polymer-free rapamycin-eluting YUKON stent (A) has demonstrated noninferiority compared with the polymer-based paclitaxel-eluting TAXUS stent (B). To test for equivalency in unselected real-world patients with coronary lesions of various complexities, we retrospectively compared both stent designs. METHODS: A total of 410 patients with symptomatic CAD were successfully treated with A (n = 205) or with B (n = 205). Baseline clinical characteristics, coronary lesion location, lesion length, and the number of stents implanted per lesion were equally distributed between the treatment groups. All patients underwent QCA-analysis at baseline. Clinical follow-up with assessment of MACE and noncardiac deaths was obtained at 30 days and 6 months. RESULTS: Nominal stent diameter was 2.96 +/- 0.38 mm in Group A vs. 3.05 +/- 0.42 mm in Group B (P = 0.2); nominal length of stented segmentwas 22.97 +/-13.0 mm vs. 23.63 +/- 10.0 (P = 0.56). Analysis of MACE after 6 months resulted in one angiographically documented stent thrombosis causing MI in B (0.2%) vs. none in A. No other MI or cardiac deaths occurred in either group, while two noncardiac deaths in A (1.0%) were reported. Fifteen target lesion revascularizations (7.3%) were performed in A vs. 7 (3.4%) in B. Differences in study endpoints at 6 months did not reach statistical significance (P > 0.05). CONCLUSIONS: Up to 6 months after PCI of real-world coronary lesions, there were no statistically significant differences in MACE between patients treated with the polymer-free rapamycin-eluting YUKON stent and the polymer-based paclitaxel-eluting TAXUS stent.
Comment In: Catheter Cardiovasc Interv. 2008 Feb 15;71(3):340-118288754