Outcomes of diabetics receiving bare‐metal stents versus drug‐eluting stents

Objectives : We sought to determine if differences existed in in‐hospital outcomes, long‐term rates of target vessel revascularization (TVR), and/or long‐term mortality trends between patients with diabetes mellitus undergoing percutaneous coronary intervention (PCI) with either a drug‐eluting stent(s) (DES) or a bare metal stent(s) (BMS). Background : Short‐ and long‐term clinical outcomes of patients with diabetes mellitus undergoing PCI with DES versus BMS remain inconsistent between randomized‐controlled trials (RCTs) and observational studies. Methods : Data were collected prospectively on diabetics undergoing PCI with either DES or BMS from January 2000 to June 2008. Demographic information, medical histories, in‐hospital outcomes, and long‐term TVR and mortality trends were obtained for all patients. Results : A total of 1,319 patients were included in the study. Diabetics receiving DES had a significant reduction in index admission MACE compared to diabetics receiving BMS. Using multivariable adjustment, after a mean follow‐up of 2.5 years (maximum 5 years), diabetics who received DES had a 38% decreased risk of TVR compared to diabetics with BMS [HR 0.62 (95% CI: 0.43–0.90)]; diabetics with DES had an insignificant adjusted improvement in long‐term survival compared to diabetics with BMS [HR 0.72 (95% CI: 0.52–1.00)]. These long‐term survival and TVR rates were confirmed using propensity scoring. Conclusions : The use of DES when compared with BMS among diabetics undergoing PCI is associated with significant improvement in long‐term TVR, with an insignificant similar trend in all‐cause mortality. The long‐term results of this observational study are consistent with prior RCTs after adjusting for confounding variables. © 2010 Wiley‐Liss, Inc.     

Decreased risk of stent fracture‐related restenosis between paclitaxel‐eluting stents and sirolimus eluting stents: Results of long‐term follow‐up

Objective: To compare the outcomes between paclitaxel‐eluting stents (PES) and sirolimus‐eluting stents (SES) for the treatment of drug‐eluting stent (DES) fracture. Background: DES fracture is considered as an important predictor of in‐stent restenosis (ISR). However, little data are available evaluating the optimal treatment for this complication of coronary stenting. Methods: From January 1, 2004 to December 31, 2008, patients with DES ISR treated with a second DES were identified and evaluated for stent fracture. Stent fracture was defined by the presence of strut separation in multiple angiographic projections, assessed by two independent reviewers. Target lesion revascularization (TLR) at 6 and 12 months were the primary end points. Results: Of 131 lesions with DES ISR treated with a second DES, we found 24 patients (24 lesions, 18.2%) with angiographically confirmed stent fracture. Of these, 20 patients (20 lesions) treated with either PES (n = 11/55%) or SES (n = 9/45%) were included in the study. TLR at 6 months occurred in 9% of patients treated with PES and 22% of those treated with SES (P = 0.41). After 12 months, TLR was 9% and 55.5%, respectively (P = 0.024). Conclusions: This study demonstrates a high incidence of stent fracture in patients presenting with DES ISR in need of further treatment with another DES. The suggested association between treatment of stent fracture‐associated DES ISR with PES as compared with SES, and better long‐term outcomes, is in need of confirmation by larger prospective registries and randomized trials. © 2011 Wiley Periodicals, Inc.     

Five‐year clinical outcomes of sirolimus‐eluting versus paclitaxel‐eluting stents in high‐risk patients

Objectives and Background : First generation drug‐eluting stents have shown differential efficacy in high‐risk patient subsets at one year. It is unclear whether these differences endure over the medium‐ to long‐term. We compared the five‐year clinical efficacy and safety of sirolimus‐eluting stents (SES) and paclitaxel‐eluting stents (PES) in a population of high‐risk patients. Methods : The patient cohorts of the ISAR‐DESIRE, ISAR‐DIABETES, and ISAR‐SMART‐3 randomized trials were followed up for five years and data were pooled. The primary efficacy endpoint of the analysis was the need for target lesion revascularization (TLR) during a five‐year follow‐up period. The primary safety endpoint was the combination of death or myocardial infarction (MI) after five years. Results : A total of 810 patients (405 patients in the SES group and 405 patients in the PES group) was included. Over five years TLR was reduced by 39% with SES compared with PES stent (hazard ratio [HR] 0.61; 95% confidence interval [CI] 0.44–0.85; P = 0.004). No difference was observed according to death or MI rates between the two groups (HR 1.10; 95% CI 0.80–1.50; P = 0.57). Definite stent thrombosis occurred in 0.2% (n = 1) in the SES group and in 1.6% (n = 6) in the PES group (HR 0.16; 95% CI 0.02–1.34; P = 0.12). Conclusions : In high‐risk patient subsets the lower rate of 12‐month TLR observed with SES in comparison PES is maintained out to five years. In terms of safety, although there was no difference in the overall incidence of death or MI, there was a trend towards more frequent stent thromboses with PES. © 2011 Wiley‐Liss, Inc.     

Sirolimus‐ versus paclitaxel‐eluting stents for coronary bifurcations intervention

Backgrounds : Relative efficacy and safety of sirolimus‐eluting stents (SES) compared with paclitaxel‐eluting stents (PES) remains controversial. It is unknown whether there are different effect and safety in coronary bifurcation treatment between SES and PES. Objectives : The meta‐analysis was performed to compare the clinical outcomes of SES and PES in coronary bifurcation intervention. Methods : Five head‐to‐head clinical trials of SES versus PES in coronary bifurcation intervention were included. A total of 2,567 patients were involved in the meta‐analysis. Mean follow‐up period ranged from 6 to 35 months. The primary end points were the need for target lesion revascularization (TLR) and main‐branch restenosis. Secondary end points were target vessel revascularization (TVR), cardiac death, major adverse cardiac events (MACE), and stent thrombosis. Results : Compared with PES, SES significantly reduced the risk of TLR (5.3% vs. 10.6%, odds ratio (OR) 0.52; 95% confidence interval (CI) = 0.38–0.70, P < 0.001), main‐branch restenosis (4.59% vs. 12.59%, OR 0.31; 95% CI = 0.18–0.55, P < 0.001) and TVR (7.05% vs. 12.57%, OR 0.58; 95% CI = 0.42–0.81, P = 0.001) in coronary bifurcation intervention. In addition, SES group also had a significantly lower incidence of MACE (8.20% vs. 14.13%, OR 0.58; 95% CI = 0.40–0.84, P = 0.004) than PES group. However, there were no statistical difference with respect to the incidence of cardiac death (1.64% vs. 1.09%, P = 0.19) and stent thrombosis (0.84% vs. 1.08%, P = 0.64) between SES and PES groups. Conclusions : Compared with PES, SES reduced the incidence of TLR, main‐branch restenosis and MACE in coronary bifurcation intervention, while the risk of stent thrombosis was similar between SES and PES groups. © 2011 Wiley Periodicals, Inc.     

Polymer‐free drug‐eluting stents for coronary artery disease

Polymer‐free drug‐eluting stents (PF‐DES) were designed with the expectation of avoiding late restenosis and thrombosis related to the polymer used in traditional DES platforms. Furthermore, due to similarities with bare metal stents after drug elution, PF‐DES has been considered as particularly suitable for patients at high bleeding risk. A variety of PF‐DES platforms have been clinically tested. Despite their theoretical advantages, PF platforms showed comparable clinical outcomes with modern permanent‐ or biodegradable polymer‐based DES up to 5 years after implantation. Use of more biocompatible polymers on the modern DES platforms is one of the reasons therefore. Their improved safety profile allows already less intensive antithrombotic regimes after DES. Hence, nowadays PF‐DES platforms can be considered as one of many DES options for percutaneous treatment of coronary artery disease.

     

Infrapopliteal drug‐eluting stents for chronic limb ischemia

Objective: We report our experience with the elective placement of below‐knee, drug‐eluting stents in patients with chronic limb ischemia. Background: Infrapopliteal percutaneous transluminal angioplasty has been associated with a lower rate of procedural success and high rate of restenosis because of the small size of the tibial vessels and the prevalence of calcified and diffuse atherosclerotic disease. Prior published data reports 3‐year patency rates below 25%. Bare metal stents have been reported in bailout situations. Drug‐eluting stents have markedly reduced restenosis compared to bare metal stents in the coronary vasculature, but there is little data supporting the use of these devices below the knee. Methods: Elective placement of drug‐eluting stents in infrapopliteal lesions was performed on 10 patients with severe (≥Fontaine Stage IIb) claudication (n = 1) or limb‐threatening ischemia (n = 9) (rest pain, nonhealing ulcers and gangrene). Results: A total of 17 drug‐eluting stents were electively placed in 12 below‐knee arteries in 10 patients, resulting in an average of 1.7 ± 0.7 stents per patient. The mean lesion length was 24.8 ± 10.9 mm, the mean total stent length was 38.3 ± 19.1 mm, and the mean nominal stent diameter was 2.8 ± 0.3 mm. One patient required target vessel revascularization (TVR) at 3 weeks because of stent thrombosis. TVR was 10% at 12.4 ± 6.5 months of follow‐up. Clinically driven angiography in three different patients was performed at 4, 15, and 16 months and confirmed drug‐eluting stent patency in each case. Conclusions: The use of below‐knee drug‐eluting stents is feasible and appears to be safe in our small series of complex infrapopliteal lesions causing chronic limb ischemia. The occurrence of a single case of stent thrombosis warrants continued observation in this cohort. Prospective clinical trials will be necessary to confirm the benefits and justify the costs of this strategy for treating patients with infrapopliteal culprit lesions and chronic limb ischemia. © 2008 Wiley‐Liss, Inc.     

Kissing drug eluting balloons for in‐stent restenosis complicating bifurcations treated with drug‐eluting stents

The management of in‐stent restenosis (ISR) complicating bifurcation lesions is technically challenging and implant of further stents may not be feasible. The use of drug‐eluting balloons provides an attractive option for treatment of such lesions allowing a technically simple procedure without the need for further complex stenting. The SeQuent Please paclitaxel‐eluting balloon (B. Braun, Berlin, Germany) has been shown to be superior to a paclitaxel eluting stent or balloon angioplasty for ISR complicating a bare‐metal stent. However, there is no data on the efficacy of the SeQuent Please in ISR complicating drug‐eluting stents or bifurcation lesions. We report two cases where the SeQuent Please was used in this setting with angiographic success and freedom from target vessel failure and angina at 24 months. In both cases the Sheathless Eau Cath guide (Asahi Intecc, Japan) was employed to perform a kissing‐balloon dilatation with the SeQuent Please, so allowing treatment via radial access. © 2012 Wiley Periodicals, Inc.