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.     

Polymer‐free versus permanent polymer‐coated drug eluting stents for the treatment of coronary artery disease: A meta‐analysis of randomized trials

Background

Polymer‐free drug eluting stents (PF‐DES) were developed, in part, to overcome risk of late ischemic events observed with permanent polymer‐coated DES (PP‐DES). However, trial results are inconsistent with longer‐term safety and efficacy of PF‐DES remaining unknown. We performed a meta‐analysis of randomized trials assessing outcomes of patients receiving PF‐DES versus PP‐DES for treatment of coronary artery disease (CAD).

Methods

Electronic searches were performed for randomized trials comparing outcomes between PF‐DES and PP‐DES. Trials reporting major adverse cardiovascular events (MACE), myocardial infarction (MI), stent thrombosis (ST), all‐cause death, target lesion/vessel revascularization (TLR/TVR), and late lumen loss (LLL) were included. Analyses were performed at longest follow‐up and landmarked beyond 1‐year.

Results

Twelve trials (6,943 patients) were included. There was no significant difference in MACE between PF‐DES and PP‐DES at longest follow‐up (Odds Ratio [OR] 0.96, 95%CI 0.85‐1.10, P = 0.59) or landmark analysis beyond 1‐year (OR 0.96, 95%CI 0.76‐1.20, P = 0.70). Although PF‐DES were associated with a significant reduction in all‐cause death (OR 0.85, 95%CI 0.72‐1.00, P < 0.05), this effect was not present on landmark analysis beyond 1‐year (OR 0.89, 95%CI 0.73‐1.10, P = 0.30). There were no differences observed for MI (OR 1.00, 95%CI 0.77‐1.28, P = 0.99) or ST (OR 0.95, 95%CI 0.54‐1.68, P = 0.86), with similar efficacy outcomes including TVR (OR 1.07, 95%CI 0.91‐1.26, P = 0.42), TLR (OR 1.03, 95%CI 0.88‐1.21, P = 0.68) and angiographic LLL (pooled mean difference 0.01 mm, 95%CI ?0.08 to 0.11, P = 0.76).

Conclusions

PF‐DES are as safe and efficacious as PP‐DES for the treatment of patients with CAD, but do not significantly reduce late ischemic complications.

     

Angiographic and intravascular ultrasound follow up of paclitaxel‐ and sirolimus‐eluting stent after poststent high‐pressure balloon dilation: From the poststent optimal stent expansion trial

Objectives : The aims of this study were to identify the efficacy of optimal stent expansion (OSE) according to the Multicenter Ultrasound Stenting in Coronaries Study (MUSIC Study) criteria in drug‐eluting stent (DES) and compare paclitaxel‐eluting stent (PES) to sirolimus‐eluting stent (SES). Background : Although poststent high‐pressure balloon dilatation is proposed after bare metal stent implantation according to OSE, defined by the criteria of the MUSIC Study, very little data are available in DES. Methods : Two hundred fifty patients (M:F = 149:101; age, 61.5 ± 9.2 years) who underwent 9‐month follow‐up angiography in the Poststent Optimal Stent Expansion Trial (POET) were included in this study. We assessed angiographic in‐stent restenosis (ISR) and neointima volume (NV) using IVUS at 9 months. Results : At 9‐month follow up, there were no significant differences in ISR and NV index (NV/stent length, mm²) between patients with and without OSE. However, the rate of ISR and NV index were higher in PES [ISR: 18 (13.7%) and 4 (3.4%), P = 0.004; NV index: 1.02 ± 0.99 mm² and 0.21 ± 0.37, P < 0.001 in PES and SES]. Conclusions : OSE according to the MUSIC Study criteria was not related to ISR and NV in the DES era but PES had a significantly higher ISR rate and NV than SES after poststent high‐pressure balloon dilatation. © 2010 Wiley‐Liss, Inc.     

In‐Stent Restenosis

The introduction of coronary stents marked a major turning point in the practice of interventional cardiology. Whereas the efficacy of balloon angioplasty was challenged both by immediate mechanical complications and by a high incidence of restenosis, coronary stents offered cardiologists a means by which to not only augment immediate procedural success, but also to reduce the incidence of restenosis following coronary intervention. However, despite technological advances and an improved understanding of the restenotic process, the overall rate of in‐stent restenosis following bare metal stent implantation remains high. Although the introduction of drug‐eluting stents has further reduced the incidence of restenosis, the “real‐world” application of drug‐eluting stents in increasingly complex lesion and patient subsets has given way to the even greater clinical challenge of managing drug‐eluting stent restenosis. Although the standard treatment of bare metal stent restenosis typically involves placement of a drug‐eluting stent, the optimal therapeutic approach to drug‐eluting stent restenosis remains less defined. The issue of in‐stent restenosis (especially following implantation of a drug‐eluting stent) remains a clinical challenge, and investigation into therapeutic options remains ongoing. As technology evolves, such investigation will likely incorporate novel approaches including drug‐coated balloons novel stent designs.     

Comparison between imported versus domestic drug‐eluting stents in China: A large single‐center data

Background

In recent years, most drug‐eluting stents (DESs) were domestically produced in China, but how domestic DESs perform compared to imported DESs was still unknown.

Methods

A total of 9011 consecutive cases with DESs implantation in a single center throughout 2013 were prospectively collected. Two‐year clinical outcomes were evaluated between patients implanted with imported and domestic DESs.

Results

During 2‐year follow‐up, the rates of all‐cause death, cardiac death, myocardial infarction, stroke, and stent thrombosis were not significantly different between two groups. However, the rate of revascularization was significantly higher in domestic DES group, shown as higher rates of overall revascularization, target vessel revascularization (TVR), and target lesion revascularization (TLR) (9.7% vs 6.4%, P < 0.001; 5.6% vs 3.2%, P < 0.001; 4.5% vs 2.2%, P < 0.001, respectively). Accordingly, major adverse cardiac events (MACE) rate was significantly higher in domestic DES group (12.1% vs 8.5%, P < 0.001). Multivariable Cox regression analysis indicated that domestic DES was an independent risk factor of MACE (HR [95%CI]: 1.22 [1.05‐1.41]), overall revascularization (HR [95%CI]: 1.29 [1.09‐1.53]), TVR (HR [95%CI]: 1.54 [1.22‐1.94]), and TLR (HR [95%CI]: 1.85 [1.41‐2.42]). After propensity score matching, the rates of overall revascularization, TVR, and TLR were still significantly higher in domestic DES group, and domestic DES was still predictive of overall revascularization, TVR, and TLR in multivariate Cox regression analysis.

Conclusions

Domestic DESs showed the same safety as imported DESs in this real‐world cohort. But, patients implanted with domestic DESs had a higher risk of revascularization than imported DESs.

     

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.     

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.

     

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.