Different Drug-eluting Stents Research Articles

Clinical outcomes of contemporary drug-eluting stents in patients with and without diabetes mellitus: Multigroup propensity-score analysis using data from stent-specific, multicenter, prospective registries.

Whether the diabetic status differentially affects the clinical outcomes with different drug-eluting stents (DES) has been controversial. From stent-specific, prospective DES registries, we evaluated 17,184 patients (11,428 in non-diabetics and 5,756 in diabetics) who received several contemporary DES: 3570 sirolimus-eluting stents (SES), 5,023 cobalt-chromium everolimus-eluting stents (CoCr-EES), 2,985 platinum-chromium EES (PtCr-EES), 2,913 Resolute zotarolimus-eluting stents (Re-ZES), and 2,693 biodegradable-polymer biolimus-eluting stents (BP-BES). The primary outcome was patient-oriented composite endpoint (POCE, a composite of all-cause death, any myocardial infarction, and any revascularization) at 3-year follow-up and target-vessel failure (a composite of cardiac death, target-vessel myocardial infarction, and target-vessel revascularization) at 3 years was also evaluated. In non-diabetics, the rates of POCE were not significantly different (CoCr-EES 14.3%, PtCr-EES 13.0%, Re-ZES 14.3%, BP-BES 13.4%, and SES 14.6%; overall p = .39). In diabetics, similar results were revealed (CoCr-EES 18.4%, PtCr-EES 20.3%, Re-ZES 17.3%, BP-BES 17.7%, and SES 17.8%; overall p = .44). In multiple treatment propensity-score weighting analysis, regardless of the diabetic status, the hazard ratios for POCE between-individual comparison were similar. Target-vessel failure (a composite of cardiac death, target-vessel myocardial infarction, and target-vessel revascularization) was also comparable except the higher ratio of Re-ZES than PtCr-EES (hazard ratio 1.25, 1.26, 95% confidence interval 1.00-1.55, p = .048) in patients without diabetes. In this clinical-practice registry study, regardless the diabetic status, the 3-year rates of the primary outcome were similar among different types of DES, suggesting no differential clinical response between contemporary DES in patients with or without diabetes.

TCT-486 Acute Thrombogenicity and Inflammation in Response to a Durable Fluoropolymer Everolimus-Eluting Stent Relative to a Durable BioLinx polymer Zotarolimus-Eluting Stent

Clinical data indicate differences in acute thrombosis among different drug-eluting stents (DES), which may relate to properties of DES polymer coatings and stent design. We sought to investigate stent thrombogenicity between a durable fluoropolymer coated DES (Xience Alpine, X-EES, Abbott Vascular

A randomized multicenter trial comparing the XIENCE everolimus eluting stent with the CYPHER sirolimus eluting stent in the treatment of female patients with de novo coronary artery lesions: The SPIRIT WOMEN study

BackgroundThe comparative performance of different drug-eluting stents (DES) among female patients has not been assessed in a randomized manner.ObjectivesThe SPIRIT Women Clinical Evaluation trial compared the durable polymer everolimus-eluting XIENCE stent (DP-EES) with the durable polymer sirolimus-eluting Cypher stent (DP-SES) in women undergoing percutaneous coronary intervention (PCI).MethodsA total of 455 female patients with stable CAD were randomly assigned to receive DP-EES (n = 304) or DP-SES (n = 151). The powered angiographic outcome of the trial was in-stent late lumen loss (LLL) at 9 months after the index procedure. Secondary angiographic end points included in-segment LLL, in-stent and in-segment binary restenosis and percent diameter stenosis. The primary clinical outcome was a composite of all-cause death, myocardial infarction (MI) or target vessel revascularization (TVR).ResultsAt 9-month follow-up, in-stent LLL was 0.19±0.38 mm and 0.11±0.37 mm in patients assigned to DP-EES and DP-SES, respectively. The one-sided upper 95% CI of the difference in in-stent LLL between the groups of 0.08 mm was 0.15 and therefore within the pre-specified non-inferiority margin of 0.17 mm (p for non-inferiority = 0.013). However, the test for superiority showed a borderline significant difference in terms of LLL between DP-EES and DP-SES (p for superiority = 0.044). There were no significant differences in binary restenosis (2.0% vs. 0.72%, p = 0.44) and percent diameter stenosis (14.97±12.17 vs. 13.36±10.82, p = 0.19). The rate of definite stent thrombosis at 12 months was lower in patients treated with DP-EES (0% vs. 2.0%, p = 0.036).ConclusionsAmong women undergoing PCI, DP-EES was associated with a small but probably clinically relevant increase in in-stent LLL at 9 months as compared to DP-SES and with a lower risk of definite stent thrombosis at 12 months.Trial registrationClinicalTrials.gov NCT01182428.https://clinicaltrials.gov/

Difference in vascular response between sirolimus-eluting- and everolimus-eluting stents in ostial left circumflex artery after unprotected left main as observed by optical coherence tomography

BackgroundKissing-balloon technique (KBT) is commonly performed during percutaneous coronary intervention of distal unprotected left main coronary artery (ULM) aiming at obtaining optimal opening of the side branch (left circumflex artery; LCX) ostium. Nonetheless, detailed evaluation of vascular response to stents in LCX ostium is lacking. We therefore evaluated the vascular response to different drug-eluting stents (DES) in ostial LCX after ULM by means of optical coherence tomography (OCT). MethodsWe prospectively enrolled 38 consecutive patients with ULM disease, who were treated with single-stent procedure using DES, crossover the ULM-left anterior descending artery (LAD) followed by KBT. Twelve patients were treated with sirolimus-eluting stents (SES) and 26 patients were treated with everolimus-eluting stents (EES). OCT was conducted at post-PCI and 9-month follow-up. We evaluated the DES–vessel interactions and number of stent struts at the side branch (LCX) ostium (SO) at post-PCI, and compared the narrowing of ostial area at LCX between SES and EES. ResultsPost-procedure, the number of stent struts at SO was significantly higher in SES compared to EES (median 14.47% vs 0.19%, p<0.001). The narrowing of LCX ostial area at follow-up was more pronounced in SES compared with EES (29.16% vs 2.46%, respectively, p<0.001). Linear regression analysis showed a high correlation between the number of stent struts in LCX ostium and ostial area narrowing (r=0.771, p<0.001). ConclusionsOCT showed differences between EES– and SES–vessel interactions at ULM bifurcation PCI. Number of LCX ostium struts at post-PCI impacted the narrowing of ostial area at 9-month follow-up.

TCT-468 Acute Thrombogenicity and Inflammation in Response to a Durable Fluoropolymer Everolimus-Eluting Stent Relative to a Contemporary Sirolimus-Eluting Stent with an Abluminal Biodegradable Polymer Coating

Clinical data indicates differences in acute thrombosis among different drug-eluting stents (DES), which may relate to properties of DES polymer coatings and stent design. We sought to investigate differences between a durable fluoropolymer coated DES (Xience Alpine, X-EES, Abbott Vascular), an

Three-year follow-up outcomes of SES and PES in a randomized controlled study stratified by the presence of diabetes mellitus: J-DEsSERT trial

BackgroundThree-year clinical follow-up of patients with diabetes mellitus (DM) in the Japan-Drug Eluting Stents Evaluation; a Randomized Trial (J-DESsERT) using 2 different drug eluting stents (DES). A recent study demonstrated that efficacy of sirolimus eluting stents (SES) attenuated over time in diabetic patients. MethodsIn the largest trial of its kind, 1724 DM patients out of 3533 enrolled patients were randomized to either SES or paclitaxel eluting stents (PES). ResultsThere were no significant differences in baseline clinical characteristics aside from hypertension. Incidence of major adverse cardiac cerebrovascular events (MACCE) mainly due to higher target vessel failure (TVF) initially indicated a benefit in SES (MACCE rate at 1year: SES 9.4%, PES 12.2%, p=0.08); however this had attenuated by the time of the 3-year follow-up (MACCE rate from 1 to 3years: SES 8.4%, PES 6.1%, p=0.10). A similar pattern was observed in insulin-treated patients: MACCE rate from 1 to 3years was 10.5% in SES and 6.4% in PES (p=0.25). Angiographic follow-up also resulted in higher major adverse cardiac event (MACE) rates at 1year (presence 11.5%, absence 8.3%, p=0.04); however by 3years rates were similar regardless of the presence of angiographic follow-up (MACE rate at 3years: presence 16.0%, absence 14.5%, p=0.35). ConclusionsThe superiority of SES over PES in MACCE at 1year had attenuated by 3-year follow-up. Eventually, the 3-year safety and efficacy profiles were similar regardless of insulin treatment.

Clinical Outcomes With Drug-Eluting and Bare-Metal Stents in Patients With ST-Segment Elevation Myocardial Infarction: Evidence From a Comprehensive Network Meta-Analysis

The authors investigated the relative safety and efficacy of different drug-eluting stents (DES) and bare metal stents (BMS) in patients with ST-segment elevation myocardial infarction (STEMI) using a network meta-analysis. The relative safety of DES and BMS in patients with STEMI continues to be debated, and whether advances have been made in this regard with second-generation DES is unknown. Randomized controlled trials comparing currently U.S. approved DES or DES with BMS in patients with STEMI were searched using MEDLINE, EMBASE, and Cochrane databases. Information on study design, inclusion and exclusion criteria, sample characteristics, and clinical outcomes was extracted. Twenty-two trials including 12,453 randomized patients were analyzed. At 1-year follow-up, cobalt-chromium everolimus eluting stents (CoCr-EES) were associated with significantly lower rates of cardiac death or myocardial infarction (MI) and stent thrombosis (ST) than BMS. Differences in ST were apparent as early as 30 days and were maintained for 2 years. CoCr-EES were also associated with significantly lower rates of 1-year ST than paclitaxel-eluting stents (PES). Sirolimus-eluting stents (SES) were also associated with significantly lower rates of 1-year cardiac death/myocardial infarction than BMS. CoCr-EES, PES, and SES, but not zotarolimus-eluting stents, had significantly lower rates of 1-year target vessel revascularization (TVR) than BMS, with SES also showing lower rates of TVR than PES. In patients with STEMI, steady improvements in outcomes have been realized with the evolution from BMS to first-generation and now second-generation DES, with the most favorable safety and efficacy profile thus far demonstrated with CoCr-EES.

Resolute zotarolimus-eluting stent to treat bifurcated lesions according to the provisional technique: A procedural performance comparison with sirolimus- and everolimus-eluting stents

Different drug-eluting stents (DES) may have different performance in bifurcation PCI. Thus, we compared the performance of a novel zotarolimus-eluting stent (ZRS) with that obtained using two other DES in bifurcation PCI. Consecutive patients with bifurcated lesions undergoing DES implantation were treated by a provisional approach with sirolimus-eluting stent (SES) or everolimus-eluting stent (EES) during a former period, and then by ZRS in a second period. The PCI procedural details were prospectively recorded and angiographic results were evaluated by a 3-dimensional quantitative coronary analysis software. Primary procedural end-point was "side-branch (SB) trouble" (occurrence, after MV stenting, of: SB TIMI flow<3 or need of specific wires for SB rewiring, or failure to re-wire/dilate the SB). Primary angiographic end-point was post-PCI minimal-lumen-diameter at SB-ostium. During the study, 225 patients were enrolled and treated by ZRS (n=75), by SES (n=75) or by EES (n=75). Among procedural characteristics, "SB trouble" occurred in 4% of patients treated by ZRS, a figure significantly lower compared to SES (16%, P=0.014) and non-significantly lower compared to EES (11%, P=0.12). At multivariable analysis, DES type, pre-PCI SB flow <3 and bifurcation complexity were the only predictors of "SB trouble". After the procedure, minimal-lumen-diameter at SB ostium was significantly larger with ZRS compared to SES (1.94 vs. 1.64 mm, P=0.008) and similar to that of EES. ZRS is associated to improved performance and SB angiographic results compared to SES. These results support the hypothesis that DES selection may influence the procedural course and the acute angiographic result of bifurcation PCI.

Impact of Diabetes Mellitus on Vessel Response in the Drug-Eluting Stent Era

Exaggerated neointimal hyperplasia is considered as the primary mechanism for increased restenosis in patients with diabetes mellitus (DM) treated with bare-metal stent. However, the vessel response in DM and non-DM treated with different drug-eluting stents (DES) has not been systematically evaluated. We investigated 3D intravascular ultrasound (postprocedure and 6 to 9 months) in 971 patients (267 with DM and 704 without DM) treated with sirolimus- (n=104), paclitaxel- (n=303), zotarolimus- (n=391), or everolimus- (n=173) eluting stents. Volumetric data were standardized by length as volume index (VI). At postprocedure, lumen VI at the stented segment was significantly smaller in DM than in non-DM, whereas vessel VI was similar between the 2 groups. At follow-up, neointimal obstruction and maximum cross-sectional narrowing (neointimal area/stent area) were not significantly different between the 2 groups with no interaction for the DES type. Consequently, lumen VI was smaller in DM than in non-DM at follow-up. In the reference segments, residual plaque burden at postprocedure was significantly greater in DM than in non-DM, although change in lumen VI was similar between the 2 groups. The arterial responses at the reference segments also showed no interaction for the DES type. DM and non-DM lesions showed similar vessel response in both in-stent and reference segments regardless of the DES type. In the DES era, the follow-up lumen in DM patients seems to be determined primarily by the smaller lumen at postprocedure rather than exaggerated neointima within the stent or plaque proliferation at the reference segments.

Prospective Randomized Comparison of Sirolimus- or Everolimus-Eluting Stent to Treat Bifurcated Lesions by Provisional Approach

This study sought to compare the procedural performance and the acute angiographic result on side-branch ostium obtained using 2 different drug-eluting stents (DES) to treat patients with bifurcated coronary lesions. Drug-eluting stents are routinely used in percutaneous coronary interventions (PCI) of bifurcated coronary lesions. Different DES types have major technical differences that may influence the procedural and clinical performance in bifurcation PCI. Consecutive patients with bifurcated lesions undergoing DES implantation using a systematic provisional-stenting strategy were randomized to sirolimus-eluting stent (SES) or everolimus-eluting stent (EES) before intervention. The procedural details for PCI were prospectively recorded to assess the occurrence of any trouble in the side-branch (SB) management (primary end point). Post-PCI angiographic result (primary end point: minimal lumen diameter at SB ostium) was evaluated offline by 3-dimensional reconstruction and quantitative coronary analysis. Clinical outcome was prospectively recorded up to 18 months to assess the occurrence of target bifurcation failure. A total of 150 patients were enrolled in the study (29% diabetics, 17% unprotected left main). The stent was successfully implanted according to randomization in all cases. Procedural performance was not significantly different between the 2 kinds of DES. Three-dimensional reconstruction and quantitative coronary analysis showed similar post-PCI results in the main vessel and better results in the SB with EES than with SES (minimal lumen diameter at SB ostium: 1.94 ± 0.72 mm vs. 1.64 ± 0.62 mm; p = 0.013). At 18 months, target bifurcation failure occurred in 7 (9.0%) of SES-treated patients versus 8 (10.7%) of EES patients (p = 0.57). In patients with bifurcated lesions treated by provisional stenting technique, EES compared with SES is associated with similar procedural performance and better 3-dimensional reconstruction and quantitative coronary analysis result in the SB. Both DES are associated with low rates of major adverse events and angiographic failure. (Sirolimus Versus Everolimus-Eluting Stent Randomized Assessment in Bifurcated Lesions and Clinical Significance of Residual Side-Branch Stenosis [SEA-SIDE]; NCT00697372).

Outcomes after differential use of drug‐eluting stents in diabetic patients: 1‐Year results from the DES.DE (Drug‐Eluting Stent.DEutschland) registry

The prospective multicenter German DES.DE registry provides real world data to evaluate the therapeutic principle of two different drug-eluting stents (DES) [Sirolimus- (SES) and Paclitaxel-eluting stent (PES)] in the context of the German Health System. Differential DES have been effective in randomized trials, but their difference in safety and efficacy in diabetic patients has not been well studied. Baseline, predefined procedural as well as clinical in-hospital and follow-up events were recorded for all 1,526 diabetic patients. The composite of death, myocardial infarction (MI), and stroke defined as major adverse cardiac and cerebrovascular events (MACCE) and target vessel revascularization (TVR) were defined as primary endpoints. Between October 2005 and October 2006, 1,526 diabetic patients, 34.2% of them being insulin-dependent, were enrolled (SES: n = 612; PES: n = 914) at 98 DES.DE sites. Overall, one third of patients were admitted with acute coronary syndrome (ACS) and 70% had multivessel-disease reflecting a real world scenario. With similar baseline clinical and descriptive morphology of coronary artery disease (CAD) in both DES groups, there were no statistical differences in 1-year follow-up with respect to rates of overall mortality (5.8% vs. 5.4%), TVR (12.0% vs. 11.3%), overall stent thrombosis (5.6% vs. 4.6%) and MACCE (11.4% vs. 10.3%) between both DES. The data collected in DES.DE revealed no differences in clinical outcomes within 1 year between SES and PES in diabetic patients in a "real-world" setting.

Sirolimus- Versus Paclitaxel-Eluting Stents for the Treatment of Cardiac Allograft Vasculopathy

The aim of this study was to compare outcomes after percutaneous coronary intervention (PCI) with sirolimus-eluting stents (SES) and paclitaxel-eluting stents (PES) in the treatment of cardiac allograft vasculopathy (CAV). PCI in patients with CAV is associated with increased rates of restenosis compared with PCI in patients without CAV. There are no dedicated studies on the influence of different drug-eluting stents (DES) on the outcomes of patients with CAV. This is a retrospective observational study of 108 consecutive patients with CAV who underwent PCI with SES and PES at UCLA Medical Center and University of Padova Medical Center between 2002 and 2008. Baseline characteristics were similar among SES (n = 68) and PES (n = 40) patients with the exception of older patients, larger minimal lumen diameter, and smaller diameter stenosis in the SES-treated patients. Angiographic follow-up at 1 year was high in the SES and PES groups (74% vs. 76%, p = 0.8). The SES and PES groups had similar binary restenosis rates (10% vs. 9%, p = 0.7), percent diameter stenosis (24 +/- 24% vs. 24 +/- 18%, p = 0.94), and late lumen loss (0.67 +/- 1.03 mm vs. 0.68 +/- 1.11 mm, p > 0.9). One-year clinical outcomes were not significantly different among CAV patients treated with either SES or PES (major adverse cardiac events: 10% vs. 15%, p = 0.5; death: 3% vs. 5%, p = 0.4; myocardial infarction: 3% vs. 5%, p = 0.4; target vessel revascularization: 4% vs. 8%, p = 0.3). In patients who underwent PCI for CAV, both SES and PES were safe and effective with no significant differences in clinical and angiographic outcomes. Randomized clinical trials comparing different DES with longer follow-up are necessary to identify the optimal treatment strategy for patients with CAV.

Mid-term angiographic benefit of sirolimus-eluting stents compared with paclitaxel-eluting stents in patients with acute myocardial infarction

We compared angiographic and clinical outcomes among different drug-eluting stents (DESs) in Korean acute myocardial infarction (AMI) patients. A total of 109 consecutive AMI patients who underwent percutaneous coronary intervention (PCI) with either sirolimus-eluting (SES, n=56 pts) or paclitaxel-eluting stents (PES, n=53 pts) were enrolled from August 2004 to December 2006. The angiographic outcomes at 6 months and clinical outcomes at 1 year were compared between the two groups. Baseline clinical and procedural characteristics were similar between the two groups. At 6 months, the rate of binary restenosis was 17.0% in the PES group compared with 3.6% in the SES group (p=0.026). Percent restenosis was 24.9+/-28.6% in the PES group compared with 11.2+/-17.6% in the SES group (p=0.004). Length of restenosis segment was 3.21+/-9.02 mm in the PES group compared with 0.89+/-2.38 mm in the SES group (p=0.048). Late loss was 0.73+/-0.89 mm in the PES group compared with 0.28+/-0.37 mm in the SES group (p=0.001). However, there were no differences in clinical outcomes at 1 year including mortality, myocardial infarction, repeat PCI, and major cardiac adverse events between two groups. SES implantation in patients with AMI was associated with reduction in angiographic restenosis at 6 months compared with PES, however, these angiographic benefits were not translated into better clinical outcomes in real world clinical practice.

Letter by Brugaletta et al Regarding Article, “Interference of Drug-Eluting Stents and Endothelium-Dependent Coronary Vasomotion: Evidence for Device-Specific Responses”

To the Editor: We read with interest the article by Hamilos et al,1 demonstrating a variable endothelium-dependent coronary vasomotor response at coronary segments adjacent to different drug-eluting stents (DES) and bare metal stents. In particular, a better coronary vasodilatation induced by pacing was observed in patients receiving zotarolimus-eluting or biolimus A9–eluting stents when compared with patients receiving paclitaxel- or sirolimus-eluting stents. As discussed by the authors, endothelial dysfunction after first-generation DES may be induced by the effect of the drug, its release kinetics, the proinflammatory effect of the polymer, or the combination of these factors. However, before drawing easy conclusions, several …

Lack of Clinical Benefit of Improved Angiographic Results With Sirolimus-Eluting Stents Compared With Paclitaxel and Zotarolimus-Eluting Stents in Patients With Acute Myocardial Infarction Undergoing Percutaneous Coronary Intervention

There is limited information regarding the angiographic and clinical outcomes among the different drug-eluting stents (DESs) in patients with acute myocardial infarction (AMI) undergoing percutaneous coronary intervention (PCI). A total 355 consecutive AMI patients who underwent PCI with a sirolimus- (SES, n=116) or paclitaxel- (PES, n=153) or zotarolimus-eluting stent (ZES, n=86) were enrolled. The 6-month angiographic and 1-year clinical outcomes were compared among the 3 groups. At 6 months, there was a trend toward a higher incidence of binary restenosis in the PES group (SES: 8.6%, PES: 19.8%, ZES: 8.3%, P=0.052). Percentage of restenosis was higher in the PES group compared with SES, but was similar to ZES (SES: 18.75 +/-18.16%, PES: 29.32 +/-24.16%, ZES: 23.91 +/-17.03%, P=0.006). Late loss was lower in the SES group compared with PES and ZES (SES: 0.44 +/-0.52, PES: 0.83 +/-0.87, ZES: 0.75 +/-0.63, P<0.001). However, clinical outcomes, including mortality, MI, repeat PCI and major adverse cardiac events, were not different among the 3 groups. The angiographic benefit of SES did not translate into a clinical benefit for up to 1 year in AMI patients.

Paclitaxel‐Eluting Stents: Are They All Equal?

In Germany, four different drug eluting stents (DES) systems are currently commercially available. Whereas sirolimus has been clinically tested in only a single type of stent with a single type of coating in only a single dose, paclitaxel has been tested on various stent designs, in various dose densities, and in various release formulations with or without a polymer carrier. Therefore, the question arises: are all paclitaxel stents equally safe and effective? Six clinical randomized trials investigated the safety and efficacy of paclitaxel-eluting stents in patients with de-novo lesions: TAXUS-I (61 pats), TAXUS-II (536 pats), ASPECT (177 pats), ELUTES (190 pats), DELIVER-I (1041 pats) and TAXUS-IV (1314 pats). In the TAXUS-series, paclitaxel released from the stent was controlled by the Translute polymer. In the other studies, however, no polymer carrier was used. In TAXUS-I, II & IV, the dose density of 1 microg/mm2 significantly reduced angiographic parameters of restenosis and improved clinical outcomes. In ASPECT and ELUTES there was a dose-dependent effect on angiographic parameters of restenosis with the best results for a paclitaxel dose density of approximately 3.0 microg/mm2. Clinical outcomes at 6 and 12 months, however, were not improved in these studies without coating. The studies unanimously show that the paclitaxel-eluting stents are safe, if clopidogrel is added to ASA for 3 to 6 months. The safety of paclitaxel-eluting stents is independent of the stent design, the dose density and the presence or absence of a polymer carrier system. For paclitaxel-eluting stents using a polymer carrier, the dose density of 1 microg/mm2 is highly effective, whereas for paclitaxel-eluting stents without a polymer carrier, the minimal effective dose density is much higher (3 microg/mm2). Despite their improvement of angiographic parameters, paclitaxel-eluting stents without a polymer carrier did not demonstrate a positive effect on clinical outcome. In contrast, polymer-based paclitaxel elution produced significant clinical benefit.