Platinum Chromium Everolimus-eluting Stent Research Articles

The Promus Premier everolimus-eluting platinum chromium stent with durable polymer evaluated in a real world all-comer population in Rotterdam cardiology hospital (the P-SEARCH registry)

BackgroundA new-generation everolimus eluting platinum-chromium stent (EePCS), offering improved radial strength, radiopacity and conformability compared to everolimus-eluting cobalt-chromium stents (EeCCS), was evaluated with regard to safety and efficacy in an all-comer cohort. MethodsA total of 1000 consecutive all-comer patients (including acute coronary syndrome, multivessel disease, calcified lesions) treated with an EePCS (Promus Premier™, Boston Scientific, Natick, Massachusetts) from May 2013 to October 2014 were compared to 1000 consecutive patients treated with an EeCCS (Xience Prime™, Abbott Vascular, Santa Clara, California) from April 2012 to May 2013. Patients were clinically followed for 1year. ResultsMean age was 66±12years with diabetes in 20.7%, previous infarction in 22.7%, and ACS as the indication in 71.2% of patients. The mean number of stents per patient was 1.8±1.13. Total stented length was 35±25mm. Lesion classification was B2/C in 73.9% of patients. At 1year the primary endpoint of major adverse cardiac events (all-cause mortality, myocardial infarction [MI], ischemia-driven target vessel revascularization [TVR]) was reached in 11.7% in the EePCS cohort and 10.9% in the EeCCS cohort (adjusted HR 1.01 [0.77–1.33]; p=0.95). No significant differences were noted in the individual clinical endpoints all-cause mortality (6.8% versus 6.4%), MI (2.2% versus 2.3%), and TVR (4.3% versus 3.7%) in the respective EePCS and EeCCS cohorts. Stent thrombosis occurred in 0.8% and 1.0% respectively. ConclusionsIn all-comer patients undergoing percutaneous coronary intervention, the use of EePCS was associated with similar 1-year clinical outcome as compared to EeCCS.

Safety and efficacy of a bioabsorbable polymer-coated, everolimus-eluting coronary stent in patients with diabetes: the EVOLVE II diabetes substudy.

Bioabsorbable polymer drug-eluting stents (DES) may reduce the inflammation and delayed healing associated with some permanent polymer-coated DES. Whether late clinical outcomes are improved, particularly among patients with medically treated diabetes, is unknown. Therefore, we analysed outcomes from a pre-specified substudy of the EVOLVE II trial to evaluate the safety and effectiveness of the SYNERGY stent in patients with diabetes mellitus. SYNERGY is a thin-strut, platinum-chromium everolimus-eluting stent with an ultra-thin bioabsorbable poly(DL-lactide-co-glycolide) abluminal polymer. The EVOLVE II randomised, controlled trial proved the non-inferiority of the SYNERGY versus the PROMUS Element Plus stent for one-year target lesion failure (TLF: ischaemia-driven target lesion revascularisation [ID-TLR], target vessel myocardial infarction [TVMI], or cardiac death). The pre-specified EVOLVE II diabetes substudy prospectively pooled randomised patients with diabetes (N=263) with a sequential single-arm diabetic cohort (n=203). The substudy primary endpoint was one-year TLF compared with a pre-specified performance goal (14.5%). The primary endpoint occurred in 7.5% of SYNERGY-treated patients with diabetes, significantly less than the performance goal (p<0.0001). The two-year rate of TLF was 11.2% (cardiac death 1.5%, TVMI 6.4%, ID-TLR 6.8%) and definite/probable stent thrombosis occurred in 1.1% of patients. The EVOLVE II diabetes substudy demonstrates the efficacy and safety of the SYNERGY stent in patients with medically treated diabetes.

Twelve-month results of a prospective, multicentre trial to assess the everolimus-eluting coronary stent system (PROMUS Element): the PLATINUM PLUS all-comers randomised trial.

The aim of the study was to compare the safety and efficacy of the platinum-chromium-based everolimus-eluting stent (EES) with a cobalt-chromium EES. We performed a prospective, multicentre, single-blind non-inferiority all-comers study randomising patients with stable or unstable coronary artery disease (2:1) to treatment with the platinum-chromium EES (n=1,952) or the control cobalt-chromium EES (n=1,028) in Europe (PLATINUM PLUS trial). The primary endpoint was target vessel failure (TVF) at 12 months, a composite of target vessel-related cardiac death, myocardial infarction (MI), and ischaemia-driven target vessel revascularisation (TVR). Among 2,980 patients, 33% presented with acute coronary syndromes, and 48% with multivessel disease. At 12 months, the intention-to-treat analysis determined that the platinum-chromium EES was non-inferior to the cobalt-chromium EES for the primary endpoint (86 [4.6%] patients vs. 32 [3.2%], absolute difference 1.4%, 95% confidence interval [CI]: -0.1-2.9; upper limit of the one-sided 95% CI: 2.57%; non-inferiority p=0.012; superiority analysis: hazard ratio [HR] 1.44, 95% CI: 0.96-2.16, p=0.08). In the per protocol analysis, however, the primary endpoint was significantly more common in the platinum-chromium EES (HR 1.64, 95% CI: 1.05-2.55, p=0.03). There were no significant differences in the rates of cardiac death (1.1% vs. 1.0%, p=0.78), MI (1.6% vs. 0.8%, p=0.09), or ischaemia-driven TLR (2.0% vs. 1.6%, p=0.49). The rates of ARC definite or probable stent thrombosis were comparable between platforms (0.8% vs. 0.5%, p=0.44). At one year, the platinum-chromium EES satisfied the pre-specified criteria for non-inferiority relative to the control cobalt-chromium EES in this all-comers trial.

Twelve-month results of a prospective, multicentre trial to assess the everolimus-eluting coronary stent system (PROMUS Element): the PLATINUM PLUS all-comers randomised trial.

The aim of the study was to compare the safety and efficacy of the platinum-chromium-based everolimus-eluting stent (EES) with a cobalt-chromium EES. We performed a prospective, multicentre, single-blind non-inferiority all-comers study randomising patients with stable or unstable coronary artery disease (2:1) to treatment with the platinum-chromium EES (n=1,952) or the control cobalt-chromium EES (n=1,028) in Europe (PLATINUM PLUS trial). The primary endpoint was target vessel failure (TVF) at 12 months, a composite of target vessel-related cardiac death, myocardial infarction (MI), and ischaemia-driven target vessel revascularisation (TVR). Among 2,980 patients, 33% presented with acute coronary syndromes, and 48% with multivessel disease. At 12 months, the intention-to-treat analysis determined that the platinum-chromium EES was non-inferior to the cobalt-chromium EES for the primary endpoint (86 [4.6%] patients vs. 32 [3.2%], absolute difference 1.4%, 95% confidence interval [CI]: -0.1-2.9; upper limit of the one-sided 95% CI: 2.57%; non-inferiority p=0.012; superiority analysis: hazard ratio [HR] 1.44, 95% CI: 0.96-2.16, p=0.08). In the per protocol analysis, however, the primary endpoint was significantly more common in the platinum-chromium EES (HR 1.64, 95% CI: 1.05-2.55, p=0.03). There were no significant differences in the rates of cardiac death (1.1% vs. 1.0%, p=0.78), MI (1.6% vs. 0.8%, p=0.09), or ischaemia-driven TLR (2.0% vs. 1.6%, p=0.49). The rates of ARC definite or probable stent thrombosis were comparable between platforms (0.8% vs. 0.5%, p=0.44). At one year, the platinum-chromium EES satisfied the pre-specified criteria for non-inferiority relative to the control cobalt-chromium EES in this all-comers trial.

CRT-200.65 Real-world Clinical Experience With an Everolimus Eluting Platinum Chromium Stent With an Abluminal Biodegradable Polymer - A Report From the Swedish Coronary Angiography and Angioplasty Registry (SCAAR)

In unselected patients from a nationwide registry we describe the initial real-world experience with a novel everolimus eluting platinum chromium stent with biodegradable polymer (SYNERGY). All implanted SYNERGY stents were compared to all new generation DES (n-DES) with more than 1000

Abstract 15274: Post-stenting Changes in the Coronary Geometry and In-stent Restenosis in Angulated Coronary Lesions: Comparison Between Platinum Chromium and Cobalt Chromium Everolimus-eluting Stents

Purpose: Geometric changes in the coronary arteries at the site of coronary stent implantation can lead wall shear stress reduction with decreased coronary flow, which affect the clinical outcome after coronary intervention. Newly developed Platinum Chromium (PtCr)-Everolimus-eluting stent (EES) is expected to improve vessel conformability and restore the natural shape of the vessel with its modified scaffold design, using the same durable polymer and antiproliferative drug as the Cobalt Chromium (CoCr)-EES. The aim of this study was to investigate the long-term effect of PtCr-EES implantation on in-stent restenosis in angulated coronary lesions, comparing with CoCr-EES. Methods: This retrospective study included 250 lesions with CoCr-EES implantation and 217 lesions with PtCr-EES implantation for de novo angulated lesions (&gt;45-degree by quantitative coronary angiography). The angle of the lesions was measured in diatole and systole, and cyclic changes in the coronary angle &gt;20 degree was defined as hinge-like motion. Long-term coronary in-stent restenosis was defined as &gt;50% angiographic stenosis in 8 month after the procedure. Results: Changes in maximum coronary angle at the site of stent implantation were significantly smaller in PtCr-EES group than in CoCr-EES group compared with original angle (20.65±15.42 vs. 26.25±18.36 degree, p &lt;0.01). There were no significant differences in the occurrence of significant in-stent restenosis between PtCr-EES and CoCr-EES (6.7% vs 10.1%, p=0.32). CoCr-EES tended to show more restenosis than PtCr-EES (12.9% vs. 0.0%, p=0.07) in extremely angulated lesions (&gt;100-degree). Interestingly, in the lesions with hinge-like motion, PtCr-EES group showed significantly higher rate of restenosis compared with CoCr-EES group (26.3% vs 7.7%, p= 0.04). Conclusions: In comparison with CoCr-EES, PtCr-EES tended to restore the original curvature of the coronary vessels, and this may lead less restenosis rate in extremely angulated lesions. However, PrCr-EES might have adverse effect on long-term result after coronary stenting in the lesion with hinge-like cyclic motion.

TCT-547 Efficacy and safety of platinum-chromium everolimus-eluting stents compared with other second-generation drug-eluting stents. Meta-analysis from 5 randomized trials including 7,896 patients

TCT-547 Efficacy and safety of platinum-chromium everolimus-eluting stents compared with other second-generation drug-eluting stents. Meta-analysis from 5 randomized trials including 7,896 patients

Incidence and Clinical Impact of Stent Fracture After PROMUS Element Platinum Chromium Everolimus-Eluting Stent Implantation.

This study sought to assess the incidence and clinical impact of stent fracture (SF) after the PROMUS Element platinum-chromium everolimus-eluting stent (PtCr-EES). SF remains an unresolved, clinically relevant issue, even in the newer-generation drug-eluting stent era. From March 2012 to August 2013, 816 patients with 1,094 lesions were treated only with PtCr-EES and 700 patients (85.7%) with 898 lesions undergoing follow-up angiography within 9 months after the index procedure were analyzed. SF was defined as complete or partial separation of the stent, as assessed by plain fluoroscopy, intravascular ultrasound, or optical coherence tomography during the follow-up. We assessed the rate of SF and the cumulative incidence of clinically driven target lesion revascularization and definite stent thrombosis within 9 months after the index procedure. SF was observed in 16 of 898 lesions (1.7%) and 16 of 700 patients (2.2%). Lesions with in-stent restenosis at baseline (odds ratio [OR]: 14.2, 95% confidence intervals [CI]: 5.09 to 39.7; p < 0.001) or hinge motion (OR: 4.31, 95% CI: 1.12 to 16.5; p = 0.03), and total stent length (per 10-mm increase; OR: 1.32, 95% CI: 1.12 to 1.57; p = 0.001) were predictors of SF. Cumulative incidence of clinically driven target lesion revascularization within 9-months was numerically higher in the SF group than that in the non-SF group (18.7% vs. 2.3%). Cumulative incidence of definite stent thrombosis within 9 months after the index procedure was similar between the SF and non-SF groups (0.0% vs. 0.23%). SF after PtCr-EES occurs in 1.7% of lesions and appears to be associated with clinically driven target lesion revascularization.

TCTAP A-150 The Efficacy of 2.25mm Everolimus-Eluting Stents for Very Small Vessel Lesions in Real-World Patients

Very small vessel coronary artery disease represents a challenging entity for treatment with percutaneous coronary intervention. Recently, 2.25 mm platinum chromium everolimus-eluting stent (PtCr-EES) is available. We evaluated the efficacy of 2.25 mm PtCr-EES in real-world patients. Between

INCIDENCE AND CLINICAL IMPACT OF LONGITUDINAL STENT DEFORMATION AFTER THE PROMUS ELEMENT PLATINUM CHROMIUM-EVEROLIMUS ELUTING STENT IMPLANTATION

The PROMUS Element platinum-chromium everolimus-eluting stent (PtCr-EES) has a novel metal and stent design intended to improve deliverability, comformability, and radial strength, whereas such features might have the trade-off of reducing longitudinal stent strength, which would account for the

Comparison of biolimus A9-eluting (Nobori) and everolimus-eluting (Promus Element) stents in patients with de novo native long coronary artery lesions: a randomized Long Drug-Eluting Stent V trial.

Procedural and clinical outcomes still remain unfavorable for patients with long coronary lesions who undergo percutaneous coronary intervention. The current study, therefore, evaluated 2 innovative drug-eluting stents for the management of long-lesion coronary artery disease. This randomized, multicenter, prospective trial, called the Long Drug-Eluting Stent (LONG-DES) V trial, compared the biodegradable polymer-based biolimus A9-eluting stent (BES) and the durable polymer-based platinum chromium everolimus-eluting stent (PtCr-EES) in 500 patients with long (≥ 25 mm) coronary lesions. The primary end point of the trial was in-segment late luminal loss at the 9-month angiographic follow-up. The BES and PtCr-EES groups had similar baseline characteristics, with a slightly shorter lesion length in the BES group versus the PtCr-EES group (29.24 ± 12.17 versus 32.27 ± 13.84 mm; P = 0.016). In-segment late luminal loss was comparable between the 2 groups at the 9-month angiographic follow-up (BES, 0.14 ± 0.38 versus PtCr-EES, 0.11 ± 0.37 mm; difference, 0.031; 95% confidence interval, -0.053 to 0.091; P = 0.03 for a noninferiority margin of 0.11, P = 0.45 for superiority), as was in-stent late luminal loss (0.20 ± 0.41 versus 0.24 ± 0.38 mm; P = 0.29). The incidence of in-segment (6.1% versus 4.9%; P = 0.63) and in-stent (3.7% versus 4.9%; P = 0.59) binary restenosis was also similar between the groups. There was no significant between-group difference in the rate of composite outcome of death, myocardial infarction, and target vessel revascularization (41, 16.7% in BES versus 42, 16.5% in PtCr-EES; P=0.94). BES and PtCr-EES implantation showed analogous angiographic and clinical outcomes for patients with de novo long coronary lesions. http://www.clinicaltrials.gov. Unique identifier: NCT01186120.

Impact of coronary stent designs on acute stent recoil

BackgroundAcute stent recoil has been often observed following stent delivery balloon deflation in coronary arteries and the recoil rate varies by stent design. Accordingly, the purpose of the present study was to evaluate the impact of stent designs on acute stent recoil after new generation drug-eluting stent implantation. Methods and resultsA total of 154 lesions [56 treated with biolimus-eluting stent (BES), 46 with cobalt chromium everolimus-eluting stent (CoCr-EES), and 52 with platinum chromium everolimus-eluting stent (PtCr-EES)] were evaluated. Quantitative coronary angiography was used to measure the minimal lumen diameter (MLD). MLD1 was defined as a MLD of complete expansion of the last stent delivery balloon at the highest pressure. MLD2 was defined as a MLD immediately after the last stent delivery balloon deflation. Acute stent recoil was determined by the calculation as (MLD1−MLD2)/MLD1. Acute stent recoil was significantly higher in the CoCr-EES group versus the BES group and PtCr-EES group (10.1±6.9%, 6.7±5.5%, and 6.5±4.8%, respectively, p=0.01). Multivariate linear regression analysis demonstrated that the use of CoCr-EES and the number of stent delivery balloon inflations were independent predictors of acute stent recoil (r=0.26, β=0.21, p=0.01 and r=−0.51, β=−0.58, p<0.01, respectively). ConclusionAcute stent recoil occurred more frequently with the CoCr-EES compared with both BES and PtCr-EES. Strategies with multiple balloon inflation might be needed to overcome this recoil phenomenon.

Three-Year Results Comparing Platinum-Chromium PROMUS Element and Cobalt-Chromium XIENCE V Everolimus-Eluting Stents in De Novo Coronary Artery Narrowing (from the PLATINUM Trial)

In the randomized PLATINUM trial, the PROMUS Element platinum-chromium everolimus-eluting stent (PtCr-EES; Boston Scientific, Natick, Massachusetts) was noninferior to the XIENCE V cobalt-chromium everolimus-eluting stent (CoCr-EES; Boston Scientific and Abbott Vascular, Santa Clara, California) for the primary end point of 1-year target lesion failure. This study reports the 3-year outcomes. Patients (n=1,530) with 1 or 2 de novo native coronary artery lesions (baseline vessel diameter≥2.50 mm to ≤4.25 mm and length≤24 mm) were randomized 1:1 to PtCr-EES versus CoCr-EES. Three-year follow-up was available in 93.9% (703 of 749) of patients with CoCr-EES and 96.7% (733 of 758) of patients with PtCr-EES. Comparing CoCr-EES with PtCr-EES, 3-year rates of death (4.3% vs 3.7%, hazard ratio [HR] 0.88, 95% confidence interval [CI] 0.52 to 1.48, p=0.62), cardiac death (1.9% vs 1.2%, HR 0.63, 95% CI 0.27 to 1.45, p=0.27), myocardial infarction (2.5% vs 2.3%, HR 0.92, 95% CI 0.48 to 1.79, p=0.81), ischemia-driven target lesion revascularization (4.9% vs 3.5%, HR 0.72, 95% CI 0.43 to 1.20, p=0.21), and Academic Research Consortium definite or probable stent thrombosis (0.5% vs 0.7%, HR 1.23, 95% CI 0.33 to 4.57, p=0.76) were not significantly different. In conclusion, 3-year results of the PLATINUM randomized, controlled, clinical trial demonstrate comparable safety and efficacy outcomes of the PROMUS Element PtCr-EES and the XIENCE V CoCr-EES.

Bare metal stents, durable polymer drug eluting stents, and biodegradable polymer drug eluting stents for coronary artery disease: mixed treatment comparison meta-analysis

Objective To compare the efficacy and safety of biodegradable polymer drug eluting stents with those of bare metal stents and durable polymer drug eluting stents.Design Mixed treatment comparison meta-analysis of...

Comparison of stent axial integrity in first- versus second-generation drug-eluting stents: insights from intravascular ultrasound analysis

Background: Longitudinal stent deformation (LSD) is a recently reported complication of coronary intervention. To date, however, the axial integrity of stents has not been systematically examined. This study aimed to assess the rate of LSD after implantation using intravascular ultrasound (IVUS). Methods: A total of 182 drug-eluting stents (DES) of 165 patients who underwent IVUS after implantation for de-novo lesions were included. Stent length was determined using automatic pullback device. The absolute value of the difference in length [IVUS - label], and the absolute value of the relative difference in length [(IVUS- label)/label] were analyzed. Results: Stent distribution was as follows: 38.4% sirolimus-eluting stents (SES); 18.7% paclitaxel-eluting stents (PES); 20.3% Cobalt-chromium everolimus-eluting stents (Cc-EES); and 22.5% Platinum-chromium everolimus-eluting stents (Pc-EES). The absolute difference in length did not differ among groups. There were no differences in the absolute value of the relative difference between the Pc-EES and any other stents. The absolute relative difference of >5% was lower in the SES group (p=0.027). Significant change (>15%) in length was low and similar among groups. ![Figure][1] Conclusions: This IVUS analysis proved that SES has the lowest differences in stent length and that there are no significant differences in axial stent integrity among PES and second-generation DES. The anecdotal reports of LSD are unsubstantiated in contemporary clinical practice. [1]: pending:yes

Comparison of Platinum Chromium Versus Cobalt Chromium Everolimus-eluting Stent in Real World Practice: Outcomes from the Multicenter Prospective IRIS-DES Registry

Large clinical studies compared platinum chromium everolimus-eluting stent (PtCr EES) and cobalt chromium everolimus-eluting stent (CoCr EES) was limited. Therefore, we sought to evaluate the safety and efficacy of PtCr EES and CoCr EES in “real world” practice.

A novel platinum chromium everolimus-eluting stent for the treatment of coronary artery disease.

The development of coronary stents represents a major step forward in the treatment of obstructive coronary artery disease since the introduction of percutaneous coronary intervention. The initial enthusiasm for bare metal stents was, however, tempered by a significant incidence of in-stent restenosis, the manifestation of excessive neointima hyperplasia within the stented vessel segment, ultimately leading to target vessel revascularization. Later, drug-eluting stents, with controlled local release of antiproliferative agents, consistently reduced this need for repeat revascularization. In turn, the long-term safety of first-generation drug-eluting stents was brought into question with the observation of an increased incidence of late stent thrombosis, often presenting as myocardial infarction or sudden death. Since then, new drugs, polymers, and platforms for drug elution have been developed to improve stent safety and preserve efficacy. Development of a novel platinum chromium alloy with high radial strength and high radiopacity has enabled the design of a new, thin-strut, flexible, and highly trackable stent platform, while simultaneously improving stent visibility. Significant advances in polymer coating, serving as a drug carrier on the stent surface, and in antiproliferative agent technology have further improved the safety and clinical performance of newer-generation drug-eluting stents. This review will provide an overview of the novel platinum chromium everolimus-eluting stents that are currently available. The clinical data from major clinical trials with these devices will be summarized and put into perspective.

Longitudinal compression of the platinum‐chromium everolimus‐eluting stent during coronary implantation: Predisposing mechanical properties, incidence, and predictors in a large patient cohort

To assess the longitudinal compression behavior of platinum-chromium everolimus-eluting stents, evaluate frequency of inadvertent longitudinal compression during percutaneous intervention, and define patient- and lesion-related predictors of this complication. Platinum-chromium stents of Element family have unique design features to improve flexibility that may, however, impair longitudinal stability. Incidence of longitudinal stent compression during implantation and predictors for this complication are not well understood. Five contemporary stent platforms were longitudinally compressed in a bench test experiment, and spring constant, yield force, and ultimate strength were calculated from force-strain curves. We also evaluated all coronary cases treated with an Element stent from January 1, 2010, to October 31, 2011, for documented longitudinal compression. We compared baseline characteristics and periprocedural data between patients with and without longitudinal stent compression and assessed predictors for this event by multiple logistic regression models. Yield force and ultimate strength were significantly lower for the Element compared with all other tested stents. In 20 patients (1.4%) and 20 lesions (0.7%) from 1,392 cases with 2,839 atherosclerotic lesions longitudinal stent compression was reported. Ostial segments, number of stents, and the presence of a bifurcation were significant predictors (adjusted odds ratios [95% confidence intervals]: 8.33 [3.30-21.28], 1.57 [1.01-2.45], 3.57 [1.36-9.35], respectively). The Element stent exhibits the lowest overall longitudinal strength compared with four contemporary platforms. Longitudinal compression of the Element stent is a rare complication and occurs more frequently in ostial or bifurcation lesions and with multiple stents.

Initial clinical experience with an everolimus eluting platinum chromium stent (Promus Element) in unselected patients from the Swedish Coronary Angiography and Angioplasty Registry (SCAAR)

BackgroundThe safety and efficacy of the Promus Element stent have been recently demonstrated in a selected population from one randomized trial. The aim of this study was to describe the initial clinical experience with the everolimus eluting platinum chromium stent (Promus Element) in unselected patients from a real life nationwide registry. MethodsThe Promus Element DES was compared to all other DES implanted in Sweden (with more than 500 implants) from November 2009 to March 2011. The results were assessed using Cox regression. ResultsA total of 13,577 stents (Promus Element, n=2724, Cypher, n=782; Endeavor, n=747; Taxus Liberté, n=1393, Xience V/Promus, n=4832, Resolute, n=1566, Xience Prime, n=4832) were implanted at 8375 procedures. At one year the restenosis rate in the Promus Element was not significantly different from the overall DES group (2.8% vs. 2.7%, adjusted HR:1.17, 95% CI: 0.75–1.75). A significantly lower restenosis rate was observed in the Promus Element when compared with Endeavor (2.8% vs. 5.8%; adjusted HR: 0.44; 95% CI: 0.26–0.74). The stent thrombosis (ST) rate at one year was not significantly different in the Promus Element as compared with the overall DES group (0.2% vs. 0.5% adjusted HR: 0.59; 95% CI: 025–1.40). ST rate was significantly lower as compared with Endeavor stent (0.2% vs. 0.8%; HR: 0.24; 95% CI: 0.08–0.67). ConclusionsIn a large unselected population the Promus Element stent appears to be safe and effective with a low risk of restenosis and ST.

PLATINUM QCA: a prospective, multicentre study assessing clinical, angiographic, and intravascular ultrasound outcomes with the novel platinum chromium thin-strut PROMUS Element everolimus-eluting stent in de novo coronary stenoses

Assess clinical, angiographic, and intravascular ultrasound results in lesions treated with the PROMUS Element platinum chromium everolimus-eluting stent (EES). Patients (N=100) with one de novo target lesion ≤ 34 mm long and reference vessel diameter (RVD) ≥ 2.25-≤ 4.25 mm were enrolled at 14 sites. The primary endpoint was the 30-day composite of cardiac death, myocardial infarction, target lesion revascularisation (TLR), or definite/probable stent thrombosis (ST). The efficacy endpoint of 9 month in-stent late loss in workhorse lesions (defined as RVD ≥ 2.5-≤ 4.25 mm, lesion ≤ 24 mm) was compared to a performance goal based on historical results with TAXUS Express paclitaxel-eluting stents. Post-procedure incomplete stent apposition (ISA) was compared to a performance goal based on results with the PROMUS/XIENCE V EES in SPIRIT III. Mean age was 61.8 ± 9.9 years; 77.0% were male; 19% had medically treated diabetes. Baseline RVD was 2.72 ± 0.53 mm; lesion length was 15.4 ± 7.0 mm. The primary endpoint occurred in one patient (periprocedural ST with TLR) with no additional major clinical events through one year. Nine-month in-stent late loss in workhorse lesions (0.17 ± 0.25 mm, N=73) and post-procedure ISA (5.7%, 5/88) were below performance goals (p<0.001). Through one year, PROMUS Element EES had an acceptable safety and efficacy profile with low in-stent late loss and post-procedure ISA.