PROMUS Element (PE) Plus post-approval study was a large prospective, observational, all-corners study designed to evaluate the safety and performance of a thin-strut platinum chromium everolimus-eluting PE Plus stent in everyday clinical practice. A total of 2,683 "real-world" patients with limited clinical or anatomic exclusion criteria were enrolled at 52 clinical sites in the United States. The study met its primary end point of 12-month cardiac death or myocardial infarction (CD/MI) compared with a prespecified performance goal (p<0.0001). Five-year clinical outcomes were evaluated in overall PE Plus post-approval study patients and high-risk subgroups. During the 5-year follow-up period, CD/MI and stent thrombosis related to the PE Plus stent occurred in 9% and 2.2% overall patients, respectively. The reported all-cause mortality rate was 15%, with 7% classified as cardiac-related. A total of 18% patients underwent target vessel revascularization, and 11 % were reported as target lesion revascularization. The rates of PE Plus stent-related CD/MI remained low in patients with medically treated diabetes (13%), small vessels (9%), and long stents (10%). PE Plus stent-related thrombosis through 5 years in patients with diabetes, small vessels and long stents was 4.2%, 2.2%, and 2.6%, respectively. The occurrence of target lesion revascularization was numerically higher in patients with diabetes (16%) and long lesions (18%) than the small vessels subgroup (11 %). In conclusion, the final 5-year results establish the long-term safety and efficacy of the PE Plus stent in a broad, unselected patient population representative of "real-world" clinical practice. (C) 2019 Elsevier Inc. All rights reserved.

Background Previous studies showed more adverse events with coronary bioresorbable vascular scaffolds (BVS) than with metallic drug-eluting stents (DES), although in one randomised trial angina was reduced with BVS. However, these early studies were unmasked, lesions smaller than intended for the scaffold were frequently enrolled, implantation technique was suboptimal, and patients with myocardial infarction, in whom BVS might be well suited, were excluded. Methods In the active-controlled, blinded, multicentre, randomised ABSORB IV trial, patients with stable coronary artery disease or acute coronary syndromes aged 18 years or older were recruited from 147 hospitals in five countries (the USA, Germany, Australia, Singapore, and Canada). Enrolled patients were randomly assigned (1:1) to receive polymeric everolimus-eluting BVS (Absorb; Abbott Vascular, Santa Clara, CA, USA) with optimised implantation technique or cobalt-chromium everolimus-eluting stents (EES; Xience; Abbott Vascular, Santa Clara, CA, USA). Randomisation was stratified by diabetic status, whether patients would have been eligible for enrolment in the previous ABSORB III trial, and site. Patients and clinical assessors were masked to randomisation. The primary endpoint was target lesion failure (cardiac death, target vessel myocardial infarction, or ischaemia-driven target lesion revascularisation) at 30 days, tested for non-inferiority with a 2.9% margin for the risk difference. Analysis was by intention to treat. The trial is registered with ClinicalTrials.gov, number NCT02173379, and is closed to accrual. Findings Between Aug 15, 2014, and March 31, 2017, we screened 18 722 patients for eligibility, 2604 of whom were enrolled. 1296 patients were assigned to BVS, and 1308 patients were assigned to EES. Follow-up data at 30 days and 1 year, respectively, were available for 1288 and 1254 patients with BVS and for 1303 and 1272 patients with EES. Biomarker-positive acute coronary syndromes were present in 622 (24%) of 2602 patients, and, by angiographic core laboratory analysis, 78 (3%) of 2893 of lesions were in very small vessels. Target lesion failure at 30 days occurred in 64 (5.0%) patients assigned to BVS and 48 (3.7%) patients assigned to EES (difference 1.3%, upper 97. 5% confidence limit 2.89; one-sided Pnon-inferiority=0. 0244). Target lesion failure at 1 year occurred in 98 (7.8%) patients assigned to BVS and 82 (6.4%) patients assigned to EES (difference 1.4%, upper 97.5% confidence limit 3.4; one-sided Pnon-inferiority =0. 0006). Angina, adjudicated by a central events committee at 1 year, occurred in 270 (20.3%) patients assigned to BVS and 274 (20.5%) patients assigned to EES (difference -0.3%, 95% CI -3.4% to 2.9%; one-sided Pnon-inferiority=0. 0008; two-sided P-superiority=0. 8603). Device thrombosis within 1 year occurred in nine (0.7%) patients assigned to BVS and four (0.3%) patients assigned to EES (p=0.1586). Interpretation Polymeric BVS implanted with optimised technique in an expanded patient population resulted in non-inferior 30-day and 1-year rates of target lesion failure and angina compared with metallic DES. Copyright (C) 2018 Elsevier Ltd. All rights reserved.

The PROMUS Element Plus US Post-Approval Study (PE-Plus PAS) was a prospective, open-label, multicenter, observational study designed to examine outcomes in everyday clinical practice in patients treated with everolimus-eluting, platinum-chromium PROMUS Element Plus stents at 52 centers in the United States. This is the first report of results from this large study. The primary end point of the PE-Plus PAS was 12-month cardiac death or myocardial infarction in the more restricted population of "PLATINUM-like" patients pooled from the PE-Plus PAS, PE-PROVE (PROMUS Element European post-approval study), and PLATINUM Workhorse/Small Vessel trials. Additional clinical end points were tested in the overall PE-Plus PAS patient population. Of the 2,683 patients enrolled in PE-Plus PAS, 70% were men, mean age was 64 years, 33% had diabetes, and 29% were "PLATINUM-like." Among the PLATINUM-like patients, 12-month cardiac death or myocardial infarction was 1.8% (33 of 1,855) with an upper 1-sided 95% confidence interval of 2.3%, which was significantly less than the prespecified performance goal of 3.2% (p(noninferiority) <0.001). In the overall PE-Plus population, 12-month target vessel failure (defined as death, MI, or revascularization related to the target vessel) was 6.7% (170 of 2,554), cardiac death was 1.4% (37 of 2,554), MI was 1.1% (28 of 2,554), and ARC-definite/probable stent thrombosis was 0.7% (19 of 2,554). A prespecified secondary end point of 12 month target vessel failure in diabetic patients demonstrated a rate of 4.2% (14 of 332) with an upper 1-sided 95% confidence interval of 6.03%, which was significantly less than the performance goal of 12.6% (p(noninferiority) <0.001). In conclusion, in this large registry of unselected patients, coronary artery revascularization with the PROMUS Element Plus everolimus-eluting stent demonstrates favorable results with low 1-year clinical event rates. (C) 2016 Elsevier Inc. All rights reserved.

The safety and efficacy of the XIENCE V everolimus-eluting stent (EES) compared to the Taxus Express(2) paclitaxel-eluting stent (PES) has been demonstrated through 2 years in the SPIRIT II and III randomized clinical trials, but limited longer-term data have been reported. In the SPIRIT III trial, 1,002 patients with up to 2 lesions in 2 coronary arteries were randomized 2:1 to EESs versus PESs at 65 United States sites. At completion of 3-year follow-up, treatment with EES compared to PES resulted in a significant 30% decrease in the primary clinical end point of target vessel failure (cardiac death, myocardial infarction, or ischemic-driven target vessel revascularization, 13.5% vs 19.2%, hazard ratio 0.70, 95% confidence interval 0.50 to 0.96, p = 0.03) and a 43% decrease in major adverse cardiovascular events, cardiac death, myocardial infarction, or ischemic-driven target lesion revascularization (9.1% vs 15.7%, hazard ratio 0.57, 95% confidence interval 0.39 to 0.83, p = 0.003). In a landmark analysis, major adverse cardiovascular events were decreased to a similar extent with EES compared to PES 0 through 1 year and 1 year through 3 years (hazard ratio 0.56, 95% confidence interval 0.35 to 0.90; hazard ratio 0.59, 95% confidence interval 0.31 to 1.11, respectively). In conclusion, patients treated with EES rather than PES in the SPIRIT III trial had significantly improved event-free survival at 3 years. From 1 year to 3 years hazard curves continued to diverge in favor of EES, consistent with an improving long-term safety and efficacy profile of EES compared to PES, with no evidence of late catchup.

We performed a pooled analysis based on patient-level data from the TITAX-AMI and BASE-ACS trials to evaluate the outcome of titanium-nitride-oxide-coated bioactive stents vs drug-eluting stents in patients with ST-segment elevation myocardial infarction at 2-year follow-up.The TITAX-AMI trial compared bioactive stents with paclitaxel-eluting stents in 425 patients with acute myocardial infarction. The BASE-ACS trial compared bioactive stents with everolimus-eluting stents in 827 patients with acute coronary syndrome. The primary endpoint for the pooled analysis was major adverse cardiac events: a composite of cardiac death, recurrent myocardial infarction, or ischemia-driven target lesion revascularization at 2-year follow-up.The pooled analysis included 501 patients; 245 received bioactive stents, and 256 received drug-eluting stents. The pooled bioactive stent group was associated with a risk ratio of 0.85 for major adverse cardiac events (95% confidence interval, 0.53-1.35; P = .49) compared to the pooled drug-eluting stent group. Similarly, the pooled bioactive stent group was associated with a risk ratio of 0.71 for cardiac death (95% confidence interval, 0.26-1.95; P = .51), 0.44 for recurrent myocardial infarction (95% confidence interval, 0.20-0.97; P = .04), and 1.39 for ischemia-driven target lesion revascularization (95% confidence interval, 0.74-2.59; P = .30), compared to the pooled drug-eluting stent group. These results were confirmed by propensity-score adjusted analysis of the combined datasets.In patients with ST-segment elevation myocardial infarction, bioactive stents were associated with lower rates of recurrent myocardial infarction compared to drug-eluting stents at 2-year follow-up; yet, the rates of cardiac death and ischemia-driven target lesion revascularization were similar.Análisis combinado basado en los datos de pacientes de los ensayos TITAX-AMI y BASE-ACS para evaluar los resultados clínicos obtenidos con stents bioactivos con recubrimiento de titanio-óxido nítrico comparados con los stents liberadores de fármacos en pacientes con infarto agudo de miocardio con elevación del segmento ST tras un seguimiento de 2 años.El ensayo TITAX-AMI comparó los stents bioactivos con los liberadores de paclitaxel en 425 pacientes con infarto agudo de miocardio. El ensayo BASE-ACS comparó stents bioactivos con stents liberadores de everolimus en 827 pacientes con síndrome coronario agudo. El objetivo principal para el análisis combinado fueron los eventos adversos cardiacos mayores: muerte cardiaca, infarto de miocardio recurrente o revascularización de la lesión diana por causa isquémica tras un seguimiento de 2 años.El análisis combinado incluyó a 501 pacientes; se trató a 245 con stents bioactivos y se implantó stent liberador de fármacos a 256. En el análisis conjunto, el grupo de stents bioactivos presentó un cociente de riesgos de eventos adversos cardiacos mayores de 0,85 (intervalo de confianza del 95%, 0,53-1,35; p = 0,49) comparado con el grupo de stents liberadores de fármacos. De igual modo, el grupo conjunto de stents bioactivos mostró un cociente de riesgos de muerte cardiaca de 0,71 (intervalo de confianza del 95%, 0,26-1,95; p = 0,51); de infarto de miocardio recurrente, 0,44 (intervalo de confianza del 95%, 0,20-0,97; p = 0,04), y de revascularización de la lesión diana por causa isquémica, 1,39 (intervalo de confianza del 95%, 0,74-2,59; p = 0,30), en comparación con el grupo conjunto tratado con stents liberadores de fármacos. Estos resultados se confirmaron por un análisis de puntuación de propensión ajustado respecto a la serie de datos conjunta.En pacientes con infarto agudo de miocardio con elevación del segmento ST, los stents bioactivos, comparados con los stents liberadores de fármacos, se asociaron a menores tasas de infarto de miocardio recurrente tras un seguimiento de 2 años; no obstante, las tasas de muerte cardiaca y de revascularización de la lesión diana por causa isquémica fueron similares.

AIMS AND METHODS:The rates of side branch occlusion and subsequent periprocedural MI during everolimus-eluting stent (EES) and paclitaxel-eluting stent (PES) placement were examined in the randomised SPIRIT III trial. Periprocedural myocardial infarction (MI) following drug-eluting stent placement is associated with long-term adverse outcomes. Occlusion of side branches may be an important factor contributing to periprocedural MIs. Consecutive procedural angiograms of patients randomly assigned to EES (n=669) or PES (n=333) were analysed by an independent angiographic core laboratory. Side branch occlusion was defined as Thrombolysis In Myocardial Infarction (TIMI) flow grade 0 or 1. Clinical outcomes through three years were compared by stent type and presence of side branch occlusion.CONCLUSIONS:A total of 2,048 side branches were evaluated (EES N=1,345 side branches in 688 stented lesions, PES N=703 side branches in 346 stented lesions). Patients with compared to those without transient or final side branch occlusion had significantly higher non-Q-wave MI (NQMI) rates in-hospital (9.0% vs. 0.5%, p<0.0001). By multivariable analysis side branch occlusion was an independent predictor of NQMI (OR 4.45; 95% CI [1.82, 10.85]). Transient or final side branch occlusion occurred less frequently in patients receiving EES compared to PES (2.8% vs. 5.2%, p=0.009), contributing to the numerically lower rates of in-hospital NQMI with EES arm compared to PES (0.7% vs. 2.3%, p=0.05). Patients treated with EES rather than PES were less likely to develop side branch occlusion during stent placement, contributing to lower rates of periprocedural MI with EES compared to PES.

Objective: To evaluate whether an everolimus‐eluting stent (EES) with thinner stent struts and polymer results in less periprocedural myonecrosis and adverse outcomes. Background: Higher periprocedural myocardial infarction (MI) rates have been reported with the TAXUS® EXPRESS 2 paclitaxel‐eluting stent (PES) compared to the bare metal EXPRESS 2 ® stent due to more frequent side branch compromise, presumably attributable to the thickness of the stent/polymer on the PES. Methods: In the SPIRIT III trial, we identified 113 patients in the XIENCE V® EES group and 63 patients in the TAXUS EXPRESS 2 PES group who met the criteria of having a lesion with a jailed side branch (<2 mm diameter, and <50% stenosis). Two‐year clinical outcomes were evaluated. Results: A periprocedural increase in Creatine Kinase‐MB >1× upper normal level occurred in 9.0% of EES compared to 29.7% of PES patients with jailed side branches, P = 0.01. Through 2 years, major adverse cardiac events (MACE; cardiac death, MI, or target lesion revascularization [TLR]) occurred in 6.8% of EES and 19.0% of PES jailed side branch patients ( P = 0.03), with numerically lower rates of MI (2.9% vs. 10.3%, P = 0.07) and TLR (3.9% vs. 10.3%, P = 0.17) in the EES group, with comparable rates of cardiac death (1.9% vs. 1.7%, P = 1.00). Conclusions: In this post‐hoc analysis of the SPIRIT III RCT, patients undergoing stenting of target lesions with jailed side branches with the thin strut and polymer XIENCE V EES compared to the thicker strut TAXUS PES had lower rates of MACE through 2 years due to fewer MIs and TLRs. © 2010 Wiley‐Liss, Inc.

Background— In the prospective randomized Clinical Evaluation of the Xience V Everolimus Eluting Coronary Stent System in the Treatment of Patients with de novo Native Coronary Artery Lesions (SPIRIT) III trial, an everolimus-eluting stent (EES) compared with a widely used paclitaxel-eluting stent (PES) resulted in a statistically significant reduction in angiographic in-segment late loss at 8 months and noninferior rates of target vessel failure (cardiac death, myocardial infarction, or target vessel revascularization) at 1 year. The safety and efficacy of EES after 1 year have not been reported. Methods and Results— A total of 1002 patients with up to 2 de novo native coronary artery lesions (reference vessel diameter, 2.5 to 3.75 mm; lesion length ≤28 mm) were randomized 2:1 to EES versus PES. Antiplatelet therapy consisted of aspirin indefinitely and a thienopyridine for ≥6 months. Between 1 and 2 years, patients treated with EES compared with PES tended to have fewer episodes of protocol-defined stent thrombosis (0.2% versus 1.0%; P =0.10) and myocardial infarctions (0.5% versus 1.7%; P =0.12), with similar rates of cardiac death (0.3% versus 0.3%; P =1.0) and target vessel revascularization (2.9% versus 3.0%; P =1.0). As a result, at the completion of the 2-year follow-up, treatment with EES compared with PES resulted in a significant 32% reduction in target vessel failure (10.7% versus 15.4%; hazard ratio, 0.68; 95% confidence interval, 0.48 to 0.98; P =0.04) and a 45% reduction in major adverse cardiac events (cardiac death, myocardial infarction, or target lesion revascularization; 7.3% versus 12.8%; hazard ratio, 0.55; 95% confidence interval, 0.36 to 0.83; P =0.004). Among the 360 patients who discontinued clopidogrel or ticlopidine after 6 months, stent thrombosis subsequently developed in 0.4% of EES patients versus 2.6% of PES patients ( P =0.10). Conclusions— Patients treated with EES rather than PES experienced significantly improved event-free survival at a 2-year follow-up in the SPIRIT III trial, with continued divergence of the hazard curves for target vessel failure and major adverse cardiac events between 1 and 2 years evident. The encouraging trends toward fewer stent thrombosis episodes after 6 months in EES-treated patients who discontinued a thienopyridine and after 1 year in all patients treated with EES rather than PES deserve further study.

CONTEXTA thin, cobalt-chromium stent eluting the antiproliferative agent everolimus from a nonadhesive, durable fluoropolymer has shown promise in preliminary studies in improving clinical and angiographic outcomes in patients with coronary artery disease.OBJECTIVETo evaluate the safety and efficacy of an everolimus-eluting stent compared with a widely used paclitaxel-eluting stent.DESIGN, SETTING, AND PATIENTSThe SPIRIT III trial, a prospective, randomized, single-blind, controlled trial enrolling patients at 65 academic and community-based US institutions between June 22, 2005, and March 15, 2006. Patients were 1002 men and women undergoing percutaneous coronary intervention in lesions 28 mm or less in length and with reference vessel diameter between 2.5 and 3.75 mm. Angiographic follow-up was prespecified at 8 months in 564 patients and completed in 436 patients. Clinical follow-up was performed at 1, 6, 9, and 12 months.INTERVENTIONSPatients were randomized 2:1 to receive the everolimus-eluting stent (n = 669) or the paclitaxel-eluting stent (n = 333).MAIN OUTCOME MEASURESThe primary end point was noninferiority or superiority of angiographic in-segment late loss. The major secondary end point was noninferiority assessment of target vessel failure events (cardiac death, myocardial infarction, or target vessel revascularization) at 9 months. An additional secondary end point was evaluation of major adverse cardiac events (cardiac death, myocardial infarction, or target lesion revascularization) at 9 and 12 months.RESULTSAngiographic in-segment late loss was significantly less in the everolimus-eluting stent group compared with the paclitaxel group (mean, 0.14 [SD, 0.41] mm vs 0.28 [SD, 0.48] mm; difference, -0.14 [95% CI, -0.23 to -0.05]; P < or = .004). The everolimus stent was noninferior to the paclitaxel stent for target vessel failure at 9 months (7.2% vs 9.0%, respectively; difference, -1.9% [95% CI, -5.6% to 1.8%]; relative risk, 0.79 [95% CI, 0.51 to 1.23]; P < .001). The everolimus stent compared with the paclitaxel stent resulted in significant reductions in composite major adverse cardiac events both at 9 months (4.6% vs 8.1%; relative risk, 0.56 [95% CI, 0.34 to 0.94]; P = .03) and at 1 year (6.0% vs 10.3%; relative risk, 0.58 [95% CI, 0.37 to 0.90]; P = .02), due to fewer myocardial infarctions and target lesion revascularization procedures.CONCLUSIONSIn this large-scale, prospective randomized trial, an everolimus-eluting stent compared with a paclitaxel-eluting stent resulted in reduced angiographic late loss, noninferior rates of target vessel failure, and fewer major adverse cardiac events during 1 year of follow-up.TRIAL REGISTRATIONclinicaltrials.gov Identifier: NCT00180479.