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Concept: Drug-eluting stent

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Although drug-eluting stents have dramatically reduced angiographic restenosis and clinical need for repeat revascularization procedures, some adverse effects, such as late stent thrombosis, have been described. We evaluated clinical performance of paclitaxel-eluting stents coated with a new bioactive polymer system (P-5) based on a copolymer of an acrylic derivative of triflusal in patients with coronary artery disease.

Concepts: Atherosclerosis, Coronary artery disease, Cardiology, Atheroma, Artery, Stent, Cardiovascular system, Drug-eluting stent

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Background Bioresorbable vascular scaffolds were developed to overcome the shortcomings of drug-eluting stents in percutaneous coronary intervention (PCI). We performed an investigator-initiated, randomized trial to compare an everolimus-eluting bioresorbable scaffold with an everolimus-eluting metallic stent in the context of routine clinical practice. Methods We randomly assigned 1845 patients undergoing PCI to receive either a bioresorbable vascular scaffold (924 patients) or a metallic stent (921 patients). The primary end point was target-vessel failure (a composite of cardiac death, target-vessel myocardial infarction, or target-vessel revascularization). The data and safety monitoring board recommended early reporting of the study results because of safety concerns. This report provides descriptive information on end-point events. Results The median follow-up was 707 days. Target-vessel failure occurred in 105 patients in the scaffold group and in 94 patients in the stent group (2-year cumulative event rates, 11.7% and 10.7%, respectively; hazard ratio, 1.12; 95% confidence interval [CI], 0.85 to 1.48; P=0.43); event rates were based on Kaplan-Meier estimates in time-to-event analyses. Cardiac death occurred in 18 patients in the scaffold group and in 23 patients in the stent group (2-year cumulative event rates, 2.0% and 2.7%, respectively), target-vessel myocardial infarction occurred in 48 patients in the scaffold group and in 30 patients in the stent group (2-year cumulative event rates, 5.5% and 3.2%), and target-vessel revascularization occurred in 76 patients in the scaffold group and in 65 patients in the stent group (2-year cumulative event rates, 8.7% and 7.5%). Definite or probable device thrombosis occurred in 31 patients in the scaffold group as compared with 8 patients in the stent group (2-year cumulative event rates, 3.5% vs. 0.9%; hazard ratio, 3.87; 95% CI, 1.78 to 8.42; P<0.001). Conclusions In this preliminary report of a trial involving patients undergoing PCI, there was no significant difference in the rate of target-vessel failure between the patients who received a bioresorbable scaffold and the patients who received a metallic stent. The bioresorbable scaffold was associated with a higher incidence of device thrombosis than the metallic stent through 2 years of follow-up. (Funded by Abbott Vascular; AIDA ClinicalTrials.gov number, NCT01858077 .).

Concepts: Myocardial infarction, Cardiology, Heart, Percutaneous coronary intervention, Stroke, Cardiac arrest, Stent, Drug-eluting stent

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Background The choice of drug-eluting stent in the treatment of patients with diabetes mellitus and coronary artery disease who are undergoing percutaneous coronary intervention (PCI) has been debated. Previous studies comparing paclitaxel-eluting stents with stents eluting rapamycin (now called sirolimus) or its analogues (everolimus or zotarolimus) have produced contradictory results, ranging from equivalence between stent types to superiority of everolimus-eluting stents. Methods We randomly assigned 1830 patients with diabetes mellitus and coronary artery disease who were undergoing PCI to receive either a paclitaxel-eluting stent or an everolimus-eluting stent. We used a noninferiority trial design with a noninferiority margin of 4 percentage points for the upper boundary of the 95% confidence interval of the risk difference. The primary end point was target-vessel failure, which was defined as a composite of cardiac death, target-vessel myocardial infarction, or ischemia-driven target-vessel revascularization at the 1-year follow-up. Results At 1 year, paclitaxel-eluting stents did not meet the criterion for noninferiority to everolimus-eluting stents with respect to the primary end point (rate of target-vessel failure, 5.6% vs. 2.9%; risk difference, 2.7 percentage points [95% confidence interval, 0.8 to 4.5]; relative risk, 1.89 [95% confidence interval, 1.20 to 2.99]; P=0.38 for noninferiority). There was a significantly higher 1-year rate in the paclitaxel-eluting stent group than in the everolimus-eluting stent group of target-vessel failure (P=0.005), spontaneous myocardial infarction (3.2% vs. 1.2%, P=0.004), stent thrombosis (2.1% vs. 0.4%, P=0.002), target-vessel revascularization (3.4% vs. 1.2%, P=0.002), and target-lesion revascularization (3.4% vs. 1.2%, P=0.002). Conclusions In patients with diabetes mellitus and coronary artery disease undergoing PCI, paclitaxel-eluting stents were not shown to be noninferior to everolimus-eluting stents, and they resulted in higher rates of target-vessel failure, myocardial infarction, stent thrombosis, and target-vessel revascularization at 1 year. (Funded by Boston Scientific; TUXEDO-India Clinical Trials Registry-India number, CTRI/2011/06/001830 ).

Concepts: Myocardial infarction, Atherosclerosis, Hypertension, Coronary artery disease, Cardiology, Heart, Percutaneous coronary intervention, Drug-eluting stent

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We sought to investigate the impact of the self-apposing, sirolimus-eluting STENTYS stent on midterm and long-term stent apposition and strut coverage compared with a zotarolimus-eluting balloon-expandable stent in ST-segment elevation myocardial infarction (STEMI) patients undergoing primary percutaneous coronary intervention (PPCI).

Concepts: Myocardial infarction, Atherosclerosis, Cardiology, Heart failure, Percutaneous coronary intervention, Atheroma, Acute coronary syndrome, Drug-eluting stent

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AimsThe purpose of this pre-specified analysis of the PROlonging Dual antiplatelet treatment after Grading stent-induced Intimal hyperplasia studY (PRODIGY) was to assess device-specific outcomes relative to different duration of dual antiplatelet therapy (DAPT) after Everolimus- (EES), Paclitaxel (PES), Zotarolimus- (ZES-S) eluting, or bare metal stents (BMS).Methods and resultsWe randomized 2013 patients to BMS, ZES-S, PES, or EES implantation. At 30 days, each stent group underwent up to 6 or 24 months clopidogrel therapy. The primary endpoint, which was a composite of death, myocardial infarction, or cerebrovascular accident, did not differ in patients receiving BMS [HR: 0.89 (95%CI: 0.54-1.45)], PES [HR: 0.74 (95%CI: 0.43-1.25)], or EES [HR: 0.63 (95%CI: 0.33-1.21)] implantation across DAPT groups, whereas it was significantly higher in ZES-S patients undergoing long when compared with short-term DAPT therapy (HR: 2.85, P = 0.0018), with positive interaction testing (P-value = 0.004). At the 6-month landmark analysis, heterogeneity across stent types persisted for the primary study endpoint and other secondary clinical outcomes, whereas patients receiving PES showed a significantly higher rate of definite, probable and definite, probable, possible stent thrombosis in the short DAPT regimen. No association in absolute or relative terms was noted between stent potency in inhibiting intimal hyperplasia and greater vulnerability to shorter DAPT therapy.ConclusionOur study suggests that optimal duration of DAPT may be stent-specific and it does not support a clear association between stent potency and vulnerability to shorter DAPT therapy.Trial Registration clinicaltrials.gov Identifier: NCT00611286. http://clinicaltrials.gov/ct2/show/NCT00611286?term=prodigy&rank=2.

Concepts: Myocardial infarction, Atherosclerosis, Percutaneous coronary intervention, Stroke, Aspirin, Drug-eluting stent, Bare-metal stent, Intimal hyperplasia

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Drug-eluting stents (DES) have been in clinical use for nearly a decade; however, the relative short- and long-term efficacy and safety of DES compared with bare-metal stents (BMS) and among the DES types are less well defined.

Concepts: Randomized controlled trial, Drug-eluting stent, Coronary stent, Bare-metal stent, Hedge fund

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OBJECTIVE: To investigate the accuracy of 128-slice dual-source CT using high-pitch spiral mode (HPS) for the assessment of coronary stents. METHODS: We conducted a prospective study on patients with previous stent implantation due to recurred suspicious symptoms of angina with positive findings at stress testing scheduled for coronary angiography (CA), while dual source computed tomography (DSCT) examinations were randomly done by one of the three different scan modes [HPS, sequential mode (SEQ), low-pitch spiral mode (LPS)] one week before CA examinations. The image quality, radiation dose and stent patency of DSCT were evaluated blinded to the results of CA. RESULTS: 180 patients with total 256 stents were enrolled in this study. There was no significant difference on the image quality of DSCT by HPS (1.4±0.5), SEQ (1.5±0.5) and LPS (1.3±0.6) (P>0.05). The noise of images reconstructed with B26f kernel in HPS is significantly increased than in SEQ/LPS (P<0.05), while no significant difference with images reconstructed with B46f kernel (P>0.05). Heart rate (HR) variability had a slight impact on the image quality for HPS (P<0.05), not for LPS/SEQ (P>0.05). In the assessment of stent restenosis compared with CA on per-stent basis, there was no significant difference on sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) of DSCT using HPS (100%, 97.1%, 83.3%, 100%), LPS (92.3%, 95.9%, 80%, 98.6%) and SEQ (93.3%, 97.3%, 87.5%, 98.6%) (P>0.05). The effective dose of DSCT by HPS (1.0±0.5mSv) is significant less than that by SEQ (3.0±1.4mSv) or LPS (13.0±5.4mSv) (P<0.01). CONCLUSIONS: DSCT using HPS provides good diagnostic accuracy on coronary stent patency compared with CA, similar to that by SEQ/LPS, whereas with lower effective dose in patients with HR lower than 65bpm.

Concepts: Angina pectoris, Positive predictive value, Negative predictive value, Cardiology, Sensitivity and specificity, Stent, Drug-eluting stent, Coronary stent

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Aims: To investigate the incidence of cardiac events in octogenarians who underwent percutaneous coronary intervention (PCI) with stenting, as well as to evaluate the efficacy and safety of drug-eluting stents (DES) in this population. Methods and results: The study included 6,129 consecutive patients who underwent PCI with stenting from 2000 to 2005 in our centre, of whom 291 (4.7%) were octogenarians. After adjusting for confounders, age ≥80 years appeared a significant predictor of high mortality at 30 days (adjusted hazard ratio [aHR] 1.92, 95% CI 1.23-3.01), and four years (aHR 2.25, 95% CI 1.77-2.85). No differences were seen with respect to incident myocardial infarction (MI), but target lesion (63.2 vs. 32.6 per 1,000 person-years at one year and 27.9 vs. 16.6 per 1,000 person-years at four years) and vessel (83.1 vs. 52.9 per 1,000 person-years at one year and 37.7 vs. 25.0 per 1,000 person-years at four years) revascularisation rates were lower in octogenarians. When comparing DES with bare metal stents (BMS) in octogenarians, mortality and MI rates were comparable, but there was a significantly lower incidence of target lesion revascularisation at one- (9.5 vs. 0.6 per 1,000 person-years, aHR 0.07, 95% CI 0.01-0.57) and four-year (3.4 vs. 0.7 per 1,000 person-years, aHR 0.16, 95% CI 0.04-0.59) follow-up in patients who received a DES. Conclusions: Octogenarians undergoing PCI with stenting have an increased mortality risk, whereas the rates of repeat revascularisation in octogenarians are lower. This study suggests that the benefit of DES in reducing revascularisation rates is extended to elderly patients.

Concepts: Myocardial infarction, Atherosclerosis, Medical statistics, Cardiology, Percutaneous coronary intervention, Stent, Drug-eluting stent, Bare-metal stent

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The EucaTax stent (EUPES) is a coronary stent with biodegradable polymer and camouflage coating that has been developed to promote the complete elution of drugs and decrease the risk of late complications. The aim of this study was to evaluate the efficacy and safety of the double-coated EUPES in patients with stable angina versus sirolimus-eluting stent CYPHER (SES) with permanent polymer coating.

Concepts: Angina pectoris, Cardiology, Percutaneous coronary intervention, Stent, Drug-eluting stent, Coronary stent

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BACKGROUND: THE EFFICACY AND SAFETY OF DRUG-ELUTING STENTS (DES) IN PATIENTS WITH ST-SEGMENTELEVATION MYOCARDIAL INFARCTION (STEMI) IS CONTROVERSIAL. CONSEQUENTLY, DES IMPLANTATION HAS A CLASS IIA INDICATION IN THE AMERICAN COLLEGE OF CARDIOLOGY/AMERICAN HEART ASSOCIATION AND THE EUROPEAN SOCIETY OF CARDIOLOGY STEMI GUIDELINES.METHODS AND RESULTS: PUBMED, EMBASE, AND CENTRAL WERE SEARCHED FOR RANDOMIZED CLINICAL TRIALS, UNTIL MARCH 2013, COMPARING ANY OF THE 5 FOOD AND DRUG ADMINISTRATIONAPPROVED DURABLE STENT AND POLYMER DES (SIROLIMUS ELUTING STENT, PACLITAXEL ELUTING STENT, EVEROLIMUS-ELUTING STENT [EES], ZOTAROLIMUS-ELUTING STENT, AND ZOTAROLIMUS-ELUTING STENT RESOLUTE), AGAINST EACH OTHER OR BARE METAL STENTS (BMS), AND ENROLLING 50 PATIENTS WITH STEMI. EFFICACY (TARGET VESSEL REVASCULARIZATION) AND SAFETY (DEATH, MYOCARDIAL INFARCTION, AND STENT THROMBOSIS) OUTCOMES AT THE LONGEST REPORTED FOLLOW-UP TIMES WERE EVALUATED. TWENTY-EIGHT RANDOMIZED CLINICAL TRIALS WITH 34 068 PATIENT-YEARS OF FOLLOW-UP ON SUBJECTS WITH STEMI FULFILLED THE INCLUSION CRITERIA. WHEN COMPARED WITH BMS (REFERENCE RATE RATIO [RR] OF 1), SIROLIMUS ELUTING STENT (RR, 0.46; 95% CREDIBILITY INTERVAL [CRI], 0.360.56), PACLITAXEL ELUTING STENT (RR, 0.69; 95% CRI, 0.530.87), AND EES (RR, 0.42; 95% CRI, 0.260.62) WERE ASSOCIATED WITH A STATISTICALLY SIGNIFICANT REDUCTION IN RATE OF TARGET VESSEL REVASCULARIZATION, WITH THE POINT ESTIMATE FOR ZOTAROLIMUS-ELUTING STENT RESOLUTE TRENDING IN A SIMILAR DIRECTION. THERE WAS NO INCREASE IN THE RISK OF DEATH, MYOCARDIAL INFARCTION, OR STENT THROMBOSIS WITH ANY DES COMPARED WITH BMS. MOREOVER, EES WAS ASSOCIATED WITH A STATISTICALLY SIGNIFICANT REDUCTION IN THE RATE OF STENT THROMBOSIS WHEN COMPARED WITH SIROLIMUS ELUTING STENT (RR, 0.38; 95% CRI, 0.210.74), PACLITAXEL ELUTING STENT (RR, 0.39; 95% CRI, 0.210.73), AND EVEN BMS (RR, 0.42; 95% CRI, 0.230.76). THERE WAS A 74% PROBABILITY THAT EES HAD THE LOWEST RATE OF ANY STENT THROMBOSIS WHEN COMPARED WITH ALL OTHER STENT TYPES (NO DATA ON ZOTAROLIMUS-ELUTING STENT RESOLUTE). THERE WAS NO INCREASE IN VERY LATE STENT THROMBOSIS WITH EES VERSUS BMS (RR, 0.89; 95% CRI, 0.098.67).CONCLUSIONS: In patients with STEMI, DES versus BMS was associated with substantial decrease in the risk of target vessel revascularization without compromising safety. EES had the added advantage of substantial reduction in the risk of stent thrombosis when compared with first-generation DES and BMS with no increase in very late stent thrombosis.

Concepts: Statistics, Myocardial infarction, Cardiology, Percutaneous coronary intervention, Randomized controlled trial, Statistical significance, Drug-eluting stent, Bare-metal stent