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Background: It has been pronounced that everolimus-eluting stent (EES) had lower charge of goal-lesion revascularization and stent thrombosis as compared with sirolimus-eluting stents (SES).The goal of this observation was to compare the efficacy and protection of EES with SES in primary percutaneous coronary intervention (PCI) for acute myocardial infarction (AMI). Methods: In this retrospective study, a total of 404 patients with coronary artery stenosis who underwent angioplasty of one or more coronary arteries were included in the study. Of these, 202 were treated with SES and the others with EES. The data were collected by a questionnaire through which the annual incidence of coronary stent complications including the occurrence of stent thrombosis (confirmed by re-angiography), the occurrence of acute coronary syndrome leading to hospitalization, the occurrence of vascular myocardial infarction related to the stenting vessel, the need for re-angiography and angioplasty and finally the incidence of cardiac mortality were evaluated. Results: This study showed that the odds ratio of EES thrombosis to SES stent in the unadjusted model is 1.01 (0.06-16.34) and in the adjusted model for confounding variables was equal to 0.80 (0.04-13.35) which in both models, these values were not statistically significant. Conclusion: The findings of the present study indicate that there is no statistically significant difference between the outcomes in the two groups treated with SES and EES release stents.

Background: It has been pronounced that everolimus-eluting stent (EES) had lower charge of goal-lesion revascularization and stent thrombosis as compared with sirolimus-eluting stents (SES). The goal of this observation was to compare the efficacy and protection of EES with SES in primary percutaneous coronary intervention (PCI) for acute myocardial infarction (AMI). Methods: In this retrospective study, a total of 404 patients with coronary artery stenosis who underwent angioplasty of one or more coronary arteries were included in the study. Of these, 202 were treated with SES and the others with EES. The data were collected by a questionnaire through which the annual incidence of coronary stent complications including the occurrence of stent thrombosis (confirmed by re-angiography), the occurrence of acute coronary syndrome leading to hospitalization, the occurrence of vascular myocardial infarction related to the stenting vessel, the need for re-angiography and angioplasty and finally the incidence of cardiac mortality were evaluated. Results: This study showed that the odds ratio of EES thrombosis to SES stent in the unadjusted model is 1.01 (0.06-16.34) and in the adjusted model for confounding variables was equal to 0.80 (0.04-13.35) which in both models, these values were not statistically significant. Conclusion: The findings of the present study indicate that there is no statistically significant difference between the outcomes in the two groups treated with SES and EES release stents. [ABSTRACT FROM AUTHOR]

Objective: The aim of this study was to determine the frequency of major adverse cardiac events in patients with de novo coronary artery disease revascularized with everolimus-eluting stents. Methodology: This prospective cross sectional study was carried out in the department of cardiology, Lady Reading Hospital Peshawar from October 2011 to November 2012. Patients with de novo coronary artery disease, who were revascularized with everolimus-eluting stents, were included in the study. Their baseline clinical and procedural characteristics were recorded from hospital record. Data regarding MACE defined as composite of myocardial infarction, stent thrombosis, recurrence of ischemia and death were obtained on follow up. Results: A total of 420 patients were included in the study in which 320(76.2%) were male. Risk factors for coronary artery disease were; diabetes mellitus 147(35%), hypertension 256(61%), hypercholesterolemia 147(35%) and smoking 100(23.8%). Most of patients had stable angina 285(67.9%). On coronary angiography, 98(23.3%) of patients had single vessel disease, 152(36.2%) had two vessel disease and 170(40.5%) had three vessel disease. Left anteriordescending artery was mostfrequently affected vessel 242(57.6%). Mean lesion length was 25±8.1 mm. Mean stent length/lesion was 26.03±7.09 mm while mean stent diameter/lesion was 3.14±0.29mm. Tirofiben (Agrastate) was used in 19(4.5%) of patients. On follow up, MACE occurred in 16(3.8%) patients, 6(1.4%) patients developed myocardial infarction, 5(1.2%) developed recurrence of ischemia, 6(1.4%) of patients developed stent thrombosis and 6(1.4%) of patients died during study period. Conclusion: Everolimus-eluting stents carries a lower risk of major adverse cardiac events in patients with de novo coronary disease. [ABSTRACT FROM AUTHOR]

Background Endeavor zotarolimus-eluting stents (E-ZES) and everolimus-eluting stents (EES) as second-generation stents were approved for use in percutaneous coronary interventions (PCIs) in 2008. We aimed to evaluate the long-term outcomes of E-ZES vs. EES using New York State (NYS) cardiac registries and to compare long-term effectiveness of E-ZES vs. EES in six “off-label” and two “high-risk” subgroups. Methods We created a longitudinal database by linking the NYS cardiac registries, the statewide hospital discharge data, the National Death Index, and the U.S. Census file (2010) for patients receiving either E-ZES or EES from July 2008 through December 2010. We examined outcome measures of all-cause mortality, acute myocardial infarction (AMI), target lesion PCI (TLPCI), and target vessel coronary artery bypass graft (TVCABG) surgery for 13,663 propensity score matched pairs in the 6-year follow-up period. We applied Kaplan-Meier methods and Cox proportional hazards regression for further adjustment of propensity-matched pairs. Results Compared with patients receiving EES, patients receiving E-ZES had a significantly higher rate of 6-year all-cause mortality (adjusted hazard ratio (AHR): 1.10, 95% confidence interval (CI): 1.04–1.17, P = 0.003), AMI (AHR: 1.12, 95% CI: 1.02–1.23, P = 0.01), TLPCI (AHR: 1.28, 95% CI: 1.18–1.39, P < 0.001), and TVCABG (AHR: 1.47, 95% CI: 1.26–1.71, P < 0.001). EES had better or similar long-term outcomes than E-ZES for the subgroups that were examined. Conclusion At 6 years, patients receiving EES generally had better or comparable mortality, AMI, TLPCI, and TVCABG outcomes compared with patients receiving E-ZES. [ABSTRACT FROM AUTHOR]

The Comparison of Bioactive-Stent to the Everolimus-Eluting Stent in Acute Coronary Syndrome (BASE-ACS) trial demonstrated an outcome of titanium-nitride-oxide-coated bioactive stents (BAS) non-inferior to everolimus-eluting stents (EES) in patients presenting with acute coronary syndrome (ACS). We performed a post hoc analysis of the BASE-ACS trial in patients with, versus those without, preexisting vascular disease. We randomized 827 patients (1:1) presenting with ACS to receive either BAS or EES. The primary end point was major adverse cardiac events (MACE): a composite of cardiac death, non-fatal myocardial infarction (MI), or ischemia-driven target lesion revascularization (TLR). A total of 169 (20.4%) patients had preexisting vascular disease. Median follow-up was 5.0 years. The incidence of MACE was higher in patients with, versus those without, preexisting vascular disease (22.5% vs 13.5%, respectively, P = .004). This was driven by more frequent cardiac death and non-fatal MI (5.9% vs 2.4% and 11.8% vs 5.5%, P = .02 and P = .003, respectively). The rates of ischemia-driven TLR were comparable (P > .05). All events were comparable between the 2 matched-pair subgroups (P > .05 for all). In patients treated with early percutaneous coronary intervention for ACS, the long-term outcome was worse in patients with, versus those without, preexisting vascular disease. [ABSTRACT FROM AUTHOR]

Background: Recent evidence suggests that bioresorbable vascular scaffolds (BVS) are associated with an excess of thrombotic complications compared with metallic everolimus-eluting stents (EES).Objectives: This study sought to investigate the comparative effectiveness of the Food and Drug Administration-approved BVS versus metallic EES in patients undergoing percutaneous coronary intervention at longest available follow-up.Methods: The authors searched MEDLINE, Scopus, and web sources for randomized trials comparing BVS and EES. The primary efficacy and safety endpoints were target lesion failure and definite or probable stent thrombosis, respectively.Results: Seven trials were included: in sum, 5,583 patients were randomized to receive either the study BVS (n = 3,261) or the EES (n = 2,322). Median time of follow-up was 2 years (range 2 to 3 years). Compared with metallic EES, risk of target lesion failure (9.6% vs. 7.2%; absolute risk difference: +2.4%; risk ratio: 1.32; 95% confidence interval: 1.10 to 1.59; number needed to harm: 41; p = 0.003; I2 = 0%) and stent thrombosis (2.4% vs. 0.7%; absolute risk difference: +1.7%; risk ratio: 3.15; 95% confidence interval: 1.87 to 5.30; number needed to harm: 60; p < 0.0001; I2 = 0%) were both significantly higher with BVS. There were no significant differences in all-cause or cardiovascular mortality between groups. The increased risk for ST associated with BVS was concordant across the early (<30 days), late (30 days to 1 year), and very late (>1 year) periods (pinteraction = 0.49).Conclusions: Compared with metallic EES, the BVS appears to be associated with both lower efficacy and higher thrombotic risk over time. (Bioresorbable vascular scaffold compare to everolimus stents in long term follow up; CRD42017059993). [ABSTRACT FROM AUTHOR]

Background The BASE ACS trial demonstrated an outcome of titanium–nitride–oxide-coated bioactive stents (BAS) that was non-inferior to everolimus-eluting stents (EES) in patients presenting with acute coronary syndrome (ACS). We performed a post hoc analysis of elderly versus non-elderly patients from the BASE ACS trial. Methods We randomized 827 patients (1:1) presenting with ACS to receive either BAS or EES. The primary endpoint was major adverse cardiac events (MACE): a composite of cardiac death, non-fatal myocardial infarction (MI), or ischemia-driven target lesion revascularization (TLR). Follow-up was planned at 12 months and yearly thereafter for up to 7 years. Elderly age was defined as ≥ 65 years. Results Of the 827 patients enrolled in the BASE ACS trial, 360 (43.5%) were elderly. Mean follow-up duration was 4.2 ± 1.9 years. MACE was more frequent in elderly versus younger patients (19.7% versus 12.0%, respectively, p = 0.002), probably driven by more frequent cardiac death and non-fatal MI events (5.3% versus 1.5%, and 9.7% versus 4.5%, p = 0.002 and p = 0.003, respectively). The rates of ischemia-driven TLR were comparable ( p > 0.05). In propensity score-matched analysis (215 pairs), only cardiac death was more frequent in elderly patients (6% versus 1.4%, respectively, p = 0.01). Diabetes independently predicted both MACE and cardiac death in elderly patients. Conclusions Elderly patients treated with stent implantation for ACS had worse long-term clinical outcome, compared with younger ones, mainly due to a higher death rate. [ABSTRACT FROM AUTHOR]

Background: It has been pronounced that everolimus-eluting stent (EES) had lower charge of goal-lesion revascularization and stent thrombosis as compared with sirolimus-eluting stents (SES).The goal of this observation was to compare the efficacy and protection of EES with SES in primary percutaneous coronary intervention (PCI) for acute myocardial infarction (AMI)., Methods: In this retrospective study, a total of 404 patients with coronary artery stenosis who underwent angioplasty of one or more coronary arteries were included in the study. Of these, 202 were treated with SES and the others with EES. The data were collected by a questionnaire through which the annual incidence of coronary stent complications including the occurrence of stent thrombosis (confirmed by re-angiography), the occurrence of acute coronary syndrome leading to hospitalization, the occurrence of vascular myocardial infarction related to the stenting vessel, the need for re-angiography and angioplasty and finally the incidence of cardiac mortality were evaluated., Results: This study showed that the odds ratio of EES thrombosis to SES stent in the unadjusted model is 1.01 (0.06-16.34) and in the adjusted model for confounding variables was equal to 0.80 (0.04-13.35) which in both models, these values were not statistically significant., Conclusion: The findings of the present study indicate that there is no statistically significant difference between the outcomes in the two groups treated with SES and EES release stents., Competing Interests: There is no conflict of interest.

Background The BASE ACS randomized trial demonstrated non-inferiority of titanium-nitride-oxide-coated bioactive stents (BAS), compared with everolimus-eluting stents (EES), for the primary endpoint of major adverse cardiac events (MACE) in patients presenting with acute coronary syndrome (ACS) at 12-month follow-up. We report the final long-term clinical outcome of the trial. Methods We randomly assigned 827 patients with ACS to receive either BAS (417) or EES (410). The primary endpoint was MACE: a composite of cardiac death, non-fatal myocardial infarction (MI) or ischemia-driven target lesion revascularization (TLR) at 12-month follow-up. Analysis was performed by intention to treat. Follow-up was planned at 12 months, and yearly thereafter through 7 years. Results Mean follow-up duration was 4.2 ± 1.9 years (median 5.0 years). At 5-year follow-up, BAS was non-inferior to EES for the primary endpoint of MACE (14.4% versus 17.8%, respectively; hazard ratio for BAS versus EES, 0.82; 95% confidence interval, 0.58–1.16; p = 0.26 for superiority; p < 0.001 for non-inferiority). The rate of non-fatal MI was lower in the BAS group (5.9% versus 9.7%, respectively, p = 0.028). The rates of cardiac death and ischemia-driven TLR were comparable (2.8% versus 3.8%, and 8.3% versus 9.9%; p = 0.76 and p = 0.58, respectively). Conclusions In the current final report of the randomized BASE ACS trial in patients with ACS, BAS implantation was associated with a rate of cumulative MACE at long-term follow-up that was statistically non-inferior to EES. [ABSTRACT FROM AUTHOR]

Objectives: The BASE-ACS trial demonstrated non-inferiority of titanium-nitride-oxide-coated bioactive stents (BAS), versus everolimus-eluting stents (EES), for major adverse cardiac events (MACE) at 1- and 2-year follow-up, in patients with acute coronary syndrome (ACS). We presented the 4-year outcome of the BASE-ACS trial.Design: We randomized 827 patients with ACS to receive either BAS (417) or EES (410). MACE was a composite of cardiac death, non-fatal myocardial infarction (MI) or ischemia-driven target lesion revascularization (TLR) at 12-month follow-up. Analyses were performed by intention to treat. Follow-up was planned at 12 months, and yearly thereafter for 5 years.Results: Four-year clinical follow-up was completed in 753 (91.1%) patients. At 4 years, BAS were non-inferior to EES for MACE (14.7% versus 17.8%, respectively; p = 0.24 for superiority; p = 0.001 for non-inferiority). Non-fatal MI was less frequent with BAS (5.0% versus 9.2%, respectively; p = 0.025). Cardiac death and ischemia-driven TLR were comparable (2.9% versus 3.5%, and 8.6% versus 9.2%; p = 0.62 and p = 0.80, respectively). Independent predictors of MACE were calcified lesions (HR 1.54, p = 0.021), the number of vessels treated (HR 1.53, p = 0.025), and reference vessel diameter (HR 0.54, p = 0.006).Conclusions: In patients presenting with ACS, BAS was associated with a clinical outcome non-inferior to EES at 4-year follow-up. [ABSTRACT FROM AUTHOR]

Background:The BASE ACS trial demonstrated an outcome of titanium-nitride-oxide-coated bioactive stents (BAS) that was non-inferior to everolimus-eluting stents (EES) in patients with acute coronary syndrome (ACS). We performed a post-hoc analysis of diabetic versus non-diabetic patients from the trial. Methods:We randomised 827 patients (1:1) with ACS to receive either BAS or EES. The primary endpoint was major adverse cardiac events (MACE): a composite of cardiac death, non-fatal myocardial infarction (MI) or ischaemia-driven target lesion revascularisation (TLR). Follow-up was planned yearly through 7 years. Results:Of 827 patients, 140 (16.9%) were diabetic; of these, 36 (25.7%) were insulin-treated. Mean follow-up duration was 4.2 ± 1.9 years. MACE was more frequent in diabetics versus non-diabetics (23.6% versus 13.7%, respectively, p = 0.003), mainly driven by more frequent cardiac death (7.9% versus 2.2%, respectively, p = 0.002). The rates of non-fatal MI, ischaemia-driven TLR were comparable (p > 0.05 for all). In diabetic patients, MACE was comparable between the two stent arms (18.5% versus 28.0%, for BAS versus EES, respectively, p = 0.18). Conclusions:Diabetic patients treated with early percutaneous coronary intervention for ACS had worse long-term outcome, compared with non-diabetics, mainly driven by more frequent cardiac death. The long-term outcome of BAS was comparable to EES in diabetics.Key MessagesDiabetic patients presenting with acute coronary syndrome who were treated with early percutaneous coronary intervention had worse long-term clinical outcome, compared with non-diabetics, mainly driven by a high incidence of cardiac death.Age independently predicted both major adverse cardiac events and cardiac death in diabetic patients.The long-term clinical outcome of titanium-nitride-oxide-coated bioactive stents was comparable to that of everolimus-eluting stents in the diabetic, as well as in the non-diabetic subgroup. [ABSTRACT FROM PUBLISHER]

Background Previous reports have suggested the importance of delayed arterial healing and the development of neoatherosclerosis as major contributors to stent thrombosis and delayed restenosis. The difference of in vivo assessment of long-term vessel healing between first-generation drug-eluting stents and current generation everolimus-eluting stents (EESs) is limited. The aim of this study was to evaluate long-term arterial healing in EES in comparison with the first generation sirolimus-eluting stents (SES). Methods We evaluated 31 EES (23 patients) and 8 SES (7 patients) by serial optical coherence tomography at 12 months (mid-phase) and 24 months (late-phase) after stenting and evaluated the change in neointimal thickness (NIT), the percentages of uncovered struts, peri-strut low intensity area (PLIA; region around stent struts homogenously lower-intensity appearance than surrounding tissue), and thrombus. Results Although the average NIT showed no significant changes from the mid- to the late-phase follow-up in both EES and SES groups, the change in NIT and minimum lumen area was significantly larger in SES than EES (5.2 ± 29.4 vs. 37.2 ± 48.9; p = 0.02, −0.06 ± 0.36 vs. −0.45 ± 0.74; p = 0.04, respectively). The incidence of uncovered struts and struts with PLIA of EES was lower than those of SES, at both phases. Stents with in-stent thrombus of EES tended to be lower than that of SES at both phase follow-ups. Conclusion Although both SES and EES showed progressive luminal narrowing from the mid- to the late-phase follow-up, the extent of delayed lumen narrowing and delayed neointimal proliferation was significantly less in the second generation EES than the first generation SES. EESs seem to offer sustained stability in efficacy, without sacrificing safety, up to 2 years after implantation. [ABSTRACT FROM AUTHOR]

Background In contrast to many studies comparing everolimus-eluting stent (EES) with paclitaxel-eluting stent (PES), data directly comparing EES with sirolimus-eluting stent (SES) are limited, especially in patients with acute myocardial infarction (AMI). Methods This study includes 2911 AMI patients treated with SES (n = 1264) or EES (n = 1701) in Korea Acute Myocardial Infarction Registry (KAMIR). Propensity score matching was applied to adjust for baseline imbalance in clinical and angiographic characteristics, yielding a total of 2400 well-matched patients (1200 receiving SES and 1200 receiving EES). One-year clinical outcomes were compared between the two propensity score matched groups. Results Baseline clinical and angiographic characteristics were similar between the two propensity score matched groups. One-year clinical outcomes of the propensity score matched cohort were comparable between the EES versus the SES groups including the rates of cardiac death (4.8% vs. 4.8%, P = 1.000), recurrent myocardial infarction (1.4% vs. 1.7%, P = 0.619), target lesion revascularization (1.4% vs. 1.6%, P = 0.737), target lesion failure (7.0% vs. 7.3%, P = 0.752), and probable or definite stent thrombosis (0.5% vs. 0.9%, P = 0.224) except for a trend toward lower incidence of target vessel revascularization (1.9% vs. 3.0%, P = 0.087) and a lower rate of total major adverse cardiac events (9.3% vs. 11.9%, P = 0.034) in the EES group. Conclusions The present propensity score matched analysis performed in a large-scale, prospective, multicenter registry suggests that the second-generation drug-eluting stent EES has at least comparable or even better safety and efficacy profiles as compared with SES in the setting of AMI. [ABSTRACT FROM AUTHOR]

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The consequences of acute strut malapposition in everolimus-eluting stents (EES) are unknown. This study investigated the impact of strut-vessel (S-V) distance and plaque type underneath acute strut malapposition on the mid-term vessel response in EES. Twenty-nine patients (35 EES) underwent optical coherence tomography (OCT) immediately after percutaneous coronary intervention and at 8-month follow-up. S-V distance and plaque type (lipid, calcified, or fibrous) underneath acute strut malapposition were evaluated. Follow-up OCT classified acute strut malapposition as persistent or resolved. The S-V cutoff value for predicting resolved strut malapposition and the incidence of intra-stent thrombi were determined. Among 569 cases of acute strut malapposition, involving 29,168 struts, 139 (24.4 %) were persistent. Mean S-V distance was significantly longer in persistent than in resolved strut malapposition (600 ± 294 vs. 231 ± 95 μm; P < 0.0001). S-V distance ≤380 μm was the best cutoff value for predicting resolved strut malapposition (sensitivity 93.5 %, specificity 69.8 %, area under curve 0.878). Acute strut malapposition with S-V distance ≤380 μm remained persistent more frequently over lipid/calcified than over fibrous plaques (lipid: 13.4 %, calcified: 18.2 %, fibrous: 4.2 %; lipid vs. fibrous, P = 0.001; calcified vs. fibrous, P = 0.02). Intra-stent thrombi were more frequent in stents with ≥1 persistent strut malapposition than in those without [4/11 stents (36.3 %) vs. 0/24 (0 %); P = 0.006]. Lipid and calcified plaque, together with S-V distance, affect the resolution of acute strut malapposition in EES. Persistent strut malapposition is associated with the presence of thrombi at follow-up, which could be the substrate for late stent thrombosis. [ABSTRACT FROM AUTHOR]

Incomplete stent endothelialization is associated with late and very late stent thrombosis. In a post hoc analysis of the BASE-ACS trial, we sought to assess neointimal coverage and coronary flow reserve (CFR) 9 months after implantation of titanium-nitride-oxide-coated bioactive stents (BAS) versus everolimus-eluting stents (EES) in patients with acute coronary syndrome (ACS). In the BASE-ACS trial, 827 patients with ACS were randomized to receive either BAS or EES. In the current study, we examined neointimal growth and strut coverage by optical coherence tomography and CFR by trans-thoracic echocardiography in 28 consecutive non-diabetic patients with the culprit lesion in the left anterior descending coronary artery. The primary endpoints were binary stent strut coverage and CFR at 9-month follow-up. A total of 13 patients were included in the BAS group (2,033 struts); 15 in the EES group (2,898 struts). Binary stent strut coverage was higher and malapposed struts lower with BAS versus EES (99.4 vs 89.2, and 0.2 vs 4.6 %, respectively, p < 0.001 for both). Neointimal hyperplasia thickness was greater with BAS versus EES (274.2 vs 100.1 μm, respectively, p < 0.001). CFR was lower with EES versus BAS (2.2 ± 0.8 vs 3.0 ± 0.5, respectively, p = 0.001). Abnormal CFR (<2.5) were detected in 10 patients in the EES group versus one in the BAS group ( p = 0.002). The current study demonstrated that in patients with ACS, BAS resulted in improved neointimal stent strut coverage and better coronary vasodilator function as compared with EES at 9-month follow-up. [ABSTRACT FROM AUTHOR]

Background. The BASE-ACS trial demonstrated an outcome of the titanium-nitride-oxide-coated bioactive stents (BAS) statistically non-inferior to that of the everolimus-eluting stents (EES) at 12-month follow-up in patients presenting with acute coronary syndrome (ACS). We performed a post hoc analysis of the BASE-ACS trial with particular focus on stent-oriented versus patient-oriented outcome at 24-month follow-up. Methods. A total of 827 patients with ACS were randomly assigned to receive either BAS (417) or EES (410). Stent-oriented outcome was defined as a composite of cardiac death, target vessel-related non-fatal myocardial infarction, or ischemia-driven target lesion revascularization. Patient-oriented outcome was defined as a composite of all-cause death, any non-fatal myocardial infarction, or any revascularization. Results. Clinical follow-up for 24 months was completed in 406 (97.4%) patients in the BAS group and in 398 (97.1%) in the EES group. Stent-oriented outcome at 24-month follow-up occurred at similar frequencies in the two stent groups (10.1% for BAS versus 11.2% for EES, P = 0.53). Likewise, patient-oriented outcome at 24-month follow-up was similar in the two groups (16.3% versus 19.8%, respectively, P = 0.2). Conclusions. In patients presenting with ACS, the rates of both stent-oriented and patient-oriented outcomes at 24-month follow-up in the BAS group were similar to those in the EES group. [ABSTRACT FROM AUTHOR]

Objectives: This study sought to compare everolimus-eluting stents (EES) with zotarolimus-eluting stents (ZES) in patients with acute myocardial infarction (AMI). Background: There is a paucity of data to exclusively evaluate the safety and efficacy of second-generation drug-eluting stents (DES) in the setting of AMI. Methods: The present study enrolled 3,309 AMI patients treated with ZES (n = 1,608) or EES (n = 1,701) in a large-scale, prospective, multicenter registry—KAMIR (Korea Acute Myocardial Infarction Registry). Propensity score matching was applied to adjust for differences in baseline clinical and angiographic characteristics, producing a total of 2,646 patients (1,343 receiving ZES, and 1,343 receiving EES). Target lesion failure (TLF) was defined as the composite of cardiac death, recurrent nonfatal myocardial infarction, or target lesion revascularization. Major clinical outcomes at 1 year were compared between the 2 propensity score-matched groups. Results: After propensity score matching, baseline clinical and angiographic characteristics were similar between the 2 groups. Clinical outcomes of the propensity score-matched patients showed that, despite similar incidences of recurrent nonfatal myocardial infarction and in-hospital and 1-year mortality, patients in the EES group had significantly lower rates of TLF (6.5% vs. 8.7%, p = 0.029) and probable or definite stent thrombosis (0.3% vs. 1.6%, p < 0.001), compared with those in the ZES group. Furthermore, there was a numerically lower rate of target lesion revascularization (1.2% vs. 2.2%, p = 0.051) in the EES group than in the ZES group. Conclusions: In this propensity-matched comparison, EES seems to be superior to ZES in reducing TLF and stent thrombosis in patients with AMI. [Copyright &y& Elsevier]

Objectives: This study sought to compare the safety and efficacy of 2 dose formulations of SYNERGY, a novel bioabsorbable polymer everolimus-eluting stent (EES) (Boston Scientific Corp., Natick, Massachusetts) compared with the durable polymer PROMUS Element EES (Boston Scientific Corp.). Background: Durable polymer coatings on drug-eluting stents have been associated with chronic inflammation and impaired healing. Bioabsorbable polymer-coated drug-delivery systems may reduce the risk of late adverse events, including stent thrombosis, and thus the need for prolonged dual-antiplatelet therapy. Methods: A total of 291 patients with a de novo lesion ≤28 mm in length, in a coronary artery of ≥2.25 to ≤3.5 mm diameter, were enrolled in the EVOLVE study, a prospective, randomized, single-blind, noninferiority trial. Patients were randomly assigned in a 1:1:1 ratio to PROMUS Element, SYNERGY, or SYNERGY half dose. The primary clinical endpoint was the 30-day rate of target lesion failure, defined as cardiac death or myocardial infarction related to the target vessel, or target lesion revascularization. The primary angiographic endpoint was 6-month in-stent late loss measured by quantitative coronary angiography. Results: The 30-day primary clinical endpoint of target lesion failure occurred in 0%, 1.1%, and 3.1% of patients in the PROMUS Element, SYNERGY, and SYNERGY half dose groups, respectively. The 6-month in-stent late loss was 0.15 ± 0.34 mm for PROMUS Element, 0.10 ± 0.25 mm for SYNERGY, and 0.13 ± 0.26 mm for SYNERGY half dose (SYNERGY, difference −0.06, upper 95.2% confidence limit: 0.02, p for noninferiority <0.001; SYNERGY half dose, difference −0.03, upper 95.2% confidence limit: 0.05, p for noninferiority <0.001). Clinical event rates remained low and comparable between groups, with no stent thromboses in any group at 6 months. Conclusions: The EVOLVE trial confirms the effective delivery of everolimus by a unique directional bioabsorbable polymer system utilizing the SYNERGY stent. (A Prospective Randomized Multicenter Single-Blind Noninferiority Trial to Assess the Safety and Performance of the Evolution Everolimus-Eluting Monorail Coronary Stent System [Evolution Stent System] for the Treatment of a De Novo Atherosclerotic Lesion [EVOLVE]; NCT01135225) [Copyright &y& Elsevier]

Bare metal stents have a proven safety record, but limited long-term efficacy due to in-stent restenosis. First-generation drug-eluting stents successfully countered the restenosis rate, but were hampered by concerns about their long-term safety. Second generation drug-eluting stents have combined the low restenosis rate of the first generation with improved long-term safety. We review the evolution of drug-eluting stents with a focus on the safety, efficacy, and unique characteristics of everolimus-eluting stents. [ABSTRACT FROM AUTHOR]

Objectives: This study was conducted to use optical coherence tomography (OCT) to compare vascular healing between bioresorbable polymer (BP) and durable polymer (DP) everolimus-eluting stents (EES) in patients with acute coronary syndromes (ACS)., Background: Whether BP-EES induce better vascular healing compared to contemporary DP-EES remains controversial, especially for ACS., Methods: In this prospective, randomized, non-inferiority trial, we used OCT to compare 6-month vascular healing in patients with ACS randomized to BP versus DP-EES: percent strut coverage (primary endpoint, non-inferiority margin of 2.0%) and neointimal thickness and percent neointimal hyperplasia (NIH) volume. As an exploratory analysis, morphological factors related to the endpoints and the effect of underlying lipidic plaque on stent healing were evaluated., Results: A total of 104 patients with ACS were randomly assigned to BP-EES (n = 52) versus DP-EES (n = 52). Of these, 86 patients (40 BP-EES and 46 DP-EES) were included in the final OCT analyses. Six-month percent strut coverage of BP-EES (83.6 ± 11.4%) was not non-inferior compared to those of DP-EES (81.6 ± 13.9%), difference 2.0% (lower 95% confidence interval-2.6%), p non-inferiority  = 0.07. There were no differences in neointimal thickness 70.0 ± 33.9 μm versus 67.2 ± 33.9 μm, p = 0.71; and percent NIH volume 7.5 ± 4.7% versus 7.3 ± 5.3%, p = 0.85. By multivariable linear regression analysis, stent type was not associated with percent strut coverage or percent NIH volume; however, percent baseline embedded struts or stent expansion was positively associated with percent NIH volume. Greater NIH volume was observed in lipidic compared with non-lipidic segments (8.7 ± 5.6% vs. 6.1 ± 5.2%, p = 0.005)., Conclusions: Six-month strut coverage of BP-EES was not non-inferior compared to those of DP-EES in ACS patients. Good stent apposition and expansion were independently associated with better vascular healing., (© 2021 The Authors. Catheterization and Cardiovascular Interventions published by Wiley Periodicals LLC.)

Hyperglycemia is an important risk factor for poor clinical outcomes in patients with acute myocardial infarction (AMI). The relative superiority of the long-term clinical outcomes of durable-polymer (DP) -based and biodegradable-polymer (BP) -based newer-generation drug-eluting stents (DESs) after successful percutaneous coronary intervention (PCI) in patients with AMI and prediabetes is not well established. We compared the clinical outcomes in such patients between DP-based and BP-based newer-generation DESs.A total of 4,377 patients with AMI and prediabetes were divided into the following two groups: the DP-DES group (n = 3,775; zotarolimus-eluting stents [ZES; n = 1,546] and everolimus-eluting stents [EES; n = 2,229]) and the BP-DES group (n = 602; biolimus-eluting stents [BES]). The primary endpoint was the occurrence of major adverse cardiac events (MACEs), defined as all-cause death, recurrent myocardial infarction (re-MI), or any repeat revascularization. The secondary endpoint was the occurrence of stent thrombosis (ST).The 2-year adjusted hazard ratio (aHR) of MACEs for ZES versus EES, ZES versus BES, EES versus BES, and ZES/EES versus BES (aHR: 1.125; 95% confidence interval [CI], 0.834-1.518; P = 0.440) were similar. The cumulative incidence of ST was also comparable between the DP-DES and BP-DES groups (aHR: 1.407; 95% CI, 0.476-4.158; P = 0.537). Moreover, the 2-year aHRs of all-cause death, CD, re-MI, target lesion revascularization (TLR), target vessel revascularization (TVR), and non-TVR were similar.Patients with AMI and prediabetes who received DP-DES or BP-DES during PCI showed comparable safety and efficacy during the 2-year follow-up period.

Objective: The aim of the study was to investigate the impact of chronic kidney disease (CKD) on the 5-year clinical outcomes of everolimus-eluting stent (EES) implantation., Background: Recent studies have demonstrated the safety and efficacy of EES. However, limited information exists on the long-term clinical outcomes associated with CKD., Methods: The Tokyo-MD PCI study is a multi-center observational study designed to describe the clinical outcomes of unselected patients after EES implantation. In this subanalysis, patients on maintenance hemodialysis were excluded, and patients with (n = 316) or without (n = 1,424) CKD were evaluated for their 5-year incidence rates of major adverse cardiac events (MACEs), defined as death, non-fatal myocardial infarction, ischemia driven target lesion revascularization (ID-TLR), and stent thrombosis (ST)., Results: The mean and median follow-up duration were 1,391 ± 557 days and 1,769 days (interquartile range, 1,012-1,800 days), respectively. Although the incidence of ID-TLR and ST was similar between patients with and without CKD (4.9% vs. 3.7%, P = 0.26, 0.5% vs. 1.0%, P = 0.20, respectively), cardiac death and MACE were significantly higher in patients with CKD than in those without CKD (6.5% vs. 2.9%, P = 0.007, 26.9% vs. 14.0%, P < 0.001, respectively). In multivariate analysis, CKD was an independent predictor of MACE (hazard ratio 1.22 [95% confidence interval 1.04-1.43], P = 0.01)., Conclusions: Patients with CKD had similar ID-TLR and ST rates as those without CKD at 5 years after EES implantation. The risk of long-term MACEs appeared to be associated with CKD., (© 2019 Wiley Periodicals, Inc.)

Coronary artery stents revolutionized the practice of interventional cardiology after they were first introduced in the mid-1980s. Since then, there have been significant developments in their design, the most notable of which has been the introduction of drug-eluting stents. This paper reviews the benefits, risks, and current status of Food and Drug Administration-approved drug-eluting stents. [ABSTRACT FROM AUTHOR]

Background: In contrast to many studies comparing everolimus-eluting stent (EES) with paclitaxel-eluting stent (PES), data directly comparing EES with sirolimus-eluting stent (SES) are limited, especially in patients with acute myocardial infarction (AMI)., Methods: This study includes 2911 AMI patients treated with SES (n=1264) or EES (n=1701) in Korea Acute Myocardial Infarction Registry (KAMIR). Propensity score matching was applied to adjust for baseline imbalance in clinical and angiographic characteristics, yielding a total of 2400 well-matched patients (1200 receiving SES and 1200 receiving EES). One-year clinical outcomes were compared between the two propensity score matched groups., Results: Baseline clinical and angiographic characteristics were similar between the two propensity score matched groups. One-year clinical outcomes of the propensity score matched cohort were comparable between the EES versus the SES groups including the rates of cardiac death (4.8% vs. 4.8%, P=1.000), recurrent myocardial infarction (1.4% vs. 1.7%, P=0.619), target lesion revascularization (1.4% vs. 1.6%, P=0.737), target lesion failure (7.0% vs. 7.3%, P=0.752), and probable or definite stent thrombosis (0.5% vs. 0.9%, P=0.224) except for a trend toward lower incidence of target vessel revascularization (1.9% vs. 3.0%, P=0.087) and a lower rate of total major adverse cardiac events (9.3% vs. 11.9%, P=0.034) in the EES group., Conclusions: The present propensity score matched analysis performed in a large-scale, prospective, multicenter registry suggests that the second-generation drug-eluting stent EES has at least comparable or even better safety and efficacy profiles as compared with SES in the setting of AMI., (Copyright © 2014 Elsevier Ireland Ltd. All rights reserved.)

Introduction: The issue of whether various drug-eluting stents (DES) provide similar benefit in diabetic patients with coronary artery disease remains unclear. The purpose of the study is to assess the clinical utility of the second-generation and first-generation DES in patients with diabetes mellitus by a meta-analysis., Material and Methods: A systematic literature search of PubMed, EMBASE, and Cochrane databases was conducted. We included randomized trials involving head-to-head comparison of clinical outcomes of second- versus first-generation DES in patients with a diagnosis of diabetes with at least 6-month follow-up data. Summary statistics were calculated using random-effects models., Results: A total of 10 trials with 4503 patients were available for analysis. The pooled analyses showed that the second-generation everolimus-eluting stent (EES) significantly lowered all-cause mortality (risk ratio (RR) = 0.58, 95% CI: 0.37-0.90; p = 0.01) and the risk of stent thrombosis (RR = 0.46, 95% CI: 0.22-0.95; p = 0.03) compared with the first-generation sirolimus-eluting stents (SES) and the overall first-generation DES, respectively. Moreover, the EES showed a tendency toward reducing the incidence of recurrent myocardial infarction when compared with paclitaxel-eluting stents (PES) (RR = 0.58, p = 0.08). In contrast, the second-generation zotarolimus-eluting stents (ZES) were associated with increased rates of stent thrombosis and risk of target lesion revascularization in comparison with the SES (both p < 0.05) or the overall first-generation DES (both p < 0.05)., Conclusions: The second-generation EES are highly effective in reducing the risk of major cardiac events in diabetic patients with coronary artery disease.

Background: Newer generation everolimus-eluting stents (EES) improve clinical outcome compared to early generation sirolimus-eluting stents (SES) and paclitaxel-eluting stents (PES). We investigated whether the advantage in safety and efficacy also holds among the high-risk population of diabetic patients during long-term follow-up., Methods: Between 2002 and 2009, a total of 1963 consecutive diabetic patients treated with the unrestricted use of EES (n=804), SES (n=612) and PES (n=547) were followed throughout three years for the occurrence of cardiac events at two academic institutions. The primary end point was the occurrence of definite stent thrombosis., Results: The primary outcome occurred in 1.0% of EES, 3.7% of SES and 3.8% of PES treated patients ([EES vs. SES] adjusted HR=0.58, 95% CI 0.39-0.88; [EES vs. PES] adjusted HR=0.29, 95% CI 0.13-0.67). Similarly, patients treated with EES had a lower risk of target-lesion revascularization (TLR) compared to patients treated with SES and PES ([EES vs. SES], 5.6% vs. 11.5%, adjusted HR=0.68, 95% CI: 0.55-0.83; [EES vs. PES], 5.6% vs. 11.3%, adjusted HR=0.51, 95% CI: 0.33-0.77). There were no differences in other safety end points, such as all-cause mortality, cardiac mortality, myocardial infarction (MI) and MACE., Conclusion: In diabetic patients, the unrestricted use of EES appears to be associated with improved outcomes, specifically a significant decrease in the need for TLR and ST compared to early generation SES and PES throughout 3-year follow-up., (© 2013.)