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  • Ovid Technologies (Wolters Kluwer Health)  (19)
  • 1
    In: Circulation, Ovid Technologies (Wolters Kluwer Health), Vol. 146, No. 9 ( 2022-08-30), p. 657-672
    Kurzfassung: Apolipoprotein B (apoB) provides an integrated measure of atherogenic risk. Whether apoB levels and apoB lowering hold incremental predictive information on residual risk after acute coronary syndrome beyond that provided by low-density lipoprotein cholesterol is uncertain. Methods: The ODYSSEY OUTCOMES trial (Evaluation of Cardiovascular Outcomes After an Acute Coronary Syndrome During Treatment With Alirocumab) compared the proprotein convertase subtilisin/kexin type 9 inhibitor alirocumab with placebo in 18 924 patients with recent acute coronary syndrome and elevated atherogenic lipoproteins despite optimized statin therapy. Primary outcome was major adverse cardiovascular events (MACE; coronary heart disease death, nonfatal myocardial infarction, fatal/nonfatal ischemic stroke, hospitalization for unstable angina). Associations between baseline apoB or apoB at 4 months and MACE were assessed in adjusted Cox proportional hazards and propensity score–matched models. Results: Median follow-up was 2.8 years. In proportional hazards analysis in the placebo group, MACE incidence increased across increasing baseline apoB strata (3.2 [95% CI, 2.9–3.6], 4.0 [95% CI, 3.6–4.5] , and 5.5 [95% CI, 5.0–6.1] events per 100 patient-years in strata 〈 75, 75– 〈 90, ≥90 mg/dL, respectively; P trend 〈 0.0001) and after adjustment for low-density lipoprotein cholesterol ( P trend =0.035). Higher baseline apoB stratum was associated with greater relative ( P trend 〈 0.0001) and absolute reduction in MACE with alirocumab versus placebo. In the alirocumab group, the incidence of MACE after month 4 decreased monotonically across decreasing achieved apoB strata (4.26 [95% CI, 3.78–4.79], 3.09 [95% CI, 2.69–3.54] , and 2.41 [95% CI, 2.11–2.76] events per 100 patient-years in strata ≥50, 〉 35– 〈 50, and ≤35 mg/dL, respectively). Compared with propensity score–matched patients from the placebo group, treatment hazard ratios for alirocumab also decreased monotonically across achieved apoB strata. Achieved apoB was predictive of MACE after adjustment for achieved low-density lipoprotein cholesterol or non–high-density lipoprotein cholesterol but not vice versa. Conclusions: In patients with recent acute coronary syndrome and elevated atherogenic lipoproteins, MACE increased across baseline apoB strata. Alirocumab reduced MACE across all strata of baseline apoB, with larger absolute reductions in patients with higher baseline levels. Lower achieved apoB was associated with lower risk of MACE, even after accounting for achieved low-density lipoprotein cholesterol or non–high-density lipoprotein cholesterol, indicating that apoB provides incremental information. Achievement of apoB levels as low as ≤35 mg/dL may reduce lipoprotein-attributable residual risk after acute coronary syndrome. Registration: URL: https://www.clinicaltrials.gov ; Unique identifier: NCT01663402.
    Materialart: Online-Ressource
    ISSN: 0009-7322 , 1524-4539
    Sprache: Englisch
    Verlag: Ovid Technologies (Wolters Kluwer Health)
    Publikationsdatum: 2022
    ZDB Id: 1466401-X
    Standort Signatur Einschränkungen Verfügbarkeit
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  • 2
    In: Circulation, Ovid Technologies (Wolters Kluwer Health), Vol. 116, No. suppl_16 ( 2007-10-16)
    Kurzfassung: Background: The value of drug-eluting stents in patients (P) with in-stent restenosis (ISR) has been established. However, the long-term results of this strategy in P with ISR remains unknown. Objective: We sought to determine the long-term clinical outcome of P treated with sirolimus-eluting stents (SES) for ISR. Methods: A systematic, pre-specified, long-term clinical follow-up (FU) was performed in all P included in the RIBS II (Restenosis Intra-stent: Balloon angioplasty [BA] vs elective SES implantation) randomized trial. In RIBS II 150 P with ISR after bare-metal stent implantation were included: 74 allocated to BA and 76 to SES. Late angiography was obtained in 96% of eligible P. A structured clinical questionnaire (cardiac/non cardiac death, myocardial infarction [MI] , target vessel revascularization [TVR], thrombosis [TH] , and medical therapy) was used during FU. Results: Angiographic restenosis (primary end-point) was more frequently found in the BA arm (39% vs 11%, p 〈 0.001). Clinical FU at 1-year was obtained in 150 P (100%). During this time period 6 P died (3 SES, 3 BA), 4 P suffered a MI (2 SES, 2 BA), 2 P experienced TH (1 P in each arm) and 30 required TVR (8 SES, 22 BA, p 〈 0.01). A complete clinical FU 〉 3 years was obtained in 145 P (97%) (mean 38±9 months, median 40 months [IQR 37–42]). Late events (after 1 year, non-exclusive) included: 3 deaths (1 SES, 2 BA), 3 MI (3 SES, 2 due to late TH) and 7 late TVR (5 SES, 2 BA). At 4 years, event-free survival was 76% in the SES arm and 65% in the BA arm (p=0.03). Survival free from TVR at 4 years was 80% in the SES arm and 67% in the BA arm (p=0.02). Conclusion: In P with ISR SES implantation improve the long-term clinical outcome as compared with BA treatment.
    Materialart: Online-Ressource
    ISSN: 0009-7322 , 1524-4539
    Sprache: Englisch
    Verlag: Ovid Technologies (Wolters Kluwer Health)
    Publikationsdatum: 2007
    ZDB Id: 1466401-X
    Standort Signatur Einschränkungen Verfügbarkeit
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  • 3
    In: Circulation: Cardiovascular Interventions, Ovid Technologies (Wolters Kluwer Health), Vol. 9, No. 10 ( 2016-10)
    Kurzfassung: The main causes of late ( 〉 1 month) stent thrombosis (ST) are stent uncoverage, malapposition, and neoatherosclerosis. First-generation drug-eluting stents were associated with higher rate of late ST compared with bare-metal stents (BMS), especially in patients with ST-segment–elevation myocardial infarction. Second-generation everolimus-eluting stents (EES) have shown similar rate of late ST than BMS. The aims of the study are to compare the ratio of uncovered to total struts per cross-section ≥30% and other optical coherence tomographic findings associated with ST between EES and BMS in patients with ST-segment–elevation myocardial infarction at 5 years. Methods and Results— One hundred and sixty-nine consecutive event-free patients of the randomized EXAMINATION study (A Clinical Evaluation of Everolimus Eluting Coronary Stents in the Treatment of Patients With ST-Segment Elevation Myocardial Infarction) were screened for optical coherence tomographic imaging at 5 years. Patients with target vessel–related events or life-threatening comorbidities were excluded. Finally, 64 patients (32 EES and 32 BMS) underwent optical coherence tomographic imaging. At 5 years, uncovered struts (4.1% versus 1.0%; P 〈 0.01), length of uncoverage (3.4 versus 1.4 mm; P =0.02), and ratio of uncovered to total struts per cross-section ≥30% (35.5% versus 9.7%; P =0.02) were larger with EES than that with BMS. Malapposed struts (1.2% versus 0.3%; P =0.02) and malapposition length (1.3 versus 0.4 mm; P =0.06) were also larger with EES. Neoatherosclerotic plaques (16.1% versus 25.8%; P =0.35) and macrophage accumulations (19.4% versus 48.4%; P =0.02) were numerically more frequent with BMS. Conclusions— Despite substantial dropout of patients, the healing pattern in event-free ST-segment–elevation myocardial infarction patients differs between EES and BMS at 5 years. EES presented with larger amount of uncovered and malapposed struts and similar rate of neoatherosclerosis as compared with BMS. The clinical relevance of these findings warrants longer follow-up. Clinical Trial Registration— URL: http://www.clinicaltrials.gov . Unique identifier: NCT00828087.
    Materialart: Online-Ressource
    ISSN: 1941-7640 , 1941-7632
    Sprache: Englisch
    Verlag: Ovid Technologies (Wolters Kluwer Health)
    Publikationsdatum: 2016
    ZDB Id: 2450801-9
    Standort Signatur Einschränkungen Verfügbarkeit
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  • 4
    In: Journal of the American Heart Association, Ovid Technologies (Wolters Kluwer Health), Vol. 11, No. 10 ( 2022-05-17)
    Kurzfassung: In the GLOBAL LEADERS trial, ticagrelor monotherapy beyond 1 month compared with standard antiplatelet regimens after coronary stent implantation did not improve outcomes at intention‐to‐treat analysis. Considerable differences in treatment adherence between the experimental and control groups may have affected the intention‐to‐treat results. In this reanalysis of the GLOBAL LEADERS trial, we compared the experimental and control treatment strategies in a per‐protocol analysis of patients who did not deviate from the study protocol. Methods and Results Baseline and postrandomization information were used to classify whether and when patients were deviating from the study protocol. With logistic regressions, we derived time‐varying inverse probabilities of nondeviation from protocol to reconstruct the trial population without protocol deviation. The primary end point was a composite of all‐cause mortality or nonfatal Q‐wave myocardial infarction at 2 years. At 2‐year follow‐up, 1103 (13.8%) of 7980 patients in the experimental group and 785 (9.8%) of 7988 patients in the control group qualified as protocol deviators. At per‐protocol analysis, the rate ratio for the primary end point was 0.88 (95% CI, 0.75–1.03; P =0.10) on the basis of 274 versus 325 events in the experimental versus control group. The rate ratio for the key safety end point of major bleeding was 1.00 (95% CI, 0.79–1.26; P =0.99). The per‐protocol and intention‐to‐treat effect estimates were overall consistent. Conclusions Among patients who complied with the study protocol in the GLOBAL LEADERS trial, ticagrelor plus aspirin for 1 month followed by ticagrelor monotherapy was not superior to 1‐year standard dual antiplatelet therapy followed by aspirin alone at 2 years after coronary stenting. Registration URL: https://www.clinicaltrials.gov ; Unique identifier: NCT01813435.
    Materialart: Online-Ressource
    ISSN: 2047-9980
    Sprache: Englisch
    Verlag: Ovid Technologies (Wolters Kluwer Health)
    Publikationsdatum: 2022
    ZDB Id: 2653953-6
    Standort Signatur Einschränkungen Verfügbarkeit
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  • 5
    In: Coronary Artery Disease, Ovid Technologies (Wolters Kluwer Health), Vol. 31, No. 1 ( 2020-01), p. 1-6
    Kurzfassung: Diabetes mellitus predicts poorer outcomes in patients with acute coronary syndrome (ACS), but the magnitude of this association in patients at older ages remains controversial. Methods Data were extracted from the Codi Infart database. All consecutive patients with diagnosis of ST-segment elevation myocardial infarction (STEMI) undergoing primary percutaneous coronary intervention (PCI) between 2010 and 2015 were included. We assessed the impact of diabetes mellitus on 30-day and one-year mortality in patients aged less than and at least 75 years. Results A total of 12 792 cases were registered, of whom 3023 (23.6%) were aged at least 75 years. About 20% patients had previous diabetes mellitus diagnosis. Patients aged at least 75 years had higher prevalence of comorbidities, higher proportion of heart failure at admission, a more extensive coronary artery disease and significant delay to reperfusion ( P 〈 0.001). Diabetes mellitus was associated with higher 30-day mortality both in young [odds ratio (OR) 1.97, 95% confidence interval (CI): 1.43–2.70] and in elderly patients (OR 1.43, 95% CI: 1.07–1.91). After adjusting for potential confounders, this association remained significant in young patients (OR 1.47, 95% CI: 1.00–2.16, P = 0.047), but not in the elderly (OR 1.14, P = 0.43). Likewise, a crude association between diabetes mellitus and one-year mortality was observed in both groups (young patients: HR = 1.93; 95% CI: 1.51–2.46; older patients: HR = 1.33; 95% CI: 1.08–1.64). However, after adjusting for potential confounders, this association remained significant in younger patients (HR = 1.46; 95% CI: 1.13–1.89; P 〈 0.001), but not in the elderly (HR = 1.16; P = 0.17). Conclusion A significant proportion of these nonselected patients with STEMI had previous diabetes mellitus. The association between diabetes mellitus and outcomes is different according to age.
    Materialart: Online-Ressource
    ISSN: 0954-6928
    Sprache: Englisch
    Verlag: Ovid Technologies (Wolters Kluwer Health)
    Publikationsdatum: 2020
    ZDB Id: 2042449-8
    Standort Signatur Einschränkungen Verfügbarkeit
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  • 6
    In: Coronary Artery Disease, Ovid Technologies (Wolters Kluwer Health), Vol. 32, No. 2 ( 2021-03), p. 96-104
    Kurzfassung: Currently drug-eluting stents (DES) and drug-eluting balloons are recommended in patients with in-stent restenosis (ISR). However, the efficacy of bioresorbable vascular scaffolds (BVS) after scoring balloon (SCB) predilation in these patients is unknown. Methods RIBS VI (NCT02672878) and RIBS VI ‘Scoring’ (NCT03069066) are prospective multicentre studies assessing the value of BVS in patients with ISR. Inclusion and exclusion criteria were identical in both studies. Results of conventional BVS implantation (112 patients) were compared with those obtained with systematic SCB therapy before BVS (108 patients). Angiographic follow-up was scheduled for all patients. Results On late angiography (93% of eligible patients) the in-segment minimal lumen diameter (primary end-point) (1.88 ± 0.5 vs. 1.90 ± 0.4 mm, P = 0.81), % diameter stenosis (28 ± 17 vs. 29 ± 15%), late lumen loss (0.23 ± 0.4 vs. 0.22 ± 0.4 mm) and binary restenosis rate (8.5 vs. 9.3%) were similar in the conventional BVS and SCB + BVS groups, respectively. At 1-year follow-up (100% of patients) target lesion revascularization (TLR) requirement (9.8 vs. 11.1%) was similar with the two strategies. Freedom from cardiac death, myocardial infarction and TLR was 88% and 87%, respectively. Results remained unchanged after adjusting for potential baseline confounders and were consistent in 10 prespecified subgroups. Conclusion This study suggests that results of conventional BVS implantation in patients with ISR are not improved by systematic predilation with SCB. ClinicalTrials.gov ID: NCT02672878 (RIBS VI) and NCT03069066 (RIBS VI ‘Scoring’).
    Materialart: Online-Ressource
    ISSN: 0954-6928
    Sprache: Englisch
    Verlag: Ovid Technologies (Wolters Kluwer Health)
    Publikationsdatum: 2021
    ZDB Id: 2042449-8
    Standort Signatur Einschränkungen Verfügbarkeit
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  • 7
    In: Circulation: Cardiovascular Interventions, Ovid Technologies (Wolters Kluwer Health), Vol. 9, No. 7 ( 2016-07)
    Kurzfassung: Treatment of patients with drug-eluting stent (DES) in-stent restenosis (ISR) is more challenging than that of patients with bare-metal stent ISR. However, the results of everolimus-eluting stents (EES) in these distinct scenarios remain unsettled. Methods and Results— A pooled analysis of the RIBS IV (Restenosis Intra-Stent of Drug-Eluting Stents: Paclitaxel-Eluting Balloon vs Everolimus-Eluting Stent) and RIBS V (Restenosis Intra-Stent of Bare Metal Stents: Paclitaxel-Eluting Balloon vs Everolimus-Eluting Stent) randomized trials was performed using patient-level data to compare the efficacy of EES in bare-metal stent ISR and DES-ISR. Inclusion and exclusion criteria were identical in both trials. Results of 94 patients treated with EES for bare-metal stent ISR were compared with those of 155 patients treated with EES for DES-ISR. Baseline characteristics were more adverse in patients with DES-ISR, although they presented later and more frequently with a focal pattern. After intervention, minimal lumen diameter (2.22±0.5 versus 2.38±0.5 mm, P =0.01) was smaller in the DES-ISR group. Late angiographic findings (89.3% of eligible patients), including minimal lumen diameter (2.03±0.7 versus 2.36±0.6 mm, P 〈 0.001) and diameter stenosis (23±22 versus 13±17%, P 〈 0.001) were poorer in patients with DES-ISR. Results were consistent in the in-segment and in-lesion analyses. On multiple linear regression analysis, minimal lumen diameter at follow-up remained significantly smaller in patients with DES-ISR. Finally, at 1-year clinical follow-up (100% of patients), mortality (2.6 versus 0%, P 〈 0.01) and need for target vessel revascularization (8 versus 2%, P =0.03) were higher in the DES-ISR group. Conclusions— This patient-level pooled analysis of the RIBS IV and RIBS V randomized clinical trials suggests that EES provide favorable outcomes in patients with ISR. However, the results of EES are less satisfactory in patients with DES-ISR than in those with bare-metal stent ISR. Clinical Trial Registration— URL: http://www.clinicaltrials.gov . Unique identifiers: NCT01239953 and NCT01239940.
    Materialart: Online-Ressource
    ISSN: 1941-7640 , 1941-7632
    Sprache: Englisch
    Verlag: Ovid Technologies (Wolters Kluwer Health)
    Publikationsdatum: 2016
    ZDB Id: 2450801-9
    Standort Signatur Einschränkungen Verfügbarkeit
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  • 8
    In: Journal of Cardiovascular Medicine, Ovid Technologies (Wolters Kluwer Health), Vol. 21, No. 1 ( 2020-01), p. 27-33
    Kurzfassung: Anemia is associated with poorer outcomes in patients with acute coronary syndromes (ACS), but the magnitude of this association in elderly patients remains poorly understood. No study has assessed the prognostic impact of anemia according to frailty status in this setting. Methods The LONGEVO-SCA registry included unselected ACS patients aged at least 80 years. A geriatric assessment was performed during hospitalization, including frailty assessment using the FRAIL scale. Anemia was defined by the WHO criteria. We evaluated the impact of anemia on 6-month mortality according to the presence of frailty. Results A total of 517 patients were assessed. Mean age was 84.3 years, and a total of 236 patients (45.6%) had anemia. Patients with anemia had a higher prevalence of comorbidities and higher prevalence of frailty (30.6 vs. 22.3%, P  = 0.007). A total of 60 patients (12.1%) died at 6 months [40 with anemia (17.5%) and 20 without anemia (7.5%), P  = 0.001]. Anemia was independently associated with mortality at 6 months in the whole cohort (hazard ratio 2.28, 95% CI 1.13–457, P  = 0.021). The association of anemia and mortality was different according to frailty status, being significant in patients without frailty (hazard ratio 3.94, 95% CI 1.84–8.45, P  = 0.001), but not in frail patients (hazard ratio 1.17, 95% CI 0.53–2.57, P  = 0.705), ( P value for interaction = 0.035). Conclusion A high proportion of elderly patients with ACS have anemia, leading to a worse prognosis in the whole cohort. The association between anemia and mortality was especially significant in robust patients, whereas the poorer prognosis in frail patients was not modified by the presence of anemia.
    Materialart: Online-Ressource
    ISSN: 1558-2027 , 1558-2035
    Sprache: Englisch
    Verlag: Ovid Technologies (Wolters Kluwer Health)
    Publikationsdatum: 2020
    Standort Signatur Einschränkungen Verfügbarkeit
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  • 9
    In: Circulation: Cardiovascular Interventions, Ovid Technologies (Wolters Kluwer Health), Vol. 4, No. 3 ( 2011-06), p. 280-286
    Kurzfassung: Atrioventricular (AV) block is one of the most frequent complications of CoreValve transcatheter aortic valve implantation (TAVI). The aim of this study was to analyze the effects of CoreValve implantation on AV conduction. Methods and Results— Electrophysiological study was performed immediately before and after CoreValve implantation in 18 consecutive, permanent pacemaker-free patients. An electrode was placed on the His bundle during valve implantation, and data were continuously recorded during the procedure. With surface ECG, a median (first, third quartile) QRS width of 96 (84, 116) to 150 (121, 164) ms ( P =0.001) and PR interval of 180 (159, 216) to 210 (190, 240) ms ( P =0.008) were significantly prolonged, and QRS axis was left deviated 30° (−32°, 46°) to −20° (−60°, 2°) ( P =0.005). With intracardiac electrograms, the AH (97 [70, 123] to 115 [96, 135] ms, P =0.021) and HV (52 [42, 55] to 60 [50, 70] ms, P =0.002) intervals were increased. At the end of the procedure, we observed significant ECG- or electrophysiological study-persistent conduction disturbances in 14 (78%) patients. Five patients experienced transient changes (2 AV blocks and 3 left bundle branch blocks). Conclusions— CoreValve implantation worsens AV conduction in most patients, either transiently or permanently. This worsening is the result of direct damage either on the His bundle or on the AV node.
    Materialart: Online-Ressource
    ISSN: 1941-7640 , 1941-7632
    Sprache: Englisch
    Verlag: Ovid Technologies (Wolters Kluwer Health)
    Publikationsdatum: 2011
    ZDB Id: 2450801-9
    Standort Signatur Einschränkungen Verfügbarkeit
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  • 10
    In: Circulation: Cardiovascular Interventions, Ovid Technologies (Wolters Kluwer Health), Vol. 12, No. 9 ( 2019-09)
    Kurzfassung: Drug-eluting stents (DES) showed improved efficacy and safety compared with bare-metal stents (BMS), and international guidelines recommend their use as first line treatment. Yet, BMS are still widely used in practice, especially in large coronary vessels. We aimed to compare efficacy and safety of second-generation DES over BMS in large coronary culprit ST-segment elevated myocardial infarction lesions. Methods: We evaluated impact of large coronary stents (maximum size ≥3.50 mm) or smaller stents ( 〈 3.50 mm), among 1498 patients with ST-segment elevated myocardial infarction undergoing primary percutaneous coronary intervention, randomly allocated to everolimus-eluting DES or to an equivalent BMS platform in the EXAMINATION trial (Clinical Evaluation of the Xience-V Stent in Acute Myocardial Infarction Trial). Clinical events up to 5 years of follow-up were evaluated. Results: Large coronary stents were used in 683 patients (45.9%). At 5-year follow-up, the crude rate of the primary end point, a composite of all-cause death, any myocardial infarction, or any revascularization, was similar among patients treated with large or smaller coronary stents. The impact of DES versus BMS implantation was consistent irrespective of the stent size both for the primary end point ( P int =0.82) and other secondary ischemic end points. Within patients treated with bigger stents, DES implantation was associated to a trend toward a reduction of target lesion (hazard ratio, 0.53; 95% CI, 0.27–1.02; P =0.05) and target vessel revascularization (hazard ratio, 0.60; 95% CI, 0.34–1.03; P =0.066). Conclusions: Our results do not support the preferential use of BMS for patients with large coronary vessels. DES may warrant improved efficacy irrespective of stent size among patients undergoing primary percutaneous coronary intervention. Clinical Trial Registration: URL: https://www.clinicaltrials.gov . Unique identifier: NCT00828087.
    Materialart: Online-Ressource
    ISSN: 1941-7640 , 1941-7632
    Sprache: Englisch
    Verlag: Ovid Technologies (Wolters Kluwer Health)
    Publikationsdatum: 2019
    ZDB Id: 2450801-9
    Standort Signatur Einschränkungen Verfügbarkeit
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