The effect of β-blockers on infarct size when used in conjunction with primary percutaneous coronary intervention is unknown. We hypothesize that metoprolol reduces infarct size when administered ...early (intravenously before reperfusion).
Patients with Killip class II or less anterior ST-segment-elevation myocardial infarction (STEMI) undergoing percutaneous coronary intervention within 6 hours of symptoms onset were randomized to receive intravenous metoprolol (n=131) or not (control, n=139) before reperfusion. All patients without contraindications received oral metoprolol within 24 hours. The predefined primary end point was infarct size on magnetic resonance imaging performed 5 to 7 days after STEMI. Magnetic resonance imaging was performed in 220 patients (81%). Mean ± SD infarct size by magnetic resonance imaging was smaller after intravenous metoprolol compared with control (25.6 ± 15.3 versus 32.0 ± 22.2 g; adjusted difference, -6.52; 95% confidence interval, -11.39 to -1.78; P=0.012). In patients with pre-percutaneous coronary intervention Thrombolysis in Myocardial Infarction grade 0 to 1 flow, the adjusted treatment difference in infarct size was -8.13 (95% confidence interval, -13.10 to -3.16; P=0.0024). Infarct size estimated by peak and area under the curve creatine kinase release was measured in all study populations and was significantly reduced by intravenous metoprolol. Left ventricular ejection fraction was higher in the intravenous metoprolol group (adjusted difference, 2.67%; 95% confidence interval, 0.09-5.21; P=0.045). The composite of death, malignant ventricular arrhythmia, cardiogenic shock, atrioventricular block, and reinfarction at 24 hours in the intravenous metoprolol and control groups was 7.1% and 12.3%, respectively (P=0.21).
In patients with anterior Killip class II or less ST-segment-elevation myocardial infarction undergoing primary percutaneous coronary intervention, early intravenous metoprolol before reperfusion reduced infarct size and increased left ventricular ejection fraction with no excess of adverse events during the first 24 hours after STEMI.
http://www.clinicaltrials.gov. Unique identifier: NCT01311700. EUDRACT number: 2010-019939-35.
Vessel Shrinkage as a Sign of Atherosclerosis Progression in Type 2 Diabetes
A Serial Intravascular Ultrasound Analysis
Pilar Jiménez-Quevedo 1 ,
Nobuaki Suzuki 2 ,
Cecilia Corros 1 ,
Cruz Ferrer 1 ,
...Dominick J. Angiolillo 2 ,
Fernando Alfonso 1 ,
Rosana Hernández-Antolín 1 ,
Camino Bañuelos 1 ,
Javier Escaned 1 ,
Cristina Fernández 3 ,
Marco Costa 2 ,
Carlos Macaya 1 ,
Theodore Bass 2 and
Manel Sabaté 1
1 Cardiovascular Institute, San Carlos University Hospital, Madrid, Spain
2 University of Florida, Jacksonville, Florida
3 Research Unit, San Carlos, University Hospital, Madrid, Spain
Corresponding author: Manel Sabaté, manelsabate1{at}telefonica.net
Abstract
OBJECTIVE— The aim of this study was to determine the natural history of vascular remodeling of atherosclerotic plaques in patients with
type 2 diabetes and the predictors of vessel shrinkage.
RESEARCH DESIGN AND METHODS— In this serial intracoronary ultrasound (IVUS) study, 237 coronary segments from 45 patients enrolled in the DIABETES I, II,
and III trials were included. Quantitative volumetric IVUS analyses (motorized pullbacks at 0.5 mm/s) were performed in the
same coronary segment after the index procedure and at the 9-month follow-up. Nontreated mild lesions (angiographic stenosis
<25%) with ≥0.5 mm plaque thickening and length of ≥5 mm assessed by IVUS were included. Vessel shrinkage was defined as a
Δexternal elastic membrane area/Δplaque area < 0. Statistical adjustment by multiple segments and multiple lesions per patient
was performed.
RESULTS— Vessel shrinkage was identified in 37.1% of segments and was associated with a significant decrease in lumen area at 9 months
(vessel shrinkage, 10 ± 4 mm 2 vs. non–vessel shrinkage, 11 ± 4 mm 2 ; P = 0.04). Independent predictors of vessel shrinkage were insulin requirements (odds ratio 4.6 95% CI 1.40–15.10; P = 0.01), glycated hemoglobin (1.5 1.05–2.10; P = 0.02), apolipoprotein B (0.96 0.94–0.98; P < 0.001), hypertension (3.7 1.40–10.30; P = 0.009), number of diseased vessels (5.6 2.50–12.50; P < 0.001), and prior revascularization (17.5 6.50–46.90; P < 0.001).
CONCLUSIONS— This serial IVUS study suggests that progression of coronary artery disease in patients with type 2 diabetes may be mainly
attributed to vessel shrinkage. Besides, vessel shrinkage is influenced by insulin requirements and metabolic control and
is associated with more advanced coronary atherosclerosis.
Footnotes
Published ahead of print at http://diabetes.diabetesjournals.org on 1 October 2008.
Clinical trial reg. no. NCT00755443, clinicaltrials.gov.
Readers may use this article as long as the work is properly cited, the use is educational and not for profit, and the work
is not altered. See http://creativecommons.org/licenses/by-nc-nd/3.0/ for details.
The costs of publication of this article were defrayed in part by the payment of page charges. This article must therefore
be hereby marked “advertisement” in accordance with 18 U.S.C. Section 1734 solely to indicate this fact.
Accepted September 14, 2008.
Received March 17, 2008.
DIABETES
Abstract
Aims
To evaluate long-term safety and efficacy of ticagrelor monotherapy in patients undergoing percutaneous coronary interventions (PCIs) in relation to chronic obstructive pulmonary ...disease (COPD) at baseline and the occurrence of dyspnoea reported as adverse event (AE) that may lead to treatment non-adherence.
Methods and results
This is a non-prespecified, post hoc analysis of the randomized GLOBAL LEADERS trial (n = 15 991), comparing the experimental strategy of 23-month ticagrelor monotherapy following 1-month dual antiplatelet therapy (DAPT) after PCI with the reference strategy of 12-month DAPT followed by 12-month aspirin monotherapy. Impact of COPD and dyspnoea AE (as a time-dependent covariate) on clinical outcomes was evaluated up to 2 years. The primary endpoint was a 2-year all-cause mortality or non-fatal, centrally adjudicated, new Q-wave myocardial infarction. The presence of COPD (n = 832) was the strongest clinical predictor of 2-year all-cause mortality after PCI hazard ratio (HR) 2.84; 95% confidence interval (CI) 2.21–3.66; P adjusted = 0.001 in this cohort (n = 15 991). No differential treatment effects on 2-year clinical outcomes were found in patients with and without COPD (primary endpoint: HR 0.88; 95% CI 0.58–1.35; P = 0.562; P int = 0.952). Overall, at 2 years dyspnoea was reported as an AE in 2101 patients, more frequently among COPD patients, irrespective of treatment allocation (27.2% in experimental arm vs. 14.5% in reference arm, P = 0.001). Its occurrence was not associated with a higher rate of the primary endpoint (P adjusted = 0.640) in the experimental vs. the reference arm.
Conclusion
In this exploratory analysis, COPD negatively impacted long-term prognosis after PCI. Despite higher incidence of dyspnoea in the experimental arm, in particular among COPD patients, the safety of the experimental treatment strategy appeared not to be affected.
Clinical trial registration unique identifier
NCT01813435.
Concerns regarding radiation exposure and its effects during pregnancy are often quoted as an important barrier preventing many women from pursuing a career in Interventional Cardiology. Finding the ...true risk of radiation exposure from performing cardiac catheterisation procedures can be challenging and guidelines for pregnancy exposure have been inadequate. The Women in Innovations group of Cardiologists with endorsement of the Society for Cardiovascular Angiography and Interventions aim to provide guidance in this publication by describing the risk of radiation exposure to pregnant physicians and cardiac catheterisation personnel, to educate on appropriate radiation monitoring and to encourage mechanisms to reduce radiation exposure. Current data do not suggest a significant increased risk to the foetus of pregnant women in the cardiac catheterisation laboratory and thus do not justify precluding pregnant physicians from performing procedures in the cardiac catheterisation laboratory. However, radiation exposure amongst pregnant physicians should be properly monitored and adequate radiation safety measures are still warranted.
Atrial fibrillation (AF) has been associated with a poor prognosis in patients with ST-segment elevation myocardial infarction. There is considerable controversy regarding the prognostic implications ...of different types of AF.
We analyzed 913 patients consecutively admitted to our center with ST-segment elevation myocardial infarction undergoing a primary percutaneous coronary intervention. Clinical, ECG, and angiographic data were collected. We carried out univariate and multivariate analysis, using a combined endpoint of death, reinfarction, stroke, and clinically relevant bleeding. AF was documented in 117 patients. Among them, 25 presented AF at admission (previous AF) and 92 developed new-onset AF (66% transient, 13% persistent). Patients with AF were older, more frequently men, and had a worse Killip class, and a poorer left-ventricular ejection fraction. When analyzing the different types of AF, patients with new-onset AF (persistent and transient) had a higher Killip class and a worse left-ventricular ejection fraction. AF was associated with significantly higher in-hospital mortality and with a greater incidence of in-hospital adverse events. An increase in in-hospital mortality was recorded both for previous and for new-persistent AF, but after adjusting for confounding factors, only persistent AF was found to carry a worse short-term prognosis.
In patients undergoing primary angioplasty in the stent era, AF is associated with a poor prognosis. This risk appears to be particularly high among patients with persistent AF.
Objectives This study sought to study the efficacy and safety of newer-generation drug-eluting stents (DES) compared with bare-metal stents (BMS) in an appropriately powered population of patients ...with ST-segment elevation myocardial infarction (STEMI). Background Among patients with STEMI, early generation DES improved efficacy but not safety compared with BMS. Newer-generation DES, everolimus-eluting stents, and biolimus A9-eluting stents, have been shown to improve clinical outcomes compared with early generation DES. Methods Individual patient data for 2,665 STEMI patients enrolled in 2 large-scale randomized clinical trials comparing newer-generation DES with BMS were pooled: 1,326 patients received a newer-generation DES (everolimus-eluting stent or biolimus A9-eluting stent), whereas the remaining 1,329 patients received a BMS. Random-effects models were used to assess differences between the 2 groups for the device-oriented composite endpoint of cardiac death, target-vessel reinfarction, and target-lesion revascularization and the patient-oriented composite endpoint of all-cause death, any infarction, and any revascularization at 1 year. Results Newer-generation DES substantially reduce the risk of the device-oriented composite endpoint compared with BMS at 1 year (relative risk RR: 0.58; 95% confidence interval CI: 0.43 to 0.79; p = 0.0004). Similarly, the risk of the patient-oriented composite endpoint was lower with newer-generation DES than BMS (RR: 0.78; 95% CI: 0.63 to 0.96; p = 0.02). Differences in favor of newer-generation DES were driven by both a lower risk of repeat revascularization of the target lesion (RR: 0.33; 95% CI: 0.20 to 0.52; p < 0.0001) and a lower risk of target-vessel infarction (RR: 0.36; 95% CI: 0.14 to 0.92; p = 0.03). Newer-generation DES also reduced the risk of definite stent thrombosis (RR: 0.35; 95% CI: 0.16 to 0.75; p = 0.006) compared with BMS. Conclusions Among patients with STEMI, newer-generation DES improve safety and efficacy compared with BMS throughout 1 year. It remains to be determined whether the differences in favor of newer-generation DES are sustained during long-term follow-up.
•Native aortic valve regurgitation (NAVR) presents technical challenges for TAVR.•This is the largest study on NAVR patients treated with the ACURATE neo valve.•Intraprocedural mortality was 0%, ...device success 87.5% and moderate PVL rate 8.3%.•Device success tended to be higher with perimeter-based >10% oversizing.
Transcatheter aortic valve replacement (TAVR) has been validated for the treatment of severe symptomatic aortic stenosis in patients at high and intermediate surgical risk. Recently, TAVR has been proposed as an alternative to medical therapy in inoperable patients with severe native aortic valve regurgitation (NAVR). This multicenter international registry sought to evaluate safety and efficacy of TAVR with the self-expandable ACURATE neo valve in a cohort of patients with NAVR.
A total of 24 patients with severe NAVR treated by TAVR between September 2016 and October 2018 in 13 European centers were included. Clinical, procedural and follow up data were inserted in a dedicated database. Outcomes were codified according to Valve Academic Research Consortium-2 criteria.
Mean age was 79.4 years, 58.4% were female. Mean EuroSCORE II and STS score were 5% and 3.9%, respectively. Device success was 87.5%. Moderate paravalvular leak (PVL) was found in two (8.3%) of patients, both with a perimeter oversizing index <10%. Implantation of a second device was necessary in three cases (12.5%), one for severe PVL and two for device displacement. New pacemaker implantation rate was 21.1%. At 30 days, stroke and all-cause mortality rates were 0% and 4.1%, respectively.
This multicenter study suggests good feasibility and early safety of transfemoral TAVR with the self-expandable ACURATE neo device in patients with severe NAVR refused for surgery. Rates of moderate PVL, new pacemaker implantation and need for a second valve were higher than those reported for TAVR in aortic stenosis.
The currently recommended maintenance dose of clopidogrel is often associated with inadequate platelet inhibition, suggesting the need for a higher dose. The aim of this pilot study was to assess the ...functional impact of a high (150 mg/day) maintenance dose of clopidogrel in patients undergoing elective percutaneous coronary intervention (PCI). This is a prospective, randomized, platelet function study which was performed in elective PCI patients assigned to treatment with either a 75 mg (n = 20) or 150 mg (n = 20) daily maintenance dose of clopidogrel for 30 days; afterwards, all patients resumed standard dosing. Platelet aggregation was performed using light transmittance aggregometry following 20 microM and 5 microM adenosine diphosphate (ADP) stimuli 30 days after randomization and 30 days after resuming standard dosing. Patients treated with 150 mg/day clopidogrel had lower 20 microM ADP-induced platelet aggregation compared to patients on 75 mg/day (52.1 +/- 9% vs. 64.0 +/- 8%; p < 0.001; primary endpoint). The dose-dependent effect was confirmed by the absolute and relative increase in platelet aggregation after resuming standard dosing (p < 0.001). No changes were observed in patients randomized to standard dosing. Parallel findings were observed following 5 microM ADP stimuli for all assessments. A broad variability in clopidogrel-induced antiplatelet effects was observed irrespective of dosing. In conclusion, a 150 mg/day maintenance dose regimen of clopidogrel is associated with reduced platelet reactivity and enhanced platelet inhibition compared to that achieved with the currently recommended 75 mg/day in patients undergoing elective PCI.
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