Background No randomized studies have thus far evaluated intravascular ultrasound (IVUS) guidance in the drug-eluting stent (DES) era. The aim was to evaluate if IVUS optimized DES implantation was ...superior to angiographic guidance alone in complex lesions. Methods Randomized, multicentre, international, open label, investigator-driven study evaluating IVUS vs angiographically guided DES implantation in patients with complex lesions (defined as bifurcations, long lesions, chronic total occlusions or small vessels). Primary study endpoint was post-procedure in lesion minimal lumen diameter. Secondary end points were combined major adverse cardiac events (MACE), target lesion revascularization, target vessel revascularization, myocardial infarction (MI), and stent thrombosis at 1, 6, 9, 12, and 24 months. Results The study included 284 patients. No significant differences were observed in baseline characteristics. The primary study end point showed a statistically significant difference in favor of the IVUS group (2.70 mm ± 0.46 mm vs. 2.51 ± 0.46 mm; P = .0002). During hospitalization, no patient died, had repeated revascularization, or a Q-wave MI. No difference was observed in the occurrence of non-Q wave MI (6.3% in IVUS vs. 7.0% in angio-guided group). At 24-months clinical follow-up, no differences were still observed in cumulative MACE (16.9%vs. 23.2 %), cardiac death (0%vs. 1.4%), MI (7.0%vs. 8.5%), target lesion revascularization (9.2% vs. 11.9%) or target vessel revascularization (9.8% vs. 15.5%), respectively in the IVUS vs. angio-guided groups. In total, only one definite subacute stent thrombosis occurred in the IVUS group. Conclusions A benefit of IVUS optimized DES implantation was observed in complex lesions in the post-procedure minimal lumen diameter. No statistically significant difference was found in MACE up to 24 months.
SPIRIT Women is the first interventional trial dedicated exclusively to women, focusing on symptoms at presentation, referral time to coronary intervention and the safety and performance of the ...XIENCE V stent.
SPIRIT Women is a prospective, open-label, multicentre study in which 1,573 women were enrolled at 73 sites outside the United States. The primary endpoint is the composite of all death, Academic Research Consortium (ARC) defined myocardial infarction (MI) and target vessel revascularisation (TVR) at one year. Data collected included symptoms at presentation and referral to coronary intervention. To allow comparison by gender, the latter were compared to data from male patients from the SPIRIT V study. The one- and two-year composite of all death, MI and TVR was 12% and 15%, respectively. Target lesion revascularisation (TLR) and stent thrombosis (definite and probable) rates were 2.4% and 0.59%, respectively, at one year and 3.6% and 0.73%, at two years. The total referral time for coronary intervention in women was four days longer than for men in the SPIRIT V study.
The XIENCE V stent is safe and effective with low TLR and stent thrombosis rates. More efforts remain to be made to increase the awareness of women and physicians of the risk for coronary artery disease (CAD).
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.
In recent years, various specific techniques and materials have been developed for the treatment of coronary chronic total occlusions (CTO).
To evaluate the current situation in the treatment of CTO ...(techniques and material) in our setting.
We evaluated data on techniques and material used in the CIBELES (ChronIc coronary occlusion treated By EveroLimus Eluting Stent) trial, a randomized comparison of sirolimus- and everolimus-eluting stents in 207 patients with CTO in 13 centers in Spain and Portugal.
A radial approach was used in 23% of patients, and retrograde techniques were used in only 5%. A high number of balloons were used (2.2±0.9 per patient). Microcatheters were used in 33% of patients, and post-dilatation balloons in only 25%. The mean number of stents implanted per patient was 2.1±1.0, with a mean total stent length of 49±24 mm. Other devices and techniques used were: Tornus penetration catheter in 4% of patients, rotational atherectomy in 2%, and cutting balloon in 1%. Intracoronary ultrasound was used in only 6% of patients. In 34% of cases, operators used guidewires that were not specifically for CTO. Considerable variability between centers was detected in the use of different techniques, the highest and lowest variability being observed in the use of intracoronary ultrasound and the use of CTO guidewires, respectively.
In the CIBELES trial, techniques and devices specifically designed for the treatment of CTO were used in a relatively low proportion of patients. Considerable variability between centers was detected.
Durante os últimos anos foram desenvolvidos materiais e técnicas específicos para o tratamento de oclusões totais crónicas (OTC).
Avaliar a situação atual no tratamento de OTC (técnicas e material) na nossa realidade.
Avaliámos os dados relacionados com as técnicas e material usados no estudo CIBELES (ChronIc coronary occlusion treated By EveroLimus Eluting Stent) que comparou de forma aleatororizada stents eluidores de sirolimus e everolimus em 207 doentes com OTC em 13 centros de Espanha e Portugal.
A abordagem radial foi usada em 23% dos doentes e as técnicas retrógradas foram usadas em apenas 5%. Foi usado um elevado número de balões (2,2±0,9 por doente). Microcatéteres foram usados em 33% e balões de pós-dilatação apenas em 25% dos doentes. O número médio de stents implantados por doente foi de 2,1±1,0, com um comprimento total médio de 49±24 mm. Outro material foi: tornus 4%, aterectomia rotacional 2% e cutting balloon em 1% dos doentes. Ecografia intra-coronária foi usada em apenas 6% dos doentes. Em 34% dos casos os operadores usaram fios-guia que não eram específicos de OTC. Uma alta variabilidade entre centros foi detetada no uso de diferentes técnicas, sendo a variabilidade observada mais alta e mais baixa no uso de ecografia intra-coronária e no uso de guias de OTC, respetivamente.
No estudo CIBELES, técnicas e material especificamente desenvolvidos para o tratamento de OTC foram usados numa proporção relativamente baixa dos doentes. Foi detetada uma alta variabilidade entre centros.
Introducción y objetivos: La exposición a las radiaciones ionizantes influye en que las cardiólogas desestimen subespecializarse en áreas intervencionistas. La normativa en España (RD 783/2001) ...permite trabajar en sala durante la gestación si el feto recibe una dosis equivalente "64; 1 mSv. Por ello, es necesario saber la dosis equivalente en el abdomen de cardiólogas expuestas a radiaciones ionizantes durante la gestación.
Métodos: Encuesta electrónica anónima entre cardiólogos de 40 años o más años miembros de la Sociedad Española de Cardiología.
Resultados: Respondieron a la encuesta 256 personas. El 51% tenía actividad en hemodinámica y el 13% en electrofisiología. Había 108 mujeres con actividad intervencionista; de ellas, el 59% dijo conocer la normativa de nuestro país sobre exposición ocupacional a radiaciones ionizantes durante el embarazo. Sin embargo, 62/108 (57%) consideraban que no era posible mantener la actividad en sala durante este. Tuvieron al menos un embarazo 55/108 cardiólogas y 47 respondieron las preguntas sobre embarazo. Solo 11 (23%) se plantearon mantener la actividad en sala durante el mismo. De ellas, 4 refieren objeciones por los departamentos de riesgos laborales/protección radiológica. Finalmente, 10/11 mantuvieron la acti- vidad en sala. Todas recibieron dosímetro de abdomen. En 7, la dosis equivalente fue inferior a la dosis límite, 1 recibió una dosis cercana y 2 no lo recuerdan.
Conclusiones: Según la encuesta electrónica, el 57% de las cardiólogas con actividad intervencionista desconocen que la normativa permite mantener la actividad en sala durante el embarazo. Solo el 23% de las hemodinamistas/electrofisiólogas embarazadas se plantearon mantener la actividad en sala. La dosis equivalente recibida en los 8 casos con información disponible fue "64; 1 mSv.
Interventional cardiologists are amongst the most intensive radiation users within medicine. To assess the implications of this usage, the "Women In Innovation" Group (WIN) created a web-based survey ...called "WIN for Safety" distributed through the European Association of Percutaneous Coronary Intervention (EAPCI) to all catheterisation laboratory healthcare professionals, enquiring about radiation protection measures, compliance with monitoring, health (orthopaedic issues), radiation-associated problems (cataracts and cancer) and restrictions imposed upon the pregnant female.
In total, there were 615 participants: 72.8% were interventional cardiologists. Most (73.5%) of them were male and 63.3% were aged 31-50 years. A radiation collar badge was used by the majority (64.4%) and the most frequently utilised protective measure was the thyroid shield (87.2%). Potential illnesses related to radiation exposure included 19.5% orthopaedic problems (back/neck/hip pain), 5.5% varicose veins, 2.4% blood count problems and 2.0% cataracts. Notably, an association between orthopaedic problems and years of exposure was found (p=0.001). Overall, only 2.2% had ever been diagnosed with a cancer, with a trend for more females to be affected (4.4% vs. 1.8%; p=0.067). Finally, 62.1% have restrictions imposed upon the pregnant female in the working environment.
Awareness of radiation in the field of interventional cardiology is essential. The main risk is orthopaedic problems and measures should be taken for prevention. Cancer has not been demonstrated to be a direct consequence; however, we should remain vigilant and monitor individuals.
In patients with multivessel coronary artery disease (CAD) presenting with ST-segment elevation myocardial infarction (STEMI), complete revascularization reduces major cardiovascular events compared ...with culprit lesion-only percutaneous coronary intervention (PCI). Whether complete revascularization also improves angina-related health status is unknown.
To determine whether complete revascularization improves angina status in patients with STEMI and multivessel CAD.
This secondary analysis of a randomized, multinational, open label trial of patient-reported outcomes took place in 140 primary PCI centers in 31 countries. Patients presenting with STEMI and multivessel CAD were randomized between February 1, 2013, and March 6, 2017. Analysis took place between July 2021 and December 2021.
Following PCI of the culprit lesion, patients with STEMI and multivessel CAD were randomized to receive either complete revascularization with additional PCI of angiographically significant nonculprit lesions or to no further revascularization.
Seattle Angina Questionnaire Angina Frequency (SAQ-AF) score (range, 0 daily angina to 100 no angina) and the proportion of angina-free individuals by study end.
Of 4041 patients, 2016 were randomized to complete revascularization and 2025 to culprit lesion-only PCI. The mean (SD) age of patients was 62 (10.7) years, and 3225 (80%) were male. The mean (SD) SAQ-AF score increased from 87.1 (17.8) points at baseline to 97.1 (9.7) points at a median follow-up of 3 years in the complete revascularization group (score change, 9.9 95% CI, 9.0-10.8; P < .001) compared with an increase of 87.2 (18.4) to 96.3 (10.9) points (score change, 8.9 95% CI, 8.0-9.8; P < .001) in the culprit lesion-only group (between-group difference, 0.97 points 95% CI, 0.27-1.67; P = .006). Overall, 1457 patients (87.5%) were free of angina (SAQ-AF score, 100) in the complete revascularization group compared with 1376 patients (84.3%) in the culprit lesion-only group (absolute difference, 3.2% 95% CI, 0.7%-5.7%; P = .01). This benefit was observed mainly in patients with nonculprit lesion stenosis severity of 80% or more (absolute difference, 4.7%; interaction P = .02).
In patients with STEMI and multivessel CAD, complete revascularization resulted in a slightly greater proportion of patients being angina-free compared with a culprit lesion-only strategy. This modest incremental improvement in health status is in addition to the established benefit of complete revascularization in reducing cardiovascular events.
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