Myocardial function may improve equally in diabetic patients following both multivessel percutaneous coronary intervention and coronary artery bypass grafting: results from a CARDia trial substudy.

AIMS: The CARDia (Coronary Artery Revascularization in Diabetes) trial compared coronary artery bypass grafting (CABG) and optimal percutaneous coronary intervention (PCI) in diabetic patients with multivessel coronary disease. Patients enrolled had symptoms of myocardial ischaemia. As symptom assessment is flawed in diabetic patients, a substudy was undertaken to compare the extent to which these revascularization strategies alter reversible ischaemia. METHODS AND RESULTS: Seventy-one patients underwent stress echo at baseline and at 6 months. A 17-segment echocardiographic wall motion score index (WMSI) was assigned at baseline [WMSI(pre)] and at 6 months [WMSI(post)]. An overall score defined the difference: WMSI(∂) = WMSI(pre)--WMSI(post). Of 71 patients recruited, 42 underwent PCI and 29 CABG. Mean WMSI(pre) in the PCI group was 1.63 and mean WMSI(post) was 1.32. Mean WMSI(pre) in the CABG group was 1.69 and mean WMSI(post) was 1.46. The PCI WMSI(∂) was 0.31 and CABG WMSI(∂) was 0.23 (P = 0.8). Of 42 PCI patients, 39 demonstrated ischaemia at baseline. At 6 months 31 had improvements in ischaemia (79%), 5 showed no improvement, and 3 ischaemia worsened. Of 29 CABG patients, 23 demonstrated ischaemia at baseline. At 6 months, 20 had improvements in ischaemia (87%), 2 had no improvement, and in 1 ischaemia worsened. No difference was seen in the number of patients with improvements in reversible ischaemia between PCI and CABG [79 vs. 87%, (P = 0.9)]. CONCLUSION: Optimal revascularization in diabetic patients with multivessel disease remains controversial. This subset analysis of the CARDia trial suggests both PCI and CABG achieve similar improvement in reversible ischaemia.

The cost effectiveness of primary angioplasty compared to thrombolysis in the real world: one year results from West London.

AIMS: The aim of this study is to use real-world data from West London to compare the cost-effectiveness of a contemporary primary angioplasty (PPCI) service to thrombolysis which it superseded over a time horizon of one year. Previous studies have depended on randomised trials and economic modelling. METHODS AND RESULTS: Resource and outcome data were collected on 400 consecutive patients treated for ST segment elevation myocardial infarction (STEMI) at the hub and two spoke sites over three years. After the first 200 received thrombolysis, the PPCI service was introduced providing treatment for the next 200 cases. The incidence of major adverse cardiac events was significantly less in the PPCI group at 30 days (46.2% versus 7.0%, adjusted odds ratio (AOR) 12 p<0.001) and one year (57.4% versus 13.2%, AOR 8.6 p<0.001) driven by reductions in mortality and ischaemia driven revascularisations. Mean index and one year cumulative costs did not differ significantly between thrombolysis and PPCI (£7,016 versus £6,802; p=0.653 and £8442 versus £7,731; p=0.213 respectively). Initial angioplasty costs were significantly higher in the PPCI group offset by reduced hospital stay (8.5 versus 4 days; p<0.001). CONCLUSIONS: This model of PPCI delivery is associated with larger than expected benefits and is cost-neutral when compared to thrombolysis.

Simple versus complex approaches to treating coronary bifurcation lesions: direct assessment of stent strut apposition by optical coherence tomography.

INTRODUCTION AND OBJECTIVES: Stenting of coronary bifurcation lesions carries an increased risk of stent deformation and malapposition. Anatomical and pathological observations indicate that the high stent thrombosis rate in bifurcations is due to malapposition of stent struts. METHODS: Strut apposition was assessed with optical coherence tomography (OCT) in bifurcation lesions treated either using the simple technique of stent implantation in the main vessel only or a complex technique (i.e. Culotte's). A strut was regarded as malapposed if the gap between its endoluminal surface and the vessel wall was greater than its thickness plus an OCT resolution error margin of 15 microm. RESULTS: Simple and complex (i.e. Culotte's) approaches were used in 17 and 14 patients, respectively. Strut malapposition was significantly more frequent for the half of the bifurcation on same side as the vessel side branch (median, 46.1%; interquartile range [IQR], 35.3-62.5%) than for the half opposite the side branch (9.1%; IQR, 2.2-21.6%), the distal segment (7.5%; IQR, 2.3-20.2%) or the proximal segment (12.6%; IQR, 7.8-23.1%; P< .0001); the gap between strut and vessel wall in malapposed struts was significantly greater in the first segment than the others: 98 microm (IQR, 37-297 microm) vs. 31 microm (IQR, 13-74 microm), 49 microm (IQR, 20-100 microm) and 38 microm (IQR, 17-90 microm), respectively (P< .0001). Using the complex technique had no effect on the prevalence of strut malapposition in the four segments relative to the simple technique (P=.31) but was associated with a smaller gap in the proximal segment (47 microm vs. 60 microm; P=.0008). CONCLUSIONS: In coronary bifurcation lesions, strut malapposition occurred most frequently and was most significant close to the side branch ostium. The use of Culotte's technique did not significantly increase the prevalence of strut malapposition compared with a simple technique.

Estrategia simple o compleja para lesiones de bifurcaciones coronarias: evaluación inmediata de la aposición de los struts del stent mediante tomografía de coherencia óptica / Simple versus complex approaches to treating coronary bifurcation lesions: direct assessment of stent strut apposition by optical coherence tomography

Introducción y objetivos. La implantación de stents en lesiones de bifurcaciones coronarias comporta un riesgo elevado de deformación y mala aposición del stent. Las observaciones anatomopatológicas han atribuido a la mala aposición de los struts un papel causal en la elevada tasa de trombosis de los stents que se observa en las bifurcaciones. Métodos. Se evaluó la aposición de los struts en las lesiones de bifurcaciones tratadas con una técnica simple de implantación de stent solo en el vaso principal o con una técnica compleja (de culotte) mediante el empleo de tomografía de coherencia óptica (OCT). La mala aposición de un strut se definió por el hecho de que la distancia entre su superficie intraluminal y la pared vascular fuera superior a su grosor más un margen de error de resolución de la OCT de 15 μm. Resultados. En 17 pacientes se utilizó la estrategia simple y en 14, la técnica compleja (de culotte). Los struts con mala aposición fueron significativamente más frecuentes y la distancia entre el strut y la pared vascular en los casos de mala aposición fue mayor en la mitad de la bifurcación situada hacia la rama lateral (RL) (46,1% [35,3-62,5]) en comparación con la mitad del lado opuesto (9,1% [2,2-21,6]), el segmento distal (7,5% [2,3-20,2]) y el segmento proximal (12,6% [7,8-23,1]; p < 0,0001) (distancias, 98 μm [37-297] frente a 31 μm [13-74], 49 μm [20-100] y 38 μm [17-90], respectivamente; p < 0,0001). El empleo de la técnica compleja no afectó a la prevalencia de struts con mala aposición en los 4 segmentos en comparación con la estrategia simple (p = 0,31) y se asoció a una menor distancia strut-pared en el segmento proximal (47 frente a 60 mm; p = 0,0008). Conclusiones. En las lesiones de bifurcaciones coronarias, la mala aposición de los struts se produce con mayor frecuencia y es más importante en la zona de origen de la RL. El empleo de la técnica de culotte no aumenta de manera significativa la prevalencia de la mala aposición de los struts en comparación con una estrategia simple (AU)

Introduction and objectives. Stenting of coronary bifurcation lesions carries an increased risk of stent deformation and malapposition. Anatomical and pathological observations indicate that the high stent thrombosis rate in bifurcations is due to malapposition of stent struts. Methods. Strut apposition was assessed with optical coherence tomography (OCT) in bifurcation lesions treated either using the simple technique of stent implantation in the main vessel only or a complex technique (i.e. Culotte’s). A strut was regarded as malapposed if the gap between its endoluminal surface and the vessel wall was greater than its thickness plus an OCT resolution error margin of 15 µm. Results. Simple and complex (i.e. Culotte’s) approaches were used in 17 and 14 patients, respectively. Strut malapposition was significantly more frequent for the half of the bifurcation on same side as the vessel side branch (median, 46.1%; interquartile range [IQR], 35.3–62.5%) than for the half opposite the side branch (9.1%; IQR, 2.2–21.6%), the distal segment (7.5%; IQR, 2.3–20.2%) or the proximal segment (12.6%; IQR, 7.8–23.1%; P<.0001); the gap between strut and vessel wall in malapposed struts was significantly greater in the first segment than the others: 98 µm (IQR, 37–297 µm) vs. 31 µm (IQR, 13–74 µm), 49 µm (IQR, 20–100 µm) and 38 µm (IQR, 17–90 µm), respectively (P<.0001). Using the complex technique had no effect on the prevalence of strut malapposition in the four segments relative to the simple technique (P=.31) but was associated with a smaller gap in the proximal segment (47 µm vs. 60 µm; P=.0008). Conclusions. In coronary bifurcation lesions, strut malapposition occurred most frequently and was most significant close to the side branch ostium. The use of Culotte’s technique did not significantly increase the prevalence of strut malapposition compared with a simple technique (AU)

Randomized comparison of percutaneous coronary intervention with coronary artery bypass grafting in diabetic patients. 1-year results of the CARDia (Coronary Artery Revascularization in Diabetes) trial.

OBJECTIVES: The purpose of this study was to compare the safety and efficacy of percutaneous coronary intervention (PCI) with stenting against coronary artery bypass grafting (CABG) in patients with diabetes and symptomatic multivessel coronary artery disease. BACKGROUND: CABG is the established method of revascularization in patients with diabetes and multivessel coronary disease, but with advances in PCI, there is uncertainty whether CABG remains the preferred method of revascularization. METHODS: The primary outcome was a composite of all-cause mortality, myocardial infarction (MI), and stroke, and the main secondary outcome included the addition of repeat revascularization to the primary outcome events. A total of 510 diabetic patients with multivessel or complex single-vessel coronary disease from 24 centers were randomized to PCI plus stenting (and routine abciximab) or CABG. The primary comparison used a noninferiority method with the upper boundary of the 95% confidence interval (CI) not to exceed 1.3 to declare PCI noninferior. Bare-metal stents were used initially, but a switch to Cypher (sirolimus drug-eluting) stents (Cordis, Johnson & Johnson, Bridgewater, New Jersey) was made when these became available. RESULTS: At 1 year of follow-up, the composite rate of death, MI, and stroke was 10.5% in the CABG group and 13.0% in the PCI group (hazard ratio [HR]: 1.25, 95% CI: 0.75 to 2.09; p=0.39), all-cause mortality rates were 3.2% and 3.2%, and the rates of death, MI, stroke, or repeat revascularization were 11.3% and 19.3% (HR: 1.77, 95% CI: 1.11 to 2.82; p=0.02), respectively. When the patients who underwent CABG were compared with the subset of patients who received drug-eluting stents (69% of patients), the primary outcome rates were 12.4% and 11.6% (HR: 0.93, 95% CI: 0.51 to 1.71; p=0.82), respectively. CONCLUSIONS: The CARDia (Coronary Artery Revascularization in Diabetes) trial is the first randomized trial of coronary revascularization in diabetic patients, but the 1-year results did not show that PCI is noninferior to CABG. However, the CARDia trial did show that multivessel PCI is feasible in patients with diabetes, but longer-term follow-up and data from other trials will be needed to provide a more precise comparison of the efficacy of these 2 revascularization strategies. (The Coronary Artery Revascularisation in Diabetes trial; ISRCTN19872154).

Optical coherence tomography assessment of a new dedicated bifurcation stent.

AIMS: Dedicated bifurcation stents should facilitate deployment and improve coverage of bifurcational lesions. We used optical coherence tomography (OCT) to assess bifurcation lesions treated with a dedicated stent implanted in the side branch (SB) in conjunction with drug eluting stents in the main vessel (MV) in a culotte-like fashion. METHODS AND RESULTS: Nine patients treated with the Tryton stent underwent postprocedural OCT examination. Total percent of malapposed struts per patient was 18.1+/-8.7%. The longitudinal distribution of the percent of malapposed struts per patient showed that the prevalence of malapposed struts was significantly higher at the level of the bifurcation (33.3%), than in both the proximal segment and the distal segment (18.5% and 9.8%, respectively, p=0.011). When the bifurcation was divided into two halves (opposite SB and toward SB), the highest percent of malapposed struts was toward the SB (47.6%). Also the wall-strut distance for malapposed struts was significantly higher in the bifurcation half toward the SB than in the proximal and the distal segment. CONCLUSIONS: Malapposed struts are frequent in bifurcations despite the use of a dedicated stent. The highest frequency and largest vessel wall-stent strut distance are observed in the bifurcation half toward the SB.

Sirolimus-eluting versus uncoated stents in acute myocardial infarction.

BACKGROUND: Sirolimus-eluting stents reduce rates of restenosis and reintervention, as compared with uncoated stents. Data are limited regarding the safety and efficacy of such stents in primary percutaneous coronary intervention (PCI) for acute myocardial infarction with ST-segment elevation. METHODS: We performed a single-blind, multicenter, prospectively randomized trial to compare sirolimus-eluting stents with uncoated stents in primary PCI for acute myocardial infarction with ST-segment elevation. The trial included 712 patients at 48 medical centers. The primary end point was target-vessel failure at 1 year after the procedure, defined as target-vessel-related death, recurrent myocardial infarction, or target-vessel revascularization. A follow-up angiographic substudy was performed at 8 months among 174 patients from selected centers. RESULTS: The rate of the primary end point was significantly lower in the sirolimus-stent group than in the uncoated-stent group (7.3% vs. 14.3%, P=0.004). This reduction was driven by a decrease in the rate of target-vessel revascularization (5.6% and 13.4%, respectively; P<0.001). There was no significant difference between the two groups in the rate of death (2.3% and 2.2%, respectively; P=1.00), reinfarction (1.1% and 1.4%, respectively; P=1.00), or stent thrombosis (3.4% and 3.6%, respectively; P=1.00). The degree of neointimal proliferation, as assessed by the mean (+/-SD) in-stent late luminal loss, was significantly lower in the sirolimus-stent group (0.14+/-0.49 mm, vs. 0.83+/-0.52 mm in the uncoated stent group; P<0.001). CONCLUSIONS: Among selected patients with acute myocardial infarction, the use of sirolimus-eluting stents significantly reduced the rate of target-vessel revascularization at 1 year. (ClinicalTrials.gov number, NCT00232830 [ClinicalTrials.gov].).

Percutaneous coronary intervention for revascularization of the diabetic patient.

The field of interventional cardiology has progressed rapidly in recent years with the advent of new technology and expanding role of adjunctive pharmacology. This article provides an overview of both current and historical approaches to treating coronary artery disease in the diabetic patient.

Has anything changed in multivessel coronary artery revascularization in diabetes since BARI?

Diabetic patients have an increased risk of coronary disease partly due to a higher frequency of associated risk factors including hypertension and hyperlipidemia but also from specific risks largely resulting from insulin resistance, hyperinsulinemia and hyperglycemia. This has resulted in a greater need for revascularization. Despite this there are few randomized data comparing surgery and angioplasty in patients with diabetes. The evidence to define the best operative strategy is limited, mainly confined to a subanalysis of the BARI trial suggesting the superiority of surgery in patients with multivessel disease. However there has been in Europe a wide increase in multivessel angioplasty, even in diabetic patients. This article discusses the higher risk of patients with diabetes, the data comparing surgery and angioplasty and outlines the advances in angioplasty since BARI.

Current perceptions of cardiovascular gene therapy.

Due to differences in their knowledge base, scientists, health care professionals, and the general public have varying perceptions of the expectations and risks of using gene therapy for the treatment of cardiovascular disease. Gene therapists are aware of the importance of selecting the right vector, the right gene, and the right administration procedure for a specific application and for characterization of the heterogeneity of the physiologic response to gene expression. They also recognize the need for large-scale clinical trials to demonstrate short- and long-term safety, in addition to efficacy, for widespread acceptance. Interventional cardiologists are more likely to judge a therapy primarily on its ability to improve cardiovascular pathophysiology and function, although they too will demand safety data. Once convinced of the benefits of a gene therapy, interventional cardiologists will rely on regulatory and reimbursement authorities to approve the procedure. Attitudes of less-specialized physicians toward gene therapy and, specifically, therapeutic angiogenesis will be influenced by the level of clinical trial activity in their country and opinions expressed in the media. However, all will want safety and efficacy data as well as clear guidance on the type of patients who should be referred for treatment. Nurses' roles are set to expand with the introduction of gene-based therapies; most will need further genetics education to rise to these challenges with confidence. The success of a gene therapy will also rely on patients' perceptions and their willingness to receive the treatment. Any misconceptions based on unreliable information sources need to be addressed.