Treatment of In-Stent Restenosis by Excimer Laser Coronary Atherectomy and Drug-Coated Balloon: Serial Assessment with Optical Coherence Tomography.

OBJECTIVES: We aimed to compare the results of neointimal modification before drug-coated balloon (DCB) treatment with excimer laser coronary atherectomy (ELCA) plus scoring balloon predilation versus scoring balloon alone in patients presenting with in-stent restenosis (ISR). BACKGROUND: Treatment of ISR with ELCA typically results in superior acute gain by neointima debulking. However, the efficacy of combination therapy of ELCA and DCB remains unknown. METHODS: A total of 42 patients (44 ISR lesions) undergoing DCB treatment with ELCA plus scoring balloon (ELCA group, n = 18) or scoring balloon alone (non-ELCA group, n = 24) were evaluated via serial assessment by optical coherence tomography (OCT) performed before, after intervention, and at 6 months. RESULTS: Although there was significantly greater frequency of diffuse restenosis and percent diameter stenosis (%DS) after intervention in the ELCA group, comparable result was shown in %DS, late lumen loss, and binary angiographic restenosis at follow-up. On OCT analysis, a decreased tendency in the minimum lumen area and a significant decrease in the minimum stent area were observed in the ELCA group between 6-month follow-up and after intervention (-0.89 ± 1.36 mm2 vs. -0.09 ± 1.25 mm2, p = 0.05, -0.49 ± 1.48 mm2 vs. 0.28 ± 0.78 mm2, p = 0.03, respectively). The changes in the neointimal area were similar between the groups, and target lesion revascularization showed comparable rates at 1 year (11.1% vs. 11.4%, p = 0.85). CONCLUSIONS: Despite greater %DS after intervention, ELCA before DCB had possible benefit for late angiographic and clinical outcome.

Incidence, procedural management, and clinical outcomes of coronary in-stent restenosis: Insights from the National VA CART Program.

BACKROUND: In-stent restenosis (ISR) remains a common clinical problem associated with significant morbidity. We sought to evaluate the temporal trends in incidence and procedural management of coronary restenosis as well as evaluate the association between different treatment modalities and clinical outcomes. METHODS: We identified all patients treated for coronary ISR within the Veterans Affairs Healthcare System from October 1, 2006 to September 30, 2014. The temporal trends in incidence as well as intraprocedural management were assessed. Among patients treated for single vessel restenosis, a propensity matched cohort was created for those treated with drug-eluting stents (DES) or other treatment modalities. Target vessel revascularization (TVR) and mortality were compared between the two subpopulations. RESULTS: From 2006 to 2014, 65,443 patients underwent percutaneous coronary intervention and 6,872 patients (10.5%) with 8,921 lesions were treated for ISR. The proportion of patients undergoing revascularization for restenosis increased 0.28% per year (P = 0.055). Among a propensity-matched cohort of 6,231, the rates of TVR (subdistribution HR: 0.623, 95% CI: 0.511-0.760) and mortality (HR: 0.730, 95% CI: 0.641-0.830) were significantly lower among patients treated with a DES compared with other treatments. After adjustment for known risk factors, treatment with DES continued to be associated with a reduction in mortality rate (Adjusted HR: 0.802, 95% CI: 0.704-0.913). CONCLUSIONS: There is a trend toward an increasing proportion of coronary interventions for ISR in a national cohort of Veterans and treatment with a DES is associated with the lowest rate of TVR and overall mortality.

Same or Different Drug-Eluting Stent Re-Implantation for Drug-Eluting Stent Restenosis: An Assessment Including Second-Generation Drug-Eluting Stents.

OBJECTIVES: We examined the long-term outcomes of implanting a different type of drug-eluting stent (DES), including second-generation DES, for treatment of DES-in stent restenosis (ISR). BACKGROUND: Treatment for DES-ISR has not been standardized. METHODS: The subjects were 80 patients with 89 lesions underwent DES implantation for DES-ISR. The patients were divided into the group of patients receiving the same DES for DES-ISR (Homo-stent: 24 patients, 25 lesions) and a different DES for DES-ISR (Hetero-stent: 56 patients, 64 lesions). The primary endpoint was survival free of major adverse cardiovascular events (MACE), including cardiac death, myocardial infarction, and target vessel revascularization (TVR). The secondary endpoint was late loss at 8-12 months follow-up. In the subgroup of patients who were treated with second-generation DES for DES-ISR, we also assessed the survival free of MACE. RESULTS: During a mean follow-up of 45.1 ± 21.2 months, 26 patients experienced MACE. There was no significant difference in the survival free of MACE (Log rank P = 0.17). In the sub-analysis of second generation DES, MACE was significantly higher in the Homo-stent group compared to the Hetero-stent group (Log rank P = 0.04). Late loss was significantly higher in the Homo-stent group than in the Hetero-stent group (0.86 ± 1.03 vs. 0.38 ± 0.74 mm, P = 0.03). This trend was prominent in the first-generation DES group. CONCLUSIONS: Although there was no significant difference in MACE between the Hetero-stent and the Homo-stent groups including both first and second-generation DES, the sub-analysis demonstrated different DES implantation for DES-ISR significantly improved the MACE rate among patients treated with second-generation DES. (J Interven Cardiol 2016;29:311-318).

STACCATO (Assessment of Stent sTrut Apposition and Coverage in Coronary ArTeries with Optical coherence tomography in patients with STEMI, NSTEMI and stable/unstable angina undergoing everolimus vs. biolimus A9-eluting stent implantation): a randomised controlled trial.

AIMS: To compare tissue coverage in coronary lesions stented with durable fluoropolymer-coated everolimus-eluting stents (EES) vs. biodegradable polymer-coated biolimus A9-eluting stents (BES). METHODS AND RESULTS: Sixty-four patients (64 lesions) with de novo coronary artery lesions were randomised to percutaneous treatment with XIENCE EES (Abbott Vascular, Santa Clara, CA, USA) vs. BioMatrix BES (Biosensors, Morges, Switzerland). The primary endpoint was the percentage of uncovered struts, as assessed with OCT, at nine months. The average percentage of uncovered struts was significantly lower with EES (4.3±4.8% vs. 8.7±7.8% with BES, p=0.019). There was no difference in the average percentage of malapposed struts at baseline (6.8±6.9% vs. 6.9±7.0%, respectively, p=0.974) and at follow-up (0.1±0.3% vs. 0.6±1.3%, p=0.143). Neointimal thickness at nine months was 109±43 µm in EES vs. 64±18 µm in BES (p<0.001), and angiographic LLL was 0.15 mm in EES vs. 0.10 mm in BES (p=0.581). We did not observe differences in the incidence of MACE and ST. CONCLUSIONS: A significantly higher percentage of uncovered struts was detected in the BioMatrix BES compared with the XIENCE EES at nine-month follow-up. Our findings do not support a preferential use of stents with biodegradable polymer-based biolimus elution to reduce the risk for ST.

Cateter balão farmacológico no tratamento da reestenose coronariana intra-stent / Pharmacological balloon catheter in the treatment of intra-stent coronary restenosis

CONTEXTO: A incorporação do cateter balão farmacológico para a reestenose intra-stent foi avaliada num primeiro momento em 2013 quando a CONITEC deliberou por sua não incorporação até que o stent farmacológico fosse avaliado para tratamento da mesma doença. Com a incorporação do stent farmacológico no SUS por meio da Portaria SCTIE/MS nº 29 de 28 de agosto de 2014, uma nova demanda para incorporação do cateter balão farmacológico foi apresentada. A reestenose intra-stent ocorre pela hiperplasia mio-intimal excessiva, reobstruindo a luz do vaso coronariano. Os tratamentos existentes no SUS para essa doença consistem na angioplastia através de cateter balão comum (não farmacológico), intervenção cirúrgica para revascularização e implantes de stent convencional e, agora também, de stent farmacológico. EVIDÊNCIAS CIENTÍFICAS: As evidências científicas parecem indicar que o uso do cateter balão farmacológico pode reduzir a perda tardia de luz no vaso e o risco de eventos adversos cardíacos maiores quando comparado com a angioplastia com balão comum, possuindo resultados semelhantes quando comparado ao implante de stents farmacológicos. CONSIDERAÇÕES FINAIS: A evidência atualmente disponível sobre eficácia e segurança do cateter balão farmacológico para tratamento da reestenose intra-stent é baseada em revisão sistemática e estudos clínicos randomizados. Na revisão sistemática de Indermuehle et al.19 os dados indicam redução do risco de eventos adversos cardíacos maiores impulsionado principalmente por uma menor necessidade revascularização da lesão alvo. O risco de mortalidade também é reduzido em comparação à angioplastia com cateter balão comum. No tratamento da ISR comum, o cateter balão farmacológico mostrou-se superior ao balão de angioplastia comum e ao stent comum. Comparado ao stent farmacológico, os resultados foram semelhantes com a vantagem de o cateter balão farmacológico evitar o acúmulo de múltiplas camadas de stents, mas com a desvantagem de possuir um custo unitário bem mais elevado que o valor atual do stent farmacológico no SUS. DELIBERAÇÃO FINAL: Os membros da CONITEC presentes na reunião do plenário do dia 02/07/2015 deliberaram, por unanimidade, ratificar a recomendação de não incorporar o cateter balão farmacológico no tratamento da reestenose intra-stent. DECISÃO: Foi publicada a portaria nº 35, de 27 de julho de 2015, da decisão de não incorporar o cateter balão farmacológico para o tratamento de pacientes com reestenose coronariana intra-stent no âmbito do Sistema Único de Saúde - SUS. Publicação no DOU nº 141 de 27 de julho de 2015. DECISÃO: A PORTARIA Nº 35, de 24 de julho de 2015 - Torna pública a decisão de não incorporar o cateter balão farmacológico para o tratamento de pacientes com reestenose coronariana intra-stent no âmbito do Sistema Único de Saúde - SUS.

Comparative assessment of angiotensin II type 1 receptor blockers in the treatment of acute myocardial infarction: surmountable vs. insurmountable antagonist.

BACKGROUND: The mechanisms of antagonism vary between the angiotensin II type 1 receptor blockers (ARBs): insurmountable antagonism and surmountable antagonism. Recent retrospective observational studies suggest that ARBs may not have equivalent benefits in various clinical situations. The aim of this study was to compare the effect of two categories of ARBs on the long-term clinical outcomes of patients with acute myocardial infarction (AMI). METHODS: We analyzed the large-scale, prospective, observational Korea Acute Myocardial Infarction Registry study, which enrolled 2740 AMI patients. They divided by the prescription of surmountable ARBs or insurmountable ARBs at discharge. Primary outcome was major adverse cardiac events (MACEs), defined as a composite of cardiac death, nonfatal MI, and re-percutaneous coronary intervention, coronary artery bypass graft surgery. RESULTS: In the overall population, the MACEs rate in 1 year was significantly higher in the surmountable ARB group (14.3% vs. 11.2%, p=0.025), which was mainly due to increased cardiac death (3.3% vs. 1.9%, p=0.031). Matching by propensity-score showed consistent results (MACEs rate: 14.9% vs. 11.4%, p=0.037). In subgroup analysis, the insurmountable ARB treatment significantly reduced the incidence of MACEs in patients with left ventricular ejection fraction greater than 40%, with a low killip class, with ST segment elevation MI, and with normal renal function. CONCLUSIONS: In our study, insurmountable ARBs were more effective on long-term clinical outcomes than surmountable ARBs in patients with AMI.

Repeat coronary revascularization after coronary artery bypass surgery in older adults: the Society of Thoracic Surgeons' national experience, 1991-2007.

BACKGROUND: A major advantage of coronary artery bypass graft surgery (CABG) relative to percutaneous coronary intervention is its durability, yet there is a paucity of information on rates and predictors of repeat coronary revascularization after CABG in the modern era. METHODS AND RESULTS: We included patients ≥65 years from the Society of Thoracic Surgeons' National Adult Cardiac Surgery Database who were undergoing first-time isolated CABG from 1991 to 2007 (n=723 134, median age 73 years). After linking to Medicare claims data, long-term outcomes of CABG (up to 18 years after surgery) were examined by use of cumulative incidence curves. Multivariable Cox proportional hazard analysis was used to identify factors associated with 1- and 5-year repeat revascularization trends and variability. We found that the overall 18-year survival rate was 20%. Cumulative incidences of any repeat revascularization (percutaneous coronary intervention or CABG, yet most often percutaneous coronary intervention) were 2%, 7%, 13%, and 16% at 1, 5, 10, and 18 years after surgery, respectively. The rates of repeat CABG procedures were quite low for all time points (0.1%, 0.6%, 1.3%, and 1.7%, respectively). Female sex, disease severity represented by a history of percutaneous coronary intervention, preoperative dialysis, and partial revascularization were strongly associated with a higher revascularization rate, whereas advanced age, left main disease, and smoking were associated with a lower rate. There was approximately a 2-fold variation in repeat revascularization rates across centers at 1 year (interquartile range 1.7-3.6%) and 5 years (interquartile range 6.7-12.0%). CONCLUSIONS: Repeat revascularization is performed infrequently among older patients who undergo CABG; however, these rates vary substantially by patient subgroups and among providers.

Coronary artery bypass grafting using the radial artery: clinical outcomes, patency, and need for reintervention.

BACKGROUND: Radial artery (RA) grafts are an attractive second arterial conduit after the left internal thoracic artery (LITA) for coronary artery bypass graft (CABG) surgery. However, long-term outcomes and the need for subsequent reintervention have not been defined. METHODS AND RESULTS: We performed a retrospective cohort study of our single institution's 16-year experience with 1851 consecutive patients (average age, 58 years; 82% men, 36% diabetic) undergoing primary, isolated CABG with the LITA, RA, and saphenous vein as needed. Average grafts per patient were 3.8, with 2.4 arterial grafts per patient. Survival was determined using the Social Security Death Index. Grafts were nonpatent if they had a >50% stenosis, a string sign, or were occluded. Five patients (0.3%) died in hospital and 0.8% had a myocardial infarction, 1.1% a stroke, and 0.6% renal failure. Kaplan-Meier-estimated 1-, 5-, 10-, and 15-year survival was 99%, 96%, 89%, and 75%, respectively. Of the cohort, 278 symptomatic patients underwent cardiac catheterization at our institution an average of 5.0±3.8 years (range, 0.1-12 years) after CABG. Overall RA (n=420 grafts) patency was 82% and SV (n=364 grafts) patency, 47% (P<0.0001). LITA (n=287 grafts including 9 sequential grafts) patency was 85% and right internal thoracic artery (n=15 grafts) patency was 80% (P=0.6). RA patency was not different from LITA patency (P=0.3). Overall freedom from catheterization, percutaneous coronary intervention, and CABG was 85%, 97%, and 99%, respectively. CONCLUSIONS: RA grafting is a highly effective revascularization strategy providing excellent short and long-term outcomes with very low rates of reintervention. RA patency is similar to LITA patency and is much better than SV patency. RA grafting should be more widely utilized in patients undergoing CABG.

A novel 3-d reconstruction system for the assessment of bifurcation lesions treated by the mini-crush technique.

BACKGROUND: Conventional two-dimensional angiography lacks the ability to properly image the true bifurcation geometry, and its percutaneous coronary intervention-induced changes in the clinical setting. METHODS AND RESULTS: A novel three-dimensional reconstruction system was investigated by retrospectively analyzing 39 lesions in 35 consecutive patients with coronary bifurcation disease treated with the mini-crush technique. At baseline, significant correlations were proved between two- and three-dimensional systems in terms of either reference vessel diameter (R(2)= 0.68 and 0.29 for main and side branches, respectively), minimum lumen diameter (R(2)= 0.73 and 0.36), stenosis diameter (R(2)= 0.69 and 0.29), and lesion length (R(2)= 0.48 and 0.58). These results were consistent with those observed after the procedure and at 8-month follow-up. Lesion length was significantly longer with the three-dimensional compared to the two-dimensional system for both main and side branches (P < 0.001, and P = 0.007, respectively). CONCLUSIONS: The three-dimensional quantitative reconstruction system may provide accurate evaluation of the complex curvilinear structure of bifurcation lesions when using a double stent technique.

Comparison of multiple drug-eluting stent percutaneous coronary intervention and surgical revascularization in patients with multivessel coronary artery disease: one-year clinical results and total treatment costs.

PURPOSE: Consecutive patients with multivessel coronary artery disease treated with multiple drug-eluting-stent (DES) percutaneous coronary intervention (PCI) (111 patients) or coronary artery bypass graft (CABG) (95 patients) on the basis of clinico-anatomical judgment were examined to investigate mediumterm clinical results and initial and total costs. METHODS: Clinical and procedural characteristics, duration of hospital stay, initial and total costs and 12-month follow-up events were considered in both groups. RESULTS: Previous revascularization procedures and acute coronary syndromes were more frequent in the PCI group, while triple-vessel and left main disease occurred more often in the CABG group. The mean number of treated vessels in multiple DES PCI was 2.7/patient, with 2.8 DES/patient. Complete revascularization was achieved in 70% of cases. Inhospital events were postprocedural non-Q-wave acute myocardial infarction in 5.4%, and 2 retroperitoneal hemorrhages. CABG was performed with a mean of 3.9 grafts/patient; 16 patients (17%) had early complications; mean hospital stay was significantly longer than for the PCI patients (23.5 +/- 10 vs. 5.3 +/- 3 days; p < 0.001). Twelve-month total mortality and acute myocardial infarction incidents were similar, while target vessel revascularization was significantly more frequent in the PCI group (12.6% PCI vs. 2.1% CABG; p < 0.001); cumulative major adverse cardiac events were not significantly different (15.3% PCI vs. 9.5% CABG; p = 0.271). Initial and final costs were lower for multivessel PCI with DES (20,050 +/- 2,702 for CABG vs. 10,214 +/- 4,184 for PCI; p < 0.001), but not completely covered by current DRG reimbursement. CONCLUSIONS: Multiple DES PCI showed good earlyand medium-term results with substantially lower costs than CABG.

Advances in coronary heart disease surgery in Latin America.

BACKGROUND: The beginnings of coronary artery bypass graft in Latin America could be set in the year 1971. Since then, improvements in technique and greater experience have resulted in a rapid increase in the rate of interventions performed in the region. METHODS AND RESULTS: Searches through PubMed and Literatura Latinoamericana y del Caribe en Ciencias de la Salud, as well as personal communications from specialists from Latin America, have been the source of information. Articles were selected by their content related to the theme, and the authors' nationality and information is mainly from Latin America. Demographic information of the population of Latin America denotes higher age averages, and this implies an increase in the severity of comorbidities in patients who undergo surgery. Longer life expectancy and improvements in medical therapy have implied that patients survive a first intervention beyond the expected time a bypass persists patent. Wall vessel properties of arterial conduits, plus a better anastomotic technique, seem to be the current solution to worsening in the coronary health of patients who undergo revascularization surgery in Latin America. CONCLUSIONS: Despite scarce economic investment in medical sciences, many academic groups contribute to the exploration of therapeutic pharmacological combinations and inclusively apply genetic strategies.

[Coronary artery dissection after blunt chest trauma: subacute and chronic phase assessment by intravascular ultrasonography: a case report].

A 35-year-old man sustained a steering wheel injury in a motor vehicle accident. Initial electrocardiography showed ST-segment elevation. Coronary angiography revealed a dissection of the right coronary artery and perfusion delay in the left anterior descending artery. Coronary stents were inserted into the left anterior descending artery. One month later, coronary angiography and intravascular ultrasonography showed that the dissection of the right coronary artery was still present. Coronary stents were inserted from the aorto-ostial lesion to the mid portion of the right coronary artery. Six months later, coronary angiography and intravascular ultrasonography revealed diffuse neointimal hyperplasia inside all of the stents, and the aorto-ostial stent had severe stenosis with perfusion delay. Severe neointimal hyperplasia was found inside the stents used for repair of the coronary artery dissection.

Cost analysis of aprotinin for coronary artery bypass patients: analysis of the randomized trials.

BACKGROUND: The full kallikrein-inhibiting dose of aprotinin has been shown to reduce blood loss, transfusion requirements, and the systemic inflammatory response associated with cardiopulmonary bypass graft surgery (CABG). A half-dose regimen, although having a reduced delivery cost, inhibits plasmin and fibrinolysis without substantially effecting kallikrein-mediated inflammation associated with bypass surgery. The differing pharmacologic effects of the two regimens impact the decision-making process. The current study assessed the medical cost offset of full-dose and half-dose aprotinin from short- and long-term perspectives to provide a rational decision-making framework for clinicians. METHODS: To estimate CABG admission costs, resource utilization and clinical data from aprotinin clinical trials were combined with unit costs estimated from a Duke University-based cost model. Lifetime medical costs of stroke and acute myocardial infarction were based on previous research. RESULTS: Relative to placebo, the differences in total perioperative cost for primary CABG patients receiving full-dose or half-dose aprotinin were not significant. When lifetime medical costs of complications were considered, total costs in full-dose and half-dose aprotinin-treated patients were not different relative to that of placebo. Total perioperative cost was significantly lower for repeat CABG patients treated with aprotinin, with savings of $2,058 for full-dose and $2,122 for half-dose patients when compared with placebo. Taking lifetime costs of stroke and acute myocardial infarction into consideration, the cost savings estimates were $6,044 for full-dose patients and $4,483 for half-dose patients, due to substantially higher lifetime stroke costs incurred by the placebo patients. CONCLUSIONS: Using this cost model, use of full-dose and half-dose aprotinin in primary CABG patients was cost neutral during hospital admission, whereas both dosing regimens were significantly cost saving in reoperative CABG patients. Additional lifetime cost savings were realized relative to placebo due to reduced complication costs, particularly with the full-dose regimen. As the full kallikrein-inhibiting dose of aprotinin has been shown to be safe and effective, the current results support its use in both primary and repeat CABG surgery. No demonstrable economic advantage was observed with the half-dose aprotinin regimen.