The role of drug-coated balloons for coronary bifurcation management: results from the prospective EASTBOURNE-BIF study.

BACKGROUND: Coronary bifurcation lesions are associated with less favourable outcome as compared to other lesion subsets. The role of drug-coated balloons (DCB) for bifurcation lesions has been only investigated in small studies so far, which reported encouraging results. We here describe the results of EASTBOURNE-BIF prospective registry, in which a sirolimus-DCB was used for the treatment of bifurcation lesions. METHODS: Overall, 194 patients with bifurcations lesions identified in the EASTBOURNE study (Medina 1.1.1/1.1.0/1.0.1/0.1.1/0.1.0) were compared with 1049 patients with de-novo lesions from the same registry. Both a blended-strategy using a drug-eluting stent in the main branch and a DCB in the side branch as well as a full-DCB approach were used in the treatment of bifurcation lesions. RESULTS: At one year of follow-up the study primary endpoint, target-lesion revascularization occurred at a similar rate in the bifurcation group versus the de-novo group (4.2 vs. 2%, P=0.28). Similar outcomes were observed in terms of all-cause death (3.3 vs. 1.4%, P=0.138), major adverse cardiovascular events (8.8 vs. 5.2%, P=0.081) and the rate of spontaneous myocardial infarction (2.8 vs. 1.0%, P=0.117). CONCLUSIONS: The results of EASTBOURNE-BIF study show how the use of this DCB alone or in combination with drug eluting stents could represent a safe and effective alternative to stents for the treatment of bifurcations.

Drug coated balloons and their role in bifurcation coronary angioplasty: appraisal of the current evidence and future directions.

INTRODUCTION: Coronary Bifurcation lesions are technically more challenging and Bifurcation percutaneous coronary intervention (PCI) remains a challenge with unpredictable and sub-optimal clinical and angiographic results. Drug-Coated Balloons (DCB) are emerging devices in the field of coronary intervention with promising results that may overcome some of drug eluting stents limitations and may have potential advantages in complex bifurcation PCI. AREAS COVERED: We have performed a re-appraisal about the issues with current bifurcation PCI techniques and the use of DCB in the treatment of Bifurcation lesions. Several studies performed utilizing DCB are described and critically appraised. Over the recent years, there have been tremendous developments in the DCB technology, lesion preparation, clinical experience, and clinical data during bifurcation PCI. The current review describes the advances in the DCB technology, pharmacokinetics, role of excipients, and optimization of the technique. Special emphasis in lesion preparation and potential pathway of using DCB in bifurcation PCI is proposed. EXPERT OPINION: Although different proof of concept and pilot studies have shown promising results in treatment of bifurcation lesions with DCB, larger randomized trials and/or international consensus papers are required to enable worldwide translation of this idea to clinical practice.

Postpericardiotomy syndrome incidence, diagnostic and treatment strategies: experience AT two collaborative centers.

Postpericardiotomy syndrome (PPS) is worsening or new formation of pericardial and/or pleural effusion mostly 1 to 6 weeks after cardiac surgery, as a result of autoimmune inflammatory reaction within pleural and pericardial space. Its incidence varies among different studies and registries (2% to 30%), as well as according to the type of cardiac surgery performed. We conducted this retrospective analysis of PPS incidence and diagnostic and treatment strategies in patients referred for cardiac surgery for revascularization, valvular and/or aortic surgery. We retrospectively analyzed 461 patients referred for an urgent or elective cardiac surgery procedure between 2009 and 2015. PPS diagnosis was established using well defined clinical criteria. Demographic and clinical characteristics were used in regression subanalysis among patients having undergone surgery of aortic valve and/or ascending aorta. Within 6 weeks after cardiac surgery, 47 (10.2%) patients had PPS. The median time from the procedure to PPS diagnosis was 14 days. The incidence of PPS was 26% after aortic valve and/or aorta surgery, and 7.9% and 8.3% after coronary bypass and mitral valve surgery, respectively. Among patients subjected to aortic valve and/or aortic surgery, regression analysis showed significant association of fever, C-reactive protein (CRP) elevation between 5 and 100 mg/L, urgent procedure and postoperative antibiotic use with PPS diagnosis, whereas younger age showed near-significant association. All patients had complete resolution of PPS, mostly after corticosteroid therapy, with only 2 cases of recurrent PPS that successfully resolved after colchicine therapy. Pleural drainage was indicated in 15 (32%) patients, whereas only one patient required pericardial drainage. In conclusion, PPS incidence in our retrospective analysis was similar to previous reports. Patients having undergone aortic valve and/or aortic surgery were most likely to develop PPS. The most relevant clinical criteria for diagnosis in these patients were fever, CRP elevation between 5 and 100 mg/L, and pericardial and/or pleural effusion formation or worsening 2 weeks after cardiac surgery.

SEVEN-YEAR TRENDS IN THE CROATIAN PRIMARY PERCUTANEOUS CORONARY INTERVENTION NETWORK.

The authors investigated trends in the Croatian primary Percutaneous Coronary Intervention (pPCI) Network results among three consecutive time intervals (2005-2007, first phase; 2008-2009, second phase; and 2010-2011, third phase). Data on 5650 patients with acute myocardial infarction with ST-elevation (STEMI) transferred or directly admitted and treated with pPCI in 11 Croatian PCI centers during the study period were collected and analyzed. The number of patients with acute STEMI treated with pPCI per year rose continuously during the study period (581 vs. 1272 vs. 1949 patients/year). The patient risk profile worsened during the study period: age (60 vs. 61 vs. 63 years; p<0.01), anterior myocardial wall involvement (43% vs. 44% vs. 51%; p<0.01), shock rate (7% vs. 9% vs. 11%; p<0.05), and percentage of transferred patients (42% vs. 36% vs. 46%; p<0.01). While the door-to-balloon time shortened (108 vs. 98 vs. 75 min; p<0.01), the symptom onset-to-door time increased (130 vs. 175 vs. 195 min; p<0.01), but without statistically significant influence on the total ischemic time. Multivariate log-linear analysis eliminated influence of a higher risk profile on the results of treatment and yielded no statistically significant changes in final TIMI 3 flow (Thrombolysis In Myocardial Infarction 3), in-hospital mortality, and six-month mortality rate, but revealed a significant increase in the rate of angina pectoris (12 vs. 22 vs. 36%; p<0.01) and other major adverse cardiovascular events (MACE; 6 vs. 23 vs. 14%; p<0.01) during follow up. In conclusion, the Croatian pPCI Network continuously ensures very good results of STEMI treatment in this economically less developed European country despite worsening of the risk profile in treated patients and opening of new, less experienced PCI centers. The higher percentage of MACE over time could be explained by changes in the pPCI strategy introduced over time (the culprit lesion only) and higher availability of PCI centers for additional PCI after acute STEMI. However, there is room for improvement, especially in reducing prehospital delay.

Duke Treadmill Score in prioritizing patients for coronary angiography: retrospective study of a Croatian regional hospital.

Aim of the study was to determine the potential of Duke Treadmill Score (DTS) in prioritizing patients for coronary angiography in a transitional country clinical setting. We analyzed 114patients with suspected stable coronary artery disease who underwent exercise treadmill testing, and coronary angiography in Slavonski Brod General Hospital. DTS was calculated from treadmill test as: exercise time--(5 x ST deviation in mm)--(4 x exercise angina). Regarding the score, patients were grouped into three groups of risk for coronary artery disease: low risk, medium risk, and high risk patients. All patients underwent coronary angiography, and were grouped in accordance to the severity of the coronary artery disease into three groups: insignificant, significant, or severe coronary artery disease. All patients scored as high risk DTS had significant or severe coronary artery disease. Medium and low risk DTS patients had insignificant coronary artery disease in 50%, and 90% of cases, respectively. Medium risk patients with significant or severe coronary artery disease were significantly older, and had more frequent history of typical chest pain with higher number of episodes per week (P<0.05), whereas there were no differences regarding gender or presence of risk factors. There were no significant differences among medium risk patients regarding the severity of coronary artery disease in exercise time or ST deviation. However, the presence of limiting exercise angina in medium risk patients was significantly more related with significant and severe coronary artery disease (P<0.05). High risk DTS result showed great potential in stratifying patients for immediate coronary angiography. This scoring system may be used in prioritizing patients for coronary angiography in a transitional clinical setting.

Increased bone mineral density in postmenopausal women with type 2 diabetes mellitus.

BACKGROUND AND OBJECTIVES: Studies of bone mineral density (BMD) in women with type 2 diabetes mellitus have shown conflicting results. We conducted this study to determine whether postmenopausal women with diabetes have higher BMD than non-diabetic women of similar age, and to investigate the relationship between BMD and relevant clinical characteristics in these groups of women. PATIENTS AND METHODS: We retrospectively analyzed lumbar spine, femoral neck, and radius BMD data and other relevant clinical data for 130 postmenopausal women with type 2 diabetes mellitus and 166 non-diabetic women collected during a voluntary screening for osteoporosis in postmenopausal women without a history of low bone mass or osteoporotic fractures. RESULTS: Women with type 2 diabetes mellitus had significantly higher mean lumbar spine BMD ( 0.903+/-0.165 vs. 0.824+/-0.199, respectively, P<.001) and mean femoral neck BMD (0.870+/-0.132 vs. 0.832+/-0.134, respectively, P<.05) than non-diabetic women. In both groups of women, age correlated negatively with BMD levels at all three anatomical sites. Higher body mass index was associated only with higher lumbar spine BMD in both groups. Alkaline phosphatase levels showed a negative correlation with BMD at all sites in women with type 2 diabetes mellitus. CONCLUSION: Postmenopausal women with type 2 diabetes mellitus have higher BMD levels than non-diabetic women with similar clinical characteristics, and require a more scrutinized approach in managing low bone mass.