The use of bioresorbable vascular scaffold Absorb BVS® in patients with stable coronary artery disease: one-year results with special focus on the hybrid bioresorbable vascular scaffolds and drug eluting stents treatment.

BACKGROUND: The number of percutaneous coronary interventions (PCI) with bioresorbable vascular scaffolds (BVS) is in-creasing because these procedures offer additional benefits compared to PCI with classical drug eluting stents (DES) made of permanent metallic prostheses. AIM: To present the current experience of using BVS in a real life scenario in patients with stable coronary artery disease (CAD), with a special focus on the assessment of safety and effectiveness of the hybrid strategy (single stage BVS and DES implantation). METHODS: We performed a one-arm prospective registry, which enrolled patients with stable CAD in five interventional cardiology centres in Poland. All patients who met inclusion and exclusion criteria and had received at least one BVS stent during index PCI were included. The primary endpoint was the cumulative rate of major adverse cardiovascular events (MACE), consist-ing of cardiac death, myocardial infarction (MI), and clinically-driven target lesion revascularisation (TLR) at 12 months. The analysis was performed in the whole population as well as in the subgroup with the hybrid treatment (BVS + DES). RESULTS: Between August 2013 and April 2014 139 patients were enrolled. The mean age was 59.5 ± 5.5 years, and 34.5% of the population were women. The target vessel was located in the left anterior descending artery in most cases (65.5%). The device success rate was 100%. At 12 months, in the whole population the cumulative MACE incidence was 7.2% (n = 10), while the clinically-driven TLR rate was 5.0% (n = 7). In further analysis, in the hybrid subgroup there was no death, MI, or stent thrombosis, and only one case of clinically-driven TLR (4.5%). CONCLUSIONS: The obtained data enable us to say that in particular clinical scenarios the simultaneous use of BVS and DES might be safe and effective.

Novel paclitaxel-eluting, biodegradable polymer coated stent in the treatment of de novo coronary lesions: a prospective multicenter registry.

OBJECTIVES: The purpose of the present study was to evaluate the efficacy and safety of a biodegradable polymer coated, paclitaxel eluting stent (Luc-Chopin(2)) based on 9-months angiographic and 12-months clinical follow-up results. BACKGROUND: First-generation drug-eluting stents utilize nonbioabsorbable polymeric coatings, whose persistent presence in the arterial wall may negatively affect long-term outcomes. Bioabsorbable coatings with a degradation period matched to that of the drug elution may be a better alternative, clinically and economically. METHODS: We conducted a prospective, multicenter first-in-man registry of a novel, locally developed, bioabsorbable-coated, paclitaxel-eluting coronary stent in 116 patients with single-lesion de novo coronary disease. RESULTS: Major adverse cardiac events occurred in 7.8% patients within 12 months. There were no late thrombotic events, death, stroke, or surgical revascularization in that period. There were two myocardial infarctions, one related to recent subacute stent thrombosis and another associated with restenosis. By 12 months, target vessel revascularization was performed in 7.8%; 2.9% were ischemia-driven and the rest were mandated at 9 months in accordance with a control angiography protocol. Core-lab assessed binary in-stent restenosis (> or =50% DS) was noted in 11.9% patients and mean late loss was 0.46 +/- 0.47 mm. CONCLUSIONS: This first-in-man experience obtained in a multicenter registry of real-world de novo lesions (almost half of lesions were class B2 or C by AHA classification) showed a favorable safety profile and acceptable efficacy through 12 months. Randomized comparison with a benchmark nonbioabsorbable polymer coated paclitaxel eluting stent should be undertaken to validate this initial positive experience.

[Age and effects of long-term cardiac training in patients with ischemic heart disease]. / Wiek a efekty dlugoterminowego treningu kardiologicznego u pacjentów z choroba niedokrwienna serca.

UNLABELLED: Ongoing with age decline of physical capacity reflects permanent processes of aging occurring in organism. It leads to a successive reduction of physical activity level, resulting with time in restrictions of independent life ability, which then causes anxiety and progressing social isolation. THE AIM: Evaluation of relation between age and effort tolerance in patients with chronic ischemic heart disease and comparison of cardiac rehabilitation effects in two patient groups at significantly various age. MATERIAL AND METHOD: The study comprised 103 patients (69 males and 34 females) at the mean age of 61.2 +/- 0,8 years. The patients were referred to rehabilitation because of undergone invasive treatment of IHD, using CABG (44 pts) and PTCA (48 pts), or acute coronary syndromes (11 pts). The study group was divided to the two subgroups, "A" and "B", differing significantly (p < 0.01) from each other by age. "A" group was constituted by 30 the youngest patients, with the mean age of 51.6 +/- 0.5 yrs, whereas "B" group comprised 30 the oldest patients, with the mean age of 70.9 +/- 0.6 yrs. The examined groups were comparable as to the drug treatment, clinical status, echocardiographic parameters and BMI values. During the observation period no changes in treatment and diet were made. The all patients were subjected to six-month cardiac rehabilitation, consisting of cycle ergometer training (3 times/week) and generally improving exercises (2 times/week). The parameters analyzed were the values of metabolic equivalent (MET) obtained at the initial and the final exercise treadmill test, likewise the delta of MET. RESULTS: For a population of 103 patients with IHD, the negative, statistically significant correlation Pearson's coefficient between age and MET values of initial and final exercise tests and insignificant Pearson's coefficient between age and values of MET delta were obtained. Comparison analysis of the mean MET of initial and final exercise test and the mean MET delta did not show any significant differences between the both examined "A" (young) and "B" (old) groups. CONCLUSIONS: In the examined patients with IHD, there were observed a negative, significant correlation between age and effort tolerance before and after the cardiac rehabilitation cycle, and a lack of significant correlation between age and delta of effort tolerance. There was found no considerable difference concerning a delta of effort tolerance between the patients with IHD falling into the young and the old groups.

[Hypotensive effect of 6-months cardiac rehabilitation in elderly patients]. / Efekt hipotensyjny szesciomiesiecznej rehabilitacji kardiologicznej u chorych w podeszlym wieku.

UNLABELLED: Both effective treatment of arterial hypertension and prevention from its complications are considered very important issues, especially in a population of elderly people, in whom hypertension occurs along with other risk factors, resulting in increase of incidence of myocardial infarction and stroke. THE AIM: There were assessed an influence of 6-month ambulatory cardiac rehabilitation on level of resting and peak systolic and diastolic arterial pressure in elderly patients with chronic ischemic heart disease (IHD) and arterial hypertension (AH), likewise relations between the pressure alterations and the age of the examined patients. MATERIAL AND METHOD: A group of 70 patients with IHD and AH treated invasively was subjected to a rehabilitation program. Group A consisted of 37 patients with the mean age of 69.0 +/- 0.5 years, and group B of 33 patients with the mean age of 51.5 +/- 0.5 years. The patients from the both groups differed significantly only as to the age, whereas they were comparable regarding current clinical status, echocardiographical parameters, BMI values and applied pharmacological treatment. During a follow-up period, neither drug regimen, established at least three months earlier, nor a diet were not modified. The all patients underwent a 6-month cardiac rehabilitation, combining exercises on cycle ergometers (3 times per week) and generally improving training (2 times per week). There were analyzed: the mean values of resting and of peak systolic and diastolic blood pressure at the beginning of the rehabilitation and upon completion of the program. RESULTS: Comparison of the patients from groups A and B did not reveal any significant differences concerning the initial mean values of both resting and peak pressure (systolic and diastolic). Just after the rehabilitation finishing, in A group, a statistically significant reduction of resting systolic and diastolic pressure, likewise insignificant reduction of peak systolic and diastolic pressure were observed. Contrarily, in B group, it was noted a significant reduction of resting systolic and diastolic pressure and insignificant reduction of peak diastolic pressure. In this group, yet, an insignificant increase of peak systolic pressure was found. In the both groups, there was no statistically significant correlation between the age and the delta values of resting and peak systolic and diastolic pressure. CONCLUSION: Long-term ambulatory cardiac rehabilitation caused a profitable blood pressure lowering in patients with IHD and AH, regardless of the age. A changes intensity of resting and of peak blood pressure did not show a dependence on the patients' age.

[Effect of long-term cardiac training on lipids concentration in patients with chronic heart ischemic disease treated with simvastatin]. / Wplyw dlugotrwalego treningu kardiologicznego na stezenie lipidów u chorych z przewlekla choroba niedokrwienna serca leczonych simwastatyna.

UNLABELLED: Dyslipidemia worsens a prognosis in patients with chronic heart ischemic disease, who underwent myocardial infarction. Therefore, new methods, besides drugs, are being sought, for optimizing a serum concentration of lipid fractions. THE AIM: An effect of 6-month of ambulatory long-term cardiac rehabilitation on the lipidogram fractions concentration in patients with chronic heart ischemic disease treated with simvastatin, as well as a correlation between lipids changes and cardiac training intensity was assessed. MATERIAL AND METHOD: Rehabilitation was performed in 66 patients with previous myocardial infarction treated invasively (27 CABG and 39 PTCA), who constituted group I. A control group (group II) consisted of 32 patients with previous myocardial infarction also treated invasively (24 CABG and 8 PTCA), but not subjected to rehabilitation. The two analyzed groups did not differ significantly from each other as to age, applied drug regimen, current clinical status, echocardiographic parameters and BMI values. Group I was subjected to 6-month cardiac rehabilitation program, comprising 45-minute training on cycle ergometer (three times per week) and generally improving exercises (2 times per week). Blood concentration of lipidogram fractions was assessed: total cholesterol (TC), HDL- and LDL-cholesterol, and triglicerides (TG) at the onset and upon completion of the rehabilitation cycle. RESULTS: The both patient groups were comparable concerning the initial concentration of the lipid fractions. After finishing the rehabilitation program, in the group I, a statistically significant reduction of TC, LDL and TG concentration was found out. In addition, a significant increase of HDL concentration was noted. In contrary, in the group II (without rehabilitation), the only significant change concerned a concentration of HDL fraction, which decreased. Furthermore, in the group I, it was noted a negative, statistically significant correlation between intensity of cardiac training, expressed by training workload and delta of work, and a difference in blood concentration of triglicerides, measured just before the training onset and after the program was finished. CONCLUSION: It was revealed that long-term ambulatory cardiac rehabilitation has a profitable effect on serum concentration of the all lipid fractions in patients with chronic heart ischemic disease cured with simvastatin, regardless of training intensity. It was also ascertained that an extent of changes in triglicerides serum concentration was related to an intensity of the cardiac training applied to the patients.

[Effect of ambulatory supervised cardiac training on arterial hypertension in patients with coronary artery disease and arterial hypertension]. / Wplyw ambulatoryjnego kontrolowanego treningu kardiologicznego na cisnienie tetnicze u chorych na chorobe niedokrwienna serca i nadcisnienie tetnicze.

UNLABELLED: Arterial hypertension is one of the most common health problems occurring in highly developed countries. It was proved that long-term and regular physical activity results in hypotensive effect. THE AIM: A goal of the present study was to assess an influence of six-month ambulatory cardiac rehabilitation on arterial pressure level in patients with coronary artery disease and hypertension as well as analysis of correlation between pressure values alterations and intensity of cardiac training. MATERIAL AND METHODS: A study group comprised 103 patients (mean age: 61.2 +/- 0.8 years) manifesting coronary artery disease accompanied by arterial hypertension. A control group constituted 39 normotensive patients with coronary artery disease (mean age: 59.4 +/- 1.3 years). The both observed groups differ from each other only with values of left ventricle mass index and drug regimen established at least three months prior to the follow-up onset. During the rehabilitation cycle, no treatment corrections were made and no new preparations were added. The all patients were enrolled to the six-month cardiac rehabilitation program. The program comprised 45-minute training with cycle ergometer, three times a week, and generally improving gym exercises, two times a week. The analyses concerned systolic and diastolic pressure values, measured just before each training (resting pressure) and just after peak exercise interval (peak pressure), at the beginning and at the end of the rehabilitation cycle. At the initial stage, the patient group with hypertension demonstrated the higher pressure values (resting and peak), as compared with the control group. RESULTS: Cardiac rehabilitation performed in the examined patients caused a statistically significant reduction of the mean resting pressure, both systolic (p < 0.01) and diastolic (p < 0.01). As to the mean peak pressure in this group, systolic diminished slightly (NS), but diastolic was reduced significantly (p < 0.01). In the control group, after six-month rehabilitation the values appeared to be lowered insignificantly in relation to systolic and diastolic resting pressure, likewise diastolic peak pressure, and contrarily systolic peak pressure increased slightly. Assessing an interrelation between the final outcome of the rehabilitation program, expressed as delta of arterial pressure, and terminal training workload and delta of training workload, only for delta of systolic pressure and final training workload, a positive correlation of statistical significance was found out, which is considered an implication of physiological reaction against an increase of training workload. CONCLUSIONS: Long-term and regular cardiac training induced the larger alterations of pressure values in the patients with hypertension, as compared with the normotensive patients. A positive effect of cardiac rehabilitation on arterial pressure level in the hypertensive patients was found to be independent of the training intensity.

[Interrelation between arterial hypertension and body mass index in patients with concomitant ischemic heart disease treated with cardiac rehabilitation]. / Zaleinosc cisnienia tetniczego od indeksu masy ciala u pacjentów z choroba niedokrwienna serca poddanych rehabilitacji kardiologicznej.

A goal of the study was to investigate the interrelations between body mass index (BMI) and arterial pressure level and its alterations induced by a long-term cardiac rehabilitation. In the patients with arterial hypertension with concomitant ischemic heart disease (IHD). The study group consisted of 73 patients (46 males and 27 females), with age range 54-64 years (the mean: 59.59 +/- 0.67 years), subjected to the 6-month ambulatory supervised cardiac rehabilitation, which comprised stamina training with cycloergometer combined with generally improving exercises. Arterial pressure level was measured in the resting state (just before the training onset) and at the interval training peak (peak pressure) during the consecutive three initial and three final training sessions. Upon completion of the rehabilitation cycle, statistically significant reduction of resting systolic pressure: 116.85 +/- 1.68 mmHg vs 105.12 +/- 1.43 mmHg (p<0.01) and insignificant reduction of resting diastolic pressure 79.85 +/- 1.24 mmHg vs 77.44 +/- 1.21 mmHg (NS) were observed. Additionally, insignificant lowering both systolic and diastolic peak pressure was noted, respectively: 119.45 +/- 1.92 vs 118.75 +/- 2.3 mmHg and 78.63 +/- 1.22 mmHg vs 76.96 +/- 1.30 mmHg. Correlation analysis concerning the values of resting systolic and diastolic pressure, likewise of peak systolic and diastolic pressure, on the one hand, and the values of body mass index, on the other hand, yielded in the all considered cases the statistically insignificant positive Pearson's coefficients. The further dependence analyzed, between the delta of resting and peak pressure, systolic and diastolic, and the body mass index values was featured by the insignificant statistically negative correlation coefficients. In result of the 6-month rehabilitation, 36 out of 73 patients demonstrated BMI value reduction by 0.65 +/- 0.33, which did not affect significantly an extent of the arterial pressure lowering. Therefore, in the examined patient group with hypertension and IHD, body mass index turned out to determine neither the initial nor the after-rehabilitation pressure levels, both systolic and diastolic.

PRimary coronary angioplasty versus thrombolytic therapy. Comparison of mortality in the acute phase of myocardial infarction - a single centre experience.

BACKGROUND: Patency of an infarct-related artery may be achieved by the use of primary coronary angioplasty or thrombolysis. In spite of the growing number of reports dealing with this topic, controversies exist as to the superiority of either of these therapeutic options. Moreover, the role of primary angioplasty has not yet been clearly defined in the guidelines of the Polish Cardiac Society. AIM: To compare mortality in the acute phase of myocardial infarction (MI) in patients treated with primary angioplasty versus patients receiving thrombolytic treatment. METHODS: Using prospectively collected data from all consecutive patients with acute MI admitted to our institution, we analysed retrospectively mortality in patients treated with primary angioplasty versus those who received thrombolysis. RESULTS: Between May 1996 and October 2000, 657 patients with acute MI were hospitalised. Of this group, in 66 (10%) patients primary angioplasty was performed, and 278 (42.3%) received thrombolysis. Cardiogenic shock complicated MI in 20 (30%) patients treated with angioplasty and in 19 (7%) thrombolysed patients. Total mortality in the acute phase of MI was 12 (18.2%) patients in the angioplasty group versus 26 (9.4%) patients in the medically treated group (p<0.05). Mortality among patients with cardiogenic shock was significantly higher in those who received thrombolysis than in those who underwent angioplasty [17 (89.5%) patients versus 11 (55%) patients (p<0.05)] and tended to be higher among patients without cardiogenic shock [9 (3%) thrombolysed patients versus 1 (2.2%) patient who underwent angioplasty, NS]. CONCLUSIONS: Primary coronary angioplasty improves the outcome in patients with acute MI complicated by cardiogenic shock and tends to decrease mortality among patients without cardiogenic shock.