Treatment of in-stent restenosis (ISR) with conventional percutaneous transluminal coronary angioplasty (PTCA) causes significant recurrent neointimal tissue growth in 30-85%. Therefore, laser ablation of intrastent neointimal hyperplasia before balloon dilation can be an attractive alternative. However, the long-term outcomes of such treatment have not been studied thoroughly enough. This prospective case-control study evaluated angiographic and clinical outcomes of PTCA alone and a combination of excimer laser coronary angioplasty (ELCA) and adjunct PTCA in 125 patients with ISR. ELCA was performed before balloon dilation in 67 patients, PTCA alone was performed in 58 patients. Basic demographic and clinical data were comparable in both groups. Lesions included in ELCA group were longer (17.1+/-9.9 vs 13.6+/-9.1 mm; p = 0.034), more complex (36.5% type C stenoses vs 14.3%; p = 0.006), and more frequently had reduced distal blood flow (TIMI <3: 18.9% vs 4.8%; p = 0.025) compared to lesions in the PTCA group. Immediate angiographic results of PTCA and ELCA + PTCA appeared to be comparable. PTCA alone was successful in 57 patients (98.3%), ELCA + PTCA, in 66 patients (98.5%). The rates of hospital complications were comparable (3.0% in ELCA group vs 8.6% in PTCA group). The 1-year follow-up showed that the rates of major adverse cardiac events (MACE) were comparable in the 2 groups (37.3% in ELCA group vs 46.6% in PTCA group). The rates of target vessel revascularization (TVR) within 1 year after the intervention were also similar in the 2 groups (32.8% vs 34.5%). The data mean that ELCA in patients with complex ISR is efficient and safe. Despite a higher complexity of lesions in the ELCA group, no increase in the rate of complications was registered.
Aims A comparison influence of renal denervation versus pharmacological treatment with sympathetic nervous system blockers on blood pressure in patients with resistant hypertension. Methods 125 patients with resistant hypertension without comorbidities after a 3-week standardized treatment with Losartan 100 mg, Amlodipine 10 mg and Indapamid 1,5 mg and confirmation of their resistance were randomly assigned into three groups, depending on medication supplemented to previously administered: IM group – selective I1-imidazoline agonist Moxonidine, IIB group – cardioselective beta-blocker Bisoprolol and IIID group – renal artery denervation. Patients were assessed by ambulatory blood pressure monitoring at baseline, 3, 6 and 12 month follow-up. The compliance to drug treatment was confirmed by 8-item Morisky Medication Adherence Scale. Renal denervation was performed with a Symplicity Spyral catheter. Results The mean 24 hour systolic blood pressure (SBP m/24 h) at baseline were 179.0±2.02 mmHg in IM group versus 177.96±2.44 mmHg in IIB group and 176.92±1.97 mmHg in IIID group, p>0.05. Statistically significant dynamics was recorded starting with 3 months of evaluation in all three groups, the group of patients undergoing denervation of the renal arteries demonstrating a net superior effect compared with pharmacological treatment: −6.48±0.81 mmHg in I M group versus −6.2±0.88 mmHg in II B group and −23.28±1.9 mmHg in III D group, p<0.001. The beneficial effect was maintained until the end of the study, when in observational group supplemented with Moxonidine SBP m/24 h were 159.6±1.72 mmHg with a total reduction of −19.9±0.7 mmHg from baseline, in Bisoprolol group −164.08±1.93 mmHg with a reduction of −13.88±1.13 mmHg and 141.76±0.77 mmHg in renal denervation group with a total reduction of −35.16±2.23 mmHg, p<0.001. The mean 24 hour diastolic blood pressure (DBP m/24 h) increased at baseline in all three groups (105.52±1.28 mmHg in IM versus 108.6±1.6 mmHg in IIB and 107.24±0.92 mmHg in IIID, p>0.05) similar to SBP m/24 h noted a significantly reduction at 3 month follow-up: −4.8±0.96 mmHg in IM group versus −3.64±0.47 mmHg in IIB group and −12.08±0.63 mmHg in IIID group, p<0.001. The maximum reduction in DBP m/24 h were registered at 12 month follow-up, a comparative analyses of dynamics between groups showing a presence of statistical difference due to superiority of renal denervation treatment in amelioration of this parameter: −13.68±0.83 mmHg in IM group versus −10.72±0.64 mmHg in IIB group and −20.2±1.28 mmHg in IIID group, p<0.001. Conclusions The application of all three treatment regimens has been shown to be effective in reducing SBP and DBP values m/24 hours in patients with resistant hypertension, with a superior but comparable effect of Moxonidine to Bisoprolol and the absolute superiority of renal denervation treatment versus both pharmacological treatment regimens. Funding Acknowledgement Type of funding source: None
Background Recent studies have shown proven efficacy of renal denervation in arterial hypertension, but there is a continuing need to assess the duration of antihypertensive effect. Purpose Evaluation of the long-term antihypertensive effect of renal denervation in patients with resistant hypertension. Methods 125 apparently resistant patients without comorbidities after a 3-week standardized treatment with Losartan 100 mg, Amlodipin 10 mg and Indapamid 1.5 mg and confirmation of their resistance were randomly assigned into three groups depending on treatment supplemented to previously administered: group I - selective I1-imidazoline agonist Moxonidine, group II - cardioselective beta-blocker Bisoprolol and group III – renal artery denervation. The compliance to treatment was confirmed using 8-item Morisky Medication Adherence Scale. Renal denervation was performed in the main renal arteries and their branches. Patients were assessed by ambulatory blood pressure monitoring at baseline, 3, 12, 24 and 36 months follow-up. Results The mean 24 hour systolic blood pressure (SBP) at baseline were 179.0±2.02 mmHg in group I versus 177.96±2.44 mmHg in group II and 176.92±1.97 mmHg in group III, p>0.05. A statistically significant reduction in SBP m/24 h was noted in all three groups starting at 3 months, the group of patients undergoing renal denervation showing superiority over both groups of pharmacological treatment: −6.48±0.81 mmHg in group I versus −6.2±0.88 mmHg in group II and −23.28±1.9 mmHg in group III, p<0.001. The progressive improvement continued until the end of the study, so at 3 years of evaluation in observational group supplemented with Moxonidine SBP m/24 h were 146.36±1.36 mmHg with a total reduction of −32.64±1.56 mmHg from baseline, in Bisoprolol group −152.88±1.56 mmHg with a reduction of −25.08±1.65 mmHg and 133.16±0.73 mmHg in renal denervation group with a total reduction of −282±1.30 mmHg in group III, p<0.001. The mean 24 hour diastolic blood pressure (DBP) increased at baseline in all three observational groups (105.52±1.28 mmHg in group I versus 108.6±1.6 mmHg in group II and 107.24±0.92 mmHg in group III, p>0.05) similar with SBP m/24 h noted an authentic reduction at 3 months follow-up. The maximum reduction in DBP m/24 h were registered at 3 years of evaluation, a comparative analyses of dynamics between groups showing a presence of statistical difference due to superiority of renal denervation in amelioration of this parameter: −18.36±1.88 mmHg in group I versus −16.84±1.76 mmHg in group II and −28.2±1.30 mmHg in group III, p<0.001. Conclusions All three regimens have been shown to be effective in reducing SBP and DBP m/24 h in patients with resistant hypertension, with a superior but comparable effect of Moxonidine to Bisoprolol and the absolute superiority of renal denervation treatment, the beneficial effect being maintained for a period of 3 years. Funding Acknowledgement Type of funding sources: Public Institution(s). Main funding source(s): National Agency for Research and Development
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