Magne Brekke

Stenting in chronic coronary occlusion (SICCO): A randomized, controlled trial of adding stent implantation after successful angioplasty

OBJECTIVES This study investigated whether stenting improves long-term results after recanalization of chronic coronary occlusions. BACKGROUND Restenosis is common after percutaneous transluminal coronary angioplasty (PTCA) of chronic coronary occlusions. Stenting has been suggested as a means of improving results, but its use has not previously been investigated in a randomized trial. METHODS We randomly assigned 119 patients with a satisfactory result after successful recanalization by PTCA of a chronic coronary occlusion to 1) a control (PTCA) group with no other intervention, or 2) a group in which PTCA was followed by implantation of Palmaz-Schatz stents with full anticoagulation. Coronary angiography was performed before randomization, after stenting and at 6-month follow-up. RESULTS Inguinal bleeding was more frequent in the stent group. There were no deaths. One patient with stenting had a myocardial infarction. Subacute occlusion within 2 weeks occurred in four patients in the stent group and in three in the PTCA group. At follow-up, 57% of patients with stenting were free from angina compared with 24% of patients with PTCA only (p < 0.001). Angiographic follow-up data were available in 114 patients. Restenosis (> or = 50% diameter stenosis) developed in 32% of patients with stenting and in 74% of patients with PTCA only (p < 0.001); reocclusion occurred in 12% and 26%, respectively (p = 0.058). Minimal lumen diameter (mean +/- SD) at follow-up was 1.92 +/- 0.95 mm and 1.11 +/- 0.78 mm, respectively (p < 0.001). Target lesion revascularization within 300 days was less frequent in patients with stenting than in patients with PTCA only (22% vs. 42%, p = 0.025). CONCLUSIONS Stent implantation improved long-term angiographic and clinical results after PTCA of chronic coronary occlusions and is thus recommended regardless of the primary PTCA result.

Adjusted Drug Treatment Is Superior to Renal Sympathetic Denervation in Patients With True Treatment-Resistant Hypertension

&NA; We aimed to investigate for the first time the blood pressure (BP)–lowering effect of renal sympathetic denervation (RDN) versus clinically adjusted drug treatment in true treatment-resistant hypertension (TRH) after excluding patients with confounding poor drug adherence. Patients with apparent TRH (n=65) were referred for RDN, and those with secondary and spurious hypertension (n=26) were excluded. TRH was defined as office systolic BP (SBP) >140 mm Hg, despite maximally tolerated doses of ≥3 antihypertensive drugs including a diuretic. In addition, ambulatory daytime SBP >135 mm Hg after witnessed intake of antihypertensive drugs was required, after which 20 patients had normalized BP and were excluded. Patients with true TRH were randomized and underwent RDN (n=9) performed with Symplicity Catheter System versus clinically adjusted drug treatment (n=10). The study was stopped early for ethical reasons because RDN had uncertain BP-lowering effect. Office SBP and diastolic BP in the drug-adjusted group changed from 160±14/88±13 mm Hg (±SD) at baseline to 132±10/77±8 mm Hg at 6 months (P<0.0005 and P=0.02, SBP and diastolic BP, respectively) and in the RDN group from 156±13/91±15 to 148±7/89±8 mm Hg (P=0.42 and P=0.48, SBP and diastolic BP, respectively). SBP and diastolic BP were significantly lower in the drug-adjusted group at 6 months (P=0.002 and P=0.004, respectively), and absolute changes in SBP were larger in the drug-adjusted group (P=0.008). Ambulatory BPs changed in parallel to office BPs. Our data suggest that adjusted drug treatment has superior BP lowering effects compared with RDN in patients with true TRH. Clinical Trial Registration— URL: http://www.clinicaltrials.gov. Unique identifier: NCT01673516

n-3 fatty acids do not prevent restenosis after coronary angioplasty: results from the CART study ☆

Abstract OBJECTIVES The aim of the study was to investigate whether omega-3 fatty acids (n-3 FA) reduce the occurrence of restenosis after percutaneous transluminal coronary angioplasty. BACKGROUND Meta-analyses have shown significant reduction of restenosis after coronary angioplasty upon supplementation with n-3 FA. METHODS In a prospective, placebo-controlled, double-blind study, 500 patients were randomly allocated to treatment with n-3 FA (Omacor™, Pronova AS, Oslo, Norway) 5.1 g/day or corn oil (placebo) starting at least two weeks prior to elective coronary angioplasty. The treatment was continued until restenosis evaluation by quantitative coronary angiography after six months. Stenosis was defined as a minimal luminal diameter (MLD) 50% or an increase in stenosis of ≥0.7 mm. Three-hundred ninety-two patients fulfilled the criteria for initial stenosis and successful coronary angioplasty, and, except four patients who died, none were lost for follow-up. RESULTS Restenosis occurred in 108/266 (40.6%) of the treated stenoses in the Omacor group and in 93/263 (35.4%) in the placebo group (odds ratio [OR] 1.25, 95% confidence interval [CI] [0.87–1.80] p = 0.21). In the Omacor group one or more restenoses occurred in 90/196 (45.9%) patients as compared with 86/192 (44.8%) in the placebo group (OR 1.05, 95% CI [0.69–1.59] p = 0.82). CONCLUSIONS Supplementation with 5.1 g n-3 FA/day for six months, initiated at least two weeks prior to coronary angioplasty did not reduce the incidence of restenosis.

Renal Sympathetic Denervation in Patients With Treatment-Resistant Hypertension After Witnessed Intake of Medication Before Qualifying Ambulatory Blood Pressure

&NA;It is unknown whether the decline in blood pressure (BP) after renal denervation (RDN) is caused by denervation itself or concomitantly improved drug adherence. We aimed to investigate the BP lowering effect of RDN in true treatment-resistant hypertension by excluding patients with poor drug adherence. Patients with resistant hypertension (n=18) were referred for a thorough clinical and laboratory work-up. Treatment-resistant hypertension was defined as office systolic BP>140 mm Hg, despite maximally tolerated doses of ≥3 antihypertensive drugs, including a diuretic. In addition, ambulatory daytime systolic BP>135 mm Hg was required after witnessed intake of antihypertensive drugs to qualify. RDN (n=6) was performed with Symplicity Catheter System. The mean office and ambulatory BPs remained unchanged at 1, 3, and 6 months in the 6 patients, whereas there was no known change in antihypertensive medication. Two patients, however, had a fall in both office and ambulatory BPs. Our findings question whether BP falls in response to RDN in patients with true treatment-resistant hypertension. Additional research must aim to verify potential BP lowering effect and identify a priori responders to RDN before this invasive method can routinely be applied to patients with drug-resistant hypertension. Clinical Trial Registration—URL: http://www.clinicaltrials.gov. Unique identifier: NCT01673516.

Mean HbA1c over 18 years predicts carotid intima media thickness in women with type 1 diabetes

Aims/hypothesisIntima media thickness (IMT) of the common carotid artery (CCA) is a validated surrogate marker of early atherosclerosis. The aim of our study was to assess the association between IMT in CCA and long-term mean HbA1c in type 1 diabetes. We also elucidated the association between carotid IMT and preclinical coronary atherosclerosis.MethodsIn 39 individuals with type 1 diabetes, HbA1c was measured prospectively over 18 years. The IMT examinations were performed with high-resolution ultrasound. The association between carotid IMT and preclinical coronary atherosclerosis (assessed by intravascular ultrasound [IVUS]) was tested in 29 of the patients.ResultsMean HbA1c over 18 years was 8.2% (range: 6.6–11.3%). Mean age at follow-up after 18 years was 43 years and mean duration of diabetes was 30 years. IMT was significantly higher in diabetic patients than in an age- and sex-matched reference population. The IMT values were at the same level as for controls who were 20 years older. In women, HbA1c was significantly associated with mean average CCA IMT (r2=0.77, p<0.0001 when adjusted for age), whereas there was no significant association for men. Among women, a significant association was also found between carotid IMT and the percentage of coronary vessel area stenosis (r=0.65, p=0.03).Conclusions/interpretationThe present findings suggest an important role of long-term hyperglycaemia in the development of atherosclerosis, especially in women with type 1 diabetes.Type 1 diabetes patients have earlier development of, and more advanced, atherosclerosis compared with an age- and sex-matched reference population. In women, carotid IMT reflects preclinical coronary atherosclerosis.

Intracoronary ultrasound examinations reveal significantly more advanced coronary atherosclerosis in people with type 1 diabetes than in age- and sex-matched non-diabetic controls

Aims/hypothesis: The extent of coronary atherosclerosis is significantly more advanced in symptomatic type 1 diabetes patients than in symptomatic non-diabetic patients. Whether this difference exists between asymptomatic individuals with diabetes and controls is not documented. In vivo imaging techniques allow quantification of the difference at a preclinical stage. Methods: The degree of coronary atherosclerosis in early onset type 1 diabetes patients without symptoms of cardiovascular disease was compared with that of age- and sex-matched controls. Intracoronary ultrasound (IVUS) examinations were performed to determine the degree of atherosclerosis. The mean age of the patients was 43 years (35–58), they had a mean duration of disease of 30 (23–39) years and the diagnosis of type 1 diabetes was made at a mean age of 12.5 years. The controls were people with transplanted hearts; donors were sex- and age-matched and had a mean age of 43 (35–58) years. Results: The degree of subclinical coronary atherosclerosis was significantly more severe in type 1 diabetes patients than in controls. This was the case for all parameters measured. The mean plaque area was ≥ 40% in 71% (54/76) of diabetic arteries as opposed to 33% (25/76) of arteries from controls (p<0.0001). The mean plaque thickness was 0.59±0.38 mm vs. 0.44±0.30mm in controls (p<0.0001). The mean lumen area was 8.6±3.8mm2 in type 1 diabetes and 12.1±4.3 mm2 in controls (p<0.0001). Conclusions/interpretation: Asymptomatic individuals with type 1 diabetes have significantly more advanced sub-clinical coronary atherosclerosis than controls. Coronary atherosclerosis in type 1 diabetes develops at an early age.

Elective Placement of Covered Stents in Native Coronary Arteries

Purpose: To study the feasibility of placing a polytetrafluoroethylene (PTFE)-covered stent graft into native coronary arteries and assess the complications and the restenosis rate. Material and Methods: Fifty consecutive patients with stable angina pectoris were included and the stent graft was placed into native coronary arteries. Clinical and angiographic follow-up were performed after 6 months. Results: The stent grafts were successfully placed in all patients. The mean reference diameter was 3.3 ± 0.6 mm. During follow-up the stent grafts occluded in patients after 1, 2 and 2.5 months and one more was occluded at 6 months. Three patients experienced myocardial infarction, 2 Q wave and one non-Q wave. After 6 months 42 (84%) patients had angina NYHA class 0 or 1. Target vessel revascularization was done in 11 cases for restenosis in the graft (n = 4), outside the graft (n = 3) and both (n = 4), giving a restenosis rate of 24%. The total major adverse coronary events at 6 months was 24%. Conclusion: The stent graft was deployed with a high success rate. The restenosis rate was not higher than expected for bare stents. However, this study showed that subacute occlusion may occur more frequently and we therefore recommend that ticlopidine or clopidogrel treatment should be prolonged to at least 3 months.

Predictors of restenosis after coronary angioplasty. A study on demographic and metabolic variables.

OBJECTIVE The major concern about percutaneous transluminal coronary angioplasty (PTCA) is the high incidence of restenosis. METHODS Demographic, clinical and biochemical data were recorded 2 weeks prior to PTCA in 388 patients fulfilling the criteria for initial stenosis, successful PTCA, and angiographic follow-up after 6 months. Restenosis was evaluated by quantitative coronary angiography. RESULTS Variables predictive of restenosis in univariate analysis were diabetes mellitus, male gender, and the levels of high density lipoprotein (HDL) cholesterol, apolipoprotein A1 (Apo A1) and thio-barbituric acid-reactive substances (TBARS). In trend analysis through quartiles TBARS and fasting glucose levels were significantly associated with restenosis (p = 0.016 and 0.044, respectively), whereas the negative predictivity of Apo A1 and HDL-cholesterol were of borderline significance. In multivariate analysis male gender and diabetes mellitus showed predictivity of significance, and a negative predictivity was also apparent for HDL-cholesterol. CONCLUSION We conclude that diabetes mellitus, male gender, and low HDL-cholesterol are predictors of restenosis 6 months after PTCA. In addition, TBARS may be a marker for the development of restenosis after PTCA.Objective - The major concern about percutaneous transluminal coronary angioplasty (PTCA) is the high incidence of restenosis. Methods - Demographic, clinical and biochemical data were recorded 2 weeks prior to PTCA in 388 patients fulfilling the criteria for initial stenosis, successful PTCA, and angiographic follow-up after 6 months. Restenosis was evaluated by quantitative coronary angiography. Results - Variables predictive of restenosis in univariate analysis were diabetes mellitus, male gender, and the levels of high density lipoprotein (HDL) cholesterol, apolipoprotein A1 (Apo A1) and thio-barbituric acid-reactive substances (TBARS). In trend analysis through quartiles TBARS and fasting glucose levels were significantly associated with restenosis (p = 0.016 and 0.044, respectively), whereas the negative predictivity of Apo A1 and HDL-cholesterol were of borderline significance. In multivariate analysis male gender and diabetes mellitus showed predictivity of significance, and a negative predictivity was also apparent for HDL-cholesterol. Conclusion - We conclude that diabetes mellitus, male gender, and low HDL-cholesterol are predictors of restenosis 6 months after PTCA. In addition, TBARS may be a marker for the development of restenosis after PTCA.

Impaired left ventricular function and myocardial blood flow reserve in patients with long-term type 1 diabetes and no significant coronary artery disease: associations with protein glycation.

Our aims were to study left ventricular (LV) function and myocardial blood flow reserve (MBFR) in long-term type 1 diabetes and associations with advanced glycation end products (AGEs). A total of 20 type 1 diabetes patients from the Oslo Study without significant stenosis on coronary angiography were compared with 26 controls. LV systolic and diastolic functions were assessed by two-dimensional strain and the ratio between pulsed Doppler transmitral early (E) velocity and tissue Doppler velocity (E′), respectively. MBFR was evaluated by contrast echocardiography. The AGE methylglyoxal-derived hydroimidazolone was analysed in serum. Glyoxal hydroimidazolone in skin collagen was determined by liquid chromatography-mass spectrometry. Strain was significantly reduced (−19.5% ± 1.9% vs −21.4% ± 3.5%, p < 0.05), and E/E′ increased in the diabetes patients compared to controls, 7.3 ± 2 versus 6.0 ± 1.5, p < 0.05. Significant lower MBFR was present in the diabetes patients, 3.4 (2.1, 5.3) versus 5.9 (3.9, 9.6), p < 0.01. Both AGEs correlated significantly with E/E′. The impaired LV function with correlation to AGEs in concert with reduced MBFR in diabetics without coronary artery disease may indicate possible mechanisms for diabetic cardiomyopathy.

LV systolic impairment in patients with asymptomatic coronary heart disease and type 1 diabetes is related to coronary atherosclerosis, glycaemic control and advanced glycation endproducts

To evaluate whether heart failure in type 1 diabetes is linked to poor glycaemic control, coronary atherosclerosis or advanced glycation endproducts (AGEs).