Safety and Efficacy of Paclitaxel-Eluting Balloon Angioplasty for Dysfunctional Hemodialysis Access: A randomized trial Comparing with Angioplasty Alone.

PURPOSE: To assess whether angioplasty of hemodialysis access (HA) stenosis with a drug-coated balloon (DCB) would prevent restenosis in comparison with plain-balloon percutaneous transluminal angioplasty (PTA). MATERIALS AND METHODS: This prospective randomized clinical trial enrolled 120 patients with dysfunctional arteriovenous fistulae (n = 109) and grafts (n = 11), due to a ≥50% stenosis between March 2014 and April 2018. All patients underwent high-pressure balloon angioplasty and were then randomized to either DCB (n = 60) or PTA (n = 60). Patients were followed-up for 1 year, and angiography was performed 6 months after angioplasty. The primary endpoint was the late lumen loss (LLL) at 6 months. Secondary endpoints included other angiographic parameters at 6 months and HA failures, adverse event, and mortality at 12 months. Continuous variables were compared with a Student t-test, and Kaplan-Meier curves were used for freedom from HA failure and for mortality. RESULTS: LLL in the DCB and in the PTA group were 0.64 mm ± 1.20 and 1.13 mm ± 1.51, respectively (P = .082, adjusted P = .0498). DCB was associated with lower percentage stenosis (54.2% ± 19.3 vs 61.7% ± 18.2; P = .047) and binary restenosis ≥50% (56.5% vs 81.1%; P = .009) than PTA. The number of HA failures after 12 months was lower for DCB than for PTA (45% vs 66.7%; P = .017). Mortality at 12 months was 10% and 8.3% in the DCB and PTA groups, respectively (P = .75). CONCLUSIONS: Despite LLL improvement that failed to reach statistical significance, this study demonstrated decreased incidence and severity of restenosis with DCB compared with PTA to treat dysfunctional HA.

Results of a randomized clinical trial of external beam radiation to prevent restenosis after superficial femoral artery stenting.

OBJECTIVE: The objective of this study was to evaluate the safety and efficacy of external beam radiation (EBR) in preventing restenosis after superficial femoral artery (SFA) stenting in comparison with a control group treated with SFA stenting only. METHODS: In this Institutional Review Board-approved study, patients who provided written informed consent were randomly assigned to 0 Gy or 14 Gy of EBR to the stent site 24 hours after SFA stenting. The primary end point was the angiographic binary restenosis rate 2 years after stenting. Categorical and continuous end points were respectively analyzed using logistic regression models and Wilcoxon tests. End points expressed as time to event were analyzed using a log-rank test. RESULTS: The study included 155 patients, 46 women and 109 men (mean age, 66 years; range, 45-85 years). In the 0 and 14 Gy groups, binary restenosis was present, respectively, in 44% (34/77) and 68% (52/76; P = .003) 2 years after stenting. Stent thrombosis occurred in 13% (10/78) of the 0 Gy group and in 33% (25/77) of the 14 Gy group (P = .003). Target lesion revascularization at 2 years was 26% (25/78) in the 0 Gy group and 30% (23/77) in the 14 Gy group (P = .56). There were no significant differences in total walking distances change from baseline to 2 years (46 ± 100 and 26 ± 79 m, respectively, in the 0 Gy and 14 Gy group; P = .25). There were no procedure-related deaths and no major amputations. CONCLUSIONS: A single 14 Gy dose of EBR to the SFA stenting site did not prevent in-stent restenosis.

Value of C-Arm Computed Tomography to Evaluate Stent Deployment During Femoro-Popliteal Revascularization.

PURPOSE: To compare the accuracy of C-arm computed tomography (CT) and digital subtraction angiography (DSA) in detecting incomplete stent expansion (ISE) after superficial femoral artery (SFA) stenting using intravascular ultrasound (IVUS) as a gold standard. MATERIALS: Fifty patients with symptomatic SFA occlusive disease requiring angioplasty were prospectively included. Once technical success (<30 % residual stenosis) was obtained on post-procedural DSA, C-arm CT and IVUS were acquired. DSA and C-arm CT examinations were reviewed by 2 investigators and correlated with IVUS. C-arm CT image quality was rated on a four-point scale. Doppler ultrasound was performed at 1-year follow-up. RESULTS: The ankle-brachial index was 0.69 ± 0.10 and 0.99 ± 0.40, respectively, pre- and post-procedure. C-arm CT imaging quality was rated as good or excellent in 80%. In-stent minimal luminal diameter (MLD) was evaluated at 4.71 ± 0.7 mm on DSA, 3.39 ± 0.6 mm on IVUS, and 3.12 ± 0.9 mm on C-arm CT. Compared to IVUS, DSA demonstrated an overestimation of MLD (p = 0.0001), an underestimation of ISE (DSA = 18.8% ± 7.6; IVUS = 29.8% ± 9) (p < 0.0001), and a poor inter-technique intra-class correlation coefficient (ICC = 0.24). No difference was observed between IVUS and C-arm CT in ISE as calculated by diameter (29.8 ± 9 vs. 28.2 ± 12.5%, p = 0.5) and area (30.2 ± 8.4 vs. 33.3 ± 9.5%, p = 0.2). Inter-technique ICC between C-arm CT and IVUS was 0.72 [95%CI 0.49; 0.85] for MLA measurements. The inter-observer ICC for MLD and MLA measurements on C-arm CT were, respectively, estimated at 0.75 [95% CI 0.40, 0.89] and 0.77 [95% CI 0.43, 0.90)]. CONCLUSIONS: C-arm CT presents a better correlation with IVUS than DSA to determine lumen diameter and ISE immediately after percutaneous revascularization.

Effects of the high-density lipoprotein mimetic agent CER-001 on coronary atherosclerosis in patients with acute coronary syndromes: a randomized trial.

AIM: High-density lipoproteins (HDLs) have several potentially protective vascular effects. Most clinical studies of therapies targeting HDL have failed to show benefits vs. placebo. OBJECTIVE: To investigate the effects of an HDL-mimetic agent on atherosclerosis by intravascular ultrasonography (IVUS) and quantitative coronary angiography (QCA). DESIGN AND SETTING: A prospective, double-blinded, randomized trial was conducted at 51 centres in the USA, the Netherlands, Canada, and France. Intravascular ultrasonography and QCA were performed to assess coronary atherosclerosis at baseline and 3 (2-5) weeks after the last study infusion. PATIENTS: Five hundred and seven patients were randomized; 417 and 461 had paired IVUS and QCA measurements, respectively. INTERVENTION: Patients were randomized to receive 6 weekly infusions of placebo, 3 mg/kg, 6 mg/kg, or 12 mg/kg CER-001. MAIN OUTCOME MEASURES: The primary efficacy parameter was the nominal change in the total atheroma volume. Nominal changes in per cent atheroma volume on IVUS and coronary scores on QCA were also pre-specified endpoints. RESULTS: The nominal change in the total atheroma volume (adjusted means) was -2.71, -3.13, -1.50, and -3.05 mm(3) with placebo, CER-001 3 mg/kg, 6 mg/kg, and 12 mg/kg, respectively (primary analysis of 12 mg/kg vs. placebo: P = 0.81). There was also no difference among groups for the nominal change in per cent atheroma volume (0.02, -0.02, 0.01, and 0.19%; nominal P = 0.53 for 12 mg/kg vs. placebo). Change in the coronary artery score was -0.022, -0.036, -0.022, and -0.015 mm (nominal P = 0.25, 0.99, 0.55), and change in the cumulative coronary stenosis score was -0.51, 2.65, 0.71, and -0.77% (compared with placebo, nominal P = 0.85 for 12 mg/kg and nominal P = 0.01 for 3 mg/kg). The number of patients with major cardiovascular events was 10 (8.3%), 16 (13.3%), 17 (13.7%), and 12 (9.8%) in the four groups. CONCLUSION: CER-001 infusions did not reduce coronary atherosclerosis on IVUS and QCA when compared with placebo. Whether CER-001 administered in other regimens or to other populations could favourably affect atherosclerosis must await further study. Name of the trial registry: Clinicaltrials.gov; Registry's URL: http://clinicaltrials.gov/ct2/show/NCT01201837?term=cer-001&rank=2; TRIAL REGISTRATION NUMBER: NCT01201837.

Plexus network between internal mammary graft and pulmonary vasculature after coronary bypass grafting.

Left internal mammary artery to pulmonary vasculature fistulas are rare complications following coronary artery bypass grafting surgery. In symptomatic cases, management may either be conservative, or involve coil embolisation or surgical ligation of the fistula. We describe a 52-year-old male patient who suffered from an acute coronary syndrome due to significant stenosis of the right coronary artery 12 years after coronary artery bypass grafting surgery. Coronary angiography accidentally revealed a fistulous connection between the left internal mammary artery and the left pulmonary vasculature. The patient underwent percutaneous coronary intervention for his right coronary artery and was managed conservatively for his fistula.

Percutaneous coronary intervention on a single coronary artery: case report.

An isolated single coronary artery is a rare congenital anomaly and an uncommon finding in patients undergoing coronary angiography. In this report, we describe a rare case of a patient who had an anomaly of the left and right coronary arteries with a single coronary ostium in the right sinus of Valsalva, in which percutaneous coronary intervention was successfully performed in the right coronary artery.

A forme fruste of Shone's anomaly in a 65 year-old patient.

Shone's anomaly, a congenital cardiac malformation complex, consists of multiple levels of left heart obstruction. A rare case of an incomplete form of this anomaly discovered incidentally during cardiac catheterization for an unrelated event is described.

Effects of the antioxidant succinobucol (AGI-1067) on human atherosclerosis in a randomized clinical trial.

BACKGROUND: The antioxidant AGI-1067 was shown to reduce experimental atherosclerosis. The present study originally intended to study restenosis as a primary endpoint but was subsequently modified to primarily investigate the effects of AGI-1067 on coronary atherosclerosis. METHODS AND RESULTS: This placebo-controlled randomized trial assessed the effects of AGI-1067 280 mg qd started before percutaneous coronary intervention (PCI) and administered for 12 months after PCI on atherosclerosis progression as assessed by coronary intravascular ultrasound (IVUS). Among patients with IVUS examinations considered technically adequate both at baseline and follow-up upon central laboratory assessments (n=232), plaque volume was not significantly modified with placebo (least squares mean change: -0.4mm(3), P=0.85 versus baseline), but was significantly reduced by -4.0mm(3) at end of treatment in the AGI-1067 group (P=0.001 versus baseline, P=0.12 versus placebo). LDL-cholesterol varied by -9% and +4% in the placebo and AGI-1067 groups, respectively (P<0.05 between groups), and HDL-cholesterol was reduced by 1% with placebo and 14% with AGI-1067 (P<0.05 between groups). Plasma myeloperoxidase was reduced by 6% with AGI-1067 (P<0.05) but hs-CRP was not significantly different between groups. CONCLUSIONS: Atherosclerosis regression (-4.0mm(3)) was observed in patients treated with AGI-1067, although this was not significantly different from placebo. The anti-inflammatory effect of AGI-1067 is supported by reduced levels of myeloperoxidase.

Comparison of intravascular ultrasound and quantitative coronary angiography for the assessment of coronary artery disease progression.

BACKGROUND: The relative merits of quantitative coronary analysis (QCA) and intravascular ultrasound (IVUS) for the assessment of progression/regression in coronary artery disease are uncertain. To explore this subject further, we analyzed the angiographic and IVUS data derived from a contemporary clinical trial population. METHODS AND RESULTS: We investigated the relationships between QCA and IVUS at single time points (n=525) and also for the changes over time (n=432). QCA and IVUS data underwent central laboratory analyses. Statistically significant correlations were observed between the QCA coronary artery score and the IVUS-derived lumen volume (r=0.65, P<0.0001) and total vessel volume (r=0.55, P<0.0001) and between the QCA cumulative coronary stenosis score and percent atheroma volume on IVUS (r=0.32, P<0.0001) at baseline for matched segments. A similar pattern of correlations was observed for global (all segments) QCA-derived and single-vessel IVUS-derived data. There were statistically significant but weak correlations between the changes over time in lumen dimensions on QCA and IVUS (P=0.005) and between the change in cumulative coronary stenosis score on QCA and percent atheroma volume on IVUS (r=0.14, P=0.01). Nevertheless, patients with and without angiographic progression had changes in plaque volume on IVUS of 9.13 and 0.20 mm3, respectively (P=0.028). CONCLUSIONS: QCA- and IVUS-derived measures of lumen dimensions are correlated at single time points and for changes over time. Although the change in percent atheroma volume is only weakly correlated with QCA changes as continuous variables, disease progression on QCA is associated with significant increases in plaque volume on IVUS compared with no angiographic progression.

Effects of reconstituted high-density lipoprotein infusions on coronary atherosclerosis: a randomized controlled trial.

CONTEXT: High-density lipoprotein (HDL) cholesterol is an inverse predictor of coronary atherosclerotic disease. Preliminary data have suggested that HDL infusions can induce atherosclerosis regression. OBJECTIVE: To investigate the effects of reconstituted HDL on plaque burden as assessed by intravascular ultrasound (IVUS). DESIGN AND SETTING: A randomized placebo-controlled trial was conducted at 17 centers in Canada. Intravascular ultrasound was performed to assess coronary atheroma at baseline and 2 to 3 weeks after the last study infusion. PATIENTS: Between July 2005 and October 2006, 183 patients had a baseline IVUS examination and of those, 145 had evaluable serial IVUS examinations after 6 weeks. INTERVENTION: Sixty patients were randomly assigned to receive 4 weekly infusions of placebo (saline), 111 to receive 40 mg/kg of reconstituted HDL (CSL-111); and 12 to receive 80 mg/kg of CSL-111. MAIN OUTCOME MEASURES: The primary efficacy parameter was the percentage change in atheroma volume. Nominal changes in plaque volume and plaque characterization index on IVUS and coronary score on quantitative coronary angiography were also prespecified end points. RESULTS: The higher-dosage CSL-111 treatment group was discontinued early because of liver function test abnormalities. The percentage change in atheroma volume was -3.4% with CSL-111 and -1.6% for placebo (P = .48 between groups, P<.001 vs baseline for CSL-111). The nominal change in plaque volume was -5.3 mm3 with CSL-111 and -2.3 mm3 with placebo (P = .39 between groups, P<.001 vs baseline for CSL-111). The mean changes in plaque characterization index on IVUS (-0.0097 for CSL-111 and 0.0128 with placebo) and mean changes in coronary score (-0.039 mm for CSL-111 and -0.071 mm with placebo) on quantitative coronary angiography were significantly different between groups (P = .01 and P =.03, respectively). Administration of CSL-111 40 mg/kg was associated with mild, self-limiting transaminase elevation but was clinically well tolerated. CONCLUSIONS: Short-term infusions of reconstituted HDL resulted in no significant reductions in percentage change in atheroma volume or nominal change in plaque volume compared with placebo but did result in statistically significant improvement in the plaque characterization index and coronary score on quantitative coronary angiography. Elevation of HDL remains a valid target in vascular disease and further studies of HDL infusions, including trials with clinical end points, appear warranted. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00225719

Depression, C-reactive protein and two-year major adverse cardiac events in men after acute coronary syndromes.

BACKGROUND: We investigated the impact of depression and inflammatory markers, assessed 2 months after acute coronary syndrome (ACS), on major adverse cardiac events over 2 years (MACEs; cardiac death, survived myocardial infarction, survived cardiac arrest, and nonelective revascularization). METHODS: Depression symptoms (Beck Depression Inventory-II; BDI-II), major depression, C-reactive protein (CRP), interleukin-6, and soluble intercellular adhesion molecule were assessed in 741 ACS patients (including 602 men). RESULTS: Some 102 (78 men) experienced at least one MACE. Beck Depression Inventory-II scores of > or =14 predicted MACEs (p = .007). The increase in risk was marked in men (hazard ratio [HR] = 1.96, 95% confidence interval [CI] = 1.24-3.09, p = .004), with little evidence of a relationship in women (p = .85). Subsequent analyses were limited to men. Results were similar after covariate adjustment (HR = 1.72, 95% CI = 1.07-2.77, p = .024). C-reactive protein levels were also associated with increased MACE risk (adjusted HR for CRP > or = 2.0 mg/L = 1.67, 95% CI = 1.07-2.62, p = .025). C-reactive protein levels and BDI-II scores interacted in predicting MACEs. Men with both BDI-II scores of > or =14 and CRP of > or =2.0 mg/L experienced an increase in risk similar to those with only one of these factors. CONCLUSIONS: In men assessed 2 months after ACS, depression and CRP are overlapping prognostic risks. Patients with either risk may benefit from similar therapies.

Accuracy and rate of coronary artery segment visualization with CT angiography for the non-invasive detection of coronary artery stenoses.

OBJECTIVES: To evaluate CT coronary angiography (CTA) when compared with catheter coronary angiography (CCA), for the detection of coronary artery stenoses and rate of optimal coronary artery segment visualization. METHOD: Retrospective, two-center study enrolling 26 patients who underwent CCA and ECG-gated 16-detector CTA (slice thickness 0.6 mm; rotation 500 ms). RESULTS AND CONCLUSION: 283 segments were available for postprocessing. Sensitivity, specificity, and positive predictive value were, respectively, 80, 100, and 100%, for detecting more than 50% luminal stenoses, when optimally visualized segments were considered, in comparison to CCA. Negative predictive value was excellent (98%). Rate of non-optimally visualized coronary segments was 26%. Most clinical benefits of coronary CT angiography should probably be obtained when it is performed to exclude significant stenoses on selected populations of patients with a low pre-test probability of severe coronary artery disease, and under optimal conditions of controlled heart rate and minimal presence of calcium.

Importance of collateral circulation in coronary heart disease.

AIMS: Collateral arteries are a common but inconsistent finding in coronary heart disease (CHD). We endeavoured to review the methods for coronary artery collateral assessment, the predictors and clinical importance of collateral blood flow, and the potential for therapeutic augmentation of collateral anastomoses. METHODS AND RESULTS: While many methods have been used to assess collateral blood flow only a few have been formally validated. Collateral flow index, as determined by measurement of intra-coronary pressure or flow velocity, is the most robust measure of collateral flow. These techniques have led to important advances in our understanding of collateral artery function. Coronary collateral arteries may prevent myocardial ischaemia in healthy subjects and in patients with CHD. A functional collateral circulation may lead to reduced ischaemia, preservation of ventricular function, and an improved prognosis. Recent trials have demonstrated that vascular progenitor cell therapies may improve ventricular function following acute myocardial infarction, raising the possibility of effective biological treatments to improve myocardial blood flow and prognosis in CHD. CONCLUSIONS: Coronary collateral anastomoses represent a prognostically important adaptive response in patients with CHD. Therapeutic augmentation of collaterals with emerging biological therapies represents a desirable goal for treating CHD patients.

Role of angiography for the assessment of coronary artery disease in patients with diabetes mellitus.

Diabetes is associated with a two- to fourfold increase in cardiovascular morbidity and mortality, and clinical manifestations of atherosclerosis are the leading causes of death in diabetic populations. Because there are reports of benefits associated with active treatment of ischemia, including revascularization, findings from pathological and angiographic studies confirming more diffuse and distal atherosclerosis in diabetic patients highlight the value of angiography to define the optimal therapeutic strategy in these patients. While coronary angiography cannot be recommended as a screening test for asymptomatic or mildly symptomatic patients with diabetes, it should be emphasized that it is necessary to determine the severity of the underlying atherosclerotic disease, especially the presence of left main, three-vessel or proximal left anterior descending artery disease in patients deemed to be at moderate or high risk on the basis of the clinical evaluation and noninvasive testing. Angiography remains the only helpful modality in determining the suitability of the coronary vessels for either percutaneous interventions or surgical bypass when indicated.

External beam radiation to prevent restenosis after superficial femoral artery balloon angioplasty.

BACKGROUND: Femoropopliteal percutaneous transluminal angioplasty (PTA) remains limited by restenosis. Although vascular brachytherapy may be effective in reducing restenosis, external beam radiation would be more practical to administer after PTA. METHODS AND RESULTS: After femoropopliteal PTA without stent placement, 99 patients were randomly assigned to 0 Gy (placebo; n=24), 7 Gy (n=24), 10.5 Gy (n=26), or 14 Gy (n=25) of external beam radiation of the PTA site (with a 3-cm margin at both extremities) in 1 session 24 hours after PTA. The primary end point was minimum lumen diameter on quantitative angiography 1 year after PTA. One year after PTA, the mean minimum lumen diameter was 1.92, 1.64, 1.92, and 2.91 mm, respectively, for the 0-, 7-, 10.5-, and 14-Gy groups (P=0.0072 for 0 versus 14 Gy). Mean luminal loss was 1.14, 1.27, 1.08, and 0.14 mm, respectively, for the 4 groups (P=0.0072 for 0 versus 14 Gy). Restenosis >50% was present in 50%, 65%, 48%, and 25% of patients, respectively, for the 0-, 7-, 10.5-, and 14-Gy groups (P=0.072). At 18 months, repeated revascularizations were required in 25% of patients in the 0-Gy group versus 12% of patients in the 14-Gy group (P=0.24). CONCLUSIONS: A single session of external beam radiation of 14 Gy of the femoropopliteal angioplasty site significantly reduces restenosis at 1 year.

Sustained elevation of serum CD40 ligand levels one month after coronary angioplasty predicts angiographic restenosis.

BACKGROUND: Percutaneous coronary intervention induces an early inflammatory reaction. The intensity of such a reaction as measured by high-sensitivity C-reactive protein has been correlated with recurrent ischemic events, but its association with restenosis remains uncertain. OBJECTIVES: To characterize the type and duration of the postangioplasty inflammatory reaction and to identify new inflammatory markers correlating with restenosis. METHODS: Fifty-three consecutive patients who underwent successful balloon angioplasty were studied. Levels of specific inflammatory markers were measured before intervention, and at one-month and six-month follow-up. Six-month clinical and angiographic follow-up was conducted in all patients, and quantitative coronary analysis was systematically performed. RESULTS: Levels of soluble CD40 ligand (sCD40L) and matrix metalloproteinase-2 showed a rise and fall pattern over six months, with peak levels measured at one month (P < 0.0001), while levels of soluble vascular cell adhesion molecule-1 increased after angioplasty and remained elevated at six months (P = 0.07). Plasma levels of sCD40L at one month correlated with angiographic late loss (r = 0.48, P = 0.001) and were predictive of six-month restenosis (area under receiver operating characteristic curve 0.75 [95% CI 0.61 to 0.88]). CONCLUSIONS: The results imply that inflammation persists for at least one month following angioplasty and that future therapeutic interventions targeting inflammation to prevent restenosis should be active during this period. Furthermore, the ability of sCD40L levels to predict restenosis at six months may indicate the relevance of this pathway as a therapeutic target for restenosis prevention.

Effect of cholesterol lowering and cardiovascular risk factors on the progression of aortoiliac arteriosclerosis: a quantitative cineangiography study.

The post-Coronary Artery Bypass Graft (Post-CABG) trial has shown that aggressive compared to moderate lowering of low-density lipoprotein cholesterol (LDL-C) delayed the progression of obstructive disease in aortocoronary saphenous vein grafts and in the left main coronary artery. Patients had been allocated to high-and low-dose lovastatin therapy for a 4-5 year period. The present study evaluated the effect of LDL-C lowering and the role of cardiovascular risk factors on the progression of arteriosclerosis in the distal abdominal aorta and common iliac arteries. From one of the participating centers of the post-CABG trial, 145 patients who had adequate imaging of the aortoiliac arteries at baseline and follow-up were included. Angiographic outcomes, presumed to reflect progression of arteriosclerosis and obtained from lumen diameter (LD) measurements using quantitative cineangiography, were as follows: significant decrease of the minimum lumen diameter (LD) and increase of the maximum LD, percent lumen stenosis, and percent lumen dilatation. These outcomes were not significantly less frequent in patients randomly allocated to aggressive compared to moderate LDL-C lowering. Of 9 cardiovascular risk factors, only 2 were significantly related to progression of aortoiliac arteriosclerosis. Current smoking predicted both percent lumen stenosis increase and, to a lesser degree, percent lumen dilatation increase (p = 0.010 and p = 0.055, respectively). Abnormally high body mass index (BMI > or = 25 kg/m2) correlated with percent lumen dilatation increase (p = 0.006). Aggressive compared to moderate LDL-C lowering did not prevent or delay the progression of aortoiliac arteriosclerosis. Smoking predicted both lumen narrowing and dilatation presumably caused by arteriosclerosis. Abnormally high BMI, reflecting overweight or obesity, was strongly associated with vessel dilatation.

Long-term safety of intravascular ultrasound in nontransplant, nonintervened, atherosclerotic coronary arteries.

OBJECTIVES: The goal of this study was to demonstrate that intravascular ultrasound (IVUS) examination of native coronary arteries does not result in an acceleration of the atherosclerotic process. BACKGROUND: Intravascular ultrasound is increasingly used to assess the effects of pharmacologic agents on atherosclerosis. METHODS: Intravascular ultrasound examinations of one coronary artery and coronary angiography were performed in 525 patients at baseline. Patients then underwent a follow-up angiogram 18 to 24 months later. All end points were evaluated in IVUS-related and non-IVUS arteries using quantitative coronary analysis. The study end points were the coronary change score (per-patient mean of minimum lumen diameter changes for all lesions measured), occurrence of new coronary lesions, and progression of preexistent lesions at follow-up. Acute angiographic and clinical complications were also analyzed. RESULTS: Coronary change score was -0.06 +/- 0.23 mm and -0.05 +/- 0.21 mm for IVUS-related and non-IVUS arteries, respectively (p = 0.35). The increase in percent diameter stenosis from baseline to follow-up was 0.8 +/- 6.7% and 1.2 +/- 7.0% in the IVUS-related and non-IVUS arteries (p = 0.29). New lesions occurred in 3.6% and 3.9% of IVUS-related and non-IVUS arteries, respectively (p = 0.84). When all coronary lesions were considered, the incidence of lesion progression was not significantly different between IVUS-related (11.6%) and non-IVUS (9.8%) arteries. Coronary spasm occurred in 1.9% of IVUS procedures, and there was one case of acute occlusion with no long-term sequelae. CONCLUSIONS: Intravascular ultrasound does not significantly accelerate atherosclerosis in native coronary arteries and can be used safely to assess progression/regression in clinical trials.

Angiographic and clinical outcomes of polytetrafluoroethylene-covered stent use in significant coronary perforations.

Coronary perforations remain a rare but life-threatening complication of percutaneous coronary intervention. In the setting of complex coronary lesions, 14 of 25 consecutive perforations related to percutaneous coronary intervention were managed with stents covered with polytetrafluoroethylene (PTFE), and 11 were managed conventionally with reversal of anticoagulation and prolonged balloon inflation. Procedural success was achieved in 71.4% (10 of 14 perforations) of the PTFE arm compared with 27.3% (3 of 11 perforations) in the standard management arm (p = 0.047). Smaller final percent diameter stenosis and postprocedural cessation of dye extravasation were achieved with PTFE-covered stents. No delayed cardiac tamponade or in-hospital mortality was reported among patients in the PTFE group.