Arterial stenting and balloon angioplasty in ostial atherosclerotic renovascular disease: a randomised trial

BACKGROUND: Percutaneous transluminal angioplasty (PTA) for ostial atherosclerotic renal-artery stenosis has poor results. Angioplasty with stent placement (PTAS) may be more effective. We undertook a randomised prospective study to compare PTA with PTAS in patients with ostial atherosclerotic renal-artery stenosis. METHODS: Patients with ostial atherosclerotic renal-artery stenosis were assigned to receive PTA or PTAS. Secondary PTAS was allowed if PTA failed immediately or during 6 months' follow-up. Analysis was by intention to treat. FINDINGS: 42 patients were assigned PTA and 43 were assigned PTAS, but one patient in the PTAS group was excluded from the study. Primary success rate (<50% residual stenosis) of PTA was 57% (24 patients) compared with 88% (37 patients) for PTAS (difference between groups 31% [95% CI 12-50]). Complications were similar. At 6 months, the primary patency rate was 29% (12 patients) for PTA, and 75% (30 patients) for PTAS (46% [24-68]). Restenosis after a successful primary procedure occurred in 48% of patients for PTA and 14% for PTAS (34% [11-58]). 12 patients underwent secondary stenting for primary or late failure of PTA within the follow-up period: success was similar to that of primary PTAS. Evaluation based on intention to treat showed no difference in clinical results at six months for PTA or PTAS. INTERPRETATION: PTAS is a better technique than PTA to achieve vessel patency in ostial atherosclerotic renal-artery stenosis. Primary PTAS and primary PTA plus PTAS as rescue therapy have similar outcomes. However, the burden of reintervention after PTA outweighs the potential saving in stents, so primary PTAS is a better approach to use.     

The atherosclerotic Yucatan animal model to study the arterial response after balloon angioplasty: the natural history of remodeling

OBJECTIVE: Remodeling in de novo atherosclerosis and in restenosis after balloon angioplasty constitutes a change in total arterial circumference which, together with plaque growth or neointimal formation, determines the lumen of the artery. To better understand the fundamental biology of neointimal formation, remodeling and their interaction, animal studies are needed. In this study, we described in detail the methodology used and the natural history of neointimal formation and remodeling after balloon angioplasty in atherosclerotic Yucatan micropigs. METHODS AND RESULTS: Atherosclerosis was induced in 60 peripheral arteries of sixteen Yucatan micropigs by a combination of denudation and atherogenic diet. Balloon angioplasty was performed in 38 arteries, with serial intravascular ultrasound (IVUS) and quantitative angiography before and after intervention and at 2, 4, 7, 14 or 42 days follow-up. Remodeling, expressed as late media-bounded area (MBA) loss, increased progressively over time. At 42 days, late MBA loss after balloon angioplasty was significantly different compared to late MBA loss in control arteries, 2.2 +/- 1.0 versus -0.3 +/- 1.1 mm2 and p = 0.02. Late lumen loss increased over time and was highest at 42 days after balloon angioplasty (2.8 +/- 0.7 mm2). The contribution of neointimal formation to late lumen loss decreased over time and the contribution of late MBA loss to late lumen increased over time and was highest at 42 days (78%). Medial necrosis was 48% at two days after balloon angioplasty and the repopulation of the media was almost completed at seven days. CONCLUSION: Remodeling following balloon angioplasty has an early onset and progresses with neointimal formation to cause restenosis over the standard 42-day time course for Yucatan micropigs. This correlates to six months renarrowing in humans. In this model, atherosclerosis and the natural history of restenosis, both with respect to neointimal formation and remodeling, resemble the human disease quite closely.     

Coronary-artery stenting compared with balloon angioplasty for restenosis after initial balloon angioplasty. Restenosis Stent Study Group

BACKGROUND: Intracoronary stenting reduces the rate of restenosis after angioplasty in patients with new coronary lesions. We conducted a prospective, randomized, multicenter study to determine whether intracoronary stenting, as compared with standard balloon angioplasty, reduces the recurrence of luminal narrowing in restenotic lesions. METHODS: A total of 383 patients who had undergone at least one balloon angioplasty and who had clinical and angiographic evidence of restenosis after the procedure were randomly assigned to undergo standard balloon angioplasty (192 patients) or intracoronary stenting with a Palmaz-Schatz stent (191 patients). The primary end point was angiographic evidence of restenosis (defined as stenosis of more than 50 percent of the luminal diameter) at six months. The secondary end points were death, Q-wave myocardial infarction, bypass surgery, and revascularization of the target vessel. RESULTS: The rate of restenosis was significantly higher in the angioplasty group than in the stent group (32 percent as compared with 18 percent, P= 0.03). Revascularization of the target vessel at six months was required in 27 percent of the angioplasty group but in only 10 percent of the stent group (P=0.001). This difference resulted from a smaller mean (+/-SD) minimal luminal diameter in the angioplasty group (1.85+/-0.56 mm) than in the stent group (2.04+/-0.66 mm), with a mean difference of 0.19 mm (P=0.01) at follow-up. Subacute thrombosis occurred in 0.6 percent of the angioplasty group and in 3.9 percent of the stent group. The rate of event-free survival at 250 days was 72 percent in the angioplasty group and 84 percent in the stent group (P=0.04). CONCLUSIONS: Elective coronary stenting was effective in the treatment of restenosis after balloon angioplasty. Stenting resulted in a lower rate of recurrent stenosis despite a higher incidence of subacute thrombosis.     

Arterial remodeling after balloon angioplasty of the coronary artery: an intravascular ultrasound study. PICTURE Investigators. PostTreatment IntraCoronary Transluminal Ultrasound Result Evaluation

OBJECTIVE: Before balloon dilation, failure of compensatory enlargement and even arterial shrinkage are frequently observed at the lesion site in response to plaque accumulation. Balloon angioplasty may be regarded as artificial remodeling to enlarge the artery. The prevalence of the different types of arterial wall remodeling after applied stretch by balloon angioplasty is unknown. METHODS AND RESULTS: In 181 patients an intravascular ultrasound study was performed after coronary balloon angioplasty (n = 200 lesions). The vessel area was measured at a proximal and distal reference site and at the lesion site. Subsequently, the relative vessel area [(Vessel area lesion site)/Vessel area reference site) x 100] was calculated. Lesions were classified in three groups on the basis of their relative vessel areas: > or =105%, <105% but >95%, and < or =95%. A relative vessel area > or =105%, indicating enlargement compared with the reference site, was observed in 84 (44%) lesions. A relative vessel area <105% but >95% was observed in 43 (22%) lesions. A relative vessel area < or =95%, indicating "shrinkage" compared with the reference site, was observed in 66 (34%) lesions. CONCLUSIONS: After balloon angioplasty, the vessel area was found to be smaller compared with the reference site in 34% of the lesions. This small vessel area at the lesion site compared with a reference site may be a reflection of insufficient stretch by balloon angioplasty.     

The relation between de novo atherosclerosis remodeling and angioplasty-induced remodeling in an atherosclerotic Yucatan micropig model

Geometric remodeling in de novo atherosclerosis and in restenosis after balloon angioplasty constitutes a change in total arterial circumference that, together with plaque growth or neointima formation, determines the lumen of the artery. The heterogeneous nature of arterial obstructions raises the question of whether early and late outcomes (restenosis) of angioplasty are affected by the degree and direction of de novo atherosclerotic remodeling. This study was designed to assess the relationship between atherosclerotic remodeling and the degree and mechanism of restenosis after balloon angioplasty. Atherosclerosis was induced in 27 peripheral arteries of 18 Yucatan micropigs by a combination of denudation and atherogenic diet. Balloon angioplasty was performed, with serial intravascular ultrasound and quantitative angiography before and after intervention and at 42 days' follow-up. We used the relative media-bounded area (MBA), defined as the MBA of the treated site divided by the MBA of the reference, before angioplasty as a measure of remodeling in de novo atherosclerosis and late MBA loss as a measure of remodeling after balloon angioplasty. Relative MBA before angioplasty was not correlated with angiographic and echographic acute gain after balloon angioplasty (r=.22, P=.28 and r=.14, P=.48) or with late lumen loss (r=-.05, P=.81 and r=.19, P=.33). No correlation was found between relative MBA and late MBA loss (r=.14 and P=.48). In the atherosclerotic Yucatan micropig, remodeling during de novo atherosclerosis has no relevance for acute gain and late lumen loss after balloon angioplasty. Both the direction and the extent of remodeling after balloon angioplasty are not related to the direction and extent of remodeling during de novo atherosclerosis.     

Balloon angioplasty combined with primary stenting versus balloon angioplasty alone in femoropopliteal obstructions: A comparative randomized study

PURPOSE: The objective of this research is to describe aspects of the organization of adolescent sexual behavior in order to understand factors associated with risk for sexually transmitted diseases (STD). METHODS: Subjects were 82 females (ages 16-19 years; 77% African-American) participating in a larger STD study. Subjects completed diaries for each coital event, recording date of event, partner initial, condom use, and use of drugs or alcohol before intercourse. Partner change was defined as any event for which the sex partner initials differed from those listed for the most recent previous coital event. RESULTS: The 82 subjects recorded 1265 coital events; the average span of the records was 10 weeks. Intercourse was least likely on Sundays (154 of 1265; 12.2%) and most common on Friday and Saturday (221 of 1265 for each day; 17.5%). The proportion of coital events associated with drugs or alcohol increased from Sunday to Saturday, although the proportion of coital events in which a condom was used did not vary significantly. Intercourse was most common in spring and summer, and least frequent in winter. CONCLUSIONS: These data indicate substantial temporal organization of adolescent sexual behaviors that may be related to risk of sexually transmitted diseases. Some STD-preventive interventions may be most effective when targeted to higher risk times.     

Comparison of balloon angioplasty versus debulking devices versus stenting in right coronary ostial lesions

Angioplasty of aorto-ostial stenosis is associated with lower procedural success and a higher complication rate. The aim of the present study was to compare the acute and long-term results of balloon and new device angioplasty in 110 consecutive patients with right coronary ostial lesions. Patients were divided into 3 groups according to the angioplasty device used: group I (balloon only, n = 26), group II (debulking devices including excimer laser, directional and rotational atherectomy, n = 26), group III (stent, n = 58). Procedural success was highest in group III (96%) followed by group I (88%), and group II (77%). In-hospital complications were similar among the groups (p = NS). Patients in group III achieved the highest acute gain (2.61 mm) followed by groups II (1.92 mm), and I (1.39 mm, p <0.05). During follow up, target lesion revascularization and/or bypass surgery was required in 24% of patients in group III compared with 47% and 40% in groups I and II, respectively (p <0.05). Cardiac-event free survival was highest in the stent group (74%, p <0.005) and was similar between the balloon (39%) and debulking device groups (45%). Thus, among the currently available technologies, stenting of right coronary ostial lesions appears to provide excellent angiographic and long-term results.     

Effects of locally administered argatroban on restenosis after balloon angioplasty: experimental and clinical study

1. This study was undertaken to evaluate the preventive effects of locally administered argatroban, a competitive inhibitor of thrombin-induced platelet activation, on restenosis after balloon angioplasty. 2. A hydrogel-coated balloon catheter was immersed three times in argatroban/saline solution (1 mg/mL) for 60 s, inflated to a pressure of 606 kPa and left in the rabbit common carotid artery for 1 min. The same procedure was performed, without drug, as a control. The pharmacokinetics of delivered argatroban in the arterial wall were assessed using [14C]-argatroban. Platelet deposition 2 h after balloon injury was quantified by fluorescence studies using antiplatelet antibody. Vascular smooth muscle cell (VSMC) proliferation 3 days after balloon injury was assessed by immunohistochemical staining for proliferative cell nuclear antigen (PCNA). In a clinical study, we divided 50 elective patients into two groups: argatroban and control. 3. In the experimental study, the mean quantities of argatroban at 0, 2 and 6 h after deflation were 24.63, 0.49 and 0.11 nmol/g wet weight of artery, respectively. Argatroban was undetected 24 h after deflation. Two hours after deflation, argatroban-treated arteries showed less platelet adhesion than saline-treated controls. The mean number of PCNA-positive cells was 16.9 and 43.8% in the argatroban and control groups, respectively (P < 0.01). In the clinical study, the mean late gain loss was 8.2 and 27.3% in the argatroban and control groups, respectively (P < 0.05). The mean late restenosis rate was 11.1 and 41.4% in the argatroban and control groups, respectively (P < 0.05). 4. These data suggest that blood coagulation plays a significant role in VSMC proliferation after balloon injury and that locally administered argatroban using hydrogel-coated balloon catheter may prevent post-percutaneous transluminal coronary angioplasty restenosis.     

Effect of the antioxidant Nicanartine on the proliferative and inflammatory response after experimental balloon angioplasty

BACKGROUND: Antioxidant treatment seems to reduce the development of restenosis after percutaneous transluminal angioplasty. In this study, the effect of Nicanartine, a new antioxidant drug with both antiproliferative and lipid-lowering properties, on the proliferative and inflammatory response after balloon angioplasty was investigated in a rabbit model of restenosis. METHODS: To induce pre-interventional plaques in the common carotid artery of 48 New Zealand White rabbits, electrostimulation was carried out for 28 days. After a break of 7 days, balloon angioplasty was performed in 36 animals, of which 18 received Nicanartine at a dose of 120 mg/kg body weight; the other 18 served as a control group. The vessels were excised by day 7 and 28 after balloon angioplasty and examined for intimal plaque size, macrophage content and proliferative activity. Bromodeoxyuridine labeling was used to determine proliferating cells in the dilated segment; macrophages were detected using the RAM-11 antibody. RESULTS: In the Nicanartine-treated group, immunohistological quantification 7 days after intervention showed a statistically significant (P< 0.05) reduction of both cells undergoing DNA synthesis (1.6+/-1.4% versus 3.7+/-2.2%) and intimal macrophages (0.7+/-1.2% versus 1.3+/-0.6%). Twenty-eight days after balloon angioplasty, proliferative activity in both groups was decreased to a level comparable to the non-dilated control groups. A clear trend towards smaller plaques could be seen in the Nicanartine group (0.146+/-0.077 mm2 versus 0.255+/-0.174 mm2). Total cholesterol levels did not differ significantly between the groups. CONCLUSION: Under treatment with Nicanartine a clear reduction in the proliferative and inflammatory response after balloon angioplasty was observed. Antioxidant treatment, especially with compounds having antiproliferative and lipid-lowering properties, appears to be an effective secondary preventive strategy after interventional treatment in patients with coronary artery disease.     

Endovascular beta-irradiation after percutaneous transluminal coronary balloon angioplasty

PURPOSE: Intraluminal beta-irradiation has been shown to markedly decrease fibrointimal proliferation after arterial injury in experimental models. With the aim of reducing the incidence of restenosis after percutaneous transluminal coronary angioplasty (PTCA), we undertook a pilot clinical evaluation to assess both the technical feasibility and the clinical safety of this treatment after balloon coronary angioplasty. METHODS AND MATERIALS: Between June 21 and November 15, 1995, 15 patients (6 women and 9 men, aged 72 +/- 5 years) underwent intracoronary beta-irradiation immediately after a conventional PTCA procedure. Both the PTCA and irradiation procedure were done in a conventional catheterization laboratory, using an endoluminally centered pure metallic 90Y source, a newly developed technique of intracoronary beta-irradiation. This was done after documenting the ability of the system to generate reproducible dose delivery to the arterial wall. RESULTS: Both the PTCA and the irradiation procedure were technically feasible in all attempted cases, and a dose of 18 Gy was delivered with a local exposure time of 391 +/- 206 s (range 153-768). In four patients, the intervention was completed by intraarterial stent implantation because of dissection induced by the initial PTCA. No in-hospital complications occurred, and serial creatine kinase measurements remained within the normal range in all cases. CONCLUSION: Our early experience thus suggests that reliable and reproducible dose delivery can be achieved, and that coronary endoluminally centered beta-brachytherapy is both feasible and safe on a short-term basis in the clinical setting. Whether this novel mode of therapy will favorably influence post-PTCA restenosis in patients, as it does in experimental models, must await long-term angiographic follow-up of the present series as well as further clinical study.     

Restenosis and remodeling after percutaneous transluminal carotid angioplasty

INTRODUCTION: The characteristics of restenosis and remodeling after carotid percutaneous transluminal angioplasty (PTA) were badly known. OBJECTIVE: To describe these characteristics in our series of carotid PTA. PATIENTS AND METHODS: A total of 78 cases of PTA for symptomatic > 70% atherosclerotic stenosis of the extracranial internal carotid artery, were selected from our series of PTA if follow-up was > 12 months. All of them were followed with extracranial continuous-wave Doppler. RESULTS: Restenosis of any degree was found in 17 cases (21.79%) and always asymptomatic. A restenosis > or = 70% was found in 5 cases (6.4%). Restenosis was mainly found in cases without residual stenosis nor dissection after PTA (p = 0.002). Restenosis was found in 16 cases (94.11%) in the first 6-months, with no progression thereafter. Remodeling of residual stenosis was frequent (17 cases; 53.11%) and found mainly during the first month after PTA. Its incidence was highest in patients with dissection treated with heparin. In cases with restenosis, remodeling was infrequent, incomplete and occurred after 18-24 months. CONCLUSIONS: 1. Significant restenosis after PTA due to myointimal proliferation, was infrequent. All cases were asymptomatic, under antiplatelet treatment. A new interventional procedure might not be necessary. 2. Complete remodeling was frequently found after 1-month control, mainly in arteries with some residual stenosis and dissection after PTA.     

Randomized comparison of coronary stenting with balloon angioplasty in selected patients with acute myocardial infarction

BACKGROUND: Although the benefits of primary angioplasty in acute myocardial infarction have been demonstrated, several areas for improvement remain. Therefore, a prospective randomized trial comparing primary stenting with balloon angioplasty in patients with acute myocardial infarction was conducted. METHODS AND RESULTS: Patients with acute myocardial infarction were randomly assigned to undergo either primary stenting (n=112) or balloon angioplasty (n=115). The clinical end points were death, recurrent infarction, subsequent bypass surgery, or repeat angioplasty of the infarct-related vessel. The overall mortality rate at 6 months was 2%. Recurrent infarction occurred in 8 patients (7%) after balloon angioplasty and in 1 (1%) after stenting (P=0.036). Subsequent target-vessel revascularization was necessary in 19 (17%) and 4 (4%) patients, respectively (P=0.0016). The cardiac event-free survival rate in the stent group was significantly higher than in the balloon angioplasty group (95% versus 80%; P=0.012). CONCLUSIONS: In selected patients with acute myocardial infarction, primary stenting can be applied safely and effectively, resulting in a lower incidence of recurrent infarction and a significant reduction in the need for subsequent target-vessel revascularization compared with balloon angioplasty.     

Enhanced monocyte tissue factor response after experimental balloon angioplasty in hypercholesterolemic rabbit: inhibition with dietary L-arginine

BACKGROUND: There is evidence that tissue factor (TF) is a major contributor to the thrombogenicity of a ruptured atherosclerotic plaque. Nitric oxide (NO) has antiatherogenic and antithrombotic properties. We investigated whether L-arginine (L-arg), the endogenous precursor of NO, might affect the ability of monocytes to produce TF. METHODS AND RESULTS: We studied TF expression in 18 rabbits with atherosclerosis induced by bilateral iliac damage and 10 weeks of a 2% cholesterol diet. Six weeks after the initiation of the diet, an angioplasty was performed. After angioplasty, the surviving rabbits (n=15) were randomized to receive L-arg (2.25%) supplementation in drinking water (L-arg group, n=8) or no treatment (untreated group, n=7). TF expression was evaluated in mononuclear cells from arterial blood in the presence and absence of endotoxin stimulation. Monocyte TF expression, as assessed with an amidolytic assay, did not differ significantly before or after the induction of atherosclerotic lesions (87+/-15 versus 70+/-12 mU of TF/1000 monocytes, P=NS). Endotoxin-stimulated TF activity increased significantly 4 weeks after angioplasty (138+/-22 versus 70+/-12 mU of TF/1000 monocytes, P=0.02). This increase was blunted by L-arg (43+/-16 mU of TF/1000 monocytes, P=0.01). CONCLUSIONS: This study demonstrates that angioplasty-induced plaque rupture is associated with a marked increase in monocyte TF response that is blunted by the oral administration of L-arg. This suggests that the documented antithrombotic properties of NO may be related in part to an inhibitory effect on monocyte TF response.     

Anti-atherogenicity in women does not prevent restenosis after balloon angioplasty

To test the hypothesis that anti-atherogenicity in women exerts beneficial effects to prevent restenosis formation after coronary angioplasty, we studied 493 men (988 lesions) and 81 women (159 lesions), aged 40-60 years, who had undergone successful balloon angioplasty and had follow-up angiography, 4.9 +/- 4.1 months later. We compared the extent of restenosis between men and women, and between pre- and post-menopausal women, which was assessed by a categorical definition of restenosis (more than 50% diameter stenosis at follow-up) and by percent diameter measured immediately after angioplasty and at follow-up. Hypertension was more frequent in women and a significantly lower percentage of women smoked. In women, the levels of total cholesterol and low-density lipoprotein cholesterol were higher. The location of dilated lesions, frequency of angioplasty for lesions with chronic total occlusion, and frequency of emergency angioplasty in patients with unstable angina or acute myocardial infarction were similar in men and women. Restenosis formation, estimated by the categorical definition or percent diameter, did not differ between men and women, or between pre- and post-menopausal women. Menopausal status or sex was not an independent predictor of restenosis by multivariate analysis. Thus, the benefit of anti-atherogenicity in women does not play an important role in preventing restenosis after coronary angioplasty.     

Follow-up study after intracranial percutaneous transluminal cerebral balloon angioplasty

BACKGROUND AND PURPOSE: Our objective was to find the specific angiographic characteristics of atherosclerotic lesions that indicate suitability for intracranial percutaneous transluminal cerebral balloon angioplasty (PTCBA). METHODS: Forty-two clinically symptomatic patients with 42 hemodynamically significant intracranial lesions (>70% stenosis) were treated by PTCBA between January 1992 and May 1996. Before treatment, the patients were assigned to three groups according to the angiographic characteristics of the lesions, as follows: type A, short (5 mm or less in length) concentric or moderately eccentric lesions less than totally occlusive; type B, tubular (5 to 10 mm in length), extremely eccentric or totally occluded lesions, less than 3 months old; and type C, diffuse (more than 10 mm in length), extremely angulated (>90 degrees) lesions with excessive tortuosity of the proximal segment, or totally occluded lesions, and 3 months old or older. The patients were followed up for a period of 1 month to 6 years to compare the results of PTCBA treatment among the three groups. Primary end points were death, stroke, or bypass surgery. RESULTS: The clinical success rates for the type A, B, and C groups were 92%, 86%, and 33%, respectively. Cumulative risks of fatal or nonfatal ischemic stroke or ipsilateral bypass surgery in type A, B, and C groups were 8%, 26%, and 87%, respectively. The cumulative risk of 8% among patients in the type A group appeared to be smaller than in studies reported in the literature. CONCLUSION: PTCBA for intracranial simple (type A) lesions yields a favorable clinical outcome for symptomatic patients.     

Risk factors for restenosis after balloon angioplasty in focal iliac stenosis

BACKGROUND: The risk factors for restenosis after angioplasty have not yet been established because of the inconsistencies among treated lesions, differences in the techniques used, and variable end points. We evaluated the predictive variables relating to postangioplasty restenosis. METHODS: One hundred sixty-one transluminal balloon angioplasties were studied in 138 consecutive patients with focal iliac arterial stenosis (< or = 4 cm) caused by arteriosclerosis between January 1981 and December 1995. Restenosis was diagnosed on the basis of recurrent symptoms associated with an apparent drop in the ankle-brachial pressure index and angiographic visualization of restenosis. RESULTS: Being younger than 60 years (risk ratio 2.585) and poor runoff (risk ratio 2.328) were found to be important variables predicting restenosis by the Cox regression model. The restenosis-free patency rates were significantly better in patients older than 60 years of age (p = 0.0242), with good distal runoff (p = 0.0487), and without diabetes (p = 0.0111). CONCLUSIONS: Being younger than 60 years of age and poor distal runoff are important predictors of restenosis after iliac balloon angioplasty.     

Restenosis rates in diabetic patients: a comparison of coronary stenting and balloon angioplasty in native coronary vessels

BACKGROUND: Diabetes is a major risk factor for restenosis after coronary balloon angioplasty. Recent studies have shown that coronary stenting significantly reduces restenosis compared with balloon angioplasty alone. However, limited information is available on the effect of coronary stenting in diabetic patients. METHODS AND RESULTS: We designed this study to analyze the effect of diabetes on restenosis in patients treated with either balloon angioplasty or coronary stenting who were enrolled in a 6-month angiographic follow-up program. Three hundred consecutive patients, 19% of whom were diabetics, who underwent coronary stent implantation during a single-vessel procedure on native coronary vessels and who had 6-month angiographic follow-up constituted the study group (stent group). Three hundred consecutive patients who underwent 6-month angiographic follow-up after single-vessel conventional balloon angioplasty served as control patients (balloon group). Preprocedural, postprocedural, and follow-up angiograms were analyzed with quantitative angiography. In the balloon group, the restenosis rate was almost twofold higher in diabetic than in nondiabetic patients (63% versus 36%; P=.0002) owing to both a greater late loss (0.79+/-0.70 versus 0.41+/-0.61 mm, respectively; P<.0001) and a higher rate of late vessel occlusion (14% versus 3%, respectively; P<.001). In the stent group, restenosis rates were similar in diabetics and nondiabetics (25% versus 27%, respectively). Furthermore, in the stent group, late loss (0.77+/-0.65 versus 0.79+/-0.57 mm, respectively) and the rate of late vessel occlusion (2% versus 1%, respectively) did not differ significantly between diabetic and nondiabetic patients. CONCLUSIONS: Although diabetics have increased rates of restenosis and late vessel occlusion after simple balloon angioplasty, they have the same improved outcome with coronary stenting that has been documented in nondiabetic patients.     

A cost comparison of balloon angioplasty and stenting versus endarterectomy for the treatment of carotid artery stenosis

PURPOSE: Percutaneous transluminal angioplasty with stenting (PTAS) of the carotid artery has been advocated as an alternative treatment for high-grade stenosis. Rationale for this approach includes less morbidity, shorter recovery, and lower cost when compared with carotid endarterectomy (CEA). METHODS: The clinical results and hospital charges of patients who underwent elective treatment for carotid stenosis were reviewed. During a concurrent 14-month period, 218 patients were admitted 229 times for 234 procedures for the treatment of 239 carotid bifurcation stenoses, 109 by PTAS and 130 by CEA. Hospital charges were reviewed for each hospitalization and were categorized according to radiology, operating room, cardiac catheterization laboratory, and all other hospital charges. RESULTS: The combined incidence of postprocedure strokes and deaths were: PTAS, eight strokes (7.7%) and one death (0.9%); CEA, two strokes (1.5%) and two deaths (1.5%). Total hospital charges per admission for the two groups were $30,140 for PTAS and $21,670 for CEA. The average postprocedure length of stay for PTAS was 2.9 days (median, 2 days) and for CEA was 3.1 days (median, 3 days). Cardiac catheterization laboratory charges for the PTAS group were $12,968, whereas the operating room charges for the CEA group were $4263. When hospitalizations that were extended by complications were excluded, the average total charges for the PTAS group (n = 84) dropped to $24,848 (mean length of stay, 1.9 days) and for the CEA group (n = 111) to $19,247 (mean length of stay, 2.6 days). CONCLUSIONS: After evaluating hospital charges, PTAS for the treatment of carotid stenosis cannot currently be justified on the basis of reduced costs alone. With future cost-containing measures, total hospital charges can be reduced in both groups.