Influence of a nonionic, iso-osmolar contrast medium (iodixanol) versus an ionic, low-osmolar contrast medium (ioxaglate) on major adverse cardiac events in patients undergoing percutaneous transluminal coronary angioplasty: A multicenter, randomized, double-blind study. Visipaque in Percutaneous Transluminal Coronary Angioplasty [VIP] Trial Investigators.

BACKGROUND: The potential merits and disadvantages of the use of ionic or nonionic contrast media in patients undergoing percutaneous transluminal coronary angioplasty (PTCA) have been the subjects of controversy. The present study was designed to evaluate the possible influence of both types of contrast media on major adverse cardiac events (MACE) in patients undergoing PTCA. METHODS AND RESULTS: In a randomized, parallel-group, double-blind study, 1411 patients received either iodixanol (a nonionic, iso-osmolar contrast medium) or ioxaglate (an ionic, low-osmolar contrast medium) during PTCA. A standardized anticoagulation regimen was followed. Patients were monitored in the hospital for 2 days and followed-up at 1 month. The primary end point, a composite of MACE (death, stroke, myocardial infarction, coronary artery bypass grafting, and re-PTCA) after 2 days, occurred in 4.3% of the total population, with no statistically significant difference between groups (iodixanol, 4.7%; ioxaglate, 3.9%; P=0.45). Further, between 2-day and 1-month follow-ups, no significant difference (P=0.27) existed between the groups in the rates of MACE. Hypersensitivity reactions (P=0.007) and adverse drug reactions (P=0.002) were significantly less frequent in the iodixanol group. The only significant predicting factors for the occurrence of MACE were dissection/abrupt closure and country. CONCLUSIONS: No significant differences were observed between the iodixanol and ioxaglate groups with regard to MACE, although hypersensitivity and adverse drug reactions were significantly less frequent in patients who received iodixanol.

Biocompatibility of polymer-coated oversized metallic stents implanted in normal porcine coronary arteries.

Polymer coatings have been suggested to decrease the thrombogenicity of metallic intravascular stents. The purpose of the present study was to investigate the intimal response to two different polymers when used as coatings for stents implanted in normal porcine coronary arteries. Non-articulated stainless steel-slotted tube stents were coated with either a biodegradable poly(organo)phosphazene with amino-acid ester side groups or a biostable polyurethane prepared from an amphiphilic polyether, dephenylmethane-4,4'-diisocyanate and butane diol as chain extender. In order to induce vascular wall injury, the stents were deployed using an oversized balloon. At 6 weeks follow-up, the angiographic luminal diameter measured in four polyurethane-coated stents and in six bare metallic stents was similar and 20% less than immediately post-stenting. However, in four polyphosphazene-coated stents the difference was 65% (P = 0.01 when compared to bare metal). At post-mortem morphometry the degree of luminal area stenosis was also similar in polyurethane-coated and in bare metallic stents (32 +/- 7.6% vs. 39 +/- 14%, NS) but reached 81 +/- 19% in polyphosphazene-coated stents (P < 0.03 when compared to bare metal). Thus, poly(organo)phosphazene induced a more pronounced histiolymphocytic and fibromuscular reaction than amphiphilic polyurethane, which appeared to be promising as biocompatible stent coating and, consequently, as a potential carrier for vasoactive drugs.

An updated meta-analysis of calcium-channel blockers in the prevention of restenosis after coronary angioplasty.

BACKGROUND: In 1994, a meta-analysis of 5 small randomized trials reported a 30% reduction in the odds of angiographic restenosis when calcium-channel blockers (CCB) were given after percutaneous coronary intervention. Recently, the results of 2 large similar trials (Nisoldipine In Coronary Artery Disease in Leuven [NICOLE], and Coronary AngioPlasty Amlodipine in REstenosis Study [CAPARES]) were published. An extended meta-analysis including the results of the latter trials was performed. METHODS: A total of 2380 patients were analyzed. Statistical analysis included calculation of odds ratios for each trial, common odds ratio, and homogeneity for treatment effects across trials. RESULTS: The incidence of angiographic restenosis was 36% in the CCB-treated group and 42% in the placebo group. The odds ratio of restenosis with CCB therapy was 0.78 (95% CI 0.64-0.95) compared with control patients (P =.01). Treatment effects were homogeneous across the trials. For the combined end point of death, coronary artery bypass grafting, repeat percutaneous transluminal coronary angioplasty, and myocardial infarction, 126 of 626 events occurred in the CCB group and 191 of 655 in the placebo group (odds ratio 0.61 [95% CI 0.47-0.80], P <.001). CONCLUSIONS: This extended meta-analysis confirmed a reduction in the odds of restenosis and clinical events when CCBs were added to standard therapy after percutaneous coronary intervention.

Platelet survival in patients with angiographically diseased and normal coronary arteries.

Platelets may contribute to the pathogenesis of atherosclerosis and to the complications of coronary artery disease. Therefore, platelet kinetics were studied in 69 patients with angiographically documented coronary artery disease and in 16 patients with a normal coronary angiogram. Platelet survival time was calculated from the decay of radioactivity after injection of 51Cr-labeled autologous platelets. None of the mathematical models used was able to discriminate between the two patients groups. No correlation existed between survival time and extent of the arterial disease. Patients with a high serum cholesterol did not exhibit an enhanced platelet consumption. Thus, these studies do not support the idea that turnover is enhanced in patients with coronary artery disease as compared to those with normal coronary arteries.

Usefulness of the Wiktor stent for treatment of threatened or acute closure complicating coronary angioplasty. The European Wiktor Stent Study Group.

The purpose of this study was to determine the results of the first Wiktor stent implantations in bailout conditions. From December 1990 to July 1991, in a total of 10 centers, 69 patients presenting with threatened or total closure after balloon angioplasty each received the Wiktor stent in 1 coronary artery. In these 69 coronary arteries, a total of 72 stent deliveries were attempted and 69 were successful (delivery success rate 95%). Delivery failure was treated conservatively in 2 patients and surgically in 1 patient. Emergency surgery was also performed in 2 patients, who after successful stent delivery showed progressive distal extension of the dissection. In addition, 5 patients underwent elective surgery to avoid the possibility of stent thrombosis because the myocardial area at risk was considered too large. Postprocedural blood transfusion was performed in 6% of the patients, whereas stent thrombosis occurred in 10 of 59 patients (17%), resulting in 2 deaths. Finally, 65% of the patients had a successful stent implantation without major periprocedural complications. At 6-month follow-up, only 9% of the patients experienced recurrent angina, whereas a > 50% arterial diameter narrowing was observed in 27% of the patients. Thus, the radiopaque Wiktor stent can be accurately and conveniently implanted in dissected coronary arterial segments. However, as for similar bailout devices, the number of thrombotic and bleeding events remains high.

Angina pectoris and coronary artery disease in severe aortic regurgitation.

A consecutive series of 198 patients (148 men and 50 women, mean age 51 years, range 18 to 76) with pure, isolated, severe aortic regurgitation was retrospectively studied to determine the prevalence of angiographically significant coronary artery disease (CAD) and its relation to angina pectoris and coronary risk factors. Significant CAD (coronary diameter stenoses greater than 50%) was found in 28 patients (14%). Typical angina was present in 18% and atypical chest pain in 16%. Angina alone had a sensitivity of 57% to detect significant CAD. The predictive accuracy of a positive history of angina was 46% and that of a negative test 93%. By using multivariate logistic regression, a risk score could be calculated that increased the sensitivity to 74% at equal specificity. Almost 40% of the total population had a risk score of less than -2.9 (only 1 patient in this group had CAD). It is concluded that coronary arteriography can safely be omitted in many patients with severe aortic regurgitation if they have no symptoms of myocardial ischemia or risk factors known to increase its incidence.

Frequency of angina pectoris and coronary artery disease in severe isolated valvular aortic stenosis.

A consecutive series of 192 patients (121 men and 71 women, mean age 59 years, range 28 to 82) with isolated, severe valvular aortic stenosis was with isolated, severe valvular aortic stenosis was analyzed retrospectively to determine the relation of angina pectoris and coronary risk factors to angiographically significant coronary artery disease (CAD). Significant CAD (diameter reduction greater than or equal to 50%) was found in 47 patients (24%). Angina was present in 83% of them, but it was also found in 61% of the non-CAD patients. This symptom had as a result a low positive predictive value (31%). Of the patients without angina (n = 65) 12% had significant CAD. The negative predictive value of angina alone was thus 88%. By using multivariate logistic regression, a risk score could be calculated based on angina, age and sex, which increased the negative predictive value to 95%. It was concluded that coronary arteriography can only be omitted in severe aortic valvular stenosis, when patients have no angina and when they are less than 40 years of age for men and less than 50 years for women. For all other cases, coronary arteriography should be recommended.

Coronary arterial lesions in young men who survived a first myocardial infarction: clinical and electrocardiographic predictors of multivessel disease.

An analysis was made of clinical and electrocardiographic prognostic determinants of multiple vessel disease in 100 men, aged under 45 years, who survived a myocardial infarction. All patients underwent selective coronary arteriography within 1 year after sustaining a myocardial infarction. Multivessel disease was present in 64 patients; 33 patients had single vessel disease and 3 had either normal coronary arteries or minimal lesions. Exercise stress testing, electrocardiographic location of the infarction, total serum cholesterol and clinical features including body build, arterial blood pressure, smoking habits, family history of coronary artery disease and the presence of angina pectoris either before or after the acute event proved to be poor predictors of multiple vessel disease. Only 74 percent of the patients were correctly classified by a discriminant function analysis. Thus, for prognostic reasons, coronary arteriography seems warranted in young patients after acute myocardial infarction, even in the absence of residual angina or multiple risk factors.

Normalized first derivative ofthe left apex cardiogram in assessment of left ventricular function.

The relation between the left displacement apex cardiogram and the left ventricular pressure during isovolumic contraction was studied in 30 patients with cardiac disease. Using the instantaneous relation between the first time derivative and the magnitude of both the left apex cardiogram and the left ventricular pressure, normalized derivatives were obtained. These noramized velocities were correlated with each other and with several indexes of left ventricular function. The normalized derivatives of the left apex cardiogram (dD/dt/D) and the left ventricular pressure (dP/dt/P) were similar in magnitude, standard deviation and variation coefficient. No such similarity was present when the first time derivatives of each tracing (dD/dt and dP/dt) were compared. A highly significant relation was found between normalized displacement velocity and normalized pressure velocity using both total (r = 0.76, P less than 0.001) and developed (r = 0.75, P less than 0.001) displacement and pressure. Significant correlations with several other indexes of left ventricular function (end-diastolic pressure, peak dP/dt, maximal velocity of the contractile elements at zero load[Vmax]) were also observed. It is concluded that the index dD/dt/D of the left apex cardiogram is an important noninvasive tool for assessing left ventricular function in man.

Immediate and short-term results of a 1988-1989 coronary angioplasty registry.

To determine the relevance of recent refinements in angioplasty technology to our particular practice, the records of 507 consecutive patients undergoing a first percutaneous transluminal coronary angioplasty (PTCA) at our center between October 1988 and May 1989 were reviewed. At the time of PTCA, 41% of these patients had class IV angina and 44% were identified as having multivessel disease. Dilatation was attempted in 734 lesions (mean 1.5 per patient), of which 95 (13%) were chronic total occlusions. Overall, 69% of the 734 lesions were judged anatomically complex, and, in dilating these lesions, a rail-type device was used almost exclusively. Successful dilatation was achieved in 659 of the 734 (90%) attempted lesions. There were low incidences of the major complications of death (0.4%), myocardial infarction (1.8%) and emergency bypass surgery (1.8%). Acute rethrombosis occurred in 54 patients (11%). In these patients, initial strategy of repeat dilatation was successful in 38 of 47 patients (81%). Overall, primary clinical success at PTCA was achieved in 480 patients (95%). At a mean follow-up of 7.5 +/- 1.5 months in 497 of the study patients, the event-free rate (freedom from cardiac death, myocardial infarction, repeat PTCA or coronary bypass surgery or recurrence of severe [class III to IV] angina) was 71%. In conclusion, despite the often complex coronary disease in patients currently presenting to our center, a high initial success rate and acceptable short-term outcome of PTCA was achieved.

Ridogrel in the setting of percutaneous transluminal coronary angioplasty.

The safety of the combination of heparin and ridogrel therapy and its antiplatelet efficacy was examined in the setting of percutaneous transluminal coronary angioplasty (PTCA). In 32 patients without known aspirin intake for 10 days before PTCA, therapy with ridogrel (300-mg intravenous bolus) was begun just before PTCA and continued orally at a dose of 300 mg twice daily until discharge. Heparin was administered as a 10,000 IU bolus dose before PTCA and followed by an intravenous infusion at a rate of 1,000 IU/hour for 24 hours. Bleeding problems at the arterial entry site occurred in 13 patients, which required a blood transfusion in only 2 patients. One patient underwent emergency bypass surgery without specific problems of hemostasis. Ridogrel virtually eliminated thromboxane B2 from the serum (29,990 +/- 6,555 pg/0.1 ml before vs 63 +/- 7 pg/0.1 ml at 2 hours after ridogrel), with a concomitant increase in serum 6-keto-prostaglandin F1 alpha (511 +/- 34 pg/0.1 ml before vs 1,190 +/- 146 pg/0.1 ml at 24 hours after ridogrel). There were no acute reocclusions in the ridogrel-treated patients, whereas acute reocclusions occurred in 5.6% of the patients taking the standard aspirin + heparin regimen during the same period. Furthermore, at 6-month clinical follow-up patients treated with ridogrel compared favorably with those receiving standard treatment.

Effect of intravenous diltiazem on myocardial ischemia occurring during percutaneous transluminal coronary angioplasty.

To investigate the antiischemic efficacy of intravenously administered diltiazem, 42 patients were randomly allocated to receive placebo or active treatment before 1-vessel percutaneous transluminal coronary angioplasty (PTCA). The development of myocardial ischemia was studied using subjective (pain) and objective (electrocardiography) parameters. Pretreatment with intravenous diltiazem resulted in a significantly delayed onset of ischemic pain and ST-segment elevation; these variables also returned to baseline earlier after balloon deflation. Thus, intravenous diltiazem prevents or delays the onset of myocardial ischemia during repetitive transient coronary occlusions; improvement of the myocardial blood flow distal to the coronary occlusion or impedance of calcium entry into the ischemic cell are considered as possible mechanisms. Because PTCA is increasingly used in patients with poor left ventricular function and more extensive disease, and because recent evidence suggests that better PTCA results could be obtained by the use of longer inflation times, the addition of diltiazem to the classic armamentarium could be beneficial.

Coronary hemodynamics and coronary flow reserve after intracoronary diltiazem in humans.

To analyze the effect of the calcium antagonist diltiazem on coronary hemodynamics, epicardial coronary artery diameter, coronary blood flow and coronary blood flow velocity were assessed at baseline and after a 0.5 mg intracoronary bolus of diltiazem in nonstenotic coronary arteries of awake humans. Patients (n = 20) were first randomized to pretreatment with either placebo (n = 10) or isosorbide dinitrate (0.5 microgram/kg/min infusion; n = 10), and coronary flow reserve was measured before and after administration of diltiazem. There were significant increases in epicardial coronary artery diameter (10%; p = 0.0001) and coronary blood flow (30%; p = 0.0001) in all patients after administration of diltiazem. Whereas basal coronary blood flow velocity increased only slightly (7%; p = not significant), there was a significant decrease in coronary flow reserve (10%; p = 0.004). Increases in coronary diameter and blood flow after diltiazem were comparable in patients pretreated with placebo or nitrates. However, the decrease in coronary flow reserve was significant only in patients pretreated with placebo (19%; p = 0.0008). This reduction in coronary flow reserve could be due to "raising the floor" (increased baseline coronary blood flow) or "lowering the ceiling" (reduction of maximal coronary blood flow).

Angiographic predictors of recurrence of restenosis after Wiktor stent implantation in native coronary arteries.

Intracoronary stenting has been proposed as an adjunct to balloon angioplasty to improve the immediate and long-term results. However, late luminal narrowing has been reported following the implantation of a variety of stents. One of the studies conducted with the Wiktor stent is a prospective registry designed to evaluate the feasibility, safety and efficacy of elective stent implantation in patients with documented restenosis of a native coronary artery. To identify angiographic variables predicting recurrence of restenosis, the angiograms of the first 91 patients with successful stent implantation and without clinical evidence of (sub)acute thrombotic stent occlusion were analyzed with the Computer Assisted Angiographic Analysis System using automated edge detection. The incidence of restenosis was 44% by patient and 45% by stent according to the 0.72 mm criterion, and 30% by patient and 29% by stent according to the 50% diameter stenosis criterion. The risk for restenosis for several angiographic variables was determined using an univariate analysis and is expressed as odds ratio with corresponding confidence interval. The only statistically significant predictor of restenosis was the relative gain when it exceeded 0.48 using the 0.72 mm criterion (odds ratio 2.7, 95% confidence interval 1.1-6.4). Furthermore, the relation between the relative gain (increase in minimal luminal diameter normalized to vessel size) as angiographic index of vessel wall injury and relative loss (decrease in minimal luminal diameter normalized to vessel size) as index of neointimal thickening was analyzed using a linear regression analysis. When using the categorical approach to address restenosis, there is an increased risk for recurrent restenosis when the relative gain exceeds 0.48. The continuous approach underscores this concept by indicating a weak but positive relation between the relative gain and relative loss.

Wiktor stent implantation in patients with restenosis following balloon angioplasty of a native coronary artery.

Intracoronary stenting has been introduced as an adjunct to balloon angioplasty aimed at overcoming its limitations, namely acute vessel closure and late restenosis. This study reports the first experience with the Wiktor stent implanted in the first 50 consecutive patients. All patients had restenosis of a native coronary artery lesion after prior balloon angioplasty. The target coronary artery was the left anterior descending artery in 26 patients, the circumflex artery in 7 patients and the right coronary artery in 17 patients. The implantation success rate was 98% (49 of 50 patients). There were no procedural deaths. Acute or subacute thrombotic stent occlusion occurred in 5 patients (10%). All 5 patients sustained a nonfatal acute myocardial infarction. Four of these patients underwent recanalization by means of balloon angioplasty; the remaining patient was referred for bypass surgery. A major bleeding complication occurred in 11 patients (22%): groin bleeding necessitating blood transfusion in 6, gastrointestinal bleeding in 3 and hematuria in 2. Repeat angiography was performed at a mean of 5.6 +/- 1.1 months in all but 1 patient undergoing implantation. Restenosis, defined by a reduction of greater than or equal to 0.72 mm in the minimal luminal diameter or a change in diameter stenosis from less than to greater than or equal to 50%, occurred in 20 (45%) and 13 (29%) patients, respectively. In this first experience, the easiness and high technical success rate of Wiktor stent implantation are overshadowed by a high incidence of subacute stent occlusion and bleeding complications.(ABSTRACT TRUNCATED AT 250 WORDS)

Immediate and follow-up results of the conservative coronary angioplasty strategy for unstable angina pectoris.

To assess the results of a conservative coronary angioplasty strategy in unstable angina pectoris, the records of 1,421 consecutive patients without previous myocardial infarction undergoing a first percutaneous transluminal coronary angioplasty (PTCA) between 1986 and 1990 were reviewed. Of these patients, 631 had unstable and 790 had stable angina pectoris. Only after an intense effort to medically control symptoms, the unstable patients underwent PTCA at an average of 15.4 days (range 1 to 76) after hospital admission. Primary clinical success was achieved in 91.7% of patients with unstable and in 94.4% of those with stable angina pectoris (p = not significant). In-hospital mortality rates were 0.3 and 0.1%, respectively (p = not significant). Nonfatal in-hospital event rates for acute myocardial infarction, cerebrovascular accident and coronary bypass surgery were only slightly higher in patients with unstable angina pectoris; however, the difference from the stable group was significant when all events were combined (9 vs 5.9%; p less than 0.04). During 6-month follow-up, no significant difference in adverse events was found between the groups. The respective rates for the unstable and stable groups were 0.4 and 0.2% for death, 5.5 and 5.1% for major nonfatal events, and 17.7 and 20.1% for repeat PTCA. These results suggest that use of a conservative PTCA strategy in the treatment of patients with unstable angina pectoris results in favorable and similar immediate and 6-month outcomes compared with those in patients with stable angina pectoris.

Usefulness of Nisoldipine for prevention of restenosis after percutaneous transluminal coronary angioplasty (results of the NICOLE study). NIsoldipine in COronary artery disease in LEuven.

The NIsoldipine in COronary artery disease in LEuven (NICOLE) study investigates (1) whether nisoldipine, a dihydropyridine calcium antagonist, reduces the progression of minor coronary arterial lesions in the long term, and (2) whether it reduces the restenosis rate after successful percutaneous transluminal coronary angioplasty (PTCA). The NICOLE study is a single-center, randomized, double-blind trial in 826 patients, who underwent a successful PTCA. Nisoldipine 40 mg coat-core or placebo was started the morning after the procedure and continued for 3 years. All coronary arterial segments were measured on preprocedural angiogram and on the second follow-up angiogram at 3 years. On the first follow-up angiogram at 6 months only the dilated segments were measured. Although the study is still ongoing until the primary end point is reached, we report in this study the angiographic restenosis data as well as the clinical events observed at 6-month follow-up. The per-protocol population consisted of 646 patients. Restenosis, defined as a > or =50% loss of the initial gain (National Heart, Lung, and Blood Institute criterion IV) occurred in 49% and 55% of the 308 nisoldipine-treated and the 338 placebo-treated patients, respectively (p = NS). At follow-up, the rates of death and myocardial infarction were low and similar in both groups, but in the nisoldipine group, less patients required early coronary angiography (18% vs 26%, p = 0.006) and subsequent revascularization procedures (32% vs 41%, p = 0.057). Thus, nisoldipine did not significantly reduce the angiographic restenosis rate after PTCA, but reduced the number of repeat revascularization procedures, which may be due to its antianginal action.

Local methylprednisolone inhibition of foreign body response to coated intracoronary stents.

BACKGROUND: When poly(organo)phosphazene coated metallic stents are implanted into normal coronary arteries of pigs a severe histolymphocytic and fibromuscular reaction is induced. Corticosteroids possess potent anti-inflammatory and immunosuppressive effects, they have been shown to decrease migration and functional capability of the cells of inflammation and they may stabilize lysosomal cell membranes. This study aims to evaluates the feasibility and efficacy of local corticosteroid delivery by implantation of methylprednisolone loaded coronary stents into coronary arteries of pigs. METHODS: Tantalum balloon expandable coronary stents were coated with poly(organo)phosphazene impregnated with 5 wt% methylprednisolone. Methylprednisolone release was calculated in vitro and then randomly either a methylprednisolone loaded stent or a plain polymercoated stent was implanted into the right coronary artery of 20 pigs. Quantitative coronary artery analysis was done before, immediately after and 6 weeks after stent implantation. The pigs were then killed and the stented arteries processed for histopathological and morphometric evaluation. RESULTS: In-vitro testing revealed that the methylprednisolone loaded stents, when incubated in physiological saline, released 96% of the drug within 24 h. Quantitative angiography of the implanted stents showed similar angiographic parameters in both treatment groups immediately after implantation, but, after 6 weeks of follow-up study the minimal luminal diameter of the stented arterial segment was considerably larger in the methylprednisolone-treated pigs than it was in the control pigs (2.74 +/- 0.34 versus 1.36 +/- 0.72 mm, P < 0.005) This angiographic finding was confirmed at post-mortem morphometry where the respective values for neointimal thickness were 0.99 +/- 0.28 and 1.74 +/- 0.84 mm (P < 0.02). CONCLUSIONS: Polymer coated stents can be loaded with methylprednisolone which inhibits the severe foreign-body reaction induced by the combination of overstretch injury and the poly(organo)phosphazene polymer coating of metallic stents.

The brachial approach for intracoronary stent implantation.

Aggressive anticoagulation after intracoronary stent implantation leads to an increased incidence of femoral hematomas and vascular complications. Out of 74 Medtronic Wiktor stent implantations, six were performed via right brachial artery cut-down. All six attempts were successful without stent closure, bleeding or vascular complications. We feel that intracoronary Wiktor stent implantation via the brachial approach is feasible. The open artery repair and uninterrupted anticoagulation may be an interesting advantage.

Intraarterial biocompatibility of polyethylene terephthalate self-expandable stents implanted in porcine peripheral arteries.

RATIONALE AND OBJECTIVES: We tested deployment feasibility and intraarterial biocompatibility of polyethylene terephthalate (PET) self-expandable vascular stents in a porcine peripheral artery model. METHODS: To assess the thrombogenicity and neointimal response to oversized PET self-expandable stents, we implanted 10 stents in porcine common iliac arteries, followed by a 6-mm balloon inflation to 6 atm. RESULTS: All pigs survived until the study termination 6 weeks after stent implantation. Control angiography revealed stent closure in three pigs. Minimal stent luminal diameter (MSLD) was measured using a semiautomated edge detection algorithm. The difference in MSLD after stent implantation and at control after 6 weeks was not significant (4.9 +/- 0.5 mm-->4.7 +/- 1.0 mm). Histopathologic examination showed signs of thrombotic occlusion and revascularization in occluded stents. In patient stents only a mild fibromuscular neointimal response was seen. CONCLUSION: PET self-expandable stents implanted in porcine iliac arteries are possibly thrombogenic but do not lead to a significant neointimal response.