Effects of coronary stenting on vessel patency and long-term clinical outcome after percutaneous coronary revascularization in diabetic patients

OBJECTIVES: We sought to compare coronary stent implantation with balloon angioplasty (BA), in a diabetic population, in terms of the six-month angiographic outcome and four-year clinical events. BACKGROUND: Diabetic patients have a poor angiographic and clinical outcome after standard coronary BA. To date, it is still unclear whether stent implantation may improve this outcome. METHODS: We investigated this issue by individual matching of 314 diabetic patients treated with either coronary stenting or standard BA. These two groups were derived from a population of consecutive diabetic patients (1993 to 1996). Matching criteria were gender, anti-diabetic regimen, stenosis location, reference diameter, and minimal luminal diameter (+/-0.4 mm). One lesion per patient was considered for matching. RESULTS: Baseline characteristics were similar between the two groups of 157 patients. At six months, the rates of restenosis (27% vs. 62%; p < 0.0001) and occlusion (4% vs. 13%; p < 0.005) were lower in the stent group than in the BA group. This was associated with a significant decrease in ejection fraction at six months in the BA group (p = 0.02) while, during the same period, no change was observed in the stent group (p = NS). Subgroup analysis demonstrated that angiographic benefit was consistent among the subgroups. At four years, the combined clinical end point of cardiac death and non-fatal myocardial infarction was lower in the stent group (14.8% vs. 26.0%; p = 0.02), as was the need for repeat revascularization (35.4% vs. 52.1%; p = 0.001). CONCLUSIONS: In a population of diabetic patients, coronary stent implantation was associated with a highly beneficial effect on the six-month angiographic outcome and four-year clinical events compared with standard BA.     

Predictive value of preprocedural fibrinogen concerning coronary stenting

Elevated fibrinogen levels after coronary balloon angioplasty have been reported to be useful in predicting restenosis. Therefore, we sought to evaluate the relationship between preprocedural fibrinogen levels and the 6-12-month outcomes of patients undergoing coronary stenting. Plasma levels of fibrinogen were measured in 390 consecutive patients prior to coronary stenting. The primary end point was binary restenosis (percent diameter stenosis of >/=50%). The secondary combined end point was death due to cardiac causes, myocardial infarction related to the target vessel and target lesion revascularization. Patients were grouped into tertiles according to fibrinogen levels. Both at baseline and immediately after procedure, clinical and angiographic characteristics were almost identical in the fibrinogen tertiles. An increase in restenosis rate was observed across the tertiles (18.6, 23.9, 38.1%, P<0.001, respectively). In addition, the frequency of the secondary end point increased in the highest tertile (14.9, 21.5, 37.2%, P<0.001, respectively). Multivariate analysis revealed that high levels of fibrinogen (per 100 mg/dl, OR 1.82, P<0.001) and stent length (P=0.034) were independent predictors for restenosis. An elevated preprocedural fibrinogen level should be considered as a stronger predictor for restenosis after coronary stenting, which might be associated with coagulation and inflammation.     

Immunosuppressive Therapy for the Prevention of Restenosis after Coronary Artery Stent Implantation (IMPRESS Study)

OBJECTIVES: This study tested the effect of oral prednisone on clinical and angiographic restenosis rate after successful stent implantation in patients with persistent elevation of systemic markers of inflammation after the procedure. BACKGROUND: Experimental studies have shown that corticosteroids have the potential to reduce the inflammatory response associated with stent implantation. METHODS: Eighty-three patients undergoing successful stenting with C-reactive protein (CRP) levels >0.5 mg/dl 72 h after the procedure were randomized to receive oral prednisone or placebo for 45 days. The primary clinical end point was 12-month event-free survival rate (defined as freedom from death, from myocardial infarction, and from recurrence of symptoms requiring additional revascularization). The angiographic end points were restenosis rate and late loss at six months. RESULTS: Twelve-month event-free survival rates were 93% and 65% in patients treated with prednisone and placebo, respectively (relative risk [RR] 0.18, 95% confidence intervals [CI], 0.05 to 0.61, p = 0.0063). Six-month restenosis rate and late loss were lower in prednisone-treated than in placebo-treated patients (7% vs. 33%, p = 0.001, and 0.39 +/- 0.6 mm vs. 0.85 +/- 0.6 mm, p = 0.001, respectively). CONCLUSIONS: In patients with persistently high CRP levels after successful coronary artery stent implantation, oral immunosuppressive therapy with prednisone results in a striking reduction of clinical events and angiographic restenosis rate.     

Local intracoronary administration of antisense oligonucleotide against c-myc for the prevention of in-stent restenosis: results of the randomized investigation by the Thoraxcenter of antisense DNA using local delivery and IVUS after coronary stenting (ITALICS) trial.

OBJECTIVE: This study was designed to determine whether antisense oligodeoxynucleotides (ODN) directed against the nuclear proto-oncogene c-myc could inhibit restenosis when given by local delivery immediately after coronary stent implantation. BACKGROUND: Failure of conventional pharmacologic therapies to reduce the incidence of coronary restenosis after percutaneous revascularization techniques has prompted interest in the use of agents that target intracellular central regulatory mechanisms. METHODS: Eighty-five patients were randomly assigned to receive either 10 mg of phosphorothioate-modified 15-mer antisense ODN or saline vehicle by intracoronary local delivery after coronary stent implantation. The primary end point was percent neointimal volume obstruction measured by computerized analysis of electrocardiogram-gated intravascular ultrasound (IVUS) at six-month follow-up. Secondary end points included clinical outcome and quantitative coronary angiography analysis. RESULTS: Analysis of follow-up IVUS data was performed on 77 patients. In-stent volume obstruction was similar between groups (44 +/- 16% and 46 +/- 14%, placebo vs. ODN; p = 0.57; 95% confidence interval: -1.13 to 0.85). Minimum luminal diameter increased from 0.84 +/- 0.36 and 0.90 +/- 0.45 (p = 0.55) to 2.70 +/- 0.37 and 2.80 +/- 0.37 (p = 0.28) after stent implantation, which decreased to 1.50 +/- 0.61 and 1.50 +/- 0.53 (p = 0.98) by six months, yielding similar loss indexes (placebo vs. ODN, respectively). There were no differences in angiographic restenosis rates (38.5 and 34.2%; p = 0.81; placebo vs. ODN) or clinical outcome. CONCLUSIONS: Treatment with 10 mg of phosphorothioate-modified ODN directed against c-myc does not reduce neointimal volume obstruction or the angiographic restenosis rate in this patient population.     

Comparison of effects of drug-eluting stents versus bare metal stents on plasma C-reactive protein levels

After coronary stenting, inflammatory mechanisms play a crucial role in the pathogenesis of neointimal proliferation and in-stent restenosis. Drug-eluting stents (DESs) have been shown to decrease in-stent restenosis in different studies. We compared plasma C-reactive protein (CRP) levels after DES implantation with levels after bare metal stent (BMS) implantation. We performed percutaneous coronary intervention with a single stent in 67 patients (54 men; 59 +/- 9 years of age; n = 21 in the BMS group, n = 46 in the DES group) who had stable angina. Plasma CRP levels were determined before intervention and at 48 hours, 72 hours, and 2 weeks after coronary stenting. There was no difference in clinical and angiographic baseline characteristics except that the DES group had more patients with diabetes (34.8% vs 9.5%, p = 0.04), smaller reference vessels (2.95 +/- 0.53 vs 3.29 +/- 0.53 mm, p = 0.02), and smaller stent diameters (3.0 +/- 0.4 mm vs 3.4 +/- 0.5 mm, p <0.01). Plasma CRP levels at 48 hours (13.4 +/- 14.7 vs 5.9 +/- 4.9 mg/L, p <0.01) and 72 hours (16.7 +/- 19.8 vs 5.4 +/- 3.9 mg/L, p <0.01) after stent implantation were significantly higher in the BMS than in the DES group. In conclusion, DESs showed significantly lower plasma CRP levels after coronary stenting compared with BMSs. This may reflect the potent effects of DESs on acute inflammatory reactions induced by coronary intervention.     

Iron status and clinical outcome in patients with coronary artery disease after coronary stenting

BACKGROUND AND AIM: So far, no studies have assessed whether there is an association between iron status and the incidence of major adverse cardiac events or restenosis after coronary stenting. We conducted this study to investigate whether there is an association between body iron status and clinical outcome in patients with coronary artery disease after coronary stenting. METHODS AND RESULTS: The study included 664 patients with coronary artery disease who underwent coronary stent implantation. The soluble transferring receptor/ferritin ratio (sTfR/ferritin ratio) was used as an index of iron status. Patients were divided into three groups according to the tertiles of sTfR/ferritin ratio: lower tertile (<11.9; n = 221), middle tertile (11.9-27.8; n = 221) and upper tertile (>27.8; n = 222). The combined incidence of major adverse cardiac events (death, myocardial infarction and target vessel revascularization) was the primary end point of the study. Patients in the lower tertile of the sTfR/ferritin ratio presented more often with unstable angina or acute myocardial infarction and had longer lesions and higher grade of stenosis than the patients in the middle or upper tertile of the sTfR/ferritin ratio. Angiographic restenosis at 6-month angiography was also evaluated. The cumulative event rate of composite end point of death, myocardial infarction or target vessel revascularization was 27.6% in patients in the lower tertile, 24.4% in patients in the middle tertile and 28.4% in patients in the upper tertile of the sTfR/ferritin ratio (p = 0.68). Restenosis was found in 27.8% (n = 45) in the lower tertile, 25.8% (n = 42) in the middle tertile and 27.5% (n = 38) in the upper tertile of the sTfR/ferritin ratio (p = 0.90). CONCLUSIONS: Our study showed no association between iron status and the incidence of major adverse cardiac events or angiographic coronary restenosis in patients with coronary artery disease after coronary stenting.     

Circulating monocytes and in-stent neointima after coronary stent implantation

OBJECTIVES: The aim of this study was to investigate the relationship between circulating monocytes and in-stent neointimal volume at six-month follow-up. BACKGROUND: In-stent neointimal hyperplasia is the main contributing factor to in-stent restenosis. There is increasing evidence that white blood cells (WBCs), especially monocytes, play a central role in restenosis after stent implantation. METHODS: We performed coronary stent implantation in 107 patients (107 lesions). Peripheral blood was obtained from all patients immediately before coronary angiography and every day for seven days after the intervention, and each WBC fraction count was analyzed. At scheduled six-month follow-up, all patients received angiographic and volumetric intravascular ultrasound analysis. RESULTS: The circulating monocyte count increased and reached its peak two days after stent implantation (from 350 +/- 167 to 515 +/- 149/mm3, p < 0.01). The maximum monocyte count after stent implantation showed a significant positive correlation with in-stent neointimal volume at six-month follow-up (r = 0.44, p < 0.0001). Other fractions showed neither significant serial changes nor a correlation with in-stent neointimal volume. Multiple regression analysis revealed that in-stent neointimal volume was independently correlated with stent volume immediately after implantation (r = 0.45, p < 0.0001) and maximum monocyte count (r = 0.35, p < 0.001). Angiographic restenosis, defined as percent diameter stenosis >50%, was observed in 22 patients (21%), and these patients showed a significantly larger maximum monocyte count than patients without restenosis (642 +/- 110 vs. 529 +/- 77/mm3, p < 0.01). CONCLUSIONS: Circulating monocytes increased after coronary stent implantation, and the peak monocyte count related to in-stent neointimal volume. Our results suggest that circulating monocytes play a role in the process of in-stent neointimal hyperplasia.     

Influence of stent length to lesion length ratio on angiographic and clinical outcomes after implantation of bare metal and drug-eluting stents (the TAXUS-IV Study)

Longer bare metal stent lengths have been associated with greater restenosis. However, the effect of the ratio of stent length to lesion length on clinical and angiographic restenosis after implantation of bare metal and drug-eluting stents has not been clearly defined. Patients in the TAXUS-IV study who underwent single-study stent placement were categorized into tertiles based on ratios of stent length to lesion length. Clinical results at 1 year and angiographic outcomes at 9 months were compared across the 3 groups. The median ratios of stent length to lesion length were 1.20, 1.58, and 2.27 in the 3 tertiles. Analysis segment restenosis rates at 9 months were similar across the 3 tertiles with bare metal stents (24.7% vs 26.7% vs 23.8%, respectively, p = 0.90 for trend) and paclitaxel-eluting stents (11.7% vs 6.5% vs 5.4%, respectively, p = 0.24). Similarly, there were no differences in 1-year rates of target lesion revascularization across the 3 tertiles for bare metal stents (14.6% vs 14.8% vs 13.7%, respectively, p = 0.91) or paclitaxel-eluting stents (6.1% vs 3.6% vs 4.0%, respectively, p = 0.38). By multivariate analysis, the ratio of stent length to lesion length was an independent predictor of neither 9-month angiographic restenosis nor 1-year target lesion revascularization in the bare metal stent arm (odds ratio 1.21, p = 0.36, and hazard ratio 0.80, p = 0.31, respectively) or in the paclitaxel-eluting stent arm (odds ratio 0.86, p = 0.76, and hazard ratio 0.58, p = 0.21, respectively). These data do not support the arbitrary use of larger ratios of stent length to lesion length in patients who undergo implantation of drug-eluting stents.     

A comparison of the clinical and angiographic evolution of diabetic and nondiabetic patients treated by conventional angioplasty versus stent implantation in native coronary arteries

INTRODUCTION AND OBJECTIVES: Diabetic patients have a high restenosis risk after balloon coronary angioplasty. Stent implantation in these patients appears to be a potential beneficial therapeutic option. The aim of this study was to compare the clinical and angiographic outcome of diabetic patients vs non-diabetic patients, treated with conventional angioplasty vs stent implantation in lesions located in native coronary arteries. MATERIAL AND METHODS: A total of 302 patients (58 diabetics and 244 non-diabetics) underwent a coronary angioplasty of one vessel in native coronary arteries with initial success and after at least six months clinical and angiographic follow-up were included in the study. Of the total number of patients, 100 were treated with conventional balloon angioplasty and 202 with stent implantation. Major adverse clinical events and angiographic restenosis rate were evaluated at follow-up. RESULTS: Mean age of patients was 65 years and 74% were male. Angiographic restenosis rate was similar in diabetic vs non-diabetic patients with stent implantation (24% vs 23% respectively). Nevertheless, diabetic patients treated with balloon angioplasty compared to diabetic patients treated with stenting, evolved with a higher restenosis rate (64% vs 24%; p < 0.05), and at the end of follow-up diabetics had need a higher rate of target vessel revascularization (40% vs 24%; p < 0.05), a lower major event free survival (56% vs 70%; p < 0.05) and worse symptomatic status (72% vs 36%; p < 0.05). CONCLUSIONS: Diabetic patients treated with conventional one vessel coronary balloon angioplasty evolved with a high restenosis rate and a bad mid-term clinical outcome. Stent implantation was able reduce to the restenosis rate and improve the mid-term clinical outcome, in a comparable population of diabetic patients.     

Vessel size and outcome after coronary drug-eluting stent placement: results from a large cohort of patients treated with sirolimus- or paclitaxel-eluting stents.

OBJECTIVES: This study sought to investigate the influence of vessel size on the outcomes of patients after drug-eluting stent (DES) implantation. BACKGROUND: There are no dedicated studies on the influence of vessel size on the outcomes of patients treated with different DES. METHODS: The study population was composed of 2,058 consecutive patients who received sirolimus-eluting stents (SES) or paclitaxel-eluting stents (PES). Patients were grouped into tertiles according to vessel size (<2.41 mm in the lower tertile, 2.41 to 2.84 mm in the middle tertile, and >2.84 mm in the upper tertile). The primary end point was target lesion revascularization (TLR). Secondary end points were binary angiographic restenosis and the composite of death or myocardial infarction. RESULTS: Vessel size did not influence the composite end point of death and myocardial infarction. The TLR rates were higher among patients in the lower tertile (12.1%) as compared with the middle (8.4%) and upper (8.0%) tertiles (p = 0.02). In a multivariate analysis, vessel size emerged an independent predictor of TLR (p = 0.009). The model showed also a significant interaction between DES type and vessel size regarding TLR (p = 0.008). There was a significant difference in TLR rates among patients treated with SESs (8.6%) and PESs (16.4%) in the lower tertile (p = 0.002), but not in the middle and upper tertiles. CONCLUSIONS: The influence of vessel size on restenosis is related to the specific DES used, with SESs providing better outcomes than PESs in small but not in large coronary vessels.     

C-reactive protein plasma levels but not factor VII activity predict clinical outcome in patients undergoing elective coronary intervention

BACKGROUND: Both vascular inflammation as determined by C-reactive protein (CRP) and extrinsic coagulation as measured by factor VII activity (F VII) may predict clinical restenosis rate in patients with stable angina pectoris undergoing elective percutaneous coronary intervention (PCI). HYPOTHESIS: The primary objective of this study was to investigate the associations between baseline CRP levels, F VII activity, and restenosis rate after elective PCI in a 6-month follow-up period. METHODS: This prospective study included 81 patients aged > or = 19 years undergoing PCI for angiographically significant (> or = 70%) stenosis, with or without stenting, and 49 controls. Factor VII activity and CRP were measured in samples collected at angiography and 16-24 h post procedure after overnight fast. Successful PCI was defined as final diameter of < 50% with TIMI 3 flow and no complication within 1 h. After 6 months all patients who had undergone PCI were evaluated via a standardized questionnaire. Clinical restenosis was defined as the occurrence of a major adverse coronary events (MACE), within the follow-up period. RESULTS: Diagnostic angiography led to a significant increase in CRP levels after 16-20 h in patients with discrete CAD (n = 22) but not in patients without any signs of coronary atherosclerosis (n = 27). During a 6-month follow-up after PCI, 17 of 81 (21%) patients developed MACE. Tertiles of CRP levels independently predicted clinical restenosis, as it developed in 33.3% of patients with the highest CRP levels (0.7-4.8 mg/dl), in 16.6% of patients with second tertile CRP levels (0.23-0.69 mg/dl), and in 7.4% of patients with lowest tertile CRP levels (0.0-0.22 mg/dl). There was a significant difference in the restenosis rate between patients from the first and the third tertiles (p = 0.018). Successful PCI was associated with a significant decrease of mean CRP levels after 6 months, whereas PCI in patients suffering from MACE led to no change in CRP levels. There was no association between factor VII activity and clinical outcome after PCI, and F VII activity did not change over a 6-month period. CONCLUSIONS: In patients with stable angina pectoris undergoing elective PCI, increased preprocedural and 6-month follow-up CRP plasma levels are associated with clinical restenosis. Factor VII plasma activity lacks such correlations.     

A randomized comparison of repeat stenting with balloon angioplasty in patients with in-stent restenosis

OBJECTIVES: This randomized trial compared repeat stenting with balloon angioplasty (BA) in patients with in-stent restenosis (ISR). BACKGROUND: Stent restenosis constitutes a therapeutic challenge. Repeat coronary interventions are currently used in this setting, but the recurrence risk remains high. METHODS: We randomly assigned 450 patients with ISR to elective stent implantation (224 patients) or conventional BA (226 patients). Primary end point was recurrent restenosis rate at six months. Secondary end points included minimal lumen diameter (MLD), prespecified subgroup analyses, and a composite of major adverse events. RESULTS: Procedural success was similar in both groups, but in-hospital complications were more frequent in the balloon group. After the procedure MLD was larger in the stent group (2.77 +/- 0.4 vs. 2.25 +/- 0.5 mm, p < 0.001). At follow-up, MLD was larger after stenting when the in-lesion site was considered (1.69 +/- 0.8 vs. 1.54 +/- 0.7 mm, p = 0.046). However, the binary restenosis rate (38% stent group, 39% balloon group) was similar with the two strategies. One-year event-free survival (follow-up 100%) was also similar in both groups (77% stent vs. 71% balloon, p = 0.19). Nevertheless, in the prespecified subgroup of patients with large vessels (> or =3 mm) the restenosis rate (27% vs. 49%, p = 0.007) and the event-free survival (84% vs. 62%, p = 0.002) were better after repeat stenting. CONCLUSIONS: In patients with ISR, repeat coronary stenting provided better initial angiographic results but failed to improve restenosis rate and clinical outcome when compared with BA. However, in patients with large vessels coronary stenting improved the long-term clinical and angiographic outcome.     

Predictive value of preintervention C-reactive protein on clinical outcome after directional coronary atherectomy followed by stent implantation.

BACKGROUND: Preprocedural C-reactive protein (CRP) serum levels have been shown to predict the recurrence of angina or major adverse cardiac events after percutaneous coronary intervention. Directional coronary atherectomy (DCA), by reducing residual plaque burden and restenosis, has been shown to improve clinical outcome after coronary stenting. Thus, we assessed the influence of preprocedural CRP serum levels on the recurrence of cardiac events after DCA followed by bare metal stent implantation. METHODS: We enrolled 40 consecutive patients (34 males; 61+/-10 years old) with single-vessel disease who were undergoing DCA. In all patients, preprocedural CRP serum levels were measured by an ultrasensitive nephelometric method. The endpoint of the study was defined as the composite incidence of death, myocardial infarction, and recurrence of angina requiring repeat revascularization at 6-month follow-up. RESULTS: CRP serum levels were a significant independent predictor of the composite endpoint at multiple regression analysis [odds ratio=1.69; 95% confidence interval (95% CI)=1.04-2.75; P=.033]. Patients with recurrence of cardiac events had CRP serum levels higher than those of patients not having events on follow-up [3.95 (2.2-5.7) vs. 2 (1.3-3.3); P=.05]. CONCLUSION: In conclusion, our study shows that baseline CRP serum levels predict cardiac events after coronary bare metal stenting despite plaque debulking with directional atherectomy.     

Preinterventional peak monocyte count and in-stent intimal hyperplasia after coronary stent implantation in human coronary arteries

BACKGROUND: The mechanism of restenosis after stent implantation principally is neointimal hyperplasia. There is evidence that monocytes play a important role in in-stent restenosis (ISR) after stent implantation. Hypothesis: This study assessed the relationship between preinterventional peak monocyte count and neointimal growth after successful stent implantation. METHODS: We performed coronary stent implantation in 85 patients (85 de novo lesions). Peripheral blood sample was obtained in all patients every 12 h before coronary angiography for measurement of peripheral monocytes. All patients received angiographic and intravascular ultrasound (IVUS) follow-up at 6 months after stenting. RESULTS: The preinterventional circulating monocyte count was significantly higher in the ISR group than that in the group without ISR (654 +/- 62/vs. 461 +/- 222/mm3, p < 0.001) and was significantly higher in the reintervention group than that in the no-reintervention group (660 +/- 72/ vs. 470 +/- 216/mm3, p< 0.001). The incidence of ISR and repeat intervention associated with preinterventional monocyte count was highest among the patients in the highest tertile, who were at a 2.64-fold increased risk of ISR and 3.22-fold increased risk of repeat intervention compared with the patients in the lowest tertile. A significant positive correlation was found between preinterventional peak monocyte count and preinterventional plaque and media cross-sectional area and follow-up neointima area (r = 0.311, p = 0.007, r = 0.465, p < 0.001, respectively). The neointima area associated with preinterventional monocyte count was largest among the patients in the highest tertile, that is, 2-fold larger than that of the patients in the lowest tertile (p < 0.001) and 1.44-fold larger than that of the patients in the middle tertile (p = 0.001). CONCLUSION: Our results suggest that circulating preinterventional monocytes play a principal role in the process of in-stent neointimal growth after successful stent implantation.     

Balloon angioplasty for the treatment of coronary in-stent restenosis: immediate results and 6-month angiographic recurrent restenosis rate

Objectives. The purpose of this prospective study was to evaluate the immediate results and the 6-month angiographic recurrent restenosis rate after balloon angioplasty for in-stent restenosis.Background. Despite excellent immediate and mid-term results, 20% to 30% of patients with coronary stent implantation will present an angiographic restenosis and may require additional treatment. The optimal treatment for in-stent restenosis is still unclear.Methods. Quantitative coronary angiography (QCA) analyses were performed before and after stent implantation, before and after balloon angioplasty for in-stent restenosis and on a 6-month systematic coronary angiogram to assess the recurrent angiographic restenosis rate.Results. Balloon angioplasty was performed in 52 patients presenting in-stent restenosis. In-stent restenosis was either diffuse (≥ 10 mm) inside the stent (71%) or focal (29%). Mean stent length was 16 ± 7 mm. Balloon diameter of 2.98 ± 0.37 mm and maximal inflation pressure of 10 ± 3 atm were used for balloon angioplasty. Angiographic success rate was 100% without any complication. Acute gain was lower after balloon angioplasty for in-stent restenosis than after stent implantation: 1.19 ± 0.60 mm vs. 1.75 ± 0.68 mm (p = 0.0002). At 6-month follow-up, 60% of patients were asymptomatic and no patient died. Eighteen patients (35%) had repeat target vessel revascularization. Angiographic restenosis rate was 54%. Recurrent restenosis rate was higher when in-stent restenosis was diffuse: 63% vs. 31% when focal, p = 0.046.Conclusions. Although balloon angioplasty for in-stent restenosis can be safely and successfully performed, it leads to less immediate stenosis improvement than at time of stent implantation and carries a high recurrent angiographic restenosis rate at 6 months, in particular in diffuse in-stent restenosis lesions.     

Effect of statin therapy on restenosis after coronary stent implantation

The effect of statins on the development of restenosis and clinical outcome after coronary stent implantation was assessed in a retrospective analysis of 525 consecutive patients. Baseline clinical, angiographic, and procedural characteristics did not differ between 258 patients with and 267 patients without statin therapy. Statin therapy was associated with a significantly (p<0.04) improved survival free of myocardial infarction and a significant reduction in repeat target vessel revascularization procedures (27.9% vs. 36.7%, p<0.05) during 6-month follow-up. Minimal lumen diameter was significantly larger (1.98+/-0.88 vs. 1.78+/-0.88 mm, p = 0.01), late lumen loss was significantly less (0.64+/-0.8 vs. 0.8+/-0.8 mm, p = 0.032), and net gain significantly increased (1.2+/-0.88 vs. 0.98+/- 0.92 mm, p = 0. 009) in patients receiving statin therapy. Dichotomous angiographic restenosis (> or =50%) rates were significantly lower, with 25.4% in the statin group compared with 38% in the no-statin group (p<0.005). Multivariate analysis identified statin therapy (p = 0.005), minimal lumen diameter immediately after stenting (p = 0.02), and stent length (p = 0.02) as independent predictors for subsequent restenosis development. Thus, statin therapy is associated with reduced recurrence rates and improved clinical outcome after coronary stent implantation.     

Usefulness of preprocedural soluble CD40 ligand for predicting restenosis after percutaneous coronary intervention in patients with stable coronary artery disease

CD40-CD40 ligand interaction is involved in the inflammatory pathogenesis of atherosclerosis but clinical data about its role in stent restenosis are still limited. We investigated the effect of preprocedural CD40 ligand (sCD40L) on stent restenosis. We enrolled 36 patients (mean age 61.4 +/- 8.5 years) with stable angina who underwent successful stent implantation. Control angiograms were performed in all patients after 6 months. Plasma sCD40L and high-sensitive C-reactive protein levels were measured before stent implantation and at 1 and 6 months after the procedure. Angiographically proven restenosis rate was 27.8%. Plasma sCD40L levels were significantly higher (preprocedural 0.74 +/- 0.79) and more prolonged in patients with stent restenosis compared with patients without stent restenosis (0.02 +/- 0.22 ng/ml, p < 0.001). According to receiver-operator characteristic analysis, sCD40L > 0.41 ng/ml was the best distinguished parameter between patients with and without restenosis. At the multivariate logistic regression analysis, preprocedural sCD40L was an independent predictor (RR 39.4, 95% confidence interval 4.05 to 383.8, p = 0.002) of stent restenosis after adjusting for confounding variables, including diabetes, reference vessel diameter, lesion length, stent diameter, stent length, and baseline high-sensitive C-reactive protein. Sensitivity, specificity, and positive and negative predictive values and likelihood ratio of preprocedural sCD40L levels in stent restenosis were 78%, 92%, 78%, 92%, and 9.37%, respectively. In conclusion, enhanced inflammation of plaque (increased sCD40L) before percutaneous coronary intervention may increase the rate of stent restenosis. Increased preprocedural sCD40L level is an independent predictor of stent restenosis. We can use this marker for the assessment of risk stratification before planning stent implantation.     

Outcomes with the polymer-based paclitaxel-eluting TAXUS stent in patients with diabetes mellitus: the TAXUS-IV trial

OBJECTIVES: We sought to determine the safety and efficacy of polymer-regulated site-specific delivery of paclitaxel in patients with diabetes mellitus undergoing stent implantation. BACKGROUND: Percutaneous coronary intervention in patients with diabetes is associated with high rates of restenosis and repeat revascularization due to excessive neointimal proliferation, a process that may be blunted with the site-specific delivery of paclitaxel. METHODS: In the TAXUS-IV trial, 1,314 patients were prospectively randomized to the slow rate-release polymer-based paclitaxel-eluting TAXUS stent or the bare-metal EXPRESS stent (Boston Scientific Corp., Natick, Massachusetts). Medically treated diabetes was present in 318 patients (24%), 105 of whom required insulin. RESULTS: Among patients with diabetes, the TAXUS stent, compared to the bare-metal stent, reduced the rate of 9-month binary angiographic restenosis by 81% (6.4% vs. 34.5%, p < 0.0001), and reduced the 12-month rates of target lesion revascularization by 65% (7.4% vs. 20.9%, p = 0.0008), target vessel revascularization by 53% (11.3% vs. 24%, p < 0.004), and composite major adverse cardiac events by 44% (15.6% vs. 27.7%, p = 0.01). The one-year rates of cardiac death (1.9% vs. 2.5%), myocardial infarction (3.2% vs. 6.4%), and subacute thrombosis (0.6% vs. 1.2%) were comparable between the paclitaxel-eluting and control stents, respectively. In the insulin-requiring subgroup, the TAXUS stent reduced angiographic restenosis by 82% (7.7% vs. 42.9%, p = 0.0065), and reduced the one-year rate of target lesion revascularization by 68% (6.2% vs. 19.4%, p = 0.07), a relative reduction similar to patients without diabetes. CONCLUSIONS: The site-specific delivery of paclitaxel after coronary stent implantation is highly effective in reducing clinical and angiographic restenosis in patients with diabetes mellitus.     

The prognostic value of IL-8 for cardiac events and restenosis in patients with coronary heart diseases after percutaneous coronary intervention

The objective of the present study was to investigate the prognostic value of plasma interleukin-8 (IL-8) for adverse cardiac events and restenosis in patients with percutaneous coronary intervention (PCI). The pre- and post-procedural peak plasma levels of IL-8 and serum C-reactive protein (CRP) were examined by immunoassay, while adverse cardiae events and restenosis within one year follow-up were observed in 134 consecutive patients who underwent PCI. Angiography revealed that 23.88% (32/134) of the patients had adverse cardiac events and 29.41% (35/119) of the patients had restenosis. Preprocedural levels of IL-8 and CRP and post-procedural peak levels of IL-8 in patients with adverse cardiac events were higher than those without adverse cardiac events (all P < 0.05). The incidence of adverse cardiac events increased from 6.67% in the bottom tertile to 31.82% in the top tertile of IL-8 levels (P = 0.001): a similar trend was observed for restenosis from 10% in low tertile to 51.28% in high tertile of IL-8 levels to 51.8% (P = 0.012). The preprocedural levels of IL-8 (RR = 5.539, CI = 1.720-17.887, P = 0.001) and CRP (RR = 2.031, CI = 1.132-2.049, P = 0.003) were the only independent predictors of adverse cardiac events. The post-procedure peak level of IL-8 (RR = 3.766, CI = 2.990-5.904, P = 0.002) and stent length (RR = 1.468, CI = 1.161-2.022. P = 0.021) were the independent predictors of restenosis. The results demonstrate that the release of IL-8 after PCI is a powerful prognostic factor for cardiac events and restenosis. The higher the peak level of post-procedure IL-8, the lower the event-free survival observed.     

The relationship between preprocedural platelet size and subsequent in-stent restenosis

OBJECTIVE: Elevated mean platelet volume predicts restenosis after percutaneous transluminal coronary angioplasty but its effect on the development of in-stent restenosis is not known. We assessed the effect of mean platelet volume measured before coronary stent implantation for stable angina pectoris on subsequent development of in-stent restenosis. METHODS AND RESULTS: We retrospectively analysed the data of 60 patients who had stent implantation on one native coronary artery for stable angina pectoris and control angiographies for clinically suspected restenosis within 6 months. Mean platelet volume was measured by auto analyzer one day before stent implantation. Clinical and demographic data and laboratory results were obtained from the hospital charts of the patients. In-stent restenosis was evaluated visually from control angiograms. Angiographic in-stent restenosis was present in 35 (58%) of 60 patients and 25 (42%) patients had no restenosis. Mean platelet volume in the in-stent restenosis group was 8.28 +/- 0.71 fl compared to 7.63 +/- 0.74 fl in the no-restenosis group (p = 0.001). There was a positive correlation between preprocedural mean platelet volume and development of in-stent restenosis (r = 0.44; p < 0.001). A mean platelet volume value of > or = 8.4 fl was associated with an odds ratio of 16.0 for development of in-stent restenosis, with high specificity and positive predictivity but poor sensitivity and negative predictivity (96%, 93%, 40% and 53%, respectively). CONCLUSIONS: Mean platelet volume measured before stent implantation is correlated with subsequent development of in-stent restenosis. If preprocedural mean platelet volume is greater than 8.4 fl, in-stent restenosis is more probable to occur.