Relation of C-reactive protein level and long-term risk of death or myocardial infarction following percutaneous coronary intervention with a sirolimus-eluting stent

Previous observations in the bare metal stent (BMS) era have demonstrated an association between a high preprocedural C-reactive protein (CRP) level and an increased incidence of death or myocardial infarction after percutaneous coronary intervention (PCI). We hypothesized that PCI with sirolimus-eluting stents (SESs) would result in a smaller increase in CRP compared with BMSs and that a high CRP level before PCI would be associated with a higher incidence of death or myocardial infarction at 12 months, regardless of the type of stent implanted. We analyzed patients who underwent PCI with stenting at the Cleveland Clinic Foundation. Patients who received BMSs and SESs were analyzed separately by categorizing them into low and high CRP groups based on whether their CRP level before PCI was above or below the median for each group. The increase in CRP that occurred with PCI was termed DeltaCRP. In total, 652 patients were included in the analysis. Median DeltaCRP was smaller in the SES group than in the BMS group (1.5 vs 0.7 mg/L, p = 0.009). In the BMS group, patients with a CRP level above the median before PCI had a higher incidence of 12-month death or myocardial infarction compared with patients with a CRP level below the median (11.3% vs 1.6%, p = 0.002). The same relation was present in the SES group, i.e., patients with a higher CRP level had a higher incidence of 12-month death or myocardial infarction compared with patients with a low CRP level (6.3% vs 1.0%, p = 0.005) and a higher 12-month mortality (5.2% vs 0%, p = 0.001). Multivariate logistic regression analysis demonstrated that the CRP level above the median before PCI was associated with a higher 12-month incidence of death or myocardial infarction, independent of the type of stent used, or DeltaCRP. In conclusion, PCI in the SES era causes a smaller increase in CRP compared with the BMS era. A high CRP level before PCI is independently associated with a higher risk of long-term death or myocardial infarction. This finding was present in the BMS and SES groups and highlights the need for aggressive risk-factor modification after PCI.     

C-Reactive protein, clinical outcome, and restenosis rates after implantation of different drug-eluting stents

Sirolimus-eluting stents (SESs), paclitaxel-eluting stents (PESs), and dexamethasone-eluting stents (DEXs) have anti-inflammatory properties; thus, the decreased in-segment restenosis rate observed with the use of these stents might be related to a weaker postprocedural inflammatory response. One hundred sixty consecutive patients with stable coronary artery disease who underwent successful single-vessel/lesion coronary artery stenting were prospectively studied. Thin-strut bare metal stents were deployed in 39 patients, SESs in 30, PESs in 61, and DEXs in 30. The 4 groups were similar with respect to demographic and angiographic variables and prevalence of risk factors. C-reactive protein (CRP) was measured at baseline and 24 and 48 hours after the procedure. Maximal increase in CRP was calculated as the increase in CRP at 48 hours/CRP compared with baseline. Angiographic follow-up was performed after 12.9 +/- 1.3 months or sooner, if needed, on the basis of clinical evidence. All patients presented a postprocedural increase in CRP that peaked at 48 hours (median 10.0 mg/L). Maximal CRP increase was similar across the 4 groups (medians 3.5 mg/L in the bare metal stent group, 3.6 mg/L in the SES group, 4.0 mg/L in the PES group, 3.5 mg/L in the DEX group, p = 0.45). Incidences of angiographic binary restenosis (>50% lumen diameter decrease) were 20.5% in the bare metal stent group, 3.3% in the SES group, 4.9% in the PES group, and 36.6% in the DEX group (p = 0.0004 for SES and PES groups vs bare metal stent and DEX groups). Postprocedural increase in CRP was significantly correlated with clinical and angiographic outcomes. In conclusion, the acute postprocedural systemic inflammatory response induced by drug-eluting stent implantation appears to be similar to that induced by bare metal stents. However, the restenosis rate is lower for SESs and PESs than for DEXs and bare metal stents. Thus, the decreased incidence of stent restenosis that was observed after SES and PES deployment is unlikely to be related to a decreased acute systemic inflammatory response, but rather to an increased local resistance to inflammatory mediators.     

Comparison of thrombosis and restenosis risk from stent length of sirolimus-eluting stents versus bare metal stents

Selection of coronary stent length varies from covering only the zone of maximum obstruction to stenting from normal- to normal-appearing vessels. With bare metal stenting, for any given lesion there is a high restenotic risk associated with longer stent length. With drug-eluting stents, the relation between stent length and restenosis has not been evaluated. In the angiographic follow-up cohort of the SIRIUS trial that compared the sirolimus-eluting Bx Velocity stent with the standard Bx Velocity stent (n = 699), we constructed a multiple regression model to predict 8-month percent diameter stenosis using the main effects of lesion length and excess stent length beyond the lesion length and adjusting for known predictors of restenosis. Stent length exceeded lesion length in 94% of lesions overall. Mean difference in length was 8.3 +/- 8.3 mm (mean lesion length 14.6 +/- 5.9 mm, mean stent length 22.9 +/- 9.6 mm). Stented lesion length and excess stent length were associated with absolute increases in percent diameter stenosis per 10 mm of 9.1% (p <0.0001) and 3.6% (p = 0.053) in the bare metal arm and 3.5% (p = 0.047) and 2.1% (p = 0.040) in the sirolimus-eluting stent arm. Although the effects of lesion length and excess stent length on restenosis were markedly decreased with sirolimus-eluting stents (vs bare metal stents), a small restenotic penalty is still paid for excessive stent length. Longer stent-to-lesion length strategies should be used only when a shorter stent is likely to result in incomplete lesion coverage and edge dissection, a strong determinant of stent thrombosis.     

Usefulness of preprocedure high-sensitivity C-reactive protein to predict death, recurrent myocardial infarction, and stent thrombosis according to stent type in patients with ST-segment elevation myocardial infarction randomized to bare metal or drug-eluting stenting during primary percutaneous coronary intervention

It is unknown whether high-sensitivity C-reactive protein (hs-CRP) predicts outcome depending on implanted stent type. We investigated the prognostic value of hs-CRP in relation to type of stent implanted in patients with ST-segment elevation myocardial infarction (STEMI). Immediately before primary percutaneous coronary intervention (pPCI), 301 patients had blood drawn. Patients were categorized according to hs-CRP levels and combination of hs-CRP (≤2 vs >2 mg/L) and stent type (bare metal stent [BMS] vs drug-eluting stent [DES]). Hs-CRP >2 mg/L (median, hazard ratio 2.7, 95% confidence interval 1.3 to 5.6, p = 0.007) and the combined variable of hs-CRP >2 mg/L and BMS (hazard ratio 2.4, 95% confidence interval 1.2 to 4.5, p = 0.006) independently predicted the composite end point of death and MI at 36-month follow-up. There was a significant interaction (p = 0.006) for hs-CRP and stent type. Survival analysis demonstrated significant differences for occurrence of death and MI: 4.8% in BMS + CRP ≤2 mg/L, 11.9% in DES + CRP ≤2 mg/L, 17.6% in DES + CRP >2 mg/L, and 27.9% in BMS + CRP >2 mg/L. None of the 14 stent thromboses occurred in patients with BMS + CRP ≤2 mg/L. In conclusion, preprocedure hs-CRP predicts outcome after pPCI in patients with STEMI. Our hypothesis-generating data indicate that BMS implantation should be preferred when hs-CRP is ≤2 mg/L and DES when hs-CRP is >2 mg/L to decrease long-term adverse outcomes including stent thrombosis in patients with STEMI treated with pPCI. These findings need confirmation in larger randomized clinical trials.     

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.     

Sirolimus-eluting stents inhibit neointimal hyperplasia in diabetic patients. Insights from the RAVEL Trial.

Patients with diabetes mellitus have less favourable outcomes after percutaneous coronary intervention (PCI) than non-diabetics. We performed a subgroup analysis of the multicentre RAVEL trial to examine the impact of the sirolimus-eluting stent (SES) on outcomes in diabetic patients. The RAVEL study randomized 238 patients to treatment with either sirolimus-eluting or bare metal stents. Forty-four patients were diabetic; 19 received sirolimus-eluting stents and 25 were treated with bare metal stents. The differences in outcomes between diabetic and non-diabetic patients treated with SES (n=101) were also assessed. Follow-up angiography was performed at 6 months. Major adverse cardiac events (MACE) defined as death, myocardial infarction (MI), or target lesion revascularization (TLR) were analysed at 12-month follow-up. Six-month in-stent late lumen loss was significantly lower for the diabetic SES than the bare stent group (0.07+/-0.2 vs 0.82+/-0.5mm; P<0.001) and similar to that in non-diabetics treated with SES (-0.03+/-0.27mm). There was zero restenosis in the SES groups (diabetic and non-diabetic) compared to a 42% rate in the diabetic population assigned to bare metal stents (P=0.001). After 12 months, there was one non-Q-wave MI and one non-cardiac death in the diabetic SES group, while 12 patients in the bare metal stent group had MACE (one death, two MI, nine TLR) (P=0.01)-an event-free survival rate of 90% vs 52%, respectively (P<0.01). There were no TLRs in both SES groups compared to 36% rate in the diabetic bare metal stent group (P=0.007).Conclusion Diabetics treated with SES were associated with a virtual abolition of neointimal proliferation and low event rates at long-term follow-up.     

持续炎症状态对冠状动脉支架内再狭窄的影响和预测分析

目的探讨PCI前后持续炎症状态对PCI后支架内再狭窄的影响和预测作用。方法选择成功行支架置入术并于3个月后至1年内复查冠状动脉造影的患者431例,分为支架内再狭窄组(再狭窄组)124例和无支架内再狭窄组(无再狭窄组)307例。患者于PCI前及复查冠状动脉造影时均检测C反应蛋白(CRP)、高敏CRP(hs-CRP)。结果与无再狭窄组比较,再狭窄组患者PCI前CRP和hs-CRP以及PCI后CRP均明显升高,差异有统计学意义(P0.05,P0.01)。将PCI前hs-CRP分为2 mg/L和≤2 mg/L2个等级,hs-CRP增高的患者支架内再狭窄的发生率明显升高(χ~2=5.03,P0.05)。logistic回归分析显示,hs-CRP高的患者发生支架内再狭窄的风险明显增加(OR=1.840,95% CI:1.076～3.157,P0.05)。结论 PCI前后持续的炎症状态是发生支架内再狭窄的危险因素和预测指标,应积极加强抗炎以改善PCI后患者的临床预后。     

Time course of release of inflammatory markers after coronary stenting: comparison between bare metal stent and sirolimus-eluting stent

BACKGROUND: High levels of release of inflammatory markers after coronary angioplasty are predictors of late restenosis. Sirolimus-eluting stent reduces the risk of restenosis. AIM OF THE STUDY: To compare the release of inflammatory markers after coronary angioplasty with sirolimus-eluting stent and bare metal stent. METHODS: Sixteen patients with a proximal left anterior descending coronery artery stenosis were randomly assigned to receive either bare metal stent (n = 8) or sirolimus-eluting stent (n = 8). We measured simultaneously aortic and coronary sinus concentrations of the von Willebrand factor antigen, tumor necrosis factor-alpha and interleukin-6 before, immediately and after 2 h after stenting. High-sensitivity C-reactive protein and troponin-I circulating levels were measured before and 6 and 24 h after coronary angioplasty. RESULTS: Before stenting, all values were similar in both groups. The coronary sinus change of the von Willebrand factor antigen level between baseline and 2 h after stenting was + 20.1 +/- 26.9% in the bare metal stent group and -5.7 +/- 23.02% in the sirolimus-eluting stent group (P < 0.05). We observed a significant increase in the von Willebrand factor antigen (from 132.8+/-58.8 to 169 +/- 40.7%, P < 0.05) systemic concentrations 24 h after stenting in the bare metal stent group but not in the sirolimus-eluting stent group (from 140.6+/-84% to 136 +/- 39.5%), P = NS). CONCLUSION: The present study shows that a difference in the release of inflammatory markers can be detected after coronary stenting with bare metal stent or sirolimus-eluting stent. The lower release of the von Willebrand factor antigen in the coronary sinus 2 h after the procedure and the lower systemic concentrations of the von Willebrand factor antigen 24 h after stenting in the sirolimus-eluting stent group are likely to reflect a reduced production of the von Willebrand factor antigen at the site of the vascular injury.     

Intravascular ultrasonic comparative analysis of degree of intimal hyperplasia produced by four different stents in the coronary arteries

Intravascular ultrasound studies were performed at angiographic follow-up on 121 native coronary lesions treated with 1 bare metal stent (n = 50), high-dose dexamethasone-eluting stents (n = 18), non-polymer-based paclitaxel-eluting stents (n = 18), or sirolimus-eluting stents (n = 35). Paclitaxel- and sirolimus-eluting stents reduced mean intimal hyperplasia thickness compared with bare metal stents by 49% and 90% (p = 0.048 and p <0.001), respectively, whereas mean intimal hyperplasia thickness treated with dexamethasone-eluting stents was similar to those lesions treated with bare metal stents.     

Effectiveness of the sirolimus-eluting stent in the treatment of patients with a prior history of coronary artery bypass graft surgery

OBJECTIVE: Percutaneous coronary intervention in patients with a history of previous coronary artery bypass grafting (CABG) is associated with an increased rate of subsequent adverse events compared to those without prior CABG. We evaluated the impact of utilizing the sirolimus-eluting stent (SES) in this high-risk population. METHODS: Since April 2002, SES implantation was utilized as the default strategy for all percutaneous procedures in our hospital. Consecutive patients with a history of previous CABG and de novo lesions (n=47) treated exclusively with SES, were compared to 66 patients who received bare stents in the 6-month period just before SES introduction. RESULTS: There were no significant differences between the groups (SES and bare stent) with respect to baseline clinical or lesion characteristics. The only difference between the groups related to the nominal diameter of stent utilized, which was smaller in the SES group than the bare stent group. (The maximum diameter of SES available was 3.0 mm). At 1 year, the cumulative incidence of major adverse events (defined as death, myocardial infarction, or target vessel revascularization) was significantly lower in the SES group than the bare stent group [8.5 versus 30.3%, hazard ratio 0.37 (95% confidence interval 0.15-0.91); P=0.03]. CONCLUSIONS: The utilization of the sirolimus-eluting stent for percutaneous intervention in a high-risk population with a history of previous CABG surgery is associated with a significant reduction in the rate of major adverse cardiac events at 1 year.     

Drug-eluting and bare nitinol stents for the treatment of atherosclerotic lesions in the superficial femoral artery: long-term results from the SIROCCO trial.

PURPOSE: To review clinical outcomes of patients with chronic limb ischemia and TASC type C lesions treated with sirolimus-eluting versus bare SMART nitinol self-expanding stents. METHODS: Data were obtained from a randomized, multicenter, double-blinded study conducted in 2 phases. All 93 patients had chronic limb ischemia and superficial femoral artery (SFA) occlusions or stenoses (average lesion length 8.3 cm). In total, 47 patients (31 men; mean age 66.3+/-9.1 years, range 50-84) received the sirolimus-eluting SMART stent and 46 patients (36 men; mean age 65.9 +/-10.8 years, range 38-83) received a bare SMART nitinol stent. Both groups were followed for a mean 24 months. RESULTS: Both the sirolimus-eluting and the bare SMART stents were effective in revascularizing the diseased SFA and in sustaining freedom from restenosis. For both types of stents, improvements in ankle-brachial indices (ABI) and symptoms of claudication were maintained over 24 months (median 24-month ABI 0.96 for the sirolimus group versus 0.87 for the bare stent group, p>0.05). At 24 months, the restenosis rate in the sirolimus group was 22.9% versus 21.1% in the bare stent group (p>0.05). The cumulative in-stent restenosis rates according to duplex ultrasound were 4.7%, 9.0%, 15.6%, and 21.9%, respectively, at 6, 9, 18, and 24 months; the rates did not differ significantly between the treatment groups. The TLR rate for the sirolimus group was 6% and for the bare stent group 13%; the TVR rates were somewhat higher: 13% and 22%, respectively. Mortality rates did not differ significantly between the groups. CONCLUSION: These data demonstrate that the sirolimus-eluting and the bare SMART stent are effective, safe, and free from restenosis in a majority of patients for up to 24 months. Because the restenosis rate in the bare stent group is unexpectedly low, no significant difference could be found between the sirolimus-eluting and the bare SMART stents.     

Risk of thrombosis with the use of sirolimus-eluting stents for percutaneous coronary intervention (from registry and clinical trial data)

We conducted a meta-analysis on 6 studies in 2,963 patients who had coronary artery disease and received a sirolimus-eluting stent or a bare metal stent for revascularization. Compared with bare metal stents, sirolimus-eluting stents did not appear to increase the risk for thrombosis up to 13.5 months after coronary intervention (risk ratio 0.49, 95% confidence interval 0.22 to 1.12, p = 0.09).     

Diagnostic value of procalcitonin serum levels in comparison with C-reactive protein in allogeneic stem cell transplantation

BACKGROUND AND OBJECTIVES: Infections represent the major complications following allogeneic stem cell transplantation (SCT). A promising marker for a more specific and early detection of bacterial or fungal infections is procalcitonin (PCT). DESIGN AND METHODS: Maximum values (m) and increase (Delta) of PCT and C-reactive protein (CRP) were prospectively analyzed during 214 clinical events in a cohort of 61 patients undergoing allogeneic SCT. Systemic reactions during bacterial or fungal infections were classified according to the ACCP/SCCM criteria. RESULTS: mPCT and mCRP (normal <0.5 microg/L and <5 mg/L, respectively) levels were high during bacterial and fungal infections (median 2.3 microg/L and 188 mg/L), moderately elevated during fever of unknown origin (median 1.5 microg/L and 82 mg/L) and low during clinical events for which there was no evidence of bacterial or fungal infections (median 0.4 microg/L and 55 mg/L). The area under the receiver operator characteristic (ROC) curve was 0.70 for mPCT, 0.76 for mCRP, 0.76 for DeltaPCT and 0.83 for DeltaCRP. Cut-off concentrations for optimum prediction of bacterial or fungal infection were: mPCT > 1 microg/L, mCRP > 100 mg/L, DeltaPCT > 1 microg/L and DeltaCRP > 50 mg/L. An increase of PCT during a bacterial or fungal infection was usually detected 1 day after the onset of fever, while the rise of CRP occurred 1 day before. mPCT was strongly correlated with the severity of systemic reaction during infection (sepsis vs severe sepsis/septic shock: p=0.0002). INTERPRETATION AND CONCLUSIONS: The diagnostic value of PCT was not superior to that of CRP in the detection of bacterial or fungal infections after allogeneic SCT. However, PCT assays may be useful in studies which compare the severity of infectious complications.     

Volumetric intravascular ultrasound assessment of neointimal hyperplasia and nonuniform stent strut distribution in sirolimus-eluting stent restenosis

The neointimal hyperplasia (IH) distribution pattern of in-stent restenotic lesions after sirolimus-eluting stent (SES) implantation has not been well described. We identified 48 in-stent restenotic lesions (41 patients) after SES implantation and performed volumetric intravascular ultrasound analyses. Lumen area, stent area, and IH area at the minimal lumen area site were 2.7 +/- 1.0, 5.4 +/- 1.9, and 2.7 +/- 1.4 mm(2), respectively. IH area at the minimal lumen site was larger in the group with a stent area > or =5.0 mm(2) than the group with a stent area <5.0 mm(2) (3.7 +/- 1.3 vs 1.9 +/- 0.8 mm(2), p <0.001). There were fewer visualized stent struts in lesions with a minimum stent area > or =5.0 mm(2) at the minimum lumen site compared with those with a stent area <5.0 mm(2) (0.69 +/- 0.25 vs 0.83 +/- 0.16, p = 0.04). When we compared lesions in patients with diabetes mellitus with patients without diabetes, minimum lumen areas, percent IH at minimal lumen area, percent IH, and neointima-free stent length were identical. In conclusion, (1) lesions without SES underexpansion at the minimum lumen site had more IH and greater nonuniform stent strut distribution compared with restenotic SESs that were underexpanded, and (2) the IH response did not appear to be more aggressive in patients with diabetes mellitus than in those without diabetes mellitus.     

Randomized trial of paclitaxel- and sirolimus-eluting stents in small coronary vessels.

AIMS: Sirolimus- and paclitaxel-eluting stents effectively reduce restenosis in small coronary vessels. The relative efficacy of these drug-eluting stents in this high-risk subset is not known. METHODS AND RESULTS: A total of 360 patients undergoing percutaneous coronary intervention for de novo lesions in native coronary vessels with a diameter of <2.80 mm received randomly paclitaxel-eluting stents (n=180) or sirolimus-eluting stents (n=180). The primary endpoint was in-stent late luminal loss. Secondary endpoints were angiographic restenosis and need of target lesion revascularization. The study intended to show that the paclitaxel-eluting stent is not inferior to the sirolimus-eluting stent with respect to the primary endpoint. The non-inferiority margin was set at 0.16 mm. Follow-up angiography was performed in 87% of the patients. In-stent late luminal loss in the paclitaxel-eluting stent group was 0.32 mm (upper 95% boundary, 0.42 mm), which was greater than that in the sirolimus-eluting stent group, failing to show the non-inferiority of the paclitaxel-eluting stent to the sirolimus-eluting stent (P>0.99). Angiographic restenosis was found in 19.0% of the lesions in the paclitaxel-eluting stent group and 11.4% of the lesions in the sirolimus-eluting stent group (P=0.047). Target lesion revascularization was performed in 14.7% of the lesions treated with paclitaxel-eluting stents and 6.6% of the lesions treated with sirolimus-eluting stents (P=0.008). CONCLUSION: The paclitaxel-eluting stent is associated with a greater late luminal loss and is less effective in reducing restenosis in small coronary vessels than the sirolimus-eluting stent.     

Thiazolidinedione treatment attenuates diffuse neointimal hyperplasia in restenotic lesions after coronary stent implantation in type 2 diabetic patients: an intravascular ultrasound study

OBJECTIVES: Thiazolidinedione treatment reduces neointimal tissue proliferation after coronary stent implantation in diabetic patients. However, in-stent restenosis still persists in patients treated with thiazolidinedione. The effect of thiazolidinedione treatment on the pattern of in-stent restenosis remains unclear. This study investigated whether thiazolidinedione treatment attenuates diffuse neointimal hyperplasia in restenotic lesions after coronary stent implantation in diabetic patients. METHODS: Volumetric intravascular ultrasound was performed at 6 months after coronary stent implantation in 76 patients with restenotic lesions who received either conventional anti-diabetic treatment (control group, n = 56) or thiazolidinedione treatment (thiazolidinedione group, n = 20). RESULTS: There were no significant differences between the two groups in stent volume (99 +/- 32 vs 90 +/- 20 mm3, respectively, p = 0.26) or in minimal lumen area in the stent (1.4 +/- 0.6 vs 1.6 +/- 0.5 mm2, respectively, p = 0.11). However, there were significant reductions in neointimal volume (56 +/- 25 vs 36 +/- 11 mm3, respectively, p < 0.01)and neointimal index (56 +/- 11% vs 41 +/- 8%, respectively, p < 0.01) in the thiazolidinedione group. Coefficient of variation of neointimal tissue accumulation was greater in the thiazolidinedione group (45.5%) than in the control group (25.2%). CONCLUSIONS: Intravascular ultrasound study demonstrated that together with reduction of overall neointimal tissue proliferation, thiazolidinedione treatment caused greater point-to-point heterogeneity in the neointimal tissue accumulation in restenotic lesions after coronary stent implantation. This finding strongly suggests that thiazolidinedione treatment attenuates diffuse in-stent restenosis in diabetic patients.     

Optimally deployed stents in the treatment of restenotic versus de novo lesions

Results from earlier trials performed before the implementation of optimal stent deployment techniques suggest that stenting for restenotic lesions may be associated with a higher risk of restenosis when compared with de novo lesions. The aim of this study was to compare the short- and long-term outcome of optimal stent deployment in restenotic versus de novo lesions. In all, 1,865 consecutive patients with 2,707 de novo lesions and 489 patients with 633 restenotic lesions underwent intravascular ultrasound-guided optimal stent deployment. In-hospital outcome was similar for both groups, except for a higher incidence of non-Q-wave myocardial infarction in the de novo group (14.6% vs 8.6%, p = 0.001). At 12-month follow-up, there was no statistical significant difference in the incidence of death or myocardial infarction, but event-free survival was better in the de novo lesion group of patients (74.5% vs 63.7%, p = 0.001). There was a higher incidence of target lesion revascularization in the restenosis group (25.1% vs 13.0%, p = 0.001). By multivariate analysis, restenotic lesions, vein graft lesions, and diabetes mellitus were strong determinants of repeat revascularization, whereas larger preprocedural reference vessel minimal lumen diameter and larger final minimal lumen diameter were associated with a reduced chance of restenosis and increased event-free survival. This study shows that optimal stent deployment for restenotic and de novo lesions has favorable short- and long-term outcome. However, the incidence of target lesion revascularization was significantly greater in restenotic lesions. Saphenous vein graft lesions and diabetes mellitus were confirmed as other independent risk factors for clinical restenosis.     

Influence of Simvastatin for In-stent Restenosis Rate and Blood Lipid Level and Inflammation Actor after Coronary Artery Stent Implantation

Objectives To investigate the effect of simvastatin on the probability of restenosis after stent implantation and serum level of lipids as well as high-sensitivity C-reactive protein (hs-CRP) in patients with coronary heart disease (CHD). Methods 118 patients with CHD after stenting therapy were divided into treatment group (n=62) and control group (n=56) randomly. All patients were treated with aspirin (100 mg/d) and clopidogrel (75 mg/d) while treatment group patients took simvastatin (40 mg qn) additionally. All patients underwent coronary angiography (CAG) to compare the difference of restenosis and the serum level of total cholesterol (TC), low-density lipoprotein cholesterol (LDL-c), high-density lipoprotein cholesterol (HDL-c), triglyceride (TG) as well as hs-CRP after the drug treatment for 6 months. Results The probability of restenosis was significantly lower in the treatment group than that of control group (P<0.01) and the results were similar between the patients with bare metal stent (P<0.01) and those with sirolimus-eluting stent (P<0.01). The serum levels of TC (P<0.01), LDL-c (P<0.01), TG (P<0.05) and hs-CRP (P<0.01) were obviously lower while the HDL-c (P<0.05) level was higher in the treatment group than those of control group. There was no death case. Conclusions Simvastatin could decrease the probability of restenosis significantly after coronary stent implantation with dose of 40 mg/d. It also has good performance on lipids control and lightening inflammatory reactions with its undoubtedly safety.     

Safety and efficacy of the 2.25-mm sirolimus-eluting Bx Velocity stent in the treatment of patients with de novo native coronary artery lesions: the SIRIUS 2.25 trial

Smaller reference vessel diameter is a recognized determinant of in-stent restenosis. The SIRIUS 2.25 trial was a prospective, nonrandomized study including 100 patients (mean age 63.4 years; 64% men, 40% with diabetes mellitus) assessing the safety and efficacy of the 2.25-mm sirolimus-eluting Bx Velocity stent in patients with de novo native coronary lesions. Using propensity score matching for gender, diabetes mellitus, left anterior descending artery target vessel, lesion length, and reference vessel diameter, the outcomes were compared with historical control groups (angioplasty and Palmaz-Schatz stent arms from the STRESS/BENESTENT I/II trials and the Bx Velocity bare metal stent arm from the RAVEL and SIRIUS trials having a reference vessel diameter <3 mm). Use of the 2.25-mm sirolimus-eluting Bx Velocity stent was associated with a high rate of procedural success (97%) and a low rate of in-hospital major adverse cardiac events (2%). The primary end point, 6-month in-lesion binary angiographic restenosis, occurred less frequently in patients treated with the 2.25-mm sirolimus-eluting Bx Velocity stent than in each of 3 historical controls (16.9% vs 30.6%, p = 0.12; 36.5%, p <0.001; 45.9%, p <0.001, respectively). This translated into lower rates of 6-month target lesion revascularization in the 2.25-mm sirolimus-eluting Bx Velocity stent group (4.0% vs 15.0% in each of 3 control groups, p = 0.01 to <0.001). By multivariate analysis, in-lesion binary restenosis was predicted by multiple implanted stents (odds ratio 10.4, p = 0.002). Four of 13 patients who developed restenosis (30.8%) had a diffuse pattern of restenosis. In the long lesion tertile (mean lesion length 19.5 mm), the in-lesion binary restenosis rate was 27.6%. In conclusion, use of the 2.25-mm sirolimus-eluting Bx Velocity stent was safe and provided favorable 6-month clinical outcomes. Use of multiple stents (in longer lesions) was an independent predictor of in-lesion restenosis.     

Clinical and angiographic follow-up of small vessel lesions treated with paclitaxel-eluting stents (from the TRUE Registry)

Several randomized trials have shown that sirolimus-eluting stents and paclitaxel-eluting stents (PES) are effective in reducing restenosis in respect to bare-metal stents, including the subset of small vessels. The objective of this study was to evaluate "real world" angiographic and clinical outcomes of a large series of patients enrolled in the TRUE registry and treated with PES for both small vessel and very small vessel lesions. A consecutive series of 675 patients (926 lesions) with reference vessel diameter <2.75 mm measured by quantitative coronary angiography analysis were analyzed. The primary end point was the rate of angiographic in-stent restenosis and 1-year major adverse cardiac events. In this study 390 lesions were identified as small vessel (reference vessel diameter >or=2.25 and <2.75 mm) and 536 lesions as very small vessel (reference vessel diameter <2.25 mm). Overall in-stent restenosis was 15.5% (n = 96). Compared with small vessel, the very small vessel lesions had more in-stent restenosis (21.7% vs 11.4%, p <0.001) and in-segment restenosis (29.3% vs 22.5%, p = 0.055). The majority of the restenotic lesions (n = 125) were focal (57%, n = 71). At 1 year, cardiac death was 1.6% (n = 11), acute myocardial infarction 0.5% (n = 4.), and the target lesion revascularization 12.8% (n = 86). Cumulative major adverse cardiac events rate was 17.3% (n = 119). The rate of definite and probable stent thrombosis was 0.9% (n = 8). In conclusion, in comparison with historical bare-metal stent controls, this large series of small vessel lesions treated with PES confirms previous results reporting the efficacy of PES in small vessels. The rate of subacute and late stent thrombosis was low in this subgroup of patients.