Long-term clinical safety and efficacy of NIROYAL vs. NIR intracoronary stent.

Research in vitro and in animal models suggested that gold electroplating of stents can attenuate neointimal hyperplasia and reduce thrombogenicity. The objective of this study was to evaluate the safety and efficacy of the gold-coated NIROYAL stent in the treatment of stenosed coronary arteries and bypass grafts. We retrospectively studied 181 consecutive patients undergoing deployment of NIR (n = 87) or NIROYAL (n = 94) coronary stents in a single tertiary referral center from July 1997 to December 1998. Mean follow-up duration for the NIR and NIROYAL patient groups were 11.6 and 11.4 (range, 3-12) months, respectively. Stent thrombosis rates were 3/87 (3%) in the NIR and 0/94 (0%) in the NIROYAL group (P = 0.07). The need for target lesion revascularization (TLR) in the NIR patient group was 8/87 (9%) compared to 11/94 (12%) in the NIROYAL patient group (P = 0.6). The overall MACE rates for the NIR and NIROYAL patient groups were 24/87 (28%) and 22/94 (23%), respectively (P = 0.5). The present study, hence, implies equivalence between the stainless steel NIR and the gold-plated NIROYAL stent with no significant difference in immediate and long-term clinical performance profiles.     

Factors predictive of cardiac events and restenosis after sirolimus-eluting stent implantation in small coronary arteries.

OBJECTIVES: Predictors of cardiac events and restenosis after sirolimus-eluting stent (SES) implantation in small coronary arteries were evaluated. BACKGROUND: Although SES implantation has markedly reduced the risk of restenosis, small vessel disease remains a major cause of SES failure. METHODS: We prospectively investigated the factors predictive of cardiac events and restenosis in 1,092 consecutive patients who received SES implantation for 1,269 lesions in small coronary arteries (< or = 2.8 mm). Follow-up angiography at 6 months was performed in 751 patients with 889 lesions (follow-up rate 70.3%). RESULTS: Restenosis (diameter stenosis > or = 50%) was angiographically documented in 65 patients with 77 lesions (8.7%): 55 focal (71.4%), 8 diffuse (10.4%), 2 diffuse proliferative (2.6%), and 12 total (15.6%). Lesion length, stent length, reference artery size, and in-stent restenotic lesions were univariate predictors of restenosis. By multivariate analysis, lesion length (OR 1.04; 95% CI 1.02-1.05; P < 0.001) and in-stent restenotic lesions (OR 3.38; 95% CI 1.80-6.35; P < 0.001) were significant independent predictors of restenosis. During follow-up (23.2 +/- 7.9 months), there were 17 deaths (5 cardiac and 12 noncardiac), 5 nonfatal Q-wave myocardial infarctions, and 42 target lesion revascularizations. The cumulative probability of survival without major adverse cardiac events (MACE) was (96.6 +/- 0.6)% at 1 year and (95.1 +/- 0.7)% at 2 years. In multivariate analysis, lesion length (HR 1.04; 95% CI 1.01-1.07; P = 0.004) and in-stent restenotic lesions (HR 3.29; 95% CI 1.58-6.86; P = 0.001) were independently related to MACE. CONCLUSIONS: SES implantation in small coronary arteries is safe and effective, with lesion length having a major impact on restenosis and MACE.     

Predictors of restenosis after placement of drug-eluting stents in one or more coronary arteries

Although drug-eluting stents (DESs) have been increasingly used in a wide variety of clinical and anatomic situations, limited data are available regarding the predictors of DES failure in unselected lesions. We investigated the incidence and predictors of restenosis after implantation of DESs in routine clinical practice. A total of 1,795 consecutive patients underwent successful implantation of sirolimus-eluting (1,374 patients, 1,788 lesions) or paclitaxel-eluting (421 patients, 517 lesions) stents. Of the 1,743 eligible patients (2,221 lesions), follow-up angiography at 6 months was obtained for 1,228 patients (70.5%, 1,577 lesions). All data were prospectively recorded and analyzed to predict the occurrence of restenosis, defined as a diameter stenosis of > or =50%. Restenosis was documented in 125 patients with 138 lesions (8.8%), and target lesion revascularization was required in 70 patients with 82 lesions (5.2%). The pattern of restenosis was 85 focal (62%), 29 diffuse (21%), 11 diffuse proliferative (8%), and 13 total (9%). Lesion length, stent length, postintervention minimal lumen diameter, preintervention minimal lumen diameter, reference artery size, complex lesions, and use of a paclitaxel-eluting stent were univariate predictors of restenosis. Multivariate analysis showed that the use of a paclitaxel-eluting stent (odds ratio [OR] 4.37, 95% confidence interval [CI] 2.90 to 6.58, p <0.001), postintervention minimal lumen diameter (OR 0.32, 95% CI 0.20 to 0.50, p <0.001), and lesion length (OR 1.02, 95% CI 1.01 to 1.04, p <0.001) were independent predictors of restenosis. In conclusion, the rate of restenosis after DES implantation in routine clinical practice was similar to the rate reported in clinical trials, confirming the efficacy of DES in routine clinical practice.     

Low restenosis rate of the NIR coronary stent: results of the Danish multicenter stent study (DANSTENT)--a randomized trial comparing a first-generation stent with a second-generation stent

Background Larger studies evaluating the angiographic results of second-generation stents are scarce. The objectives of this study were to assess current standards of angiographic and clinical outcomes after implantation of the second-generation stainless steel stent, NIR (Medinol Ltd, Tel Aviv, Israel), and to compare the outcomes with those of the first-generation Palmaz-Schatz (PS) stent (Johnson & Johnson, Warren, NJ). Methods Patients having coronary artery lesions that could be covered by a stent of 15 mm in length were randomly assigned to receive the NIR or the PS. Procedural success, 6-month angiographic findings, and 1-year clinical outcomes were determined. Results In 424 patients included in the study, the overall procedural success rate was high (NIR 98%, PS 99%, P = .90). Follow-up angiography was conducted in 91% of the patients. The overall rate of angiographic restenosis was low in both groups (NIR 9.9%, PS 12.6%, P = .35). We found a low restenosis rate in vessels with a minimal lumen diameter >3.1 mm after the procedure, particularly in the NIR group (<6%). The rate of target lesion revascularization after 1 year did not differ (NIR 12%, PS 10%, P = .47). Conclusions The angiographic and clinical outcomes after implantation of the second-generation stainless steel stent were not significantly better than those of the first-generation stent. The low restenosis rates, particularly in patients with the largest minimal lumen diameters after stent implantation, warrants circumspection when planning the evaluation of newer stent technologies that aim to further reduce coronary restenosis. (Am Heart J 2003;145:e5.)     

Longitudinal straightening effect of stents is an additional predictor for major adverse cardiac events. Austrian Wiktor Stent Study Group and European Paragon Stent Investigators

OBJECTIVES: The aim of this study was to perform an investigation of the effects of the longitudinal straightening of coronary arteries by stents and the possible association with major adverse cardiac events (MACE) (primary end point) and angiographic restenosis (secondary end point). BACKGROUND: Stent deployment straightens a tortuous artery, and any consequent arterial longitudinal stretch may contribute to MACE and stent restenosis severity. METHODS: Clinical, qualitative and quantitative angiographic data on 404 patients with single stent implantation were subjected to multivariate nominal logistic regression analysis for the prediction of MACE. The predictive accuracy, sensitivity and specificity values and cut-off points of the continuous variables were determined via receiver operating characteristics curves. The longitudinal straightening effect of stents was characterized through the changes in vessel angle (defined by the tangents to the proximal and distal parts of the stenoses/stents). RESULTS: Follow-up angiography on 354 patients revealed 73 cases of stent restenosis (> or =50% diameter stenosis). Coronary bypass surgery was performed in 4 patients and repeated percutaneous transluminal coronary angioplasty in 56 patients; acute myocardial infarction (AMI) occurred in 2 patients, and 4 patients died during the follow-up. The overall incidence of MACE (death, AMI and revascularization) was 16.3% (66 patients). The best predictive accuracies and sensitivities/specificities of factors indicative of MACE were found for the minimal lumen diameter (MLD) at follow-up (predictive accuracy: 0.9305, sensitivity/specificity: 86.6%), the post-stent MLD (0.773, 77.2%), the percent diameter stenosis (%DS) at follow-up (0.9432, 87.1%), the prestent vessel angulation (0.6797, 68.2%) and the poststent changes in vessel angulation (0.6279, 62.2%). Multivariate nominal logistic regression analysis demonstrated that a poststent MLD < or =2.63 mm (p = 0.0017, odds ratio [OR] = 17.961, 95% confidence interval [CI] = 17.45-20.428), an MLD at follow-up < or =1.7 mm (p = 0.0059, OR = 11.880, 95% CI = 11.490-14.093), a %DS at follow-up > or =42.2% (p = 0.0000, OR = 49.553, 95% CI = 48.024-53.507), a prestent vessel angulation > or =33.5 degrees (p = 0.0477, OR = 5.404, 95% CI = 5.382-7.142) and poststent changes in vessel angulation > or =9.1 degrees (p = 0.0026, OR = 19.161, 95% CI = 18.562-21.750) were significant predictors for MACE. Multiple linear regression revealed that the poststent MLD (multivariate p = 0.0001), the MLD at follow-up (p = 0.0000), the prestent vessel angulation (p = 0.0431) and the changes in vessel angulation after stent implantation (p = 0.0316) were significant independent variables predicting angiographic stent restenosis severity. CONCLUSIONS: The longitudinal straightening effect of coronary artery stents contributes significantly to the occurrence of MACE and angiographic restenosis, and this finding may have an impact on future stent design.     

A randomized comparison of the value of additional stenting after optimal balloon angioplasty for long coronary lesions: final results of the additional value of NIR stents for treatment of long coronary lesions (ADVANCE) study

OBJECTIVES: We sought to investigate the clinical benefit of additional stent implantation after achieving an optimal result of balloon angioplasty (BA) in long coronary lesions (>20 mm). BACKGROUND: Long coronary lesions are associated with increased early complications and late restenosis after BA. Stenting improves the early outcome, but stent restenosis is also related to both lesion length and stent length. METHODS: A total of 437 patients with a single native lesion 20 to 50 mm in length were included and underwent BA, using long balloons matched to lesion length and vessel diameter (balloon/artery ratio 1.1) to achieve a diameter stenosis (DS) <30% by on-line quantitative coronary angiography (QCA). "Bail-out stenting" was performed for flow-limiting dissections or >50% DS. Patients in whom an optimal BA result was achieved were randomized to additional stenting (using NIR stents) or no stenting. The primary end point was freedom from major adverse cardiac events (MACE) at nine months, and core laboratory QCA was performed on serial angiograms. RESULTS: Bailout stenting was necessary in 149 patients (34%) and was associated with a significantly increased risk of peri-procedural infarction (p < 0.02). Among the 288 randomized patients, the mean lesion length was 27+/-9 mm, and the vessel diameter was 2.78+/-0.52 mm. The procedural success rate was 90% for the 143 patients assigned to BA alone (control group), as compared with 93% in the 145 patients assigned to additional stenting (stent group), which resulted in a superior early minimal lumen diameter (0.54 mm, p < 0.001) and led to reduced angiographic restenosis (27% vs. 42%, p = 0.022). Freedom from MACE at nine months was 77% in both groups. CONCLUSIONS: A strategy of provisional stenting for long coronary lesions led to bailout stenting in one-third of patients, with a threefold increase in peri-procedural infarction. Additional stenting yielded a lower angiographic restenosis rate, but no reduction in MACE at nine months.     

Immediate and mid-term outcomes of sirolimus-eluting stent implantation for chronic total occlusions.

AIMS: To evaluate the outcomes of sirolimus-eluting stent (SES) implantation for the treatment of chronic total occlusion (CTO). METHODS AND RESULTS: We identified 122 patients who underwent revascularization in CTO lesions with SES from April 2002 to April 2004 (SES group). A control group was composed of 259 consecutive patients with CTO lesions treated with bare metal stents (BMS) in the 24 months immediately before the introduction of SES (BMS group). At 6-month follow-up, the cumulative rate of major adverse cardiac events (MACE) was 16.4% in the SES group and 35.1% in the BMS group (P<0.001). The incidence of restenosis was 9.2% in the SES group and 33.3% in the BMS group (P<0.001). The need for revascularization in the SES group was significantly lower, both target lesion revascularization (7.4 vs. 26.3%, P<0.001) and target vessel revascularization (9.0 vs. 29.0%, P<0.001). BMS implantation (HR: 2.97; 95% CI: 1.80-4.89; P<0.001), lesion length (>20 mm) (HR: 2.02; 95% CI: 1.37-2.99; P=0.0004), and baseline reference vessel diameter (>2.8 mm) (HR: 0.62; 95% CI: 0.42-0.92; P=0.02) were identified as predictors of MACE during 6-month follow-up. CONCLUSION: Compared with BMS, SES implantation in CTO lesions appears to be effective in reducing the incidence of restenosis and the need for revascularization at 6 months.     

Three-year follow-up after intracoronary beta-radiation therapy for in-stent restenosis.

BACKGROUND: Most studies that proved intracoronary radiation therapy (IRT) to be highly effective to reduce recurrent restenosis after treatment of in-stent restenosis (ISR) have looked at time periods up to 12 months. Whether the beneficial effect from radiation is sustained during long-term follow-up remains a concern. This study sought to evaluate the effectiveness of IRT using a beta-emitter during a 3-year follow-up period. METHODS: One hundred twenty-eight consecutive symptomatic patients (mean age, 63 +/- 11 years) with 134 in-stent restenotic lesions were treated for ISR with IRT (noncentred beta-emitter, Novoste; radiation dosis 21.1 +/- 3.1 Gy). Six-month angiographic follow-up was obtained in 104 patients (81%) with 105 lesions (78%). All patients underwent 36-month clinical follow-up. RESULTS: Six-month angiographic restenosis rate was 22% in stent (29% in lesion) with an in-stent late loss of 0.49 +/- 0.62 mm. Target lesion resvascularization (TLR) at 6-month follow-up was performed in 23 cases (18%). MACE (death, myocardial infarction, and target vessel revascularisation) was observed in 24 patients (19%). At 36-month follow-up, TLR increased to 36 cases (28%) and MACE was observed in 47 patients (37%). In a multivariate analysis, minimal lumen diameter before treatment of ISR using IRT was the only predictor of recurrent TLR at 36 months (OR = 0.131; 95% CI, 0.068-0.254; p = 0.002). In a subgroup of patients (N = 15) without restenosis at 6-month angiography but with clinically driven recurrent late angiography (mean, 18 +/- 7 months); in-lesion late loss increased from 0.47 +/- 0.54 mm at 6 months to 1.27 +/- 0.76 mm at repeated angiography (p = 0.005). CONCLUSION: There is a considerable number of delayed recurrent restenosis post IRT for ISR. This is due to ongoing late loss more than 6-month post IRT. The minimal lumen diameter before IRT predicts the need for recurrent TLR at 36 months.     

Intravascular ultrasound predictors of major adverse cardiac events in patients with unstable angina

BACKGROUND: Intravascular ultrasound (IVUS) predictors of native culprit lesion morphology for occurrence of major adverse cardiac events (MACE) have not been reported. Moreover, the published data on IVUS predictors of restenosis include patients with stable and unstable angina, although the development and progression of atherosclerosis related to unstable coronary syndrome is different from that of stable angina. HYPOTHESIS: This study investigated whether IVUS-derived qualitative and quantitative parameters of native (preangioplastic) plaque morphologic features can predict major adverse cardiac events in patients with unstable angina. METHODS: Clinical (age, gender, coronary risk factors), qualitative and quantitative angiographic (lesion localization, morphology, pre- and postangioplastic minimal lumen diameter, reference diameter, and percent diameter stenosis), and IVUS variables (soft/fibrocalcific plaque, calcification, presence of thrombus or plaque disruption, different types of arterial remodeling, pre- or postangioplastic minimal lumen, external elastic membrane and plaque cross-sectional area, and plaque burden of the target lesion and reference segments) were analyzed by regression analyses using the Cox model, assuming proportional hazards. RESULTS: Of 60 consecutively enrolled patients, 21 suffered from MACE, while 39 remained event-free during the followup period. Multivariate regression analyses revealed that the presence of adaptive remodeling [p = 0.0177, risk ratio (RR) = 3.108, with 95% confidence interval (CI) = 1.371-8.289] and the preangioplastic lumen cross-sectional area (p = 0.0130, RR = 0.869, with 95% CI = 0.667-0.913) are independent predictors of MACE during follow-up, as is postangioplastic angiographic minimal lumen diameter (p = 0.0330, RR = 0.715 with 95% CI = 0.678-0.812). CONCLUSIONS: Adaptive remodeling and preangioplastic lumen cross-sectional area determined by IVUS and postangioplastic minimal lumen diameter calculated by quantitative angiography are significant independent predictors of time-dependent MACE in patients with unstable angina.     

Comparison of one-year cardiac events with drug-eluting versus bare metal stent implantation in rescue coronary angioplasty

Rescue percutaneous coronary intervention (PCI) with bare metal stent (BMS) implantation is useful in patients with acute myocardial infarction (AMI) and failed thrombolysis. Drug-eluting stent (DESs) are more effective in reducing restenosis compared to BMS. No data are available comparing the clinical outcomes between the 2 types of stents nor has information ever been provided about the predictors of events in patients treated with rescue PCI in the current era. The aims of the present study were to evaluate the outcomes of patients undergoing rescue PCI with DES implantation compared to BMS implantation and to determine the independent predictors of events during 1 year of follow-up. The study population consisted of 311 consecutive patients with ST-segment elevation AMI and evidence of failed fibrinolysis undergoing successful revascularization with DES (n = 134) or BMS (n = 177) implantation. The end point of the present study was the incidence of major adverse cardiac events (MACE) defined as death, recurrent AMI, and target vessel revascularization. No differences were found in the number of MACE at 1 year of follow-up between the DES and BMS groups (n = 10 and 19, respectively, p = 0.29). The Cox proportional hazards model identified cardiogenic shock (adjusted hazard ratio 7.05, 95% confidence interval 2.08 to 23.9, p = 0.001), age (hazard ratio 1.51, 95% CI 1.09 to 2.08, p = 0.011), and final minimal lumen diameter (hazard ratio 0.42, 95% confidence interval 0.21 to 0.83, p = 0.013) as independent predictors of MACE at 1 year of follow-up. After propensity score adjustments, the predictors did not change. In conclusion, we found no differences between DESs and BMSs with respect to MACE at 1 year of follow-up in patients with AMI treated with rescue PCI. Cardiogenic shock, age, and final minimal luminal diameter were identified as predictors of MACE.     

Long-term outcomes after stenting of bifurcation lesions with the "crush" technique: predictors of an adverse outcome.

OBJECTIVES: The purpose of this study was to evaluate predictors of an adverse outcome after "crush" bifurcation stenting. BACKGROUND: The "crush" technique is a recently introduced strategy with limited data regarding long-term outcomes. METHODS: We identified 231 consecutive patients treated with drug-eluting stent implantation with the "crush" technique for 241 de novo bifurcation lesions. Clinical follow-up was obtained in 99.6%. RESULTS: The in-hospital major adverse cardiac event (MACE) rate was 5.2%. At 9 months, 10 (4.3%) patients had an event consistent with possible post-procedural stent thrombosis. Survival free of target lesion revascularization (TLR) was 90.3%; the only independent predictor of TLR was left main stem (LMS) therapy (odds ratio [OR] 4.97; 95% confidence interval [CI] 2.00 to 12.37, p = 0.001). Survival free of MACE was 83.5% and independent predictors of MACE were LMS therapy (OR 3.79; 95% CI 1.76 to 8.14, p = 0.001) and treatment of patients with multivessel disease (OR 4.21; 95% CI 0.95 to 18.56, p = 0.058). Angiographic follow-up was obtained in 77% of lesions at 8.3 +/- 3.7 months. The mean late loss of the main vessel and side branch were 0.30 +/- 0.64 mm and 0.41 +/- 0.67 mm, respectively, with binary restenosis rates of 9.1% and 25.3%. Kissing balloon post-dilation significantly reduced the side branch late lumen loss (0.24 +/- 0.50 mm vs. 0.58 +/- 0.77 mm, p < 0.001). CONCLUSIONS: The crush technique of bifurcation stenting with drug-eluting stents is associated with favorable outcomes for most lesions; however, efficacy appears significantly reduced in LMS bifurcations, and further research is needed before the technique can be routinely recommended in this group. Furthermore, the incidence of possible stent thrombosis is of concern and requires further investigation. Kissing balloon post-dilatation is mandatory to reduce side branch restenosis.     

Intracoronary Stenting for Restenosis: Long-Term Follow-up: A Single Center Experience

One-hundred thirteen stents (78 Wallstents, 29 Palmaz-Schatz and 6 Wiktor) were implanted in 106 patients aged 63 +/- 5 years to treat a restenosis following previous angioplasty in a native coronary artery (86 cases) and in a venous graft (20 cases). Implantation was technically possible in all cases. The native vessels had a mean reference diameter of 3.3 +/- 0.3 mm and their mean minimal lumen diameter increased from 1.2 +/- 0.3 mm before angioplasty to 2.8 +/- 0.8 after stent implantation. The venous grafts mean reference diameter was 4.4 +/- 0.7 mm and their mean minimal lumen diameter increased from 1.3 +/- 0.4 mm before angioplasty to 4.0 +/- 0.7 mm after implantation. Percentage stenosis in the native arteries and in the venous grafts were respectively 78 +/- 13% and 69 +/- 14% before angioplasty and 24 +/- 8% and 22 +/- 8% after stent implantation. Complications at 6 months, presented as a ranking scale with 100% follow-up rate were, overall, of 20% clinical events (4% deaths, 6% myocardial infractions, 2% coronary artery bypass grafting and 8% re-angioplasty). Angiographic complications were of 8% subacute thrombosis and 19% restenosis and chronic occlusions. Long-term, at 65 +/- 9 months, clinical (86% follow-up) and angiographic (74% follow-up) showed that only a further 9% clinical events and 14% restenosis (12% of them between 6 and 12 months) occurred after 6 months. At an estimated follow-up time of 104 months, 70% patients remain event-free and the survival rate is 95%. In conclusion, stent implantation in the treatment of restenosis following conventional balloon angioplasty is a valid strategy with good long-term results.     

A meta-analysis of randomized controlled trials appraising the efficacy and safety of cilostazol after coronary artery stent implantation

Objectives: To evaluate the impact of cilostazol on the angiographic and clinical outcomes in patients undergoing percutaneous coronary intervention (PCI) with stents and treated with aspirin and thienopyridine. Methods: A total of 11 randomized controlled trials including 8,525 patients comparing triple antiplatelet therapy (aspirin, thienopyridine and cilostazol) with standard dual antiplatelet therapy were included in the analysis. The primary end points were in-segment late loss and angiographic restenosis at angiographic follow-up. Secondary end points included mortality, stent thrombosis, target lesion revascularization (TLR) and major adverse cardiac events (MACE). Results: Triple antiplatelet therapy was associated with a significant reduction in late loss [weighted mean difference 0.14, 95% confidence interval (CI) 0.08-0.20; p < 0.001] and angiographic restenosis [odds ratio (OR) 0.58, 95% CI 0.48-0.71; p < 0.001]. Addition of cilostazol to dual antiplatelet therapy was associated with a significant reduction in TLR (OR 0.56, 95% CI 0.41-0.77; p < 0.001) and MACE (OR 0.72, 95% CI 0.60-0.86; p < 0.001) with no differences in mortality (p = 0.29), stent thrombosis (p = 0.60) or bleeding episodes (p = 0.77). Conclusions: Cilostazol in addition to dual antiplatelet therapy appears to be effective in reducing the risk of restenosis and repeat revascularization after PCI without any significant benefits for mortality or stent thrombosis.     

Usefulness of intravascular low-power laser illumination in preventing restenosis after percutaneous coronary intervention

Despite the several years of studies, no factor that could reduce the restenosis rate without significant limitations has been introduced. The aim of the present study was to evaluate the influence of low-power 808-nm laser illumination of coronary vessels after percutaneous angioplasty in preventing restenosis. The procedure of laser intravascular illumination was performed on 52 patients (laser group), and another 49 patients formed the control group. All patients were monitored for major adverse cardiac events (MACE) at the 6- and 12-month follow-up points. The MACE rate after 6 and 12 months was 7.7% in the laser group at both points. The MACE rate was 14.3% and 18.5% at 6 and 12 months of follow-up in the control group, respectively (p = NS). Follow-up coronary angiography was performed after 6 months. The difference in the restenosis rate was insignificant (15.0% vs 32.4%); however, significant differences were observed in the minimal lumen diameter (2.18 ± 0.70 vs 1.76 ± 0.74 mm; p < 0.05), late lumen loss (0.53 ± 0.68 vs 0.76 ± 0.76 mm; p < 0.01), and the late lumen loss index (0.28 ± 0.39 vs 0.46 ± 0.43; p < 0.005) in favor of the laser group. In conclusion, the new therapy seemed effective and safe. Marked differences between late loss, late loss index, and minimal lumen diameter were observed. The late lumen loss in the laser group was only slightly greater than that in studies of drug-eluting stents, and MACE rate remained within very comparable ranges. This suggests that intravascular laser illumination could bring advantages comparable to those of drug-eluting stents without the risk of late thrombosis.     

The Canadian study of the sirolimus-eluting stent in the treatment of patients with long de novo lesions in small native coronary arteries (C-SIRIUS)

OBJECTIVES: We assessed the safety and effectiveness of the sirolimus-eluting stent (SES) in treating single de novo long lesions in small native coronary arteries compared to an identical bare metal stent (BMS). BACKGROUND: The SES was previously demonstrated to reduce restenosis significantly. However, patients with long lesions in small vessels have not been well studied and may define a group at very high risk. METHODS: The Canadian Study of the Sirolimus-Eluting Stent in the Treatment of Patients With Long De Novo Lesions in Small Native Coronary Arteries (C-SIRIUS) was a multicenter, randomized, double-blind trial comparing SES versus identical BMS. The primary end point was in-stent minimal lumen diameter (MLD) at eight months. Secondary end points included angiographic restenosis at 8 months, target lesion revascularization (TLR), and major adverse cardiac events (MACE) at 270 days. RESULTS: A total of 100 patients were enrolled at eight Canadian sites. The in-stent MLD at eight months was 2.46 +/- 0.37 mm in the SES compared with 1.49 +/- 0.75 mm in the BMS (a 65% increase, p < 0.001). Angiographic restenosis occurred in 1 of 44 SES patients (2.3%, with no in-stent restenosis) and in 23 of 44 BMS patients (52.3%, p < 0.001). At 270 days, there were two clinically driven TLRs in the SES (4%) and nine in the BMS (18%, p = 0.05). The Kaplan-Meier estimate of freedom from MACE at 270 days was 96.0% for SES patients and 81.7% for BMS patients (p = 0.029). CONCLUSIONS: Patients with long lesions in small vessels are at very high risk of restenosis. In these patients, the SES dramatically reduces the risk of restenosis at eight months, translating into an excellent clinical outcome at nine months.     

Drug-eluting stent-supported percutaneous coronary intervention for chronic total coronary occlusion.

OBJECTIVES: This study sought to determine the clinical and angiographic outcomes after drug-eluting stent (DES)-supported percutaneous coronary intervention (PCI) for chronic total coronary occlusion (CTO). BACKGROUND: There are few data about the efficacy of DES-supported PCI for CTO. METHODS: All consecutive patients who had a sirolimus-eluting stent or a paclitaxel-eluting stent implanted for CTO from December 2003 to December 2004 were analyzed. Clinical and angiographic outcomes of patients treated with DES were compared with a case-matched control group of patients treated with bare metal stents (BMS) in the 12 months before the routine use of DES. RESULTS: Successful DES-supported PCI was performed in 92 patients and 104 CTO. The case-matched control group consisted of 26 patients and 27 CTO successfully treated with BMS. There were no differences between groups in baseline clinical and angiographic characteristics. Stent length in the DES group was higher as compared with that of BMS group (51+/-28 mm vs. 40+/-19 mm, P=0.073). The 6-month major adverse cardiac event (MACE) rate was lower in the DES group as compared with that of BMS group (9.8% vs. 23%, P=0.072). The angiographic follow-rate was 80% in the DES group and 81% in the BMS group. The 6-month restenosis rate was 19% in the DES group and 45% in the BMS group (P<0.001). By multivariate analysis, it was found that in the DES group, the only predictors of restenosis were stented segment length (OR 1.031, 95% CI 1.01-1.06, P=0.009) and a target vessel reference diameter<2.5 mm (OR 6.48, 95% CI 1.51-27.83, P=0.012), while the only predictor of MACE was stent length (OR 1.04, 95% CI 1.01-1.08, P=0.006). CONCLUSIONS: DES implantation for CTO decreases the risk of mid-term restenosis and MACE. Small vessels and diffuse disease requiring the implantation of multiple stents and very long stents for full coverage of the target lesion are still associated with a relatively high risk of restenosis.     

Impact of carbon coating on the restenosis rate after stenting of atherosclerotic renal artery stenosis.

PURPOSE: To investigate the impact of carbofilm coating and low-profile rapid exchange stent devices on the restenosis rate after stent-angioplasty of atherosclerotic renal artery stenosis (RAS). METHODS: During a 2-year period (7/2002-7/2004), 143 consecutive patients with 179 primary ostial atherosclerotic RAS>or=70% diameter stenosis were treated with stents selected at the discretion of the operator. Eighteen patients (32 lesions) treated with 9 different types of stents were excluded from the analysis, leaving 125 patients (69 men; mean age 67 years, range 42 to 90) with 147 lesions who received either a Radix carbofilm-coated stent in 78 (53%) lesions (68 [54%] patients) or a Palmaz Genesis bare stainless steel stent in 69 (47%) lesions (57 [46%] patients). The target vessel diameter ranged from 5 to 7 mm. RESULTS: Baseline characteristics were similar in both groups except the mean stent diameter, which was larger in the bare stent cohort (6.4+/-0.7 versus 5.9+/-0.5 mm, p<0.001). Primary success was 100% in both groups; the initial mean diameter stenosis was reduced from 79%+/-14% and 80%+/-14% in the coated versus bare stent groups to 3+/-5% and 2+/-6%, respectively. After a mean follow-up of 22+/-5 months, the restenosis rate was 6.4% for the coated stent and 5.8% for the bare stent (p=0.87). For the entire cohort, restenosis rates varied significantly (p<0.05) according to stent diameter: 19% (5/26) for 5 mm, 4% (3/81) for 6 mm, and 2.5% (1/40) for 7 mm. In a binary logistic regression analysis including carbofilm coating, stent diameter, gender, diabetes, smoking status, and body mass index, stent diameter was the only independent predictor of restenosis (odds ratio 0.12, 95% CI 0.03 to 0.48 [p=0.003] for a 1-mm increase in vessel diameter). CONCLUSIONS: Using modern low-profile stent devices, carbofilm coating does not significantly reduce the restenosis rate compared to a bare metal stent. With contemporary stent devices, the restenosis rate has been decreasing compared to earlier reports in the literature.     

Clinical and sequential angiographic follow-up six months and 10 years after successful percutaneous transluminal coronary angioplasty

Sequential angiographic follow-up is needed for interpreting coronary events that occur after successful percutaneous translumial coronary angioplasty (PTCA). One hundred eight consecutive patients who had undergone successful dilatation were followed for 10 years, and quantitative sequential angiograms were recorded at 6 months (n = 101) and 10 years (n = 68). The 10-year event rate was: 5.8 +/- 2.4% for cardiac death, 9.7 +/- 3.3% for Q-wave acute myocardial infarction, 18.3 +/- 4.5% for additional surgery, and 22.4 +/- 4.9% for repeated angioplasty. Using Cox's proportional-hazards regression, multivessel coronary artery disease (CAD) (RR 5.6; 95% confidence intervals [CI] 1.2 to 24.7; p = 0.02), restenosis within 6 months (RR 7.8; 95% CI 3.1 to 20.0; p = 0.0001), and CAD progression over 10 years (RR 10.6; 95% CI 1.3 to 87.1; p = 0.004) were the strongest predictors of all-cause death, repeated PTCA, and additional surgery, respectively, after controlling for age and coronary risk factors. The minimal luminal diameter of 48 narrowings with complete sequential angiographic follow-up and without restenosis remained stable from 6 months (2.13 +/- 0.60 mm) to 10 years (2.18 +/- 0.61 mm). Disease progression was similar in nondilated arteries and dilated arteries (32% vs 30%). The 10-year risk of coronary events was higher in patients with baseline multivessel CAD than in those with 1-vessel CAD because of more frequent progression of CAD (RR 3.8; 95% CI 1.6 to 6.8; p = 0.001). Thus, early cardiac events after successful PTCA were related to restenosis, and late events to CAD progression. Nevertheless, after the restenosis period, the target lesion remained stable for the next 10 years. Coronary disease progression was not related to the angioplasty procedure.     

Comparison of early and late results of a Carbofilm-coated stent versus a pure high-grade stainless steel stent (the Carbostent-Trial)

The long-term success of coronary interventions with stents is largely determined by the development of restenosis. The aim of this study was to compare a Carbofilm-coated and a pure stainless steel stent with regard to early and late adverse events. In this prospective, randomized trial, the Carbofilm-coated Carbostent and Sirius stent (same stent design, newly developed delivery system) were compared with the stainless steel stents S660, S670, and S7 (newly developed delivery system, same principal stent design with a few changes). The primary end point was relative late luminal loss, and secondary end points were diameter stenosis at 6 months, rate of restenosis, and major adverse cardiac events (MACEs) (myocardial infarction, reintervention, and death). From March 2000 to June 2002 at 18 centers in Canada and Europe, 420 patients were randomized. Relative late luminal loss (Carbofilm 28.9 +/- 23.0% vs stainless steel 26.7 +/- 20.2%, p = 0.95) as the primary end point, absolute late luminal loss (1.00 +/- 0.72 vs 0.93 +/- 0.62 mm, p = 0.95), net gain (1.32 +/- 0.82 vs 1.40 +/- 0.74 mm, p = 0.75), and the degree of stenosis (40.7 +/- 22.9% vs 38.0 +/- 20.1%, p = 0.92), as well as restenosis rates (23.5% vs 15.9%, p = 0.09) and MACEs (20.1% vs 13.7%, p = 0.11) were not significantly different. Thus, the Carbofilm coating of stents does not lead to an improvement in angiographic results or a reduction of restenosis rate and MACEs. These results agree with other trials using inactive coatings on stents, which also could not demonstrate any advantage over pure stainless steel stents.     

Percutaneous and surgical interventions for in-stent restenosis: long-term outcomes and effect of diabetes mellitus

OBJECTIVE: We examined long-term outcomes of patients with in-stent restenosis (ISR) who underwent different percutaneous interventions at the discretion of individual operators: balloon angioplasty (BA), repeat stent or rotational atherectomy (RA). We also examined long-term outcomes of patients with ISR who underwent coronary artery bypass surgery (CABG). BACKGROUND: In-stent restenosis remains a challenging problem, and its optimal management is still unknown. METHODS: Symptomatic patients (n = 510) with ISR were identified using cardiac catheterization laboratory data. Management for ISR included BA (169 patients), repeat stenting (117 patients), RA (107 patients) or CABG (117 patients). Clinical outcome events of interest included death, myocardial infarction, target vessel revascularization (TVR) and a combined end point of these major adverse cardiovascular events (MACE). Mean follow-up was 19+/-12 months (range = 6 to 61 months). RESULTS: Patients with ISR treated with repeat stent had significantly larger average post-procedure minimal lumen diameter compared with BA or RA (3.3+/-0.4 mm vs. 3.0+/-0.4 vs. 2.9+/-0.5, respectively, p < 0.05). Incidence of TVR and MACE were similar in the BA, stent and RA groups (39%, 40%, 33% for TVR and 43%, 40%, 33% for MACE, p = NS). Patients with diabetes who underwent RA had similar outcomes as patients without diabetes, while patients with diabetes who underwent BA or stent had worse outcomes than patients without diabetes. Patients who underwent CABG for ISR, mainly because of the presence of multivessel disease, had significantly better outcomes than any percutaneous treatment (8% for TVR and 23% for MACE). CONCLUSIONS: In this large cohort of patients with ISR and in the subset of patients without diabetes, long-term outcomes were similar in the BA, repeat stent and RA groups. Tissue debulking with RA yielded better results only in diabetic patients. Bypass surgery for patients with multivessel disease and ISR provided the best outcomes.