Simultaneous stent implantation to treat bifurcation stenoses in the pulmonary arteries: Initial results and long‐term follow up

Background : Balloon angioplasty of bifurcating pulmonary artery (PA) stenoses is often inadequate, and stent treatment often requires simultaneous implantation of two stents. This study evaluates initial results and long‐term follow up of transcatheter stent placement in bifurcating PAs. Methods : This is a retrospective review of patients (pts) who had bifurcating PA stents placed in main and lobar branches from 1993 to 2007. Results : Forty‐nine pts had bifurcating PA stents placed at a median age of 10.9 years (range 1–43 years). The mean minimum vessel diameter increased from 5.7 ± 2.5 mm to 11.0 ± 3.6 mm (P < 0.001), the mean gradient across the stenoses decreased from 37.0 ± 26.9 to 9.2 ± 13 mm Hg (P < 0.001), whereas the mean RV:FA ratio decreased from 0.76 ± 0.29 to 0.53 ± 0.24 (P < 0.001). There was one death due to severe pulmonary hemorrhage. F/U data were available in 38 pts (mean duration 6.3 ± 4.1 years, range 1.2–13.1 years). Thirty pts underwent repeat catheterizations (mean 2.3 ± 2.2 years poststent), with 26 requiring further interventions: Fifteen had balloon angioplasty alone and 11 had additional stents placed. There were no complications at f/u catheterization. Six pts underwent further palliative surgeries, although none for repair of branch PA stenoses. Conclusions : Simultaneous transcatheter placement of bifurcating PA stents provides immediate gradient relief of bifurcating stenoses in the proximal or lobar branch PAs and reduces RV systolic pressure. Further interventions can be safely performed in future procedures, and the presence of stents does not complicate future surgeries. © 2009 Wiley‐Liss, Inc.     

Stenting of stenotic or occluded iliofemoral veins,superior and inferior vena cavae in children with congenital heart disease: Acute results and intermediate follow up

Objectives:

To determine the short and intermediate term outcome following systemic venous stent placement in children with congenital heart disease.

Background:

Patients with congenital heart disease are at risk of stenosis or occlusion of systemic veins following indwelling lines or catheterizations. Stent dilation may ameliorate symptoms and open the vessel for use during future procedures. We report our acute and intermediate results.

Methods:

All patients with systemic venous stent placement in the iliofemoral veins, inferior or superior vena cava at our institution between 1998 and 2006 were included. Initial and the follow‐up catheterization data were reviewed retrospectively.

Results:

70 stents were placed in 33 patients (36 vessels). Median age was 2.6 years (0.2–14.2) and weight 11.5 kg (3.8–78.7). 17/36 vessels (47%) were occluded requiring recanalization. Following stent delivery, the mean minimum vessel diameter increased from 3.1 ± 3.2 to 7.2 ± 3.0 mm (P < 0.001). There were no major complications. Seventeen patients and vessels had a total of 62 follow‐up catheterizations, with median length of follow‐up 4.1 years (0.7–9.3). During intermediate follow up, 7/17 vessels (41%) required additional intervention. Six patients had additional balloon dilation of existing stents, and one additional stent was placed. Vessels were further dilated to 8.4 ± 3.5 mm at the last catheterization.

Conclusion:

Systemic venous stents are safe and effective in recanalizing stenosed or occluded vessels. At follow‐up, reocclusion can occur, however, previously placed stents can be safely recanalized if necessary. Future studies will determine if stenting is indicated in a broader population. © 2009 Wiley‐Liss, Inc.     

Results of stent implantation for native and recurrent coarctation of the aorta—follow‐up of up to 13 years

Background: To evaluate the mid and long‐term prognosis after stenting of native or recurrent CoA, we studied the cardiovascular parameters in the follow‐up period up to 13 years. Methods and results: Between 1993 and 2006, 68 patients underwent stent implantation for aortic coarctation (average age 25.5 years, range 5.7–65 years, average weight 65.5 kg, range 32–122 kg). Forty‐six (68%) patients were aged >17 years. Stenting was performed for native coarctation in 41 and for recurrent coarctation in 27 patients, in 23 (34%) patients with a covered stent. Redilation was carried out in 26 (38%) patients. The invasive systolic gradient decreased from mean (±SD) 25 (±15) mm Hg to 5 (±5) mm Hg (P < 0.0005). The descending aorta pressure increased from 80 (±15) mm Hg to 101 (±18) mm Hg. The systolic right arm blood pressure decreased from a mean of 153 (±24) mm Hg to 129 (±18) mm Hg (P < 0.0005). Complications like small dissections were rare. Follow‐up (6 days to 13 years, mean 41 months) was available in 66 patients, in 23 after reintervention at a mean of 71 months, range of 8 months to 10.3 years. Fifty‐one percent remained clinically hypertensive. Conclusions: Stenting of aortic coarctation gives good medium‐term results. Frequent reintervention relate to deliberately under‐dilating stents during the initial procedure. The reintervention rate has reduced since the introduction of covered stents. © 2011 Wiley‐Liss, Inc.     

Intravascular Stents in Congenital Heart Disease: Short- and Long-Term Results From a Large Single-Center Experience

Objectives. This report describes the results of the Food and Drug Administration’s phase 1 and 2 clinical trials of intravascular stents at Texas Children’s Hospital.Background. Since the late 1980s, intravascular stent implantation for the treatment of arterial and venous stenoses in congenital heart disease has been highly successful.Methods. Stents were placed in postoperative pulmonary artery (PA) stenoses, congenital PA stenoses or stenoses of systemic veins/venous anastomoses. Prospective collection of data according to protocol was done before intervention, after stent implantation and at follow-up catheterization.Results. At stent implantation, pressure gradients decreased significantly in all three groups (mean ± SD): from 46 ± 25 to 10 ± 13 mm Hg in postoperative PA stenoses (p < 0.001); from 71 ± 45 to 15 ± 21 mm Hg in congenital PA stenoses (p < 0.001); and from 7 ± 6 to 1 ± 2 mm Hg in stenoses of systemic veins/venous anastomoses stenoses (p < 0.001). Vessel diameters markedly increased: from 6 ± 3 to 12 ± 3 mm in postoperative PA stenoses (p < 0.001); from 3 ± 1 to 9 ± 1 mm in congenital PA stenoses (p < 0.001); and from 3 ± 4 to 12 ± 4 mm in stenoses of systemic veins/venous anastomoses (p < 0.001). In the postoperative and congenital PA stenoses groups, right ventricular pressure decreased (right ventricular pressure indexed to femoral artery pressure ratio): from 0.63 ± 0.2 to 0.41 ± 0.02 (p < 0.001) and from 0.71 ± 0.3 to 0.55 ± 0.35 (p = 0.04), respectively. Perfusion to a single affected lung increased from 31 ± 17% to 46 ± 14% (p < 0.001). On recatheterization (mean 14 months), results varied minimally. Repeat angioplasty of residual stent stenoses was safe and effective. Complications included four early patients with stent migration, three with stent thrombosis and two deaths. There were no late complications. Significant restenosis occurred in only three patients.Conclusions. Intravascular stents for the treatment of vascular stenoses in congenital heart disease provide excellent immediate and long-term results.     

Stent implantation is effective treatment of vascular stenosis in young infants with congenital heart disease: Acute implantation and long‐term follow‐up results

Background: Stents implantation in infants has been shown to be feasible, however, there are no published reports examining long‐term outcomes. Concerns exist regarding creation of fixed obstructions secondary to the stent if expansion to larger diameters over time is not possible. Methods: A retrospective analysis of the earliest consecutive series of infants who underwent stent placement at our institution between October 1995 and December 1999. Results: Implantation of 33 stents were attempted in 27 infants, median age = 10 (25–24) months, wt = 8.1 (3.4–14.5) kg. Stents used were as follows: 16 large, 13 medium, and 4 coronary. Acute implant success was 94%. There were three nonprocedure‐related deaths within 30 days of implantation, 1 patient was lost to follow‐up and 1 had acute stent thrombosis. The remaining 22 patients (26 stents) form the long‐term follow‐up study group. Nineteen stents underwent 33 redilations. Following latest redilation, 67.0 (37–113) months postimplantation, minimal luminal diameter increased from 7.0 ± 1.8 mm immediately following implantation to 8.7 ± 2.3 mm (P < 0.001). Seven stents were electively removed/ligated during a planned surgery. All 18 remaining in situ stents are patent without significant obstruction 102 (84–116) months following implantation. There was one late death 51 months after stent implantation. The remaining 21 patients are alive and well. Conclusions: Stent implantation in infants is safe and effective. Serial redilation is possible to keep pace with somatic growth; however, efforts should be made to implant stents with adult diameter potential in children who will not require further cardiac surgery. Implantation of small‐ and medium‐sized stents can provide effective palliation and should be considered in carefully selected infants who will ultimately require future surgery. © 2008 Wiley‐Liss, Inc.     

Acute and long‐term clinical and angiographic outcomes of coronary stenting using Palmaz‐Schatz stent and ACS Multi‐Link stent

Acute and long‐term (≥ 3 years) outcomes of coronary artery stenting using Palmaz‐Schatz and Multi‐Link stent implantations between November 1995 and October 1999 were analyzed. There were 655 Palmaz‐Schatz stent implantations in 577 lesions on 477 patients (group A) and 428 Multi‐Link stent implantations in 381 lesions on 326 patients (group B). The baseline characteristics were similar in the two groups. Group B had more complex lesions, longer stenotic lesions, and larger reference vessel sizes than group A. However, both groups had a similar in‐hospital cardiac events. Four hundred and two patients with 488 lesions in group A and 260 patients with 307 lesions in group B underwent a 6‐month follow‐up coronary angiography. The restenotic rate per lesion was 16% in both groups (P = 0.872). A 3‐year angiographic follow‐up was performed in 262 patients of group A (301 lesions) and 139 patients of group B (162 lesions), and restenosis was noted in only 3 patients (1.36%) in group A and 5 patients (4%) in group B, in which the lesion was patent at the 6‐month angiographic follow‐up. Significant increase in minimal luminal diameter was noted from 2.23 ± 0.66 mm at 6 months to 2.33 ± 0.64 mm in group A (P < 0.01), and insignificant increase from 2.23 ± 0.77 to 2.28 ± 0.82 mm was noted in group B (P = 0.27). No differences were noted between the two groups in mortality, reinfarction, recurrent angina, target lesion angioplasty, or elective coronary artery bypass surgery during a follow‐up period of 60 ± 3 months. Forty‐five patients (9.4%) in group A and 18 patients (5.5%) in group B received additional stenting procedures for newly developed lesions. The overall cardiac event‐free survival was 66% in group A and 72% in group B (P = 0.844). In conclusion, the procedural success rate, in‐hospital morbidity, 6‐month angiographic results, and long‐term (≥ 3 years) clinical and angiographic outcomes were similar with coronary stenting using either Palmaz‐Schatz or Multi‐Link stent. The stented lesions were stable; however, late regression of minimal luminal diameter was noted in both groups, and progression of atherosclerotic change in the nonstented site was noted during long‐term follow‐up. Catheter Cardiovasc Interv 2004;62:453–460. © 2004 Wiley‐Liss, Inc.     

Coarctation of the aorta treated with the Advanta V12 large diameter stent: Acute results

Objectives: To report on the early results of treatment of coarctation of the aorta by dilation with a new polytetrafluoroethylene covered stent. Background: Transcatheter dilation of aortic coarctation carries the risk of aneurysm or rupture. Covered stent implantation reduces this risk but requires a large delivery system. The Advanta V12 LD covered stent is premounted and requires a 9–11 Fr delivery system. Methods: Covered stents on balloons of a diameter sufficient to anchor the stent in the coarctation were implanted using the smallest available delivery system. Secondary dilation with larger diameter balloons was performed until the pressure gradient was <20 mm Hg and the stent was opposed to the aortic wall. Results: Twenty‐five patients with aortic coarctation underwent stent implantation. Coarctation diameter increased from (6.3 ± 3.5) mm to (14.4 ± 2.3) mm (P < 0.0001). Peak pressure gradient decreased from (25.3 ± 11.6) mm Hg to (2.5 ± 3.0) mm Hg (P < 0.0001). The stent achieved the desired diameter in all cases. There were no complications. At short‐term median follow‐up of 4.9 months, all patients are alive and well with no evidence of recoarctation or aneurysm. Conclusions: These initial results show that the covered Advanta V12LD stent is safe and effective in the immediate treatment of coarctation of the aorta through a low profile delivery system of 8–11 Fr. Long term follow up is required. © 2009 Wiley‐Liss, Inc.     

Comparison of long‐term outcomes of drug‐eluting stents and bare metal stents for saphenous vein graft stenosis

Objective : Our aim was to compare the long‐term outcomes between drug‐eluting stents and bare‐metal stents for saphenous vein graft stenosis. Background : The ideal type of stent to treat saphenous vein graft stenosis has not been clearly established. Short‐term randomized controlled trial results comparing drug‐eluting stents with bare‐metal stents for saphenous vein graft stenosis are conflicting, intermediate‐term retrospective studies and meta‐analyses at two years suggest no difference in outcomes, and there are no long term follow‐up studies. The need for long term follow‐up data has become emerged with concern over late stent thrombosis. Methods : 246 saphenous vein graft patients undergoing stenting from August 2002–December 2008 were studied. Overall survival and event‐free survival were compared by Kaplan‐Meier method. Hazard ratios (HR) were calculated by Cox‐proportional hazards models. Results : We treated 133 patients with DES (median follow‐up four years) and 113 patients with BMS (median follow‐up four years) for SVG stenosis. Overall survival (77.0% ± 3.9% vs. 70.6% ± 4.6%, log‐rank P = 0.60) and MACE‐free survival (57.5% ± 4.6% vs. 56.8% ± 4.9, log‐rank P = 0.70) were not significantly different between the DES and BMS groups. Although BMS was associated with increased risk of target lesion revascularization (TLR) (freedom from TLR 85.2% ± 3.5% vs. 90.0% ± 3.0%, HR 2.07, 95% CI 0.97–4.42, log‐rank P = 0.05), there was no significant difference in the freedom from myocardial infarction (86.7% ± 3.3% vs. 88.7% ± 3.2%, log‐rank P = 0.39) or target vessel revascularization (77.1% ± 4.2% vs. 76.1% ± 4.2%, log‐rank P = 0.33) between the two groups. Conclusions : Although mortality is not statistically different between DES and BMS for SVG stenosis, BMS is associated with increased risk of revascularization, thus suggesting the superiority of DES over BMS in the long term. © 2011 Wiley Periodicals, Inc.     

Comparison of sirolimus‐eluting stent,paclitaxel‐eluting stent,and bare metal stent in the treatment of long coronary lesions

Objective: This study compared the efficacy of the sirolimus‐eluting stent (SES), the paclitaxel‐eluting stent (PES), and the bare metal stent (BMS) for long coronary lesions. Background: The outcome of drug‐eluting stent (DES) implantation in long coronary lesions remains unclear. Methods: The study involved 527 patients with de novo long coronary lesions (≥24 mm), which were treated with long (≥28 mm) SESs (223 lesions), PESs (194 lesions), or BMSs (201 lesions). Results: Lesions in the SES (36.0 ± 14.9 mm, P < 0.001) and PES (36.3 ± 14.5 mm, P < 0.001) groups were longer than those in the BMS group (32.0 ± 12.3 mm), meaning the two DES groups had longer stented segments than did the BMS group. Six‐month angiographic follow‐up showed the SES (9.3%, P < 0.001) and PES (21.3%, P < 0.001) groups had lower in‐segment restenosis rates than that of the BMS group (42.5%). The rate of major adverse cardiac events (MACE) including death, myocardial infarction, and target lesion revascularization at 9 months was higher in the BMS group (26.6%) than that in the SES (13.0%, P < 0.001) and PES (15.7%, P < 0.001) groups. Posthoc analysis of the two DES groups showed that the in‐segment restenosis rate was lower for the SES than that for the PES group (P = 0.002), while the MACE rate was similar. Conclusions: The use of DESs for long coronary lesions appears to be safe and more effective than the use of BMSs in terms of restenosis and adverse clinical events. SES use was associated with lower late luminal loss and a lower angiographic restenosis rate compared with PES use. © 2006 Wiley‐Liss, Inc.     

Selective drug‐eluting stent implantation for high‐risk patients with acute ST‐elevation myocardial infarction: Rationale and safety

Background : A selective policy of drug‐eluting stent (DES) implantation in ST‐elevation myocardial infarction (STEMI) patients at high risk of restenosis may maximize the benefit from restenosis reduction and minimize risk from late stent thrombosis (LaST). Objectives : We sought to prospectively determine the safety of selective DES implantation for long lesions (>20 mm), small vessels (<2.5 mm) and diabetic patients in patients with STEMI using a prospective single‐center registry. Methods : A total of 252 patients who underwent primary PCI between January 2005 and December 2006 were included: 126 consecutive patients receiving DES were compared with 126 age‐, sex‐, and vessel‐matched controls with STEMI who received bare‐metal stents. Composite major adverse cardiovascular events (MACE) (death, AMI, and target vessel revascularization) were used as the primary outcome measure. Results : Baseline clinical and angiographic characteristics and outcomes were similar between groups except for the prespecified diabetes, lesion length, and maximum stent diameter. Long‐term outcomes at a median follow up of 34 ± 6 months showed significant reductions in reinfarction (2% vs. 11%, P = 0.03), target vessel revascularization (TVR) (10% vs. 24%, P = 0.02), and composite MACE (18% vs. 31%, P = 0.03) with DES, with no excess of death (9% vs. 7%, P = NS) or LaST (2% vs. 1%, P = NS). In a Cox multivariate model, clopidogrel cessation at long‐term follow‐up was the most powerful predictor of hierarchical MACE (HR: 5.165; 95%CI: 2.019–13.150, P = 0.001). Conclusions : Selective DES implantation in patients with high‐risk STEMI appears safe, and exposes fewer patients to the risk of LaST. A randomized comparison of selective versus routine DES use in patients with STEMI should be considered. © 2010 Wiley‐Liss, Inc.     

Long‐term risk of clinical events from stenting side branches of coronary bifurcation lesions with drug‐eluting and bare‐metal stents: An observational meta‐analysis

Objectives : To compare the long‐term risks of coronary bifurcation lesions treated with side‐branch stenting using drug‐eluting versus bare‐metal stents. Background : Side‐branch stenting is an off‐label practice, but when needed, the incidence of late adverse events may differ between drug‐eluting and bare‐metal stents. Methods : We systematically searched PubMed, and the National Institutes of Health and Cochrane Registries for studies of coronary bifurcation stenting reporting clinical outcomes over at least 5 months. Data were extracted and cross checked independently by two investigators for inclusion in an observational meta‐analysis. Clinical outcomes included major adverse clinical events (MACE), death, myocardial infarction, target vessel revascularization (TVR), and definite stent thrombosis. We used random‐effects models and meta‐regression in 6,825 subjects from 42 studies. Results : Most (79%) of the heterogeneity in MACE between treatment groups was explained by differences in stent type, side‐branch stenting, and length of follow‐up. Compared with drug‐eluting stents without side‐branch stenting, drug‐eluting stents with side‐branch stenting had a 3% higher incidence of myocardial infarction [95% confidence interval (CI) = 0.3%, 5%, P < 0.05], but no significant increase in MACE, death, TVR, or stent thrombosis. Bare‐metal stenting without side‐branch stenting had 10% (95% CI = 3%, 16%, P < 0.01) higher MACE, and 10% (95% CI = 4%, 17%, P < 0.01) higher TVR, whereas bare‐metal side‐branch stenting had 31% (95% CI = 23%, 39%, P < 0.001) higher MACE, and 19% (95% CI = 10%, 28%, P < 0.001) higher TVR. Conclusions : Side‐branch stenting has a much smaller impact on long‐term MACE with drug‐eluting stents compared with bare‐metal stents. Although this study does not support routine side‐branch stenting, when side‐branch stenting is required, drug‐eluting stents are associated with less adverse outcomes.© 2011 Wiley‐Liss, Inc.     

Angiographic outcomes with biodegradable polymer and permanent polymer drug‐eluting stents

Background : In the Intracoronary Stenting and Angiographic Results: Test Efficacy of 3 Limus‐Eluting Stents (ISAR‐TEST‐4) trial, we demonstrated the noninferiority of biodegradable polymer (BP) sirolimus‐eluting stent to permanent polymer (PP) sirolimus/everolimus‐eluting stent (Cypher/Xience‐V) on the basis of clinical outcomes. In this study, we compare the antirestenotic efficacy of these stents in ISAR‐TEST‐4 patients with paired angiographic studies. Methods : Patients with de novo coronary lesions in native vessels (excluding left main lesions) were randomly assigned to receive a BP stent or a PP stent. Endpoints of interest of this study were in‐stent late lumen loss, in‐segment binary restenosis, and restenosis morphology at 6–8‐month follow‐up angiogram. Results : Of the 2,603 patients (3,372 lesions) enrolled in ISAR TEST‐4 trial, 2,016 patients (2,637 lesions) underwent repeat angiographic examination 6–8 months after randomization: 1,006 patients (1,323 lesions) treated with BP stents and 1,010 patients (1,314 lesions) treated with PP stents. No difference was observed between BP and PP stents in in‐stent late lumen loss (0.24 ± 0.6 vs. 0.26 ± 0.5 mm, respectively, P = 0.49) or in in‐segment binary restenosis (11.6% [153 lesions] vs. 11.8% [155 lesions], P = 0.85). Focal pattern of restenosis was observed in the majority of patients receiving either BP or PP stents. The diffuse pattern of restenosis was observed in 26.8% of patients treated with BP stent and 26.5% of patients treated with PP stent (P = 0.79). Conclusion : Angiographic characteristics of restenosis after BP‐based limus‐eluting stents are similar to those of PP‐based limus‐eluting stents. © 2011 Wiley‐Liss, Inc.     

Lack of clinical long‐term benefit with the use of a drug eluting stent compared to use of a bare metal stent in saphenous vein grafts

Background: Small randomized trials have shown short‐term improved outcome with drug‐eluting stents (DES) over bare metal stent (BMS) in saphenous vein graft (SVG) interventions by reducing in‐stent restenosis and target vessel revascularization (TVR). It is not clear, however, if these benefits are maintained long term. The aim of this study is to compare the outcome in a larger cohort of patients undergoing SVG stent implantation with DES or BMS, at 2 years. Methods: From among 250 patients who underwent SVG stenting, 225 patients with available follow‐up were selected from data bases at the three participating institutions. One‐hundred‐six patients had DES (sirolimus, paclitaxel or tacrolimus eluting stent) and 119 patients had any available BMS from April 2002 to December 2006. The primary endpoint was MACE rate, a combination of cardiac death, S‐T elevation myocardial infarction (STEMI) and target lesion revascularization. Secondary end points were the individual components of the primary endpoint. Follow‐up was obtained by mailed interviews or telephone calls and review of the hospital chart. Results: The DES and BMS groups had similar age (71 ± 8 years vs. 70 ± 7 years, P = 1.0), diabetes (45% vs. 36%, P = 0.3), history of MI (58% vs. 51%, P = 0.6), EF (44% vs. 47%, P = 0.2) and previous PCI (40% vs. 35%, P = 0.4). Reference vessel diameter (3.15 ± 0.5 mm vs. 3.5 ± 0.5 mm. P = 0.001) and stent size (3.3 ± 0.4 mm vs. 3.9 ± 0.5 mm, P = 0.001) were smaller in the DES group; however, the BMS were longer (24 ± 10 mm vs. 21 ± 6 mm, P = 0.05). At one year there was a trend (P = 0.1) for lower MACE rate in the DES group, but at two years there was no difference in MACE free survival between the DES and BMS groups (81 % vs. 82%, P = 0.9). The death rate was similar (6% each) with three patients having STEMI (two in the DES and one in the BMS). TVR was also similar (14% in each group). Conclusion: In patients undergoing treatment of SVG disease with a stent, the marginal benefit of DES seen at 1 year was lost at 2‐year follow‐up. © 2008 Wiley‐Liss, Inc.     

Late target lesion revascularization after implantation of sirolimus‐eluting stent

Objectives : We evaluated the incidence, clinical presentation, and angiographic in‐stent restenosis (ISR) pattern of late target lesion revascularization (TLR) after sirolimus‐eluting stent (SES) implantation. Background : Late TLR is an unusual finding beyond 6–9 months after bare‐metal stent implantation. However, late TLR after SES implantation has not been sufficiently evaluated. Methods : The study population consisted of 804 patients with 1,020 native lesions that were patent at 6‐month follow‐up angiogram after SES implantation. Results : Late TLR was performed in 18 patients with 18 lesions (1.8%) at 24.1 ± 2.6 months (range; 18–30 months) after SES implantation. Clinical presentation of late TLR patients was silent ischemia in eight patients and recurrent angina in 10 patients, but none had an acute coronary syndrome. Angiographic ISR pattern of late TLR lesions were focal ISR in 12 lesions (67%) and diffuse ISR in six lesions (33%). Serial quantitative coronary angiographic analysis of these lesions showed a minimal lumen diameter of 2.6 ± 0.5 mm immediately after SES implantation, 2.4 ± 0.4 mm at 6‐month follow‐up and 0.7 ± 0.6 mm at 24‐month follow‐up (ANOVA P < 0.001). By stepwise multiple logistic regression analysis, the only independent predictor of late TLR was stent length (P < 0.001, OR = 1.040, 95% CI = 1.019–1.061). Conclusions : Late TLR was performed in 1.8% of 1,020 native lesions that were patent at 6‐month follow‐up angiogram. Clinical presentations of late TLR was either silent ischemia or recurrent angina, but not acute coronary syndrome. Two‐thirds of late TLR lesions had a focal angiographic ISR pattern. © 2007 Wiley‐Liss, Inc.     

Redilation of e‐PTFE covered CP stents

Objectives: To evaluate the possibility to redilate covered Cheatham‐Platinum stents during follow‐up, in particular in growing children with aortic coarctation. Background: There are no data in the literature about the redilation of ePTFE covered CP stents. Methods: Sixty covered CP stents were implanted in patients with aortic coarctation or recoarctation between January 2004 and October 2007. Seven patients (mean age 14.2 ± 3.7 years) needed to repeat the hemodynamic study due to somatic growth and increase of aortic gradient with the occurrence of systemic hypertension. Two had near‐atretic aortic coarctation, three had postsurgical recoarctation and aneurysm formation, one had native aortic coarctation associated with aneurysm of the arterial wall, and one had severe native aortic coarctation. Results: Procedures were performed a mean of 20 ± 5 months (range, 12–24 months) after the primary stent implantation. Fluoroscopy time ranged between 7 and 15 min (median, 10 min) whereas procedure time ranged between 60 and 75 min (median, 65 min). After redilation the gradient across the stenosis decreased from a median value of 35 mm Hg to a median value of 5 mm Hg. The stent diameter increased of 20–50% the predilation value. No complications occurred and angiographic controls showed that the stenoses have been relieved. Follow‐up: During a median follow‐up of 12 months (6–30 months) the results were stable without complications. Conclusion: Covered Cheatham‐Platinum stents can be easily redilated © 2008 Wiley‐Liss, Inc.     

Endovascular stents for treatment of coarctation of the aorta: Acute results and follow‐up experience

Balloon angioplasty as treatment for coarctation of the aorta is increasingly performed. Endovascular stents have been proposed as a means of improving the efficacy and safety of the procedure. In this report, we describe one institution's immediate results and clinical follow‐up after implantation of endovascular stents. Retrospective analysis for endovascular stent placement for coarctation of the aorta between 1993 and 2002 was made. The immediate hemodynamic results and clinical follow‐up were reviewed. Thirty‐two patients underwent attempted stent placement for coarctation. Twenty‐three patients had postoperative recurrent coarctation and nine had native coarctation. The systolic gradient decreased from 31 to 1.8 mm Hg (P = 0.001) and the diameter was increased 8.1 to 13.5 mm (P–0.001). Mean follow‐up was 1.5 years. The mean follow‐up gradient as assessed by sphygomomanometry was 13.1 mm Hg. Eight patients underwent 10 successful further dilations. Complications included one stent migration and one aortic dissection. The use of stents as an adjunct to balloon angioplasty in selected patients with coarctation can be performed with low complication rates and provides excellent immediate relief of obstruction with promising follow‐up. Further dilation of these stents is possible. Long‐term follow‐up is warranted. Catheter Cardiovasc Interv 2004;62:499–505. © 2004 Wiley‐Liss, Inc.     

The Paclitaxel‐Eluting Coroflex™ Stent Study II (PECOPS II) Acute and 6‐Month Clinical and Angiographic Follow‐Up, 1‐Year Clinical Follow‐Up

Background and Objectives: Paclitaxel‐coated stents have proven their efficacy for reducing restenosis in de novo coronary artery lesions and in‐stent restenoses with superiority compared to bare metal stents. This study was performed to evaluate the procedural and 1 year results of the Paclitaxel‐eluting Coroflex? Please stent in coronary artery lesions. Methods: One‐hundred and twenty‐nine patients (66.2 ± 8.2 years, 31.0% diabetics, 20.2% unstable angina, 41.8% multivessel disease) were enrolled per protocol for elective single stent deployment into native de novo or post‐PTCA restenotic coronary lesions.The mean reference diameter was 2.84 ± 0.43 mm, the lesion length 12.51 ± 4.6 mm, and the minimal lumen diameter 0.75 ± 0.29 mm. Follow‐up was performed clinically in 129/129 (100%) after 6 and 12 months and angiographically in 120/129 (93%) patients after 6 months. Results: The success rates of the procedure and deployment were 100% and 95.3%, respectively. The in‐stent late loss and the late‐loss index were 0.27 ± 0.59 mm and 0.17 ± 0.40 resulting in binary in‐stent restenoses in 16/120 (13.3%) subjects and in‐segment restenoses in 20/120 (16.7%) subjects. Major adverse cardiac events occurred in 23/129 (17.8%) during the first 6 months of follow‐up with 3/129 (2.3%) myocardial infarctions, 1/129 (0.8%) secondary to stent thrombosis. From 6 to 12 months, 2/129 (1.6%) nonlesion related PCI were performed. Conclusion: The data of the Paclitaxel‐eluting Coroflex? Please stent evaluated in PECOPS II are within the range of the other currently available Paclitaxel‐eluting stent. (J Interven Cardiol 2010;23:160‐166)     

Comparison of clinical outcomes of coronary artery stent implantation in patients with end‐stage chronic kidney disease including hemodialysis for three everolimus eluting (EES) stent designs: Bioresorbable polymer‐EES,platinum chromium‐EES,and cobalt chrome‐EES

Backgrounds

New‐generation bioresorbable polymer‐everolimus eluting stents (BP‐EES) are available. This study aimed to compare the clinical outcomes for BP‐EES compared to more established stent designs, namely the platinum chromium‐EES (PtCr‐EES) and cobalt chrome‐EES(CoCr‐EES) in patients with the end‐stage chronic kidney disease (CKD) including hemodialysis (HD).

Methods

One‐hundred‐forty‐one consecutive stents (BP‐EES [n = 44], PtCr‐EES [n = 45], and CoCr‐EES [n = 52]) were implanted in 104 patients with CKD. All patients underwent a follow‐up coronary angiography at 12 months after implantation. End‐stage CKD was defined as an estimated glomerular filtration rate (eGFR) <30 mL/min/1.73 m², or the need for HD. The following outcome variables were compared among the three stent groups after implantation and the 12‐month follow‐up: target lesion revascularization (TLR), stent thrombosis (ST), and major adverse cardiac event (MACE). Minimal stent diameter (MSD) and %diameter‐stenosis (%DS) were measured using quantitative coronary angiography.

Results

The overall rate of TLR and MACE was 14.6% and 30.8%, respectively, with no incidence of ST. Immediately after implantation, the MSD (P = 0.22) and %DS (P = 0.42) were equivalent among the three groups. However, at the 12‐month follow‐up, a tendency towards higher TLR was observed for the BP‐EES group (22.7%) compared with the PtCr‐EES (8.8%) and CoCr‐EES (9.6%) groups (P = 0.07). Late loss in lumen diameter was also significantly greater for the BP‐EES (0.51 ± 0.64 mm) group than either the PtCr‐EES (0.20 ± 0.61 mm) and CoCr‐EES (0.25 ± 0.70 mm) groups (P = 0.03).

Conclusions

BP‐EES might increase the risk of in‐stent restenosis in patients with end‐stage of CKD or the need for HD.     

Comparison of a polymer‐free rapamycin‐eluting stent (YUKON) with a polymer‐based paclitaxel‐eluting stent (TAXUS) in real‐world coronary artery lesions

Background : In selected patient cohorts the polymer‐free rapamycin‐eluting YUKON stent (A) has demonstrated noninferiority compared with the polymer‐based paclitaxel‐eluting TAXUS stent (B). To test for equivalency in unselected real‐world patients with coronary lesions of various complexities, we retrospectively compared both stent designs. Methods : A total of 410 patients with symptomatic CAD were successfully treated with A (n = 205) or with B (n = 205). Baseline clinical characteristics, coronary lesion location, lesion length, and the number of stents implanted per lesion were equally distributed between the treatment groups. All patients underwent QCA‐analysis at baseline. Clinical follow‐up with assessment of MACE and noncardiac deaths was obtained at 30 days and 6 months. Results : Nominal stent diameter was 2.96 ± 0.38 mm in Group A vs. 3.05 ± 0.42 mm in Group B (P = 0.2); nominal length of stented segmentwas 22.97 ±13.0 mm vs. 23.63 ± 10.0 (P = 0.56). Analysis of MACE after 6 months resulted in one angiographically documented stent thrombosis causing MI in B (0.2%) vs. none in A. No other MI or cardiac deaths occurred in either group, while two noncardiac deaths in A (1.0%) were reported. Fifteen target lesion revascularizations (7.3%) were performed in A vs. 7 (3.4%) in B. Differences in study endpoints at 6 months did not reach statistical significance (P > 0.05). Conclusions : Up to 6 months after PCI of real‐world coronary lesions, there were no statistically significant differences in MACE between patients treated with the polymer‐free rapamycin‐eluting YUKON stent and the polymer‐based paclitaxel‐eluting TAXUS stent. © 2008 Wiley‐Liss, Inc.     

Early and long‐term results of percutaneous coronary intervention for unprotected left main trifurcation disease

Objectives: We aimed to conduct a retrospective cohort study focusing on our 5‐year experience in the percutaneous treatment of unprotected left main (ULM) trifurcation disease. Background: Percutaneous treatment of ULM trifurcation remains a challenging and rare procedure for most interventional cardiologists. Moreover, data on long‐term outcomes are lacking. Methods: We retrieved all patients with ULM trifurcation disease treated percutaneously at our Institution since 2002, and adjudicated baseline, procedural, and outcome data. The primary end point was the long‐term rate of major adverse cardiovascular events (MACE, i.e., cardiac death, myocardial infarction, bypass surgery, or target vessel revascularization). Results: A total of 27 patients underwent percutaneous coronary intervention with stent implantation for ULM trifurcation disease, with 14 (52%) cases of true trifurcations, i.e., with concomitant significant stenoses of the distal ULM/ostial left anterior descending plus ostial ramus intermedius and ostial circumflex. Bare‐metal stents were implanted in 8 (29%) patients and drug‐eluting stents (DES) in 26 (96%), with a main branch stent only strategy in 11 (40%), T stenting in 9 (33%), and V stenting in 6 (27%). Procedural and clinical success occurred in 26 (96%), with one postprocedural death. Angiographic follow‐up was obtained in 22 patients (81%), and clinical follow‐up was completed in all subjects after a median of 28 ± 17 months, showing overall MACE in 9 (33%), with cardiac death in 4 (15%), myocardial infarction in 1 (4%), coronary artery bypass grafting (CABG) in 4 (15%), and percutaneous target vessel revascularization in 5 (19%). Definite stent thrombosis was adjudicated in 1 (3%) patient. Treatment of a true trifurcation lesion and recurrence of angina during follow‐up were significantly associated with an increased risk of MACE (P = 0.029 and P = 0.050, respectively). Conclusions: Percutaneous treatment of ULM trifurcation disease is feasible, associated with favorable mid‐term results, and may be considered given its low invasiveness in patients at high surgical risk or with multiple comorbidities. © 2008 Wiley‐Liss, Inc.