Level of agreement between three-dimensional transthoracic and transesophageal echocardiography for mitral annulus evaluation: A feasibility and comparison study.

INTRODUCTION: Mitral annulus assessment is of utmost importance for the management of patients with mitral valve (MV) abnormalities, as it helps to determine the decision for surgical or transcatheter treatment. Three-dimensional (3D) transesophageal echocardiography (TOE) has been the only reliable echocardiographic method for the evaluation of the mitral annulus by now. However, newer transthoracic echocardiography (TTE) 3D probes have enabled to provide accurate measurements as well and become a valuable tool when TOE is contraindicated. The aim of this study is to assess the feasibility of 3D TTE analysis of mitral annulus and the level of agreement with 3D TOE measurements. METHODS: A total of 121 consecutive patients were assessed with 3D TTE and TOE. All mitral annulus parameters were retrospectively analyzed with the dedicated 4D autoMVQ application. Bland-Altman analysis and intraclass correlation coefficient were used for the comparison and agreement between the two methods. Half of our patients had normal mitral valves and served as control group, while the other half had various mitral valve pathologies. RESULTS: AutoMVQ analysis was not feasible in 11 out of 121 TTE examinations (91% feasibility) and in 4 out of 121 TOE examinations (96% feasibility). Mitral annular area and perimeter were slightly larger in TTE than those measured by TOE (12.7 ± 3.6 vs. 12.4 ± 3.2 cm2 for area and 12.7 ± 1.7 vs. 12.5 ± 1.6 cm for perimeter), however still showing strong correlation (r = .942 and r = .922, respectively). The majority of mitral valve measurements (anterior-posterior, medial-lateral and commissural diameter, aorto-mitral angle and anterior leaflet length) were similar among the two methods with strong correlation (r > .80). Inter-trigonal distance, posterior leaflet length and tenting height showed weaker agreement between TTE and TOE (r = .687, r = .687, r = .634, respectively). Mitral annular dimensions (by 3D area) were found to be significantly larger in patients with MV pathology (13.5 ± 3.5 vs. 11 ± 2.3 cm2 ), atrial fibrillation (14.4 ± 3 vs. 11.4 ± 2.8 cm2 ), left ventricular (13.8 ± 3.1 vs. 11.7 ± 3.1cm2 ) and left atrial dilatation (13 ± 3.3 vs. 10.6 ± 2.3cm2 ) compared to the individuals in the control group (p < .001 for all comparisons). CONCLUSIONS: Assessment of the MV with 3D TTE with dedicated MVQ software is feasible and accurate, showing strong correlation and agreement with TOE measurements.

Percutaneous pulmonary valve implantation in the native right ventricular outflow tract.

Percutaneous pulmonary valve implantation into dysfunctional right ventricular (RV) to pulmonary artery conduits is being increasingly performed in many European and North American centers with satisfactory results and low-complication rates. We report the first application of this elaborate technique in the native RV outflow tract of a young patient who developed severe supravalvular pulmonary stenosis following an arterial switch operation for transposition of the great arteries. The procedure may be used as an alternative to surgical repair for the treatment of selected patients with supravalvular pulmonary stenosis complicating congenital heart surgery.

Improved diagnostic accuracy with 16-row multi-slice computed tomography coronary angiography.

OBJECTIVES: We sought to compare the diagnostic value of multi-slice computed tomography (MSCT) coronary angiography (CA) to detect significant stenoses (> or =50% lumen diameter reduction) with that of invasive CA. BACKGROUND: The latest 16-row MSCT scanner has a faster rotation time (375 ms) and permits scanning with a higher X-ray tube current (500 to 600 mA) during MSCT CA when compared with previous scanners. METHODS: We studied 51 patients (37 men, mean age 58.9 +/- 10.0 years) with stable angina or atypical chest pain. Patients with pre-scan heart rates > or =70 beats/min received oral beta-blockade. The heart was scanned after intravenous injection of 100 ml contrast (iodine content, 400 mg/ml). Mean scan time was 18.9 +/- 1.0 s. The MSCT scans were analyzed by two observers unaware of the results of invasive angiography, and all available coronary branches > or =2 mm were included. RESULTS: Invasive CA demonstrated normal arteries in 16% (8 of 51), non-significant disease in 21% (11 of 51), single-vessel disease in 37% (19 of 51), and multi-vessel disease in 26% (13 of 51) of patients. There were 64 significant lesions. Sensitivity, specificity, and positive and negative predictive values for detection of significant lesions on a segment-based analysis were 95% (61 of 64, 95% confidence interval [CI] 86 to 99), 98% (537 of 546, 95% CI 96 to 99), 87% (61 of 70, 95% CI 76 to 98), and 99% (537 of 540, 95% CI 98 to 99), respectively. All patients with angiographically normal coronary arteries or significant lesions were correctly identified. Three of 11 patients with <50% lesions were incorrectly classified as having single-vessel disease. CONCLUSIONS: The 16-row MSCT CA reliably detects significant coronary stenoses in patients with atypical chest pain or stable angina pectoris.

Graft failure prior to discharge after coronary artery bypass surgery: a prospective single-centre study using dual 64-slice computed tomography.

AIMS: The purpose of this study was to assess the incidence and predictors of graft failure prior to discharge. Multi-slice computed tomography has the ability to evaluate graft patency in a non-invasive way. METHODS AND RESULTS: Of 145 consecutive patients who were screened, 73 were included in the study (78% male, mean age 65 years). A total of 206 grafts were analysed (2.8±0.9 grafts/patient). Of the 206 grafts, 126 were venous, 72 were left internal mammary, five were right internal mammary and three were radial grafts. We evaluated 100% of proximal anastomoses sites and 92% (190/206) of the distal anastomoses. We identified five patients (6.8%) who had at least one occluded graft. A total of seven out of 206 (3.4%) grafts were occluded. Independent predictors of successful graft outcome were left anterior descending artery as a recipient artery, good distal run-off as assessed by a surgeon and vessel size larger than 2 mm. CONCLUSIONS: The results demonstrate that the in-hospital acute graft failure rate is 3.4% (6.8% of patients). Multi-slice computed tomography is a robust technique to assess novel therapies to reduce the rate of graft attrition further, and might be clinically useful in patients with persistent or early recurrence of symptoms after CABG.

Post-sirolimus-eluting stent restenosis treated with repeat percutaneous intervention: late angiographic and clinical outcomes.

BACKGROUND: We evaluated the clinical and angiographic outcomes of patients presenting with restenosis after sirolimus-eluting stent (SES) implantation treated with repeated percutaneous intervention. METHODS AND RESULTS: A total of 24 consecutive patients have undergone repeated percutaneous intervention to treat post-SES restenosis (27 lesions). The restenosis was located within the stent in 93% of lesions. From the 27 lesions, 1 (4%) was re-treated with a bare stent, 3 (11%) were treated with balloon dilatation, and the remaining 23 lesions (85%) were treated with repeated drug-eluting stent implantation (SES in 12 lesions [44%], paclitaxel-eluting stents in 11 lesions [41%]). The event-free survival rate was 70.8% after a median follow-up of 279 days from the post-SES treatment. The overall recurrent restenosis rate was 42.9%. The risk of recurrent restenosis was increased for patients with hypercholesterolemia, previous angioplasty, failed brachytherapy, post-SES restenosis needing early (<6 months) treatment, and post-SES restenosis treated with balloon dilatation. The recurrent restenosis rate of originally de novo lesions re-treated with drug-eluting stents was 18.2%. CONCLUSIONS: Even though de novo lesions treated with SES at baseline and re-treated with drug-eluting stents had reasonably better outcomes than other lesion types and strategies, our study shows that the treatment of post-SES restenosis is currently suboptimal and warrants further investigation.

Sirolimus-eluting stent implantation in ST-elevation acute myocardial infarction: a clinical and angiographic study.

BACKGROUND: Sirolimus-eluting stents (SES) have recently been proven to reduce restenosis and reintervention compared with bare stents. Safety and effectiveness of SES in acute myocardial infarction remain unknown. METHODS AND RESULTS: Since April 16, 2002, a policy of routine SES implantation has been instituted in our hospital, with no clinical or anatomic restrictions, as part of the RESEARCH (Rapamycin-Eluting Stent Evaluated At Rotterdam Cardiology Hospital) registry. During 6 months of enrollment, 96 patients with ST-elevation acute myocardial infarction underwent percutaneous recanalization and SES implantation; these patients comprise the study population. The incidence of major adverse cardiac events (death, nonfatal myocardial infarction, reintervention) was evaluated. Six-month angiographic follow-up was scheduled per protocol. At baseline, diabetes mellitus was present in 12.5% and multivessel disease in 46.9%. Primary angioplasty was performed in 89 patients (92.7%). Infarct location was anterior in 41 (42.7%) of the cases, and 12 patients (12.5%) had cardiogenic shock. Postprocedural TIMI-3 flow was achieved in 93.3% of the cases. In-hospital mortality was 6.2%. One patient (1.1%) had reinfarction and target lesion reintervention the first day as a result of distal dissection and acute vessel occlusion. During follow-up (mean follow-up of 218+/-75 days), 1 patient died (1.1%), no patient had recurrent myocardial infarction, and there were no additional reinterventions. No early or late stent thromboses were documented. At angiographic follow-up (70%), late loss was -0.04+/-0.25, and no patient presented angiographic restenosis. CONCLUSIONS: In this study, sirolimus-eluting stent implantation for patients with ST-elevation acute myocardial infarction was safe without documented angiographic restenosis at 6 months.

Unrestricted utilization of sirolimus-eluting stents compared with conventional bare stent implantation in the "real world": the Rapamycin-Eluting Stent Evaluated At Rotterdam Cardiology Hospital (RESEARCH) registry.

BACKGROUND: The effectiveness of sirolimus-eluting stents in unselected patients treated in the daily practice is currently unknown. METHODS AND RESULTS: Sirolimus-eluting stent implantation has been used as the default strategy for all percutaneous procedures in our hospital as part of the Rapamycin-Eluting Stent Evaluated At Rotterdam Cardiology Hospital (RESEARCH) registry. Consecutive patients with de novo lesions (n=508) treated exclusively with sirolimus-eluting stents (SES group) were compared with 450 patients who received bare stents in the period just before (pre-SES group). Patients in the SES group more frequently had multivessel disease, more type C lesions, received more stents, and had more bifurcation stenting. At 1 year, the cumulative rate of major adverse cardiac events (death, myocardial infarction, or target vessel revascularization) was 9.7% in the SES group and 14.8% in the pre-SES group (hazard ratio [HR], 0.62 [95% CI, 0.44 to 0.89]; P=0.008). The 1-year risk of clinically driven target vessel revascularization in the SES group and in the pre-SES group was 3.7% versus 10.9%, respectively (HR, 0.35 [95% CI, 0.21 to 0.57]; P<0.001). CONCLUSIONS: Unrestricted utilization of sirolimus-eluting stents in the "real world" is safe and effective in reducing both repeat revascularization and major adverse cardiac events at 1 year compared with bare stent implantation.

Clinical, angiographic, and procedural predictors of angiographic restenosis after sirolimus-eluting stent implantation in complex patients: an evaluation from the Rapamycin-Eluting Stent Evaluated At Rotterdam Cardiology Hospital (RESEARCH) study.

BACKGROUND: The factors associated with the occurrence of restenosis after sirolimus-eluting stent (SES) implantation in complex cases are currently unknown. METHODS AND RESULTS: A cohort of consecutive complex patients treated with SES implantation was selected according to the following criteria: (1) treatment of acute myocardial infarction, (2) treatment of in-stent restenosis, (3) 2.25-mm diameter SES, (4) left main coronary stenting, (5) chronic total occlusion, (6) stented segment >36 mm, and (7) bifurcation stenting. The present study population was composed of 238 patients (441 lesions) for whom 6-month angiographic follow-up data were obtained (70% of eligible patients). Significant clinical, angiographic, and procedural predictors of post-SES restenosis were evaluated. Binary in-segment restenosis was diagnosed in 7.9% of lesions (6.3% in-stent, 0.9% at the proximal edge, 0.7% at the distal edge). The following characteristics were identified as independent multivariate predictors: treatment of in-stent restenosis (OR 4.16, 95% CI 1.63 to 11.01; P<0.01), ostial location (OR 4.84, 95% CI 1.81 to 12.07; P<0.01), diabetes (OR 2.63, 95% CI 1.14 to 6.31; P=0.02), total stented length (per 10-mm increase; OR 1.42, 95% CI 1.21 to 1.68; P<0.01), reference diameter (per 1.0-mm increase; OR 0.46, 95% CI 0.24 to 0.87; P=0.03), and left anterior descending artery (OR 0.30, 95% CI 0.10 to 0.69; P<0.01). CONCLUSIONS: Angiographic restenosis after SES implantation in complex patients is an infrequent event, occurring mainly in association with lesion-based characteristics and diabetes mellitus.

Coronary restenosis after sirolimus-eluting stent implantation: morphological description and mechanistic analysis from a consecutive series of cases.

BACKGROUND: We describe the clinical and morphological patterns of restenosis after sirolimus-eluting stent (SES) implantation. METHODS AND RESULTS: From 121 patients with coronary angiography obtained >30 days after SES implantation, restenosis (diameter stenosis >50%) was identified in 19 patients and 20 lesions (located at the proximal 5-mm segment in 30% or within the stent in 70%). Residual dissection after the procedure or balloon trauma outside the stent was identified in 83% of the proximal edge lesions. Lesions within the stent were focal, and stent discontinuity was identified in some lesions evaluated by intravascular ultrasound. CONCLUSIONS: Sirolimus-eluting stent edge restenosis is frequently associated with local trauma outside the stent. In-stent restenosis occurs as a localized lesion, commonly associated with a discontinuity in stent coverage. Local conditions instead of intrinsic drug-resistance to sirolimus are likely to play a major role in post-SES restenosis.

Short- and long-term clinical benefit of sirolimus-eluting stents compared to conventional bare stents for patients with acute myocardial infarction.

OBJECTIVES: This study investigated the clinical outcomes of patients with ST-segment elevation myocardial infarction (MI) treated with sirolimus-eluting stents (SESs) or with conventional bare stents. BACKGROUND: The clinical impact of SES implantation for patients with ST-segment elevation MI is currently unknown. METHODS: Primary angioplasty was performed with SESs in 186 consecutive patients with acute MI who were compared with 183 patients treated with bare stents. The incidence of death, reinfarction, and repeat revascularization was assessed at 30 and 300 days. RESULTS: Postprocedure vessel patency, enzymatic release, and the incidence of short-term adverse events were similar in both the sirolimus and the bare stents (30-day rate of death, reinfarction, or repeat revascularization: 7.5% vs. 10.4%, respectively; p = 0.4). Stent thrombosis was not diagnosed in any patient in the sirolimus group and occurred in 1.6% of patients treated with bare stents (p = 0.1). At 300 days, treatment with SESs significantly reduced the incidence of combined adverse events (9.4% vs. 17%; hazard ratio [HR] 0.52 [95% confidence interval (CI) 0.30 to 0.92]; p = 0.02), mainly due to a marked reduction in the risk of repeat intervention (1.1% vs. 8.2%; HR 0.21 [95% CI 0.06 to 0.74]; p = 0.01). CONCLUSIONS: Compared to conventional bare stents, the SESs were not associated with an increased risk of stent thrombosis and were effective in reducing the incidence of adverse events at 300 days in unselected patients with ST-segment elevation acute MI referred for primary angioplasty.

Early outcome after sirolimus-eluting stent implantation in patients with acute coronary syndromes: insights from the Rapamycin-Eluting Stent Evaluated At Rotterdam Cardiology Hospital (RESEARCH) registry.

OBJECTIVES: This study evaluated the early outcomes of patients with acute coronary syndromes (ACS) treated with sirolimus-eluting stents (SES). BACKGROUND: The safety of SES implantation in patients with a high risk for early thrombotic complications is currently unknown. METHODS: Sirolimus-eluting stents have been utilized as the device of choice for all percutaneous procedures in our institution, as part of the Rapamycin-Eluting Stent Evaluated At Rotterdam Cardiology Hospital (RESEARCH) registry. After four months of enrollment, 198 patients with ACS had been treated exclusively with SES (64% of those treated in the period) and were compared with a control group composed of 301 consecutive patients treated with bare stents in the same time period immediately before this study. The incidence of major adverse cardiac events (MACE) during the first month was evaluated (death, nonfatal myocardial infarction [MI], or re-intervention). RESULTS: Compared with control patients, patients treated with SES had more primary angioplasty (95% vs. 77%; p < 0.01), more bifurcation stenting (13% vs. 5%; p < 0.01), less previous MI (28% vs. 45%; p < 0.01), and less glycoprotein IIb/IIIa inhibitor utilization (27% vs. 42%; p < 0.01). The 30-day MACE rate was similar between both groups (SES 6.1% vs. control patients 6.6%; p = 0.8), with most complications occurring during the first week. Stent thrombosis occurred in 0.5% of SES patients and in 1.7% of control patients (p = 0.4). In multivariate analysis, SES utilization did not influence the incidence of MACE (odds ratio 1.0 [95% confidence interval: 0.4 to 2.2]; p = 0.97). CONCLUSIONS: Sirolimus-eluting stent implantation for patients with ACS is safe, with early outcomes comparable with bare metal stents.

Fluvastatin reduces the impact of diabetes on long-term outcome after coronary intervention--a Lescol Intervention Prevention Study (LIPS) substudy.

BACKGROUND: Diabetes increases the risk of developing cardiovascular disease. Patients with diabetes undergoing percutaneous coronary intervention (PCI) show poorer outcomes compared with nondiabetic patients. The aim of this study was to determine the clinical benefit of long-term fluvastatin in patients with diabetes who had undergone a successful PCI. METHODS: This subanalysis of a prospective, multicenter, randomized, double-blind, placebo-controlled trial of patients who had undergone PCI and were treated with fluvastatin determined the impact of fluvastatin on the survival-free period of major adverse cardiac events (MACE) (defined as cardiac death, nonfatal myocardial infarction, and reintervention procedure [coronary artery bypass grafting, repeat PCI, PCI for a new lesion]). Patients with baseline total cholesterol levels of 135 to 270 mg/dL (3.5-7.0 mmol/L) and triglyceride levels of 400 mg/dL (4.5 mmol/L) were randomized at discharge either to fluvastatin (n = 844) or to placebo (n = 833); follow-up was 3 to 4 years. Among these patients, there were 202 with diabetes (120 on fluvastatin, 82 placebo) and 1475 without diabetes (724 on fluvastatin, 751 on placebo). The primary clinical outcome was survival time free of MACE and MACE excluding restenosis. RESULTS: The presence of diabetes increased the risk of MACE by almost 2-fold in placebo-treated patients (RR 1.78, 95% CI 1.20-2,64, P = .0045). In contrast, in diabetic patients treated with fluvastatin, the risk of MACE was not significantly different from that in patients without diabetes. Fluvastatin reduced the risk of MACE in diabetic patients by 51% (P = .0088). CONCLUSIONS: Diabetes is a consistent clinical predictor of cardiovascular complications and fluvastatin reduces the increased incidence of long-term adverse complications associated with the presence of diabetes.

Long-term fluvastatin reduces the hazardous effect of renal impairment on four-year atherosclerotic outcomes (a LIPS substudy).

Mild renal impairment is an important risk factor for late cardiovascular complications. This substudy of the Lescol Intervention Prevention Study (LIPS) assessed the effect of fluvastatin on outcome of patients who had renal dysfunction and those who did not. Complete data for creatinine clearance calculation (Cockcroft-Gault formula) were available for 1,558 patients (92.9% of the LIPS population). Patients were randomized to fluvastatin or placebo after successful completion of a first percutaneous coronary intervention. Follow-up time was 3 to 4 years. The effect of baseline creatinine clearance on coronary atherosclerotic events (cardiac death, nonfatal myocardial infarction, and coronary reinterventions not related to restenosis) was evaluated. Baseline creatinine clearance (logarithmic transformation) was inversely associated with an incidence of adverse events among patients who received placebo (hazard ratio 0.99, 95% confidence interval 0.982 to 0.998, p = 0.01). However, no association was noted between creatinine clearance and the incidence of adverse events among patients who received fluvastatin (hazard ratio 1.0, 95% confidence interval 0.99 to 1.0, p = 0.63). No further deterioration in creatinine clearance was observed during follow-up, regardless of baseline renal function or allocated treatment. Occurrence of adverse events was not related to changes in renal function during follow-up. Fluvastatin therapy markedly decreased the risk of coronary atherosclerotic events after percutaneous intervention in patients who had lower values of creatinine clearance at baseline. The benefit of fluvastatin was unrelated to any effect on renal function.

Impact of baseline renal function on mortality after percutaneous coronary intervention with sirolimus-eluting stents or bare metal stents.

Renal impairment is an important predictor of mortality after percutaneous coronary intervention and may increase the restenosis rate. However, the relation between restenosis and the risk of death in patients who have renal impairment remains unclear. We evaluated the incidences of repeat revascularization and mortality in patients who had renal impairment and those who did not and who received sirolimus-eluting stents or bare stents. A total of 1,080 consecutive patients treated for 1 year had available data to calculate baseline creatinine clearance. Patients received bare stents (first 6 months, n = 543) or sirolimus-eluting stents (last 6 months, n = 537) and were grouped according to the presence or absence of renal impairment (creatinine clearance <60 ml/min). Patients who had renal impairment had a higher mortality rate at 1 year (7.6% vs 2.5%, hazard ratio 3.14, 95% confidence interval 1.68 to 5.88, p <0.01), with no differences in mortality between patients who received bare stents and those who received sirolimus-eluting stents (hazard ratio 0.91, 95% confidence interval 0.49 to 1.68, p = 0.8). The incidence of target vessel revascularization decreased significantly in patients who were treated with sirolimus-eluting stents and did not have renal impairment (hazard ratio 0.59, 95% confidence interval 0.39 to 0.90, p = 0.01) and in those who had decreased renal function (hazard ratio 0.37, 95% confidence interval 0.15 to 0.90, p = 0.03). Thus, sirolimus-eluting stents compared with conventional stents decreased clinical restenosis in patients who had renal impairment. However, this benefit was not paralleled by a decrease in the risk of death in this population. It seems unlikely that restenosis could be a contributing factor that influenced the increased mortality of patients who had impaired renal function.

Fluvastatin reduces the 4-year cardiac risk in patients with multivessel disease.

BACKGROUND: To evaluate the impact of the extent of coronary disease (single- or multivessel) and of fluvastatin treatment on the incidence of long-term cardiac atherosclerotic complications in the Lescol Intervention Prevention Study (LIPS). METHODS: A total of 1063 patients with single-vessel disease and 614 patients with multivessel disease were randomized to receive fluvastatin (40 mg bid) or placebo for at least 3 years following a first successful percutaneous coronary intervention. The incidence of cardiac atherosclerotic events (cardiac death, non-fatal myocardial infarction, and coronary re-interventions not related to restenosis) was evaluated. RESULTS: Patients with multivessel disease tended to be older and presented a higher prevalence of associated risk factors and cardiovascular antecedents. The presence of multivessel disease markedly increased the risk of cardiac atherosclerotic events compared with single-vessel disease among patients allocated to placebo (RR 1.67 [95% CI: 1.24-2.25]; p<0.001). In patients treated with fluvastatin, however, no significant differences in long-term outcomes were observed between patients with multivessel disease and patients single-vessel disease (RR 1.28 [95% CI: 0.90-1.81]; p=0.2). CONCLUSIONS: Multivessel coronary disease impaired the 4-year outcomes after percutaneous intervention. However, the hazardous effect of multivessel disease was significantly reduced by long-term fluvastatin treatment.

Effect of fluvastatin on long-term outcome after coronary revascularization with stent implantation.

We assessed the impact of long-term fluvastatin treatment on adverse atherosclerotic cardiac events (cardiac death, myocardial infarction, and revascularization excluding repeat interventions due to restenosis in the first 6 months) in 847 patients (fluvastatin [n = 417] or placebo [n = 430]) with average cholesterol levels treated with stents in the Lescol Intervention Prevention Study (LIPS). During the 4-year follow-up period, fluvastatin significantly decreased total cholesterol and low-density lipoprotein cholesterol levels and decreased the risk of first adverse atherosclerotic cardiac events by 30% compared with placebo (95% confidence interval -49 to -3.4, p = 0.03).

Comparison of three-year outcomes after coronary stenting versus coronary artery bypass grafting in patients with multivessel coronary disease, including involvement of the left anterior descending coronary artery proximally (a subanalysis of the arterial revascularization therapies study trial).

The long-term effect of stents in patients with multivessel disease involving the proximal left anterior descending artery was investigated. At 3 years, there was no difference in the combined incidence of death, stroke, and myocardial infarction in either group, but the need for repeat revascularization was more frequent in the group with stenting than in the group with coronary artery bypass grafting.

Incidence of thrombotic stent occlusion during the first three months after sirolimus-eluting stent implantation in 500 consecutive patients.

Sirolimus-eluting stents have been used in our institution for all percutaneous interventions, without clinical or anatomic exclusion criteria, as part of the Rapamycin-Eluting Stent Evaluated At Rotterdam Cardiology Hospital registry. We analyzed the incidence of (sub)acute stent thrombosis after sirolimus-eluting stent implantation in an unselected population of 510 consecutive patients. At 3-month follow-up, (sub)acute stent thrombosis was diagnosed in 2 patients (0.4%) 6 hours and 11 days after the procedure, respectively. These cases occurred in diabetic women with complex coronary lesions. Intravascular ultrasound examination showed inadequate stent expansion and uncovered distal dissection as possible mechanical explanations for the thrombosis.

Very long sirolimus-eluting stent implantation for de novo coronary lesions.

Long-length stenting has a poor outcome when bare metal stents are used. The safety and efficacy of the sirolimus-eluting stent (SES) in long lesions has not been evaluated. Therefore, the aim of the present study was to evaluate the clinical and angiographic outcomes of SES implantation over a very long coronary artery segment. Since April 2002, all patients treated percutaneously at our institution received a SES as the device of choice as part of the Rapamycin Eluting Stent Evaluated At Rotterdam Cardiology Hospital (RESEARCH) registry. During the RESEARCH registry, stents were available in lengths of 8, 18, and 33 mm. The present report includes a predefined study population consisting of patients treated with >36-mm-long stented segments. Patients had a combination of >or=2 overlapping stents at a minimum length of 41 mm (i.e., one 33-mm SES overlapping an 8-mm SES) to treat native de novo coronary lesions. The incidence of major cardiac adverse events (death, nonfatal myocardial infarction, and target lesion revascularization) was evaluated. The study group comprised 96 consecutive patients (102 lesions). Clinical follow-up was available for all patients at a mean of 320 days (range 265 to 442). In all, 20% of long-stented lesions were chronic total occlusions, and mean stented length per lesion was 61.2 +/- 21.4 mm (range 41 to 134). Angiographic follow-up at 6 months was obtained in 67 patients (71%). Binary restenosis rate was 11.9% and in-stent late loss was 0.13 +/- 0.47 mm. At long-term follow-up (mean 320 days), there were 2 deaths (2.1%), and the overall incidence of major cardiac events was 8.3%. Thus, SES implantation appears safe and effective for de novo coronary lesions requiring multiple stent placement over a very long vessel segment.

Treatment of very small vessels with 2.25-mm diameter sirolimus-eluting stents (from the RESEARCH registry).

A total of 91 patients with 112 lesions received 2.25-mm sirolimus-eluting stents (SESs), and these lesions were compared with those treated with SESs of > or =2.5-mm diameter in the same procedure (n = 109). The reference diameters were 1.88 +/- 0.34 and 2.52 +/- 0.57 mm, respectively (p <0.01). At follow-up, the late lumen loss was 0.07 +/- 0.48 mm for the 2.25-mm SES versus 0.03 +/- 0.38 mm for the larger SES (p = 0.5), and the binary restenosis rate was 10.7% versus 3.9%, respectively (p = 0.1). The 12-month target lesion revascularization rate was 5.5%. In conclusion, 2.25-mm SESs were associated with low rates of clinical and angiographic late complications.