A Seixas

Lack of Neointimal Proliferation After Implantation of Sirolimus-Coated Stents in Human Coronary Arteries

Background—Restenosis remains an important limitation of interventional cardiology. Therefore, we aimed to determine the safety and efficacy of sirolimus (a cell-cycle inhibitor)-coated BX Velocity...

Two-Year Angiographic and Intravascular Ultrasound Follow-Up After Implantation of Sirolimus-Eluting Stents in Human Coronary Arteries

Background—The safety and efficacy of sirolimus-eluting stenting have been demonstrated, but the outcome of patients treated with this novel technology beyond the first year remains unknown. We sought to evaluate the angiographic, intravascular ultrasound (IVUS), and clinical outcomes of patients treated with sirolimus-eluting stents 2 years after implantation. Methods and Results—This study included 30 patients treated with sirolimus-eluting Bx Velocity stenting (slow release [SR], n=15, and fast release [FR], n=15) in São Paulo, Brazil. Twenty-eight patients underwent 2-year angiographic and IVUS follow-up. No deaths occurred during the study period. In-stent late loss was slightly greater in the FR group (0.28±0.4 mm) than in the SR group (−0.09±0.23 mm, P =0.007). No patient had in-stent restenosis. At 2-year follow-up, only 1 patient (FR group) had a 52% diameter stenosis within the lesion segment, which required repeat revascularization. The target-vessel revascularization rate for the entire cohort was 10% (3/30) at 2 years. All other patients had ≤35% diameter stenosis. Angiographic lumen loss at the stent edges was also minimal (in-lesion late loss was 0.33±0.42 mm [FR] and 0.13±0.29 mm [SR]). In-stent neointimal hyperplasia volume, as detected by IVUS, remained minimal after 2 years (FR= 9.90±9 mm3 and SR=10.35±9.3 mm3). Conclusions—This study demonstrates the safety and efficacy of sirolimus-eluting Bx Velocity stents 2 years after implantation in humans. In-stent lumen dimensions remained essentially unchanged at 2-year follow-up in the 2 groups, although angiographic lumen loss was slightly higher in the FR group. Restenosis “catch-up” was not found in our patient population.

Four-Year Angiographic and Intravascular Ultrasound Follow-Up of Patients Treated With Sirolimus-Eluting Stents

Background—Despite the proven superiority of sirolimus-eluting stents (SESs) compared with bare stents in the first year after implantation, long-term outcomes of patients treated with these novel devices remain unknown. Our goal was to evaluate the clinical, angiographic, and intravascular ultrasound (IVUS) outcomes of patients treated with SESs 4 years after implantation. Methods and Results—The study included 30 patients treated with sirolimus-eluting Bx Velocity stenting (slow release [SR; n=15] and fast release [FR; n=15]). Twenty-six patients underwent 4-year angiographic and IVUS follow-up and had matched assessments at all time points (index and 4-, 12-, 24-, and 48-month follow-up). One death occurred during the study period in a patient with a patent SES. There were no target-vessel revascularizations or thromboses between 2- and 4-year follow-up examinations. There was no stent thrombosis, target-lesion revascularization, death, or myocardial infarction in the SR group up to 4 years. Cumulative event-free survival rate was 87% for the total population (80% in the FR group and 93% in the SR group). In-stent late loss was slightly greater in the FR group (0.41±0.49 mm) than the SR group (0.09±0.23) after 4 years. One patient in the FR group had a 52% in-stent restenosis lesion. Percent neointimal hyperplasia volume, as detected by IVUS, remained minimal after 4 years (FR=9.1% and SR=5.7%). Conclusions—This study confirms the longevity of the optimal outcomes observed in patients treated with sirolimus-eluting Bx Velocity stents 4 years after implantation. In-stent lumen dimensions remained essentially unchanged at 4-year follow-up, particularly in the population treated with the currently available SES (SR formulation).

Volumetric Analysis of In-Stent Intimal Hyperplasia in Diabetic Patients Treated With or Without Abciximab Results of the Diabetes Abciximab steNT Evaluation (DANTE) Randomized Trial

Background—In diabetic patients in the Evaluation of Platelet IIb/IIIa Inhibitor for Stenting (EPISTENT) trial, abciximab reduced target vessel revascularization by ≈50% compared with placebo. Whether this is a result of a lower restenosis rate caused by inhibition of intimal hyperplasia remains to be defined. Methods and Results—The purpose of this study was to determine whether abciximab at the time of stent implantation would reduce in-stent intimal hyperplasia measured by intravascular ultrasound at 6-month follow-up in type 2 diabetics. Ninety-six diabetic patients (96 lesions) who underwent elective stent implantation for a de novo lesion in a native coronary artery were randomly assigned to receive abciximab or no abciximab. In-stent intimal hyperplasia volume, expressed as percentage of stent volume, did not differ between groups: 41.3±21.0% for those treated with abciximab versus 40.5±18.3% for those treated without abciximab (P =0.9). There were also no significant differences in angiographic minimal luminal diameter at follow-up (1.74±0.69 versus 1.66±0.63 mm; P =0.5), late loss (1.03±0.63 versus 1.07±0.58 mm; P =0.7), restenosis rate (17.8% versus 22.9%; P =0.5), or cumulative incidence of major adverse cardiac events at 12 months (19.1% versus 20.4%; P =0.9). Conclusions—Six-month intravascular ultrasound volumetric analysis showed that abciximab, at the time of coronary stent implantation, was not associated with a reduction of in-stent intimal hyperplasia in diabetic patients.

Vascular Healing 4 Years After the Implantation of Sirolimus-Eluting Stent in Humans A Histopathological Examination

A 60-year-old male patient with coronary disease was included in the “First-in Man” study1 and received a single sirolimus-eluting stent (SES, fast release) in December 1999 to treat a 90% diameter stenosis lesion located in the proximal right coronary artery (RCA). The patient had mild to moderate (<50% diameter stenosis) obstructions in the left anterior descending and left circumflex arteries. Coronary angiography and intravascular ultrasound (IVUS) revealed minimal neointimal growth in the midstent region at 4 months, 1 year, and 2 years after implantation. The patient underwent aortic and mitral valve replacement without complication 3 years after SES implantation. Left ventricle ejection fraction was 22%. He had a cardiac arrest out of the hospital in January 2004 (4-year follow-up). The patient was resuscitated but suffered severe cerebral damage. Postarrest angiography showed a widely patent …A 60-year-old male patient with coronary disease was included in the “First-in Man” study1 and received a single sirolimus-eluting stent (SES, fast release) in December 1999 to treat a 90% diameter stenosis lesion located in the proximal right coronary artery (RCA). The patient had mild to moderate (<50% diameter stenosis) obstructions in the left anterior descending and left circumflex arteries. Coronary angiography and intravascular ultrasound (IVUS) revealed minimal neointimal growth in the midstent region at 4 months, 1 year, and 2 years after implantation. The patient underwent aortic and mitral valve replacement without complication 3 years after SES implantation. Left ventricle ejection fraction was 22%. He had a cardiac arrest out of the hospital in January 2004 (4-year follow-up). The patient was resuscitated but suffered severe cerebral damage. Postarrest angiography showed a widely patent …

The use of intravascular ultrasound in deciding on the treatment of moderate coronary lesions

). The patients were followed up to determine the rate of major cardiac events (MCE) in 2 years, the need for revascularization of the target lesion, and to identify the clinical, angiographic, and ultrasound predictors of events. Results Seventy-five (43%) patients had MLA ≥ 4.0 mm 2 and were clinically treated; 98 (57%) patients had MLA < 4.0 mm 2 and ; P < 0.001)). The clinical impact of the decision was favorable, and no difference was observed in regard to the occurrence of major cardiac events: (group 1: 5 (7%) vs group 2: 14 (15%); P = 0.09). The need for revasculari- zation of the target lesion also did not differ (group 1: 3 (4%) vs group 2: 11 (12%); P = 0.07). The predictive variables for MCE were diabetes, functional class III (FC III) angina before hospitali- zation, and MLA assessed on ultrasound. Conclusion This strategy for deciding on appropriate treatment guarantees low rates of MCE in both groups in the 24-month follow-up, with reduced revascularization rates. The predictive variables of major cardiac events were as follows: diabetes mellitus, FC III angina, and MLA on intravascular ultrasound.

IMPACT trial: angiographic and intravascular ultrasound observations of the first human experience with mycophenolic acid-eluting polymer stent system

The purpose of the study was to examine the safety and efficacy of two different formulations of mycophenolic acid (MPA)‐eluting Duraflex stents on coronary de novo lesions. Recent data indicate that local delivery of MPA in the porcine overstretch coronary model significantly reduces neointimal hyperplasia (NIH). Patients were divided into three consecutive groups. The first (n = 50) and second (n = 55) groups received moderate‐ and slow‐release MPA‐eluting Duraflex stent, respectively. The last group (n = 50) received the bare metal Duraflex stent. Clinical, angiographic, and intravascular ultrasound analysis were performed at 6‐month follow‐up. All stents were successfully deployed and patients were discharged home without clinical events. Compared to controls, 6‐month in‐lesion and in‐stent minimum luminal diameter as well as late lumen loss were not significantly different in the moderate‐ and slow‐release treatment groups. At follow‐up, percentage obstruction and NIH volume were also similar between the three groups. At 30 days and 6 and 12 months, there were no differences noted between the three groups with respect to major adverse cardiac events as well as the individual rates of mortality, myocardial infarction, or repeat revascularization. There were no cases of subacute or late thrombosis. In this feasibility trial, the MPA‐eluting Duraflex stents in either slow‐ or moderate‐release formulations were well tolerated, but showed no benefit for treatment of coronary lesions when compared to controls. Further testing with different drug dosing or delivery rate might improve these results.

Vascular Healing 4 Years After the Implantation of Sirolimus-Eluting Stent in Humans

A 60-year-old male patient with coronary disease was included in the “First-in Man” study1 and received a single sirolimus-eluting stent (SES, fast release) in December 1999 to treat a 90% diameter stenosis lesion located in the proximal right coronary artery (RCA). The patient had mild to moderate (<50% diameter stenosis) obstructions in the left anterior descending and left circumflex arteries. Coronary angiography and intravascular ultrasound (IVUS) revealed minimal neointimal growth in the midstent region at 4 months, 1 year, and 2 years after implantation. The patient underwent aortic and mitral valve replacement without complication 3 years after SES implantation. Left ventricle ejection fraction was 22%. He had a cardiac arrest out of the hospital in January 2004 (4-year follow-up). The patient was resuscitated but suffered severe cerebral damage. Postarrest angiography showed a widely patent …A 60-year-old male patient with coronary disease was included in the “First-in Man” study1 and received a single sirolimus-eluting stent (SES, fast release) in December 1999 to treat a 90% diameter stenosis lesion located in the proximal right coronary artery (RCA). The patient had mild to moderate (<50% diameter stenosis) obstructions in the left anterior descending and left circumflex arteries. Coronary angiography and intravascular ultrasound (IVUS) revealed minimal neointimal growth in the midstent region at 4 months, 1 year, and 2 years after implantation. The patient underwent aortic and mitral valve replacement without complication 3 years after SES implantation. Left ventricle ejection fraction was 22%. He had a cardiac arrest out of the hospital in January 2004 (4-year follow-up). The patient was resuscitated but suffered severe cerebral damage. Postarrest angiography showed a widely patent …

Stents farmacológicos versus não-farmacológicos para o tratamento de pacientes uniarteriais portadores de lesão em artéria descendente anterior: seguimento clínico de dois anos

INTRODUCTION: Percutaneous treatment (PCI) of single lesions in the LAD with balloon angioplasty or bare-metal stent (BMS) often have poorer outcomes when compared to PCI of lesions in the other major coronary arteries. OBJECTIVE: To compare the long term safety and efficacy of DES vs. BMS for the treatment of single lesions in the LAD. METHODS: Between June 2002 and June 2003, 166 patients with single lesions in the LAD were treated with DES and compared to a historic cohort of 141 patients treated with BMS under the same inclusion/exclusion criteria. Long term clinical follow-up (approximately 2 years) was obtained in all patients. The primary endpoint was the comparison of major adverse cardiac events (MACE) defined as cardiac death, non fatal MI and target-lesion revascularization (TLR) between the two groups. RESULTS: Baseline clinical characteristics did not differ between groups. Procedure success was achieved in all cases with no in hospital MACE. After two years of follow-up, 95.7% of patients treated with DES and 73.7% treated with BMS were free from any MACE (p < 0.0001). TLR occurred in 15.6% and 1.2% of the patients receiving BMS and DES respectively (p < 0.0001). Although not significantly reduced, cardiac death was less frequent among patients treated with these DES (6.38% vs. 1.81%, p = 0.07). CONCLUSION: The use of DES for the treatment of single LAD lesions was superior to BMS due to a marked reduction in MACE rates, mainly at the expense of a very low need for RLA.

Análise angiográfica e ultra-sonográfica do stent liberador de novolimus para o tratamento de lesões coronárias de novo: resultados do estudo EXCELLA I

BACKGROUND: Stent restenosis suffered a marked reduction with drug-eluting stents (DES) reaching levels below 10% in most clinical and angiographic scenarios. Since then, new devices with different drugs have been tested in order to obtain an efficiency equivalent to first generation DES (Cypher® and Taxus®), although with better long-term safety. Our objective was to evaluate safety and neointimal proliferation inhibition with novolimuseluting stent through clinical and angiographic endpoints. METHODS: Single-center, first-in-man study, including 15 patients with angina pectoris submitted to novolimuseluting stent implantation. RESULTS: Angiographic analysis with quantitative coronary angiography (QCA) and intravascular ultrasound (IVUS) performed immediately after stent implantation and at 4-month follow-up revealed instent and in-segment late loss of 0.15 mm ± 0.29 mm and 0.07 mm ± 0.3 mm, respectively. In-stent volume obstruction was 2.6 ± 2.6%. No cases of binary restenosis were observed. The six-month clinical follow-up revealed no major acute cardiovascular events (MACE). CONCLUSION: The new novolimus-eluting stent proved to be efficient in reducing late loss and supressing neointimal proliferation. Late results in more complex group of patients are needed to confirm the safety of this new device.