Effect of randomized prophylactic nitroglycerin on radial artery spasm during transradial catheterization: An analysis based on operator experience.

One limitation to transradial access (TRA) is the occurrence of spasms (RAS), for which the use of prophylactic medications is recommended. Improvement in TRA material combined with the increase in operators' expertise, might mitigate this benefit. We assess the effect of preventive nitroglycerin on RAS during TRA, evaluating the role of the operator's experience. Patients received 500 µg nitroglycerin or placebo. The operator's expertise was classified as: inexperienced (I), intermediate (M), and experienced (E). 2040 patients were included. Prophylactic use of nitroglycerin did not reduce RAS (10.8% vs. 13.4% (placebo), p = 0.07). RAS incidence was 14.5% in I, 12.5% in M, and 9.7% in E (p = 0.01). In group I, nitroglycerin reduced RAS (17.4% vs. 11.1%, p = 0.04), which was not observed in other groups. Overall, nitroglycerin does not prevent RAS, which is more common among inexperienced operators. More experienced operators could abolish preventive nitroglycerin use.

Mid- to long-term clinical and echocardiographic outcomes after transcatheter aortic valve replacement with a new-generation, self-expandable system.

OBJECTIVES: The aim of the study was to evaluate mid- to late clinical and echocardiographic outcomes after transcatheter aortic valve replacement (TAVR) with Acurate neo™ (Boston Scientific, Boston, MA). BACKGROUND: TAVR is an established treatment for aortic stenosis (AS). Few data exist on mid- to long-term outcomes and durability after new-generation valves. METHODS: All consecutive patients (n = 104) who underwent Acurate neo™ implantation from 2012 to 2018 were included. Follow-up was systematically performed at 1, 6, 12, and 24 months and yearly thereafter. Outcomes were reported according to VARC-2, and structural valve deterioration (SVD) or bioprosthetic valve failure defined accordingly to new definitions. RESULTS: Mean age was 82 ± 5.4 years, 56.7% were female and the Society of Thoracic Surgeons score for mortality was 5.9 ± 4%. Patients were followed for a median of 3 years (1,092 days; IQR 1.5-4 years), and the maximum follow-up was 7 years. All-cause mortality values at 1 and 5 years were 8.5% and 40.5%, respectively. No relevant changes in mean gradient and orifice area occurred (7.9 ± 3.8 mmHg and 1.9 ± 0.3 cm2 at 1 year; 6.6 ± 2.1 mmHg and 1.8 ± 0.3 cm2 at 5 years), and there was a significant rate of paravalvular leaks resolution at 1, 2, and 3 years (p = .004; p < .001; p < .001, respectively). None of the patients had leaflet thrombosis or endocarditis. One patient developed SVD at 84 months. CONCLUSIONS: Acurate neo™ was associated with sustained echocardiographic results. Reassuring mid- to long-term outcomes was observed in this cohort of elderly patients with severe AS.

Prospective comparison between three TAVR devices: ACURATE neo vs. CoreValve vs. SAPIEN XT. A single heart team experience in patients with severe aortic stenosis.

OBJECTIVE: We sought to compare the new transcatheter aortic valve replacement (TAVR) device ACURATE neo (ACT) with the already established CoreValve (MCV) and SAPIEN XT (SXT) for the treatment of severe aortic stenosis (AS). BACKGROUND: Very few data on TAVR devices are available beyond MCV and SAPIEN and there is no previous study comparing ACT with MCV and SXT. METHODS: We prospectively evaluated consecutive patients who underwent transfemoral TAVR for the treatment of severe AS. Clinical outcomes were reported following Valve Academic Research Consortium 2 (VARC-2) criteria. RESULTS: A total of 162 patients (ACT n = 49, MCV n = 56, SXT n = 57), were included. MCV group had higher valve embolization/migration rates (ACT none; MCV 9%; SXT 2%; P = 0.034) causing lower device success rates (ACT 98%; MCV 86%; SXT 95%; P = 0.043). At 30 days, there was no significant difference in all-cause mortality (P = 0.22), cardiovascular mortality (P = 0.20), periprocedural myocardial infarction (P = 0.40), stroke (P = 0.64), major vascular complications (P = 0.48), life-threatening bleeding (P = 0.29), acute kidney injury stage 2/3 (P = 0.69), or VARC-2 composite early safety endpoints (P = 0.21). MCV group had higher rates of new permanent pacemaker implantation (ACT 6%; MCV 25%; SXT 11%; P = 0.013). Follow-up echocardiography showed no significant difference in aortic valve mean pressure gradient (P = 0.73) or moderate/severe aortic regurgitation (P = 0.19) between groups. CONCLUSIONS: In a "real world" registry, ACT compared favorably against the well-studied SXT and MCV devices in both safety and efficacy. MCV implantation was associated with lower device success rates and higher rates of new permanent pacemaker implantation. © 2016 Wiley Periodicals, Inc.

A Randomized Trial of Creatine-kinase Leak After Rosuvastatin in Elective Percutaneous Coronary Intervention (CLEAR-PCI).

OBJECTIVES: To determine the impact of percutaneous coronary intervention (PCI) performed at the same time of the peak concentration of rosuvastatin to reduce periprocedural myocardial infarction (PMI). BACKGROUND: Prior studies suggest that a high dose of statin before PCI reduce periprocedural myocardial infarction. However, there is no information regarding the elective PCI performed at the time of the peak of statin concentration to reduce PMI. METHODS: From 2001 to 2013, at a single center in Brazil we enrolled 544 patients who underwent elective PCI and after exclusions for baseline biases in clinical and angiographic characteristics, yielding 528 patients, we prospectively randomly assigned them to either a high loading dose of Rosuvastatin before PCI (n = 264) or standard treatment (n = 264). After exclusions for biases in procedural characteristics a total of 487 patients underwent to end points analysis. The primary outcome was the incidence of MB fraction of creatine kinase (CK-MB) greater than three times the upper limit of normal. RESULTS: The primary end point occurred in 7.6% in the rosuvastatin and 4.8% in the control group (P = 0.200). There was a higher incidence in elevation of CK-MB than normal baseline in the rosuvastatin (67.1% vs 59.2%, P = 0.701). There was no difference in major adverse event (0% in the rosuvastatin group vs 0.8% in control).

Early improvement in left atrial remodeling and function after mitral valve repair or replacement in organic symptomatic mitral regurgitation assessed by three-dimensional echocardiography.

BACKGROUND: Left atrial (LA) dilation is associated with worse prognosis in various clinical situations including chronic mitral regurgitation (MR). Real time three-dimensional echocardiography (3DE) has allowed a better assessment of LA volumes and function. Little is known about LA size and function in early postoperative period in symptomatic patients with chronic organic MR. We aimed to investigate these aspects. METHODS: By means of 3DE, 43 patients with symptomatic chronic organic MR were prospectively studied before and 30 days after surgery (repair or bioprosthetic valve replacement). Twenty subjects were studied as controls. Maximum (Vol-max), minimum, and preatrial contraction LA volumes were measured and total, passive, and active LA emptying fractions were calculated. RESULTS: Before surgery patients had higher LA volumes (P < 0.001) but smaller LA emptying fractions than controls (P < 0.01). After surgery there was a reduction in all 3 LA volumes and an increase in active atrial emptying fraction (AAEF). Multivariate analysis showed that independent predictors of early postoperative Vol-max reduction were preoperative diastolic blood pressure (coefficient = -0.004; P = 0.02), lateral mitral annular early diastolic velocity (e') (coefficient = 0.023; P = 0.008), and the mean transmitral diastolic gradient increment (coefficient = -0.035; P < 0.001). Furthermore, e' was also independently associated with AAEF increase (odds ratio = 1.66, P = 0.027). CONCLUSION: Early LA reverse remodeling and functional improvement occur after successful surgery of symptomatic organic MR regardless of surgical technique. Diastolic blood pressure and transmitral mean gradient augmentation are variables negatively related to Vol-max reduction. Besides, e' is positively correlated with both Vol-max reduction and AAEF increase.

Serial Assessment of Coronary Artery Healing of a Biodegradable Polymer Drug-Eluting Stent at 1, 2, and 3 Months by Optical Coherence Tomography (OCT)-The REPAIR Trial.

BACKGROUND: Although first-generation drug-eluting stent (DES) devices have effectively achieved their main goal of reducing restenosis, their safety has been limited by suboptimal polymer biocompatibility, delayed stent endothelialization, and local drug toxicity, which ultimately prompted the development of new-generation DES options carrying biocompatible or even biodegradable polymers. AIMS: We sought to assess the vessel-healing pattern of the novel sirolimus-eluting Inspiron DES (Scitech Medical) using serial optical coherence tomography (OCT) and assuming the hypothesis that this thin-strut (75-µm), biodegradable-polymer DES promotes a faster healing, with very early strut coverage. METHODS: This is a prospective, multicenter, open-label, single-arm study enrolling 68 patients who underwent percutaneous coronary intervention guided by OCT. These patients were consecutively assigned into 3 groups. The first group had its OCT imaging follow-up performed at 3 months, the second group at 2 months, and the third group at 1 month. RESULTS: Mean age was 59.5 years, 70.6% were male, 41.2% had type 2 diabetes, and 29.4% presented with acute coronary syndrome. A total of 72 lesions were treated and 1.06 stents were implanted per patient. OCT assessment of the stents at 1, 2, and 3 months showed a strut coverage of 90.41%, 93.96%, and 97.21%, respectively (P=.04). CONCLUSION: The Inspiron DES showed an early strut healing pattern, with >90% of the struts covered by neointima within the first month and with almost all struts covered by the third month.

Randomized Clinical Trial on Prevention of Radial Occlusion After Transradial Access Using Nitroglycerin: PATENS Trial.

OBJECTIVES: The aim of this study was to evaluate whether administration of nitroglycerin at the beginning or end of a transradial approach (TRA) procedure would preserve radial patency. BACKGROUND: The TRA is becoming the preferred vascular access route in coronary interventions. Radial artery occlusion (RAO) is the most frequent complication. Routine vasodilator treatment aims to reduce spasm and possibly prevent RAO. METHODS: The authors designed a prospective, multicenter, randomized, double-blind, 2-by-2 factorial, placebo-controlled trial encompassing patients undergoing the TRA. Patients were randomized to either 500 µg nitroglycerin or placebo; each arm was also subrandomized to early (upon sheath insertion) or late (right before sheath removal) nitroglycerin administration to evaluate the superiority of nitroglycerin in the prevention of RAO with 24 hours on Doppler ultrasound. RESULTS: A total of 2,040 patients were enrolled. RAO occurred in 49 patients (2.4%). Fifteen of these patients (30.6%) showed re-establishment of flow at 30 days. Nitroglycerin, compared with placebo, did not reduce the risk for RAO at either of the 2 time points (early, 2.5% vs 2.3% [P = 0.66]; late, 2.3% vs 2.5% [P = 0.66]). By multivariable analysis, the presence of spasm (OR: 3.53; 95% CI: 1.87-6.65; P < 0.001) and access achieved with more than 1 puncture attempt (OR: 2.58; 95% CI: 1.43-4.66; P = 0.002) were independent predictors of RAO. CONCLUSIONS: The routine use of nitroglycerin was not associated with a reduction in the rate of RAO, regardless of the time of administration (at the beginning or end of the TRA procedure).

Comparison of Minimum Pressure and Patent Hemostasis on Radial Artery Occlusion After Transradial Catheterization.

OBJECTIVES: The aim of this study was to compare two hemostatic techniques, minimum pressure technique and patent hemostasis, on radial artery occlusion (RAO) after transradial catheterization. BACKGROUND: RAO is an infrequent complication of transradial procedures. One of the strategies used to reduce this complication is the patent hemostasis technique. Use of minimum pressure in hemostatic wristband, without monitoring patency, might have the same efficacy for preventing RAO. METHODS: This is a multicenter study encompassing patients submitted to transradial catheterization. After pneumatic wristband application, the band was deflated to the lowest allowable volume while preserving hemostasis. Radial artery patency was subsequently evaluated. The group with no return of plethysmographic curve was labeled "minimum pressure," and the group in which the signal returned was labeled "patent hemostasis." RAO was verified by Doppler evaluation within the first 24 hours of the procedure. RESULTS: A total of 1082 patients were enrolled, with mean age of 61.4 ± 10.4 years. The majority (61.0%) were male and 34.5% had diabetes. Patent hemostasis was achieved in only 213 cases (20%). Early RAO occurred in 16 patients (1.8%) in the minimum pressure group and in 4 patients (1.9%) in the patent hemostasis group (P=.97). No major bleeding was observed among the entire cohort. EASY scale for hematoma grade was similar between the cohorts (EASY grades 1-3: 7.0% in the minimum pressure group vs 7.5% in the patent hemostasis group; P=.96). CONCLUSION: Checking radial patency during hemostatic compression may not be necessary after the procedure when adopting a mild and short hemostatic compression.

Association between left atrial strain and left ventricular diastolic function in patients with acute coronary syndrome.

BACKGROUND: Left ventricular diastolic function is an important prognostic marker in acute coronary syndrome. However, classification of the dysfunction grade using isolated echocardiographic parameters remains difficult. Therefore, it is necessary to combine multiple data in diagnostic algorithms. The purpose of this study was to evaluate the capacity of left atrial strain (LAS) components to classify left ventricular diastolic dysfunction (DD) grade. METHODS: Cross-sectional study with 109 consecutive patients admitted to the emergency room with acute coronary syndrome. Patients were referred for echocardiographic evaluation within 72 h. Mean values of LAS, corresponding to three phases of atrial function (reservoir, conduit and contraction), were obtained by speckle-tracking echocardiography. Patients were divided according to the diastolic dysfunction grade for later association with the LAS. RESULTS: The three LAS components showed moderate correlation with most diastolic variables (left atrial volume index, E/e' ratio and e' wave). In addition, there was related reduction of the LAS, which was inversely proportional to the DD grade (p < 0.05). LAS was effective for the identification of patients with DD grade III [area under the curve (AUC) for the reservoir = 0.99; conduit AUC = 0.89; contraction AUC = 0.99) and also those with DD grade II or III (reservoir AUC = 0.94; conduit AUC = 0.92; contraction AUC = 0.80]. CONCLUSIONS: LAS alone presented excellent capacity to classify DD in patients with acute coronary syndrome and may represent an additional tool for this purpose.

The revascular active percutaneous interventional device for coronary total occlusions study.

BACKGROUND: Despite the well-documented benefit of recanalization of an occluded vessel in some symptomatic patients, attempt is only performed in a minority of them. Percutaneous coronary intervention (PCI) of CTO is associated with high incidence of complications and unsuccessful procedure, mainly due to inability to cross the lesion. We sought to evaluate the efficacy and safety of the novel RVT CTO Guidewire Device (RVT-GDW, ReVascular Therapeutics, Sunnyvale, CA) in this complex scenario. METHODS: The RAPID-CTO study is a non-randomized, single center, first-in-man evaluation of a new guidewire system for treatment of CTO. The RVT-GDW is a new device designed to provide enhanced penetration and positioning control for crossing CTO via: (1) an 0.014 "guidewire with a mechanically active distal end; (2) a handle attached proximally to the guidewire, with an adjustable torquer, and interfaced to (3) a non-disposable, battery-operated, control unit, that provides activation control and audio feedback during the CTO crossing procedure. Per protocol, the RVT-GDW device was only used after at least 5 min (fluoroscopy time) of attempt with commercially available conventional guidewires to cross the target lesion. RESULTS: A total of 16 patients (16 lesions) were treated with the RVT-GDW. Mean age was 56.25 years, 56.2% were men, and 25% diabetics. The average duration of occlusion was 4.7 +/- 2.1 months. The mean vessel reference diameter was 2.76 +/- 0.31 mm and the mean lesion length was 16.64 +/- 7.70 mm (range 4.37-35.0 mm). Thirteen patients (81.2%) had "tapered stump" morphology at the proximal end of the occlusion, and a side branch was involved in 12 (75.0%). All lesions had contralateral circulation; bridging collaterals were seen in three (18.7%). Procedural success was achieved in 10 lesions (62.5%), with an average procedural time of 111.43 +/- 35.76 min. There were no major adverse cardiac events at both in-hospital and 30-day clinical follow-up. CONCLUSIONS: The first-in-man RAPID-CTO study suggests that the novel RVT-GDW device is technically feasible, safe and effective in crossing chronically occluded coronary arteries. Larger studies are warranted.

Percutaneous coronary revascularization using a trilayer metal phosphorylcholine-coated zotarolimus-eluting stent.

The ZoMaxx Coronary Stent System elutes the antiproliferative agent zotarolimus via a biocompatible phosphorylcholine polymer loaded onto a novel, thin, stainless steel stent platform containing an 0.0007-inch inner layer of tantalum that enhances fluoroscopic radiopacity. The objective of this single-arm prospective clinical trial was to assess the safety and performance of the ZoMaxx stent for the treatment of coronary artery stenosis. Forty consecutive patients with ischemic coronary occlusive disease due to single de novo obstructive lesions of native coronary arteries were treated with 3 x 18 mm ZoMaxx stents at the Dante Pazzanese de Cardiologie in Saõ Paulo, Brazil, between April and July 2005. Independent core laboratories analyzed quantitative coronary angiography and intravascular ultrasound results immediately after stent implantation, and after 4 months. The lesion, procedure, and device-deployment success rates were all 100% (40 of 40). There were no major adverse cardiac events during the study. Follow-up quantitative coronary angiography at 4 months revealed in-stent and in-segment late lumen losses of 0.20 +/- 0.35 and 0.17 +/- 0.35 mm, respectively. Follow-up intravascular ultrasound at 4 months revealed 6.5 +/- 6.2% neointimal volume obstruction. There were no instances of late acquired stent incomplete apposition or stent thrombosis. In conclusion, the ZoMaxx Coronary Stent can be safely implanted for the treatment of de novo coronary artery stenosis. The inhibition of neointima formation as measured by follow-up angiography and IVUS after 4 months suggests therapeutic potential for the reduction of restenosis.

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).

Influence of age and coronary artery disease on homocysteine levels in the young old compared with the old old and the oldest old.

A total of 172 elderly individuals, divided into case and control groups based on the diagnosis of coronary artery disease, underwent coronary angiography to investigate the influence of age and coronary artery disease on homocysteine levels. The subjects were divided into three age ranges: 65-74 years, 75-79 years, and 80 years and older. Continuous homocysteinemia was associated with a risk ratio for coronary artery disease of 1.07 for each micromol/L increase in homocysteine level. Hyperhomocysteinemia (values above 14 micromol/L) constituted an independent risk factor for coronary artery disease, with a risk ratio of 2.03. There was a progression of homocysteine levels between the young old and the oldest old only among the case group elderly. There was no difference among the control group elderly. There were no significant differences in vitamin levels. The rise in homocysteine levels from the young old to the oldest old may be considered not a normal pattern, but rather a pattern associated with coronary artery disease.

[Comparative analysis of intimal hyperplasia after sirolimus-eluting stent and thin-strut bare-metal stent implantation in small coronary arteries]. / Análise comparativa da hiperplasia intimal após o implante de stents com e sem sirolimus em artérias coronárias de pequeno calibre.

OBJECTIVE: This study aimed at evaluating reduction in intimal hyperplasia volume following angioplasty using sirolimus-eluting stents (Cypher) compared with thin-strut bare-metal stents (Pixel) in patients with small vessels. METHODS: Eighty patients with coronary artery disease were prospectively included in two consecutive series, the first using sirolimus-eluting stents (50) and the second using bare-metal stents (30). RESULTS: The use of sirolimus-eluting stents reduced: in-stent net volume obstruction [5.0% (SE = 0.77) x 39.0% (SE = 4.72), p < 0.001], in-stent late loss [0.25 mm (SE = 0.03) x 1,11 mm (SE = 0.13), p < 0.001], in-segment late loss [0.30 mm (SE = 0.04) x 0.83 mm (SE = 0.11), p < 0.001], in-stent restenosis (0% x 33.3%, p < 0.001) and in-segment restenosis (4% x 36.7%, p < 0.001). The event-free survival rate was 96% in the sirolimus-eluting stent group versus 86.7% in the bare-metal stent group (BMS) (p = 0.190). CONCLUSION: Sirolimus-eluting stents are superior to thin-strut bare-metal stents in reducing intimal hyperplasia (less in-stent obstruction and less late lumen loss) in patients with small vessels. The use of these stents significantly reduced angiographic restenosis at eight months.

[Adenosine myocardial perfusion SPECT with Tc-99m-MIBI in patients with obstructive coronary artery disease: correlation between quantitative coronary angiography and intravascular ultrasound measurements]. / Cintilografia do miocárdio com tecnécio 99m-MIBI e administração de adenosina em portadores de doença arterial coronária: correlação dos resultados com a angiografia coronária e o ultra-som intracoronário.

OBJECTIVE: To correlate myocardial perfusion scintigraphy (MPS) with Tc-99m-MIBI and adenosine infusion using quantitative coronary angiography (QCA) and intravascular ultrasound (IVUS). METHODS: Seventy patients with coronary artery disease (CAD) referred for myocardial perfusion scintigraphy (MPS) with MIBI and adenosine were studied. Clinical, electrocardiographic (ECG), and scintigraphic findings were correlated with variables of visual and quantitative angiographic analysis, as well as to those of IVUS. RESULTS: The mean age of patients was 60.6 years, and 39 were male. Coronary angiography showed percentage of diameter stenosis (% DS) of 49.94% in 105 arteries, 83 of which were re-evaluated by QCA (79%), mean of 44.20%, p<0.05. ST-segment depression during adenosine infusion was associated with higher degrees of % DS (55.0% vs. 47.8%), p<0.05). Scintigraphic ischemia was correlated with greater cross-sectional area of lumen obstruction by IVUS (% CSA). Clinical, ECG, and IVUS findings were considered together and expressed as global ischemic versus non-ischemic responses. Ischemia was associated with lower values of minimal lumen diameter (MLD) and minimal lumen area (MLA) determined by QCA and IVUS. CONCLUSION: Tc-99m-MIBI and adenosine myocardial SPECT is correlated with % CSA on IVUS, perfusion images considered. Global results assessment showed association between lumen diameter and area at obstructed sites as determined by QCA and IVUS.

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 < or =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.

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 approximately 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.

Sirolimus-eluting stent for the treatment of in-stent restenosis: a quantitative coronary angiography and three-dimensional intravascular ultrasound study.

BACKGROUND: We have previously reported the safety and effectiveness of sirolimus-eluting stents for the treatment of de novo coronary lesions. The present investigation explored the potential of this technology to treat in-stent restenosis. METHODS AND RESULTS: Twenty-five patients with in-stent restenosis were successfully treated with the implantation of 1 or 2 sirolimus-eluting Bx VELOCITY stents in São Paulo, Brazil. Nine patients received 2 stents (1.4 stents per lesion). Angiographic and volumetric intravascular ultrasound (IVUS) images were obtained after the procedure and at 4 and 12 months. All vessels were patent at the time of 12-month angiography. Angiographic late loss averaged 0.07+/-0.2 mm in-stent and -0.05+/-0.3 mm in-lesion at 4 months, and 0.36+/-0.46 mm in-stent and 0.16+/-0.42 mm in-lesion after 12 months. No patient had in-stent or stent margin restenosis at 4 months, and only one patient developed in-stent restenosis at 1-year follow-up. Intimal hyperplasia by 3-dimensional IVUS was 0.92+/-1.9 mm(3) at 4 months and 2.55+/-4.9 mm(3) after 1 year. Percent volume obstruction was 0.81+/-1.7% and 1.76+/-3.4% at the 4- and 12-month follow-up, respectively. There was no evidence of stent malapposition either acutely or in the follow-up IVUS images, and there were no deaths, stent thromboses, or repeat revascularizations. CONCLUSION: This study demonstrates the safety and the potential utility of sirolimus-eluting Bx VELOCITY stents for the treatment of in-stent restenosis.

First human experience with the 17-beta-estradiol-eluting stent: the Estrogen And Stents To Eliminate Restenosis (EASTER) trial.

OBJECTIVES: The purpose of the study was to examine the safety and efficacy of 17-beta-estradiol-eluting stent implantation on coronary de novo lesions. BACKGROUND: Recent animal data indicate that local delivery of 17-beta-estradiol promotes re-endothelialization, inhibits cell migration and proliferation, and prevents restenosis. METHODS: A total of 30 consecutive patients underwent 17-beta-estradiol-eluting BiodVysio (Biocompatibles Ltd., London, United Kingdom) stent implantation for the treatment of coronary de novo lesions. Clinical, angiographic, and intravascular ultrasound (IVUS) analysis was performed at six-month follow-up. RESULTS: All stents were successfully deployed and patients were discharged home without clinical events. A total of two patients exceeded 50% intra-stent narrowing by angiography, whereas no patients experienced edge restenosis. One patient had focal intra-stent restenosis (60% diameter stenosis) with no symptoms and negative stress test, whereas the other patient had diffuse restenosis, requiring target vessel revascularization. No other patient experienced any major adverse cardiac event. Follow-up IVUS revealed a neointimal hyperplasia volume of 32.3 +/- 16.4 mm(3), whereas the stent volume was 143.7 +/- 43.7 mm(3), resulting in a neointimal volume obstruction of 23.5 +/- 12.5%. None of the patients had > or =50% volume obstruction by IVUS. CONCLUSIONS: Implantation of 17-beta-estradiol-eluted BiodVysio stents appears feasible and safe, showing low rates of binary restenosis and revascularization. These results warrant further confirmation with a large, randomized multicenter trial.

Evaluation of the Safety and Efficacy of the Novel Svelte Acrobat Integrated Delivery System via Radial Approach With 5 Fr Catheters.

PURPOSE: To evaluate the safety and efficacy of the Svelte Acrobat integrated delivery system (IDS) via radial approach with 5 Fr catheters. The direct stenting (DS) system enables easy delivery, deployment, and postdilatation of a cobalt-chromium stent. METHODS: Patients with coronary artery disease (CAD) were prospectively enrolled at three centers to undergo percutaneous coronary intervention with DS via radial approach using 5 Fr catheters. The primary endpoint was IDS success, which was defined as DS without postdilatation and final stenosis <20% with Thrombolysis in Myocardial Infarction (TIMI)-3 flow. RESULTS: Fifty consecutive patients with 55 lesions were included. The procedure success rate was 98%. The device could not cross the lesion in 2 cases, so DS success was 96%. Fifty lesions met the primary study objective; thus, IDS success rate was 91%. The procedure duration was 21 ± 9 minutes, fluoroscopy time was 7.3 ± 4.7 minutes, and contrast volume per vessel was 103 ± 33 cm3. The final residual stenosis, by quantitative coronary angiography, was 3.4 ± 4%. The reduced need for additional catheters resulted in a 20% procedural cost reduction. There were no bleeding or vascular complications. At 8 months, the event-free survival rate was 84%. CONCLUSIONS: DS using the Svelte Acrobat IDS via radial approach with low-profile catheters is safe and efficacious in select coronary artery disease patients, and its use is associated with potential procedural cost savings.