Comparison of a vascular closure device versus the radial approach to reduce access site complications in non-ST-segment elevation acute coronary syndrome patients: The angio-seal versus the radial approach in acute coronary syndrome trial.

OBJECTIVES: To compare the radial versus femoral approach using Angio-Seal for the incidence of access site complications among non-ST-segment elevation acute coronary syndrome patients undergoing invasive strategy. BACKGROUND: Arterial access is a major site of complications after invasive coronary procedures. Vascular closure devices provide more comfort to patients decreasing time to hemostasis and need for bed rest. However, the inconsistency of data proving their safety limits their routine adoption as a strategy to prevent vascular complications. METHODS: Single-center non-inferiority trial where 240 patients were randomized to radial or femoral access using Angio-Seal. The primary objective was the occurrence of complications at the arterial puncture site until 30 days after the procedure. RESULTS: There were no baseline clinical differences between groups, except for a greater prevalence of female patients in the radial group (33.3 vs. 20.0%, P = 0.020). Hemostasis was achieved in the entire radial group with the use of TR Band and in 95% of the procedures in the femoral group with Angio-Seal (P = 0.029). Except for a higher incidence of asymptomatic arterial occlusion in the radial group, there were no differences among the other analyzed outcomes. According to the noninferiority test, the use of Angio-Seal was noninferior to the radial approach, considering the margin of 15% (12.5 vs. 13.3%, difference -0.83%, 95% CI -9.31 - 7.65, P for noninferiority <0.001). CONCLUSIONS: Angio-Seal seems noninferior in the incidence of access site complications at 30 days when compared with the radial approach. © 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).

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).

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.

A novel mechanism explaining early lumen loss following balloon angioplasty for the treatment of in-stent restenosis.

We performed serial intravascular ultrasound analysis in patients who underwent balloon dilatation for in-stent restenosis. Early lumen loss was detected by intravascular ultrasound and was associated with minimal changes at the edges and at the external elastic membrane. These results on intravascular ultrasound suggest compression and decompression as the main mechanisms for early lumen loss after dilatation of in-stent restenotic lesions.

Comparison between sirolimus-eluting stents and intracoronary catheter-based beta radiation for the treatment of in-stent restenosis.

We report the outcomes of patients who had in-stent restenosis (IRS) that was treated with intravascular brachytherapy (IVBT) or sirolimus-eluting stent (SES) implantation. The benefit of IVBT for treating ISR is well documented. SES implantation decreases first-time ISR and, in preliminary reports, has been used to treat ISR. Fifty consecutive patients who had ISR were treated; the first 25 patients underwent SES implantation and the next 25 patients were treated with IVBT using a beta-Cath System (a 40-mm strontium-90/yttrium-90 source). Quantitative angiographic and intravascular ultrasound follow-up were performed at 5.2 +/- 1.1 and 12.1 +/- 1.2 months; clinical follow-up was performed at 15 months. SES deployment and IVBT were successful in all patients. At 12-month follow-up, 8 patients who underwent IVBT had angiographic recurrence (4 in the stent and 4 at the stent edge); only 1 patient who underwent SES implantation developed recurrent ISR. At 12 months, in-stent late luminal loss was similar between the SES and IVBT groups (0.35 +/- 0.45 vs 0.34 +/- 0.46 mm, p = 0.9); however, in-stent net luminal gain was higher in the SES group than in the IVBT group (1.32 +/- 0.13 vs 0.57 +/- 0.19 mm, p <0.0001), and in-lesion late luminal loss was higher in the IVBT group (0.48 +/- 0.32 vs 0.16 +/- 0.42 mm, p = 0.004). At 12 months, intravascular ultrasound stent volume obstruction was higher after IVBT versus than after SES implantation (38.7% vs 6.7%, p <0.0001). At 15-month clinical follow-up, 64% and 96% (p <0.01) of patients who underwent IVBT and SES implantation, respectively, were free of major adverse cardiac events. In conclusion SES implantation for the treatment of ISR was effective and superior to catheter-based IVBT in preventing recurrent neointimal proliferation and angiographic restenosis at 1-year follow-up.

Intravascular ultrasound study of effects of overlapping sirolimus-eluting stents.

Drug-eluting stents have been investigated as a treatment option for in-stent restenosis after bare metal stenting. However, it remains unclear whether overlapping drug-eluting stents have a toxic effect on the vessel wall. The aim of this study was to analyze the 1-year intravascular ultrasound findings after 2 overlapping sirolimus-eluting stent implantations in patients with in-stent restenosis lesions. Eight patients required 2 sirolimus-eluting stents, 18 mm in length, for full lesion coverage; these stents were implanted with >1-mm overlap. At 1-year follow-up, there were no significant quantitative changes in intravascular ultrasound measurements within the overlapped segment.

Angiographic and volumetric intravascular ultrasound comparison between direct sirolimus-eluting stent implantation versus predilation.

Conventional sirolimus-eluting stent (SES) implantation typically follows balloon predilation. The impact of direct SES implantation on in-stent neointimal hyperplasia and the adjacent reference segments has not been evaluated. The aim of this study was to analyze direct and conventional SES implantation techniques by angiography and serial intravascular ultrasound. Fifty-three patients with single de novo coronary lesions underwent successful conventional (n = 26) and direct (n = 27) SES implantation. At 6-month follow-up, similar in-stent late luminal loss and decreased neointimal hyperplasia volume were seen in the 2 groups, preserving the luminal dimensions at the edges of the stents.

Intracoronary brachytherapy. Treatment of in-stent restenosis with the Beta-Cath system. Initial experience in Latin America.

OBJECTIVE: To assess the safety and efficacy of intracoronary brachytherapy using the Beta-Cath system for preventing recurrence of in-stent restenosis (ISR), by analyzing clinical, angiographic, and intracoronary ultrasound (ICUS) results. METHODS: This study assessed 30 patients with ISR in native coronary arteries who underwent balloon catheter angioplasty followed by intracoronary beta radiation with the Beta-Cath system (90Sr/Y). RESULTS: The study comprised complex, extensive (18.66 +/- 4.15 mm) restenotic lesions, 77% of which were of the diffuse-proliferative type. Brachytherapy was successful in 100% of the cases. The mean radiation dose used was 20.7 +/- 2.3 Gy, released for a mean period of 3.8 +/- 2.1 minutes. On late follow-up, the in-stent minimum luminal diameter (MLD) slightly decreased (from 1.98 +/- 0.30 mm to 1.84 +/- 0.39 mm at 6 months; P=0.13), with a late loss of 0.14 +/- 0.18 mm. The intrasegmentary MLD was significantly smaller than the in-stent diameter (1.55 +/- 0.40 mm vs 1.84 +/- 0.39 mm; P=0.008), and was associated with a more significant late loss (0.40 +/- 0.29 mm vs 0.14 +/- 0.18 mm; P=0.0001). On ICUS, a mild increase of 6.8 +/- 14.3 mm3 in the neointimal tissue was observed at 6 months (P=0.19), and the percentage of volumetric obstruction increased by 4.7 +/- 7.5%. Binary restenosis and revascularization of the target vessel recurred in 17% of the cases; late occlusion associated with myocardial infarction occurred in 1 case (3%). Event-free survival was 80%. CONCLUSION: The management of in-stent restenosis with intracoronary beta radiation proved to be a safe and effective procedure, with a high rate of immediate success, representing a therapeutic option for inhibiting neointimal hyperplasia.

Clinical outcomes at 30 days in the Brazilian Registry of Acute Coronary Syndromes (ACCEPT).

BACKGROUND: There are few registries documenting clinical practice in Brazilian patients with acute coronary syndrome. OBJECTIVES: Demography description, occurrence of major clinical adverse events and comparative analysis in patients submitted or not to an invasive strategy (coronary angiography and myocardial revascularization) in a Brazilian multicenter registry of acute coronary syndrome. METHODS: The ACCEPT/SBC registry prospectively collected data on acute coronary syndrome patients from 47 Brazilian hospitals. The current analysis reports the occurrence of major clinical outcomes and according to the performance or not of a procedure for myocardial revascularization at the end of 30 day follow-up. RESULTS: Between August 2010 and December 2011, 2.485 patients were enrolled in this registry. Of these, 31.6% had unstable angina, 34.9% and 33.4% had acute coronary syndrome without and with ST-segment elevation. At 30 days, the performance of a myocardial revascularization procedure was progressively higher according to the severity of clinical presentation (38.7% vs. 53.6% vs. 77.7%, p < 0.001). Cardiac mortality among those submitted or not to myocardial revascularization procedure was 1.0% vs. 2.3% (p = 0.268), 1.9% vs. 4.2% (p = 0.070) and 2.0% vs. 8.1% (p < 0.001), in those with unstable angina, acute coronary syndrome without and with ST-segment elevation, respectively. CONCLUSIONS: The prescription of a myocardial revascularization procedure was progressively more frequent according to the severity of clinical presentation; for those treated during acute coronary syndrome without and with ST-segment elevation, there was a trend and significant decrease in mortality rate at 30 day of follow-up, respectively.

Correlation between quantitative angiographic and intravascular ultrasound parameters in patients treated with sirolimus analogous-eluting stents.

Despite the undeniable contribution of intravascular ultrasound (IVUS) and quantitative coronary angiography (QCA) to assess drug-eluting stent (DES) effectiveness, the way these image modalities correlate to each other and to target-lesion revascularization (TLR) after PCI, is yet to be established. Thus we sought to evaluate whether there is an acceptable correlation between QCA and IVUS after DES implantation. We analyzed 204 pts treated with DES: Zotarolimus- (126), Sirolimus- (57), and Biolimus (31) with baseline and follow-up QCA and IVUS. The correlation between QCA lumen loss (LL) and intimal hyperplasia (IH) volume obstruction by IVUS was assessed by multiple regression analysis. Two QCA parameters (in-segment diameter stenosis and in-segment LL) and one IVUS variable (in-stent volume of IH) were evaluated as quantitative surrogates of 6 month TLR. The receiver operating characteristic method with c-statistics was used to assess the ability of each surrogate endpoint to predict TLR. QCA LL correlated positively with IVUS IH volume of obstruction (r = 0.69; CI95% 0.61-0.75: P < 0.0001), independent of DES type. The 2 QCA parameters were superior to the IVUS parameter as surrogates for TLR. Of note, QCA LL (c = 0.99) correlated best with TLR, even better than percent DS. In the DES era there is a good correlation between QCA measured LL and IVUS IH volume and therefore can be used as a surrogate of DES efficacy.

Desfechos clínicos aos 30 dias do registro brasileiro das síndromes coronárias agudas (ACCEPT) / Clinical outcomes at 30 days in the brazilian registry of acute coronary syndromes (ACCEPT)

FUNDAMENTO: São escassos os registros documentando a prática clínica brasileira na vigência de uma síndrome coronária aguda. OBJETIVOS: Descrição da demografia, ocorrência de desfechos graves e análise comparativa dentre aqueles que efetivaram ou não uma estratégia invasiva (cinecoronariografia e revascularização miocárdica) em um registro brasileiro multicêntrico de portadores de uma síndrome coronária aguda. MÉTODOS: O registro ACCEPT/SBC coletou prospectivamente, em 47 centros hospitalares brasileiros, pacientes na vigência de uma síndrome coronária aguda. Apresentamos a ocorrência de desfechos clínicos graves, de modo integral, e de acordo com a submissão ou não a um procedimento de revascularização do miocárdio ao final dos primeiros 30 dias de seguimento. RESULTADOS: De agosto de 2010 até dezembro de 2011, 2.485 pacientes foram incluídos neste registro. Destes, 31,6% eram portadores de angina instável e 34,9% e 33,4%, com síndrome sem e com supradesnível do segmento ST. Aos 30 dias, a submissão a procedimento de revascularização do miocárdio foi progressivamente maior de acordo com a gravidade da apresentação clínica (38,7% versus 53,6% versus 77,7%; p < 0,001). A ocorrência de mortalidade cardíaca, dentre aqueles submetidos ou não à revascularização miocárdica, foi de 1,0% versus 2,3% (p = 0,268), 1,9% versus 4,2% (p = 0,070) e 2,0% versus 8,1% (p < 0,001), angina instável, síndrome sem e com supradesnível do segmento ST, respectivamente. CONCLUSÕES: A prescrição de revascularização do miocárdio foi progressivamente mais frequente de acordo com a gravidade da apresentação clínica; naqueles atendidos na vigência de síndrome coronária sem e com supradesnível do segmento ST, promoveu tendência e redução significativa da mortalidade, aos 30 dias, respectivamente.

BACKGROUND: There are few registries documenting clinical practice in Brazilian patients with acute coronary syndrome. OBJECTIVES: Demography description, occurrence of major clinical adverse events and comparative analysis in patients submitted or not to an invasive strategy (coronary angiography and myocardial revascularization) in a Brazilian multicenter registry of acute coronary syndrome. METHODS: The ACCEPT/SBC registry prospectively collected data on acute coronary syndrome patients from 47 Brazilian hospitals. The current analysis reports the occurrence of major clinical outcomes and according to the performance or not of a procedure for myocardial revascularization at the end of 30 day follow-up. RESULTS: Between August 2010 and December 2011, 2.485 patients were enrolled in this registry. Of these, 31.6% had unstable angina, 34.9% and 33.4% had acute coronary syndrome without and with ST-segment elevation. At 30 days, the performance of a myocardial revascularization procedure was progressively higher according to the severity of clinical presentation (38.7% vs. 53.6% vs. 77.7%, p < 0.001). Cardiac mortality among those submitted or not to myocardial revascularization procedure was 1.0% vs. 2.3% (p = 0.268), 1.9% vs. 4.2% (p = 0.070) and 2.0% vs. 8.1% (p < 0.001), in those with unstable angina, acute coronary syndrome without and with ST-segment elevation, respectively. CONCLUSIONS: The prescription of a myocardial revascularization procedure was progressively more frequent according to the severity of clinical presentation; for those treated during acute coronary syndrome without and with ST-segment elevation, there was a trend and significant decrease in mortality rate at 30 day of follow-up, respectively.

Use of drug-eluting stents in Brazil: the CENIC (National Registry of Cardiovascular Interventions) registry.

BACKGROUND: Drug-eluting stents (DES) represent a major advance in the management of ischemic heart disease, but the extrapolation of favorable results from clinical trials to the real-world practice has been criticized. OBJECTIVE: To assess the use of DES in Brazil between 2000 and 2005. METHODS: Using the database of the National Registry of Cardiovascular Interventions (CENIC - Central Nacional de Intervenções Cardiovasculares) of the Brazilian Society of Hemodynamics and Interventional Cardiology (SBHCI - Sociedade Brasileira de Hemodinâmica e Cardiologia Intervencionista), all PCI procedures with DES implantation performed between 2000 and 2005 were analyzed. The groups were divided into the following biennia: 2000-2001(A), 2002-2003 (B), and 2004-2005 (C), and patient's clinical and angiographic characteristics were compared, as well as their short-term clinical outcome. Statistical analyses were performed using the chi-square test or ANOVA, and p values of less than 0.05 were considered to be statistically significant. RESULTS: A total of 154,406 PCI procedures were studied, and DES was used in 10,426 (7%) interventions. A progressive and statistically significant increase was found in the use of DES during the period studied: 0.14% from 2000 to 2001, 5% from 2002 to 2003, and 14% from 2004 to 2005 (p < 0.0001). After 2001, there was an increase in success rates (96.58% in 2000-2001 (A), 99.69% in 2002-2003 (B), and 99.56% in 2004-2005 (C), A x B with p < 0.001; B x C with p = 0.015) and a decrease in hospital mortality rates (1.59% in group A, 0.38% in group B, and 0.66% in group C, with p = 0.59 for A x B and p < 0.0001 for B x C). CONCLUSION: In Brazil, the use of drug-eluting stents increased significantly during recent years, resulting in higher success rates and lower hospital mortality.

Late incomplete apposition after drug-eluting stent implantation: incidence and potential for adverse clinical outcomes.

AIM: Late-acquired incomplete stent apposition (ISA) has been documented after drug-eluting stent (DES) implantation; however, its clinical role remains controversial. We sought to investigate the incidence and long-term clinical consequences of late ISA after implantation of sirolimus- (SES) or paclitaxel-eluting stent (PES) in a non-selected population. METHODS AND RESULTS: From our database, we analysed 195 consecutive patients who underwent DES placement (175 with SES and 20 with PES) into native artery lesions and had serial intravascular ultrasound studies (IVUS) performed at index procedure and after 6-8 months. They were clinically followed for 29 +/- 15 months (median of 24.3 months, interquartile range 18.1-31.6 months). Late ISA was defined as separation of at least one stent strut from the vessel wall in a segment without a side-branch and where the immediate post-implantation IVUS revealed complete apposition of stent struts. We identified 10 patients (5.1%) with late ISA, three patients after PES, and seven patients after SES implantation. ISA was localized almost exclusively at body of the stents (nine out of 10 cases). Mean ISA volume and length were 44.5 +/- 41.9 mm(3) and 7.4 +/- 11 mm, respectively. There was a marked increase in vessel volume from 416.0 +/- 163.9 mm(3) at baseline to 514.4 +/- 247.9 mm(3) at follow-up (P = 0.001) with no significant change in plaque volume (232.4 +/- 52.7 at baseline and 226.4 +/- 22.3 mm(3) at follow-up, P = 0.3) in patients who presented with late-acquired ISA. During the follow-up period, one patient with SES and one patient with PES who presented late-acquired ISA had late stent thrombosis and acute myocardial infarction. CONCLUSION: Late-acquired ISA was observed in 5.1% of patients after DES implantation and is related to regional vessel positive remodelling. The relationship between late-acquired ISA and long-term adverse outcomes (e.g. stent thrombosis) requires further analysis.