Jose de Ribamar Costa

Impact of Intravascular Ultrasound Imaging on Early and Late Clinical Outcomes Following Percutaneous Coronary Intervention With Drug-Eluting Stents

OBJECTIVES This study sought to assess the impact of intravascular ultrasound (IVUS)-guided versus angiography-guided drug-eluting stent (DES) implantation. BACKGROUND There are limited data on IVUS guidance in the DES era. Therefore, we investigated the impact of IVUS guidance on clinical outcomes in the MATRIX (Comprehensive Assessment of Sirolimus-Eluting Stents in Complex Lesions) registry. METHODS The MATRIX registry prospectively enrolled consecutive, unselected patients treated with sirolimus-eluting stents (SES) (n = 1,504); 631 patients (42%) underwent IVUS-guided stenting, and 873 (58%) had only angiographic guidance. We assessed 30-day, 1-year, and 2-year rates of death/myocardial infarction (MI), major adverse cardiac events (cardiac death, MI, or target vessel revascularization), and definite/probable stent thrombosis in 548 propensity-score matched patient pairs. RESULTS After matching, baseline and angiographic characteristics were similar in IVUS and no-IVUS groups. Patients in the IVUS group had significantly less death/MI at 30 days (1.5% vs. 4.6%, p < 0.01), 1 year (3.3% vs. 6.5%, p < 0.01), and 2 years (5.0% vs. 8.8%, p < 0.01). Patients in the IVUS group had significantly less major adverse cardiac events at 30 days (2.2% vs. 4.8%, p = 0.04) and numerically less major adverse cardiac events at 1 year (9.1% vs. 13.5%, p = 0.07) and 2 years (12.9% vs. 16.7%, p = 0.18). Rates of MI were significantly lower in the IVUS group at 30 days (1.5% vs. 4.0%, p < 0.01), 1 year (1.8% vs. 4.8%, p < 0.01), and 2 years (2.1% vs. 5.7%, p < 0.01). CONCLUSIONS IVUS-guided stent implantation appears to be associated with a reduction in both early and long-term clinical events. Further investigation in randomized controlled trials is warranted.

Assessment of drug-eluting stents and bioresorbable stents by grayscale IVUS and IVUS-based imaging modalities

Grayscale IVUS and IVUS-based imaging modalities during the last years have become useful in the assessment not only of drug eluting stent, but also of new bioresorbable vascular scaffolds. Although IVUS resolution is not sufficient for determining stent coverage (optical coherence tomography is the gold standard), serial IVUS can measure intimal hyperplasia, assess acute and late incomplete stent apposition, detect the presence and persistence of edge dissections, study edge effects and look for causes of restenosis and thrombosis. In addition other IVUS-based imaging modalities, such as IVUS-VH, iMAP or palpography, can be used to study the serial compositional and mechanical changes of the plaque behind stent struts and also to follow the bioresorption of the new bioresorbable scaffolds, analyzing the backscattering signal coming from the polymeric struts. This review details and evaluates grayscale IVUS and IVUS-based techniques findings in clinical trials, highlighting the usefulness of these imaging modalities in the study of drug eluting stents and bioresorbable vascular scaffold.

Evolução tardia após intervenção coronária percutânea com stents farmacológicos em pacientes diabéticos do Registro DESIRE (Drug-Eluting Stents In the REal world)

BACKGROUND: Diabetes mellitus is related to the occurrence of unfavorable outcomes after percutaneous coronary interventions. Drug-eluting stents can confer a better late evolution to this subgroup. The aim of this study was to assess the performance of these devices in diabetic patients. METHODS: The DESIRE is a single-center, prospective registry that included 2,365 consecutive patients treated with drug-eluting stents between May 2002 and January 2008. For the present analysis, patients with a diagnosis of acute myocardial infarction, those with saphenous vein grafts lesions and those within 6 months of the index procedure, were excluded. RESULTS: Therefore, 1,705 patients were divided into two groups: non-diabetics (n = 1,211 P/71.1%) and diabetics (n = 494 P/28.9%), of which 109 P (6.4%) were insulin-dependent. Among the diabetics there was a higher number of older people (64.8 ± 9.8 years old vs. 63.4 ± 11.7 years old; p = 0.025), females (28.9 vs. 22.5%; p = 0.005), patients with obesity (35.2 vs. 23.5%; p < 0.001), hypertension (86.6 vs. 73.7%; p < 0.001), multi-vessel disease (63.4 vs. 54.4%; p = 0.001), small-vessel disease (2.70 ± 0.51 mm vs. 2.75 ± 0.42 mm; p < 0.001) and calcified lesions (32.3 vs. 27.1%; p = 0.009). In the late clinical follow up (2.2 ± 1.1 years), the combined cardiac events occurred more frequently in the diabetic patients (9.8 vs. 7.0%; p = 0.048). The multivariate analysis showed that diabetes mellitus (OR = 1.45; 95% confidence interval 1.0 to 2.1) and the presence of a calcified lesion (OR = 3.06; 95% CI 1.47 to 6.34) were independent predictors of major adverse cardiac events. CONCLUSION: The use of drug-eluting stents in diabetics showed to be a safe and efficient approach. The major adverse cardiac events, although in very low rates, occurred more frequently in the diabetics.

TWO-YEAR SUSTAINED EFFICACY OF A NOVEL, POLYMER-FREE SIROLIMUS ELUTING STENT: LATE RESULTS OF THE VESTASYNC II TRIAL

Background: Nonpolymeric drug-eluting stents (DES) have arisen as an attractive alternative to minimize local inflammatory reactions and potentially reduce the adverse events observed following the 1st generation of DES with thick, durable polymers. We sought to assess the long term efficacy of the novel VESTAsyncTM Eluting Stent (VES) combining a Cro-Co platform with a nanothin-microporous hydroxyapatite surface coating impregnated with a polymer-free low-dose of Sirolimus (55μg).

Stents liberadores de sirolimus com e sem cobertura polimérica: análise seriada com angiografia e ultrassom intracoronariano tridimensional

ABSTRACT Sirolimus-Eluting Stents with and without PolymericCoating: Serial Angiography and Three-dimensionalIntravascular Ultrasound Analysis Background: The long-term presence of the stent polymerin contact with the vessel wall has been associated tointense inflammatory response and late adverse events.However, absence of the stent polymer may compromisedrug dose and drug delivery kinetics, leading to someefficacy issues. We aimed to compare, by means of serialquantitative coronary angiography (QCA) and intravascularultrasound (IVUS), the efficacy of the novel nonpolymericlow-dose (55 µg) VESTAsync™ (VES) sirolimus-eluting stent,with the permanent polymer, high-dose (140 µg) Cypher™sirolimus-eluting stent (CYP). Methods: Fifteen patients withsingle, de novo lesions < 14 mm, in native vessels of 2.5 mmto 3.5 mm diameter, were treated with VES and comparedto a paired historical cohort of 15 patients treated withCYP. QCA and IVUS data were obtained post-procedureand at 4 and 12-month follow-up. Primary endpoints werethe comparison of in-stent late luminal loss and percentageof intimal hyperplasia obstruction.

Trombose de stent farmacológico no "mundo-real": análise crítica do Registro DESIRE (Drug-Eluting Stent in the Real World)

BACKGROUND: We report the incidence of stent thrombosis (ST) predictors in a large cohort of complex patients treated with drug eluting stents (DES) in the real world. METHODS: From May 2002 until January 2008, 2,365 non-selected patients with > 1 coronary lesion with stenosis of > 50% were treated with DES. The clinical follow-up up to five years (mean time 2.2 ± 1.5 years) was completed in 98.3%. RESULTS: Twenty nine percent of patients had diabetes and 60% multi-vessel disease, 40% presented acute coronary syndrome (15%, acute myocardial infarction [AMI]). The anterior descending artery was the target vessel most frequently treated (35.8%), and 67% were complex lesions (Type B2/C). In all, 3,634 DES were implanted and 40% received multiple stents. Stent thrombosis (classification of the Academic Research Consortium) occurred in 1.6% (n = 38), 60.5% with angiographic confirmation, 42% occurred between 1 and 12 months and 47% of the events had a fatal outcome. The independent predictors of ST were: current smoking [relative risk (RR) 2.59; 95% confidence interval (CI) 1.18-5.67; p = 0.018], AMI intervention (RR 3.50; 95% CI 1.31-9.40; p = 0.013), moderate to severe calcification (RR 2.38; 95% CI 1.34-4.23; p = 0.003), excentric lesion (RR 1.86; 95% CI 1.03-3.34; p = 0.039), > 1 DES implanted per myocardial territory (RR 1.81; 95% CI 1.09-3.02; p = 0.023), post-dilatation (RR 0.50; 95% CI 0.29-0.90; p = 0.020) and intra-stent residual stenosis [RR 1.04 (per % unit increase); 95% CI 1.01-1.06; p = 0.003]. CONCLUSIONS: In this real world prospective registry, the cumulative incidence of stent thrombosis up to 5 year follow-up was rare (1.6%), and associated to smoking, PCI in the AMI, complex lesion morphology, multiple stents implanted per myocardial territory and subexpantion of the stent.

Long‐term clinical follow‐up of patients undergoing percutaneous alcohol septal reduction for symptomatic obstructive hypertrophic cardiomyopathy

Alcohol septal ablation (ASA) is an alternative treatment for symptomatic hypertrophic obstructive cardiomyopathy (HOCM) patients refractory to pharmacological therapy. We sought to evaluate the immediate and long‐term incidence of death and changes in life quality in a consecutive cohort submitted to ASA.

Intervenção coronária percutânea em pontes de veia safena com uso de stents farmacológicos: resultados agudos e tardios dos pacientes incluídos no registro DESIRE

INTRODUCTION: Despite the advent of drug-eluting stents, per-cutaneous coronary interventions in saphenous vein bypass grafts remain a challenge, with a high incidence of early complications and uncertainty regarding late outcomes. This study was aimed at evaluating clinical outcomes of patients with saphenous vein graft lesions treated with drug-eluting stents. METHOD: From May 2002 to January 2009, a total of 151 patients with 196 saphenous vein graft lesions were consecutively submitted to percutaneous coronary intervention with 211 drug-eluting stents and included in this trial. Patients were pretreated with enoxiparin, clopidogrel and acetylsalicylic acid for 3 to 5 days prior to percutaneous coronary intervention. Dual antiplatelet therapy (acetylsalicylic acid + clopidogrel) was prescribed for 12 months. The objective was to determine the rate of major adverse cardiac events (MACE) during hospitalization and in the long-term. Clinical follow-up was obtained at 1, 6 and 12 months and then, yearly after that. RESULTS: Mean age was 68.2 years, with a prevalence of male patients (89.1%). Diabetes mellitus was observed in 30.7% cases and mean age of venous grafts was 10.4 years. Angiographic success was obtained in 98.2% of the cases. During hospitalization, MACE rate was 8.7%, especially due to post-procedural enzyme increase (7.1%). In the first follow-up year, the rate of MACE increased to 14.2%, with a 3.9% rate of target-lesion revascularizations. In the late follow-up (mean of 2.6 years), the rate of MACE increased to 28.5%, with 6.0% of cardiac deaths and 16.6% of acute myocardial infarctions. Five cases of thrombosis (all of them definitive) were observed in this population. CONCLUSION: In the present subanalysis of the DESIRE Registry, the use of optimized antithrombotic therapy (acetylsalicylic acid + thienopyridines + low molecular weight heparin, for 3 to 5 days before the intervention) and the use of drug-eluting stents for the treatment of saphenous vein grafts is correlated to excellent early clinical outcomes and in the first year after percutaneous intervention. However, after the first year, these results significantly deteriorate, indicating the more aggressive character of vascular disease in the venous conduits. Thrombosis rates may be considered low, favoring the safety of these devices in such complex scenario.

Late vascular response at the edges of sirolimus analogous-eluting stents in diabetic patients: An intravascular ultrasound study.

Introduction: Vascular response at edges of drug‐eluting stents is still not well established, particularly in diabetic patients who are prone to aggressive atherosclerosis progression. Recently, Biolimus and Zotarolimus have demonstrated potent antiproliferative effects. Objective: To compare the vascular responses at edges of sirolimus analogous‐eluting stents in patients with and without diabetes, using intravascular ultrasound (IVUS). Methods: 306 edges were analyzed in 153 patients treated with drug‐eluting stents and divided in: diabetics (122 edges) and nondiabetics (166 edges). IVUS was performed postintervention and at 6‐month follow‐up and included 5 mm distal and proximal to the stented segment. Vessel, lumen, and plaque volumes were calculated. Volume variation (follow‐up minus basal) was also calculated. Edge restenosis was defined as obstruction >50%. Results: Baseline characteristics were similar between groups. In both groups the entire lesion length was covered (stent length/lesion length ratio was 1.5 for both groups). There were no differences in edge volumes and restenosis rate between the groups. Among diabetics, there was no significant volume variation. However, in nondiabetic patients there was significant increase in vessel volume in proximal (from 67.1 ± 22 mm3 to 72.2 ± 25 mm3: P = 0.02) and distal (from 54.4 ± 22 mm3 to 59.8 ± 22 mm3: P = 0.001) edges. Conclusion: Nondiabetic patients showed a significant positive vascular remodeling in proximal and distal edges of sirolimus analogous‐eluting stent. This vascular mechanism was not observed in diabetic patients. Although different vascular responses were observed, restenosis rates were equivalent between the 2 groups at 6‐month follow‐up.

Pressure-mediated versus pharmacologic treatment of radial artery spasm during cardiac catheterisation: a randomised pilot study

AIMS The aim of the study was to determine the effectiveness of a novel strategy to treat radial artery spasm (RAS). METHODS AND RESULTS We conducted a prospective, randomised, single-centre, open-label trial comparing a novel strategy of pressure-mediated dilatation versus intra-arterial administration of a combination of nitroglycerine plus verapamil for the treatment of RAS. The primary endpoint was radial artery intraluminal diameter acute gain assessed by quantitative radial angiography. After screening two hundred and twenty consecutive cases, twenty patients presented with RAS and were randomised 1:1 to either strategy. Overall the mean age was 60.8±11.5 years and 53% were females. Pre-treatment angiographic characteristics were similar between the groups. The primary endpoint of radial artery acute gain was significantly greater in the pressure-mediated dilatation group (0.85±0.46 mm vs. 0.03±0.24 mm, p<0.001). Blood pressure drop was significantly lower in the pressure-mediated dilatation group (ΔBP -3.8±24 vs. -31.6±19 mmHg, p<0.001). There was one case of radial artery occlusion in the pressure-mediated dilatation group at follow-up. Short-duration pain was observed during the application of pressure. CONCLUSIONS Pressure-mediated dilatation for the treatment of RAS was feasible, with superior angiographic results compared to a pharmacologic vasodilator strategy, with no impact on blood pressure. This novel approach proved to be safe and effective and should be tested in a large randomised trial.