Manuel Cano

Incidence and Predictors of Very Late (≥4 Years) Major Cardiac Adverse Events in the DESIRE (Drug-Eluting Stents in the Real World)-Late Registry

OBJECTIVES Our aim was to access the incidence of late major adverse cardiac events (MACE) and stent thrombosis (ST) in nonselected, complex patients followed for a period >/=4 years. BACKGROUND Despite the efficacy of drug-eluting stents (DES) in reducing repeated target lesion revascularization, concerns regarding the occurrence of late and very late ST have partially obscured the benefits of this novel technology. METHODS All consecutive patients treated solely with DES between May 2002 and January 2005 were enrolled into this prospective, nonrandomized, single-center registry. The primary end point was long-term occurrence of MACE up to 7 years. Independent predictors of MACE, cardiac death, target lesion revascularization, and ST were obtained by a multivariate Cox proportional hazards regression model. RESULTS A total of 1,010 patients were enrolled. Most of them were men (77%) with a mean age of 63.7 years. Stent/patient rate was 1.4. Patients were kept in dual antiplatelet therapy for 3 and 6 months after Cypher (Cordis, Johnson & Johnson, Miami Lakes, Florida) and Taxus (Boston Scientific Corp., Natick, Massachusetts) stent implantation, respectively. Follow-up was obtained in 98.2% of the cohort (median 5.01 years). Survival free of MACE and cumulative incidence of definite/probable ST were 84.6% and 1.7%, respectively. Independent predictors of ST were percutaneous coronary intervention in the setting of acute myocardial infarction, DES overlapping, treatment of multivessel disease, presence of moderate-to-severe calcification at lesion site, and in-stent residual stenosis. CONCLUSIONS The deployment of DES in complex, real-world patients resulted in a low rate of very long-term MACE and ST. However, ST still occurs very long after the index procedure.

Long-term clinical outcomes of the Drug-Eluting Stents in the Real World (DESIRE) Registry.

BACKGROUND Recently, cardiologists have treated more complex patients and lesions with drug-eluting stents (DES). However, long-term efficacy and safety of the off-label use of these new devices is yet to be demonstrated. METHODS The Drug-Eluting Stents in the Real World (DESIRE) registry is a prospective, nonrandomized single-center registry with consecutive patients treated solely with DES between May 2002 and May 2007. The primary end-point was long-term occurrence of major adverse cardiac events (MACE). Patients were clinically evaluated at 1, 3, and 6 months and then annually up to 5 years. RESULTS A total of 2,084 patients (2,864 lesions and 3,120 DES) were included. The mean age was 63.8 +/- 11.5 years. Diabetes was detected in 28.9% and 40.7% presented with acute coronary syndrome. Cyphertrade mark was the predominant DES in this registry (83.5%). Mean follow-up time was 2.6 +/- 1.2 years and was obtained in 96.5% of the eligible patients. Target lesion revascularization (TLR) was performed in 3.3% of the patients. Q wave myocardial infarction (MI) occurred in only 0.7% of these patients and total stent thrombosis rate was 1.6% (n = 33). Independent predictors of thrombosis were PCI in the setting of MI (HR 11.2; 95% CI, 9.6-12.4, P = 0.001), lesion length (HR 4.6; 95% CI, 3.2-5.3, P = 0.031), moderate to severe calcification at lesion site (HR 13.1; 95% CI, 12.1-16.7, P < 0.001), and in-stent residual stenosis (HR 14.5; 95% CI, 10.2-17.6, P < 0.001). CONCLUSION The use of DES in unselected population is associated with long-term safety and effectiveness with acceptable low rates of adverse clinical events.

Pulmonary valvoplasty ― experience of 100 cases

One-hundred patients with pulmonary valve stenosis underwent pulmonary valvoplasty, their ages ranging from 1 to 59 years. The systolic gradient across the valve ranged from 47 to 260 mm Hg (97.67 +/- 41.15) prior to the valvoplasty, and from 0 to 55 mm Hg (14.72 +/- 11.40) immediately after dilatation (P less than 0.0001). The clinical follow-up of 18.2 months of 56 patients showed a tendency for the systolic thrill to disappear, the systolic murmur became softer and there was a tendency to normalization of the electrocardiogram. A hemodynamic restudy was carried out in 54 patients and the systolic gradients across the valve ranged from 21.55 +/- 23.86. Seven patients required redilatation. In patients with hypertrophy of the infundibulum prior to valvoplasty this was observed to regress, indicating that infundibular hypertrophy is reversible.

Evolução clínica tardia dos stents farmacológicos: segurança e eficácia até cinco anos do Registro DESIRE

BACKGROUND: Indications for the implantation of sirolimusand paclitaxel-eluting stents are expanding and include complex lesions and subsets of patients with clinical and demographic characteristics very different from those of early pivotal randomized trials. The DESIRE Registry was planned to monitor the safety of both Cypher® and Taxus® stent available in Brazil since 2002. METHODS AND RESULTS: From May 2002 through March 2007, 2043 patients treated with one or more than one stent (either Cypher® or Taxus®) at Hospital do Coracao da Associacao do Sanatorio Sirio were included in this Registry. Mean age was 63.8 (11.3) years; 76.6% were male and 28.4% had diabetes. A total of 2,415 lesions were treated and 2,983 stents were implanted: 2,608 Cypher® and 375 Taxus®. Acute and subacute ( 360 days) occurred in 0.34%, 0.73% and 0.34% of the patients, adding up to a 1.42% overall rate. Likewise, the major adverse cardiac event rate was low and added up to 8.6% (154 patients), including: 45 (2.51%) cardiac deaths; 50 (2.8%) myocardial infarctions and 59 (3.3%) of additional revascularizations. CONCLUSIONS: This long-term analysis of the DESIRE Registry shows the high efficacy and safety profiles of drug-eluting stents, with a low thrombosis rate, which is similar to those of randomized trials.

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.

Vector electrocardiographic alterations after percutaneous septal ablation in obstructive hypertrophic cardiomyopathy: possible anatomic causes

OBJECTIVE Analyze the dromotropic disturbances (vector-electrocardiographic), and the possible anatomic causes, provoked by selective alcohol injection in the septal branch, for percutaneous treatment, of obstructive hypertrophic cardiomyopathy. METHODS Ten patients with a mean age of 52.7 years underwent percutaneous septal ablation (PTSA) from october 1998; all in functional class III/IV). Twelve-lead electrocardiogram was performed prior to and during PTSA, and later electrocardiogram and vectorcardiogram according to Franks method. The patients were followed up for 32 months. RESULTS On electrocardiogram (ECG) prior to PTSA all patients had sinus rhythm and left atrial enlargement, 8 left ventricular hypertrophy of systolic pattern. On ECG immediately after PTSA, 8 had complete right bundle-branch block; 1 transient total atrioventricular block; 1 alternating transient bundle-branch block either right or hemiblock. On late ECG 8 had complete right bundle-branch block confirmed by vectorcardiogram, type 1 or Grishman. CONCLUSION Septal fibrosis following alcohol injection caused a predominance of complete right bundle-branch block, different from surgery of myotomy/myectomy.

Análise da incidência e preditores clínicos e ecocardiográficos do refluxo paraprotético aórtico após o implante de prótese aórtica transcateter

INTRODUCAO: A incidencia de refluxo paraprotetico (RPP) parece maior entre os pacientes submetidos a implante de protese aortica transcateter e sua potencial associacao com aumento da mortalidade tardia tem suscitado preocupacao na comunidade cientifica. Nosso objetivo foi avaliar a incidencia e o impacto clinico e estabelecer preditores do RPP em nossa casuistica. METODOS: Entre julho de 2009 e fevereiro de 2013, 112 pacientes foram submetidos a implante de protese aortica transcateter. O grau do RPP pos-procedimento foi avaliado segundo os criterios do VARC 2. Dividiu-se a populacao em grupo RPP ausente/RPP discreto e grupo RPP moderado/RPP grave. RESULTADOS: A media da idade foi de 82,5 ± 3,9 anos, 58,9% eram do sexo feminino e o EuroSCORE logistico foi de 23,6 ± 13,4. Houve queda do gradiente sistolico medio (54,7 ± 15,3 mmHg vs. 11,7 ± 4 mmHg; P < 0,01) e ganho da area valvar aortica (0,66 ± 0,15 cm2 vs. 1,8 ± 0,3 cm2; P < 0,01). Ao final do procedimento, 46,4% nao apresentaram RPP, e RRP discreto ou moderado foi observado em 42% e 11,6% dos pacientes. Nenhum paciente apresentou RPP grave. A analise multivariada identificou sexo masculino [odds ratio (OR) 5,85, intervalo de confianca (IC] 1,29-26,7; P = 0,022), valvoplastia aortica percutânea previa (OR 18,44, IC 2,30-147,85; P = 0,006), fracao de ejecao < 35% (OR 4,160, IC 1,014-17,064; P = 0,048) e presenca de hipertensao pulmonar grave (OR 7,649, IC 1,86-31,51; P = 0,005) como preditores independentes de RPP moderado/grave. CONCLUSOES: A incidencia de RPP moderado/grave foi baixa e comparavel a de outras casuisticas. Sexo masculino, antecedente de valvoplastia aortica percutânea previa, presenca de hipertensao pulmonar grave e disfuncao ventricular esquerda grave foram preditores independentes dessa complicacao.

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.