Ricardo Pavanello

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.

Tratamento do tromboembolismo pulmonar maciço por fragmentação percutânea do trombo

OBJECTIVES: To evaluate the safety and efficacy of percutaneous thrombus fragmentation (PTF) for massive pulmonary embolism (PE) in patients with contraindications to the administration of thrombolytics. METHODS: Between July 1999 and August 2005, 10 patients (7 males, 3 females, age 57±18 years) with massive PE and contraindications to the administration of thrombolytics underwent PTF. A transthoracic doppler echocardiogram was used to evaluate arterial oxygen saturation (Sat O2), the Walsh index (WI), mean pulmonary artery pressure (PAP), mean systemic blood pressure (SBP) and right ventricular function (RVF) before and after the procedure. Statistical analysis was conducted using the paired Wilcoxon test, of which p was significant when < 0.05. RESULTS: After the PTF treatment there was an improvement in Sat. O2 [87.4 ± 1.3% vs 92.3 ± 3.1% (p < 0.001)], WI [6.4 ± 1.07 vs 4.4 ± 1.42 (p = 0.003)], PAP [31.8 ± 4.6 mmHg vs 25.5 ± 3.4 mmHg (p < 0.001)] and SBP [73.9 ± 8.7 vs 85 ± 8.3 (p = 0.001). The ten patients had severe RVF before the percutaneous treatment; however, within 10 days after PTF, 8 presented normal or discrete function and 1 presented mitigated function. There were no technical or vascular access site complications related to PTF. One patient died in the hospital (10%). The procedure was successful for the other nine patients. CONCLUSION: The lack of adverse complications related to the procedure, proves that PTF is safe. The improvement in Sat O2, WI, PAP, SBP and RVF in 90% of the cases demonstrates the efficacy of the procedure, indicating that it is an alternative treatment for massive PE in patients with contraindications for the administration of systemic thrombolytics.

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.

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.

Avaliação muito tardia do uso de stents farmacológicos para tratamento de pacientes com lesões em enxertos de veia safena: experiência de uma década do Registro DESIRE

BACKGROUND: Percutaneous coronary intervention (PCI) in saphenous vein grafts remains a challenge for interventional cardiology, due to acute complications and the lack of data on the late efficacy of drug-eluting stents (DESs). METHODS: Between May 2002 and January 2013, patients undergoing PCI with DES at Hospital do Coracao were included in the DESIRE Registry. We evaluated the results of patients undergoing PCI in saphenous vein grafts (group 1), who were compared to those undergoing PCI in native vessels (group 2.) RESULTS: Of a total of 4,655 patients, 311 were included in group 1 and 4,344 in group 2. Group 1 included older patients (68.4 ± 9.7 years vs. 64 ± 11.2 years; P < 0.01), more frequently male (87.1% vs. 76.7%; P < 0.01) with a higher incidence of comorbidities. Unstable angina was the most frequent clinical presentation in this group. Group 1 patients received large caliber stents (3.18 ± 1.11 mm vs. 2.86 ± 0.43 mm; P < 0.01) and were less frequently submitted to pre-dilation (36.3% vs. 50.7%; P < 0.01) and post-dilation (38.3% vs. 58.4%; P < 0.01). They had a higher incidence of non-fatal acute myocardial infarction during hospitalization (11.3% vs. 4.1%; P < 0.01) and late major adverse cardiovascular events (32.8% vs. 13.9%; P < 0.01), at the expense of cardiac death (7.7% vs. 3.2%; P = 0.02) and target-lesion revascularization (9% vs. 4.3%; P < 0.01). Definitive stent thrombosis was more frequent in group 1 (3.5% vs. 1%; P< 0.01). CONCLUSIONS: Despite the unquestionable benefit of DESs in the late outcomes of PCI in complex patients, the treatment of patients with saphenous vein graft lesions remains a challenge, with less favorable acute and late results than in patients with native vessel lesions.

CLINICAL IMPACT OF APPROPRIATE USE CRITERIA (AUC) FOR CORONARY REVASCULARIZATION IN CONSECUTIVE, NON-SELECTED PATIENTS TREATED WITH DRUG-ELUTING STENTS: INSIGHTS FROM THE DESIRE REGISTRY

Appropriate Use Criteria (AUC) for coronary revascularization were developed in order to deliver high-quality care; however, the prognostic impact of these criteria remains unclear. We sought to assess the outcomes of patients (pts) treated with 2nd generation DES classified according to the updated

Impacto de stents farmacológicos em pacientes com doença arterial coronária estável submetidos a intervenção coronária percutânea na prática diária do mundo real

BACKGROUND: Recent studies in patients with stable coronary artery disease suggest there is no clinical benefit of the initial strategy of percutaneous coronary intervention with bare metal stents associated to optimal medical therapy (OMT) vs OMT alone. However, the best therapeutic option for patients with stable coronary artery disease in the real world remains controversial. We report the impact of drug eluting stents (DES) in patients with stable coronary artery disease treated in the daily clinical practice. METHOD: From May 2002 to November 2009, 1,814 patients with stable coronary artery disease (stable angina or silent ischemia) were prospectively included in the DESIRE Registry and 98% of the patients were followed up to 8 years (mean 3.9 ± 2 years). RESULTS: Mean age was 64.2 ± 10.8 years, 28% had diabetes mellitus, 21% had a prior myocardial infarction and 51.7% had a prior revascularization. Left anterior descending artery was treated in 42% of the patients. When all of the lesions (n = 2,701) were taken into consideration, 66.3% were classified as complex B2/C lesions. Angiographic success was 99%. The cumulative rate of adverse events in the late clinical follow-up was: cardiac death, 3.4%; myocardial infarction, 5.5%; target-lesion revascularization (TLR), 4.8%; and stent thrombosis, 0.8%. CONCLUSION: The use of DES in stable coronary artery disease was associated to excellent late clinical follow-up including a cumulative TLR rate < 5% and stent thrombosis < 1%. When compared to historical data, such findings show a great benefit of DES in this population, suggesting that percutaneous coronary intervention with DES is a safe and effective initial strategy in patients with stable coronary artery disease.

Até que ponto a complexidade angiográfica influi nos resultados tardios de pacientes tratados com stents farmacológicos?: comparação entre indicações on-label e off-label no Registro DESIRE

INTRODUCAO: Embora os stents farmacologicos (SF) tenham se mostrado superiores aos nao-farmacologicos (SNF) em reduzir reestenose, nao esta ainda totalmente definida a seguranca desses instrumentais quando utilizados para tratar lesoes mais complexas. Objetivamos determinar os desfechos clinicos bastante tardios de pacientes tratados com SF para indicacoes off-label. METODO: Incluimos nesta analise os pacientes consecutivos tratados apenas com SF, entre maio de 2002 e janeiro de 2008, em uma unica instituicao. Foram excluidos pacientes que receberam SF e SNF no mesmo procedimento, aqueles tratados em fase aguda do infarto agudo do miocardio (IAM) e os que apresentavam lesoes em pontes de safena. Os pacientes foram divididos em dois grupos, conforme a indicacao para uso do stent: grupo on-label, pacientes com lesao unica, de novo, em vaso de calibre entre 2,5 mm e 3,5 mm, com lesoes que nao excedessem 30 mm em extensao no caso do stent CypherTM e 28 mm quando o SF utilizado fosse o TaxusTM; e grupo off-label, que incluiu os demais pacientes. Os desfechos primarios avaliados foram: ocorrencia de obito cardiaco, IAM e trombose no longo prazo (> 1 ano). RESULTADOS: A maioria dos pacientes tratados era do grupo off-label [1.702 (78,5%) pacientes de 2.167]. O seguimento clinico completo foi obtido em 98,3% da populacao. Os pacientes do grupo off-label apresentaram maiores taxas de obito cardiaco (3,0% vs. 2,6%; P = 0,037), IAM (4,1% vs. 2%; P = 0,005) e trombose do stent (1,9% vs. 0,6%; P = 0,021), porem com taxas equivalentes de nova revascularizacao da lesao-alvo. CONCLUSOES: Neste registro, o uso de SF em situacoes de elevada complexidade angiografica associou-se a baixas taxas de eventos adversos maiores (< 11%) e trombose de stent (< 2%). Entretanto, quando comparados aos pacientes de menor complexidade, essa populacao apresentou pior evolucao tardia.