Vitor Osório Gomes

Efficacy and Safety of Drug-Eluting Stents in the Real World: 8-Year Follow-Up

Background: Drug-eluting stents have been used in daily practice since 2002, with the clear advantages of reducing the risk of target vessel revascularization and an impressive reduction in restenosis rate by 50%-70%. However, the occurrence of a late thrombosis can compromise long-term results, particularly if the risks of this event were sustained. In this context, a registry of clinical cases gains special value. Objective: To evaluate the efficacy and safety of drug-eluting stents in the real world. Methods: We report on the clinical findings and 8-year follow-up parameters of all patients that underwent percutaneous coronary intervention with a drug-eluting stent from January 2002 to April 2007. Drug-eluting stents were used in accordance with the clinical and interventional cardiologist decision and availability of the stent. Results: A total of 611 patients were included, and clinical follow-up of up to 8 years was obtained for 96.2% of the patients. Total mortality was 8.7% and nonfatal infarctions occurred in 4.3% of the cases. Target vessel revascularization occurred in 12.4% of the cases, and target lesion revascularization occurred in 8% of the cases. The rate of stent thrombosis was 2.1%. There were no new episodes of stent thrombosis after the fifth year of follow-up. Comparative subanalysis showed no outcome differences between the different types of stents used, including Cypher®, Taxus®, and Endeavor®. Conclusion: These findings indicate that drug-eluting stents remain safe and effective at very long-term follow-up. Patients in the real world may benefit from drug-eluting stenting with excellent, long-term results.

Impact of chronic kidney disease on the efficacy of drug-eluting stents: long-term follow-up study

BACKGROUND: Patients with chronic kidney disease (CKD) submitted to coronary angioplasty have higher rates of target lesion revascularization (TLR) and mortality. Drug-eluting stents (DES) are associated with a lower rate of restenosis, compared to bare metal stents (BMS), although data on DES efficacy and safety is limited in patients with CKD. OBJECTIVE: We sought to evaluate the safety and efficacy of DES in patients with significant CKD as compared to patients without normal renal function in a real world registry. METHODS: 504 patients who underwent percutaneous coronary intervention with DES in two centers were included. Outcomes were stratified based on the presence of CKD, defined as a baseline glomerular filtration rate (GFR) < 60 ml/min/1.73 m². RESULTS: The mean follow-up was 22.7 months. CKD was present in 165 patients (32.7%). Patients with CKD were older, had a higher incidence of hypertension and diabetes. CKD patients presented an increased incidence of death (12.3% vs 2.4%, p < 0.001) and myocardial infarction (MI) (7.4% vs 3.3%, p = 0.04) compared to patients without CKD. TLR rates were similar between groups (4.8% vs 5.6%, p = 0.7, CKD and no CKD patients, respectively). Independent predictors of death were CKD (HR 6.93; 2.4 - 19.5, p < 0.001), current smoking (HR 3.66; 1.20 - 11.10, p = 0.02) and diabetes (HR 2.66; 1.03 - 6.60, p = 0.045). CONCLUSION: In this registry, coronary intervention with DES in patients with CKD was associated with similar TLR compared to patients without CKD, demonstrating the efficacy of DES in preventing in-stent restenosis in this patient population. CKD was related to significantly increased MI and mortality rates.BACKGROUNDnPatients with chronic kidney disease (CKD) submitted to coronary angioplasty have higher rates of target lesion revascularization (TLR) and mortality. Drug-eluting stents (DES) are associated with a lower rate of restenosis, compared to bare metal stents (BMS), although data on DES efficacy and safety is limited in patients with CKD.nnnOBJECTIVEnWe sought to evaluate the safety and efficacy of DES in patients with significant CKD as compared to patients without normal renal function in a real world registry.nnnMETHODSn504 patients who underwent percutaneous coronary intervention with DES in two centers were included. Outcomes were stratified based on the presence of CKD, defined as a baseline glomerular filtration rate (GFR) < 60 ml/min/1.73 m².nnnRESULTSnThe mean follow-up was 22.7 months. CKD was present in 165 patients (32.7%). Patients with CKD were older, had a higher incidence of hypertension and diabetes. CKD patients presented an increased incidence of death (12.3% vs 2.4%, p < 0.001) and myocardial infarction (MI) (7.4% vs 3.3%, p = 0.04) compared to patients without CKD. TLR rates were similar between groups (4.8% vs 5.6%, p = 0.7, CKD and no CKD patients, respectively). Independent predictors of death were CKD (HR 6.93; 2.4 - 19.5, p < 0.001), current smoking (HR 3.66; 1.20 - 11.10, p = 0.02) and diabetes (HR 2.66; 1.03 - 6.60, p = 0.045).nnnCONCLUSIONnIn this registry, coronary intervention with DES in patients with CKD was associated with similar TLR compared to patients without CKD, demonstrating the efficacy of DES in preventing in-stent restenosis in this patient population. CKD was related to significantly increased MI and mortality rates.

Impacto da insuficiência renal crônica na eficácia de stents farmacológicos: estudo de seguimento de longo prazo

BACKGROUND: Patients with chronic kidney disease (CKD) submitted to coronary angioplasty have higher rates of target lesion revascularization (TLR) and mortality. Drug-eluting stents (DES) are associated with a lower rate of restenosis, compared to bare metal stents (BMS), although data on DES efficacy and safety is limited in patients with CKD. OBJECTIVE: We sought to evaluate the safety and efficacy of DES in patients with significant CKD as compared to patients without normal renal function in a real world registry. METHODS: 504 patients who underwent percutaneous coronary intervention with DES in two centers were included. Outcomes were stratified based on the presence of CKD, defined as a baseline glomerular filtration rate (GFR) < 60 ml/min/1.73 m². RESULTS: The mean follow-up was 22.7 months. CKD was present in 165 patients (32.7%). Patients with CKD were older, had a higher incidence of hypertension and diabetes. CKD patients presented an increased incidence of death (12.3% vs 2.4%, p < 0.001) and myocardial infarction (MI) (7.4% vs 3.3%, p = 0.04) compared to patients without CKD. TLR rates were similar between groups (4.8% vs 5.6%, p = 0.7, CKD and no CKD patients, respectively). Independent predictors of death were CKD (HR 6.93; 2.4 - 19.5, p < 0.001), current smoking (HR 3.66; 1.20 - 11.10, p = 0.02) and diabetes (HR 2.66; 1.03 - 6.60, p = 0.045). CONCLUSION: In this registry, coronary intervention with DES in patients with CKD was associated with similar TLR compared to patients without CKD, demonstrating the efficacy of DES in preventing in-stent restenosis in this patient population. CKD was related to significantly increased MI and mortality rates.BACKGROUNDnPatients with chronic kidney disease (CKD) submitted to coronary angioplasty have higher rates of target lesion revascularization (TLR) and mortality. Drug-eluting stents (DES) are associated with a lower rate of restenosis, compared to bare metal stents (BMS), although data on DES efficacy and safety is limited in patients with CKD.nnnOBJECTIVEnWe sought to evaluate the safety and efficacy of DES in patients with significant CKD as compared to patients without normal renal function in a real world registry.nnnMETHODSn504 patients who underwent percutaneous coronary intervention with DES in two centers were included. Outcomes were stratified based on the presence of CKD, defined as a baseline glomerular filtration rate (GFR) < 60 ml/min/1.73 m².nnnRESULTSnThe mean follow-up was 22.7 months. CKD was present in 165 patients (32.7%). Patients with CKD were older, had a higher incidence of hypertension and diabetes. CKD patients presented an increased incidence of death (12.3% vs 2.4%, p < 0.001) and myocardial infarction (MI) (7.4% vs 3.3%, p = 0.04) compared to patients without CKD. TLR rates were similar between groups (4.8% vs 5.6%, p = 0.7, CKD and no CKD patients, respectively). Independent predictors of death were CKD (HR 6.93; 2.4 - 19.5, p < 0.001), current smoking (HR 3.66; 1.20 - 11.10, p = 0.02) and diabetes (HR 2.66; 1.03 - 6.60, p = 0.045).nnnCONCLUSIONnIn this registry, coronary intervention with DES in patients with CKD was associated with similar TLR compared to patients without CKD, demonstrating the efficacy of DES in preventing in-stent restenosis in this patient population. CKD was related to significantly increased MI and mortality rates.

Meta-Analysis of Individual Patient Data of Sodium Bicarbonate and Sodium Chloride for All-Cause Mortality After Coronary Angiography

We sought to examine the relation between sodium bicarbonate prophylaxis for contrast-associated nephropathy (CAN) and mortality. We conducted an individual patient data meta-analysis from multiple randomized controlled trials. We obtained individual patient data sets for 7 of 10 eligible trials (2,292 of 2,764 participants). For the remaining 3 trials, time-to-event data were imputed based on follow-up periods described in their original reports. We included all trials that compared periprocedural intravenous sodium bicarbonate to periprocedural intravenous sodium chloride in patients undergoing coronary angiography or other intra-arterial interventions. Included trials were determined by consensus according to predefined eligibility criteria. The primary outcome was all-cause mortality hazard, defined as time from randomization to death. In 10 trials with a total of 2,764 participants, sodium bicarbonate was associated with lower mortality hazard than sodium chloride at 1xa0year (hazard ratio 0.61, 95% confidence interval [CI] 0.41 to 0.89, pxa0=xa00.011). Although periprocedural sodium bicarbonate was associated with a reduction in the incidence of CAN (relative risk 0.75, 95% CI 0.62 to 0.91, pxa0= 0.003), there exists a statistically significant interaction between the effect on mortality and the occurrence of CAN (hazard ratio 5.65, 95% CI 3.58 to 8.92, p <0.001) for up to 1-year mortality. Periprocedural intravenous sodium bicarbonate seems to be associated with a reduction in long-term mortality in patients undergoing coronary angiography or other intra-arterial interventions.

Prevalência de estenose da artéria subclávia em pacientes candidatos a cirurgia de revascularização do miocárdio: registro multicêntrico

BACKGROUND: Approximately 90% of the patients submitted to coronary artery bypass graft surgery (CABG) receive a left internal thoracic artery (LITA) graft. Stenosis of the left subclavian artery can result in graft failure due to restricted coronary flow. The prevalence of stenosis of the left subclavian artery in patients with severe coronary atherosclerosis, deemed candidates to CABG, is not known. OBJECTIVE: To assess the prevalence of stenosis of left subclavian artery in CABG candidates, as well as the diagnostic effectiveness of clinical evaluation. METHODS: In a multicenter registry, selective angiography of the left subclavian artery was carried out in patients considered candidates to CABG during coronary cineangiography. Stenoses > 50% proximal to the origin of the LITA were considered significant. RESULTS: A total of 205 patients were included. Significant stenosis of the left subclavian artery was observed in 16 (7.8%) patients. Noninvasive differential arterial blood pressure measurement > 10 mmHg between both arms showed low sensitivity (37.5%) and low positive predictive value (13.3%) for stenosis identification. No clinical predictors of significant stenosis were identified by univariate analysis. CONCLUSION: Stenosis of the left subclavian artery is not uncommon in CABG candidates. Noninvasive blood pressure gradient between both arms has low diagnostic accuracy. Therefore, in patients candidates to CABG, selective angiography of the left subclavian artery should be considered, because of the risk of reduced flow and coronary-subclavian steal syndrome in patients with non-diagnosed stenosis of the subclavian artery who receive a LITA graft.

Impacto de la insuficiencia renal crónica en la eficacia de Stents farmacológicos: estudio de seguimiento de largo plazo

BACKGROUND: Patients with chronic kidney disease (CKD) submitted to coronary angioplasty have higher rates of target lesion revascularization (TLR) and mortality. Drug-eluting stents (DES) are associated with a lower rate of restenosis, compared to bare metal stents (BMS), although data on DES efficacy and safety is limited in patients with CKD. OBJECTIVE: We sought to evaluate the safety and efficacy of DES in patients with significant CKD as compared to patients without normal renal function in a real world registry. METHODS: 504 patients who underwent percutaneous coronary intervention with DES in two centers were included. Outcomes were stratified based on the presence of CKD, defined as a baseline glomerular filtration rate (GFR) < 60 ml/min/1.73 m². RESULTS: The mean follow-up was 22.7 months. CKD was present in 165 patients (32.7%). Patients with CKD were older, had a higher incidence of hypertension and diabetes. CKD patients presented an increased incidence of death (12.3% vs 2.4%, p < 0.001) and myocardial infarction (MI) (7.4% vs 3.3%, p = 0.04) compared to patients without CKD. TLR rates were similar between groups (4.8% vs 5.6%, p = 0.7, CKD and no CKD patients, respectively). Independent predictors of death were CKD (HR 6.93; 2.4 - 19.5, p < 0.001), current smoking (HR 3.66; 1.20 - 11.10, p = 0.02) and diabetes (HR 2.66; 1.03 - 6.60, p = 0.045). CONCLUSION: In this registry, coronary intervention with DES in patients with CKD was associated with similar TLR compared to patients without CKD, demonstrating the efficacy of DES in preventing in-stent restenosis in this patient population. CKD was related to significantly increased MI and mortality rates.BACKGROUNDnPatients with chronic kidney disease (CKD) submitted to coronary angioplasty have higher rates of target lesion revascularization (TLR) and mortality. Drug-eluting stents (DES) are associated with a lower rate of restenosis, compared to bare metal stents (BMS), although data on DES efficacy and safety is limited in patients with CKD.nnnOBJECTIVEnWe sought to evaluate the safety and efficacy of DES in patients with significant CKD as compared to patients without normal renal function in a real world registry.nnnMETHODSn504 patients who underwent percutaneous coronary intervention with DES in two centers were included. Outcomes were stratified based on the presence of CKD, defined as a baseline glomerular filtration rate (GFR) < 60 ml/min/1.73 m².nnnRESULTSnThe mean follow-up was 22.7 months. CKD was present in 165 patients (32.7%). Patients with CKD were older, had a higher incidence of hypertension and diabetes. CKD patients presented an increased incidence of death (12.3% vs 2.4%, p < 0.001) and myocardial infarction (MI) (7.4% vs 3.3%, p = 0.04) compared to patients without CKD. TLR rates were similar between groups (4.8% vs 5.6%, p = 0.7, CKD and no CKD patients, respectively). Independent predictors of death were CKD (HR 6.93; 2.4 - 19.5, p < 0.001), current smoking (HR 3.66; 1.20 - 11.10, p = 0.02) and diabetes (HR 2.66; 1.03 - 6.60, p = 0.045).nnnCONCLUSIONnIn this registry, coronary intervention with DES in patients with CKD was associated with similar TLR compared to patients without CKD, demonstrating the efficacy of DES in preventing in-stent restenosis in this patient population. CKD was related to significantly increased MI and mortality rates.

Cirurgia não-cardíaca e terapia antiplaquetária em pacientes tratados com stents coronários

ABSTRACT Noncardiac Surgery and Antiplatelet Therapy inPatients with Coronary Stents The increasing incidence of cardiovascular diseases andthe use of bare metal or drug eluting stents have led to anincrease in the use of dual antiplatelet therapy. Thesepatients are frequently submitted to non-cardiac surgeries,requiring adequate perioperative management of antiplateletagents. The strategy of systematic discontinuation of anti-platelet agents prior to surgery increases morbidity andmortality due to thrombotic events, especially in patientswith a high risk of in-stent thrombosis. Data indicate thereis no significant increase of bleeding complications in sur gerieswith low to moderate risk of bleeding carried out whendual antiplatelet therapy is used. Adequate risk assessmentof thrombotic events and surgical bleeding enables theidentification of the most appropriate strategy for the patient.Procedures with low or moderate risk of bleeding must becarried out under antiplatelet therapy, whereas it must bediscontinued in those with high risk of bleeding. Alternatively,one must consider postponing the surgery until antiplatelettherapy is safely discontinued. In general, in patients under-going non-cardiac surgery, the discontinuation of antiplatelettherapy involves cardiovascular risks which are higherthan bleeding complications. Thus, the maintenance ofantiplatelet agents is recommended, except in cases ofsurgery carried out in closed compartments or when the riskof bleeding is unacceptable. We propose an algorithm forthe perioperative management of antiplatelet therapy, takinginto consideration the risks of thrombotic events andbleeding.

Impacto do diabetes melito na eficácia e na segurança dos stents farmacológicos: registro com até cinco anos de seguimento

BACKGROUND: Diabetic patients are at high risk of recurrent coronary events. Drug eluting stents (DES) reduce restenosis and target lesion revascularization in both diabetic and non-diabetic patients. However, there are limited data on the long-term safety and efficacy of DES in diabetic patients. The objective of this study was to evaluate the long-term clinical outcome in this high risk population. METHOD: From May 2002 to April 2007, all patients undergoing coronary intervention with DES in two hospitals were included in the study and were followed-up for up to 5 years. RESULTS: A total of 611 patients with mean age of 63.5 ± 11.2 years were included in the registry. Diabetic patients (n = 204, 33.4%) included a smaller proportion of males, greater prevalence of hypertension, chronic renal failure, and smaller coronary reference diameter when compared to non-diabetic patients. During the follow-up, diabetics had a higher probability of combined adverse cardiac events (19.7% vs. 13.4%; P = 0.04), as a result of death (7.4% vs. 2.3%; P = 0.003), acute myocardial infarction (5.9% vs. 3.1%; P = 0.10) and definitive/probable stent thrombosis (3.9% vs. 1.3%; P = 0.04). Target vessel and target lesion revascularization, however, were not different between the groups (10.9% vs. 9.8%; P = 0.68 and 3.4% vs. 5.1%; P= 0.35, respectively). The presence of diabetes mellitus was an independent predictor of death [odds ratio (OR) 2.41; 95% confidence interval (95% CI) 1.02-5.78; P = 0.05) but not of stent thrombosis (OR 2.41; 95% CI 0.76-7.61; P = 0.13) in our patients. CONCLUSIONS: The outcomes of this study show that in patients undergoing DES implantation, the presence of diabetes was associated to higher mortality rates, acute myocardial infarction and stent thrombosis when compared to non-diabetics. The finding of similar target lesion revascularization rates in diabetic and non-diabetic patients is promising and suggests the efficacy of percutaneous revascularization with DES implantation in this population.