[Show abstract][Hide abstract] ABSTRACT: 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 Coração 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.
Revista Brasileira de Cardiologia Invasiva. 06/2013; 21(2):115-120.
[Show abstract][Hide abstract] ABSTRACT: BACKGROUND: The embolization of atheroma/thrombus fragments during percutaneous coronary intervention (PCI) causes microcirculatory perfusion disturbances. The new MGuardTM, a mesh-based bare-metal stent, demonstrated efficacy in the prevention of embolic complications during primary PCI. However, the late clinical outcome of patients treated with the MGuardTM stent remains unknown. METHODS: A series of 65 patients with de novo coronary lesions treated with MGuardTM stent was analyzed. Baseline clinical data, procedure and late clinical follow-up (mean duration, 2.6 ± 1.4 years) data were collected retrospectively by a review of medical records and/or direct telephone contact. RESULTS: Mean age was 66.1 ± 13.7 years, 32.3% of patients were diabetic, 49.2% had a previous acute myocardial infarction (AMI), and 44.6% presented with acute coronary syndrome. Two thirds of the lesions were located in a saphenous vein graft, almost half of the lesions had thrombus and most were classified as type B2/C. The MGuardTM stent was successfully implanted in all cases. At the end of the procedure, TIMI 3 flow was achieved in 93.4% and angiographic success was 91.8%. In the late clinical follow-up, adverse event rates included cardiac death in 6.2%, non-fatal AMI in 9.2%, target lesion revascularization in 9.2% and definite/probable stent thrombosis in 1.5%. CONCLUSIONS: The late follow-up of patients with complex coronary lesions treated with the MGuardTM stent demonstrated low rates of target lesion revascularization and stent thrombosis.
Revista Brasileira de Cardiologia Invasiva. 03/2013; 21(1):23-29.
[Show abstract][Hide abstract] ABSTRACT: Little is known about the correlation between modifications in plaque composition at stent edges and the changes in vessel geometry. This study sought to evaluate, by serial greyscale intravascular ultrasound (IVUS) and Virtual Histology intravascular ultrasound (VH-IVUS), the modifications in plaque composition at the edges of drug-eluting and bare metal stents and the correlation of these findings with changes in the measurements of vessel, lumen and plaque area at those segments.
Single-centre, prospective and randomised (1:1) evaluation of 40 patients with acute coronary syndrome treated with bare metal (Driver; Medtronic, Santa Clara, CA, USA; n=20 patients) or drug-eluting stents (Cypher; Cordis, Miami Lakes, FL, USA; n=20 patients). IVUS and VH-IVUS assessments were done post-procedure and at nine months. Primary endpoint included the modification in vessel, lumen and plaque area and in the composition of the plaque in the mean time between the baseline and follow-up procedure. At the proximal edge of the vessel treated with the Cypher stent, a trend toward positive vessel remodelling (D=+0.6 mm², p=0.06) was observed while at the distal edge, less plaque growth (D=+0.2 mm² vs. D=+1.1 mm², p<0.001), resulted in a larger lumen area at follow-up. By VH, there was a marked reduction in the percentage of fibrotic tissue and necrotic core at the edges of both stents and a positive correlation was seen between increase in percentage of fibro-fatty component and increase in plaque area (r=0.78, p=0.01).
Patients treated with drug-eluting stents (DES) experienced less plaque growth, especially at the distal edge of the stents. Modifications in plaque composition, with increase in fibrofatty tissue component, may partially explain these findings.
EuroIntervention: journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology 06/2012; 8(2):225-34. · 3.17 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: BACKGROUND: Type C coronary lesions represent a complex angiographic scenario, although it is a rather common one in the daily clinical practice of percutaneous coronary intervention (PCI). Our objective was to report the national clinical practice outcomes of PCIs performed in patients with type C lesions. METHODS: Retrospective study, with information obtained from the electronic database of the National Center of Cardiovascular Interventions (Central Nacional de Intervenções Cardiovasculares - CENIC) of Sociedade Brasileira de Hemodinâmica e Cardiologia Intervencionista (SBHCI) which gathers information on PCI procedures in a dedicated database, entered by volunteer physicians members of different Brazilian institutions. RESULTS: Between January 2010 and December 2011 1,693 patients with type C lesions were registered in CENIC. Most patients were male (68%), with mean age of 63 ± 26.3 years, 40.9% were diabetic and 45.4% had acute coronary syndromes. Procedure success was achieved in 95.6% of the cases, mortality was 2.1%, acute myocardial infarction was observed in 5% and target-lesion revascularization in 0.5% of the patients during hospitalization. CONCLUSIONS: PCIs in type C lesions had high success and low complication rates in a selected population group of the CENIC registry. The former morphological classification of the lesions, still adopted in the registry, does not properly stratify the outcomes of PCI currently. Updating the data collection form and measures to improve the quality control of the registry are urgently needed.
Revista Brasileira de Cardiologia Invasiva. 03/2012; 20(1):53-57.
[Show abstract][Hide abstract] ABSTRACT: BACKGROUND: Drug-eluting stents (DES) have changed contemporary interventional cardiology practice, enabling the approach of increasingly more complex clinical and angiographic scenarios. The objective of this study was to demonstrate the changes observed in the last 10 years in the indication and practice of percutaneous coronary intervention (PCI) at a tertiary private hospital in the State of São Paulo. METHODS: DESIRE is a single-center prospective registry aiming at following the acute and late outcomes of consecutive patients treated by DES. RESULTS: From 2002 to 2011, 4,299 patients were included, with mean age of 64.3 ± 11.2 years, 23% were female and 30.5 were diabetic. The total number of lesions treated was 6,518 of which 61.5% were type B2/C. During the course of the study, DES were progressively more used, reaching a penetration of 88.4% in 2011. The complexity of PCIs has increased and in the past year 1.76 lesions per patient were treated with an average of 1.89 DES. The SYNTAX score increased from 12.3 ± 4.4 (2002-2006) to 15.7 ± 4.7 (2007-2011). Clinical follow-up was obtained in 98.2% of the patients, with a median of 5.2 years, and during this period target-lesion revascularization rate was 5%, myocardial infarction was 6.7% and cardiovascular death was 4.1%. Stent thrombosis was observed in 2.4% of the cases. CONCLUSIONS: Our results showed a marked increment in the complexity profile of patients treated in the last 10 years and at the same time confirm the long-term effectiveness of DES, despite the clinical and angiographic profile of patients.
Revista Brasileira de Cardiologia Invasiva 01/2012; 20(4):355-360.
[Show abstract][Hide abstract] ABSTRACT: BACKGROUND: The SYNTAX score was developed as an angiographic tool to grade the complexity of coronary artery disease in patients with three-vessel and/or left main disease. We evaluated its role in predicting clinical outcomes after percutaneous coronary intervention (PCI) in non-selected patients, treated in the daily clinical practice of a reference center. METHODS: Analysis of patients undergoing PCI from March to September 2009 and followed-up for up to 12 months. Patients were divided in tertiles according to the SYNTAX score. The primary endpoint included major adverse cardiac events (MACE) - death, non-fatal acute myocardial infarction and target-vessel revascularization. The ability of the SYNTAX score in predicting MACE was assessed by the ROC (Receiver Operator Characteristic) curve. RESULTS: Two hundred and thirty-four patients with a mean SYNTAX score of 11.6 ± 6.2 points were included. Tertile I had a SYNTAX score < 9 (average 5.9); tertile II, > 9 and < 13 (average 10.8); and tertile III, > 13 (average 18.3). In the clinical follow-up of 7.2 ± 4.9 months, the incidence of MACE was greater in tertile III when compared to tertiles I and II (2.5% vs. 6.4% vs. 14.1%; P = 0.0075). The ROC curve showed an area under the curve of 0.667 (P = 0.012) indicating a moderate ability to anticipate the occurrence of MACE in this population. CONCLUSIONS: The SYNTAX score proved to be seful in predicting the occurrence of MACE after PCI in real world patients.
Revista Brasileira de Cardiologia Invasiva 01/2012; 20(1):35-40.
[Show abstract][Hide abstract] ABSTRACT: BACKGROUND: Although drug-eluting stents have markedly reduced restenosis and the need for repeat lesion revascularization in the vast majority of clinical and angiographic scenarios, the benefit of these devices for the treatment of saphenous-vein graft (SVG) lesions is yet to be defined. The aim of our study was to compare the rate of major adverse clinical events (MACE) between drug-eluting stents and bare-metal stents in SVG lesions in non-selected patients. METHODS: Patients treated in two tertiary hospitals between May 2006 and January 2009 were included. The primary objective was to compare the incidence of MACE between drug-eluting stents and bare-metal stents during hospitalization and in the long-term follow-up. RESULTS: Overall, 308 patients were consecutively enrolled and divided according to the type of stent deployed (209 with drug-eluting stents and 99 with bare-metal stents). Mean age was 68 years and SVG mean age was 10.9 years. In the in-hospital phase there was a trend towards higher MACE in the drug-eluting stents group (12% vs. 5.1%; P = 0.06). The incidence of MACE in up to 24 months was equivalent between groups (17.2% for the drug-eluting stents group vs. 18.2% for the bare-metal stents group; P = 0.87). Definite/probable stent thrombosis was similar in both groups (2.3% for the drug-eluting stents group vs. 2% for bare-metal stents group; P = 0.94). CONCLUSIONS: In this real world series of complex patients there was no long-term safety concerns related to the use of drug-eluting stents in the treatment of SVG lesions, with similar rates of cardiac death/myocardial infarction/stent thrombosis in both groups.
Revista Brasileira de Cardiologia Invasiva 01/2011; 19(2):122-130.
[Show abstract][Hide abstract] ABSTRACT: BACKGROUND: Previous studies comparing drug-eluting stents (DES) and bare-metal stents suggest efficacy and safety of the DES in the treatment of patients with myocardial infarction (MI). However, the late evolution of patients with MI treated with DES in the daily practice remains unknown. Our goal was to investigate the late follow-up of patients with MI recently treated with DES in the real world. METHODS: Between May 2002 and June 2009, 3,018 non-selected patients with indication for elective or urgent percutaneous coronary intervention have been consecutively treated with DES in a clinical institution. The 7-year follow-up was performed in 98% of these patients, with a median of 3.4 years. The patients were divided in two groups: patients with recent MI (< 30 days) and patients without recent MI. RESULTS: Patients with recent MI had less co-morbidities, but more multiarterial disease (68.1% vs. 60.7%; P < 0.001), lesions with thrombus (13.6% vs. 1.3%; P < 0.001), TIMI flow 0/1 (8.3% vs. 1.1%; P < 0.001), and moderate/severe LV dysfunction (23.2% vs. 10.9%; P < 0.001) when compared with patients without MI. The recent MI group received 1.6 ± 0.8 stents/patient and more glycoprotein IIb/IIIa inhibitors (19.6% vs. 2%; P < 0.001), but the angiographic success (> 99%) was similar between groups. In the late follow-up, the incidence of cardiac death (6.4% vs. 2.7%; P < 0.001) and stent thrombosis (3.6% vs. 1.3%; P < 0.001) was significantly greater in the recent MI group. Recent MI remained an independent predictor of stent thrombosis in multivariate analysis (HR 2.96, 95% CI 1.62-5.41; P < 0,001). CONCLUSIONS: Patients with MI < 30 days treated with DES had a worse prognosis when compared with patients without recent MI, including a higher incidence of cardiac death and a 2.5 times greater occurrence of stent thrombosis rate up to 7-year follow-up.
Revista Brasileira de Cardiologia Invasiva 01/2011; 19(3):244-254.
[Show abstract][Hide abstract] ABSTRACT: BACKGROUND: Radial expansion and vessel wall scaffolding properties of stainless steel stents have improved the outcomes of coronary balloon angioplasty. Thinner struts and new platform designs are characteristic of more contemporaneous stents, but it is not clear whether these changes may result in devices with less radial strength, susceptible to elastic recoil, especially in the very late follow-up. This study was aimed at assessing late stent recoil in two generations of drug-eluting stents (DES) using serial intravascular ultrasound (IVUS) analysis. METHODS: Twenty-five patients with single de novo coronary lesions, treated with DES (12 CypherTM and 13 BioMatrixTM), were included and serial IVUS analysis was performed after stent implantation and at 4-6-months and 4-5 years of follow-up. Stent volume index was compared between the procedure and the mid and long-term follow-ups. Stent recoil was defined as a decrease > 10% of the stent volume index. RESULTS: Most of the patients were male (52%), with mean age of 58.8 ± 7.6 years, and 28% were diabetic. Stent volume index, the primary objective of this study, was 7.7 ± 1.5 mm3/mm post-procedure, 7.7 ± 2.1 mm3/mm at 4-6 months and 7.8 ± 1.6 mm3/mm at 4-5 years, with a delta of -0.02 ± 1.6 mm3/mm (P = 0.97). The long-term delta stent volume index was 0.13 ± 1.8 mm3/mm (1.7%) for the CypherTM stent and -0.05 ± 1.3 mm3/mm (-0.6%) for the BioMatrixTM stent (P = 0.78). CONCLUSIONS: Serial IVUS analysis showed that stainless steel DES of different generations did not show evidence of long-term elastic recoil.
Revista Brasileira de Cardiologia Invasiva 01/2011; 19(3):292-297.
[Show abstract][Hide abstract] ABSTRACT: 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.
Revista Brasileira de Cardiologia Invasiva 01/2010; 18(4):392-399.
[Show abstract][Hide abstract] ABSTRACT: BACKGROUND: In this study, we sought to evaluate the clinical outcomes of patients with coronary lesions in small vessels in a cohort of real world patients undergoing percutaneous coronary intervention (PCI) with drug-eluting stents (DES). METHODS: Between May 2002 and December 2009, 1,380 consecutive patients from the DESIRE Registry (Drug Eluting Stents In The Real World), with 1,683 lesions in small vessels (< 2.5 mm in diameter) were consecutively submitted to elective or emergency PCI, with 1,818 DES (CypherTM, 89%; TaxusTM, 7.5%; Xience VTM/PromusTM, 3%; Endeavor, 0.33%; BiomatrixTM, 0.2%) and included in this study. The clinical follow-up of up to 7 years (median, 2.8 years) was completed for 98%, and was obtained at 1, 6, 12 months and then annually. Our objective was to determine the rates of major cardiac events (MACE) during clinical follow-up. RESULTS: Mean age was 64.5 ± 11.7 years, with a prevalence of male patients (76.7%). Diabetes mellitus was observed in 31.6% of the cases and 9.8% had chronic renal failure. Left anterior descending artery was the most frequent vessel treated (43.4%) and two-thirds of the lesions were complex lesions (B2/C). Angiographic success was obtained in 98.8% of the cases. The rate of MACE was 12.8% during follow-up with 4.5% of cardiac death, 4.2% of acute myocardial infarction, 4.5% of repeat target lesion revascularization and 1.5% of stent thrombosis. CONCLUSIONS: In the DESIRE Registry, the use of DES to treat small vessels in non-selected patients was associated with excellent early and late outcomes and low thrombosis rates.
Revista Brasileira de Cardiologia Invasiva 01/2010; 18(3):288-293.
[Show abstract][Hide abstract] ABSTRACT: We report the incidence and predictors of target lesion revascularization (TLR) in a cohort of realworld patients treated with drug eluting stents (DES). Method: From May 2002 to February 2010, 3,320 patients were treated with elective or emergency percutaneous coronaryintervention (PCI) and 5,320 DES (Cypher, 83%; Taxus, 9%; Xience V/Promus, 3%; Endeavor, 4%; BioMatrix, 1%) were implanted in a single center. The clinical follow-up of upto eight years (median time 3.4 years) was concluded in 98% patients of the group and 129 patients (3.88%) weresubmitted to TLR. Results: Of the patients with TLR, 33% had diabetes, 10% had chronic kidney disease and 61% had multivessel disease. The left anterior descending artery was the most frequent target vessel (33%) and 72.3% of the lesions were complex lesions (type B2/C). In this group,214 DES were implanted in 191 lesions and 45% of the patients received multiple stents. In the univariate analysis, TLR predictors were: diabetes mellitus [relative risk (RR) 1.88, 95% confidence interval (CI) 1.08-3.27; P = 0.025], use of Taxus stents (RR 1.73, 95% CI 1.20-2.50; P = 0.003), ostial lesion (RR 1.82, 95% CI 1.1-2.98; P = 0.018), saphenous bypass graft (RR 2.36, 95% CI 1.55-3.50; P = 0.0001), and restenotic lesions (RR 1.95, 95% CI 1.17-3.24; P = 0.009). After the multivariate analysis, the independent predictors were: diabetes mellitus, use of Taxus stents and treatment of lesions in saphenous bypass grafts (RR 1.64, 95% CI, 1.14-2.35; P = 0.008). Conclusion: In the DESIRE registry,TLR in complex patients treated with DES was low and diabetes mellitus, treatment of lesions in saphenous bypass grafts and the use of Taxus stents were the only TLR predictors in the clinical follow-up of up to 8 years.
Revista Brasileira de Cardiologia Invasiva 01/2010; 18(2):157-164.
[Show abstract][Hide abstract] ABSTRACT: 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.
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.
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.
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.
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.
[Show abstract][Hide abstract] ABSTRACT: BACKGROUND: Percutaneous coronary intervention (PCI)related bleeding is a frequent complication whose prognosis is often neglected. Several studies have shown the adverse clinical impact of bleeding, especially increased short and long-term mortality rates. The purpose of this study was to evaluate predictors and clinical impact of this complication in a large cohort of patients undergoing PCI. METHODS: We performed a prospective analysis of 2,892 consecutive patients undergoing elective or urgent PCI from January/2008 to June/2009. Patients with and without bleeding were compared for clinical, angiographic and procedure-related variables as well as in-hospital clinical outcomes. Multiple logistic regression analysis was performed to determine the influence and independence of bleeding predictors. RESULTS: Procedure-related bleeding was identified in 1.7% of the patients. Taking in account only patients with acute coronary syndrome (ACS) the incidence increased to 3.4%. Multivariate analysis identified ACS [odds ratio (OR) 3.96, 95% confidence interval (95% CI) 1.45-11.42], use of glycoprotein IIb/IIa inhibitors (OR 2.55, 95% CI 1.68-3.87), chronic renal failure (OR 2.34, 95% CI 1.11-3.49), Killip IV (OR 2.32, 95% CI 1.54-3.5) and femoral access (OR 1.72, 95% CI 1.19-3.14) as independent predictors of bleeding. Procedure-related bleeding was associated with in-hospital acute renal failure (16.7% vs. 1.6%; P < 0.001) and in-hospital mortality (10.4% vs. 0.7%; P < 0.001). CONCLUSIONS: The present study demonstrates that periprocedural bleeding, more frequently observed in patients with ACS, is a predictor of in-hospital major clinical adverse events, including increased mortality rates.
Revista Brasileira de Cardiologia Invasiva 01/2010; 18(3):281-287.