Revista Brasileira de Cardiologia Invasiva English Version, 2012
Background: Radial access is effective in reducing bleeding complications in percutaneous coronar... more Background: Radial access is effective in reducing bleeding complications in percutaneous coronary interventions (PCI). In acute coronary syndromes (ACS), the crossover from low molecular weight to unfractioned heparin increases the risk of bleeding after transfemoral PCI. The aim of this study was to evaluate the incidence of bleeding in patients with ACS undergoing PCI using the radial approach according to the occurrence or not of crossover of heparin therapy. Methods: Observational study of patients with ACS under going PCI using the radial access, divided into groups: A (with crossover) and B (without crossover). Bleeding events were classified according to GUSTO criteria; EASY criteria were used for bleeding events in the radial access. Results: We included 140 consecutive patients, 74 in group A and 66 in group B, with mean age of 59.7 ± 9.4 years, 72.8% were male, and 21.4% diabetic. There were six cases of bleeding complications (4.3%), and two (1.4%) were classified by GUSTO as moderate (one digestive bleeding and one femoral bleeding after intraaortic balloon pump), and four (2.9%) were classified as mild (hematomas with diameter ≤ 5 cm). In the comparison between groups, mod erate bleeding occurred in 1.3% in group A and 1.5% in group B (P = 0.49) and mild bleedings in 2.7% and 3.1% in groups A and B, respectively (P = 0.37). Conclusions: In this cohort of patients with ACS undergoing PCI using the radial access, a low incidence of bleeding events was observed, and most of these bleeding complications resulted from small hematomas of the access route. Crossover of
Journal of the American College of Cardiology, 2010
Background: Despite the marked efficacy of 1st generation DES in reducing the need for repeat les... more Background: Despite the marked efficacy of 1st generation DES in reducing the need for repeat lesion revascularization, the presence of durable polymers has raised concerns regarding their long-term safety. The Supralimus stent (SS) combines a stainless steel platform with bioabsorbable polymer loaded with sirolimus. We sought to determine the safety and clinical effectiveness of this novel DES in ACS pts. Methods: The E-SERIES Registry is an open-labeled, multicenter, non-randomized study with non-selected pts treated with SS. In the present analysis we included all patients with ACS as initial presentation, primarily aiming to define the long-term (up to 2 years) clinical outcomes (MACE) of this complex subset of patients. Results: A total of 1,274 pts were enrolled. Among them, 459 pts (36%) had ACS as the initial clinical presentation (13% of STEMI). Most pts were men (67%) with mean age of 63 years. DM was highly prevalent in this subset (37%).There was 6.5% of angiographic detected thrombus. Stent/ patient average was 1.2 and mean lesion length and RVD were 23.8mm and 2.9mm. The chart displays the survival-free of MACE curve up to 2 years of clinical FU. Definite/probable stent thrombosis rate was of 0.6%. Conclusions: The use of Supralimus for the treatment of ACS patients demonstrated excellent performance and safety up to two years of FU, with very low rate of overall MACE and stent thrombosis. This novel technology may represent an alternative approach in the treatment of this complex subset of patients.
Journal of the American College of Cardiology, 2010
Background: Disturbances of coronary flow due to distal embolization of thrombus/platelet agregga... more Background: Disturbances of coronary flow due to distal embolization of thrombus/platelet agreggates are associated with worse immediate and long-term prognosis after PCI. Treatment of SVG and PCI in the setting of acute coronary syndromes (ACS) are often related to this complication. Although protection devices (filterwires) have been shown to reduce distal embolization, they add time and cost to PCI. The newly developed balloon-expandable Mguard stent system is a combination of an ultra-thin polymer mesh sleeve attached to the external surface of a BMS designed to provide embolic protection during PCI. Methods: A total of 30 pts were enrolled. Inclusion critiria was de novo lesions in SVG or native vessels with angiographic evidence of instability with potential to provoke flow disturbances and/or distal embolization. Primary endpoint was the incidence of MACE (composite of cardiac death, non-fatal MI and TLR) up to 30 days of the procedure. Secondary endpoints included in-stent late lumen loss (QCA), % of stent obstruction (IVUS) at 6 months and combined up to 1 year. QCA and IVUS were performed by independent corelabs. Results: Mean population age was 63 years with 38% of diabetics. Overall, 55% presented with ACS and 57% of lesions were located in SVG. Most lesions had complex morphology including the presence of thrombus (26%) and ulceration (20%). Distal/proximal protection devices were not used. Preprocedural QCA data showed lesion length and reference vessel diameter of 12.0±4.5mm and 3.0±0.5mm. The Mguard stent was successfully delivered in all cases and final TIMI-3 was achieved in 100% with no MACE up to 30 days. At 6 months, in-stent late loss and % of stent obstruction were 1.0 ± 0.4mm and 28.5±15.6%. Up to one year clinical follow-up there was no case of cardiac death, one Q-wave MI and 6 cases of ischemiadriven TLR. Also, there was a single case of definite/probable stent thorombosis. Conclusions: The MGuard stent demonstrated excellent acute performance in a highly complex lesion subset with no adverse events up to 30 days. No further safety concerns were observed up to the 1st year of the procedure. Conversily, efficacy of the novel device was equivalent to other BMS in similar complex scenarios.
Journal of the American College of Cardiology, 2012
Background: The incidence and correlates of stent thrombosis (ST) in the very late follow-up (FU)... more Background: The incidence and correlates of stent thrombosis (ST) in the very late follow-up (FU) post drug-eluting stent (DES) implantation is still not fully understood. We report the very late FU (up to 10 years) of a large cohort of patients undergoing DES implantation in daily clinical practice. Methods: The DESIRE (Drug-Eluting Stent in the Real World) Registry is a prospective, non-randomized clinical trial evaluating the long-term clinical FU of pts undergoing elective or urgent percutaneous coronary intervention (PCI) with DES as the default strategy in a single center. From 05/02 to 05/12, 4,229 pts (6,518 lesions) were treated with 7,000 DES. Clinical FU was performed at 1, 6 and 12 months, and annually up to 10 years (FU in 97%) median ϭ 4.9 years). ST was defined according to the Academic Research Consortium criteria. Results: Overall, mean age was 64.3 years, 31% had dibetes, 30% current smoking, 23% previous myocardial infarction (MI), 9.2% renal insufficiency, given that the majority of patients (Ͼ50%) presented with acute coronary syndrome. The majority of lesions were highly complex (64% type B2C), and a mean of 1.6 stents per patient were implanted with angiographic success achieved in Ͼ99% os lesions. Regarding the DES, most of patients were treated with first-generation DES (83%) with the remaining receiving secondgeneration DES. The cumulative incidence of ST up 10 years was 2.3% (nϭ97), including definite, probable and possible ST in 52%, 2% and 46%, respectively. ST was classified as acute (1%), subacute 13%, late 27%, and very late 59%. At 10 years, 95.9% of pts were ST-free according ot the Kaplan-Meier method. In the multivariate model, the following significant predictors of ST were identified: clinical presentation of acute MI (HR 2.52, pϽ0.001), current smoking (HR 1.64, pϭ0.003), Ͼ1 DES implanted (HR 2.10, pϽ0.001), severe lesion calcification (HR 5.03, pϭ0.007), and in-stent residual stenosis (HR 1.04 per % unit increase, pϽ0.001). Conclusions: In this subanalysis, the cumulative incidence of ST up to 10 years was relatively low, given that this phenomenon was significantly associated with recent MI, smoking, multiple DES implanted, lesion complexity and residual stenosis.
Journal of the American College of Cardiology, 2012
statistically significant (see figure). Three STs were observed, all in the stable/unstable angin... more statistically significant (see figure). Three STs were observed, all in the stable/unstable angina group. Procedural success was 96% in all groups. Conclusions: Clinical outcomes were not different among patients treated with the Tryton stent presenting with stable/unstable angina, NSTEMI and STEMI. The use of the Tryton stent seems to be safe and feasible in patients presenting with MI, including STEMI.
Journal of the American College of Cardiology, 2012
Background: Little is known about the correlation between modifications in plaque composition at ... more Background: 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 grey-scale intravascular ultrasound (IVUS) and Virtual Histology™ (VH), 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. Methods: Single-center, prospective and randomized (1:1) evaluation of 40 patients with acute coronary syndrome treated with bare-metal (Driver™, n=20 patients) or drug-eluting stents (Cypher™, n=20 patients). IVUS and VH assessments were done post procedure and at 9 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. Results: At the proximal edge of both drug-eluting and bare-metal stents there was a trend to positive vessel remodeling (Δ=+0.6mm2 vs. Δ= +0.4mm2. p=0.13) which compensated the increase in plaque area (Δ=+0.5mm2 with DES vs. Δ=+0.7mm2 with BMS, p=0.10). At the distal edge, patients treated with drug-eluting stents had less plaque growth (Δ=+0.2mm2 vs. Δ=+1.1mm2. p<0.001), resulting in a larger lumen area at followup. By VH, there was a marked reduction in the % of fibrotic tissue and necrotic core in both edges of the two stents and a positive correlation was seen between increase in % of fibrofatty component and increase in plaque area (r=0.78, p=0.01). Conclusion: Patients treated with DES experienced less plaque growth, especially at the distal edge of the stents. Modifications in plaque composition, with increase in fibrofatty content, might partially explain these findings.
Objectives We sought to investigate the performance and efficacy of the third-generation polymerf... more Objectives We sought to investigate the performance and efficacy of the third-generation polymerfree Vestasync-eluting stent (VES). Background Recent concerns regarding the long-term safety of drug-eluting stents have been raised. Synthetic polymers have been associated with intensive inflammatory response and late stent thrombosis. Newly developed, the VES combines a stainless steel platform with a nanothinmicroporous hydroxyapatite surface coating impregnated with a polymer-free sirolimus formulation (55 m). Methods In May 2007, 15 patients with single de novo lesion located in native coronary arteries 3.0 to 3.5 mm in diameter and Յ14 mm in length were consecutively enrolled. Primary end points included in-stent late lumen loss and in-stent percent of obstruction at 4 months. Serial angiography and intravascular ultrasound were obtained at the index procedure and repeated at 4-month follow-up. Results Mean population age was 63.8 years; 33% of patients were diabetic. The left anterior descending artery was the prevalent target vessel (47%). Reference vessel diameter and lesion length were 2.67 Ϯ 0.32 mm and 9.98 Ϯ 1.98 mm, respectively. The VES was successfully implanted in all cases, and there were no procedure and in-hospital complications. Lifelong aspirin and 6-month clopidogrel therapy were prescribed for all patients. At 4 months, in-stent late lumen loss was 0.30 Ϯ 0.25 mm and percent of stent obstruction was 2.8 Ϯ 2.2%. After up to 6 months of clinical follow-up, no major adverse cardiac event was registered. Conclusions The third-generation VES demonstrated excellent acute results in the treatment of de novo coronary lesions. Longer follow-up with a more complex subset of patients and lesions is required to confirm these preliminary results.
Lately drug-eluting stents (DES) have dramatically reduced restenosis rates and need for repeat r... more Lately drug-eluting stents (DES) have dramatically reduced restenosis rates and need for repeat revascularization in a wide subset of lesion and patients. However, their benefit for the treatment of large vessels (&amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;gt; 3.0 mm) has yet to be established. We investigated whether DES are superior to bare metal stents (BMS) in terms of clinical outcomes for the treatment of large coronary vessels. This study assessed the long-term outcomes (cardiac death, acute myocardial infarction, and need for repeat intervention in the treated vessel) of patients treated with either a DES (Cypher and Taxus) or a BMS of &amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;gt; or = 3.5 mm in diameter. A total of 250 consecutive patients who underwent DES implantation were clinically followed for 1 year and compared to 250 patients who were treated with BMS. Interventions in the setting of acute ST elevation myocardial infarction and treatment of bypass grafts were excluded. Cypher was the DES deployed in 70.8% of cases. Most of the enrolled patients were men (78%) with single vessel disease (65.6%). The left anterior descending artery was the culprit vessel in 34.2% of cases. Bare metal stent and DES cohorts had equivalent interpolated reference vessel diameter (3.19 +/- 0.3 mm for BMS vs 3.18 +/- 0.2 for DES; P = .1). Lesion was significantly longer in the group treated with DES (13.4 +/- 5.1 mm for BMS group vs 14.3 +/- 3.5 for DES; P = .0018). After 1 year of clinical follow-up, 95.2% of patients treated with DES and 91.2% of the patients who received BMS were free of major events (P = .2). A trend toward higher target-lesion revascularization was noticed in the group treated with BMS (4.8% vs 1.6%; P = .07). Percutaneous treatment of large coronary vessels carries a low risk of clinical events irrespective of the type of stent used.
Journal of the American College of Cardiology, 2010
Background: Although DES are markedly superior in reducing the need of repeat lesion revasculariz... more Background: Although DES are markedly superior in reducing the need of repeat lesion revascularization when compared to BMS, the very long term outcomes of this novel technology remains relatively unclear, especially in more complex subsets of patients and lesions not initially investigated in controlled RCT. Methods: The DESIRE registry is a prospective, single-center registry with consecutive patients treated solely with DES between May 2002 and Mar 2009. All subsets of patients and lesions are included in this registry. The primary goal was very long-term occurrence of MACE and stent thrombosis (ST). Patients were clinically evaluated at 1, 6 and 12 months and then annually, up to 7 years (ongoing FU). A multivariate model was built to determine independent predictors of MACE, TLR and ST. Results: A total of 2,855 patients were included. The mean age was 64 + 11 years. DM was detected in 28.6% and 44.8% presented with acute coronary syndrome. SVG lesions and STEMI pts represented 7% and 12% of the cohort, respectively. Cypher™ was the predominant DES (82.2%). Follow-up was obtained in 98% of the eligible patients (median 3.5 years). Up to seven-year follow-up, 89.6% of the population was free of any MACE. TLR was performed in 3.3% of the patients. Q-wave MI occurred in only 0.7% of these patients and total ST rate was 1.6% (n=42).
Revista Brasileira de Cardiologia Invasiva English Version, 2012
Background: Radial access is effective in reducing bleeding complications in percutaneous coronar... more Background: Radial access is effective in reducing bleeding complications in percutaneous coronary interventions (PCI). In acute coronary syndromes (ACS), the crossover from low molecular weight to unfractioned heparin increases the risk of bleeding after transfemoral PCI. The aim of this study was to evaluate the incidence of bleeding in patients with ACS undergoing PCI using the radial approach according to the occurrence or not of crossover of heparin therapy. Methods: Observational study of patients with ACS under going PCI using the radial access, divided into groups: A (with crossover) and B (without crossover). Bleeding events were classified according to GUSTO criteria; EASY criteria were used for bleeding events in the radial access. Results: We included 140 consecutive patients, 74 in group A and 66 in group B, with mean age of 59.7 ± 9.4 years, 72.8% were male, and 21.4% diabetic. There were six cases of bleeding complications (4.3%), and two (1.4%) were classified by GUSTO as moderate (one digestive bleeding and one femoral bleeding after intraaortic balloon pump), and four (2.9%) were classified as mild (hematomas with diameter ≤ 5 cm). In the comparison between groups, mod erate bleeding occurred in 1.3% in group A and 1.5% in group B (P = 0.49) and mild bleedings in 2.7% and 3.1% in groups A and B, respectively (P = 0.37). Conclusions: In this cohort of patients with ACS undergoing PCI using the radial access, a low incidence of bleeding events was observed, and most of these bleeding complications resulted from small hematomas of the access route. Crossover of
Journal of the American College of Cardiology, 2010
Background: Despite the marked efficacy of 1st generation DES in reducing the need for repeat les... more Background: Despite the marked efficacy of 1st generation DES in reducing the need for repeat lesion revascularization, the presence of durable polymers has raised concerns regarding their long-term safety. The Supralimus stent (SS) combines a stainless steel platform with bioabsorbable polymer loaded with sirolimus. We sought to determine the safety and clinical effectiveness of this novel DES in ACS pts. Methods: The E-SERIES Registry is an open-labeled, multicenter, non-randomized study with non-selected pts treated with SS. In the present analysis we included all patients with ACS as initial presentation, primarily aiming to define the long-term (up to 2 years) clinical outcomes (MACE) of this complex subset of patients. Results: A total of 1,274 pts were enrolled. Among them, 459 pts (36%) had ACS as the initial clinical presentation (13% of STEMI). Most pts were men (67%) with mean age of 63 years. DM was highly prevalent in this subset (37%).There was 6.5% of angiographic detected thrombus. Stent/ patient average was 1.2 and mean lesion length and RVD were 23.8mm and 2.9mm. The chart displays the survival-free of MACE curve up to 2 years of clinical FU. Definite/probable stent thrombosis rate was of 0.6%. Conclusions: The use of Supralimus for the treatment of ACS patients demonstrated excellent performance and safety up to two years of FU, with very low rate of overall MACE and stent thrombosis. This novel technology may represent an alternative approach in the treatment of this complex subset of patients.
Journal of the American College of Cardiology, 2010
Background: Disturbances of coronary flow due to distal embolization of thrombus/platelet agregga... more Background: Disturbances of coronary flow due to distal embolization of thrombus/platelet agreggates are associated with worse immediate and long-term prognosis after PCI. Treatment of SVG and PCI in the setting of acute coronary syndromes (ACS) are often related to this complication. Although protection devices (filterwires) have been shown to reduce distal embolization, they add time and cost to PCI. The newly developed balloon-expandable Mguard stent system is a combination of an ultra-thin polymer mesh sleeve attached to the external surface of a BMS designed to provide embolic protection during PCI. Methods: A total of 30 pts were enrolled. Inclusion critiria was de novo lesions in SVG or native vessels with angiographic evidence of instability with potential to provoke flow disturbances and/or distal embolization. Primary endpoint was the incidence of MACE (composite of cardiac death, non-fatal MI and TLR) up to 30 days of the procedure. Secondary endpoints included in-stent late lumen loss (QCA), % of stent obstruction (IVUS) at 6 months and combined up to 1 year. QCA and IVUS were performed by independent corelabs. Results: Mean population age was 63 years with 38% of diabetics. Overall, 55% presented with ACS and 57% of lesions were located in SVG. Most lesions had complex morphology including the presence of thrombus (26%) and ulceration (20%). Distal/proximal protection devices were not used. Preprocedural QCA data showed lesion length and reference vessel diameter of 12.0±4.5mm and 3.0±0.5mm. The Mguard stent was successfully delivered in all cases and final TIMI-3 was achieved in 100% with no MACE up to 30 days. At 6 months, in-stent late loss and % of stent obstruction were 1.0 ± 0.4mm and 28.5±15.6%. Up to one year clinical follow-up there was no case of cardiac death, one Q-wave MI and 6 cases of ischemiadriven TLR. Also, there was a single case of definite/probable stent thorombosis. Conclusions: The MGuard stent demonstrated excellent acute performance in a highly complex lesion subset with no adverse events up to 30 days. No further safety concerns were observed up to the 1st year of the procedure. Conversily, efficacy of the novel device was equivalent to other BMS in similar complex scenarios.
Journal of the American College of Cardiology, 2012
Background: The incidence and correlates of stent thrombosis (ST) in the very late follow-up (FU)... more Background: The incidence and correlates of stent thrombosis (ST) in the very late follow-up (FU) post drug-eluting stent (DES) implantation is still not fully understood. We report the very late FU (up to 10 years) of a large cohort of patients undergoing DES implantation in daily clinical practice. Methods: The DESIRE (Drug-Eluting Stent in the Real World) Registry is a prospective, non-randomized clinical trial evaluating the long-term clinical FU of pts undergoing elective or urgent percutaneous coronary intervention (PCI) with DES as the default strategy in a single center. From 05/02 to 05/12, 4,229 pts (6,518 lesions) were treated with 7,000 DES. Clinical FU was performed at 1, 6 and 12 months, and annually up to 10 years (FU in 97%) median ϭ 4.9 years). ST was defined according to the Academic Research Consortium criteria. Results: Overall, mean age was 64.3 years, 31% had dibetes, 30% current smoking, 23% previous myocardial infarction (MI), 9.2% renal insufficiency, given that the majority of patients (Ͼ50%) presented with acute coronary syndrome. The majority of lesions were highly complex (64% type B2C), and a mean of 1.6 stents per patient were implanted with angiographic success achieved in Ͼ99% os lesions. Regarding the DES, most of patients were treated with first-generation DES (83%) with the remaining receiving secondgeneration DES. The cumulative incidence of ST up 10 years was 2.3% (nϭ97), including definite, probable and possible ST in 52%, 2% and 46%, respectively. ST was classified as acute (1%), subacute 13%, late 27%, and very late 59%. At 10 years, 95.9% of pts were ST-free according ot the Kaplan-Meier method. In the multivariate model, the following significant predictors of ST were identified: clinical presentation of acute MI (HR 2.52, pϽ0.001), current smoking (HR 1.64, pϭ0.003), Ͼ1 DES implanted (HR 2.10, pϽ0.001), severe lesion calcification (HR 5.03, pϭ0.007), and in-stent residual stenosis (HR 1.04 per % unit increase, pϽ0.001). Conclusions: In this subanalysis, the cumulative incidence of ST up to 10 years was relatively low, given that this phenomenon was significantly associated with recent MI, smoking, multiple DES implanted, lesion complexity and residual stenosis.
Journal of the American College of Cardiology, 2012
statistically significant (see figure). Three STs were observed, all in the stable/unstable angin... more statistically significant (see figure). Three STs were observed, all in the stable/unstable angina group. Procedural success was 96% in all groups. Conclusions: Clinical outcomes were not different among patients treated with the Tryton stent presenting with stable/unstable angina, NSTEMI and STEMI. The use of the Tryton stent seems to be safe and feasible in patients presenting with MI, including STEMI.
Journal of the American College of Cardiology, 2012
Background: Little is known about the correlation between modifications in plaque composition at ... more Background: 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 grey-scale intravascular ultrasound (IVUS) and Virtual Histology™ (VH), 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. Methods: Single-center, prospective and randomized (1:1) evaluation of 40 patients with acute coronary syndrome treated with bare-metal (Driver™, n=20 patients) or drug-eluting stents (Cypher™, n=20 patients). IVUS and VH assessments were done post procedure and at 9 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. Results: At the proximal edge of both drug-eluting and bare-metal stents there was a trend to positive vessel remodeling (Δ=+0.6mm2 vs. Δ= +0.4mm2. p=0.13) which compensated the increase in plaque area (Δ=+0.5mm2 with DES vs. Δ=+0.7mm2 with BMS, p=0.10). At the distal edge, patients treated with drug-eluting stents had less plaque growth (Δ=+0.2mm2 vs. Δ=+1.1mm2. p<0.001), resulting in a larger lumen area at followup. By VH, there was a marked reduction in the % of fibrotic tissue and necrotic core in both edges of the two stents and a positive correlation was seen between increase in % of fibrofatty component and increase in plaque area (r=0.78, p=0.01). Conclusion: Patients treated with DES experienced less plaque growth, especially at the distal edge of the stents. Modifications in plaque composition, with increase in fibrofatty content, might partially explain these findings.
Objectives We sought to investigate the performance and efficacy of the third-generation polymerf... more Objectives We sought to investigate the performance and efficacy of the third-generation polymerfree Vestasync-eluting stent (VES). Background Recent concerns regarding the long-term safety of drug-eluting stents have been raised. Synthetic polymers have been associated with intensive inflammatory response and late stent thrombosis. Newly developed, the VES combines a stainless steel platform with a nanothinmicroporous hydroxyapatite surface coating impregnated with a polymer-free sirolimus formulation (55 m). Methods In May 2007, 15 patients with single de novo lesion located in native coronary arteries 3.0 to 3.5 mm in diameter and Յ14 mm in length were consecutively enrolled. Primary end points included in-stent late lumen loss and in-stent percent of obstruction at 4 months. Serial angiography and intravascular ultrasound were obtained at the index procedure and repeated at 4-month follow-up. Results Mean population age was 63.8 years; 33% of patients were diabetic. The left anterior descending artery was the prevalent target vessel (47%). Reference vessel diameter and lesion length were 2.67 Ϯ 0.32 mm and 9.98 Ϯ 1.98 mm, respectively. The VES was successfully implanted in all cases, and there were no procedure and in-hospital complications. Lifelong aspirin and 6-month clopidogrel therapy were prescribed for all patients. At 4 months, in-stent late lumen loss was 0.30 Ϯ 0.25 mm and percent of stent obstruction was 2.8 Ϯ 2.2%. After up to 6 months of clinical follow-up, no major adverse cardiac event was registered. Conclusions The third-generation VES demonstrated excellent acute results in the treatment of de novo coronary lesions. Longer follow-up with a more complex subset of patients and lesions is required to confirm these preliminary results.
Lately drug-eluting stents (DES) have dramatically reduced restenosis rates and need for repeat r... more Lately drug-eluting stents (DES) have dramatically reduced restenosis rates and need for repeat revascularization in a wide subset of lesion and patients. However, their benefit for the treatment of large vessels (&amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;gt; 3.0 mm) has yet to be established. We investigated whether DES are superior to bare metal stents (BMS) in terms of clinical outcomes for the treatment of large coronary vessels. This study assessed the long-term outcomes (cardiac death, acute myocardial infarction, and need for repeat intervention in the treated vessel) of patients treated with either a DES (Cypher and Taxus) or a BMS of &amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;gt; or = 3.5 mm in diameter. A total of 250 consecutive patients who underwent DES implantation were clinically followed for 1 year and compared to 250 patients who were treated with BMS. Interventions in the setting of acute ST elevation myocardial infarction and treatment of bypass grafts were excluded. Cypher was the DES deployed in 70.8% of cases. Most of the enrolled patients were men (78%) with single vessel disease (65.6%). The left anterior descending artery was the culprit vessel in 34.2% of cases. Bare metal stent and DES cohorts had equivalent interpolated reference vessel diameter (3.19 +/- 0.3 mm for BMS vs 3.18 +/- 0.2 for DES; P = .1). Lesion was significantly longer in the group treated with DES (13.4 +/- 5.1 mm for BMS group vs 14.3 +/- 3.5 for DES; P = .0018). After 1 year of clinical follow-up, 95.2% of patients treated with DES and 91.2% of the patients who received BMS were free of major events (P = .2). A trend toward higher target-lesion revascularization was noticed in the group treated with BMS (4.8% vs 1.6%; P = .07). Percutaneous treatment of large coronary vessels carries a low risk of clinical events irrespective of the type of stent used.
Journal of the American College of Cardiology, 2010
Background: Although DES are markedly superior in reducing the need of repeat lesion revasculariz... more Background: Although DES are markedly superior in reducing the need of repeat lesion revascularization when compared to BMS, the very long term outcomes of this novel technology remains relatively unclear, especially in more complex subsets of patients and lesions not initially investigated in controlled RCT. Methods: The DESIRE registry is a prospective, single-center registry with consecutive patients treated solely with DES between May 2002 and Mar 2009. All subsets of patients and lesions are included in this registry. The primary goal was very long-term occurrence of MACE and stent thrombosis (ST). Patients were clinically evaluated at 1, 6 and 12 months and then annually, up to 7 years (ongoing FU). A multivariate model was built to determine independent predictors of MACE, TLR and ST. Results: A total of 2,855 patients were included. The mean age was 64 + 11 years. DM was detected in 28.6% and 44.8% presented with acute coronary syndrome. SVG lesions and STEMI pts represented 7% and 12% of the cohort, respectively. Cypher™ was the predominant DES (82.2%). Follow-up was obtained in 98% of the eligible patients (median 3.5 years). Up to seven-year follow-up, 89.6% of the population was free of any MACE. TLR was performed in 3.3% of the patients. Q-wave MI occurred in only 0.7% of these patients and total ST rate was 1.6% (n=42).
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Papers by Ricardo Costa