[Show abstract][Hide abstract] ABSTRACT: Aims:
To evaluate the outcomes of patients treated with a new drug-eluting stent formulation with low doses of sirolimus, built in an ultra-thin-strut platform coated with biodegradable abluminal coating.
The present study is a randomised trial that tested the main hypothesis that the angiographic late lumen loss of the novel sirolimus-eluting stent is non-inferior compared to commercially available biolimus-eluting stent. A final study population comprising 170 patients with one or two de novo lesions were 2:1 randomised for sirolimus-eluting stent or the biolimus-eluting stent respectively. The primary endpoint was 9-month angiographic in-stent late lumen loss. Adverse clinical events were prospectively collected for 1 year.
After 9 months, the novel sirolimus-eluting stent was shown non-inferior compared with the biolimus stent for the primary endpoint (angiographic in-stent late lumen loss: 0.20 ± 0.29 mm vs. 0.15 ± 0.20 mm respectively; p value for noninferiority < 0.001). The 1-year incidence of death, myocardial infarction, repeat revascularization, and stent thrombosis remained low and not significantly different between the groups.
The present randomised trial demonstrates that the tested novel sirolimus-eluting stent was angiographically non-inferior in comparison with a last-generation biolimus-eluting stent. This article is protected by copyright. All rights reserved.
[Show abstract][Hide abstract] ABSTRACT: Aims: The safety and performance of the Absorb Bioresorbable Vascular Scaffold (Absorb BVS) system (Abbott Vascular, Santa Clara, CA, USA) has been previously established in 131 patients from cohort A and cohort B of the first-in-man ABSORB trial. Following this trial, ABSORB EXTEND was initiated as a global continued access study (outside of the USA) to expand experience with the Absorb BVS system to different geographies with broader inclusion criteria to include the treatment of longer lesions and multiple vessels. We report in this manuscript the twelve-month clinical outcomes of the first 512 patients in this population. Methods and results: ABSORB EXTEND is a prospective, single-arm, open-label clinical study which will enrol up to 800 patients at up to 100 sites. Included are patients with lesions ≤28 mm in length and reference vessel diameter of 2.0-3.8 mm (as assessed by on-line QCA or IVUS). Treatment of a maximum of two de novo native coronary artery lesions is permitted when each lesion is located in a different epicardial vessel. An independent clinical events committee adjudicates all endpoint-related events. At one year, for the first 512 patients enrolled in the study, the composite endpoints of ischaemia-driven MACE and ischaemia-driven target vessel failure were 4.3% and 4.9%, respectively. The cumulative rate of ARC defined definite and probable scaffold thrombosis for this population was 0.8% at one year. Conclusions: This interim analysis of the ABSORB EXTEND study shows low rates of MACE and scaffold thrombosis. The study is registered on clinicaltrials.gov (unique identifier NCT01023789).
EuroIntervention: journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology 04/2014; 10(12). DOI:10.4244/EIJV10I12A243 · 3.77 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: Aims: To demonstrate the feasibility and efficacy of the novel InSeal VCD for the closure of large puncture holes following percutaneous structural interventions. Methods and results: Prospective, non-randomised, single-arm, single-centre study with a series of patients submitted to endovascular treatment of abdominal and thoracic aortic aneurysm as well as transcatheter aortic valve implantation in whom the InSeal VCD was used to close the access site. These patients were followed up for one year with clinical examination, ankle-brachial index and Doppler ultrasound. The primary endpoint was the occurrence of major vascular complications at the puncture site. From a total of nine patients screened, seven were selected to receive the InSeal VCD. Technical and therapeutic successes were achieved in all cases. The sheath profiles used in these procedures ranged from 18 Fr to 25 Fr. No major vascular complications were observed during the follow-up period. Average ankle-brachial index pre-intervention and at one-month follow-up were 0.85 and 0.82, respectively. Conclusions: The InSeal VCD was shown to be effective in achieving acute and chronic haemostasis after usage of higher profile endovascular devices in this study. These results translated into no clinical complications up to one-year clinical follow-up.
EuroIntervention: journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology 12/2013; 10(12). DOI:10.4244/EIJV10I12A242 · 3.77 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: This study sought to randomly compare cerebral protection with ANGIOGUARD (Cordis Corporation, Bridgewater, New Jersey) with Mo.Ma (Invatec/Medtronic Vascular Inc, Santa Rosa, California) during carotid artery stenting (CAS), using diffusion-weighted magnetic resonance imaging (DW-MRI) to detect new ischemic cerebral lesions. The number, size, and location of lesions were analyzed.
The choice of the type of cerebral protection during CAS is controversial.
From July 2008 to July 2011, 60 patients undergoing CAS were randomized to ANGIOGUARD or Mo.Ma, distributed by chance, 30 patients for each group. All patients underwent DW-MRI before and after CAS. An independent neuroradiologist blinded to the cerebral protection used analyzed the images. Univariate and multivariate logistic models were fitted to analyze new ischemic lesions. Alternatively, a propensity score approach was used to reduce the bias due to differences between the groups. For the number of lesions, we used Poisson regression models.
New ischemic lesions seen on DW-MRI were present in 63.3% of the ANGIOGUARD group versus 66.7% of the Mo.Ma cohort (p = 0.787). The number of ischemic cerebral lesions per patient, when present, was significantly lower in the Mo.Ma group (a median of 6 lesions per patient vs. a median of 10 in the ANGIOGUARD, p < 0.001). Most lesions were small (<0.5 mm) and localized in the ipsilateral territory. One patient in the ANGIOGUARD group had a minor stroke during CAS (1.66%).
New ischemic lesions seen on DW-MRI were present in both groups in >60%, but the number of lesions per patient was greater in the ANGIOGUARD group. No death or disabling stroke occurred during at least 1 year of follow-up in both cohorts.
[Show abstract][Hide abstract] ABSTRACT: IMPORTANCE The current recommendation is for at least 12 months of dual antiplatelet therapy after implantation of a drug-eluting stent. However, the optimal duration of dual antiplatelet therapy with specific types of drug-eluting stents remains unknown. OBJECTIVE To assess the clinical noninferiority of 3 months (short-term) vs 12 months (long-term) of dual antiplatelet therapy in patients undergoing percutaneous coronary intervention (PCI) with zotarolimus-eluting stents. DESIGN, SETTING, AND PATIENTS The OPTIMIZE trial was an open-label, active-controlled, 1:1 randomized noninferiority study including 3119 patients in 33 sites in Brazil between April 2010 and March 2012. Clinical follow-up was performed at 1, 3, 6, and 12 months. Eligible patients were those with stable coronary artery disease or history of low-risk acute coronary syndrome (ACS) undergoing PCI with zotarolimus-eluting stents. INTERVENTIONS After PCI with zotarolimus-eluting stents, patients were prescribed aspirin (100-200 mg daily) and clopidogrel (75 mg daily) for 3 months (n = 1563) or 12 months (n = 1556), unless contraindicated because of occurrence of an end point. MAIN OUTCOMES AND MEASURES The primary end point was net adverse clinical and cerebral events (NACCE; a composite of all-cause death, myocardial infarction [MI], stroke, or major bleeding); the expected event rate at 1 year was 9%, with a noninferiority margin of 2.7%. Secondary end points were major adverse cardiac events (MACE; a composite of all-cause death, MI, emergent coronary artery bypass graft surgery, or target lesion revascularization) and Academic Research Consortium definite or probable stent thrombosis. RESULTS NACCE occurred in 93 patients receiving short-term and 90 patients receiving long-term therapy (6.0% vs 5.8%, respectively; risk difference, 0.17 [95% CI, -1.52 to 1.86]; P = .002 for noninferiority). Kaplan-Meier estimates demonstrated MACE rates at 1 year of 8.3% (128) in the short-term group and 7.4% (114) in the long-term group (HR, 1.12 [95% CI, 0.87-1.45]). Between 91 and 360 days, no statistically significant association was observed for NACCE (39 [2.6%] vs 38 [2.6%] for the short- and long-term groups, respectively; HR, 1.03 [95% CI, 0.66-1.60]), MACE (78 [5.3%] vs 64 [4.3%]; HR, 1.22 [95% CI, 0.88-1.70]), or stent thrombosis (4 [0.3%] vs 1 [0.1%]; HR, 3.97 [95% CI, 0.44-35.49]). CONCLUSIONS AND RELEVANCE In patients with stable coronary artery disease or low-risk ACS treated with zotarolimus-eluting stents, 3 months of dual antiplatelet therapy was noninferior to 12 months for NACCE, without significantly increasing the risk of stent thrombosis. TRIAL REGISTRATION clinicaltrials.gov Identifier: NCT01113372.
JAMA The Journal of the American Medical Association 10/2013; 310(23). DOI:10.1001/jama.2013.282183 · 35.29 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: This study sought to perform clinical and imaging assessments of the DESolve Bioresorbable Coronary Scaffold (BCS).
BCS, which is drug eluting, may have potential advantages compared with conventional metallic drug-eluting stents. The DESolve system, designed to provide vessel support and neointimal suppression, combines a poly-l-lactic acid-based scaffold with the antiproliferative myolimus.
The DESolve First-in-Man (A NON-RANDOMIZED, CONSECUTIVE ENROLLMENT EVALUATION OF THE DESolve MYOLIMUS ELUTING BIORESORBABLE CORONARY STENT IN THE TREATMENT OF PATIENTS WITH DE NOVO NATIVE CORONARY ARTERY LESIONS) trial was a prospective multicenter study enrolling 16 patients eligible for treatment. The principal safety endpoint was a composite of cardiac death, myocardial infarction, and clinically indicated target lesion revascularization. The principal imaging endpoint was in-scaffold late lumen loss (LLL) assessed by quantitative coronary angiography (QCA) at 6 months. Intravascular ultrasound (IVUS) and optical coherence tomography (OCT) imaging was performed at baseline and 6 months; multislice computed tomography (MSCT) was performed at 12 months.
Acute procedural success was achieved in 15 of 15 patients receiving a study scaffold. At 12 months, there was no scaffold thrombosis and no major adverse cardiac events directly attributable to the scaffold. At 6 months, in-scaffold LLL (by QCA) was 0.19 ± 0.19 mm; neointimal volume (by IVUS) was 7.19 ± 3.56%, with no evidence of scaffold recoil or late malapposition. Findings were confirmed with OCT and showed uniform, thin neointimal coverage (0.12 ± 0.04 mm). At 12 months, MSCT demonstrated excellent vessel patency.
This study demonstrated the feasibility and efficacy of the DESolve BCS. Results showing low in-scaffold LLL, low % neointimal volume at 6 months, no chronic recoil, and maintenance of lumen patency at 12 months prompt further study. (DESolve First-in-Man; EudraCT number 2011-000027-32).
[Show abstract][Hide abstract] ABSTRACT: Small vessels represent a risk factor for restenosis in percutaneous coronary angioplasty (PCA). The Sparrow® self-expanding drug-eluting stent, which has a lower profile than the current systems, has never been tested in this scenario.
To evaluate the late effectiveness of the Sparrow® drug-eluting stent, regarding in-stent late lumen loss (LLL).
Patients with ischemia, symptomatic or documented, were submitted to PCA in vessels with reference diameter < 2.75 mm, divided into two groups regarding Sparrow® stent type: group 1: Sparrow® drug-eluting stent (DES), group 2: Sparrow® bare metal stent (BMS). Clinical follow-up duration was 12 months. Evaluation using quantitative coronary angiography (QCA) was performed immediately and at 8 months. A decrease of over 65% of in-stent LLL with DES was estimated to calculate sample size. IBM® SPSS software, release 19 (Chicago, Illinois, USA) was used for the statistical analysis.
A total of 24 patients were randomized, 12 in each group. The DES and BMS groups were similar in age (63.25 ± 10.01 vs. 64.58 ± 11.54, p = 0.765), male gender (58.3% vs. 33.3%, p = 0.412), risk factors and all angiographs aspects. Immediate results were satisfactory in both groups. At 8 months in-stent late lumen loss was significantly lower in DES than in BMS group (DES vs. BMS 0.25 ± 0.16 0.97 ± 0.76, p = 0.008).
In small-vessel PCA, the Sparrow® DES determined significant reduction in in-stent LLL, when compared to Sparrow® BMS.
[Show abstract][Hide abstract] ABSTRACT: Background
Primary percutaneous coronary intervention (PCI) improves survival compared with thrombolytic therapy in ST-segment elevation myocardial infarction (STEMI), with much of the benefit attributable to greater rates of normal epicardial and myocardial perfusion resulting in enhanced myocardial salvage. However, reduced tissue reperfusion after primary PCI may occur from distal thromboemboli with capillary plugging. The MGuard stent consists of a balloon-expandable metallic scaffold with mesh sleeve fibers of polyethylene terephthalate attached to its outer surface to trap friable debris/thrombi and reduce distal embolization. The MGuard for Acute ST Elevation Reperfusion (MASTER) trial has been designed to evaluate the MGuard stent in patients with STEMI. Study DesignThe MASTER trial is a prospective, multicenter, randomized study designed to compare the incidence of complete (=70%) ST-segment resolution with PCI using bare metal or drug-eluting stents (the control arm) versus PCI with the MGuard stent, measured 60 to 90 min after the last angiogram (primary endpoint). Secondary endpoints include the rates of TIMI flow and myocardial blush, and clinical outcomes through 1-year follow-up. The study has enrolled 432 patients with STEMI undergoing primary or rescue angioplasty within 12 hr of symptom onset and includes substudies with cardiac magnetic resonance imaging and quantitative coronary angiography to evaluate infarct size, microvascular obstruction, and angiographic restenosis. Conclusions
Distal embolization is common during primary PCI and results in reduced myocardial perfusion and lack of reduction of infarct size. The MASTER trial is a prospective, randomized trial designed to assess the potential of the novel MGuard stent with protective mesh net to reduce embolization and enhance myocardial reperfusion compared with routine PCI in the setting of STEMI. (c) 2013 Wiley Periodicals, Inc.
[Show abstract][Hide abstract] ABSTRACT: To investigate vessel remodeling and plaque distribution in side branch (SB) of true coronary bifurcation lesions with SB disease extending from its ostium. A total of 62 patients with single de novo true bifurcation lesions with SB with severe and extensive disease were enrolled. Of that, 45 patients/lesions underwent pre-intervention intravascular ultrasound (IVUS) at the SB. Left anterior descending was the most prevalent target vessel (>85 %). All lesions had significant involvement of both branches of the bifurcation, and the majority were classified as type 1,1,1 according to the Medina classification. Considering the subset with IVUS imaging, mean lesion length, reference diameter and % diameter stenosis in the SB were 8.88 ± 4.61 mm, 2.68 ± 0.59, and 70.2 ± 16.0 %, respectively. Also, mean proximal (take-off) and distal (carina) angles were 142.3 ± 21.9° and 60.7 ± 22.4°, respectively. At minimum lumena area (MLA) site, mean external elastic membrane and MLA cross-sectional areas were 6.70 ± 2.08 and 1.87 ± 0.93 mm(2), respectively; given that the mean distance measured between the SB origin and MLA site was <1 mm. In addition, mean plaque burden was 67.9 % and mean remodeling index was 0.78 ± 0.21. Importantly, only 9 cases out of 45 presented remodeling index > 1.0. Also, plaque distribution analysis within the SB ostium demonstrated preferable plaque positioning in the opposite side to the flow divider. In conclusions, significant negative remodeling is a frequent encounter in SB of complex coronary bifurcation lesions presenting with extensive and severe disease; in addition, plaque distribution in the SB ostium appears to be asymmetric in relation to the parent vessel, as plaque burden is mostly found in regions of low wall shear stress including the opposite side to the flow divider within the bifurcation anatomy.
The international journal of cardiovascular imaging 07/2013; 29(8). DOI:10.1007/s10554-013-0263-1 · 1.81 Impact Factor
[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. DOI:10.4244/EIJV8I2A36 · 3.77 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: This study sought to compare the 1-year safety and efficacy of Cypher Select or Cypher Select Plus (Cordis Corporation, Bridgewater, New Jersey) sirolimus-eluting stents (SES) with the treatment of bare-metal stents (BMS) and drug-eluting stent (DES) in-stent restenosis (ISR) in nonselected, real-world patients.
There is paucity of consistent data on DES for the treatment of ISR, especially, DES ISR.
The e-SELECT (Multicenter Post-Market Surveillance) registry is a Web-based, multicenter and international registry encompassing virtually all subsets of patients and lesions treated with at least 1 SES during the period from 2006 to 2008. We enrolled in this pre-specified subanalysis all patients with at least 1 clinically relevant BMS or DES ISR treated with SES. Primary endpoint was major adverse cardiac events and stent thrombosis rate at 1 year.
Of 15,147 patients enrolled, 1,590 (10.5%) presented at least 1 ISR (BMS group, n = 1,235, DES group, n = 355). Patients with DES ISR had higher incidence of diabetes (39.4% vs. 26.9%, p < 0.001), renal insufficiency (5.8% vs. 2.3%, p = 0.003), and prior coronary artery bypass graft (20.5% vs. 11.8%, p < 0.001). At 1 year, death (1.4% for BMS vs. 2.1% for DES, p = 0.3) and myocardial infarction (2.4% for BMS and 3.3% for DES, p = 0.3) rates were similar, whereas ischemia-driven target lesion revascularization and definite/probable late stent thrombosis were higher in patients with DES ISR (6.9% vs. 3.1%, p = 0.003, and 1.8% vs. 0.5%, p = 0.04, respectively).
Use of SES for either BMS or DES ISR treatment is safe and associated with low target lesion revascularization recurrence and no apparent safety concern.
[Show abstract][Hide abstract] ABSTRACT: The newly developed balloon-expandable Mguard stent system, a combination of an ultra-thin polymer mesh sleeve attached to the external surface of a BMS, was conceived to provide embolic protection during PCI of SVG and thrombus-containing lesions. Although the acute results (<30 days) have pointed to the efficacy of this novel device, few is known about its long-term performance.
The present article address the 1-year clinical results of a cohort of 30 patients enrolled in the INSPIRE trial. 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. The primary endpoint (incidence of MACE-composite of cardiac death, nonfatal MI, and TLR) up to 30 days of the procedure has already been published. Secondary endpoints here presented included in-stent late lumen loss (QCA), % of stent obstruction (IVUS) at 6 months and combined MACE at 1 year. QCA and IVUS were performed by independent corelabs.
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 ± 4.5 mm and 3.0 ± 0.5 mm. 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 ± 0.4 mm and 28.5 ± 15.6%. Up to 1 year there was no case of cardiac death, two MI (one Q-wave and one non-Q-wave) and six cases of ischemia-driven TLR. Of note, there was no case of definite/probable stent thorombosis.
In this series of patients treated with MGuard stent, the novel device showed no midterm efficacy and safety concerns.
[Show abstract][Hide abstract] ABSTRACT: This study sought to assess the temporal course of neointimal hyperplasia (NIH) formation following implantation of 2 different generations of drug-eluting stents (DES).
The amount of NIH following DES implantation correlates with the potency of the antiproliferative drug, its kinetic release, as well as some individual characteristics, as the presence of diabetes mellitus (DM). Recently, some publications have suggested a continuous growth of NIH following DES, which in some cases, might result in late "catch-up."
Twenty-five patients with single, de novo lesions were treated with sirolimus-eluting stents (SES) (n = 12) and biolimus-eluting stents (BES) (n = 13) and underwent intravascular ultrasound evaluation immediately after the procedure and at 9-month and 5-year follow-ups. The primary endpoint was the comparison of the percentage of NIH obstruction between mid- and long-term follow-up.
Mean age was 59 years and 28% of patients had DM. Overall, the percentage of NIH obstruction significantly increased from 9 months to 5 years (1.3% at first follow-up vs. 4.8% at second follow-up, p = 0.002). There was no significant difference in the variation of vessel volume (Δ = -0.70 mm(3)/mm BES vs. Δ = 0.18 mm(3)/mm SES, p = 0.56), lumen volume (Δ = 0.40 mm(3)/mm BES vs. Δ = -0.05 mm(3)/mm SES, p = 0.71), and percentage of NIH obstruction (Δ = 3.0% BES vs. Δ = 3.8% SES, p = 0.55) among DES. However, diabetic patients had a marked NIH increase along the years (NIH volume at second follow-up: 10.15 mm(3) DM vs. 5.11 mm(3) non-DM, p = 0.028).
The present serial intravascular ultrasound assessment supports the occurrence of continuous NIH growth following different generations of DES. These findings seem to be particularly more pronounced among patients with DM.
[Show abstract][Hide abstract] ABSTRACT: At present, percutaneous coronary intervention with drug-eluting stent (DES) implantation represents the default strategy to treat coronary artery disease in many institutions around the world. However, concerns regarding long-term safety of first-generation DES have prompted the development of novel DES systems such as the NEVO (Cordis Corporation, Johnson & Johnson, Warren, NJ) sirolimus-eluting stent with biodegradable polymer and reservoir technology. In the current report, we present, for the first time, a complete midterm invasive assessment of a patient treated with this novel device in the Res-Elution I study.