Safety and performance of the second-generation drug-eluting absorbable metal scaffold in patients with de-novo coronary artery lesions (BIOSOLVE-II): 6 month results of a prospective, multicentre, non-randomised, first-in-man trial
Haude M.,Lukaskrankenhaus GmbH |
Ince H.,Vivantes Klinikum im Friedrichshain and Am Urban |
Abizaid A.,Dante Pazzanese Institute of Cardiology |
Toelg R.,Herzzentrum Segeberger Kliniken GmbH |
And 11 more authors.
The Lancet | Year: 2016
Background Absorbable scaffolds were designed to overcome the limitations of conventional, non-absorbable metal-based drug-eluting stents. So far, only polymeric absorbable scaffolds are commercially available. We aimed to assess the safety and performance of a novel second-generation drug-eluting absorbable metal scaffold (DREAMS 2G) in patients with de-novo coronary artery lesions. Methods We did this prospective, multicentre, non-randomised, first-in-man trial at 13 percutaneous coronary intervention centres in Belgium, Brazil, Denmark, Germany, Singapore, Spain, Switzerland, and the Netherlands. Eligible patients had stable or unstable angina or documented silent ischaemia, and a maximum of two de-novo lesions with a reference vessel diameter between 2·2 mm and 3·7 mm. Clinical follow-up was scheduled at months 1, 6, 12, 24, and 36. Patients were scheduled for angiographic follow-up at 6 months, and a subgroup of patients was scheduled for intravascular ultrasound, optical coherence tomography, and vasomotion assessment. All patients were recommended to take dual antiplatelet treatment for at least 6 months. The primary endpoint was in-segment late lumen loss at 6 months. We did analysis by intention to treat. This trial is registered with ClinicalTrials.gov, number NCT01960504. Findings Between Oct 8, 2013, and May 22, 2015, we enrolled 123 patients with 123 coronary target lesions. At 6 months, mean in-segment late lumen loss was 0·27 mm (SD 0·37), and angiographically discernable vasomotion was documented in 20 (80%) of 25 patients. Intravascular ultrasound assessments showed a preservation of the scaffold area (mean 6·24 mm2 [SD 1·15] post-procedure vs 6·21 mm2 [1·22] at 6 months) with a low mean neointimal area (0·08 mm2 [0·09]), and optical coherence tomography did not detect any intraluminal mass. Target lesion failure occurred in four (3%) patients: one (<1%) patient died from cardiac death, one (<1%) patient had periprocedural myocardial infarction, and two (2%) patients needed clinically driven target lesion revascularisation. No definite or probable scaffold thrombosis was observed. Interpretation Our findings show that implantation of the DREAMS 2G device in de-novo coronary lesions is feasible, with favourable safety and performance outcomes at 6 months. This novel absorbable metal scaffold could be an alternative to absorbable polymeric scaffolds for treatment of obstructive coronary disease. Funding Biotronik AG. © 2016 Elsevier Ltd.
Panza J.A.,MedStar Washington Hospital Center |
Holly T.A.,Northwestern University |
Asch F.M.,MedStar Washington Hospital Center |
She L.,Duke University |
And 8 more authors.
Journal of the American College of Cardiology | Year: 2013
Objectives: The study objectives were to test the hypotheses that ischemia during stress testing has prognostic value and identifies those patients with coronary artery disease (CAD) with left ventricular (LV) dysfunction who derive the greatest benefit from coronary artery bypass grafting (CABG) compared with medical therapy. Background: The clinical significance of stress-induced ischemia in patients with CAD and moderately to severely reduced LV ejection fraction (EF) is largely unknown. Methods: The STICH (Surgical Treatment for IsChemic Heart Failure) trial randomized patients with CAD and EF ≤35% to CABG or medical therapy. In the current study, we assessed the outcomes of those STICH patients who underwent a radionuclide (RN) stress test or a dobutamine stress echocardiogram (DSE). A test was considered positive for ischemia by RN testing if the summed difference score (difference in tracer activity between stress and rest) was ≥4 or if ≥2 of 16 segments were ischemic during DSE. Clinical endpoints were assessed by intention to treat during a median follow-up of 56 months. Results: Of the 399 study patients (51 women, mean EF 26 ± 8%), 197 were randomized to CABG and 202 were randomized to medical therapy. Myocardial ischemia was induced during stress testing in 256 patients (64% of the study population). Patients with and without ischemia were similar in age, multivessel CAD, previous myocardial infarction, LV EF, LV volumes, and treatment allocation (all p = NS). There was no difference between patients with and without ischemia in all-cause mortality (hazard ratio: 1.08; 95% confidence interval: 0.77 to 1.50; p = 0.66), cardiovascular mortality, or all-cause mortality plus cardiovascular hospitalization. There was no interaction between ischemia and treatment for any clinical endpoint. Conclusions: In CAD with severe LV dysfunction, inducible myocardial ischemia does not identify patients with worse prognosis or those with greater benefit from CABG over optimal medical therapy. (Comparison of Surgical and Medical Treatment for Congestive Heart Failure and Coronary Artery Disease [STICH]; NCT00023595) © 2013 American College of Cardiology Foundation.
Costa R.A.,Dante Pazzanese Institute of Cardiology |
Costa M.A.,Case Western Reserve University |
Moussa I.D.,The Texas Institute
International Journal of Cardiovascular Imaging | Year: 2011
This repot reviews the angiographic and intravascular (IVUS) assessment of coronary bifurcation lesions. Overall, bifurcation lesion anatomy and morphology is critical for technical decision making, and a key factor for successful bifurcation PCI. Optimal viewing is essential for proper angiographic assessment, especially for evaluation of the degree of SB involvement. Current classifications based on the presence or absence of significant angiographic stenosis within the three segments of the bifurcation anatomy may not provide sufficient anatomic and morphologic information to guide technical decision making. Dedicated 2D bifurcation quantitative coronary angiography with segmental analysis of the bifurcation provides greater accuracy for quantification of the degree of stenosis in the PV and especially the SB ostium. IVUS assessment at preprocedure provides valuable information regarding vessel size, and plaque morphology and distribution (particularly in relation to the SB ostium) that may help select treatment strategy. At postprocedure, IVUS imaging evaluates stent apposition within the stented segment(s) and the appropriateness of stent expansion particularly at the SB ostium, what may impact long-term outcomes. © Springer Science+Business Media, B.V. 2011.
Palmerini T.,University of Bologna |
Benedetto U.,University of Oxford |
Bacchi-Reggiani L.,University of Bologna |
Riva D.D.,University of Bologna |
And 15 more authors.
The Lancet | Year: 2015
Background Despite recent studies, the optimum duration of dual antiplatelet therapy (DAPT) after coronary drug-eluting stent placement remains uncertain. We performed a meta-analysis with several analytical approaches to investigate mortality and other clinical outcomes with different DAPT strategies. Methods We searched Medline, Embase, Cochrane databases, and proceedings of international meetings on Nov 20, 2014, for randomised controlled trials comparing different DAPT durations after drug-eluting stent implantation. We extracted study design, inclusion and exclusion criteria, sample characteristics, and clinical outcomes. DAPT duration was categorised in each study as shorter versus longer, and as 6 months or shorter versus 1 year versus longer than 1 year. Analyses were done by both frequentist and Bayesian approaches. Findings We identified ten trials published between Dec 16, 2011, and Nov 16, 2014, including 31 666 randomly assigned patients. By frequentist pairwise meta-analysis, shorter DAPT was associated with significantly lower all-cause mortality compared with longer DAPT (HR 0·82, 95% CI 0·69-0·98; p=0·02; number needed to treat [NNT]=325), with no significant heterogeneity apparent across trials. The reduced mortality with shorter compared with longer DAPT was attributable to lower non-cardiac mortality (0·67, 0·51-0·89; p=0·006; NNT=347), with similar cardiac mortality (0·93, 0·73-1·17; p=0.52). Shorter DAPT was also associated with a lower risk of major bleeding, but a higher risk of myocardial infarction and stent thrombosis. We noted similar results in a Bayesian framework with non-informative priors. By network meta-analysis, patients treated with 6-month or shorter DAPT and 1-year DAPT had higher risk of myocardial infarction and stent thrombosis but lower risk of mortality compared with patients treated with DAPT for longer than 1 year. Patients treated with DAPT for 6 months or shorter had similar rates of mortality, myocardial infarction, and stent thrombosis, but lower rates of major bleeding than did patients treated with 1-year DAPT. Interpretation Although treatment with DAPT beyond 1 year after drug-eluting stent implantation reduces myocardial infarction and stent thrombosis, it is associated with increased mortality because of an increased risk of non-cardiovascular mortality not offset by a reduction in cardiac mortality. Funding None. © 2015 Elsevier Ltd.
Grube E.,University of Bonn |
Naber C.,International Heart Center |
Abizaid A.,Dante Pazzanese Institute of Cardiology |
Sousa E.,Dante Pazzanese Institute of Cardiology |
And 5 more authors.
JACC: Cardiovascular Interventions | Year: 2011
Objectives: The purpose of this pilot study was to evaluate the feasibility and safety of transcatheter aortic valve implantation (TAVI) without balloon pre-dilation. Background: Balloon pre-dilation of the stenosed aortic valve is currently believed to be a necessary step for valve preparation before device placement in patients undergoing TAVI and, therefore, is considered an obligatory part of the procedure. However, clear evidence supporting this policy is lacking. In contrast, pre-dilation might be responsible in part for distal embolizations as well as atrioventricular conduction disturbances seen during TAVI procedures. Methods: A total of 60 consecutive patients (mean age 80.1 ± 6.4 years, 53% female, mean logistic EuroScore 23.3 ± 15.2%) undergoing TAVI using the self-expanding Medtronic CoreValve prosthesis (Medtronic, Minneapolis, Minnesota) have been prospectively enrolled at 13 international centers. Results: Pre-procedural mean transaortic valve gradient was 47.8 ± 15.5 mm Hg, mean effective orifice area was 0.67 ± 0.15 cm 2. Technical success rate was 96.7% (58 of 60) of patients. Post-dilation was performed in 16.7% (10 of 60) of patients. Post-procedural mean valve gradient was 4.4 ± 2.0 mm Hg. Circular and noncircular valve configuration was present in 41 and 19 cases (68.3% vs. 31.7%), respectively, with similar effective orifice areas (1.74 ± 0.10 cm 2 vs. 1.71 ± 0.22 cm 2, p = NS). In-hospital mortality, myocardial infarction, stroke, and major vascular complications occurred in 6.7% (4 of 60), 0%, 5%, and 10% of patients. There was no valve embolization. New permanent pacing was needed in 11.7% (7 of 60) of patients. Conclusions: Transcatheter aortic valve implantation without balloon pre-dilation is feasible and safe, resulting in similar acute safety and efficacy as the current standard approach of TAVI with pre-dilation. © 2011 American College of Cardiology Foundation.
Batlouni M.,Dante Pazzanese Institute of Cardiology
Arquivos Brasileiros de Cardiologia | Year: 2010
The nonsteroidal anti-inflammatory drugs (NSAIDs) are among the most often prescribed drugs in the world. This heterogeneous class of drugs includes aspirin and several other selective or non-selective cyclooxygenase (COX) inhibitors. The non-selective NSAIDs are the oldest ones and are called traditional or conventional NSAIDs. The selective NSAIDs are called COX-2 inhibitors. In recent years, the safety of NSAID use in clinical practice has been questioned, especially that of the selective COX-2 inhibitors. The evidence on the increase in cardiovascular risk with the use of NSAIDs is still scarce, due to the lack of randomized and controlled studies with the capacity of evaluating relevant cardiovascular outcomes. However, the results of prospective clinical trials and meta-analyses indicate that the selective COX-2 inhibitors present important adverse cardiovascular effects, which include increased risk of myocardial infarction, cerebrovascular accident, heart failure, kidney failure and arterial hypertension. The risk of these adverse effects is higher among patients with a previous history of cardiovascular disease or those at high risk to develop it. In these patients, the use of COX-2 inhibitors must be limited to those for which there is no appropriate alternative and, even in these cases, only at low doses and for as little time as possible. Although the most frequent adverse effects have been related to the selective COX-2 inhibition, the absence of selectiveness for this isoenzyme does not completely eliminate the risk of cardiovascular events; therefore, all drugs belonging to the large spectrum of NSAIDs should only be prescribed after consideration of the risk/benefit balance.
Farmacologic test pre-implants in hypertension pulmonary elevated and still in candidates to heterotopic transplantation [Teste farmacológico pré-implante na hipertensão pulmonar elevada e fixa em candidatos a transplante heterotópico]
Dinkhuysen J.J.,Dante Pazzanese Institute of Cardiology
Brazilian Journal of Cardiovascular Surgery | Year: 2010
Background: Evaluation of pulmonary artery pressure just before transplanting with sodium nitroprusside may allow conversion to orthotopic technique. Methods: Between 1992 and 2007, 228 transplants were performed systematically and this was used in seven patients with preoperative hemodynamic evaluation: Pre NP (mmHg) Post NP (mmHg) Systolic systemic blood pressure (PSAS) 108-78 (101.7 ± 10.9) 90-74 (79.5 ± 15.2) pulmonary arterial systolic pressure (PASP) 88-51 (69.8 ± 13.2) 70-40 (57.8 ± 9.9) Gradient transpulmonary (GTP) 16-11 (14.2 ± 1.7) 14-11 (12.4 ± 1.2) pulmonary vascular resistance (PVR/w) 7.9 to 4.8 (6.2 ± 1 0) 5.9-4.1 (5.0 ± 0.8). Results: The intraoperative findings were: Pre NP (mmHg) e Post NP (mmHg), respectively, PSAS 91-78 (8.5 ± 5.2) and 65-59 (4.2 ± 63.8) (P = 0.017), decrease 19.9%, decrease 29.3%; PSAP 71-52 (61.8 ± 6.1) and 43-32 (37.5 ± 3.3) (P = 0.018), decrease 28%, decrease 41%. In light of these data, patients were transplanted by orthotopic technique not being observed mortality in the short and long-term evolution from 5 months to 6 years. Conclusion: This methodology allowed the conversion of the technique for heterotopic orthotopically, with good early and late otcomes.
Centemero M.P.,Dante Pazzanese Institute of Cardiology |
Stadler J.R.,Dante Pazzanese Institute of Cardiology
Expert Review of Cardiovascular Therapy | Year: 2012
Stent thrombosis is a challenging problem following percutaneous coronary intervention that can lead to serious clinical consequences, such as death and acute myocardial infarction. Its pathophysiology is not yet completely known, and there are several causes suggested, such as incomplete stent endothelization, presence of polymers and late incomplete stent apposition. One of the main predictors is the early discontinuation of dual antiplatelet therapy. Stent improvements related to their design, with more friendly metallic platforms, thinner biocompatible or biodegradable polymers, absence of polymers, and even stents manufactured with bioabsorbable materials, could make the percutaneous procedure much safer and effective, allowing its application in increasingly complex anatomic and clinical scenarios, with low thrombosis rates. © 2012 Expert Reviews Ltd.
Piegas L.S.,Dante Pazzanese Institute of Cardiology |
Haddad N.,Dante Pazzanese Institute of Cardiology
Arquivos Brasileiros de Cardiologia | Year: 2011
Background: The Brazilian Public Health System (SUS) holds approximately 80% of percutaneous coronary interventions (PCI) in Brazil. Being aware of these data will enable to design a proper plan for the treatment of coronary artery disease (CAD). Objective: To review and discuss the results of PCIs performed by the SUS. Methods: We reviewed data from SIH/DATASUS available for public consultation. Results: From 2005 to 2008, 166,514 procedures were performed in 180 hospitals. Average hospital mortality was 2.33%, ranging from 0% to 11.35%, being lower in the Southeast, 2.03% and higher in the northern region, 3.64% (p < 0.001). The mortality rate was 2.33% in 45 (25%) higher-volume hospitals, accounting for 101,218 (60.8%) of the PCIs, 2.29% in 90 (50%) medium-volume hospitals with 50,067 (34.9%) PCIs and 2.52% in 45 (25%) small-volume hospitals with 7,229 (4.3%) PCIs (p > 0.05). Mortality was higher in females (p < 0.0001) and at ages ≥ 65 to = (p ≤ 0.001). In the diagnosis of angina (79,324, 47.64%) mortality was 1.03%, and AMI (33,286, 32.30%) 6.35% (p < 0.0000001). In the single stent implantation, the most common (102,165, 61.36%), mortality was 1.20%, and Primary PCI (27,125, 16.29%), 6.96%. Conclusion: Although it is growing, the number of PCIs in Brazil is still low. High-volume hospitals, in smaller numbers, accounted for most procedures. Single stent implantation through hospital admission was reported to be most commonly used procedure. Mortality rates were highly variable among the hospitals. Primary PCI was responsible for the highest mortality rate.
Abboud C.S.,Dante Pazzanese Institute of Cardiology
Transplantation proceedings | Year: 2012
Mucormycosis is a rare but emerging fungal infection complicating solid organ transplantation (SOT), with a cumulative incidence of around 2% during the first year after SOT. The associated mortality rate is high, and surgical debridement is frequently required as part of the treatment along with antifungal therapy based mostly on amphotericin B formulations, We describe here an unusual case of hepatic mucormycosis in a liver transplant recipient that was successfully treated with clinical therapy based on liposomal amphotericin B followed by posaconazole, without surgical resection. Copyright © 2012 Elsevier Inc. All rights reserved.