Summary 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.
Objectives This study sought to assess the temporal course of neointimal hyperplasia (NIH) formation following implantation of 2 different generations of drug-eluting stents (DES). Background 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.” Methods 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. Results 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 mm3 /mm BES vs. Δ = 0.18 mm3 /mm SES, p = 0.56), lumen volume (Δ = 0.40 mm3 /mm BES vs. Δ = −0.05 mm3 /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 mm3 DM vs. 5.11 mm3 non-DM, p = 0.028). Conclusions 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.
Sinus of Valsalva Pseudoaneurysm Centemero, Marinella; Urdanetta, Luis Rafael; Maschiarelli, Ibraim ...
JACC. Case reports,
05/2023, Letnik:
14
Journal Article
Recenzirano
Odprti dostop
We present a case of a young man with complete atrioventricular block and aneurysm of the right sinus of Valsalva penetrating the interventricular septum and causing severe aortic regurgitation. ...Chest trauma and inflammatory or infectious diseases are potential causes. Bentall–de Bono surgical repair was performed. Anatomopathologic analysis demonstrated fibrosis, hyalinization, and extensive myxoid material. (Level of Difficulty: Beginner.)
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Background 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 (>3.0 mm) has yet to be established. Objective We investigated whether DES are superior to bare metal stents (BMS) in terms of clinical outcomes for the treatment of large coronary vessels. Methods 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 ≥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. Results 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). Conclusion Percutaneous treatment of large coronary vessels carries a low risk of clinical events irrespective of the type of stent used.
The ZoMaxx Coronary Stent System elutes the antiproliferative agent zotarolimus via a biocompatible phosphorylcholine polymer loaded onto a novel, thin, stainless steel stent platform containing an ...0.0007-inch inner layer of tantalum that enhances fluoroscopic radiopacity. The objective of this single-arm prospective clinical trial was to assess the safety and performance of the ZoMaxx stent for the treatment of coronary artery stenosis. Forty consecutive patients with ischemic coronary occlusive disease due to single de novo obstructive lesions of native coronary arteries were treated with 3 × 18 mm ZoMaxx stents at the Dante Pazzanese de Cardiologie in Saõ Paulo, Brazil, between April and July 2005. Independent core laboratories analyzed quantitative coronary angiography and intravascular ultrasound results immediately after stent implantation, and after 4 months. The lesion, procedure, and device-deployment success rates were all 100% (40 of 40). There were no major adverse cardiac events during the study. Follow-up quantitative coronary angiography at 4 months revealed in-stent and in-segment late lumen losses of 0.20 ± 0.35 and 0.17 ± 0.35 mm, respectively. Follow-up intravascular ultrasound at 4 months revealed 6.5 ± 6.2% neointimal volume obstruction. There were no instances of late acquired stent incomplete apposition or stent thrombosis. In conclusion, the ZoMaxx Coronary Stent can be safely implanted for the treatment of de novo coronary artery stenosis. The inhibition of neointima formation as measured by follow-up angiography and IVUS after 4 months suggests therapeutic potential for the reduction of restenosis.
Objectives The aim of this study was to evaluate the novel CardioMind Sparrow (CMS) stent (CardioMind, Inc., Sunnyvale, California) against the Multi-Link Pixel (MLP) stent (Guidant Corp., Santa ...Clara, California) for small vessel percutaneous coronary intervention (PCI). Background The CMS consists of a guidewire-based, self-expandable, ultra-thin nitinol stent with smaller profile and improved flexibility and deliverability. The performance of this novel device against a standard balloon-expandable stent for small vessel PCI has not been determined. Methods Twenty-one patients were treated with the CMS and compared with 30 patients treated with MLP. Only single de novo lesions <14 mm in length, in native vessels of 2.0 to 2.5 mm were included. The primary goal was the comparison of quantitative coronary angiography lumen loss and intravascular ultrasound intimal hyperplasia (IH) formation between groups at 6 months. Results Clinical characteristics were similar between groups. The CMS cohort had smaller vessels (2.20 ± 0.20 mm vs. 2.43 ± 0.16 mm, p < 0.0001) and shorter lesions (10.86 ± 3.19 mm vs. 13.12 ± 2.79 mm, p = 0.0091). Six-month late loss was significantly lower among CMS cohort (0.73 ± 0.57 mm vs. 1.11 ± 0.72 mm, p = 0.038). By intravascular ultrasound, 6-month IH volume was similar between groups (1.45 ± 0.46 mm3 /mm vs. 1.65 ± 1.02 mm3 /mm, p = 0.50). However, CMS presented a mean 13.39% expansion of its volumes, resulting in a significantly lower percentage of IH volumetric obstruction (31.94 ± 8.19% vs. 39.90 ± 4.72%, p = 0.0005). Conclusions Despite producing similar amounts of IH volume, the self-expanding CMS stent presented chronic expansion of its volumes, better accommodating the neoformed tissue and resulting in significantly lower late loss and percent of IH volumetric obstruction in comparison with the MLP stent.
Objectives We sought to assess the safety and efficacy of the novel VESTAsync-eluting stent (MIV Therapeutics, Atlanta, Georgia) combining a stainless steel platform with a nanothin-microporous ...hydroxyapatite surface coating impregnated with a polymer-free low-dose of sirolimus (55 μg). Background Durable polymers in first-generation drug-eluting stents (DES) have been linked to local inflammatory reaction leading to a positive vessel remodeling, late incomplete stent apposition, and in some cases, stent thrombosis. The removal of the polymer from the DES system could increase the safety profile of this novel technology. Methods A total of 15 patients with single de novo lesions in native coronary arteries with 3.0- to 3.5-mm diameter and ≤14-mm length were enrolled in this first-in-man study. Primary end point was in-stent late lumen loss (LL) at 4 and 9 months. Results Baseline characteristics included mean age of 63 years and 33% of diabetics. Reference vessel diameter and lesion length were 2.7 ± 0.3 mm and 10 ± 2.0 mm, respectively. Procedure success was obtained in all cases. Lifelong aspirin and 5-month clopidogrel treatment were prescribed to all patients. At 4 months, in-stent LL and percentage of neointimal hyperplasia were 0.3 ± 0.25 mm and 2.6 ± 2.2%, respectively, with a nonsignificant increase at 9 months (0.36 ± 0.23 mm and 4.0 ± 2.2%, respectively). Serial intravascular ultrasound did not show late incomplete stent apposition. There were no major adverse cardiac events within 1 year of follow-up. Conclusions The novel VESTAsync-eluting stent was effective in reducing LL and neointimal hyperplasia at 4 and 9 months, with no evidence of late catch-up by quantitative coronary angiography or intravascular ultrasound.
Preliminary Results of the Hydroxyapatite Nonpolymer-Based Sirolimus-Eluting Stent for the Treatment of Single De Novo Coronary Lesions: A First-in-Human Analysis of a Third-Generation Drug-Eluting ...Stent System J. Ribamar Costa, Jr, Alexandre Abizaid, Ricardo Costa, Fausto Feres, Luís Fernando Tanajura, Andréa Abizaid, Luiz Alberto Mattos, Rodolfo Staico, Dimytri Siqueira, Amanda G.M.R. Sousa, R. Bonan, J. Eduardo Sousa In this preliminary analysis, we present the 4-month clinical, angiographic, and ultrasonographic results of the first 15 patients treated with the novel Vestasync nonpolymer-based sirolimus-eluting stent. The main findings were that no clinical event occurred up to that follow-up period, with in-stent late lumen loss of 0.30 ± 0.25 mm (quantitative coronary angiography) and in-stent volume of obstruction of 2.8 ± 2.2%.
Abstract Background Optimal upfront dual antiplatelet therapy (DAPT) duration after complex percutaneous coronary intervention (PCI) with drug-eluting stents (DES) remains unclear. Objectives This ...study investigated the efficacy and safety of long- (≥12 months) versus short-term (3 or 6 months) DAPT with aspirin and clopidogrel according to PCI complexity. Methods We pooled patient-level data from 6 randomized controlled trials investigating DAPT durations after PCI. Complex PCI was defined as having at least 1 of the following features: 3 vessels treated, ≥3 stents implanted, ≥3 lesions treated, bifurcation with 2 stents implanted, total stent length >60 mm, or chronic total occlusion. The primary efficacy endpoint was major adverse cardiac events (MACE), defined as the composite of cardiac death, myocardial infarction, or stent thrombosis. The primary safety endpoint was major bleeding. Intention-to-treat was the primary analytic approach. Results Of 9,577 patients included in the pooled dataset for whom procedural variables were available, 1,680 (17.5%) underwent complex PCI. Overall, 85% of patients received new-generation DES. At a median follow-up time of 392 days (interquartile range: 366 to 710 days), patients who underwent complex PCI had a higher risk of MACE (adjusted hazard ratio HR: 1.98; 95% confidence interval CI: 1.50 to 2.60; p < 0.0001). Compared with short-term DAPT, long-term DAPT yielded significant reductions in MACE in the complex PCI group (adjusted HR: 0.56; 95% CI: 0.35 to 0.89) versus the noncomplex PCI group (adjusted HR: 1.01; 95% CI: 0.75 to 1.35; pinteraction = 0.01). The magnitude of the benefit with long-term DAPT was progressively greater per increase in procedural complexity. Long-term DAPT was associated with increased risk for major bleeding, which was similar between groups (pinteraction = 0.96). Results were consistent by per-treatment landmark analysis. Conclusions Alongside other established clinical risk factors, procedural complexity is an important parameter to take into account in tailoring upfront duration of DAPT.
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