In a randomized trial involving patients at high bleeding risk who received 1 month of dual antiplatelet therapy after PCI, use of polymer-based zotarolimus-eluting stents was noninferior to use of ...polymer-free drug-coated stents with regard to safety and effectiveness composite outcomes.
Abstract Objectives Routine device surveillance after successful left atrial appendage closure is recommended to evaluate for intermediate to late complications. The aim of this study was to assess ...the incidence and clinical impact of these complications on cardiovascular events. Methods Centers participating in the Amplatzer Cardiac Plug multicenter study were requested to submit their post-procedural transesophageal echocardiograms for independent adjudication. Thirteen of 22 centers contributed all their post-procedural echocardiograms, which included 344 from 605 consecutive patients. These images were submitted to a core laboratory and reviewed by 2 independent experts for peri-device leak, device-associated thrombus, device embolization, device migration, left atrial appendage thrombus, and left atrial thrombus. Clinical events were prospectively collected by each center. Results Of the 344 transesophageal echocardiograms, 339 were deemed analyzable. Patients’ mean age was 74.4 ± 7.5 years, and 67.3% were men. The mean CHADS2 score was 2.7 ± 1.3, the mean CHA2 DS2 -VASc score was 4.3 ± 1.5, and the mean HAS-BLED score was 3.0 ± 1.2. Amplatzer Cardiac Plug implantation was successful in all patients. Periprocedural major adverse events occurred in 2.4%. Median clinical follow-up duration was 355 days (range 179 to 622 days). Follow-up transesophageal echocardiography was performed after a median of 134 days (range 88 to 227 days). Device-associated thrombus was observed in 3.2% and peri-device leak in 12.5% (5.5% minimal, 5.8% mild, 0.6% moderate, 0.6% severe). Neither device-associated thrombus nor peri-device leak was associated with an increased risk for cardiovascular events. Independent predictors of device-associated thrombus were smoking (odds ratio: 5.79; p = 0.017) and female sex (odds ratio: 4.22; p = 0.027). Conclusions Following successful left atrial appendage closure with the Amplatzer Cardiac Plug, the presence of peri-device leak was relatively low, and device-associated thrombus was infrequent. Neither was associated with increased risk for thromboembolism.
Background:At 1 year, the international randomized BIONYX trial (ClinicalTrials.gov:NCT02508714) established non-inferiority regarding safety and efficacy of the novel Resolute Onyx ...zotarolimus-eluting stent (RO-ZES) vs. the Orsiro sirolimus-eluting stent (O-SES). Although the RO-ZES is used in daily practice, no clinical results have been published beyond 2 years.Methods and Results:We assessed 3-year clinical outcomes of 2,488 all-comers after percutaneous coronary intervention (PCI) with RO-ZES vs. O-SES. The main endpoint was target vessel failure (TVF), a composite of cardiac death, target vessel myocardial infarction (MI), or target vessel revascularization. Time-to-endpoints was assessed by Kaplan-Meier methods and between-group comparisons by log-rank tests. Follow-up was available in 2,433/2,488 (97.8%) patients. There was no significant between-stent difference in TVF (RO-ZES 112/1,243 9.2% vs. O-SES 109/1,245 8.9%, hazard ratio HR: 1.03, 95% confidence interval CI 0.79–1.34; Plog-rank=0.85) and its individual components. The all-cause mortality was significantly lower after PCI with RO-ZES (3.7% vs.5.4%, HR: 0.67, 95% CI 0.46–0.97; Plog-rank=0.034), but cardiac mortality did not differ significantly (1.1% vs.1.9%, HR: 0.56, 95% CI 0.28–1.11; Plog-rank=0.09). Definite-or-probable stent thrombosis rates were low for both groups (0.6% vs.1.2%, HR: 0.46, 95% CI 0.19–1.14; Plog-rank=0.09).Conclusions:This first 3-year randomized assessment of the RO-ZES showed a favorable rate of TVF that matched the outcomes of patients treated with O-SES. We observed a lower rate of all-cause death in the RO-ZES group, but long-term clinical follow-up is of interest.
The aim of this study was to investigate whether transradial (TR) percutaneous coronary intervention (PCI) is superior to transfemoral (TF) PCI in complex coronary lesions with large-bore guiding ...catheters with respect to clinically relevant access site–related bleeding or vascular complications.
The femoral artery is currently the most applied access site for PCI of complex coronary lesions, especially when large-bore guiding catheters are required. With downsizing of TR equipment, TR PCI may be increasingly applied in these patients and might be a safer alternative compared with the TF approach.
An international prospective multicenter trial was conducted, randomizing 388 patients with planned PCI for complex coronary lesions, including chronic total occlusion, left main, heavy calcification, or complex bifurcation, to either 7-F TR access (TRA) or 7-F TF access (TFA). The primary endpoint was defined as access site–related clinically significant bleeding or vascular complications requiring intervention at discharge. The secondary endpoint was procedural success.
The primary endpoint event rate was 3.6% for TRA and 19.1% for TFA (p < 0.001). The crossover rate from radial to femoral access was 3.6% and from femoral to radial access was 2.6% (p = 0.558). The procedural success rate was 89.2% for TFA and 86.0% for TRA (p = 0.285). There was no difference between TFA and TRA with regard to procedural duration, contrast volume, or radiation dose.
In patients undergoing PCI of complex coronary lesions with large-bore access, radial compared with femoral access is associated with a significant reduction in clinically relevant access-site bleeding or vascular complications, without affecting procedural success. (Complex Large-Bore Radial Percutaneous Coronary Intervention PCI Trial Color; NCT03846752)
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The management of patients with severe aortic valve stenosis and an abdominal aortic aneurysm is a real therapeutic challenge. Minimally invasive treatment is more beneficial than open surgery for ...treating both aortic valve stenosis and abdominal aortic aneurysm. We present a case of a 77-year-old male initially treated with a 26 mm Sapien 3 transcatheter aortic valve replacement. Subsequently, using the same femoral access points, a custom fenestrated endoprosthesis and stents in digestive trunks and renal arteries were implanted. Follow-up imaging revealed no dysfunction of the valve, endoprosthesis, or stents. This is the first reported successful concomitant management of significant aortic valve stenosis and infrarenal abdominal aortic aneurysm through transcatheter aortic valve replacement and fenestrated endovascular aortic aneurysm repair.
Optimal duration of dual antiplatelet therapy (DAPT) in patients undergoing complex percutaneous coronary intervention (PCI) remains under investigation. Our aim is to compare shortened (≤3 months) ...DAPT with longer DAPT in patients undergoing complex PCIs.
Three major databases (MEDLINE, Cochrane Central Register of Controlled Trials, and Scopus) were screened. The primary endpoint was major bleedings as they are defined by the Bleeding Academic Research Consortium (BARC) 3–5. The secondary endpoints were major adverse cardiovascular events, all-cause and cardiovascular mortality, myocardial infarction, stroke, and stent thrombosis.
Five studies were included in our analysis, with a total of 9,115 patients. Our meta-analysis met its primary endpoint, as abbreviated DAPT significantly reduced major bleedings by 43% (95% confidence intervals: 0.35–0.93). Ischemic events and mortality were not affected by the shortening of DAPT.
Shortened DAPT significantly reduced the odds of major bleedings in patients undergoing complex PCI without increasing the ischemic events or mortality. Thus, it could be considered a safe and feasible option in such patients.
Shortened DAPT is associated with significantly reduced major, BARC 3–5 bleedings, without increasing mortality and ischemic complications. Thus, it should be considered a safe and feasible approach in patients undergoing complex PCI. Maintenance is up to 12 months. A, aspirin; BARC, Bleeding Academic Research Consortium; C, clopidogrel; DAPT, dual antiplatelet therapy; PCI, percutaneous coronary interventions; P, prasugrel; S-DAPT, shortened DAPT; T, ticagrelor. Display omitted
The aim of this study was to assess 2-year safety and efficacy of the current-generation thin composite-wire-strut durable-polymer Resolute Onyx zotarolimus-eluting stent (ZES), compared with the ...ultrathin-strut biodegradable-polymer Orsiro sirolimus-eluting stent (SES) in all-comers and a pre-specified small-vessel subgroup analysis.
The Resolute Onyx ZES is widely used in clinical practice, but no follow-up data beyond 1 year have been published. The randomized BIONYX (Bioresorbable Polymer-Coated Orsiro Versus Durable Polymer-Coated Resolute Onyx Stents) trial (NCT02508714) established the noninferiority of ZES versus SES regarding target vessel failure (TVF) rates.
A total of 2,488 all-comer patients were treated at 7 coronary intervention centers in Belgium, Israel, and the Netherlands. The main endpoint, TVF, was a composite of safety (cardiac death or target vessel–related myocardial infarction) and efficacy (clinically indicated target vessel revascularization). Two-year follow-up data were analyzed using Kaplan-Meier methods.
Two-year follow-up data were available for 2,460 of 2,488 patients (98.9%). TVF occurred in 93 of 1,243 patients (7.6%) assigned to ZES versus 87 of 1,245 patients (7.1%) assigned to SES (log-rank p = 0.66). There was no significant between-stent difference in individual components of this endpoint. The incidence of definite-or-probable stent thrombosis was low for both treatment arms (0.4% vs. 1.1%; log-rank p = 0.057). In patients stented in small vessels, there was no between-stent difference (TVF 8.2% vs. 8.7% log-rank p = 0.75, target lesion revascularization 4.0% vs. 4.4% log-rank p = 0.77).
At 2-year follow-up, the novel thin composite-wire-strut durable-polymer Resolute Onyx ZES showed in all-comers similar safety and efficacy compared with the ultrathin cobalt-chromium-strut biodegradable-polymer Orsiro SES. The analysis of patients who were treated in small vessels also suggested no advantage for either stent.
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New-generation drug-eluting stents (DES) represent the current standard of care in patients undergoing percutaneous coronary intervention (PCI). Biodegradable polymer DES (BP-DES) were recently ...developed to overcome current limitations of newer-generation durable polymer DES (DP-DES) attributed to sustained inflammatory responses induced by permanent polymers. The Orsiro DES (Biotronik AG, Bülach, Switzerland) is a novel thin-strut cobalt-chromium sirolimus-eluting stent with biodegradable polymer that features some of the latest developments in DES technology. Areas covered: This article aims to review the currently available evidence on the clinical performance of the Orsiro BP-DES and its future perspectives. Expert commentary: The Orsiro DES is a recent newer-generation BP-DES that combines a highly deliverable thin-strut cobalt-chromium stent platform and a unique hybrid concept with passive and active coatings designed to enhance tissue biocompatibility. In preclinical and intravascular imaging studies, the Orsiro BP-DES was shown to induce low inflammation and promote very early arterial healing. Recently, large randomized non-inferiority clinical trials have shown similar short- and mid-term efficacy and safety outcomes with Orsiro BP-DES compared with currently established newer-generation DES among all-comers and high-risk subgroups. The potential clinical superiority of Orsiro BP-DES over Xience DP-DES in patients with STEMI is currently investigated in the BIOSTEMI trial (NCT02579031).
Left Main Coronary Artery (LMCA) disease is considered a standout manifestation of coronary artery disease (CAD), because it is accompanied by the highest mortality. Increased mortality is expected, ...because LMCA is responsible for supplying up to 80% of total blood flow to the left ventricle in a right-dominant coronary system. Due to the significant progress of biomedical technology, the modern drug-eluting stents have remarkably improved the prognosis of patients with LMCA disease treated invasively. In fact, numerous randomized trials provided similar results in one- and five-year survival of patients treated with percutaneous coronary interventions (PCI) -guided with optimal imaging and coronary artery bypass surgery (CABG). However, interventional treatment requires optimal imaging of the LMCA disease, such as intravascular ultrasound (IVUS) and optical coherence tomography (OCT). The aim of this manuscript is to review the main pathophysiological characteristics, to present the imaging techniques of LMCA, and, last, to discuss the future directions in the depiction of LMCA disease.Left Main Coronary Artery (LMCA) disease is considered a standout manifestation of coronary artery disease (CAD), because it is accompanied by the highest mortality. Increased mortality is expected, because LMCA is responsible for supplying up to 80% of total blood flow to the left ventricle in a right-dominant coronary system. Due to the significant progress of biomedical technology, the modern drug-eluting stents have remarkably improved the prognosis of patients with LMCA disease treated invasively. In fact, numerous randomized trials provided similar results in one- and five-year survival of patients treated with percutaneous coronary interventions (PCI) -guided with optimal imaging and coronary artery bypass surgery (CABG). However, interventional treatment requires optimal imaging of the LMCA disease, such as intravascular ultrasound (IVUS) and optical coherence tomography (OCT). The aim of this manuscript is to review the main pathophysiological characteristics, to present the imaging techniques of LMCA, and, last, to discuss the future directions in the depiction of LMCA disease.
Diabetes is associated with adverse outcomes after percutaneous coronary intervention with drug-eluting stents (DES), but for prediabetes this association has not been definitely established. ...Furthermore, in patients with prediabetes treated with contemporary stents, bleeding data are lacking. We assessed 3-year ischemic and bleeding outcomes following treatment with new-generation DES in patients with prediabetes and diabetes as compared to normoglycemia.
For this post-hoc analysis, we pooled patient-level data of the BIO-RESORT and BIONYX stent trials which both stratified for diabetes at randomization. Both trials were multicenter studies performed in tertiary cardiac centers. Study participants were patients of whom glycemic state was known based on hemoglobin A1c, fasting plasma glucose, or medically treated diabetes. Three-year follow-up was available in 4212/4330 (97.3 %) patients. The main endpoint was target vessel failure, a composite of cardiac death, target vessel myocardial infarction, or target vessel revascularization.
Baseline cardiovascular risk profiles were progressively abnormal in patients with normoglycemia, prediabetes, and diabetes. The main endpoint occurred in 54/489 patients with prediabetes (11.2 %) and 197/1488 with diabetes (13.7 %), as compared to 142/2,353 with normoglycemia (6.1 %) (HR: 1.89, 95 %-CI 1.38-2.58, p < 0.001, and HR: 2.30, 95 %-CI 1.85-2.86, p < 0.001, respectively). In patients with prediabetes, cardiac death and target vessel revascularization rates were significantly higher (HR: 2.81, 95 %-CI 1.49-5.30, p = 0.001, and HR: 1.92, 95 %-CI 1.29-2.87, p = 0.001), and in patients with diabetes all individual components of the main endpoint were significantly higher than in patients with normoglycemia (all p ≤ 0.001). Results were consistent after adjustment for confounders. Major bleeding rates were significantly higher in patients with prediabetes and diabetes, as compared to normoglycemia (3.9 % and 4.1 % vs. 2.3 %; HR:1.73, 95 %-CI 1.03-2.92, p = 0.040, and HR:1.78, 95 %-CI 1.23-2.57, p = 0.002). However, after adjustment for confounders, differences were no longer significant.
Not only patients with diabetes but also patients with prediabetes represent a high-risk population. After treatment with new-generation DES, both patient groups had higher risks of ischemic and bleeding events. Differences in major bleeding were mainly attributable to dissimilarities in baseline characteristics. Routine assessment of glycemic state may help to identify patients with prediabetes for intensified management of cardiovascular risk factors.
BIO-RESORT ClinicalTrials.gov: NCT01674803, registered 29-08-2012; BIONYX ClinicalTrials.gov: NCT02508714, registered 27-7-2015.
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