Four‐year clinical follow‐up of the XIENCE V everolimus‐eluting coronary stent system in the treatment of patients with de novo coronary artery lesions: The SPIRIT II trial

This report describes the 4‐year clinical outcomes of the SPIRIT II study, which randomized 300 patients to treatment with the XIENCE V everolimus‐eluting stent (EES), or the TAXUS paclitaxel‐eluting stent. At 4‐year clinical follow‐up, which was available in 256 (85.3%) patients, treatment with EES lead to a trend for lower rates of ischemia‐driven major adverse cardiovascular events, a composite of cardiac death, myocardial infarction, and ischemia‐driven target lesion revascularization (EES 7.7% vs. paclitaxel‐eluting stent 16.4%, P = 0.056). Treatment with EES also resulted in a trend toward lower rates of cardiac death and numerically lower rates of myocardial infarction, ischemia‐driven target lesion revascularization, and stent thrombosis. Overall, this study reports numerically fewer clinical events in patients treated with EES at 4‐year follow‐up, which is consistent with results from earlier follow‐up. © 2010 Wiley‐Liss, Inc.     

Novel self‐expanding stent system for enhanced provisional bifurcation stenting: Examination by StentBoost and intravascular ultrasound

A 62‐year‐old man underwent percutaneous coronary intervention of a bifurcation lesion (Medina type 010) involving the mid‐left anterior descending coronary artery and an important first diagonal branch with a novel stent specifically designed for bifurcations, the Stentys coronary bifurcation system. This is a self‐expanding nitinol stent, with Z‐shaped struts linked by interconnections that can be disconnected (in prespecified points every 1.5 mm all around the circumference and the length of the stent) at the level of the ostium of the side branch, simply by inflating an angioplasty balloon tracked to the ostium of the side branch, through the stent struts. The steps required for deployment of the stent and the final result obtained were evaluated by intravascular ultrasound examination and StentBoost Subtract, a specific X‐ray stent‐enhancing visualization technique. © 2009 Wiley‐Liss, Inc.     

Analysis of bifurcation lesions treated with novel drug-eluting dedicated bifurcation stent system: intravascular ultrasound results of the AXXESS PLUS trial.

OBJECTIVE: The aim of this intravascular ultrasound (IVUS) study was to assess the efficacy of the AXXESS Plus stent system for the treatment of bifurcation coronary lesions. BACKGROUND: The AXXESS Plus is a novel bifurcation drug-eluting stent, comprised of a self-expanding flare-shaped stent platform and bioabsorbable polymer coating that releases Biolimus A9. METHODS: Data were obtained from the AXXESS PLUS trial, a prospective, multicenter, nonrandomized, single-arm study to evaluate safety and efficacy. Six-month follow-up IVUS analysis was available in 49 cases. Volumetric analysis using Simpson's method within the AXXESS stent, and cross-sectional analysis at the ostium of main branch and/or side branch was performed. Impact of bifurcation angle on stent expansion at the carina was also evaluated. Results: Within the AXXESS stent, neointimal volume obstruction percentage was 2.3% +/- 2.2%, with a minimum lumen area of 7.9 +/- 2.6 mm(2). Lumen area was 5.2 +/- 1.7 mm(2) at main branch ostium, and 4.0 +/- 1.5 mm(2) at side branch ostium. In two cases, incomplete stent apposition was observed at the proximal edge of the AXXESS stent. In one case, a gap between the AXXESS stent and an additional stent was observed. Greater bifurcation angle inversely correlated with smaller stent area at side branch ostium (r = -0.54, P = 0.03) but not at main branch ostium (r = -0.2, P = 0.29). CONCLUSIONS: This novel self-expanding, drug-eluting bifurcation stent demonstrated effective lesion coverage along with significant neointimal suppression equivalent to current generation balloon-expandable drug-eluting stent technology.     

First nine‐month complete invasive assessment (angiography,IVUS, and OCT) of the novel NEVO™ sirolimus‐eluting stent with biodegradable polymer

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. © 2010 Wiley‐Liss, Inc.     

Percutaneous coronary intervention of unprotected left main coronary artery disease

Data have emerged demonstrating the safety and efficacy of percutaneous coronary intervention (PCI) of the unprotected left main (ULM) artery. The 2009 American College of Cardiology/American Heart Association/Society for Cardiovascular Angiography and Interventions focused guidelines for PCI no longer state that ULM PCI is contraindicated in patients with anatomic conditions that are associated with a low risk of procedural complications and clinical conditions that predict an increased risk of adverse surgical outcomes. ULM PCI should be performed by operators with experience in the management of the anatomic complexities of left main and multivessel disease, specifically in issues relating to bifurcation disease, calcification, and hemodynamic support. Patients with ostial or shaft disease have lower risk of restenosis compared with distal bifurcation disease. Drug‐eluting stents (DES) should be used whenever possible as they reduce clinical restenosis. Intravascular ultrasound is an integral component of the procedure as it provides accurate assessment of lesion severity and can confirm optimal stent expansion and apposition. Compliance with dual antiplatelet therapy for at least 12 months is essential if DES are used. A collaborative, multidisciplinary approach with a “Heart Team” represented by a cardiac surgeon, interventional cardiologist, and non‐invasive cardiologist may optimize patient education and objective decision making when obtaining informed consent. Application of clinical and angiographic variables into risk models facilitates appropriate patient selection. Randomized clinical trials will address unanswered issues and help build consensus between cardiology and surgical societies to inform clinical decision making and optimize the outcomes for patients with ULM coronary artery disease. © 2011 Wiley Periodicals, Inc.     

Value of intravascular ultrasound in the management of coronary chronic total occlusions

Failure of guide wire crossing is the commonest reason for failed procedure in chronic total occlusion (CTO) of the coronary arteries. Intravascular ultrasound can be useful in some cases to achieve. Successful guide wire crossing into the distal true lumen of the coronary artery. We describe two cases demonstrating the role of intravascular ultrasound in successful recannalization of the CTO. © 2009 Wiley‐Liss, Inc.     

Efficacy and safety of a double‐coated paclitaxel‐eluting coronary stent: The EUCATAX trial

Objectives : The aim of this study was the comparison of a new double‐coated paclitaxel‐eluting coronary stent with bare‐metal stent (BMS) in patients undergoing percutaneous coronary intervention. Background : Stent coating with biodegradable polymers as a platform for elution of drugs has the potential for complete elution of drugs and for decreasing the risk of late complications. Methods : Multicenter randomized trial comparing a paclitaxel‐eluting stent (PES) coated with a biodegradable polymer and glycocalyx with the equivalent BMS. We randomly assigned 422 patients with de novo coronary lesions to PES (211 patients) or to BMS (211 patients). Primary end point was target vessel failure (TVF) defined as cardiac death, myocardial infarction, and target vessel revascularization. Clinical secondary end points were target vessel revascularization, target lesion revascularization, stent thrombosis (ST), and major adverse cardiovascular events (MACE). Angiographic secondary end points were late loss and binary restenosis. Results : At 1 year of follow‐up, TVF rate was 9.5% in the PES group and 17.1% in the BMS group (P = 0.02), and MACE rate was 10% in PES and 19% in BMS arm (P = 0.009). All other secondary end points were reached but ST. ST rate was low and similar in both study arms. Conclusions : The study shows that patients treated with PES with dual coating technology had significantly lower incidence of TVF and MACE than those treated with BMS design; however, longer follow‐up should be necessary to assess true advantages of this technology compared with the previous one. © 2010 Wiley‐Liss, Inc.     

Safety and efficacy of drug‐eluting balloons in percutaneous treatment of bifurcation lesions the DEBIUT (drug‐eluting balloon in bifurcaton utrecht) registry

Aims: The transradial (TR) approach has potentially lower complication rates than transfemoral (TF) approach coronary angiography. However, it may be technically more challenging, especially in elderly patients with alterations in vascular anatomy. We thus determined success rates, procedural data, and complication rates of TR angiography in comparison to the TF approach in elderly patients in a randomized, prospective trial. Methods and results: Four hundred consecutive patients ≥75 years with known or suspected coronary artery disease were included in the study. After exclusion of 93 patients with contraindications to the radial approach, 152 patients were randomized to the TR and 155 to TF coronary angiography and intervention. In 13 patients randomized to TR, cross‐over to TF was necessary (9%). Total examination time was significantly longer for the TR approach (18.1 vs. 15.0 min, P = 0.009), but no difference was found for fluoroscopy time, number of catheters used, or amount of contrast agent. The rate of major complications (bleeding requiring surgery or transfusion, stroke) was 0% for TR and 3.2% for TF approach (P < 0.001). Minor complications occurred in 1.3% versus 5.8% of patients (P < 0.001). Conclusion: In elderly patients, TR coronary angiography and intervention has a high technical success rate and lower complication rates than the TF approach. © 2008 Wiley‐Liss, Inc.     

Percutaneous left main coronary artery stent for acute myocardial ischemia after repaired ALCAPA

Percutaneous coronary artery stent angioplasty is rare in the pediatric population but can be a life‐saving by rapidly reestablishing flow to an obstructed coronary artery. It is a technically challenging and high‐risk procedure in infants and further limited by the need for future surgical intervention. We report of an infant with anomalous left coronary artery from the pulmonary artery who underwent acutely successful surgical reimplantation of the left coronary artery onto the ascending aorta. One month later, she developed acute myocardial ischemia and emergent catheterization diagnosed near‐total occlusion of the left coronary artery. We implanted a 2.5 mm coronary stent in the left main coronary artery with reestablishment of flow. The patient's left ventricular systolic function recovered within 4 weeks and repeat angiography 3 months later showed complete normalization of the entire left coronary artery system. The patient weighed 3 kg and was < 6 weeks of age at the time of stent implantation which to our knowledge is the smallest and youngest reported patient to undergo coronary stent angioplasty. This case supports the feasibility of this procedure in infants as a temporizing solution to hemodynamic instability from myocardial ischemia due to coronary artery stenosis. The left ventricular systolic function remained normal at 7 months after stent placement and the patient was clinically well from a cardiac perspective. © 2014 Wiley Periodicals, Inc.     

Preoperative coronary artery revascularization and long‐term outcomes following abdominal aortic vascular surgery in patients with abnormal myocardial perfusion scans: A subgroup analysis of the coronary artery revascularization prophylaxis trial

Background: Abdominal aortic operations have the highest perioperative cardiac risk. To test the impact of preoperative coronary artery revascularization (PR) in this high‐risk subset, a post hoc analysis was performed in patients undergoing aortic surgery within the Coronary Artery Revascularization Prophylaxis (CARP) trial. Methods: The study cohort was a subset of 109 CARP patients with myocardial ischemia on nuclear imaging randomized to a strategy of PR (N = 52) or no PR (N = 57) before their scheduled abdominal aortic vascular operation. The clinical indications for vascular surgery were an expanding aneurysm (N = 62) or severe claudication (N = 47). The composite end‐point of death and nonfatal myocardial infarction (MI) was determined by an intention‐to‐treat analysis following randomization. Results: The median time (Interquartiles) from randomization to vascular surgery was 56 (40, 81) days in patients assigned to PR and 19 (10, 43) days in patients assigned to no PR (P < 0.001). At 2.7 years following randomization, the probability of remaining free of death and nonfatal MI was 0.65 with PR and 0.55 with no PR [unadjusted P = 0.08, odds ratio = 1.67, 95% confidence interval (0.93, 2.99)]. Using a Cox proportional hazard model, predictors of the composite of death and nonfatal MI (odds ratio; 95% confidence interval) were no PR (1.90; 1.06–3.43; P = 0.03) and anterior ischemia on preoperative imaging (1.79; 0.99–3.23; P = 0.07). Conclusions: In patients with an abnormal cardiac imaging before abdominal aortic vascular surgery, PR was associated with a reduced risk of death and nonfatal MI while anterior ischemia was an identifier of poor outcome independent of the revascularization status. © 2010 Wiley‐Liss, Inc.     

Three‐year outcome of drug‐eluting stent implantation for coronary artery bifurcation lesions

Objectives: To compare the very long‐term clinical outcomes of bifurcation lesions using the crush and the simultaneous kissing stent (SKS) techniques. Background: A variety of two‐stent techniques have been used to treat coronary artery bifurcation lesions in the drug‐eluting stent era, but the long‐term clinical outcome of these approaches is not known. Methods: A total of 74 consecutive patients underwent bifurcation stenting using either the crush or SKS techniques. Mean patient age was 66.91 ± 11.3 years; 26% were diabetic, and the left anterior descending/diagonal bifurcation was the most frequently treated lesion (68%). Results: In‐hospital outcomes were not significantly different between groups. Over a median follow‐up of 3.3 years, 1 patient in the SKS group and 3 patients in the crush group died (P = ns). Probable stent thrombosis leading to death according to the Academic Research Consortium definition occurred in 1 patient in the crush group. Mortality in the remaining 3 patients was noncardiac. Target lesion revascularization (TLR) occurred in 14 patients (40%) in the SKS group and 5 patients (12.8%) in the crush group (P = 0.015). Survival free from major adverse cardiac events (MACE) was significantly less in the SKS group and predominantly driven by TLR (60 vs. 88%, P = 0.001). Conclusions: In conclusion, over a median of 3.3 years of follow‐up, TLR and MACE are significantly lower in bifurcation lesions treated with the crush technique when compared with the SKS technique. Definite or probable stent thrombosis is rare with either technique. © 2009 Wiley‐Liss, Inc.     

“Over‐and‐under” pericardial covered stent with paclitaxel balloon in a saphenous vein graft

Treatment of vein graft disease remains a challenge in interventional cardiology because of the risk of embolization and no‐reflow phenomenon. Currently available distal protection devices have their limitations. The PTFE‐covered stents may be well suited for venous graft lesion treatment, but those available commercially to date have poor crossing profiles, and deliverability and high rates of restenosis. We report the first use of over‐and‐under pericardium‐covered stent in combination with drug‐eluting balloon to treat venous graft disease. © 2009 Wiley‐Liss, Inc.     

Evaluation of intermediate coronary stenosis with intravascular ultrasound and fractional flow reserve: Its use and abuse

Clinical decision making in patients with intermediate coronary stenosis is still debated. Intravascular ultrasound (IVUS) examination and/or functional assessment of coronary stenosis by fractional flow reserve (FFR) are currently used to define the severity of such lesions. There are very few studies with a small sample size that have a head‐to‐head comparison between IVUS and FFR in the evaluation of angiographically de novo intermediate lesions. There are no randomized, controlled trials to demonstrate the superiority of IVUS versus FFR in providing improved clinical outcomes in comparison with angiography alone. However, the issue of superiority might be irrelevant, because IVUS and FFR could be complementary techniques to be used in the catheterization laboratory to provide critical anatomic and functional data that permit more accurate decisions in the management of the patient. © 2009 Wiley‐Liss, Inc.