Search

Coronary artery disease with left main stenosis is associated with the highest mortality of any coronary lesion. Studies in the 1970s and 1980s comparing coronary artery bypass grafting (CABG) and medical therapy showed a significant survival benefit with revascularization. In the angioplasty era, initial experience with percutaneous intervention was associated with poor clinical outcomes. As a result, percutaneous coronary intervention (PCI) was restricted to patients who were considered inoperable, or those with prior CABG with a functional graft to the left anterior descending or circumflex artery ("protected left main disease"). With the introduction of drug-eluting stents, there are new studies demonstrating comparable survival in patients who were revascularized using PCI and CABG, although percutaneous revascularization is associated with a higher rate of repeat revascularization. In the SYNTAX (Synergy between PCI with Taxus and Cardiac Surgery) trial, the combined incidence of death, myocardial infarction, and stroke was similar between the CABG and PCI groups; however, the stroke rate was higher in the CABG group. The degree and extent of disease as defined by the SYNTAX scoring system has allowed for stratification of risk and improved assignment of patients with left main stenosis to either PCI or CABG.

Aims: The importance of improvement in the ejection fraction to the prognosis of revascularized patients with ischaemic left ventricular (LV) dysfunction is uncertain., Methods and Results: Eighty-seven patients with ischaemic LV dysfunction (mean ejection fraction 29 ± 8% by biplane Simpson's) had dobutamine echocardiography before revascularization (coronary bypass graft surgery-81, percutaneous intervention-6). Follow-up echocardiograms were performed a mean of 4.8 ± 6.2 months after revascularization. An 8% increase in the ejection fraction was considered significant (two times the inter-observer difference of 3.7%). Patients were followed for cardiac death. During a mean follow-up of 5.2 ± 3.9 years, there were 20 (23%) cardiac deaths. Class 3/4 heart failure, increasing low-dose wall motion score, increasing % non-viable myocardium, and digoxin use in follow-up were univariate predictors of death. Beta-blocker use, ejection fraction improvement, angina, aspirin use, and increasing fractional shortening were univariate predictors of survival. Ejection fraction improvement [P= 0.02, hazard ratio (HR) = 0.26], digoxin use in follow-up (P= 0.006, HR = 5.85), and low-dose wall motion score (P= 0.017, HR = 4.78) were independent predictors of outcome. In step-wise analysis, low-dose wall motion score added incremental prognostic value to ejection fraction improvement (P= 0.003), and digoxin use in follow-up (P= 0.003) added incremental value to a low-dose score and ejection fraction improvement., Conclusion: Ejection fraction improvement is an independent predictor of long-term outcome in revascularized patients but viability (low-dose wall motion score) and digoxin use in follow-up are also independent predictors and add incremental prognostic value to ejection fraction improvement.

Aim: We have recently developed a novel method transmyocardial drilling revascularization (TMDR) combined with heparinized bFGF-incorporating degradable tubular stent implantation to revascularize ischemic myocardium. The aim of the present study was to compare the effect of this new method on left ventricular (LV) remodeling and global function to traditional transmyocardial revascularization (TMR) in acute myocardial ischemia., Methods: Eighteen miniswine underwent ligation of the left anterior descending (LAD) at the mid-third and were divided into three groups (N.=6 in each group): no treatment (control), TMDR (T), and TMDR+stent implantation (TS) groups. Two channels with 3.5 mm in diameter were established (T and TS groups), followed by implantation of two stents (TS group). LV function, myocardial perfusion, expression of von Willebrand factor (vWF), transforming growth factor-β3 (TGF-β3), vascular endothelial growth factor (VEGF), interleukin-1beta (IL-1β), vascular density, and histologic and morphologic analyses were evaluated at different time-points., Results: Six weeks post-treatment, there were no differences between T and control groups. TS group showed significant improvement compared to T group as to: expressions of TGF-β3, VEGF, vWF and IL-1β (P<0.001), neovascular density (2.561±391 vs. 6.201±443 pixels/hpf, P<0.001), myocardial viability (18.913±2775 vs. 94.800±14.076 pixels/hpf, P<0.001), and dp/dtmax (1.735±161 vs. 2.242±223 mmHg/s, P<0.001), Further, there were significant decreases in changes of Mass Defect Percent (2.05±0.22% vs. -1.79±0.45%, P<0.001) and LV end diastolic volume (164.83±10.74 vs. 147.00±7.32 mL, P=0.048) in the TS group., Conclusion: TMDR and stent implantation is more effective in enhancement of myocardial viability, improvement of global LV function, and attenuation of LV remodeling than TMDR.

Purpose of Review: Ischemic mitral regurgitation (IMR) is a major source of morbidity and mortality. Although mitral valve repair has become recently popularized for the treatment of IMR, select patients may derive benefits from replacement. The purpose of this review is to describe current surgical options for IMR and to discuss when mitral valve replacement (MVR) may be favored over mitral valve repair., Recent Findings: Current surgical options for the treatment of IMR include surgical revascularization alone, mitral valve repair, or MVR. Although surgical revascularization alone may benefit patients with mild-moderate IMR, most surgeons advocate the performance of revascularization in combination with either mitral valve repair or replacement. In the current era, mitral valve repair has proven to offer improved short-term and long-term survival, decreased valve-related morbidity, and improved left ventricular function compared with MVR. However, MVR should be considered for high-risk patients and those with specific underlying mechanisms of IMR., Summary: In the absence of level one evidence, mitral valve repair offers an effective and durable surgical approach to the treatment of mitral insufficiency and remains the operation of choice for IMR. MVR, however, is preferred for select patients. Future randomized, prospective clinical trials are needed to directly compare these surgical techniques.

Purpose of Review: The aim of this review is to report on current indications and patient selection for hybrid coronary revascularization and to outline current techniques for a hybrid approach., Recent Findings: Hybrid coronary intervention is a revascularization strategy that combines surgical and catheter-based procedures for treatment of multivessel coronary artery disease. Most published studies report on application of this concept in patients with complex lesions of the left anterior descending artery and nonleft anterior descending lesions suited for percutaneous coronary intervention. Currently, the spectrum of surgical procedures in hybrid coronary revascularization ranges from left internal mammary artery bypass grafting via sternotomy and minithoracotomy to completely endoscopic robotic double vessel coronary artery bypass grafting. Percutaneous coronary intervention in hybrid procedures is performed as single or multiple coronary angioplasty with stenting using either bare metal or drug-eluting stents. Staged and simultaneous approaches can be applied. The latter are increasingly performed in the hybrid operating room., Summary: Hybrid coronary intervention is an emerging interdisciplinary approach in the treatment of coronary artery disease and a potential viable alternative to open coronary bypass surgery or multivessel stenting.

The management of patients scheduled for surgery with a coronary stent, and receiving 1 or more antiplatelet drugs, has many controversies. The premature discontinuation of antiplatelet drugs substantially increases the risk of stent thrombosis (ST), myocardial infarction, and cardiac death, and surgery under an altered platelet function could also lead to an increased risk of bleeding in the perioperative period. Because of the conflict in the recommendations, this article reviews the current antiplatelet protocols after positioning a coronary stent, the evidence of increased risk of ST associated with the withdrawal of antiplatelet drugs and increased bleeding risk associated with its maintenance, the different perioperative antiplatelet protocols when patients are scheduled for surgery or need an urgent operation, and the therapeutic options if excessive bleeding occurs.

Introduction: The release of a new bare metal stent (BMS), the Presillion stent, whose main innovative feature is its reduced strut thickness, has created expectations that it may reduce neointimal proliferation and consequently lower the restenosis rate., Objective: To evaluate the efficacy and safety profile of Presillion stent implantation in an unselected population referred for coronary revascularization with BMS., Methods: This was a prospective study of the first 20 consecutive patients undergoing implantation of at least one Presillion stent. We performed a descriptive analysis of the study population in terms of demographics, clinical context, angiographic characteristics of coronary lesions before and after angioplasty, and clinical outcome. After discharge, patients were followed up and assessed clinically at 3 and 6 months for the occurrence of MACE (cardiovascular death, myocardial infarction, stroke or revascularization). The statistical analysis consisted of calculation of means and standard deviation for continuous variables and relative proportions for categorical variables., Results: The study population was predominantly male (65%), with a mean age of 68.8 years. The indication for cardiac catheterization was acute coronary syndrome in 90% and heart failure in 10% of cases. Half the patients had multivessel disease, and 34 stents, of which 26 were Presillion stents, were implanted in 29 coronary lesions. According to the ACC/AHA classification, the coronary lesions treated with Presillion stents were classified as type A in 0% of cases, type B1 in 27% and type B2 or C in 73%; 27% of these had moderate to severe calcification. The percentage of stenosis and minimal luminal diameter (MLD) before and after angioplasty were respectively 88.5 +/- 9.7% (MLD = 0.65 +/- 0.40 mm) and 10.6 +/- 4.3% (MLD = 2.58 +/- 0.36 mm). The success rate of Presillion implantation was 100%, with no significant drop in hemoglobin, additional elevation of cardiac biomarkers or deterioration in renal function after the procedure. No MACE occurred before hospital discharge. At 6-month follow-up all patients were alive, none had had stroke, two patients (10%) had had acute myocardial infarction in territories not dependent on previously treated arteries and two patients had undergone a new revascularization, but not of the target vessel., Conclusion: This initial experience with Presillion stents showed a high efficacy rate and an excellent safety profile that was maintained over 6 months of follow-up. Their effectiveness compared to other BMS should be demonstrated in larger-scale comparative studies.

Percutaneous coronary intervention (PCI) for chronic total occlusions (CTO) remains a major challenge in interventional cardiology. Successful recanalization of a CTO can alleviate angina, reduce the need for coronary artery bypass surgery and increase long-term survival. Improving results from the historically quoted success rates of 50% to the levels now routinely quoted by some operators (80-90%), requires not just skill and experience, but also a thorough understanding of the wide array of materials and techniques now available in this area. The decision to attempt PCI of a CTO (versus continued medical therapy or surgical revascularization) requires an individualized risk/benefit analysis, encompassing clinical, imaging and technical considerations.

Background: We describe the technical details and the preliminary results of a new surgical approach for multivessel disease that involves using a lower T sternotomy, grafting of the left internal mammary artery (LIMA) to the left anterior descending coronary artery (LAD) and use of the right internal mammary artery (RIMA) as inflow to the other vessels., Operative Technique: The sternotomy was made from the xiphoid up to the fourth intercostal space and then was continued transversally (T incision). The LIMA was harvested for a length of approximately 8 cm, with preservation of the distal part. The vein was simultaneously taken from the leg. The RIMA was dissected for a length of approximately 5 cm, and the distal part was occluded. Then, 3 mg/kg heparin was given. The anastomosis between the vein and the RIMA was performed. The distal venous anastomoses were done either singly or sequentially. The anterior or posterior route was chosen according to the patient's anatomy. The LIMA was then anastomosed to the LAD. One drain was placed. The sternum was closed with 4 wires, 2 for the T incision and 2 for the sternum., Results: Between September and December 2008, 9 patients underwent their operations with this technique. The mean age was 60 years (range, 55-68 years). The mean number of grafts was 2.8. The mean hospital stay was 5.2 days. Operative mortality was 0%. All patients were reevaluated with 16-slice multislice computed tomography, and all grafts were patent. At the 3-month follow-up, all patients were alive and free of symptoms., Conclusion: This minimally invasive technique is a useful alternative for complete revascularization. The sternal mammary supply and the upper part of the sternum are preserved.

Aims: The 12-month results of RESOLUTE were favourable for the new Resolute stent. Two-year safety and efficacy results from RESOLUTE have been evaluated and are now reported., Methods and Results: RESOLUTE was a prospective, multicentre, non-randomised, single-arm, controlled trial of the Resolute stent in 139 participants with symptomatic ischaemic heart disease due to single de novo lesions in a native coronary artery. The 2-year rates of MACE (all-cause death, myocardial infarction, emergent cardiac bypass surgery, and target lesion revascularisation [TLR]), death, late stent thrombosis, target vessel revascularisation (TVR), and target vessel failure (TVF) were assessed. Clinical events included two MACE (one TLR; one non-cardiac death) occurring between year one and two resulting in cumulative 2-year TLR, TVR, and TVF rates of 1.4%, 1.4%, and 7.9%, respectively. One possible stent thrombosis event occurred in the first year after stent implantation however no late or very late ARC-defined definite and probable stent thromboses occurred through two years., Conclusions: The 2-year data from RESOLUTE demonstrated no safety concerns including no late stent thrombosis or loss of effectiveness with the Resolute stent. The finding that few events occurred in year two is encouraging, yet requires verification in a larger population.

The interventional treatment of ischemia is a complex issue grounded on an understanding of basic pathophysiology, but translated and implemented in practice by extensive clinical trial data representing patients with a spectrum of ischemia-causing clinical syndromes and anatomical variations of coronary artery disease (CAD). Percutaneous coronary intervention (PCI) has evolved to treat ischemia within this matrix of clinical and anatomical subsets using a wide array of techniques. Initial techniques using balloon angioplasty were promising, but demonstrated significant rates of restenosis due to negative arterial remodeling. The advent of stent technology prevented arterial recoil and provided a viable treatment for flow-limiting coronary dissections, thereby facilitating improved long-term patency of coronary vessels without the need for repeat revascularization. In-stent restenosis has been successfully addressed with drug elution, but late stent thrombosis has emerged as a complex issue involving dual antiplatelet therapy, patient compliance, and reexamination of the delicate balance between reducing restenosis and promoting endothelial proliferation. Finally, complex coronary lesions associated with heavy calcification or extensive plaque/thrombus burden that introduce unique challenges in obtaining ideal angiographic results have led to the development of new debulking devices aimed at optimizing procedural outcomes. This review will describe a variety of percutaneous coronary interventional techniques and technologies that are employed in the invasive treatment of ischemia under the guidance of clinical guidelines and evidence-based medicine.

Objective: To assess the impact of diabetes on 2-year mortality in current PCI practice., Background: In patients with coronary artery disease undergoing revascularization, diabetes mellitus is associated with higher mortality., Methods: A retrospective analysis was done of all patients undergoing PCI at our tertiary center between January 2000 and December 2004. There were 6,160 PCI procedures performed in 5,759 patients who received at least one stent. Of these patients, 801 (13.9%) were diabetic and 4,958 (86.1%) were nondiabetic. The primary outcome measure of the study was all-cause mortality. All patients were followed up for a period of 2 years. Multivariate logistic regression analysis was used to test for a potential independent association between diabetic status and follow-up mortality., Results: Before adjustment, a trend toward higher mortality was observed in diabetic patients compared to non-diabetics at 1 year (3.2% vs 2.4%) and 2 years (5.1% vs 3.8%), P = 0.12. Independent predictors for mortality were increasing age, renal dysfunction, peripheral vascular disease, NYHA class >2, urgent PCI, treating left main stem lesions, vessel diameter < or = 2.5 mm, and 3-vessel disease. The use of drug-eluting stent was associated with a reduction in mortality. Diabetes was found to have no independent impact on mortality following PCI (odds ratio = 1.08; 95% confidence intervals = 0.73-1.60; P = 0.71)., Conclusion: The presence of diabetes was not an independent predictor of mortality following PCI. A diabetic patient that does not require insulin treatment and has no evidence of macro- or microvascular diabetic disease could enjoy a PCI outcome similar to nondiabetic subjects.

Background: Although insertion of multiple stents into a single coronary vessel during single-vessel percutaneous coronary intervention (PCI) is common, there are no data on long-term occurrence of major adverse cardiac events (MACE) in patients treated with multiple stents versus a single stent., Methods: The incidence of MACE (death, myocardial infarction, or target vessel revascularization) during long-term follow-up was investigated in 634 patients who underwent single-vessel PCI. Of the 634 patients, 319 (50%) had a single stent, and 315 (50%) had multiple stents inserted. Stepwise Cox regression analyses were performed to identify significant independent prognostic factors for MACE., Results: At 47-month follow-up, MACE occurred in 61 of 319 patients (19%) who had a single stent versus in 57 of 315 patients (18%) who had multiple stents (P not significant). Significant independent predictors of MACE were use of vein grafts (hazard ratio = 1.94; 95% CI, 1.24-3.03; P = 0.0038) and use of drug-eluting stents (hazard ratio = 0.49; 95% CI, 0.34-0.72; P = 0.0002)., Conclusions: At long-term follow-up of single-vessel PCI, the incidence of MACE was similar in patients with multiple or single stents inserted even after controlling for the length of stents.

Objectives: To evaluate the safety and feasibility of myocardial cryotreatment for patients with coronary artery disease (CAD) and severe angina refractory to standard treatment., Background: Innovative myocardial revascularization strategies are needed for patients with CAD and severe angina uncontrolled by conventional methods. Preclinical data have demonstrated that cryotherapy can induce myocardial neovascularization through arteriogenesis., Methods: This was a two center, nonrandomized, study that enrolled 20 patients. All patients had CAD and severe angina (CCS Angina Class III or IV). Safety was the primary endpoint. Treatment involved 8-10 intramyocardial cryoapplications (at < or = -50 degrees C), for 2 min by a specially designed percutaneous catheter at an identified ischemic area of the myocardium. Primary endpoint was safety, with secondary endpoints of angina severity, exercise tolerance, quality of life, and myocardial perfusion assessed by radionuclide scintigraphy., Results: The procedure was successful in 19 patients. There were three device-related events, a pericardial tamponade requiring pericardiocenetesis, a clinically nonsignificant pericardial effusion, and an episode of ventricular tachycardia requiring cardioversion in one patient. Complete 12-month follow-up was obtained in 16 patients. Significant reduction in CCS angina scores and significant improvements in both exercise tolerance and quality of life (P < 0.05) were seen at 6 and 12-month follow-up. Although no significant differences were observed in myocardial perfusion in the overall group, marked improvement was detected in 8 (42%) patients., Conclusion: Cryotreatment is feasible and safe in patients with severe angina refractory to standard management. Early efficacy results are encouraging and further clinical study is warranted., (2009 Wiley-Liss, Inc.)

Background: The everolimus-eluting stent (EES) is a newly developed drug-eluting stent using the MULTILINK VISION stent platform combined with the drug everolimus contained in a polymer coating. Recently reported randomized trials have shown the noninferiority and subsequent superiority of the EES compared with the paclitaxel-eluting stent regarding in-stent late loss (LL) at 180 days. However, there have been no studies comparing head to head the EES with the sirolimus-eluting stent (SES), which has shown the least amount of LL among the previously released drug-eluting stent (DES). In addition, adjunctive antiplatelet therapy is a critical factor in optimizing long-term DES safety. Despite the recommendation of the American Heart Association/American College of Cardiology to maintain 12 months of dual antiplatelet therapy, there have been no prospective randomized trials comparing the efficacy and safety of different durations., Study Design: In the Efficacy of Xience/promus versus Cypher in rEducing Late Loss after stENTing (EXCELLENT) trial, approximately 1,400 patients are being prospectively and randomly assigned in a 2 x 2 factorial design according to the type of stent (EES vs SES) and the duration of dual antiplatelet therapy (6 vs 12 months). The primary end point is in-segment LL at 9 months for comparison of type of stent, and the coprimary end point is target vessel failure at 12 months for comparison of dual antiplatelet therapy duration., Summary: The EXCELLENT trial is the largest study yet performed to directly compare the efficacy and safety of the EES versus the SES. In addition, this study will also address the issue of a 6- versus 12-month duration of dual antiplatelet therapy for post-percutaneous coronary intervention management.

Objectives: We investigated the hypothesis that biological aspirin "resistance" may often be related to noncompliance in patients undergoing coronary stenting., Background: Premature discontinuation of antiplatelet therapy has been identified as a major risk factor for stent thrombosis and prior aspirin withdrawal has been associated with poor prognosis after acute coronary syndrome., Methods: We prospectively investigated the occurrence of aspirin noncompliance in 136 consecutive patients undergoing coronary stenting receiving aspirin 75 mg daily. We analyzed posttreatment maximal intensity of arachidonic acid-induced platelet aggregation (AA-Ag) during hospitalization after controlled intake of aspirin and 1 month after hospital discharge. After 1 month, all "nonresponders" received controlled aspirin 75 mg and assessment of response was repeated. Aspirin nonresponse was defined by AA-Ag >30%., Results: During inhospital period, the range of AA-Ag varied from 0% to 34% with a mean value of 7.5% +/- 10%, and 4 patients (3%) were classified as nonresponders. One month after discharge, AA-Ag of the population was significantly higher than during the hospital phase (15.3 +/- 23 vs 7.5 +/- 10%, P = .0004), and 19 patients (14%) were identified as nonresponders. After controlled administration of aspirin, all but one of these nonresponders became responders and were identified as patients with noncompliance rather than biological resistance., Conclusion: Aspirin resistance is rare in compliant patients using methods that directly indicate the degree of platelet cyclooxygenase inhibition. More than 10% of patients receiving aspirin for coronary stenting are noncompliant for aspirin therapy during the first month after stenting. These results suggest a need for improved education of these patients.

Background: The long-term incidence of stent thrombosis (ST) and complications after sirolimus-eluting stents (SES) implantation is still a matter of debate., Method: We conducted a systematic follow-up on the day of their 5-year SES implantation anniversary, in a series of consecutive real-world patients treated with a SES. The use of SES implantation was not restricted to "on-label" indications, and target lesions included in-stent restenosis, vein graft, left main stem locations, bifurcations, and long lesions. The Academic Research Consortium criteria were used for ST classification., Results: Three hundred fifty consecutive patients were treated with SES between April and December 2002 in 3 Swiss hospitals. Mean age was 63 +/- 6 years, 78% were men, 20% presented with acute coronary syndrome, and 19% were patients with diabetes. Five-year follow-up was obtained in 98% of eligible patients. Stent thrombosis had occurred in 12 patients (3.6%) [definite 6 (1.8%), probable 1 (0.3%) and possible 5 (1.5%)]. Eighty-one percent of the population was free of complications. Major adverse cardiac events occurred in 74 (21%) patients and were as follows: cardiac death 3%, noncardiac death 4%, myocardial infarction 2%, target lesion revascularization 8%, non-target lesion revascularization target vessel revascularization 3%, coronary artery bypass graft 2%. Non-TVR was performed in 8%., Conclusion: Our data confirm the good long-term outcome of patients treated with SES. The incidence of complications and sub acute thrombosis at 5 years in routine clinical practice reproduces the results of prospective randomized trials.

Background: The optimal duration of clopidogrel use for prevention of stent thrombosis with drug-eluting stent (DES) use is uncertain. Our objective was to determine whether the planned duration of clopidogrel at the time of percutaneous coronary intervention affected patient outcomes., Methods: We analyzed data from 2,980 patients who underwent percutaneous coronary intervention in the Melbourne Interventional Group registry who had 12-month follow-up. We compared outcomes at 30 days and 12 months according to planned duration of clopidogrel use., Results: Twelve-month mortality was significantly lower in patients with a DES with a longer (>or=12 months) planned duration of clopidogrel when compared with a shorter (or=12 months (log rank P = .017), and the propensity score-adjusted odds ratio was 0.59 (95% confidence interval 0.35-0.99, P = .04). Premature cessation of clopidogrel in DES patients was documented in 5.2% of patients alive at 30-day follow-up, and these patients had increased 12-month mortality (10.6% vs 1.4%, P < .0001) and major adverse cardiac events (22.4% vs 12.0%, P = .005)., Conclusions: These data suggest that in patients treated with DES, longer (>or=12 months) planned duration of clopidogrel results in reduced 12-month mortality and that premature cessation of clopidogrel results in significantly higher event rates. Randomized studies are urgently needed to address this issue.

Background: Single nucleotide polymorphisms of vitamin K epoxide reductase complex subunit 1 (VKORC1) was reported to have association with arterial vascular disease. We investigated whether single nucleotide polymorphism of VKORC1 +2255 is associated with clinical outcomes among patients who underwent drug-eluting stent (DES) implantation., Methods: We prospectively collected genomic DNA in patients who underwent DES deployment from September 2003 to December 2006 and compared clinical outcomes according to their VKORC1 genotype at the locus + 2255 (rs 2359612). The primary end point was composite of atherothrombotic events (cardiac death, myocardial infarction, and nonhemorrhagic stroke)., Results: Mean follow-up duration was 631 +/- 251 days. Genotyping was completed in 764 cases (TT genotype [n = 640, 83.8%] vs non-TT [CC or CT] genotype [n = 124, 16.2%]). Non-TT group showed more composite events than TT group (7.3% vs 3.0%, P = .032). In the Cox regression analysis, non-TT genotype of VKORC gene was a significant predictor of atherothrombotic events (hazard ratio 2.56, 95% confidence interval 1.14-5.78). In the event-free survival analysis, non-TT group also showed significantly poorer cardiovascular events-free survival rate than TT group (P = .02)., Conclusions: VKORC1 genotype is associated with cardiovascular events in patients with DES implantation, suggesting the role of coagulation system.

Background: Concern regarding the rate of delayed acute stent thrombosis associated with drug-eluting stent (DES) treatment has resulted in upward revision of the advised duration of dual antiplatelet therapy after DES implantation by both European and United States guideline writing committees. In fact, the corroboration of an increased rate of late thrombotic events remains outstanding, and these clinical practice guidelines are limited by an inadequate evidence base on which to ground their recommendations., Hypothesis: We postulate that a 6-month duration of clopidogrel therapy after DES implantation is associated with a clinical outcome that is not inferior to that of a 12-month therapy., Study Design: The Intracoronary Stenting and Antithrombotic Regimen: Safety And EFficacy of Six Months Dual Antiplatelet Therapy After Drug-Eluting Stenting (ISAR-SAFE) is a multinational, double-blind, placebo-controlled, randomized trial designed to examine the effects of a 6-month duration of clopidogrel therapy after DES implantation compared to that of 12 months. Patients on clopidogrel therapy at 6 months after DES implantation will be randomized in a 1:1 fashion to discontinuation of clopidogrel versus a further 6 months of treatment. The primary end point is a composite of death, myocardial infarction, stent thrombosis, stroke, or thrombolysis in myocardial infarction major bleeding. Clinical follow-up is scheduled at 9 months postrandomization (15 months postintervention). According to power calculations based on a noninferiority design, it is estimated that 6,000 patients are required to be enrolled., Summary: There is clinical equipoise on the issue of optimal duration of dual antiplatelet treatment after percutaneous intervention with DES. The ISAR-SAFE trial aims to assess whether discontinuation of clopidogrel 6 months after DES implantation is noninferior to routine prolongation of such therapy out to 1 year.

We compared 1-year outcomes in patients treated with paclitaxel-eluting stents (PESs) or sirolimus-eluting stents (SESs) in "real-world" clinical practice. Clinical outcomes were evaluated in 1,558 consecutive, unselected, retrospectively collected patients treated with drug-eluting stents (DESs; PES = 816, SES = 742) at 19 United States centers. The primary end point was 1-year target vessel revascularization (TVR). The study included a prespecified diabetic cohort (PES = 289, SES = 247), for which efficacy comparisons between DESs were analyzed according to vessel diameter and presence of chronic kidney disease. Baseline demographic, angiographic, and procedural characteristics were similar between patients treated with PESs and those treated with SESs. At 1 year, there were no overall statistical differences in death, myocardial infarction, TVR, or stent thrombosis. In the diabetic cohort, however, the cumulative incidence of TVR was significantly lower for patients treated with PESs (3%) compared with SESs (9%, p <0.01), which persisted after adjustment for baseline differences (hazard ratio 0.29, 95% confidence interval 0.12 to 0.67). This decrease in TVR with PES was similar in insulin- and noninsulin-requiring diabetic patients. In multivariate analysis, independent predictors of TVR included diabetes, bifurcation stenting, and overlapping stents; in the diabetic cohort, treatment with SESs was also a multivariate predictor of TVR. In conclusion, in this observational, retrospective analysis of DES-treated patients, PESs and SESs demonstrated similar overall safety and efficacy, but PESs were associated with a significant decrease in 1-year TVR rates in diabetic patients.

(1) Angioplasty is one method of unblocking a stenosed coronary artery. A metal stent is sometimes placed in the vessel lumen. Drug-eluting stents coated with an immunosuppressant or cytotoxic drug have been developed with the objective of reducing the risk of recurrent stenosis; (2) We examined the available literature on the efficacy and adverse effects of drug-eluting stents, based on the standard Prescrire methodology; (3) We found a plethora of clinical trials of drug-eluting stents, and numerous meta-analyses, reflecting the broad economic implications of the market for these devices. Yet drug-eluting stents appear to be no more effective than bare metal stents in reducing overall morality, cardiac mortality, the risk of myocardial infarction, or stent thrombosis. Few follow-up data are available beyond 4 years; (4) Revascularisation of the treated coronary artery was about half as frequent with drug-eluting stents as with bare metal stents. However, the apparent advantage is difficult to quantify because in some trials the decision to re-operate was based solely on angiographic criteria, leading to more frequent revascularization. Sirolimus-eluting stents appear to be slightly more effective than paclitaxel-eluting stents in terms of the revascularisation rate; (5) In contrast, late thrombosis (more than a year after stent placement) seems to be more frequent with drug-eluting stents than with bare metal stents. This risk can be reduced by long-term antiplatelet treatment (with clopidogrel plus aspirin), but the benefit is offset by the accompanying increased risk of severe haemorrhagic events. Serious allergic reactions have also been reported; (6) In most cases, especially when the risk of restenosis is low or moderate, it is better to use a bare metal stent. Coronary artery bypass grafting should be considered when there is a high risk of restenosis. Drug-eluting stents are just one alternative to surgery.

Background: Kidney failure (stage 5 chronic kidney disease [CKD]) is an independent risk factor for stent thrombosis (ST). Moderate (stage 3-4) CKD and proteinuria are both associated with adverse cardiovascular events, including worse outcomes after myocardial infarction (MI). Whether moderate CKD and proteinuria increase the risk of ST after MI is not known. This study evaluated the risk of ST associated with moderate CKD and dipstick proteinuria., Methods: We retrospectively analyzed clinical and laboratory data from 956 non-stage 5 CKD patients who were admitted with MI and received intracoronary stenting. Clinical follow-up was collected at 1 year for definite or probable ST, as well as for all-cause mortality, nonfatal MI or death, and target vessel revascularization or coronary artery bypass graft surgery., Results: After adjustment for multiple clinical and biochemical covariates, patients with both estimated glomerular filtration rate (GFR) of 15 to 59 mL min(-1) 1.73 m(-2) and > or =30 mg/dL dipstick proteinuria had increased cumulative incidence of ST (hazard rate [HR] 3.69, 95% CI 1.54-8.89), all-cause mortality (HR 2.68, 95% CI 1.34-5.37), and nonfatal MI or death (HR 3.20, 95% CI 1.77-5.81) at 1 year. In addition, estimated GFR of 15 to 59 mL min(-1) 1.73 m(-2) was a significant independent predictor of ST (HR 2.61, 95% CI 1.33-5.10). Dipstick proteinuria > or =30 mg/dL was associated with a trend toward increased risk for all outcomes., Conclusions: In an acute MI population, moderate CKD was identified as a novel prognostic marker for ST. In addition, patients with both decreased GFR and proteinuria had higher incidences of all-cause mortality and nonfatal MI or death than patients with either condition alone.

Intracoronary shunts (IS) are devices for maintaining distal coronary blood flow when placing anastomoses with coronary arteries. The use of IS ensures functional and electrical stability of myocardium during its revascularization on the working heart. There are reports of endothelial damage by IS leading to dysfunction of coronary shunts. This study compares 208 patients with and without IS. Results of surgery were evaluated during hospitalization period. The groups were matched for initial clinical and instrumental characteristics and the number of shunt placements. It was shown that minimally invasive myocardial revascularization with the use of IS when placing distal anastomoses has a number of advantages over similar surgery without IS, viz. smaller degree of intraoperative myocardial lesion, blood loss, and frequency of postoperative complications along with enhanced stability of intraoperative hemodynamics.

Objective: To prepare a biodegradable drug-eluting stent in myocardium channel and evaluate its effect on myocardium channel after transmyocardial revascularization (TMR)., Methods: A biodegradable drug-eluting stent was prepared using poly (epsilon-caprolactone) (PCL), bovine serum albumin (BSA), and poly (D, L-lactide-co-glycolide) (PLGA) as material of stent, model protein drug, and drug carrier respectively. The amount of BSA in stent and in vitro released BSA of stent were determined by the Coomassie brilliant blue assay. The mechanical strength of stent was tested by universal material testing machines. The material and structure of stent was characterized by nuclear magnetic resonance spectroscopy. The effect of stent on myocardium channel after TMR was evaluated in vivo by a standard animal model of chronic myocardial ischemia in miniswine., Results: The stent could carry 13.1 microg BSA per mg of stent and the stent could release about 95% of BSA after 30 days. The stent diminished 80% of initial scale under the stress of 1.7 Mpa. It also kept the myocardium channel patency after TMR., Conclusions: A biodegradable drug-eluting stent in myocardium channel was successfully prepared. It can sustain the pressure from the heart and achieve the controlled release of drug. The stent can ensure the myocardium channel patency after TMR.

Owing to the high prevalence of atherosclerotic coronary artery disease, treatment has proceeded along three separate paths: medical, surgical, and percutaneous intervention. Medical treatment is now routinely combined with both surgical treatment and percutaneous methods; however, the surgical and percutaneous routes are often viewed as in competition. Hybrid coronary revascularization, also called robotic assisted integrated coronary revascularization (RAICER), is a way of combining these two approaches. Whether any hybrid procedure will prove beneficial to patients remains unproven; however, RAICER has promise for reducing short-term complications while providing excellent and enduring treatment for coronary artery disease. Much work remains to be done on the benefits of hybrid revascularization in comparison with conventional bypass surgery or percutaneous coronary procedures.

The therapy of infarct related cardiogenic shock should primarily focus on fastest possible revascularization. In addition, rapid restoration of sufficient organ perfusion pressure is recommended for the prevention of a multi-organ dysfunction syndrome (MODS). This can be achieved by mechanical circulatory assist devices as well as individual catecholamine therapy. Since assist devices require specially trained physicians, their use is limited to specialized cardiac care centers. However, future technologies such as portable heart-lung-machines may help to further improve transfer to specialized centers and therapy of shock patients.

Drug-eluting stent failures were associated with various clinical factors. However, the clinical impact of stent deployment technique was unknown. This study was designed to evaluate the frequency and impact of suboptimal percutaneous coronary intervention on long-term outcomes of 1,557 patients treated with sirolimus-eluting stents (SESs) in 41 US hospitals. All steps of the interventional procedure were scrutinized by an independent core laboratory to determine the occurrence of geographic miss (GM). GM included longitudinal (LGM; injured or diseased segment not covered by SES) or axial GM (balloon-artery size ratio <0.9 or >1.3) mismatches. Patients with and without GM were stratified (GM vs no-GM group). Patients, investigators, and the independent clinical event adjudication committee were blind to study group assignments. The primary end point was 1-year target-vessel revascularization (TVR) rate. Incidences and predictors of GM and safety outcomes were secondary end points. GM occurred in 943 patients (66.5%): 47.6% had LGM, 35.2% had axial GM, and 16.5% had both. One-year TVR rates were 5.1% in the GM group versus 2.5% in the no-GM group (p=0.025). TVR was 6.1% in the LGM versus 2.6% in the no-LGM subgroups (p=0.001). The association of GM with 1-year TVR was independent of clinical or anatomic factors (hazard ratio 2.0, 95% confidence interval 1.0 to 4.02, p=0.05). There was a 3-fold increase in myocardial infarction rates associated with GM (2.4% vs 0.8%; p=0.04). In conclusion, GM occurred frequently during SES implantation and was associated with increased risk of TVR and myocardial infarction at 1 year. These results emphasized the need for improvement in contemporary percutaneous coronary intervention practices and technologies.

Recent reports suggest that drug-eluting stents (DESs) may increase the risk of stent thrombosis (ST) relative to bare-metal stents (BMSs). Therefore, the aim of this study was to compare DES and BMS outcomes with a specific focus on ST. We analyzed 30-day and 1-year outcomes of 2,919 patients who underwent percutaneous coronary intervention with stent implantation from the Melbourne Interventional Group registry. Academic Research Consortium definitions of ST were used: (1) definite ST (confirmed using angiography in patients with an acute coronary syndrome), (2) probable ST (unexplained death <30 days or target-vessel myocardial infarction without angiographic confirmation), and (3) possible ST (unexplained death >30 days). Multivariate analysis was performed to identify predictors of ST. The incidence of ST (early or late) was similar between BMSs and DESs (1.6% vs 1.4%; p=0.66), and DES use was not predictive of ST. Independent predictors of ST included the absence of clopidogrel therapy at 30 days (odds ratio [OR] 2.58, 95% confidence interval [CI] 1.29 to 5.29, p<0.01), renal failure (OR 3.30, 95% CI 1.43 to 7.59, p<0.01), index procedure presentation with an acute coronary syndrome (OR 2.59, 95% CI 1.14 to 5.87, p=0.02), diabetes mellitus (OR 2.25, 95% CI 1.19 to 4.23, p=0.01), and total stent length >or=20 mm (OR 1.85, 95% CI 1.00 to 3.42, p=0.04). In conclusion, DESs were not associated with increased risk of ST compared with BMSs at 12 months in this large Australian registry that selectively used DESs for patients at high risk of restenosis.

Retrograde recanalization of a mid-left anterior descending chronic total occlusion via an ipsilateral intraseptal collateral vessel was successfully completed in two cases where the antegrade approach was infeasible or failed in a previous attempt.

Few studies directly compared drug-eluting stents and bare-metal stents (BMSs) in diabetic patients. DESSERT was an Italian multicenter randomized trial to show the efficacy of sirolimus-eluting stents (SESs) compared with BMSs in de novo lesions of diabetic patients treated with insulin and/or oral antidiabetics for > or =3 months on top of glycoprotein IIb/IIIa inhibitors. The primary end point was in-stent late lumen loss, assessed using centralized quantitative coronary angiography at 8-month follow-up. Centrally adjudicated composite major adverse cardiac events (MACEs) and target-vessel failure (TVF; death, treated vessel-related acute myocardial infarction, and target-vessel revascularization) at 30 days and 9 and 12 months were secondary end points. Seventy-five patients were randomly assigned to an SES (109 lesions), and 75 (109 lesions), to a BMS. The 2 groups were well balanced for clinical, anatomic, and procedural characteristics. In-stent late lumen loss decreased from 0.96 +/- 0.61 mm for BMSs to 0.14 +/- 0.33 for SESs (p <0.001), and in-segment binary restenosis was 38.8% versus 3.6%, respectively (p <0.001). Twelve-month clinical events were significantly lower in the sirolimus group: MACEs 22.1% versus 40% (p = 0.023), target-lesion revascularization 5.9% versus 30% (p <0.001), and TVF 14.7% versus 34.3% (p = 0.008). At multivariate analysis, stent type was confirmed as an independent predictor of in-segment late loss (p <0.001), binary restenosis (p <0.001), 12-month TVF (p = 0.010), and 12-month MACEs (p = 0.037). In conclusion, the randomized DESSERT showed SESs to be safe and effective in decreasing both angiographic parameters of restenosis and incidence of MACEs compared with BMSs in diabetic patients with de novo 1- or 2-vessel coronary stenoses.

The differential safety and efficacy profiles of sirolimus-eluting stents when implanted in patients with multivessel coronary artery disease who have increased body mass indexes (BMIs) compared with those with normal BMIs are largely unknown. This study evaluated the impact of BMI on 1-year outcomes in patients with multivessel coronary artery disease treated with sirolimus-eluting stents as part of the Arterial Revascularization Therapies Study Part II (ARTS II). From February to November 2003, 607 patients were included at 45 centers; 176 patients had normal BMIs (<25 kg/m(2)), 289 were overweight (> or =25 and < or =30 kg/m(2)), and 142 were obese (>30 kg/m(2)). At 30 days, the cumulative incidence of the primary combined end point of death, myocardial infarction, cerebrovascular accident, and repeat revascularization (major adverse cardiac and cerebrovascular events) was 3.4% in the group with normal BMIs, 3.1% in overweight patients, and 2.8% in obese patients (p = 0.76). At 1 year, the cumulative incidence of major adverse cardiac and cerebrovascular events was 10.8%, 11.8%, and 7.0% in the normal BMI, overweight, and obese groups, respectively (p = 0.31). In conclusion, BMI had no impact on 1-year clinical outcomes in patients with multivessel coronary artery disease treated with sirolimus-eluting stents in ARTS II.

To determine whether 64-slice multidetector computed tomographic coronary angiography (MDCTA) can accurately assess the coronary artery lumen in symptomatic patients with previous coronary artery stents and potential in-stent restenosis (ISR). The primary aim was to determine the accuracy of binary ISR exclusion using MDCTA compared with invasive catheter angiography (ICA). Secondary aims were comparisons of stent dimensions measured using MDCTA and variables that affect accuracy. Forty patients with previous stent placement underwent both ICA and 64-slice MDCTA after elective presentation with chest pain, and ICA quantitative coronary angiographic data were used as the reference standard. Thirty-six men and 4 women (age 64 +/- 10 years; range 44 to 83) with 103 stents (2.8 +/- 1.6 stents/patient) were comparatively evaluated (stent exclusion rate 9.6%). There were 45 bare-metal and 58 drug-eluting stents (20 +/- 18 months after implantation) with an average diameter of 3.23 +/- 0.7 mm. Overall accuracy for the detection of significant ISR showed sensitivity, specificity, and positive and negative predictive values of 85%, 86%, 61%, and 96% for proximal stents > or =3 mm, which improved to 100%, 94%, 81%, and 100%; if the visible luminal diameter on MDCTA was <1.5 mm, accuracy decreased to 40%, 84%, 29%, and 90%, respectively. In conclusion, 64-slice MDCTA assessment of symptomatic patients with suspected clinically significant ISR is a realistic alternative to ICA if reference stent diameter is > or =2.5 mm and visible lumen cross-sectional diameter is > or =1.5 mm, for which a negative MDCTA result virtually excludes the presence of significant ISR.

Drug-eluting stents (DES), which locally elute antiproliferative drugs, can dramatically inhibit neointimal growth. However, several pathological studies have indicated that DES may delay healing after vascular injury, and DES implantation may be theoretically associated with a risk of coronary artery aneurysm formation. Coronary aneurysms have been reported from 3 days to up to 4 years after DES implantation procedures, with varying clinical presentations. The incidence of coronary artery aneurysms after DES implantation is low within the first 9 months, with a reported incidence of 0.2% to 2.3%, a rate similar to that reported after bare-metal stent (BMS) implantation (0.3% to 3.9%) in the DES versus BMS randomized trials. However, the true incidence of coronary aneurysms in an unselected patient population is still largely unknown. This article reviews the published literature on coronary artery aneurysms specifically relating to DES.

The recent SCORES trial demonstrated that lower dilatation pressures seen with self-expanding (SE) stents may be associated with lower rates of target lesion revascularization (TLR). To determine whether SE stents with low-pressure dilatation are as safe and effective as balloon expandable (BE) stents. We randomly assigned 254 patients with 279 coronary lesions to groups receiving either SE with low-pressure dilatation <12 atm (n = 143) or conventional BE stents (n = 136). Thereafter, acute results and long-term outcomes were compared. Baseline patient and angiographic characteristics were similar in two groups. The incidence of procedural complications, such as slow flow, side branch occlusion, and edge dissection were significantly lower in the SE group than in the BE group (overall: SE, 17; BE, 35; P < 0.01), and the occurrence of myocardial infarction tended to be lower in SE than in BE (SE, 1; BE, 4; not significant). Although acute gain was significantly smaller with SE than BE (SE, 2.21 +/- 0.65 mm; BE, 2.42 +/- 0.62; P < 0.01), probably due to gradual expansion of the SE stent, nearly identical minimum luminal diameters on follow-up angiography (SE, 2.14 +/- 0.92 mm vs. BE, 2.22 +/- 0.93; not significant) and similar angiographic restenosis (SE, 18.1% vs. BE, 20.5%). and TLR rates (SE, 16.1% vs. BE, 14.0%) were apparent. This prospective randomized trial demonstrates that SE stents with low-pressure dilatation is safe and effective strategy for treating coronary arterial stenosis.

Aims: Recent studies suggested that abciximab reduces the risk of restenosis in diabetic patients receiving coronary bare metal stent. We sought to evaluate whether abciximab may reduce in-segment late luminal loss (LLL), in patients with diabetes mellitus undergoing elective drug-eluting stents (PES) implantation., Methods and Results: We conducted a prospective, randomized, double-blind study on diabetic patients after a paclitaxel-eluting stent (PES) implantation on de novo coronary artery lesions. 132 consecutive patients with diabetes (mean age 63.1+/-7.4 years, 82 males) were randomized to abciximab (n=66) or placebo (n=66). Among the 124 (93.9%) patients who underwent a 6-months angiographic follow-up, the mean difference in in-segment LLL between patients who received abciximab and placebo was 0.02 mm (P=0.8). In addition, the rates of angiographic in-segment restenosis were comparable between the two groups (14.3 versus 9.8%, P=0.5). Cumulative rates of clinical events did not differ (death: 1.5 versus 1.5, P=0.9 and MI: 1.5 versus 3%, P=0.8) between abciximab and placebo group, respectively. Similarly, the incidence of target lesion revascularization was 9.1% and 6.1% (P=0.7) at six months, in the two groups., Conclusions: Abciximab does not seem to have any impact on the extent of in-segment LLL in diabetic patients undergoing an elective PES implantation.

We investigated the possibility of nourishing the myocardium through selective retrograde coronary venous bypass grafting (CVBG) with an off-pump technique and evaluated various methods of monitoring the physiological effects of this procedure. In a porcine model, the left internal mammary artery (LIMA) was anastomosed to the left anterior descending coronary vein (LAD vein) in an off-pump procedure. The LAD vein was ligated proximal to the anastomosis. The LAD artery was ligated proximally. The physiological effects were monitored using microdialysis, tissue oxygen tension, blood flow in LIMA, blood samples, and hemodynamic and histological analyses. As controls, 5 pigs underwent surgery involving only LAD artery ligation without CVBG. CVBG with LAD ligation was performed in 16 pigs; 12 survived CVBG and were monitored for 2-2.5 hours while in sinus rhythm, a 75% salvage rate after an otherwise lethal LAD artery occlusion. Immediately after LAD artery ligation, the anterior wall of the left ventricle became cyanotic and hypokinetic. Over time it regained color and contractility as flow in the LIMA increased. Microdialysis showed a significant increase in lactate. Initially tissue oxygen tension decreased, but with time some recovery was seen. Cardiac troponin T was elevated. Histological analysis showed ischemic changes. In control pigs, microdialysis was performed for 1.5 hours up to LAD artery ligation, after which all pigs died in ventricular fibrillation arrest. No increase in lactate was observed. These results indicate that after LAD artery occlusion, CVBG can nourish the myocardium to a certain extent and prevent death in the majority of cases, although varying degrees of ischemia remain.

As a contribution to the controversial discussion for the use of drug-eluting stents, the European Heart Institute of the European Academy of Sciences and Arts is emphasizing important factors: a) drug eluting stents (DES) should be used only in accordance with their on-label indications for use; b) to avoid off-label use of DES and to assure that patients are apprized of all their revascularization options, patients should have informed consent between the patient, interventionist and a cardiac surgeon; c) without informed consent, off-label use of DES may be considered a legal offence against the interventionist; d) at onset of new symptoms, patients must be informed that surgery is a viable and recommended option.

Purpose of Review: The purpose of this review is to assess the current state of robotics in coronary revascularization and to consider what advances may be forthcoming., Recent Findings: Several groups have been able to utilize robotic telemanipulation to perform coronary revascularization via limited access. Although the patients are highly selected, results in experienced centers are comparable to open coronary artery bypass grafting., Summary: The ultimate goal of minimally invasive coronary surgery is totally endoscopic coronary revascularization without utilization of cardiopulmonary bypass. This goal can be realized with the utilization of robotic technology.