Circulation Editors’ Picks

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HomeCirculationVol. 128, No. 5Circulation Editors’ Picks Free AccessResearch ArticlePDF/EPUBAboutView PDFView EPUBSections ToolsAdd to favoritesDownload citationsTrack citationsPermissions ShareShare onFacebookTwitterLinked InMendeleyReddit Jump toFree AccessResearch ArticlePDF/EPUBCirculation Editors’ PicksMost Read Articles in Cardiovascular Interventions The Editors The Editors Search for more papers by this author Originally published30 Jul 2013https://doi.org/10.1161/CIRCULATIONAHA.113.004657Circulation. 2013;128:e64–e71Clinical and Angiographic Risk Stratification and Differential Impact on Treatment Outcomes in the Bypass Angioplasty Revascularization Investigation 2 Diabetes (BARI 2D) TrialSummary—In this report, we examine angiographic and clinical risk scores in the Bypass Angioplasty Revascularization Investigation 2 Diabetes (BARI 2D) trial to test the hypothesis that differences in the end points of death and myocardial infarction and the composite end points of death/myocardial infarction/stroke and cardiac death/myocardial infarction observed between coronary revascularization and intensive medical therapy might be related to coronary disease extent and clinical characteristics. In the group of patients in whom percutaneous coronary intervention was chosen as the preferred revascularization option, there were no treatment differences between an initial strategy of percutaneous coronary intervention or intensive medical therapy regardless of angiographic or clinical risk score. This was not the case in the patients in whom coronary artery bypass graft surgery was selected as the preferred revascularization option because there was an increasing benefit of coronary artery bypass graft surgery in terms of reduction of cardiac end points in the highest-angiographic-risk patients, particularly in those with high clinical risk scores. Our findings indicate that among patients with diabetes mellitus and stable ischemic heart disease, a strategy of prompt coronary artery bypass graft surgery is preferred to an initial strategy of intensive medical therapy for those with extensive coronary artery disease or impaired left ventricular function to reduce the rates of myocardial infarction and death/myocardial infarction/stroke.Conclusions—Among patients with diabetes mellitus and stable ischemic heart disease, a strategy of prompt coronary artery bypass graft surgery significantly reduces the rate of death/myocardial infarction MI/stroke in those with extensive coronary artery disease or impaired left ventricular function.1A Prospective, Randomized Clinical Trial of Hemodynamic Support With Impella 2.5 Versus Intra-Aortic Balloon Pump in Patients Undergoing High-Risk Percutaneous Coronary Intervention: The PROTECT II StudySummary—Complex percutaneous coronary intervention with hemodynamic support may offer an effective therapy for high-risk patients with multivessel or unprotected left main lesions. In the PROTECT II trial we randomly assigned 452 high-risk patients undergoing percutaneous coronary intervention to hemodynamic support with intra-aortic balloon counterpulsation or a percutaneous (Impella 2.5) axial flow left ventricular assist device. Primary outcome was incidence of major adverse events at 30 days with prospectively planned follow-up to 90 days. The trial was able to enroll the most ill population of symptomatic ischemic heart disease patients ever enrolled in a percutaneous coronary intervention trial. These patients were highly symptomatic, 66% were in New York Heart Association class III or IV, 87% had a history of heart failure, 51% had diabetes mellitus, 26% had renal insufficiency, and ejection fraction was 24%. Despite these extreme risk features, the reported 30-day mortality of 6.7% is comparable to predicted surgical models. Angiography success was high, whereas stroke/transient ischemic attack and incidence of renal failure rates were low. At 90 days follow-up, 68% of patients had improvement in symptom status with 74% of patients either class I or class II. The trial was terminated prematurely because of the data safety monitoring board’s determination of futility. At 30 days, no difference in incidence of major adverse events occurred for either intent-to-treat or per protocol analysis. Planned follow-up at 90 days reveals a strong trend of benefit for Impella-treated patients (P=0.066, intent-to-treat) and significant for patients who actually qualified (P=0.023, per protocol).Conclusions—The 30-day incidence of major adverse events was not different for patients with IABP or Impella 2.5 hemodynamic support. However, trends for improved outcomes were observed for Impella 2.5–supported patients at 90 days.2Should We Emergently Revascularize Occluded Coronaries for Cardiac Arrest?: Rapid-Response Extracorporeal Membrane Oxygenation and Intra-Arrest Percutaneous Coronary InterventionSummary—Cardiac arrest is a major cause of unexpected death. Despite cardiopulmonary resuscitation (CPR), only a few patients who suffer cardiac arrest are able to return to their former lifestyles. Extracorporeal CPR, an alternative CPR method in which extracorporeal membrane oxygenation (ECMO) is used, has been reported to be effective for patients in whom conventional CPR cannot achieve the return of spontaneous circulation. Venoarterial ECMO in patients undergoing cardiac arrest provides adequate temporal perfusion to the organs before the return of spontaneous circulation. A high incidence of acute coronary syndrome is reported in cardiac arrest patients, and the use of percutaneous coronary intervention (PCI) in postresuscitation care has recently been noted to improve the outcomes of such patients. We therefore investigated the associations among extracorporeal CPR, intra-arrest PCI, and patient outcomes. In this study, rapid-response ECMO was performed in 86 patients with acute coronary syndrome who were unresponsive to conventional CPR. The study patients were usually thought to have unfavorable prognosis when treated with conventional CPR. However, we obtained encouraging results: 89% of the study patients achieved return of spontaneous heartbeat, 46% were weaned from ECMO, 25% had a 30-day survival, and 19% had favorable neurological findings at the time of hospital discharge. This study showed a definitively higher rate of return of spontaneous heartbeat (100%) and improved outcomes in cardiac arrest patients with acute coronary syndrome treated with ECMO and intra-arrest PCI. PCI is feasible in this setting and can increase return of spontaneous heartbeat and improve outcomes. Randomized studies of intra-arrest PCI based on these findings are needed.Conclusions—Rapid-response ECMO plus intra-arrest PCI is feasible and associated with improved outcomes in patients who are unresponsive to conventional cardiopulmonary resuscitation. On the basis of these findings, randomized studies of intra-arrest PCI are needed.3Risk of Elective Major Noncardiac Surgery After Coronary Stent Insertion: A Population-Based StudySummary—For patients with coronary stents, practice guidelines recommend that elective noncardiac surgery be delayed until surgery can be performed safely using antiplatelet therapy with aspirin alone. The suggested delay is 30 to 45 days for bare-metal stents and 1 year for drug-eluting stents. However, these recommendations are largely based on expert opinion and limited data. We therefore conducted a population-based cohort study in Ontario, Canada to describe the risks of major elective noncardiac surgery after stent implantation. After linking population-based administrative databases to a province-wide coronary stent registry, rates of 30-day major adverse cardiac events (mortality, readmission for acute coronary syndrome, repeat coronary revascularization) were measured among patients who underwent major elective noncardiac surgery from 2003 to 2008 after previous stent implantation. We found that when the interval between stent implantation and surgery was <45 days, event rates were high for bare-metal (6.7%) and drug-eluting (20.0%) stents. When the interval was 45 to 180 days, the event rate for bare-metal stents was 2.6%, which approached that of nonrevascularized individuals with Revised Cardiac Risk Index scores of 1 to 2. Adjusted analyses suggested this event rate increased further if this interval exceeded 180 days. For drug-eluting stents, the event rate was 1.2% once the interval exceeded 180 days, approaching that of nonrevascularized individuals with Revised Cardiac Risk Index scores of 1. These results suggest that the earliest optimal time for performing major elective noncardiac surgery is 46 to 180 days after bare-metal stent implantation and >180 days after drug-eluting stent implantation.Conclusions—The earliest optimal time for elective surgery is 46 to 180 days after bare-metal stent implantation or >180 days after drug-eluting stent implantation.4Comparison of Everolimus-Eluting and Sirolimus-Eluting Coronary Stents: 1-Year Outcomes from the Randomized Evaluation of Sirolimus-Eluting Versus Everolimus-Eluting Stent Trial (RESET)Summary—Several recent randomized trials comparing everolimus-eluting stents (EES) and sirolimus-eluting stents (SES) reported similar outcomes. However, only 1 trial was powered for a clinical end point, and no trial was powered for evaluating target-lesion revascularization. Randomized Evaluation of Sirolimus-eluting versus Everolimus-eluting stent Trial is a prospective multicenter randomized, open-label trial comparing EES with SES in Japan. The trial was powered for evaluating noninferiority of EES relative to SES in terms of target-lesion revascularization. From February and July 2010, 3197 patients were randomly assigned to receive either EES (1597 patients) or SES (1600 patients). At 1 year, the primary efficacy end point of target-lesion revascularization occurred in 65 patients (4.3%) in the EES group, and in 76 patients (5.0%) in the SES group, demonstrating noninferiority of EES to SES (Pnoninferiority<0.0001, and Psuperiority=0.34). Cumulative incidence of definite stent thrombosis was low and similar between the 2 groups (0.32% versus 0.38%; P=0.77). One-year clinical and angiographic outcome after EES implantation was noninferior to and not different from that after SES implantation in a stable coronary artery disease population with relatively less complex coronary anatomy. One-year clinical outcome after both EES and SES use was excellent with a low rate of target-lesion revascularization and a very low rate of stent thrombosis. Clinical follow-up will be continued up to 3 years. Future studies comparing different drug-eluting stents should focus more on patients with complex coronary artery disease to discern meaningful differences in safety and efficacy outcomes.Conclusions—One-year clinical and angiographic outcome after EES implantation was noninferior to and not different from that after SES implantation in a stable coronary artery disease population with relatively less complex coronary anatomy. One-year clinical outcome after both EES and SES use was excellent with a low rate of target-lesion revascularization and a very low rate of stent thrombosis.5Left Bundle-Branch Block Induced by Transcatheter Aortic Valve Implantation Increases Risk of DeathSummary—Transcatheter aortic valve implantation (TAVI) has proved to be a valuable treatment in patients with severe, symptomatic aortic valve stenosis who do not qualify for surgery. The TAVI procedure is frequently complicated by new-onset left bundle-branch block (LBBB). Although this complication has been addressed in TAVI literature, no attention has been paid to its clinical relevance, despite ample evidence of unfavorable outcome in other patient populations. Our multicenter study, comprising 679 TAVI patients from 8 centers in the Netherlands, convincingly shows that TAVI-induced LBBB is one of the strongest predictors of all-cause mortality. The observed ≈60% increase in mortality caused by TAVI-induced LBBB suggests that the benefit of valve repair is largely neutralized when LBBB develops. Mortality risk of LBBB was independent of the device type used; however, the incidence of LBBB was >4 times higher with the use of the Medtronic CoreValve System device than with the Edwards SAPIEN device (51% versus 12%). This is the first study indicating the considerable importance of LBBB in the outcome of TAVI patients. More attention should be paid to avoiding LBBB in TAVI procedures, both by implanters and by vendors of TAVI devices. With an approximately 50% rate of LBBB and an approximately 20% rate of permanent pacemaker implantations, the studied Medtronic CoreValve System prostheses (until 2010) performed significantly worse than the Edwards SAPIEN devices with regard to both patient outcome and healthcare costs. LBBB should be regarded as a serious adverse event when evaluating new TAVI devices.Conclusions—All-cause mortality after TAVI is higher in patients who develop LBBB than in patients who do not. TAVI-induced LBBB is an independent predictor of mortality.6Clinical Features, Management, and Prognosis of Spontaneous Coronary Artery DissectionSummary—Spontaneous coronary artery dissection is an infrequent but increasingly recognized cause of acute coronary syndrome. Although it is a nonatherosclerotic condition, its origin is unknown. This retrospective single-center study evaluated clinical features, associations, management strategies, and early and late outcomes in 87 patients with angiographically confirmed spontaneous coronary artery dissection. Consistent with prior studies, we found a young female preponderance with a low burden of atherosclerotic risk factors. Half of all patients presented with an ST-elevation myocardial infarction. Postpartum status was the most frequent association in women, whereas extreme exertion was the principal correlation in men. We unexpectedly identified fibromuscular dysplasia of the iliac artery in half the femoral angiograms that had been undertaken before closure device placement. This strong association raises the possibility of shared pathophysiological processes between fibromuscular dysplasia and spontaneous coronary artery dissection. The management of acute spontaneous coronary artery dissection can be challenging. We found that conservative treatment was associated with favorable early outcomes, frequently with subsequent angiographic resolution of dissection. While early clinical outcomes after percutaneous coronary interventions were not unfavorable, percutaneous coronary intervention was associated with an elevated risk of technical complications, including propagation of intramural hematoma and dissection with stent placement. Coronary artery bypass grafting, while being safe and effective in the short term, was associated with high rates of graft occlusion during follow-up, primarily as a result of resolution of the initial dissection. Spontaneous coronary artery dissection recurred in 17% of patients during long-term follow-up, all of whom were female. This underscores the need for close and continued surveillance of this challenging patient population.Conclusions—Spontaneous coronary artery dissection (SCAD) affects a young, predominantly female population, frequently presenting as ST-elevation myocardial infarction. Although in-hospital mortality is low regardless of initial treatment, percutaneous coronary intervention is associated with high rates of complication. Risks of SCAD recurrence and major adverse cardiac events in the long term emphasize the need for close follow-up. Fibromuscular dysplasia is a novel association and potentially causative factor.7Short- and Long-Term Outcomes With Drug-Eluting and Bare-Metal Coronary Stents: A Mixed-Treatment Comparison Analysis of 117 762 Patient-Years of Follow-Up From Randomized TrialsSummary—With the Food and Drug Administration’s approval of more drug-eluting stents (DES), the relative short- and long-term efficacy and safety of DES compared with bare-metal stents and among the DES types are less well defined. Although each of the DES has had claims of superior efficacy or safety, direct comparisons have been limited. Our analyses from 76 randomized clinical trials with 117 762 patient-years of follow-up showed that DES are highly efficacious at reducing the risk of target-vessel revascularization without causing an increase in any safety outcomes, including stent thrombosis. However, among the DES types, there were considerable differences, such that the everolimus-eluting stent, sirolimus-eluting stent, and zotarolimus-eluting Resolute stent were the most efficacious and the everolimus-eluting stent was the safest stent.Conclusions—DES are highly efficacious at reducing the risk of target-vessel revascularization without an increase in any safety outcomes, including stent thrombosis. However, among the DES types, there were considerable differences, such that EES, SES, and ZES-R were the most efficacious and EES was the safest stent.8Impact of the Presence and Extent of Incomplete Angiographic Revascularization After Percutaneous Coronary Intervention in Acute Coronary Syndromes: The Acute Catheterization and Urgent Intervention Triage Strategy (ACUITY) TrialSummary—The prevalence and clinical significance of incomplete coronary revascularization (ICR) in patients with acute coronary syndromes treated with percutaneous coronary intervention (PCI) are unknown. Prior studies have reported conflicting data owing to the lack of randomized clinical trial data, varying definitions of ICR, and substantial baseline differences between patients in whom complete revascularization is versus is not achieved. In the present study, using the large-scale Acute Catheterization and Urgent Intervention Triage Strategy (ACUITY) trial database, ICR after PCI was variably defined if any lesion with diameter stenosis cutoffs ranging from ≥30% to ≥70% with reference vessel diameter ≥2.0 mm (assessed at an independent angiographic core laboratory) remained after PCI. The prevalence of ICR after PCI varied widely from 17% to 75% of patients, depending on the threshold of angiographic percent diameter stenosis used to define ICR. Regardless of the threshold percent diameter stenosis used to define ICR, the presence of ICR after PCI was strongly associated with 1-year major adverse cardiovascular events, driven by increased rates of myocardial infarction and ischemia-driven unplanned repeat revascularization in patients with ICR, with numerically greater but nonsignificantly different rates of mortality. Thus, a strong relationship between ICR and major adverse cardiovascular events exists after PCI in acute coronary syndromes. A large-scale, randomized trial is thus warranted and required to determine whether a complete revascularization strategy (either single procedure or staged) is capable of reducing MACE compared with a selective ICR approach (whether angiographically or functionally guided) in acute coronary syndromes.Conclusions—Depending on the threshold of percent diameter stenosis, ICR was present in 17% to 75% of patients with acute coronary syndromes after percutaneous coronary intervention. Regardless of the threshold, ICR was strongly associated with 1-year myocardial infarction, ischemia-driven unplanned revascularization, and major adverse cardiac events.9Long-Term (>10 Years) Clinical Outcomes of First-in-Human Biodegradable Poly-l-Lactic Acid Coronary Stents: Igaki-Tamai StentsSummary—The Igaki-Tamai stent is the first-in-man fully biodegradable coronary stent made of poly-l-lactic acid (PLLA). In the present study, there was a high survival rate free of cardiac death (98% at 10 years) demonstrating the long-term safety of this stent. In the intravascular ultrasound echogenicity analysis, the Igaki-Tamai stent required 3 years to disappear from human coronary arteries. During the process of biodegradation (1–3 years), target lesion revascularization and target vessel revascularization reached a near plateau, suggesting that the process of PLLA biodegradation does not correlate with increased risk of clinical events. Although the mechanism of vessel healing in a chronic phase may not be the same between Igaki-Tamai stents and bioabsorbable drug-eluting PLLA stents, our study is essential in paving the way for a bioabsorbable drug-eluting PLLA stent, especially from the standpoint of long-term safety.Conclusions—Acceptable major adverse cardiac events and scaffold thrombosis rates without stent recoil and vessel remodeling suggested the long-term safety of the Igaki-Tamai stent.10Late Results of Percutaneous Mitral Commissurotomy up to 20 Years: Development and Validation of a Risk Score Predicting Late Functional Results From a Series of 912 PatientsSummary—Percutaneous mitral commissurotomy is the reference treatment for mitral stenosis in young patients with favorable valvular anatomy. Less favorable presentations are frequently encountered in Western countries. The evaluation of long-term functional results is clinically relevant given the relatively young age of treated patients and their good life expectancy. Predictive factors of late results have been identified, but there is currently no method for easily assessing the prognosis of individual patients. This is of particular importance given the diversity of patient subsets in mitral stenosis. The present study reports the longest follow-up, up to 20 years, in a population of 1024 patients with diverse characteristics who underwent percutaneous mitral commissurotomy. We found that 30% of patients had good functional results at 20 years, ie, survival without cardiovascular death or mitral intervention and in New York Heart Association class I or II. In the 912 patients who had good immediate results from percutaneous mitral commissurotomy, we analyzed the predictive factors of late functional results. This study highlights that, besides final mitral valve area, final gradient is a strong predictor of late functional results and thus should also be systematically considered in the evaluation of the immediate results of percutaneous mitral commissurotomy. From the predictive factors identified, we derived a user-friendly score combining 7 variables enabling the probability of good functional results to be assessed in any given patient with good discrimination and concordance between predicted and observed rates. The wide application of this original and simple score should be encouraged in current practice to improve individualized patient information and follow-up.Conclusions—Twenty years after percutaneous mitral commissurotomy in a population of patients with varied characteristics, 30% still had good functional results. Prediction of late functional results is multifactorial and strongly determined by age and the quality of immediate results. A simple validated scoring system is useful for estimating individual patient outcome.11Short- Versus Long-Term Duration of Dual-Antiplatelet Therapy After Coronary Stenting: A Randomized Multicenter TrialSummary—This study focusing on 2013 patients undergoing coronary stent implantation who received bare-metal, zotarolimus-eluting, paclitaxel-eluting, or everolimus-eluting stent implantation and were subsequently allocated to up to 6 months versus 24 months of clopidogrel therapy in addition to aspirin failed to show the anticipated superiority of long-term duration of dual-antiplatelet therapy in terms of a lower composite ischemic end point of overall death, myocardial infarction, or cerebrovascular accidents. The cumulative risk of the primary outcome at 2 years was 10.1% with 24-month dual-antiplatelet therapy compared with 10.0% with 6-month dual-antiplatelet therapy (hazard ratio, 0.98; 95% confidence interval, 0.74–1.29; P=0.91). The individual risks of death, myocardial infarction, cerebrovascular accident, or stent thrombosis did not differ between the study groups; however, there was a consistently greater risk of hemorrhage in the 24-month clopidogrel group according to all prespecified bleeding definitions, including the recently proposed Bleeding Academic Research Consortium classification. Two Korean studies have also previously reported a lack of benefit of either 12 or 24 months of clopidogrel therapy over 6 or 12 months of therapy, respectively. Therefore, altogether, the available evidence does not support the concept that the longer the duration of clopidogrel therapy after drug-eluting stent implantation, the better the outcomes. On the contrary, this study identifies the potential for harm with respect to major bleeding associated with prolonged use of dual-antiplatelet therapy.Conclusions—A regimen of 24 months of clopidogrel therapy in patients who had received a balanced mixture of drug-eluting or bare-metal stents was not significantly more effective than a 6-month clopidogrel regimen in reducing the composite of death due to any cause, myocardial infarction, or cerebrovascular accident.12Comparative Outcomes for Patients Who Do and Do Not Undergo Percutaneous Coronary Intervention for Stable Coronary Artery Disease in New YorkSummary—Little is known about the relative frequencies of different treatments that patients receive after being diagnosed with stable coronary artery disease and what the comparative outcomes are for routine medical treatment (RMT) versus percutaneous coronary intervention (PCI) with RMT for patients not in randomized controlled trials. Consequently, patients with stable coronary artery disease undergoing cardiac catheterization in New York State between 2003 and 2008 were followed up to determine the treatment they received. Patients receiving RMT and patients receiving PCI with RMT were propensity matched through the use of 20 factors that could have a bearing on outcomes. The resulting cohort of 933 matched pairs was used to compare mortality/myocardial infarction (MI), mortality, MI, and subsequent revascularization rates. Most of the patients (89%) underwent PCI. PCI/RMT patients had significantly lower adverse outcome rates at 4 years for mortality/MI (16.5% versus 21.2%; P=0.003), mortality (10.2% versus 14.5%; P=0.02), MI (8.0% versus 11.3%; P=0.007), and subsequent revascularization (24.1% versus 29.1%; P=0.005). Adjusted RMT/PCI hazard ratios were 1.49 (95% confidence interval, 1.16–1.93) for mortality/MI and 1.46 (95% confidence interval, 1.08–1.97) for mortality. There were no differences in treatment outcomes for patients <65 years of age or for patients with single-vessel disease. Most patients with stable coronary artery disease in New York undergoing catheterization between 2003 and 2008 received PCI, and those patients who received PCI experienced lower mortality, mortality/MI, and revascularization rates. The reasons for this finding need to be better understood, including the possible role of low medication adherence rates that have been found in other studies.Conclusions—Most patients with stable coronary artery disease in New York undergoing catheterization between 2003 and 2008 received PCI. Patients who received PCI experienced lower mortality, mortality/MI, and revascularization rates. The reasons for this finding need to be better understood, including the possible role of low medication adherence rates that have been found in other studies.13Validation of the Bleeding Academic Research Consortium Definition of Bleeding in Patients With Coronary Artery Disease Undergoing Percutaneous Coronary InterventionSummary—Available evidence demonstrates that occurrence of bleeding in patients undergoing percutaneous coronary intervention (PCI) signifies a worse clinical outcome compared with patients who do not bleed. Differences in the bleeding definition represent an important confounding factor that hinders the ascertainment of true bleeding occurrence and its association with clinical outcome and implementation of preventive/reducing strategies. Recently, a consensus report from the Bleeding Academic Research Consortium (BARC) proposed a standardized bleeding definition with a hierarchical approach of describing bleeding severity in patients receiving antithrombotic therapy. The BARC document is a consensus report rather than a data-based analysis and has not yet been validated. In this study, we investigated the relationship between bleeding as defined by the BARC consensus document and 1-year mortality in patients undergoing PCI and assessed whether the BARC bleeding definition is superior to Thrombolysis in Myocardial Infarction (TIMI) and Randomized Evaluation in PCI Linking Angiomax to Reduced Clinical Events (REPLACE-2) bleeding definitions. The study represents a pooled patient-level analysis of 12 459 patients recruited in 6 Intracoronary Stenting and Antithrombotic Regimen (ISAR) clinical trials. The present study found a close association between bleeding defined by BARC and 1-year mortality after PCI. The BARC bleeding definition criteria offer a balanced combination of laboratory and clinical metrics for bleeding recognition and a detailed hierarchical grading system of its severity that is closely associated with increased risk of death up to 1 year after PCI. However, all 3 bleeding definitions (BARC, TIMI, and REPLACE-2) provide comparable prognostic information with respect to 1-year mortality in patients with coronary artery disease undergoing PCI.Conclusions—The present study demonstrated a close association between bleeding events defined according to BARC and 1-year mortality after PCI.14Randomized Comparison of Everolimus-Eluting and Sirolimus-Eluting Stents in Patients Treated With Percutaneous Coronary Intervention: The Scandinavian Organization for Randomized Trials With Clinical Outcome IV (SORT OUT IV)Summary—Among drug-eluting stents released to date, the s