Early versus delayed percutaneous coronary intervention for patients with non‐ST segment elevation acute coronary syndrome: A meta‐analysis of randomized controlled clinical trials

Background: Studies assessing the timing of percutaneous coronary interventions (PCI) in patients with Non‐ST segment elevation Acute Coronary Syndromes (NSTE‐ACS) have failed to generate a consensus on how early PCI should be performed in such patients. Purpose: This meta‐analysis compares clinical outcomes at 30 days in NSTE‐ACS patients undergoing PCI within 24 hours of presentation (early PCI) with those receiving PCI more than 24 hours after presentation (delayed PCI). Data Sources: Data were extracted from searches of MEDLINE (1990‐2010) and Google scholar and from scrutiny of abstract booklets from major cardiology meetings (1990‐2010). Study selection: Randomized clinical trials (RCTs) that included the composite endpoint of death and non‐fatal myocardial infarction (MI) at 30 days after PCI were considered. Data Extraction: Two independent reviewers extracted data using standard forms. The effects of early and delayed PCI were analyzed by calculating pooled estimates for death, non‐fatal MI, bleeding, repeat revascularization and the composite endpoint of death or non‐fatal MI at 30 days. Univariate analysis of each of these variables was used to create odds ratios. Data Synthesis: Seven studies with a total of 13,762 patients met the inclusion criteria. There was no significant difference in the odds of the composite endpoint of death or non‐fatal MI at 30 days between patients undergoing early PCI and those receiving delayed PCI (OR‐0.83, 95%CI 0.62‐1.10). Patients receiving delayed PCI experienced a 33% reduction in the odds of repeat revascularization at 30 days compared to those undergoing early PCI (OR‐1.33, 95%CI 1.14‐1.56, P=0.0004).Conversely, patients undergoing early PCI experienced lower odds of bleeding than those receiving delayed PCI (OR‐0.76, 95%CI 0.63‐0.91, P = 0.0003). Conclusions: In NSTE‐ACS patients early PCI doesn't reduce the odds of the composite endpoint of death or non‐fatal MI at 30 day. This strategy is associated with lower odds of bleeding and higher odds of repeat revascularization at 30 days than a strategy of delayed PCI. © 2012 Wiley Periodicals, Inc.     

Early and long‐term results of percutaneous coronary intervention for unprotected left main trifurcation disease

Objectives: We aimed to conduct a retrospective cohort study focusing on our 5‐year experience in the percutaneous treatment of unprotected left main (ULM) trifurcation disease. Background: Percutaneous treatment of ULM trifurcation remains a challenging and rare procedure for most interventional cardiologists. Moreover, data on long‐term outcomes are lacking. Methods: We retrieved all patients with ULM trifurcation disease treated percutaneously at our Institution since 2002, and adjudicated baseline, procedural, and outcome data. The primary end point was the long‐term rate of major adverse cardiovascular events (MACE, i.e., cardiac death, myocardial infarction, bypass surgery, or target vessel revascularization). Results: A total of 27 patients underwent percutaneous coronary intervention with stent implantation for ULM trifurcation disease, with 14 (52%) cases of true trifurcations, i.e., with concomitant significant stenoses of the distal ULM/ostial left anterior descending plus ostial ramus intermedius and ostial circumflex. Bare‐metal stents were implanted in 8 (29%) patients and drug‐eluting stents (DES) in 26 (96%), with a main branch stent only strategy in 11 (40%), T stenting in 9 (33%), and V stenting in 6 (27%). Procedural and clinical success occurred in 26 (96%), with one postprocedural death. Angiographic follow‐up was obtained in 22 patients (81%), and clinical follow‐up was completed in all subjects after a median of 28 ± 17 months, showing overall MACE in 9 (33%), with cardiac death in 4 (15%), myocardial infarction in 1 (4%), coronary artery bypass grafting (CABG) in 4 (15%), and percutaneous target vessel revascularization in 5 (19%). Definite stent thrombosis was adjudicated in 1 (3%) patient. Treatment of a true trifurcation lesion and recurrence of angina during follow‐up were significantly associated with an increased risk of MACE (P = 0.029 and P = 0.050, respectively). Conclusions: Percutaneous treatment of ULM trifurcation disease is feasible, associated with favorable mid‐term results, and may be considered given its low invasiveness in patients at high surgical risk or with multiple comorbidities. © 2008 Wiley‐Liss, Inc.     

The EXTREME registry: Titanium‐nitride‐oxide coated stents in small coronary arteries

Objectives : We sought to explore the immediate results of Titan2^® stent implantation in small coronary arteries, as well as the incidence of major adverse cardiac events (MACE) at six months follow‐up. Background : The safety of Titan2^® stent has been confirmed in several studies in real‐life unselected populations. Methods : We enrolled 311 consecutive patients admitted for percutaneous intervention for at least one significant (50%) de novo lesion in a native small coronary artery (2.0–2.75 mm). All lesions were treated with Titan2^® stent implantation. Patients were prospectively followed up for at least six months. The primary endpoint was MACE at six months follow‐up [death, myocardial infarction (MI), or target vessel revascularization (TVR)]. Secondary endpoints included angiographic and clinical procedural success, in‐hospital MACE, target lesion revascularization (TLR) during follow‐up, and stent thrombosis. Results : The mean age was 67.3 ± 10.9 years (65.9% males). A total of 356 Titan2^® stents were implanted in 353 lesions. Angiographic and clinical procedural success was achieved in 344 (97.5%) patients. No case of in‐hospital MACE or acute stent thrombosis was reported. Clinical follow‐up was completed for an average of 8 ± 2 months. Two patients (0.7%) died, and 6 (2.1%) developed MI. TLR was performed in 12 (4.2%) and TVR in 16 (5.5%) patients, all were clinically driven. Cumulative MACE occurred in 20 (6.9%) patients. One patient suffered subacute stent thrombosis, but no late stent thrombosis. Conclusions : Titan2^® stent implantation in small coronary arteries achieves excellent immediate outcome, with a low incidence of MACE at mid‐term follow‐up. © 2010 Wiley‐Liss, Inc.     

Long‐term follow‐up after nonurgent percutaneous coronary intervention in unprotected left main coronary arteries

Objectives : To evaluate the long‐term outcomes of the selected patients by the local Heart Team to undergo percutaneous coronary intervention (PCI) of unprotected left main coronary artery (ULMCA) stenosis and to compare patients considered at low surgical risk versus at high surgical risk for coronary artery bypass grafting (CABG). Background : CABG is recommended in patients with ULMCA stenosis according to the AHA/ACC and ESC guidelines, and there are limited data on the long‐term outcomes in patients selected by the local Heart Team to undergo PCI. Methods : Between 1996 and 2007, 227 patients underwent PCI for ULMCA stenosis based on decision of the local Heart Team and patient's and/or physician's preference. All patients were contacted at 1 year and in November 2008. Results : Long‐term follow‐up was up to 8 years with a mean of 3.9 ± 2.6 years. Overall, the Kaplan–Meier estimate of the composite of cardiac death, myocardial infarction (MI), or target lesion revascularization (TLR) was 14.8% at 1 year, 18.3% at 3 years, and 20.9% at 5 years with no events occurring thereafter. Patients considered at low surgical risk for CABG had a significantly lower incidence of cardiac death or MI compared to patients considered at high surgical risk at 8 years (1.4 vs. 16.8%; 1.4 vs. 14.8%, respectively); however, no significant difference was observed for cardiac death, MI, or TLR (18.6 vs. 24.4%). Conclusions : PCI of ULMCA stenosis in patients selected by the Heart Team resulted in good long‐term clinical outcomes with most events occurring within the 1st year. Patients considered at low surgical risk for CABG have a significantly better long‐term survival than patients at high risk for surgery. © 2010 Wiley‐Liss, Inc.     

Comparison of 2‐year clinical outcomes between zotarolimus‐, sirolimus‐, and paclitaxel‐eluting stents in real life clinical practice

Background : There are few studies comparing the long‐term efficacy and safety of the zotarolimus‐eluting stent (ZES) with sirolimus‐ (SES) and paclitaxel‐eluting stents (PES) in the unselected cohorts that were subject to real life clinical practice. Methods : Total 2,769 patient who underwent successful percutaneous coronary intervention (PCI) with the three drug‐eluting stents (DES) between April 2006 and July 2008 were analyzed retrospectively. A total of 1,152 patients were treated with SES, 810 with PES, and 807 with ZES. The primary analysis endpoint was cumulative rate of target‐lesion failure (TLF) at 24 months, defined as the composite of cardiac death, target‐vessel‐related myocardial infarction (MI), and target‐lesion revascularization (TLR). Results : At 24 months, the incidence of TLF was significantly lower in the SES group compared with the ZES (7.6% vs. 11.3%, HR = 0.66, CI = 0.49–0.88, P = 0.005) or the PES group (7.6% vs. 10.2%, HR = 0.74, CI = 0.55–0.99, P = 0.048), while similar between the PES and the ZES groups (HR = 0.89, CI = 0.66–1.20, P = 0.443). The difference was mostly driven by higher rate of TLR in the ZES and PES groups compared with the SES group, mostly within the first year post‐PCI. However, the rate of hard endpoints (cardiac death or nonfatal MI) was similar among the three groups. These results were reproduced in the propensity score‐matched cohort.Conclusions : This observational study shows that the use of SES is superior to PES or ZES for the TLF in the overall and matched analysis. © 2011 Wiley Periodicals, Inc.     

Prognostic role of preprocedural glucose levels on short‐ and long‐term outcome in patients undergoing percutaneous coronary revascularization

Objectives : We investigated the prognostic role of preprocedural blood glucose levels (BGLs) on short‐ and long‐term outcome in patients undergoing elective percutaneous coronary intervention (PCI). Background : Hyperglycemia and hypoglycemia, with or without pre‐existing diabetes mellitus, are associated with adverse outcome in patients with coronary artery disease. Moreover, neointimal hyperplasia after coronary stent implantation is increased in presence of suboptimal glycemic control. Methods : Preprocedural BGLs were prospectively measured in 572 patients and predefined groups were considered: hypoglycemia ≤ 80 mg/dl; euglycemia 81–109 mg/dl; mild hyperglycemia 110–125 mg/dl; hyperglycemia ≥ 126 mg/dl. Primary end point was represented by the incidence of peri‐procedural myocardial infarction (MI) and secondary end point was the occurrence of major adverse cardiac events (MACE) at follow‐up. Results : Hypoglycemia was associated with an increased risk of peri‐procedural MI (51% vs 30%, 29%, and 37% in euglycemia, mild hyperglycemia and hyperglycemia groups, respectively; P for trend 0.025). After a mean follow‐up of 15 ± 8 months, the occurrence of MACE was 38% in the hypoglycemia group, 12% in the euglycemia group, 14% in the mild hyperglycemia and 22% in the hyperglycemia group (P < 0.001). The incidence of in‐stent restenosis and target vessel revascularization was also higher in patients with abnormal pre‐procedural BGLs (P for trend 0.007 and <0.001, respectively). Multivariate analysis confirmed hypoglycemia as a predictor of early and long‐term unfavorable cardiac prognosis (OR = 2.53, 95% CI 1.09‐5.81, P = 0.029 for peri‐procedural MI; OR = 2.91, 95% CI 1.26–6.69, P = 0.012 for MACE occurrence). Conclusions : We observed a significant association between preprocedural BGLs and adverse short‐and long‐term outcome in patients undergoing elective PCI. Thus, a careful glycemic monitoring should be recommended in all patients undergoing coronary stenting, irrespective of the diabetic status. © 2011 Wiley Periodicals, Inc.     

Multicenter international registry of unprotected left main coronary artery percutaneous coronary intervention with drug‐eluting stents in patients with myocardial infarction

Background: Patients who present with myocardial infarction (MI) and unprotected left main coronary artery (ULMCA) disease represent an extremely high‐risk subset of patients. ULMCA percutaneous coronary intervention (PCI) with drug‐eluting stents (DES) in MI patients has not been extensively studied. Methods: In this retrospective multicenter international registry, we evaluated the clinical outcomes of 62 consecutive patients with MI who underwent ULMCA PCI with DES (23 ST‐elevation MI [STEMI] and 39 non‐ST‐elevation MI [NSTEMI]) from 2002 to 2006. Results: The mean age was 70 ± 12 years. Cardiogenic shock was present in 24%. The mean EuroSCORE was 10 ± 8. Angiographic success was achieved in all patients. Overall in‐hospital major adverse cardiac event (MACE) rate was 10%, mortality was 8%, all due to cardiac deaths from cardiogenic shock, and one patient suffered a periprocedural MI. At 586 ± 431 days, 18 patients (29%) experienced MACE, 12 patients (19%) died (the mortality rate was 47% in patients with cardiogenic shock), and target vessel revascularization was performed in four patients, all of whom had distal bifurcation involvement (two patients underwent repeat PCI and two patients underwent bypass surgery). There was no additional MI. Two patients had probable stent thrombosis and one had possible stent thrombosis. Diabetes [hazard ratio (HR) 4.22, 95% confidence interval (CI) (1.07–17.36), P = 0.04), left ventricular ejection fraction [HR 0.94, 95% CI (0.90–0.98), P = 0.005), and intubation [HR 7.00, 95% CI (1.62–30.21), P = 0.009) were significantly associated with increased mortality. Conclusions: Patients with MI and ULMCA disease represent a very high‐risk subgroup of patients who are critically ill. PCI with DES appears to be technically feasible, associated with acceptable long‐term outcomes, and a reasonable alternative to surgical revascularization for MI patients with ULMCA disease. Randomized trials are needed to determine the ideal revascularization strategy for these patients. © 2008 Wiley‐Liss, Inc.     

Impact of acute coronary syndrome on clinical outcomes after revascularization with the dual-therapy CD34 antibody-covered sirolimus-eluting Combo stent and the sirolimus-eluting Orsiro stent

Objectives

To compare the efficacy and safety of the dual-therapy CD34 antibody-covered sirolimus-eluting Combo stent (DTS) and the sirolimus-eluting Orsiro stent (O-SES) in patients with and without acute coronary syndrome (ACS) included in the SORT OUT X study.

Background

The incidence of target lesion failure (TLF) after treatment with modern drug-eluting stents has been reported to be significantly higher in patients with ACS when compared to patients without ACS. Whether the results from the SORT OUT X study apply to patients with and without ACS remains unknown.

Methods

In total, 3146 patients were randomized to stent implantation with DTS (n = 1578; ACS: n = 856) or O-SES (n = 1568; ACS: n = 854). The primary end point, TLF, was a composite of cardiac death, target-lesion myocardial infarction (MI), or target lesion revascularization (TLR) within 1 year.

Results

At 1 year, the rate of TLF was higher in the DTS group compared to the O-SES group, both among patients with ACS (6.7% vs. 4.1%; incidence rate ratio: 1.65 [95% confidence interval, CI: 1.08–2.52]) and without ACS (6.0% vs. 3.2%; incidence rate ratio: 1.88 [95% CI: 1.13–3.14]). The differences were mainly explained by higher rates of TLR, whereas rates of cardiac death and target lesion MI did not differ significantly between the two stent groups in patients with or without ACS

Conclusion

Compared to the O-SES, the DTS was associated with a higher risk of TLF at 12 months in patients with and without ACS. The differences were mainly explained by higher rates of TLR.     

Results of percutaneous drug‐eluting stent implantation for unprotected left main coronary disease according to left ventricular systolic function

Objectives: We aimed to appraise the early and long‐term outcome after percutaneous coronary intervention (PCI) with drug‐eluting stents (DES) in patients with unprotected left main disease (ULM) and left ventricular systolic dysfunction (LVD). Background: PCI with DES has being performed with increasing frequency in subjects with ULM and LVD, but few specific data are available. Setting and Patients: We identified patients undergoing PCI with DES for ULM at our Center and distinguished those with ejection fraction (EF) >50% from those with 40% <EF ≤50% and those with EF ≤40%. The primary end‐point was the rate of major adverse cerebro‐cardiovascular events (MACCE, ie death, myocardial infarction [MI], stroke, repeat PCI or bypass surgery). Results: A total of 197 patients were included, 57.4% with EF >50%, 32.0% with 40% <EF ≤50%, and 10.6% with EF ≤40%. In‐hospital mortality was significantly higher in those with EF ≤40% (9.5% vs. 0 and 3.2%, P < 0.001). A total of 96% patients were followed for 23 ± 14 months, yielding a MACCE rate of 44.2% (41.6% in those with EF >50%, 41.6% in those with 40% <EF ≤50%, and 61.9% in those with EF ≤40%, P = 0.4). Specifically, death occurred in 2.7%, 7.9%, and 28.6% (P < 0.001), cardiac death in 1.8%, 4.8%, and 23.8% (P = 0.001), MI in 8.0%, 7.9% and 0 (P = 0.4), and TVR in 15.9%, 11.1% and 33.3% (P = 0.6). Conclusion: Systolic ventricular dysfunction is highly correlated with in‐hospital and long term death rates in patients undergoing PCI with DES for ULM disease. However it does not confer an increased risk of nonfatal adverse events or stent thrombosis. © 2009 Wiley‐Liss, Inc.     

Gender impact on prognosis of acute coronary syndrome patients treated with drug-eluting stents

Women have a higher risk of adverse outcomes after percutaneous coronary intervention (PCI) than men. However, in acute coronary syndrome (ACS), long-term outcomes after contemporary PCI with drug-eluting stent (DES) have not been fully investigated. We aimed to test the impact of gender on outcomes in patients with ACS after PCI with DES. We analyzed all patients with ACS from the prospective NOBORI-2 trial who underwent PCI with a Nobori DES from 2008 through 2009 in 125 centers worldwide. End points of the study were target lesion failure, cardiac death, myocardial infarction (MI), and clinically driven target lesion revascularization, and major adverse cardiac events (composite of cardiac death, MI, and target vessel revascularization) at 1 year and yearly up to 5 years. There were 1,640 patients with ACS, 1,268 men (77%) and 372 women (23%). Compared to men, women were 5 years older and more frequently had co-morbidities such as diabetes mellitus and hypertension. There were no gender differences for cardiac death (1.3% vs 2.7%), MI (2.1% vs 3.2%), or target lesion revascularization (2.6% vs 3.8%) at 1 year after the procedure for men and women, respectively. The trend was the same at 2 years (cardiac death 2.0% vs 2.3%, MI 2.5% vs 3.5%, target lesion revascularization 3.2% vs 4.6%). Target lesion failure rates were 4.5% and 5.9% at 1 year and 5.7% and 7.3% at 2 years in men and women, respectively (p = NS). Multivariate analysis, which included age, hypertension, diabetes mellitus, and number of diseased vessels, showed that gender was not a predictor for outcome. There were no differences in bleeding or stent thrombosis rates. Relief from anginal symptoms was similar. The same rate of adherence to dual antiplatelet therapy was observed and reached 73% at 1 year and 31% at 2 years after the ACS event and PCI. In conclusion, although women had worse baseline characteristics, no differences in outcomes were observed between men and women treated for ACS with contemporary DES.     

Validating the EXCEL hypothesis: A propensity score matched 3‐year comparison of percutaneous coronary intervention versus coronary artery bypass graft in left main patients with SYNTAX score ≤32

Objectives : The aim of this study is to verify the study hypothesis of the EXCEL trial by comparing percutaneous coronary intervention (PCI) and coronary artery bypass graft (CABG) in an EXCEL‐like population of patients. Background : The upcoming EXCEL trial will test the hypothesis that left main patients with SYNTAX score ≤32 experience similar rates of 3‐year death, myocardial infarction (MI), or cerebrovascular accidents (CVA) following revascularization by PCI or CABG. Methods : We compared the 3‐year rates of death/MI/CVA and death/MI/CVA/target vessel revascularization (MACCE) in 556 patients with left main disease and SYNTAX score ≤32 undergoing PCI (n = 285) or CABG (n = 271). To account for confounders, outcome parameters underwent extensive statistical adjustment. Results : The unadjusted incidence of death/MI/CVA was similar between PCI and CABG (12.7% vs. 8.4%, P = 0.892), while MACCE were higher in the PCI group compared to the CABG group (27.0% vs. 11.8%, P < 0.001). After propensity score matching, PCI was not associated with a significant increase in the rate of death/MI/CVA (11.8% vs. 10.7%, P = 0.948), while MACCE were more frequently noted among patients treated with PCI (28.8% vs. 14.1%, P = 0.002). Adjustment by means of SYNTAX score and EUROSCORE, covariates with and without propensity score, and propensity score alone did not change significantly these findings. Conclusions : In an EXCEL‐like cohort of patients with left main disease, there seems to be a clinical equipoise between PCI and CABG in terms of death/MI/CVA. However, even in patients with SYNTAX score ≤32, CABG is superior to PCI when target vessel revascularization is included in the combined endpoint. © 2011 Wiley‐Liss, Inc.     

Outcomes of cardiac catheterization and percutaneous coronary intervention for in‐hospital ventricular tachycardia or fibrillation cardiac arrest

Objective: This study examined outcomes of patients with sudden cardiac death attributable to primary ventricular tachycardia (VT) or ventricular fibrillation (VF) that underwent cardiac catheterization with or without percutaneous coronary intervention (PCI). Background: The decision to perform cardiac catheterization and PCI in resuscitated patients with sudden cardiac death remains controversial. Prior data suggest a potential benefit from percutaneous revascularization. Methods: All patients with an in‐hospital pulseless VT or VF cardiac arrest from August 2002 to February 2008 who underwent cardiac catheterization were included. Retrospective chart review was performed to obtain clinical, neurologic, and angiographic data. Primary endpoints were all‐cause mortality and neurologic outcome. Results: Two thousand and thirty‐four patients had in‐hospital cardiac arrest, of these 116 had pulseless VT or VF and were resuscitated and 93 (80%) underwent coronary angiography. The median time to follow‐up was 1.3 years (IQR: 0.5–2.9 years). Obstructive coronary artery disease (CAD) was observed in 74 (79%) individuals, of whom 37 underwent PCI. Thirty‐five patients with obstructive CAD (47%) died compared to 41% with nonobstructive CAD. In unadjusted and multivariable adjusted analysis PCI was not associated with lower mortality (adjusted hazard ratio: 1.54, 95% CI, 0.79–3.02, P = 0.20). No significant differences were noted in neurologic status at discharge (P = 0.49). Conclusion: In this study, an aggressive revascularization strategy with PCI did not confer a survival advantage nor was it associated with improved neurologic outcomes. There was no suggestion of harm with PCI and further studies are necessary to identify potential subgroups that may benefit from revascularization. © 2011 Wiley Periodicals, Inc.     

Impact of Acute Coronary Syndrome Classification and Procedural Technique on Clinical Outcomes in Patients With Coronary Bifurcation Lesions Treated With Drug‐Eluting Stents

Background:

We examined the impact of non–ST‐segment elevation acute coronary syndrome (NSTE‐ACS) on clinical outcomes in patients with bifurcation lesions treated with drug‐eluting stents.

Hypothesis:

We hypothesized that NSTE‐ACS would be attributable to the increased risk of major adverse cardiac events (MACE) in bifurcation percutaneous coronary intervention.

Methods:

We enrolled 1668 patients, using data from a multicenter real‐world bifurcation registry. The primary objective was to compare the 2‐year cumulative risk of MACE in patients with NSTE‐ACS to those with stable angina. Major adverse cardiac events were defined as the composite endpoint of cardiac death, myocardial infarction (MI), and target‐lesion revascularization.

Results:

Non–ST‐segment elevation acute coronary syndrome was seen in 969 (58.1%) patients and stable angina in 699. Major adverse cardiac events occurred in 7.3% of NSTE‐ACS patients and in 5.2% with stable angina (P = 0.042). However, cardiac death, MI, and target‐lesion revascularization were similar between the 2 groups. We stratified patients with NSTE‐ACS into those with non–ST‐segment elevation MI and those with unstable angina. Cumulative risks of 2‐year MACEs were 7.0% in non–ST‐segment elevation MI patients and 7.5% in unstable angina patients (P = 0.87). In the NSTE‐ACS cohort, the baseline lesion length in the side branch (adjusted hazard ratio [HR]: 1.04, 95% confidence interval [CI]: 1.01‐1.07, P = 0.022), paclitaxel‐eluting stents in the main vessel (adjusted HR: 2.02, 95% CI: 1.21‐3.40, P = 0.008), and final kissing ballooning (adjusted HR: 1.88, 95% CI: 1.10‐3.21, P = 0.021) were independent predictors of MACE.

Conclusions:

Compared with stable angina patients, the NSTE‐ACS patients who underwent bifurcation percutaneous coronary intervention had an increased risk of MACE during the 2‐year follow‐up. Clin. Cardiol. 2012 doi: 10.1002/clc.22020 Drs Pil Sang Song and Dong Ryeol Ryu contributed equally to this work. Coronary Bifurcation Stenting (COBIS) Registry in South Korea, US Department of Health and Human Services, US National Institutes of Health, ClinicalTrials.gov no. NCT00851526. This work was supported by the Korean Society of Interventional Cardiology, Seoul, South Korea. The authors have no other funding, financial relationships, or conflicts of interest to disclose.     

Percutaneous coronary intervention with rotational atherectomy for severely calcified unprotected left main: immediate and two-years follow-up results

Introduction : According to current practice guidelines, coronary bypass surgery is the standard care option for unprotected left main (ULM) stenosis. However, a group of high surgical risk patients who are not eligible for coronary bypass surgery could benefit from percutaneous coronary intervention (PCI). Severe calcification hampers PCI in this setting, and rotational atherectomy (RA) could be of great help. Methods : We retrospectively analyzed a cohort of 40 patients with severely calcified ULM stenosis, not eligible for coronary artery bypass grafting, who underwent RA in our center. Results : Forty patients (mean age, 73 ± 8 years; 26 males) with ULM stenosis were treated with RA. Twenty‐seven (67%) had distal stenosis. The mean number of treated vessels was 2.38 ± 0.74, with a mean lesion length of 30 ± 18 mm. Abciximab was used in 12 (30%) cases and an intra‐aortic balloon pump in three cases. One patient died during the procedure and another two patients died in the first 24 hr after the procedure. The major events registered after the procedure included one significant branch loss, and two minor and one major case of bleeding (the latter requiring transfusion) at the puncture point. After a median of 24.7 (IQR 19.6–34.3) months of follow‐up, 12 cardiac deaths were recorded. Survival free of cardiac death was 71 ± 7% and clinical guided target vessel revascularization 19.3 ± 7% at 2 years. Conclusion : In a group of high surgical risk patients, RA on severely calcified left main stenosis is feasible and, in spite of high mortality rates, could pose the only possible effective treatment. © 2012 Wiley Periodicals, Inc.     

Unprotected left main coronary artery stenting with zotarolimus (Endeavor) drug‐eluting stents

Objectives: To report the safety and efficacy of zotarolimus eluting stents for treatment of unprotected left main coronary artery disease. Background: Percutaneous stent insertion is an increasingly popular alternative to bypass surgery for the management of left main (LM) coronary artery disease. While data support the use of sirolimus‐ and paclitaxel‐coated stents in the LM coronary artery, there are no published series reporting results with Endeavor (zotarolimus) stents, particularly in the context of unprotected left main (ULM) lesions. Methods: We retrospectively identified 40 consecutive patients who had ULM disease treated with Endeavor stents (ZES) and who had follow‐up angiography. The primary endpoint was the prevalence of major adverse cardiac events (MACE), including cardiac/unexplained death, nonfatal myocardial infarction (MI), and in‐stent restenosis (ISR)/target lesion revascularization (TLR). Results: Angiographic and procedural success was achieved in all cases. Follow‐up angiography occurred on average 5.6 ± 0.9 months after the index procedure. There were three incidences of ISR requiring TLR and another patient who had a NSTEMI in the follow‐up period. At late follow‐up (12.4 ± 1.8 months) three patients underwent CABG (one for RCA stenosis) and four patients died without knowledge of the status of the ULM stent (two cardiovascular and two deaths related to cancer progression). Conclusions: In conclusion, our experience with Endeavor stents for the treatment of ULM disease demonstrates excellent angiographic and clinical outcomes, with a 7.5% ISR/TLR rate and a 15% MACE rate, respectively, at an average clinical follow‐up of 12.4 months. © 2011 Wiley Periodicals, Inc.     

Impact of intravascular ultrasound guidance in patients with acute myocardial infarction undergoing percutaneous coronary intervention

Objectives: The aim of this study was to examine the utility of routine intravascular ultrasound (IVUS) guidance in patients with acute myocardial infarction (MI) undergoing percutaneous coronary intervention (PCI) with stent implantation. Background: Stent thrombosis (ST) is a serious complication of PCI with stent implantation for patients presenting with acute MI. Mechanical factors such as incomplete stent expansion and smaller stent diameters are known to correlate with ST and restenosis. IVUS guidance for stent deployment is reported to reduce these events in stable patients. Methods: We analyzed a cohort of 905 consecutive patients who underwent primary PCI for acute MI and were discharged alive. The clinical outcomes of 382 patients who underwent IVUS‐guided PCI were compared to those of 523 patients who did not. Patients who presented with cardiogenic shock and rescue PCI were excluded. The primary composite endpoint of death, MI, and target lesion revascularization at 1‐year follow‐up was systematically indexed and a propensity score was performed with regard to the use of IVUS‐guided PCI. Results: Patients undergoing IVUS‐guided PCI were older, more diabetic and hypertensive, but presented with less history of previous MI. The severity of coronary artery disease was balanced between both groups. The number of treated lesions and stents used was higher in the IVUS‐guided group, with a longer procedural duration. The overall rates of the composite primary outcome were similar (14.5% vs. 14.3%, P = 0.94) as were the rates of definite and probable stent thrombosis at 1 year (2.1% vs. 2.1%, P = 0.99) in the IVUS‐guided and no‐IVUS groups, respectively. After multivariate and propensity score adjustment, IVUS guidance was not an independent predictor for the primary endpoint. Conclusion: This study does not support the routine use of IVUS guidance for stent deployment in patients who present with acute MI and undergo primary PCI. © 2009 Wiley‐Liss, Inc.     

Outcomes of primary percutaneous coronary intervention in acute myocardial infarction due to unprotected left main thrombosis: The Asia‐Pacific Left Main ST‐Elevation Registry (ASTER)

Introduction

Prior studies of ULM STEMI have been confined to small cohorts. Recent registry data with larger patient cohorts have shown contrasting results. We aim to study the outcomes of patients with unprotected left main (ULM) ST‐elevation myocardial infarction (STEMI) who underwent primary percutaneous coronary intervention (PCI).

Methods

The Asia‐pacific left main ST‐Elevation Registry (ASTER) is a multicenter retrospective registry involving 4 sites in Singapore, South Korea, and the United States. The registry included patients presenting with STEMI due to an ULM coronary artery culprit lesion who underwent emergency PCI. The primary outcome was in‐hospital mortality. Secondary outcomes included major adverse cardiovascular events.

Results

A total of 67 patients (mean age 64.2 ± 12.8 years, 53 [79.1%] males) were included. The distal left main bifurcation was most commonly involved (85%, n = 57). Fifty one (76%) patients had TIMI 3 flow post‐PCI. The in‐hospital mortality rate was 47.8% (n = 32); 61% (n = 41) had cardiac failure, 4% (n = 3) had emergency coronary artery bypass grafting, 1% (n = 1) had a re‐infarction, 3% (n = 2) had stroke and 55% (n = 37) had malignant ventricular arrhythmias. On multivariate analysis, predictors of in‐hospital mortality included older age (odds ratio (OR) 1.085 (95% confidence interval (CI) 1.002‐1.175), P = 0.044), diabetes mellitus (OR 10.882 (95%CI 11.074‐110.287), P = 0.043) and absence of post‐PCI TIMI 3 flow (OR 71.429 (95%CI 2.985‐1000), P = 0.008).

Conclusions

STEMI from culprit unprotected left main coronary artery stenosis is associated with significant mortality and morbidity. Emergency PCI provides an important treatment option in this high‐risk group, but in‐hospital mortality remains high.     

A modified provisional stenting approach to coronary bifurcation lesions: clinical application of the "jailed-balloon technique"

Objectives: To demonstrate the application of a novel provisional side branch (SB) stenting strategy for coronary bifurcation lesions using a “jailed‐balloon” technique (JBT). Background: Adverse cardiac events are higher for percutaneous coronary intervention (PCI) of bifurcation lesions. Recent studies support the use of provisional SB stenting, but a risk of SB closure and a higher rate of target lesion revascularization (TLR) remain important limitations. Methods: From December 2007 to August 2010, 100 patients with 102 bifurcation lesions underwent PCI using the JBT. Baseline and postprocedural quantitative coronary angiography (QCA) analysis were performed. Procedural and immediate clinical outcomes were reviewed. Results: The majority of patients presented with acute coronary syndrome (68%) and had Medina class 1,1,1 bifurcation lesions (91%). TIMI 3 flow was established in 100% of main branch and 99% of SB lesions. QCA revealed preservation of the bifurcation angle after PCI (pre‐PCI: 59.6 ± 30.0; post‐PCI: 63.3 ± 26.8, P = 0.41). Nine patients (9%) had lesions that required rewiring and two patients (2%) required provisional stenting of the SB. SB loss occurred in one patient (1%). The jailed‐balloon or wire was not entrapped during any PCI. One patient (1%) suffered a periprocedural myocardial infarction (MI). Conclusions: Provisional stenting of complex coronary bifurcation lesions using a JBT is associated with a high procedural success rate, improved SB patency, and a low rate of immediate cardiac events. Further study is warranted to evaluate the role of JBT in improving long‐term clinical outcomes in PCI of complex bifurcation lesions. (J Interven Cardiol 2012;25:289–296)     

Outcome in high risk patients with unprotected left main coronary artery stenosis treated with percutaneous coronary intervention

Objective : We examined mortality, risk of myocardial infarction (MI), and target lesion revascularization (TLR) in high‐risk patients with unprotected left main (LM) percutaneous coronary intervention (PCI) in Western Denmark. Background : PCI of left main coronary artery lesions may be an alternative to coronary artery bypass grafting in high‐risk surgical patients. Methods : From January 2005 to May 2007, all patients who had unprotected LM PCI with stent implantation were identified in the Western Denmark Heart Registry. The indications for PCI were: (1) ST segment elevation MI (STEMI), (2) non‐STEMI (NSTEMI) or unstable angina, and (3) stable angina. All patients were followed up for 18 months. Results : A total of 344 patients were treated with LM PCI (STEMI: 71, NSTEMI/unstable angina: 157, and stable angina: 116). In STEMI patients, the median logistic EuroSCORE was 22.5 (interquartile range 12.5–39.5), in non‐STEMI (NSTEMI)/unstable angina patients 13.8 (4.8–23.9), and in stable angina patients 4.8 (2.2–10.4). Mortality after 18 months 38.0, 18.5, and 11.2% (P < 0.001) in patients with STEMI, NSTEMI/unstable angina, and stable angina, respectively. MI after 18 months was 9.9, 6.4, and 6.0% (P = ns), respectively. Four subacute and one late definite stent thrombosis were seen. TLR occurred in 5.6, 4.5, and 6.9% (P = ns) of patients, respectively. Conclusion : After PCI, patients with STEMI and LM culprit lesion have a high‐mortality risk, whereas long‐term outcome for patients with NSTEMI and stable angina pectoris is comparable with other high surgical risk patients with unprotected left main lesion. Further, TLR rates and risk of stent thrombosis were low. © 2009 Wiley‐Liss, Inc.     

Effect of sex difference in clinical presentation (stable coronary artery disease vs unstable angina pectoris or non‐ST‐elevation myocardial infarction vs ST‐elevation myocardial infarction) on 2‐year outcomes in patients undergoing percutaneous coronary intervention

Objective

To determine whether there is a difference in 2‐year prognosis among patients across the spectrum of coronary artery disease undergoing percutaneous coronary intervention (PCI).

Methods

We analyzed all consecutive patients undergoing PCI at a single center from 1/1‐12/31/2013. Clinical presentations were compared between sexes according to baseline clinical, angiographic, and procedural characteristics and 2‐year (mean 730 ± 30‐day) outcomes.

Results

We grouped 10 724 consecutive patients based on sex and clinical presentation. Among patients with ST‐elevation myocardial infarction (STEMI), rates of all‐cause death (6.7% vs 1.4%) and cardiac death (3.8% vs 1.1%) were significantly higher in women than in men (P < 0.05), but these rates did not differ between men and women with stable coronary artery disease (SCAD) and non‐ST‐elevation acute coronary syndrome ((NSTE‐ACS). Incidence of major bleeding was greater than in men only in those women presenting with ACS. After multivariable adjustment, female sex was not an independent predictor of outcomes in STEMI (hazard ratio [HR] for all‐cause death: 1.33, 95% confidence interval [CI]:0.52‐3.38; P = 0.55; HR for cardiac death: 0.69, 95%CI: 0.23‐2.09, P = 0.51], but was still an independent predictor of bleeding in STEMI (HR: 3.53, 95%CI: 1.26‐9.91, P = 0.017).

Conclusion

Among STEMI patients, women had worse 2‐year mortality after PCI therapy, but female sex was not an independent predictor of mortality after adjustment for baseline characteristics. In STEMI patients, women were at higher bleeding risk than men after PCI, even after multivariable adjustment.