Cumulative Major Adverse Cardiac Events Rate Research Articles

Prognostic Value of Microvascular Resistance Reserve Measured Immediately After PCI in Stable Coronary Artery Disease.

Microvascular resistance reserve (MRR) has been proposed as a specific metric to quantify coronary microvascular function. The long-term prognostic value of MRR measured in stable patients immediately after percutaneous coronary intervention (PCI) is unknown. This study sought to determine the prognostic value of MRR measured immediately after PCI in patients with stable coronary artery disease. This study included 502 patients with stable coronary artery disease who underwent elective PCI and coronary physiological measurements, including pressure and flow estimation using a bolus thermodilution method after PCI. MRR was calculated as coronary flow reserve divided by fractional flow reserve times the ratio of mean aortic pressure at rest to that at maximal hyperemia induced by hyperemic agents. An abnormal MRR was defined as ≤2.5. Major adverse cardiac events (MACEs) were defined as a composite of all-cause mortality, any myocardial infarction, and target-vessel revascularization. During a median follow-up of 3.4 years, the cumulative MACE rate was significantly higher in the abnormal MRR group (12.5 versus 8.3 per 100 patient-years; hazard ratio 1.53 [95% CI, 1.10-2.11]; P<0.001). A higher all-cause mortality rate primarily drove this difference. On multivariable analysis, a higher MRR value was independently associated with lower MACE and lower mortality. When comparing 4 subgroups according to MRR and the index of microcirculatory resistance, patients with both abnormal MRR and index of microcirculatory resistance (≥25) had the highest MACE rate. An abnormal MRR measured immediately after PCI in patients with stable coronary artery disease is an independent predictor of MACE, particularly all-cause mortality.

Prognostic Value of Cardiac Magnetic Resonance Imaging in Patients With a Working Diagnosis of MINOCA-An Outcome Study With up to 10 Years of Follow-Up.

Patients with a working diagnosis of myocardial infarction with unobstructed coronary arteries (MINOCA) represent a heterogeneous cohort. The prognosis could vary substantially depending on the underlying cause. Although cardiac magnetic resonance (CMR) is considered a key diagnostic tool in these patients, there are limited data linking the CMR diagnosis with the outcome. This study is a prospective outcomes registry of consecutive patients presenting with a working diagnosis of MINOCA who were clinically referred for CMR at an academic hospital from October 2003 to February 2020. We assessed the relationships between the prespecified CMR diagnoses of acute myocardial infarction (AMI), myocarditis, nonischemic cardiomyopathy (NICM), normal CMR study, and major adverse cardiac events (MACEs). Of 252 patients, the CMR diagnosis was AMI in 63 (25%), myocarditis in 33 (13%), NICM in 111 (44%), normal CMR in 37 (15%), and other diagnoses in 8 (3%). A specific nonischemic cause was diagnosed allowing true MINOCA to be ruled-out in 57% of the cohort. During up to 10 years of follow-up (1595 patient-years), MACE occurred in 84 patients (33%), which included 64 deaths (25%). The unadjusted cumulative 10-year rate of MACE was 47% in AMI, 24% in myocarditis, 50% in NICM, and 3.5% in patients with a normal CMR (Log-rank P<0.001). The CMR diagnosis provided incremental prognostic value over clinical factors including age, gender, coronary artery disease risk factors, presentation with ST-elevation, and peak troponin (incremental χ² 17.9, P<0.001); and patients with diagnoses of AMI, myocarditis, and NICM had worse MACE-free survival than patients with a normal CMR. In patients with a working diagnosis of MINOCA, CMR allows ruling-out true MINOCA in over half of the patients. CMR diagnoses of AMI, myocarditis, and NICM are associated with worse MACE-free survival, whereas a normal CMR study portends a benign prognosis.

Association Between Serum Galectin-3 Levels and Coronary Stenosis Severity in Patients With Coronary Artery Disease.

BackgroundThe relationship between galectin-3 (Gal-3) and coronary artery disease (CAD) has not been fully elucidated.AimThis study aimed to determine the relationship between the presence and severity of CAD and serum Gal-3 levels.Patients and MethodsThree-hundred thirty-one consecutive CAD patients were enrolled as the study group. An additional 62 patients without CAD were enrolled as the control group. Serum Gal-3 levels were separately compared between the non-CAD and CAD groups, among the stable CAD and Acute coronary syndrome (ACS) groups, and between CAD patients with low and high SYNTAX scores (SSs). The 1-year cumulative rate of major adverse cardiac events (MACEs) was also compared among ACS patients by Gal-3 levels.ResultsSerum Gal-3 was significantly higher in the CAD group than in the non-CAD group 3.89 (0.16–63.67) vs. 2.07 (0.23–9.38) ng/ml, P < 0.001. Furthermore, serum Gal-3 was significantly higher in the non-ST-segment elevation ACS (NSTE-ACS) group than that in the stable CAD group, 4.72 (1.0–16.14) vs. 2.23 (0.65–23.8) ng/ml, P = 0.04 and higher in the ST-segment elevation myocardial infarction (STEMI) group than that in the stable CAD group 7.87 (0.59–63.67) vs. 2.23 (0.65–23.8) ng/ml, P < 0.001. Serum Gal-3 level was an independent predictor of ACS compared with stable CAD group (OR = 1.131, 95% CI: 1.051–1.217, P = 0.001) as well as high SS (OR = 1.030, 95% CI: 1.021–1.047, P = 0.038) after adjust other confounding risk factors. Acute coronary syndrome patients with Gal-3 levels above the median (gal-3 = 4.78 ng/ml) showed a higher cumulative MACE rate than those with Gal-3 levels below the median. After adjusting other confounding risk factors, Gal-3 remained an independent risk factor for the cumulative rate of MACEs in ACS patients (6% higher rate of MACEs incidence per 1 ng/ml increment of Gal-3).ConclusionGalectin-3 correlated with the presence of CAD as well as coronary stability and complexity. Galectin-3 may be valuable in predicting mid-term prognosis in ACS patients.

Long-term clinical outcomes of type 1 vs. type 2 myocardial infarction in patients who underwent angiography: data from the Korea acute myocardial infarction-national institute of health registry.

In the cause of increase the clinical research observational evidence on type 2 myocardial infraction (T2MI), the study compared the characteristics of T2MI and T1MI with respect to major adverse cardiac events (MACE) and mortality as long-term outcomes from a large, nationwide, prospective Korean cohort registry. From 13,105 consecutively enrolled individuals in the Korea Acute Myocardial Infarction-National Institute of Health (KAMIR-NIH) registry between October 2011 and December 2015, 11,053 acute myocardial infarction (AMI) patients were divided into the T1MI (n=10,545) and T2MI (n=508) groups. All patients completed ≥3 years of follow-up. The Kaplan-Meier curve analysis and Cox proportional hazard regression models showed that the cumulative rate of MACE was similar between the 2 groups (11.4% vs. 13.4%, log-rank P=0.185) at 3 years. However, the T2MI group showed higher rates of all-cause death [12.6% vs. 9.4%, log-rank P=0.019; hazard ratio (HR), 1.42; 95% CI: 1.08-1.85; P=0.012] and non-cardiac death (3.5% vs. 5.3%, log-rank P=0.043; HR, 1.55; 95% CI: 1.01-2.37; P=0.043) than the T1MI group. Male sex (HR 1.540; 95% CI: 1.218-1.947, P<0.001), old age (≥65 years; HR, 3.546; 95% CI: 2.645-4.753, P<0.001), low hemoglobin level (<12 g/dL; HR, 2.335; 95% CI: 1.841-2.961, P<0.001), high heart rate (>100 beats/min; HR, 1.852; 95% CI: 1.436-2.388, P<0.001), low glomerular filtration rate (GFR) (<60 mL/min/1.73 m2; HR, 2.373; 95% CI: 1.874-3.005, P<0.001), high body mass index (>25 kg/m2; HR, 0.644; 95% CI: 0.514-0.805, P<0.001), and low left ventricular ejection fraction (LVEF) (<40%; HR, 1.487; 95% CI: 1.095-2.020, P=0.011) were the independent predictors for 3-year non-cardiac mortality. Although the 2 groups did not differ in MACE, the total mortality rate was higher in T2MI than in T1MI, especially non-cardiac mortality. The independent predictors for non-cardiac mortality were male sex, old age, anemia, low GFR, tachycardia, obesity, and low LVEF.

Safety and Feasibility of Same Day Discharge Strategy for Primary Percutaneous Coronary Intervention.

Background:The strategy for early discharge after primary percutaneous coronary intervention (PCI) could have substantial financial benefits, especially in low-middle income countries. However, there is a lack of local evidence on feasibility and safety of the strategy for early discharge. Therefore, the aim of this study was to assess the safety of early discharge after primary PCI in selected low-risk patients in the population of Karachi, Pakistan.Methods:In this study 600 consecutive low-risk patients who were discharged within 48 hours of primary PCI were put under observation for major adverse cardiac events (MACE) after 7 and 30 days of discharge respectively. Patients were further stratified into discharge groups of very early (≤ 24 hours) and early (24 to 48 hours).Results:The sample consisted of 81.8% (491) male patients with mean age of 54.89 ± 11.08 years. Killip class was I in 90% (540) of the patients. The majority of patients (84%) were discharged within 24 hours of the procedure. Loss to follow-up after rate at 7 and 30 days was 4% (24) and 4.3% (26) respectively. Cumulative MACE rate after 7 and 30 days was observed in 3.5% and 4.9%, all-cause mortality in 1.4% and 2.3%, cerebrovascular events in 0.9% and 1.4%, unplanned revascularization in 0.9% and 1.2%, re-infarction in 0.3% and 0.5%, unplanned re-hospitalization in 0.5% and 0.5%, and bleeding events in 0.5% and 0.5% of the patients respectively.Conclusion:It was observed that very early (≤ 24 hours) discharge after primary PCI for low-risk patients is a safe strategy subjected to careful pre-discharge risk assessment with minimal rate of MACE after 7-days as well as 30-days.

A Non-inferiority, Randomized Clinical Trial Comparing Paclitaxel-Coated Balloon Versus New-Generation Drug-Eluting Stents on Angiographic Outcomes for Coronary De Novo Lesions

BackgroundDrug-coated balloon (DCB) has been proved efficacy for coronary small vessel disease, but data regarding outcomes of DCB in common de novo lesions (including reference vessel diameter more than 3.0mm) compared with new-generation drug-eluting stent (DES) are lacking. We hypothesized that a DCB-only strategy for coronary de novo lesions would be non-inferior to DES treatment on angiographic outcomes.MethodsIn this randomized controlled trial, we compared the effect of DCB with DES on late lumen loss (LLL) at 9-month angiographic follow-up and 12-month major adverse cardiac events (MACEs), including death, non-fatal myocardial infarction, target lesion revascularization (TLR), and target vessel revascularization (TVR).ResultsFrom July 2017 to July 2018, 288 consecutive patients with reference vessel diameter (RVD) between 2.25 and 4.0mm were screened. After proper pre-dilation, 170 patients were enrolled and randomized to the DCB and the DES groups at 1:1 ratio. Seven patients withdrew the consent forms during hospital stay (1 in DCB group, 6 in DES group). Two patients in DCB group underwent bailout stenting due to severe dissection after DCB release. The primary endpoint of 9-month LLL was −0.19±0.49mm with the DCB versus 0.03±0.64mm with the DES. The one-sided 97.5% upper confidence limit of the difference was −0.04mm, achieving non-inferiority of the DCB compared with the DES (P=0.019). The 12-month cumulative MACE rate was similar in the DCB and DES groups (2.44% vs. 6.33%, P=0.226).ConclusionsIn this prospective study, the DCB only strategy for de novo lesion was non-inferior to the new-generation DES in terms of 9-month late lumen loss.

Changes over time in serum albumin levels predict outcomes following percutaneous coronary intervention

BackgroundSerum albumin (SA) is a powerful prognostic marker in patients with cardiovascular diseases. ObjectivesTo evaluate the prognostic significance of changes in SA levels among patients that underwent percutaneous coronary intervention (PCI). MethodsPatients who underwent PCI in a tertiary medical center throughout 2004–2017 were considered for the study. Patients with missing SA values within the year before or 5 years after the PCI were excluded from the study as well as those for whom SA values were obtained throughout an acute infection. Changes in albumin were represented by Δalbumin: Albumin before PCI (closest) minus lowest albumin within the 5 years following the PCI. Δalbumin was categorized into 4 categories as follows: ≤0 g/dL, 0-0.5 g/dL, 0.5–1 g/dL, ≥1 g/dL. Primary outcome was major adverse cardiac events (MACE) that included all-cause mortality, non-fatal myocardial infarction, target vessel re-vascularization, and coronary artery bypass surgery. ResultsThe study included 5449 out of 21,763 (25%) patients, mean age 66.8 ± 12 years, 26% women. Patients with greater Δalbumin were older with higher prevalence of most cardiovascular risk factors and comorbidity. The follow-up period was 7 years (median), with cumulative MACE rate of 49.5%. MACE rates and the rates of all the MACE components increased gradually with the increase in Δalbumin. Multivariate adjusted analysis showed that Δalbumin is an independent predictor of long-term MACE following PCI [HR = 1.4 (95%CI:1.3-1.6), HR = 2.2 (95%CI:1.9-2.5), HR = 3.8 (95%CI:3.3–4.35) for Δalbumin of 0-0.5 g/dL, 0.5–1 g/dL, ≥1 g/dL, respectivelyp < 0.001 for all]. ConclusionsA decrease in albumin levels following PCI is an independent prognostic marker of worse long-term outcomes.

Three-Year Outcomes of Biodegradable Polymer-Coated Ultra-Thin (60 µm) Sirolimus-Eluting Stents in Real-World Clinical Practice

Although drug-eluting stents (DES) have outclassed the use of bare metal stents, the safety and efficacy of DES at long-term follow-up has still been conflicting because of increased occurrence of late or very late restenosis and stent thrombosis after DES implantation. Hence, the present study was aimed to evaluate the 3-year safety and clinical performance of biodegradable polymer-coated ultra-thin (60 µm) sirolimus-eluting stent (SES) in real-world patients with coronary artery disease (CAD). This was a physician-initiated, retrospective, single-centre, observational study that included 237 consecutive patients who had previously undergone implantation of only Supraflex SES (Sahajanand Medical Technologies Pvt Ltd, Surat, India) for the treatment of CAD. Follow-up was received after 1 year and 3 years of stent implantation. The primary endpoint was major adverse cardiac events (MACE), a composite of cardiac death, myocardial infarction (MI) and target lesion revascularisation (TLR). Stent thrombosis was considered as a safety endpoint. The mean age of patients was 64.1 ± 10.2 years, and 192 (81.0%) patients were male. The average stent length and diameter were 24.4 ± 9.0 mm and 3.1 ± 0.4 mm, respectively. The cumulative MACE rate at 3 years follow-up was 6.5% which included 4 (1.8%) cardiac deaths, 6 (2.8%) MI, and 4 (1.8%) TLR. There were 2 (0.9%) cases of stent thrombosis. Treatment of patients with CAD in real-world clinical practice was associated with sustained clinical safety and low rates of restenosis, stent thrombosis and MACE up to 3 years after Supraflex SES implantation.

Registro de lesiones coronarias difusas tratadas con stents liberadores de fármacos ≥ 40 mm

IntroductionLong lesions present special challenges for interventional cardiologists, including increased risk of restenosis and complications. We assessed the clinical outcome of real-world patients treated with ≥40mm drug-eluting stents (DES). MethodsProspective observational study of consecutive patients with a very long coronary lesion (> 35mm) treated by percutaneous coronary intervention with one implanted Xience Xpedition (Abbott Vascular) everolimus-eluting stent (EES) and Biomime (Palex Medical) sirolimus-eluting stent (SES) ≥40mm. We collected major adverse cardiac events (MACE) including cardiac death, nonfatal myocardial infarction and target lesion revascularization (TLR). Results94 real-world patients with 113 lesions (80% male, 63.8±10 years, 55% smoker, 77% hypertensive, 41.5% diabetic, 58% hyperlipidemic) were enrolled in the study. Clinical presentation was acute coronary syndrome in 80%. Bifurcation lesions account 44%, ostial 32%, calcified 87%, thrombotic 20.6% and 22.7% were CTO. Mean lesion length was 57.9±19mm, and mean stent length was 46±2.5mm, with overlapped stents in 59%. The total length (in mm) of stent per lesion was 64±21mm. 47 EES were implanted in 45 patients and 45 SES in 35 patients. At 14.8±11 month follow-up, 4 (4.3%) patients had died from cardiac causes, 2 (2.1%) had a nonfatal myocardial infarction and 3 (3.2%) underwent TLR. One patient had a subacute stent thrombosis (2 overlapped SES stents=1.1%). The cumulative rate of MACE was 9.6%. ConclusionsPatients with complex very long coronary lesions in a real-world population treated with long DES (≥40mm) are associated with excellent procedural results and good clinical outcomes at long term follow-up.

Angiographic and clinical performance of polymer-free biolimus-eluting stent in patients with ST-segment elevation acute myocardial infarction in a metropolitan public hospital: The BESAMI MUCHO study.

This study aimed at assessing the performance of a new generation polymer-free biolimus-eluting stent (BES) in real-world patients with ST-segment elevation myocardial infarction (STEMI). Polymers components of early-generation drug-eluting stents have been implicated in the pathogenesis of delayed arterial healing, vessel remodeling, and delayed stent thrombosis. Recently, a novel polymer-free BES has shown excellent clinical performance in clinical trial setting. Overall, 175 consecutive patients (64 ± 14 years, 141 men) treated with the BioFreedom (Biosensors Europe, Morges, Switzerland) polymer-free BES because of STEMI were included in this study. The primary endpoint was the rate of major adverse cardiac events (MACE), a composite of cardiac death, recurrent myocardial infarction, and ischemia-driven target vessel revascularization at 1year follow-up. A subgroup of patients underwent 6-month angiographic follow-up. Dual antiplatelet therapy was prescribed for 12 months after STEMI. At 1year, the cumulative rate of MACE was 4.6%. One patient (0.6%) had an arrhythmic cardiac death and five (2.9%) had ischemia-driven target vessel revascularization, although only three (1.7%) had target lesion revascularization. Two (1.1%) patients had acute stent thrombosis yielding nonfatal myocardial infarction. In 70 patients (63 ± 14 years, 61 men), quantitative coronary angiography at 6-month follow-up revealed diameter stenosis of 24.1 ± 13.7% and minimal lumen diameter of 2.29 ± 0.56 mm, yielding a late lumen loss of 0.13 ± 0.14 mm. In real-world setting, implantation of a new-generation polymer-free BES during STEMI is associated with favorable clinical and angiographic results, pointing toward the overall efficacy and safety of the device in complex clinical scenarios.

Clinical Significance of Lipid-Rich Plaque Detected by Optical Coherence Tomography: A 4-Year Follow-Up Study

BackgroundLipid-rich plaque (LRP) is thought to be a precursor to cardiac events. However, its clinical significance in coronary arteries has never been systematically investigated. ObjectivesThis study investigated the prevalence and clinical significance of LRP in the nonculprit region of the target vessel in patients undergoing percutaneous coronary intervention (PCI). MethodsThe study included 1,474 patients from 20 sites across 6 countries undergoing PCI, who had optical coherence tomography (OCT) imaging of the target vessel. Major adverse cardiac events (MACE) were defined as a composite of cardiac death, acute myocardial infarction, and ischemia-driven revascularization. Patients were followed for up to 4 years (median of 2 years). ResultsLipid-rich plaque was detected in nonculprit regions of the target vessel in 33.6% of patients. The cumulative rate of nonculprit lesion-related MACE (NC-MACE) over 48 months in patients with LRP was higher than in those without LRP (7.2% vs. 2.6%, respectively; p = 0.033). Acute coronary syndrome at index presentation (risk ratio: 2.538; 95% confidence interval [CI]: 1.246 to 5.173; p = 0.010), interruption of statin use ≥1 year (risk ratio: 4.517; 95% CI: 1.923 to 10.610; p = 0.001), and LRP in nonculprit regions (risk ratio: 2.061; 95% CI: 1.050 to 4.044; p = 0.036) were independently associated with increased NC-MACE. Optical coherence tomography findings revealed that LRP in patients with NC-MACE had longer lipid lengths (p < 0.001), wider maximal lipid arcs (p = 0.023), and smaller minimal lumen areas (p = 0.003) than LRPs in patients without MACE. ConclusionsPresence of LRP in the nonculprit regions of the target vessel by OCT predicts increased risk for future NC-MACE, which is primarily driven by revascularization for recurrent ischemia. Lipid-rich plaque with longer lipid length, wider lipid arc, and higher degree of stenosis identified patients at higher risk of future cardiac events. (The Massachusetts General Hospital Optical Coherence Tomography Registry; NCT01110538)

Orbital atherectomy for treating de novo , severely calcified coronary lesions: 3-year results of the pivotal ORBIT II trial

The presence of heavy coronary artery calcification increases the complexity of percutaneous coronary intervention (PCI) and increases the incidence of major adverse cardiac events (MACE): death, myocardial infarction (MI), target vessel revascularization (TVR), and stent thrombosis. The ORBIT II (Evaluate the Safety and Efficacy of OAS in Treating Severely Calcified Coronary Lesions) trial reported low rates of procedural, 30-day, 1-year, and 2-year ischemic complications after treatment of de novo, severely calcified lesions with the Diamondback 360° Coronary Orbital Atherectomy System (OAS) (Cardiovascular Systems, Inc.). ORBIT II was a single-arm trial that enrolled 443 patients at 49U.S. sites; in this study, de novo, severely calcified coronary lesions were treated with OAS prior to stenting. The primary safety endpoint was 30-day MACE: the composite of cardiac death, MI, and TVR (inclusive of target lesion revascularization (TLR)). The primary efficacy endpoint was procedural success: stent delivery with a residual stenosis of <50% without the occurrence of in-hospital MACE.The present analysis reports the final, 3-year follow-up results from ORBIT II. The majority of subjects (88.2%) underwent PCI with drug-eluting stents after orbital atherectomy. There were 360 (81.3%) subjects who completed the protocol-mandated 3-year visit.The overall cumulative rate of 3-year MACE was 23.5%, including cardiac death (6.7%), MI (11.2%), and TVR (10.2%). The 3-year target lesion revascularization rate was 7.8%. In the final 3-year analysis of the ORBIT II trial, orbital atherectomy of severely calcified coronary lesions followed by stenting resulted in a low rate of adverse ischemic events compared with historical controls.Orbital atherectomy represents a safe and effective revascularization strategy for patients with severely calcified coronary lesions. The ORBIT II trial enrolled 443 subjects to study orbital atherectomy followed by stenting for de novo severely calcified coronary lesions. The overall cumulative 3-year MACE rate was 23.5%, including cardiac death (6.7%), MI (11.2%), and TVR (10.2%); the 3-year target lesion revascularization rate was 7.8%. Orbital atherectomy of heavily calcified coronary lesions followed by stenting results in a low rate of adverse ischemic events compared with historical controls; it represents a reasonable revascularization strategy for patients with severely calcified coronary lesions.

A propensity score matched comparative study between paclitaxel‐coated balloon and everolimus‐eluting stents for the treatment of small coronary vessels

To compare the long-term clinical outcomes of paclitaxel drug-coated-balloons (DCB) and everolimus-eluting-stents (EES) following the treatment of de novo small vessel coronary artery disease. It is currently unclear whether treatment of de novo small vessel coronary disease with DCB is comparable to second generation drug-eluting stents, which are the current standard of care. The present study enrolled 90 patients with small vessel coronary disease from the DCB treatment arm of the BELLO (Balloon Elution and Late Loss Optimization) trial and 2,000 patients treated with EES at the San Raffaele Scientific Institute. Propensity score matching was performed to adjust for differences in baseline clinical and angiographic characteristics, yielding a total of 181 patients: 90 patients with 94 lesions receiving DCB and 91 patients with 94 lesions receiving EES. Major adverse cardiac events (MACE) were defined as the composite of cardiac death, recurrent non-fatal myocardial infarction, and target vessel revascularization. After propensity score matching, baseline clinical and angiographic characteristics were similar between the two groups. The cumulative MACE rate at 1-year was 12.2% with DCB and 15.4% with EES (P = 0.538). Patients in the DCB group had similar TLR rates as compared to EES over the same interval (4.4% vs. 5.6%; P = 0.720). There were no cases of definite or probable stent or vessel thrombosis. The use of paclitaxel-DCB appears to be associated with similar clinical outcomes when compared to second-generation-EES in small coronary artery disease. The findings of this study should be confirmed with larger prospective randomized studies with longer follow-up. © 2017 Wiley Periodicals, Inc.

Prognostic Implications of Newly Developed T-Wave Inversion After Primary Percutaneous Coronary Intervention in Patients With ST-Segment Elevation Myocardial Infarction

We investigated the prognostic value of newly developed T-wave inversion after primary percutaneous coronary intervention (PCI) in patients with ST-segment elevation myocardial infarction. New T-wave inversion was defined as new onset of T-wave inversion after the primary PCI, without negative T waves on the presenting electrocardiogram. The primary end point was the occurrence of major adverse cardiac events (MACE), which consisted of cardiovascular mortality, nonfatal myocardial infarction, and rehospitalization for heart failure. A total of 271 patients were analyzed and followed up for 24months in this study. New T-wave inversion was observed in 194 patients (72%), whereas the remaining 77 patients (28%) did not show T-wave inversion after the index PCI. Post-PCI Thrombolysis In Myocardial Infarction flow grade 2 or 3 was observed more frequently in patients with new T-wave inversion (97% vs 90%; p= 0.011). The cumulative MACE rate was significantly lower in patients with new T-wave inversion than in those without new T-wave inversion (8% vs 30%; odds ratio 0.197, 95% confidential interval 0.096 to 0.403; p <0.001). In multivariate Cox regression analysis, new T-wave inversion was an independent prognostic factor for MACE (hazard ratio 0.297, 95% confidential interval 0.144 to 0.611; p=0.001). In conclusion, newly developed T-wave inversion after primary PCI was associated with favorable long-term outcome.

Contemporary sex differences among patients with acute coronary syndrome treated by emergency percutaneous coronary intervention

Acute coronary syndrome (ACS) is an important cause of mortality and morbidity in the general population. Recent advances in percutaneous coronary intervention (PCI) and optimal medical treatment have helped to improve the prognosis of patients with ACS. The previous reports indicated that women with ACS have a higher risk of adverse outcomes. However, sex differences in clinical outcomes with contemporary coronary revascularization and medical therapy for ACS have not been elucidated. We analyzed data from 676 consecutive patients with ACS (female, n=166; male, n=510) who were treated by emergency PCI between 2011 and 2014 at Juntendo Shizuoka Hospital. The patients were grouped according to sex. We defined major adverse cardiovascular events as a composite of all-cause death and ACS recurrence at 1year and compared rates of major adverse cardiac events (MACE) between the groups. Women were older (75.4±11.0 vs. 66.2±12.2years) and had a higher rate of multi-vessel disease, chronic kidney disease, and Killip IV at presentation. The cumulative rate of MACE at 1year was significantly higher among women than men (17.5 vs. 10.2%, p=0.02, log-rank test). However, the association between women and a higher risk of MACE was attenuated after adjusting for age (HR 1.25, 95% CI 0.77-2.00, p=0.36) and other variables (HR 0.93, 95% CI 0.36-2.44, p=0.88). Adjustment for age and other risk factors attenuated sex differences in mid-term clinical outcomes among patients with ACS after emergency PCI.

Impact of gender difference on long-term outcomes of percutaneous coronary intervention for coronary artery disease in patients under statin treatment

The incidence of adverse outcomes after percutaneous coronary intervention (PCI) is higher in women than in men. Statins reduce the likelihood of cardiovascular events arising in patients with coronary artery disease (CAD), but the impact of gender difference on long-term outcomes of PCI for CAD under statin treatment has not been established. We prospectively enrolled 3,580 consecutive patients with CAD who were treated by PCI at our institution between 2000 and 2011. Among these, 2,009 (43.9%; male, n=1619; female, n=390) were under statin therapy at the time of PCI. We evaluated the incidence of major adverse cardiac events (MACE) including all-cause death and acute coronary syndrome (ACS). Age was significantly more advanced and the prevalences of hypertension and chronic kidney disease were higher among the female, than the male patients. Low-density lipoprotein cholesterol levels were significantly higher in women than in men (111.5±38.9 vs. 107.5±3 3.9mg/dL, p=0.04). During a median follow-up period of 6.3years, MACE that occurred in 336 (16.7%) patients included 206 (10.2%) with all-cause death and 154 (7.7%) with ACS. The cumulative rate of MACE tended to be higher in women than in men but the difference did not reach significance (19.7 vs. 16.0%; p=0.08, log-rank test). Multivariable Cox regression analysis showed that being female was not associated with MACE after adjusting for age (HR 1.22; 95% CI 0.94-1.57; p=0.13) and other variables (HR 1.14; 95% CI 0.86-1.49; p=0.35). Long-term clinical outcomes were comparable between male and female patients with coronary artery disease who were administered with statins and underwent PCI even though the baseline characteristics were worse among the females.

Clinical Outcomes in Patients with Deferred Coronary Lesions according to Disease Severity Assessed by Fractional Flow Reserve.

Data on the clinical outcomes in deferred coronary lesions according to functional severity have been limited. This study evaluated the clinical outcomes of deferred lesions according to fractional flow reserve (FFR) grade using Korean FFR registry data. Among 1,294 patients and 1,628 lesions in Korean FFR registry, 665 patients with 781 deferred lesions were included in this study. All participants were consecutively categorized into 4 groups according to FFR; group 1: ≥ 0.96 (n = 56), group 2: 0.86–0.95 (n = 330), group 3: 0.81–0.85 (n = 170), and group 4: ≤ 0.80 (n = 99). Primary endpoint was major adverse cardiac events (MACE), a composite of all-cause death, myocardial infarction, and target vessel revascularization. The median follow-up period was 2.1 years. During follow-up, the incidence of MACE in groups 1–4 was 1.8%, 7.6%, 8.8%, and 13.1%, respectively. Compared to group 1, the cumulative rate by Kaplan-Meier analysis of MACE was not different for groups 2 and 3. However, group 4 had higher cumulative rate of MACE compared to group 1 (log-rank P = 0.013). In the multivariate Cox hazard models, only FFR (hazard ratio [HR], 0.95; P = 0.005) was independently associated with MACE among all participants. In contrast, previous history of percutaneous coronary intervention (HR, 2.37; P = 0.023) and diagnosis of acute coronary syndrome (ACS) (HR, 2.35; P = 0.015), but not FFR, were independent predictors for MACE in subjects with non-ischemic (FFR ≥ 0.81) deferred coronary lesions. Compared to subjects with ischemic deferred lesions, clinical outcomes in subjects with non-ischemic deferred lesions according to functional severity are favorable. However, longer-term follow-up may be necessary.

TCT-638 Five-year Clinical Outcomes of Drug Eluting Stents Versus Bare Metal Stents in Patients With Large Vessel and Single Coronary Lesion

Abstract nos: 638-640 TCT-638Five-year Clinical Outcomes of Drug Eluting Stents Versus Bare Metal Stents inPatients With Large Vessel and Single Coronary LesionKyuhwan Park 1 , Chan-Hee Lee , Yoon Jung Choi 1 , Tae Hun Kwon , Kanguni Choi ,Jang Won Son 1 , Sang-Hee Lee , Ung Kim , Jong Seon Park 1 , Dong-Gu Shin 1 ,Young-Jo Kim 1 , Jeong-Hwan Cho 2 , Sang Wook Kang 2 , Yoon-Kyung Cho 3 ,Hyungseop Kim 3 , Chang-Wook Nam , Seung-Ho Hur 3 , Kwon-Bae Kim ,Dong-Kie Kim 4 , Sang-Hoon Seol , Tae-Hyun Yang1Yeungnam University Medical Center, Daegu, Korea, Republic of, 2 Daegu VeteransHospital, Daegu, Korea, Republic of, 3 Keimyung University Dongsan Medical Center,Daegu, Korea, Republic of, 4 Inje University Haeundae Paik Hospital, Busan, Korea,Republic ofBackground: The aim of this study is to evaluate long term clinical outcomes of drug-eluting stent (DES) and bare metal stent(BMS) with large vessel diameter and singlecoronary lesions for 5 years.Methods: Atotalof428consecutivepatientswhovisited3medicalcentersfromMarch2003toApril2007andhadasinglecoronarylesionwhichwastreatedwiththeuseofaDESorBMSthatwasmorethan3.5mmindiameterwereenrolledinthisstudy.Patientsweredividedinto2stentgroups:DES(n¼299),BMS(n¼129).Thestudyendpointwasa composite of major adverse cardiac events (MACE) including death, myocardialinfarction (MI), and target-vessel revascularization (TVR) for five yearsResults: Baseline characteristics were not different. 5 years follow up rate was 82.5%(355/428). The cumulative MACE rate for 5 years were not different between twogroup ( 20.4% in BMS vs. 18% in DES, p¼0.592). The rate of MI (3.1% in BMS vs.2.4% in DES, p¼0.513), death (3.7% in BMS vs. 2.0% in DES, p¼0.361) and TVR(12% in BMS vs. 10.6% in DES, p¼0.694) were not different. There was no dif-ference in MACE-free survival rate between the DES group and the BMS group(93.1% in DES vs 90.7% in BMS, P¼0.472).Conclusions: Clinical outcomes between DES and BMS are similar in a large vesseldiameter and single coronary arterial lesion for 5 years.TCT-639Impact Of The Length Of Bare Metal Stent On Clinical Events AfterPercutaneous Coronary Intervention In Current Clinical PracticeIgnacio Sanchez-Perez

One-year follow-up of patients treated with new-generation polymer-based 38 mm everolimus-eluting stent: the P38 study.

To assess the clinical outcome at 1-year follow-up of real-world patients with long coronary lesions treated with the 38 mm Xience Prime (Abbott Vascular) everolimus-eluting stent (EES). Long-lesions present special challenges to the interventional cardiologists, including increased risk of restenosis, periprocedural injury, geographical miss, and stent deliverability. Indeed, results obtained with shorter stent in the treatment of simpler lesions are of limited applicability to longer stents. Consecutive patients presenting with a long coronary lesion treated by percutaneous coronary intervention with at least one implanted 38 mm EES were enrolled in the study. Their clinical data were prospectively registered. Major adverse cardiac events (MACE) were defined as a composite of cardiac death, nonfatal myocardial infarction (according to the Universal Definition) and target vessel revascularization. Stent thrombosis was defined according to the Academic Research Consortium criteria. Overall, 203 real-world patients (152 men, 68 ± 9 years) were enrolled in the P38 Study. At 1-year follow-up, 6 (3.0%) patients had died from cardiac causes, 7 (3.4%) had a nonfatal myocardial infarction and 8 (3.9%) underwent target vessel revascularization, yielding a 10.3% cumulative rate of MACE. Two patients had a stent thrombosis (one definite and one probable). No significant differences in event rates were found between patients with and without an additional stent implanted overlapping the 38 mm one. The use of a new-generation polymer-based 38 mm EES in a real-world population with unselected long lesions is associated with excellent procedural results and good clinical outcomes at 12-month follow-up.

Ten-year clinical follow-up after sirolimus-eluting stent implantation

Little is known on the "very" long-term incidence of major adverse cardiac events (MACE), target-lesion revascularization (TLR), target-vessel revascularization and stent thrombosis after sirolimus-eluting stent (SES) implantation. We present the first study to provide a 10-year clinical follow-up in an unselected patient population who underwent SES implantation. We ran a systematic 10-year clinical follow-up in a series of 200 consecutive patients treated with unrestricted SES implantation between April 2002 and April 2003 in two Swiss hospitals. Outcomes and follow-up were obtained in all 200 patients. The cumulative 10-year MACE rate was 47% with all-cause death of 20%, cardiac death of 9%, myocardial infarction of 7%, TLR and target-vessel revascularization of 8% and 11% respectively. Academic Research Consortium-defined "definite and probable" stent thrombosis-rate was 2.5%. TLR risk was maximal between 3 to 6 years. New lesion revascularization increased throughout the study period. Incidence of TLR was maximal 3 to 6 years after SES implantation and decreased thereafter. MACE and non-TLR revascularization rates steadily increased during the complete follow-up underlining the progression of coronary artery disease.