Objective Evidence Of Ischemia Research Articles

Value of different CTO scoring systems in predicting procedural success in coronary chronic total occlusion intervention in Egyptian patients

BackgroundChronic total occlusion (CTO) lesions in coronary arteries pose a significant challenge for coronary interventionists, often leading to referrals for coronary artery bypass graft surgery (CABG). Successful percutaneous coronary intervention (PCI) for CTOs requires accurate assessment of procedural potential. This study, comprising 100 Egyptian patients aged 37–81, compares the predictive efficacy of various CTO scoring systems in PCI success determination. Patients with CTO in at least one coronary artery, planned for elective PCI based on objective evidence of ischemia, were included. Experienced operators performed PCI, recording procedural variables, and assessing complications. Logistic regression analysis revealed an inverse linear relationship between success rates and score values across all systems.ResultsAlthough, the predictive capacity of the scores was similar, with slight differences. The Euro CTO (CASTLE) score10 exhibited superior predictive efficacy, followed by the CL score9, while PROGRESS8 and J-CTO7 scores showed lower significance. ORA CTO11 score demonstrated intermediate predictive ability, and PROGRESS score8 had the least predictive value.ConclusionThe CASTLE score10 proved most effective in predicting PCI success for CTO cases in Egyptian patients, with operators advised to choose scoring systems based on experience and case characteristics. Proper planning remains crucial for optimizing success rates in CTO PCI procedures, irrespective of the scoring system employed.

A Placebo-Controlled Trial of Percutaneous Coronary Intervention for Stable Angina

BackgroundPercutaneous coronary intervention (PCI) is frequently performed to reduce the symptoms of stable angina. Whether PCI relieves angina more than a placebo procedure in patients who are not receiving antianginal medication remains unknown.MethodsWe conducted a double-blind, randomized, placebo-controlled trial of PCI in patients with stable angina. Patients stopped all antianginal medications and underwent a 2-week symptom assessment phase before randomization. Patients were then randomly assigned in a 1:1 ratio to undergo PCI or a placebo procedure and were followed for 12 weeks. The primary end point was the angina symptom score, which was calculated daily on the basis of the number of angina episodes that occurred on a given day, the number of antianginal medications prescribed on that day, and clinical events, including the occurrence of unblinding owing to unacceptable angina or acute coronary syndrome or death. Scores range from 0 to 79, with higher scores indicating worse health status with respect to angina.ResultsA total of 301 patients underwent randomization: 151 to the PCI group and 150 to the placebo group. The mean (±SD) age was 64±9 years, and 79% were men. Ischemia was present in one cardiac territory in 242 patients (80%), in two territories in 52 patients (17%), and in three territories in 7 patients (2%). In the target vessels, the median fractional flow reserve was 0.63 (interquartile range, 0.49 to 0.75), and the median instantaneous wave-free ratio was 0.78 (interquartile range, 0.55 to 0.87). At the 12-week follow-up, the mean angina symptom score was 2.9 in the PCI group and 5.6 in the placebo group (odds ratio, 2.21; 95% confidence interval, 1.41 to 3.47; P<0.001). One patient in the placebo group had unacceptable angina leading to unblinding. Acute coronary syndromes occurred in 4 patients in the PCI group and in 6 patients in the placebo group.ConclusionsAmong patients with stable angina who were receiving little or no antianginal medication and had objective evidence of ischemia, PCI resulted in a lower angina symptom score than a placebo procedure, indicating a better health status with respect to angina. (Funded by the National Institute for Health and Care Research Imperial Biomedical Research Centre and others; ORBITA-2 ClinicalTrials.gov number, NCT03742050.)

Health outcomes in patients with chronic coronary syndromes due to obstructive or non-obstructive coronary arteries

Abstract Background Angina is the clinical hallmark of myocardial ischaemia and often arises from obstructive coronary artery disease (diagnosed as stable CAD), for which there are established guideline therapies. However, when coronary angiography does not reveal obstructive CAD (i.e. &amp;lt;50% stenoses), the management pathway for these patients with Angina with Non-Obstructive Coronary Arteries (ANOCA) is less clear. Purpose To compare the clinical characteristics and outcomes of patients with Stable CAD vs. ANOCA, who were referred to invasive angiography for the assessment of angina. Methods Consecutive angina patients undergoing elective coronary angiography enrolled in the CADOSA (Coronary Angiogram Database of South Australia) Registry between 2012-2018 were included. In-hospital clinical data was extracted from CADOSA and mortality and hospitalisation data over 3 years was extracted via administrative records. Results Among 30,015 angiograms performed, there were 2,245 ANOCA (&amp;lt;50% stenosis), and 4,131 Stable CAD (≥50% stenosis) patients. ANOCA patients were younger (61±11 vs 66±11, p&amp;lt;0.05) and more often female (59% vs 27%, p&amp;lt;0.05) compared to Stable CAD. ANOCA and Stable CAD patients were indistinguishable in relation to (i) chest pain quality (tightness, 42% vs 41%, p&amp;gt;0.05) (ii) chest pain precipitant (exertion, 60% vs 65%, p&amp;lt;0.05), (iii) relieving factors (nitrates 20% vs 22%, p&amp;gt;0.05). Further, the frequency of non-invasive ischaemia test prior to angiography (64% vs 62%, p&amp;lt;0.05) and objective evidence of ischaemia (70% vs 77%, p&amp;gt;0.05) was similar between ANOCA and Stable CAD. In contrast, discharge therapies differed markedly between ANOCA and Stable CAD patients in (i) cardioprotective agents (81% vs 96%, respectively), and (ii) anti-ischaemic agents (75% vs 90%, respectively), all p&amp;lt;0.05. Only 6% of ANOCA patients received further cardiac investigation whereas revascularisation was undertaken in 35% of the Stable CAD cohort. All-cause mortality at 3 years was higher in Stable CAD patients compared to ANOCA (3% vs 2%, p&amp;lt;0.05). There were frequent return hospital visits for chest pain in both Stable CAD and ANOCA patients over 3 years including (i) emergency presentation (24% vs 18%, respectively) and (ii) hospital admission (18% vs 11%, respectively), all p&amp;lt;0.05. Conclusion Prior to angiography, the chest pain features, and non-invasive ischaemic markers are indistinguishable in ANOCA and Stable CAD patients. However, following angiography, Stable CAD patients receive an appropriate diagnosis and guideline therapy. In contrast, the ANOCA patients (a) seldom receive additional investigation to identify the underlying angina mechanisms, (b) are less often prescribed cardioprotective and anti-anginal agents, (c) yet often experience recurrent symptoms. This study underscores the need to focus improvement on diagnostic work-up for ANOCA and therapies targeted at managing symptoms.

A double-blind randomised placebo-controlled trial of percutaneous coronary intervention for the relief of stable angina without antianginal medications: design and rationale of the ORBITA-2 trial.

Percutaneous coronary intervention (PCI) is frequently performed for stable angina. However, the first blinded trial, ORBITA, did not show a placebo-controlled increment in exercise time in patients with single-vessel disease, at 6 weeks, on maximal antianginal therapy. ORBITA-2 will assess the placebo-controlled efficacy of PCI on angina frequency in patients with single- or multivessel disease, at 12 weeks, on no antianginal therapy. ORBITA-2 is a double-blind placebo-controlled trial randomising participants with (i) angina at presentation, (ii) documented angina during the 2-week pre-randomisation symptom assessment phase, (iii) objective evidence of ischaemia, (iv) single- or multivessel disease, and (v) clinical eligibility for PCI. At enrolment, antianginals will be stopped, and angina questionnaires completed. Participants will record their symptoms on a smartphone application daily throughout the trial and will undergo exercise treadmill testing and stress echocardiography at pre-randomisation. They will then undergo coronary angiography with unblinded invasive physiology assessment. Eligible participants will then be sedated to a deep level of conscious sedation and randomised 1:1 between PCI and placebo. After the 12-week blinded follow-up period, they will return for questionnaires, exercise testing and stress echocardiography assessment. If angina becomes intolerable, antianginals will be introduced using a prespecified medication protocol. The primary outcome is an angina symptom score using an ordinal clinical outcome scale for angina. Secondary outcomes include exercise treadmill time, angina frequency, angina severity and quality of life. Trial registration: ClinicalTrials.gov: NCT03742050.

Vasomotor Dysfunction in Patients with Ischemia and Non-Obstructive Coronary Artery Disease: Current Diagnostic and Therapeutic Strategies.

Many patients who present with symptoms or objective evidence of ischemia have no or non-physiologically-significant disease on invasive coronary angiography. The diagnosis of ischemic heart disease is thus often dismissed, and patients receive false reassurance or other diagnoses are pursued. We now know that a significant proportion of these patients have coronary microvascular dysfunction and/or vasospastic disease as the underlying pathophysiology of their clinical presentation. Making the correct diagnosis of such abnormalities is important not only because they impact the quality of life, with recurring symptoms and unnecessary repeated testing, but also because they increase the risk for adverse cardiovascular events. The mainstay of diagnosis remains an invasive comprehensive physiologic assessment, which further allows stratifying these patients into appropriate “endotypes”. It has been shown that tailoring treatment to the patient’s assigned endotype improves symptoms and quality of life. In addition to the conventional drugs used in chronic stable angina, multiple newer agents are being investigated. Moreover, innovative non-pharmacologic and interventional therapies are emerging to provide a bail-out in refractory cases. Many of these novel therapies fail to show consistent benefits, but others show quite promising results.

Old unsolved problems: when and how to treat silent ischaemia.

Silent myocardial ischaemia (SMI) is defined as objective evidence of ischaemia without angina (or equivalent symptoms) in the presence of coronary artery disease, differing from silent coronary artery disease. Silent myocardial ischaemia represents the majority of episodes of myocardial ischaemia at Holter monitoring. During transient myocardial ischaemia, the symptoms appear after the contraction anomalies of the left ventricle and after the ECG changes. The cause of silent myocardial ischaemia is still not well established. The severity and duration of ischaemia have been theorized as important elements in the SMI mechanism. Another possible mechanism responsible for SMI is represented by changes in the perception of painful stimuli with an increased pain threshold. Finally, a neuronal dysfunction of the diabetic, in post-infarction or a cardiac neuronal ‘stunning’ could play a role in SMI. In the pre-stent era, the SMI was associated with a worse prognosis. In patients with diabetes mellitus, SMI seems to be more represented because autonomic dysfunction is present in this category of patients. In conclusion, SMI is more frequent than symptomatic ischaemia. However, despite the presence of countless studies on the subject, it is not clear today whether medical therapy has equalized the risk and what the real prognosis of SMI is.

Abstract 269: Increasing Accuracy of Non-ST Elevation Myocardial Infarction Diagnosis Through Use of an Educational App Based on the Universal Definition of Myocardial Infarction

Background: There is a misconception among medicine trainees that an elevated troponin alone indicates a myocardial infarction (MI) even in the absence of ECG changes, imaging abnormalities, and/or typical symptoms. Misdiagnosis of non-ST elevation MI (NSTEMI) can lead to potentially harmful treatment, unneeded testing, and poor quality metrics. We tested the hypothesis that an educational app provided to trainees would increase accuracy of NSTEMI diagnoses. Methods: The app was designed using criteria for NSTEMI from the Third UDMI as well as revisions anticipated in the Fourth UDMI. An algorithm was designed to improve diagnostic accuracy of AMI by UDMI. The app was tested from 12/2017 to 08/2018. Accuracy of NSTEMI diagnosis was evaluated 4 months before and then 4 months after app implementation. 431 patient charts were reviewed. MI type was assigned based on the UDMI and assessed for accuracy. Unclear cases were adjudicated by an expert cardiologist. Results: 207 patients were in the intervention group and 224 were in the control group. Comparison revealed increased specificity of 33.6% (80.9% vs 47.3%) and increased positive predictive value of 19.7% (33.3% vs 13.6%) for NSTEMI diagnosis. Fisher’s exact test revealed a statistically significant difference for each change (p&lt;0.0001). Conclusion: Our app improved diagnostic specificity of NSTEMI by a statistically and clinically significant 33.6%. This was largely due to a substantial decrease in false positive diagnoses of patients with elevated biomarkers but no objective evidence of ischemia. This increased specificity saved patients and the hospital many unnecessary tests and procedures which likely led to improved quality of care and reduced cost. This app is a valuable tool that should be expanded to all hospital staff.

Coronary artery disease management and cost implications with fractional flow reserve guided coronary intervention in Indian patients with stable ischemic coronary artery disease.

To study the safety of stent avoidance, frequency of change in management decisions, and its cost implications while using a fractional flow reserve (FFR)-guided treatment strategy for intermediate-grade coronary artery stenosis. The impact of FFR in guiding management decisions and its cost implications has not been studied after imposition of a ceiling on stent prices by the Government of India. In 400 patients with 477 intermediate-grade coronary lesions for whom coronary intervention was planned, functional assessment using FFR was done. Incidence of the primary composite endpoint (major adverse cardiac event [MACE], cardiac death, myocardial infarction, objective evidence of ischemia, and target vessel revascularization) in the stent avoided subset was compared with the stented group at follow-up. Micro-costing analysis was done using a computed model with current stent and FFR wire prices. The overall incidence of MACE was 4.9%, 0.9% in the stent-avoided subset and 6.9% in stented group (p = 0.04, comparing the latter two) at a median follow-up of 21 months (interquartile range 12-31 months). Serious adverse events occurred only in 1% of patients receiving adenosine. The average cost saving was Indian rupees (INR) 51,847 [United States Dollar (USD) 746] per patient, resulting in total savings of INR 15,813,379 (USD 227,530). Cost savings persisted but were lower by 36% (INR 18,613/USD 268 per patient) after the ceiling of stent prices. FFR-guided percutaneous coronary intervention (PCI) strategy is safe and cost-effective in countries where majority of patients self-finance their health care, resulting in stent and PCI avoidance in approximately one in three patients referred for coronary angioplasty.

Impact of coronary revascularization on the clinical and scintigraphic outlook of patients with myocardial ischemia.

The impact of coronary revascularization on outcomes and ischemic burden among patients with objective proof of ischemia is not yet established. We appraised the impact of revascularization on outcomes and residual ischemia in patients with objective evidence of ischemia at myocardial perfusion scintigraphy (MPS). We queried our database for stable patients with myocardial ischemia at MPS, excluding those with prior myocardial infarction, systolic dysfunction, or cardiomyopathy. The impact of revascularization (defined as revascularization as first follow-up event) on outcomes and changes in myocardial ischemia at repeat MPS was appraised with propensity-matched analyses. From 6195 patients, propensity matching yielded 1262 pairs of patients undergoing revascularization versus not undergoing revascularization. After 35.2 ± 23.9 months, revascularization was associated with lower risks of cardiac death [2 (0.2%) versus 10 (0.8%) in those not revascularized, P = 0.038] and of the composite of cardiac death or myocardial infarction [17 (1.3%) versus 37 (2.9%), P = 0.007]. In addition, revascularization was associated with a higher rate of improvement in ischemia degree after 28.1 ± 20.7 months of follow-up (P < 0.001), with 257 (69.3%) patients with moderate or severe ischemia at baseline MPS improving after revascularization versus 136 (42.0%) in the nonrevascularization group. Conversely, revascularization did not prove impactful on follow-up MPS in patients with only minimal or mild ischemia at baseline MPS (P < 0.001). In a large series of patients with objective evidence of myocardial ischemia at MPS, especially when moderate or severe, revascularization was associated with a better clinical prognosis and a lower ischemic burden at repeat MPS.

Coronary Steal by LIMA Bypass Graft Side-Branches: Physiologic Functional Evaluation and Coil Embolisation

Thoracic side branches of the left internal mammary artery (LIMA) has been reported to cause a coronary steal phenomena if not ligated at the time of surgery. The haemodynamic significance of the unligated side branches remains controversial. We present a case of coronary steal phenomena with an objective evidence of ischaemia that resolved after coil embolisation. A 61-year-old male underwent CABG in 1999 for unstable angina. The LAD received a LIMA graft, vein grafts to the diagonal, obtuse marginal and right coronary artery. His presenting symptom prior to CABG was shortness of breath. He remained symptom free until a year ago where he presented with progressive shortness of breath on minimal exertion despite medical therapy. He underwent a diagnostic coronary angiogram, which revealed severe narrowing in the left main stem, ostial circumflex and proximal LAD as well as occluded right coronary artery. All his grafts were patent. The LIMA was also patent but two unligated thoracic branches were noted. The possibility of coronary steal phenomena was entertained and the patient was brought back to the catheterisation laboratory for fractional flow reserve (FFR) study with a view of coiling the unligated side branches if the FFR was positive. After maximal hyperaemia using intravenous adenosine infusion at 140 mcg/kg/min, maximal FFR was calculated at 0.74 in the distal LAD. Both LIMA branches were occluded with balloons and FFR increased to 0.94. Therefore both branches were coiled and repeat FFR was 0.94 after coil embolisation. Six months later, the patient is off his anti-anginal therapy and is symptom free.

Routine invasive versus selective invasive strategies for Non-ST-elevation acute coronary syndromes: An Updated meta-analysis of randomized trials.

To perform an updated systematic review comparing a routine invasive strategy with a selective invasive strategy for patients with non-ST-elevation acute coronary syndromes (NSTE-ACS) in the era of stents and antiplatelet therapy. Recent meta-analyses comparing both strategies have shown conflicting results. Electronic databases were searched for randomized trials that compared a routine invasive strategy (i.e., routine coronary angiography +/- revascularization) versus a selective invasive strategy (i.e., medical stabilization and coronary angiography +/- revascularization if objective evidence of ischemia or refractory ischemia) in patients with NSTE-ACS. Summary odds ratios (OR) were primarily constructed using Peto's model. Twelve trials with 9,650 patients were included. Compared with a selective invasive strategy, a routine invasive strategy was associated with a reduction in the composite of all-cause mortality or myocardial infarction (MI) [OR: 0.86, 95% confidence interval (CI) 0.77-0.96] at a mean follow-up of 39 months, primarily due to a reduction in the risk of MI (OR: 0.78, 95% CI: 0.68-0.88). The risk of all-cause mortality was non-significantly reduced with a routine invasive strategy (OR: 0.88, 95% CI: 0.77-1.01). The risk of recurrent angina was reduced with a routine invasive strategy (OR: 0.55, 95% CI: 0.49-0.62), as well as the risk of future revascularization procedures (OR: 0.35, 95% CI: 0.30-0.39). In patients with NSTE-ACS, a routine invasive strategy reduced the risk of ischemic events, including the risk of mortality or MI. Routine invasive therapy reduced the risk of recurrent angina and future revascularization procedures. © 2016 Wiley Periodicals, Inc.

Abstract 18184: Prognostic Value of Subjective and Objective Findings of Ischemia in Patients With Heart Failure

Introduction: Previous studies have shown that cardiac ischemia is a marker of poor prognosis in congestive heart failure. We determined the outcomes associated with subjective symptoms and objective findings of ischemia in patients presenting with acute heart failure. Methods: We studied 10,030 participants (mean age 76±12 years, 48% male) who presented to a hospital in Ontario, Canada with a primary diagnosis of acute heart failure. Using linked administrative databases, we analyzed the long-term impact of chest pain, ST segment depression, and positive troponin on vital status, hospital readmission, diagnostic testing, and coronary revascularization. Results: 1,724 participants presented with symptoms of chest pain, of which 348 had objective evidence of cardiac ischemia (ST segment depression or positive troponin). Of the 8,306 participants without chest pain 1,602 had objective evidence of ischemia. At baseline, the chest pain cohort had higher proportion of participants with a history of heart failure, coronary disease, revascularization, and impaired LV function. In multivariate analysis, ST segment depression and positive troponin were associated with higher cardiovascular death (HR 1.11 and 1.41, both P&lt;0.05), revascularization events (HR 1.41 and 1.48, both P&lt;0.01), hospitalization for myocardial infarction (HR 1.35 and 1.69, both P&lt;0.01) and heart failure (HR 1.08 and 1.15, both P&lt;0.05). Rates of admission for non-cardiovascular hospitalization did not differ. The presence of chest pain was associated with increased use of diagnostic testing for ischemia (HR 1.14, P&lt;0.01) and admission for ischemic symptoms (HR 1.10, P&lt;0.05), but lower risk of cardiovascular death (HR 0.86, P&lt;0.01 Figure 1). Conclusions: In this large, community-based cohort of patients presenting with acute heart failure, the presence of objective findings, but not subjective symptoms of ischemia, was associated with higher risk of major adverse cardiac outcomes.

There is only one big risk you should avoid at all costs, and that is the risk of doing nothing.

There is only one big risk you should avoid at all costs, and that is the risk of doing nothing.

Meta-Analysis of Trials on Mortality After Percutaneous Coronary Intervention Compared With Medical Therapy in Patients With Stable Coronary Heart Disease and Objective Evidence of Myocardial Ischemia

Outcomes of percutaneous coronary intervention (PCI) versus medical therapy (MT) in the management of stable ischemic heart disease (SIHD) remain controversial, with some but not all studies showing improved results in patients with ischemia. We sought to elucidate whether PCI improves mortality compared to MT in patients with objective evidence of ischemia (assessed using noninvasive imaging or its invasive equivalent). We performed a systematic review and meta-analysis of randomized controlled trials (RCTs) comparing PCI to MT in patients with SIHD. To maintain a high degree of specificity for ischemia, studies were only included if ischemia was defined on the basis of noninvasive stress imaging or abnormal fractional flow reserve. The primary outcome was all-cause mortality. We identified 3 RCTs (Effects of Percutaneous Coronary Interventions in Silent Ischemia After Myocardial Infarction II, Fractional Flow Reserve versus Angiography for Multivessel Evaluation 2, and a substudy of the Clinical Outcomes Utilizing Revascularization and Aggressive Drug Evaluation trial) enrolling a total of 1,557 patients followed for an average of 3.0 years. When compared with MT in this population of patients with objective ischemia, PCI was associated with lower mortality (hazard ratio 0.52, 95% confidence interval 0.30 to 0.92, p=0.02). There was no evidence of study heterogeneity or bias among included trials. In this meta-analysis of published RCTs, PCI was shown to have a mortality benefit over MT in patients with SIHD and objective assessment of ischemia using noninvasive imaging or its invasive equivalent. In conclusion, this study provides insight into the management of a higher-risk SIHD population that is the focus of the ongoing International Study of Comparative Health Effectiveness with Medical and Invasive Approaches trial.

The present and future of fractional flow reserve.

Revascularization of coronary artery stenosis should be based on objective evidence of ischemia. Fractional flow reserve (FFR) is an invasive physiologic index that can be easily measured in the cardiac catheterization laboratory to assess the functional significance of coronary stenosis. FFR-guided revascularization strategy has been proven to be better than angiography-guided strategy in patients with coronary artery disease. Recent development of more convenient ways to induce hyperemia will reduce the barrier to measuring FFR and further expand its clinical applicability. Invasive physiologic indices without hyperemia are also under active investigation. Moreover, a novel noninvasive FFR measurement based on coronary CT angiography and computational fluid dynamics has been developed and will soon be incorporated into clinical practice. Given the rapid adoption of invasive and noninvasive physiologic indices in daily practice, a review of the current status of FFR and future perspectives is presented.

TCT-845 Percutaneous Coronary Intervention is Associated with Lower Mortality Compared with Optimal Medical Therapy in Patients with Stable Ischemic Heart Disease and Objective Evidence of Ischemia or Abnormal Fractional Flow Reserve: A Meta-Analysis of Randomized Controlled Trials

Columbia UniversityMedical Center and the Cardiovascular Research Foundation, New York, UnitedStatesBackground: Recent randomized controlled trials (RCTs) have called into questionwhether percutaneous coronary intervention (PCI) reduces death or myocardialinfarction in patients with stable ischemic heart disease (SIHD). However, several ofthese trials randomized an unselected group of patients, including those with andwithout objective ischemia.Methods: We performed a meta-analysis of RCTs comparing PCI with medicaltherapy (MT) in pts with either ischemia (identified on non-invasive testing) orabnormal fractional flow reserve (FFR), to determine whether PCI reduces all-causemortality in this high-risk SIHD cohort.Results: Four RCTs comparing PCI vs. MT in pts with objective ischemia (or FFR-equivalent) were found; these trials randomized a total of 1,769 pts with f/u from 7months to 10 years. The point estimate of the hazard ratio (HR) for mortality followingPCI vs. MT varied from 0.33-0.73, with no trial heterogeneity (I2¼0%). Of note, thedocumented ischemia cohort of the COURAGE trial (Am Heart J 2012) comprised48% of the weight of the included studies. Overall, 28/871 (3.2%) PCI pts diedcompared with 54/898 MT pts (6.0%), consistent with a significant reduction in all-cause mortality with PCI (HR 0.56; 95% confidence interval (CI): 0.34-0.93, p¼0.02,Figure), which remained significant when 3 other ineligible RCTs were added whichincluded a PCI vs MT arm (HR 0.61 [0.42,0.89], p¼0.01).Conclusions: Despite conventional conclusions drawn from existing RCT data thatPCI and MT result in comparable survival in SIHD, when analyses are restricted to ptswith objective ischemia (or the FFR equivalent), PCI is associated with a significantand consistent 44% reduction in all-cause mortality compared with MT.TCT-846Early versus Delayed Percutaneous Coronary Intervention for High Riskpatients with Non ST Elevation-Acute Coronary Syndrome: A Meta-analysis.Naveen Rajpurohit

Randomized Trial of Preventive Angioplasty in Myocardial Infarction

BackgroundIn acute ST-segment elevation myocardial infarction (STEMI), the use of percutaneous coronary intervention (PCI) to treat the artery responsible for the infarct (infarct, or culprit, artery) improves prognosis. The value of PCI in noninfarct coronary arteries with major stenoses (preventive PCI) is unknown.MethodsFrom 2008 through 2013, at five centers in the United Kingdom, we enrolled 465 patients with acute STEMI (including 3 patients with left bundle-branch block) who were undergoing infarct-artery PCI and randomly assigned them to either preventive PCI (234 patients) or no preventive PCI (231 patients). Subsequent PCI for angina was recommended only for refractory angina with objective evidence of ischemia. The primary outcome was a composite of death from cardiac causes, nonfatal myocardial infarction, or refractory angina. An intention-to-treat analysis was used.ResultsBy January 2013, the results were considered conclusive by the data and safety monitoring committee, which recommended that the trial be stopped early. During a mean follow-up of 23 months, the primary outcome occurred in 21 patients assigned to preventive PCI and in 53 patients assigned to no preventive PCI (infarct-artery-only PCI), which translated into rates of 9 events per 100 patients and 23 per 100, respectively (hazard ratio in the preventive-PCI group, 0.35; 95% confidence interval [CI], 0.21 to 0.58; P<0.001). Hazard ratios for the three components of the primary outcome were 0.34 (95% CI, 0.11 to 1.08) for death from cardiac causes, 0.32 (95% CI, 0.13 to 0.75) for nonfatal myocardial infarction, and 0.35 (95% CI, 0.18 to 0.69) for refractory angina.ConclusionsIn patients with STEMI and multivessel coronary artery disease undergoing infarct-artery PCI, preventive PCI in noninfarct coronary arteries with major stenoses significantly reduced the risk of adverse cardiovascular events, as compared with PCI limited to the infarct artery. (Funded by Barts and the London Charity; PRAMI Current Controlled Trials number, ISRCTN73028481.)

The prospective, randomized comparison of promus everolimus-eluting and TAXUS liberte paclitaxel-eluting stent systems in patients with coronary artery disease: the PROMISE study

Background and objectives: The aim of study is to compare the procedural and clinical outcomes of the Everolimus-Eluting Promus and second-generation Paclitaxel-Eluting Liberte stent in routine clinical practice for 2 years. Materials and methods: This study is a prospective, randomized, open label, two-arm, multi-center trial inn Korea. Patients with objective evidence of ischemia and coronary artery disease eligible for PCI who have coronary arteries of ≥ 2.5 and ≤ 3.75 mm in the reference vessel diameter with a lesion of ≤ 46 mm length were randomized into everolimus-eluting stent (EES) and paclitaxel-eluting stent (PES). Primary end-point was ischemia-driven target vessel revascularization (TVR) at 2 years. Secondary end-point was major adverse cardiac events (MACE) such as all death, myocardial infarction (MI), target lesion revascularization (TLR), TVR and stent thrombosis (ST) at 2 years. Results: Total 847 patients with 1017 lesions were randomized to EES (n=425) and PES (n=422). Baseline clinical and angiographic characteristics were similar. Clinical follow-up rate for 2 years was 94.1% (797/847). The primary end point of this study (TVR at 2 years) was 3.8% in PES and 1.2% in EES (P for non-inferiority = 0.021). Total MACE rate was significantly different as 5.6% in PES and 2.5% in EES (p=0.027). The rate of MI (0.8% in PES vs. 0.2% in EES, p=0.308), all death (1.5% in PES vs. 1.2% in EES, p=0.739) and stent thrombosis (0.3% in PES vs. 0.7% in EES, p=0.325) were not different between two groups. Conclusion: The clinical outcomes of EES for 2 years were non-inferior to PES, which was mainly due to reduction of ischemia-driven TVR.

A Prospective, Randomized Comparison of Promus Everolimus-Eluting and TAXUS Liberte Paclitaxel-Eluting Stent Systems in Patients with Coronary Artery Disease Eligible for Percutaneous Coronary Intervention: The PROMISE Study

We aimed comparing two-year clinical outcomes of the Everolimus-Eluting Promus and Paclitaxel-Eluting TAXUS Liberte stents used in routine clinical practice. Patients with objective evidence of ischemia and coronary artery disease eligible for PCI were prospectively randomized to everolimus-eluting stent (EES) or paclitaxel-eluting stent (PES) groups. The primary end-point was ischemia-driven target vessel revascularization (TVR) at 2 yr after intervention, and the secondary end-point was a major adverse cardiac event (MACE), such as death, myocardial infarction (MI), target lesion revascularization (TLR), TVR or stent thrombosis. A total of 850 patients with 1,039 lesions was randomized to the EES (n=425) and PES (n=425) groups. Ischemic-driven TVR at 2 yr was 3.8% in the PES and 1.2% in the EES group (P for non-inferiority=0.021). MACE rates were significantly different; 5.6% in PES and 2.5% in EES (P = 0.027). Rates of MI (0.8% in PES vs 0.2% in EES, P = 0.308), all deaths (1.5% in PES vs 1.2% in EES, P = 0.739) and stent thrombosis (0.3% in PES vs 0.7% in EES, P = 0.325) were similar. The clinical outcomes of EES are superior to PES, mainly due to a reduction in the rate of ischemia-driven TVR.

Circulation: Clinical Summaries

Circulation: Clinical Summaries