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Objectives: The aim of the current study was to estimate adverse event rates while awaiting myocardial revascularization and review criteria for prioritizing patients., Methods: A PubMed search was performed on 19 January 2015, to identify English-language, original, observational studies reporting adverse events while awaiting coronary artery bypass grafting (CABG) or percutaneous coronary intervention (PCI). Rates of death, non-fatal myocardial infarction (MI) and emergency revascularization were calculated as occurrence rates per 1000 patient-weeks and pooled using random-effects models., Results: The search yielded 1323 articles, of which 22 were included with 66 410 patients and 607 675 patient-weeks on the wait list. When awaiting CABG, rates per 1000 patient-weeks were 1.1 [95% confidence interval 0.9-1.3] for death, 1.0 [0.6-1.6] for non-fatal MI and 1.8 [0.8-4.1] for emergency revascularization. Subgroup analyses demonstrated consistent outcomes, and sensitivity analyses demonstrated comparable event rates with low heterogeneity. Higher urgency of revascularization was based primarily on angiographic complexity, angina severity, left ventricular dysfunction and symptoms on stress testing, and such patients with a semi-urgent status had a higher risk of death than patients awaiting elective revascularization (risk ratio at least 2.8). Individual studies identified angina severity and left ventricular dysfunction as most important predictors of death when awaiting CABG. Adverse rates per 1000 patient-weeks for patients awaiting PCI were 0.1 [95% confidence interval 0.0-0.4] for death, 0.4 [0.1-1.2] for non-fatal MI and 0.7 [0.4-1.4] for emergency revascularization but were based on only a few old studies., Conclusions: Rates of death, non-fatal MI and emergency revascularization when awaiting myocardial revascularization are infrequent but higher in specific patients. Countries that not yet have treatment recommendations related to waiting times should consider introducing a maximum to limit adverse events, particularly when awaiting CABG., (© The Author 2017. Published by Oxford University Press on behalf of the European Association for Cardio-Thoracic Surgery. All rights reserved.)

Background: The fractional flow reserve (FFR) value of 0.75 has been validated against ischemic testing, whereas the FFR value of 0.80 has been widely accepted to guide clinical decision making. However, revascularization when FFR is 0.76 to 0.80, within the so-called gray zone, is still debatable., Methods and Results: From February 1997 to June 2013, all patients with single-segment disease and an FFR value within the gray zone or within the 2 neighboring FFR strata (0.70-0.75 and 0.81-0.85) were included. Study end points consisted of major adverse cardiovascular events (death, myocardial infarction, and any revascularization) up to 5 years. Of 17 380 FFR measurements, 1459 patients were included. Of them, 449 patients were treated with revascularization and 1010 patients were treated with medical therapy. In the gray zone, the major adverse cardiovascular events rate was similar (37 [13.9%] versus 21 [11.2%], respectively; P=0.3) between medical therapy and revascularization, whereas a strong trend toward a higher rate of death or myocardial infarction (25 [9.4] versus 9 [4.8], P=0.06) and overall death (20 [7.5] versus 6 [3.2], P=0.059) was observed in the medical therapy group. Among medical therapy patients, a significant step-up increase in major adverse cardiovascular events rate was observed across the 3 FFR strata, especially with proximal lesion location. In revascularization patients, the major adverse cardiovascular events rate was not different across the 3 FFR strata., Conclusions: FFR in and around the gray zone bears a major prognostic value, especially in proximal lesions. These data confirm that FFR≤0.80 is valid to guide clinical decision making., (© 2016 American Heart Association, Inc.)

Background: Fractional flow reserve (FFR) measurement of intermediate coronary stenoses is recommended by guidelines when demonstration of ischemia by noninvasive testing is unavailable. The study aims to evaluate the penetration of this recommendation into current thinking about revascularization strategies for stable coronary artery disease., Methods and Results: International Survey on Interventional Strategy was conducted via a web-based platform. First, participants' experiences in interventional cardiology were queried. Second, 5 complete angiograms were provided, presenting only focal intermediate stenoses. FFR and quantitative coronary angiography values were known; however, remained undisclosed. Determination of stenosis significance was asked for each lesion. In cases of uncertainty, the most appropriate adjunctive invasive diagnostic method among quantitative coronary angiography, intravascular ultrasound, optical coherence tomography, or FFR needed to be selected. International Survey on Interventional Strategy was taken by 495 participants who provided 4421 lesion evaluations. In 3158 (71%) decisions, participants relied solely on angiographic appearance that was discordant in 47% with the known FFR, using 0.80 as cutoff value. The use of FFR and imaging modalities was requested in 21% and 8%, respectively. Comparing 4 groups of participants according to the experience in FFR, angiogram-based decisions were less frequent with increasing experience (77% versus 72% versus 69% versus 67%, respectively; P<0.001). As a result, requests for FFR were more frequent (14% versus 19% versus 24% versus 28%, respectively; P<0.001) and rates of discordant decisions decreased (51% versus 49% versus 47% versus 43%, respectively; P<0.022)., Conclusions: The findings confirm that, even when all potential external constraints are virtually eliminated, visual estimation continues to dominate the treatment decisions for intermediate stenoses, indicative of a worrisome disconnect between recommendations and current practice., (© 2014 American Heart Association, Inc.)

Objective: To investigate whether revascularisation improves prognosis compared with medical treatment among patients with stable coronary artery disease., Design: Bayesian network meta-analyses to combine direct within trial comparisons between treatments with indirect evidence from other trials while maintaining randomisation., Eligibility Criteria for Selecting Studies: A strategy of initial medical treatment compared with revascularisation by coronary artery bypass grafting or Food and Drug Administration approved techniques for percutaneous revascularization: balloon angioplasty, bare metal stent, early generation paclitaxel eluting stent, sirolimus eluting stent, and zotarolimus eluting (Endeavor) stent, and new generation everolimus eluting stent, and zotarolimus eluting (Resolute) stent among patients with stable coronary artery disease., Data Sources: Medline and Embase from 1980 to 2013 for randomised trials comparing medical treatment with revascularisation., Main Outcome Measure: All cause mortality., Results: 100 trials in 93,553 patients with 262,090 patient years of follow-up were included. Coronary artery bypass grafting was associated with a survival benefit (rate ratio 0.80, 95% credibility interval 0.70 to 0.91) compared with medical treatment. New generation drug eluting stents (everolimus: 0.75, 0.59 to 0.96; zotarolimus (Resolute): 0.65, 0.42 to 1.00) but not balloon angioplasty (0.85, 0.68 to 1.04), bare metal stents (0.92, 0.79 to 1.05), or early generation drug eluting stents (paclitaxel: 0.92, 0.75 to 1.12; sirolimus: 0.91, 0.75 to 1.10; zotarolimus (Endeavor): 0.88, 0.69 to 1.10) were associated with improved survival compared with medical treatment. Coronary artery bypass grafting reduced the risk of myocardial infarction compared with medical treatment (0.79, 0.63 to 0.99), and everolimus eluting stents showed a trend towards a reduced risk of myocardial infarction (0.75, 0.55 to 1.01). The risk of subsequent revascularisation was noticeably reduced by coronary artery bypass grafting (0.16, 0.13 to 0.20) followed by new generation drug eluting stents (zotarolimus (Resolute): 0.26, 0.17 to 0.40; everolimus: 0.27, 0.21 to 0.35), early generation drug eluting stents (zotarolimus (Endeavor): 0.37, 0.28 to 0.50; sirolimus: 0.29, 0.24 to 0.36; paclitaxel: 0.44, 0.35 to 0.54), and bare metal stents (0.69, 0.59 to 0.81) compared with medical treatment., Conclusion: Among patients with stable coronary artery disease, coronary artery bypass grafting reduces the risk of death, myocardial infarction, and subsequent revascularisation compared with medical treatment. All stent based coronary revascularisation technologies reduce the need for revascularisation to a variable degree. Our results provide evidence for improved survival with new generation drug eluting stents but no other percutaneous revascularisation technology compared with medical treatment., (© Windecker et al 2014.)

Background: Small coronary vessels supply small myocardial territories. The clinical significance of small-vessel stenoses is therefore questionable. Moreover, percutaneous coronary intervention (PCI) of nonfunctionally significant lesions does not improve clinical outcome and might be associated with potential procedural or stent related risks. The aim of this study was to assess the clinical outcome of fractional flow reserve (FFR)-guided PCI in the treatment of small coronary vessel lesions as compared with an angio-guided PCI., Methods and Results: From January 2004 to December 2008, all patients treated with PCI for stable or unstable angina in small native coronary vessels (reference vessel diameter and stent size <3 mm) were retrospectively analyzed. Patients were divided into angio-guided and an FFR-guided PCI groups. A total of 717 patients were enrolled (495 angio-guided, 222 FFR-guided). End points were death, nonfatal myocardial infarction (MI), combined death or nonfatal MI, target vessel revascularization (TVR), and procedure costs. Major adverse cardiac events (MACE) were defined as death, nonfatal MI, and TVR. Clinical follow-up was obtained in 97.5% (median follow-up: 3.3 [from 0.01-5] years) of the patients. Seventy-eight patients (35%) had a significant FFR (<0.80) and underwent PCI. Using a propensity score adjusted Cox analysis, patients treated with FFR-guided PCI had significantly lower combined death or nonfatal MI (hazard ratio [HR], 0.413; 95% confidence interval [CI], 0.227-0.750; P=0.004), nonfatal MI (HR, 0.063; 95% CI, 0.009-0.462; P=0.007), TVR (HR, 0.517; 95% CI, 0.323-0.826; P=0.006), and MACE (HR, 0.458; 95% CI, 0.310-0.679; P<0.001). No difference was observed in mortality alone (HR, 0.684; 95% CI, 0.355-1.316; P=0.255). Procedure costs were also reduced in the FFR guided strategy (3253±102 Euros versus 4714±37 Euros, P<0.0001)., Conclusions: FFR-guided PCI of small coronary arteries is safe and results in better clinical outcomes when compared with an angio-guided PCI.

The Guidelines for Myocardial Revascularization of the European Society of Cardiology (ESC) and European Association for Cardio-Thoracic Surgery (EACTS) are the very first reported consensus document, by a writing committee balanced between non-interventional and interventional cardiologists as well as cardiac surgeons, on this specific issue. Given the strong impact that ischaemic heart disease has on the survival and quality of life of the individual as well as the economic implications for society, the importance of the ESC/EACTS guidelines is obvious.

Objectives: Our purpose was to evaluate the appropriateness of multidetector computed tomography angiography (MDCTA) as an anatomical standard for decision making in patients with known or suspected coronary artery disease., Background: Although correlative studies between MDCTA and coronary angiography (CA) show good agreement, MDCTA visualizes plaque burden and calcifications well before luminal dimensions are encroached., Methods: Pressure-derived fractional flow reserve (FFR) was obtained in 81 patients (116 vessels) who underwent both CA and MDCTA. Segments were visually graded for stenosis severity as: G0 = normal, G1 = nonobstructive (<50% diameter reduction), and G2 = obstructive (> or =50% diameter reduction)., Results: Concordance between segmental severity scores by MDCTA and CA was good (k = 0.74; 95% confidence interval: 0.56 to 0.92). Diagnostic performance of MDCTA for detection of functionally significant stenosis based on FFR was low (sensitivity 79%; specificity 64%; positive likelihood ratio 2.2; negative likelihood ratio 0.3). Revascularization was considered appropriate in the presence of reduced FFR (< or =0.75). Decision making based on MDCTA guidance would result in revascularization in the absence of ischemia in 22% of patients (18 of 81) and inappropriate deferral in 7% (6 of 81), while revascularization in the absence of ischemia would be 16% (13 of 81) and inappropriate deferral 12% (10 of 81) with decisions guided by CA. Combined evaluation of stenosis severity using both anatomy (with either CA or MDCTA) and function (with FFR) yields the highest proportion of appropriate decisions: 90% and 91%, respectively (p = 0.0001 vs. CA only, p = 0.0001 vs. MDCTA only)., Conclusions: Similar to CA, anatomical assessment of coronary stenosis severity by MDCTA does not reliably predict its functional significance.

Impaired responses to antiplatelet therapy assessed by laboratory tests are associated with an increased risk of recurrent ischemic events after percutaneous coronary intervention (PCI). This study was designed to determine the relation between responses to aspirin and clopidogrel as assessed by a point-of-care assay (Verify Now, Accumetrics, San Diego, California) and periprocedural myocardial infarction (PMI) in patients undergoing elective PCI for stable angina. One hundred twenty-two consecutive patients undergoing elective coronary stenting prospectively received aspirin 500 mg and clopidogrel 600 mg >or=12 hours before PCI. Clopidogrel response was measured with P2Y12 reaction units (PRUs) and percent inhibition P2Y12 from baseline (percent inhibition P2Y12) and aspirin response with aspirin reaction units (ARUs). Troponin T level was considered positive if it was >0.03 ng/ml. Responses to aspirin and clopidogrel were correlated (r=0.42, p <0.0001). PMI occurred in 27 patients (22%) who showed significantly lower percent inhibition P2Y12 (25.3+/-26 vs 38.3+/-25, p=0.01) and a trend toward higher PRU values (221+/-87 vs 193+/-94, p=0.21). We did not find any difference for aspirin response as assessed by ARUs in patients with or without PMI (460+/-82 vs 454+/-73, p = 0.82). Stratification of percent inhibition P2Y12 isolated a quartile of clopidogrel nonresponders (inhibition P2Y12 <15%) with significantly higher incidence of PMI (44% vs 15%, odds ratio 4.6, 95% confidence interval 1.9 to 11.5, p=0.001). In conclusion, point-of-care assessment of clopidogrel response reliably predicted PMI after low- to medium-risk elective PCI for stable angina.

Aims: To assess the accuracy of tissue Doppler imaging-derived myocardial positive pre-ejection velocity (+Vic) in detecting myocardial viability defined by dobutamine stress echocardiography (DSE), fluorine-18 fluorodeoxyglucose positron emission tomography (PET), and contrast-enhanced magnetic resonance imaging (MRI), and in predicting recovery of left ventricular (LV) function after coronary artery bypass grafting (CABG) in patients with chronic ischaemic LV dysfunction., Methods and Results: +Vic in dysfunctional segments was recorded in 54 patients treated medically and 65 patients undergoing CABG [age 67 +/- 9 year; LV ejection fraction (EF) 30 +/- 6%]. A good agreement was observed between +Vic and detection of viable myocardium at DSE, PET, and MRI (kappa = 0.76). The presence of +Vic in greater than or equal to five dysfunctional segments had the highest sensitivity (93%) and specificity (60%) to identify patients (n = 28) with > or =10% increase in LV EF between baseline and 6-month echocardiogram. During follow-up (median 333 days, interquartile range 209-490 days), 13 cardiac events (6 deaths, 7 hospitalizations) occurred in 24 patients with small extent of viable myocardium (< 5 + Vic), whereas only four hospitalizations in 39 patients with > or =5 + Vic (54% vs. 10%; P < 0.001)., Conclusion: The extent of +Vic in dysfunctional segments accurately predicts extent of viable myocardium and bears a clinical prognostic value in patients with ischaemic LV dysfunction considered for CABG.

Objective: Self-perceived health status may be helpful in identifying patients at high risk for adverse outcomes. The Euro Heart Survey on Coronary Revascularization (EHS-CR) provided an opportunity to explore whether impaired health status was a predictor of 1-year mortality in patients with coronary artery disease (CAD) undergoing angiographic procedures., Methods: Data from the EHS-CR that included 5619 patients from 31 member countries of the European Society of Cardiology were used. Inclusion criteria for the current study were completion of a self-report measure of health status, the EuroQol Questionnaire (EQ-5D) at discharge and information on 1-year follow-up, resulting in a study population of 3786 patients., Results: The 1-year mortality was 3.2% (n = 120). Survivors reported fewer problems on the five dimensions of the EQ-5D as compared with non-survivors. A broad range of potential confounders were adjusted for, which reached a p<0.10 in the unadjusted analyses. In the adjusted analyses, problems with self-care (OR 3.45; 95% CI 2.14 to 5.59) and a low rating (< or =60) on health status (OR 2.41; 95% CI 1.47 to 3.94) were the most powerful independent predictors of mortality, among the 22 clinical variables included in the analysis. Furthermore, patients who reported no problems on all five dimensions had significantly lower 1-year mortality rates (OR 0.47; 95% CI 0.28 to 0.81)., Conclusions: This analysis shows that impaired health status is associated with a 2-3-fold increased risk of all-cause mortality in patients with CAD, independent of other conventional risk factors. These results highlight the importance of including patients' subjective experience of their own health status in the evaluation strategy to optimise risk stratification and management in clinical practice.

In patients with stable CAD, PCI can be considered a valuable initial mode of revascularization in all patients with objective large ischaemia in the presence of almost every lesion subset, with only one exception: chronic total occlusions that cannot be crossed. In early studies, there was a small survival advantage with CABG surgery compared with PCI without stenting. The addition of stents and newer adjunctive medications improved the outcome for PCI. The decision to recommend PCI or CABG surgery will be guided by technical improvements in cardiology or surgery, local expertise, and patients' preference. However, until proved otherwise, PCI should be used only with reservation in diabetics with multi-vessel disease and in patients with unprotected left main stenosis. The use of drug-eluting stents might change this situation. Patients presenting with NSTE-ACS (UA or NSTEMI) have to be stratified first for their risk of acute thrombotic complications. A clear benefit from early angiography (<48 h) and, when needed, PCI or CABG surgery has been reported only in the high-risk groups. Deferral of intervention does not improve outcome. Routine stenting is recommended on the basis of the predictability of the result and its immediate safety. In patients with STEMI, primary PCI should be the treatment of choice in patients presenting in a hospital with PCI facility and an experienced team. Patients with contra-indications to thrombolysis should be immediately transferred for primary PCI, because this might be their only chance for quickly opening the coronary artery. In cardiogenic shock, emergency PCI for complete revascularization may be life-saving and should be considered at an early stage. Compared with thrombolysis, randomized trials that transferred the patients for primary PCI to a 'heart attack centre' observed a better clinical outcome, despite transport times leading to a significantly longer delay between randomization and start of the treatment. The superiority of primary PCI over thrombolysis seems to be especially clinically relevant for the time interval between 3 and 12 h after onset of chest pain or other symptoms on the basis of its superior preservation of myocardium. Furthermore, with increasing time to presentation, major-adverse-cardiac-event rates increase after thrombolysis, but appear to remain relatively stable after primary PCI. Within the first 3 h after onset of chest pain or other symptoms, both reperfusion strategies seem equally effective in reducing infarct size and mortality. Therefore, thrombolysis is still a viable alternative to primary PCI, if it can be delivered within 3 h after onset of chest pain or other symptoms. Primary PCI compared with thrombolysis significantly reduced stroke. Overall, we prefer primary PCI over thrombolysis in the first 3 h of chest pain to prevent stroke, and in patients presenting 3-12 h after the onset of chest pain, to salvage myocardium and also to prevent stroke. At the moment, there is no evidence to recommend facilitated PCI. Rescue PCI is recommended, if thrombolysis failed within 45-60 min after starting the administration. After successful thrombolysis, the use of routine coronary angiography within 24 h and PCI, if applicable, is recommended even in asymptomatic patients without demonstrable ischaemia to improve patients' outcome. If a PCI centre is not available within 24 h, patients who have received successful thrombolysis with evidence of spontaneous or inducible ischaemia before discharge should be referred to coronary angiography and revascularized accordingly--independent of 'maximal' medical therapy.

Background: Chronic kidney disease (CKD) is associated with adverse outcomes after coronary artery bypass graft surgery (CABG) and percutaneous coronary interventions (PCI), but it is unclear which of these revascularization strategies is associated with lower risk for morbidity and mortality in this population. In the Arterial Revascularization Therapies Study (ARTS), we compared long-term clinical outcomes after CABG or PCI with multivessel stenting in patients with CKD., Methods: The ARTS randomly assigned 1205 participants with and without CKD to CABG or PCI with multivessel stenting. We defined CKD as creatinine clearance < or =60 mL/min, estimated by the Cockroft-Gault equation. The primary outcome was the composite of death, myocardial infarction (MI), or stroke; and, a secondary outcome was repeat revascularization. Participants were followed for a mean of 3 years after their intervention. We evaluated whether randomization to CABG or PCI was associated with different outcomes among participants with CKD., Results: Two hundred ninety participants (25%) had CKD at entry into ARTS. One hundred fifty-one received PCI, and 139 received CABG. No difference was observed in the primary endpoint with CABG or PCI among CKD participants (adjusted Hazard Ratio [HR] CABG vs PCI = 0.93; 95% CI 0.54-1.60; P = .97). However, CABG was associated with a reduced risk for repeat revascularization (HR = 0.28; 95% CI 0.14-0.54; P < .01). Compared with participants with normal renal function, CKD was associated with a nearly 2-fold risk for the primary outcome (unadjusted HR = 1.9; 95% CI 1.4-2.7; P < .01). After multivariate adjustment, this association remained significant (HR 1.6; 95% CI 1.1-2.4)., Conclusions: In patients with multivessel CAD and CKD, treatment with CABG or PCI with multivessel stenting led to similar outcomes of death, MI, or stroke, but CABG was associated with decreased repeat revascularizations. When compared with ARTS participants with normal renal function, those with CKD had substantially elevated risk of adverse clinical outcomes after coronary revascularization.

Objectives: We sought to assess the relationship between completeness of revascularization and adverse events at one year in the ARTS (Arterial Revascularization Therapies Study) trial., Background: There is uncertainty to what extent degree of completeness of revascularization, using up-to-date techniques, influences medium-term outcome., Methods: After consensus between surgeon and cardiologist regarding the potential for equivalence in the completeness of revascularization, 1,205 patients with multivessel disease were randomly assigned to either bypass surgery or stent implantation. All baseline and procedural angiograms and surgical case-record forms were centrally assessed for completeness of revascularization., Results: Of 1,205 patients randomized, 1,172 underwent the assigned treatment. Complete data for review were available in 1,143 patients (97.5%). Complete revascularization was achieved in 84.1% of the surgically treated patients and 70.5% of the angioplasty patients (p < 0.001). After one year, the stented angioplasty patients with incomplete revascularization showed a significantly lower event-free survival than stented patients with complete revascularization (i.e., freedom from death, myocardial infarction, cerebrovascular accident and repeat revascularization) (69.4% vs. 76.6%; p < 0.05). This difference was due to a higher incidence of subsequent bypass procedures (10.0% vs. 2.0%; p < 0.05). Conversely, at one year, bypass surgery patients with incomplete revascularization showed only a marginally lower event-free survival rate than those with complete revascularization (87.8% vs. 89.9%)., Conclusions: Complete revascularization was more frequently accomplished by bypass surgery than by stent implantation. One year after bypass, there was no significant difference in event-free survival between surgically treated patients with complete revascularization and those with incomplete revascularization, but patients randomized to stenting with incomplete revascularization had a greater need for subsequent bypass surgery.

Background: The FIREHAWK is a drug-eluting stent with a fully biodegradable sirolimus-containing polymer coating localised to recessed abluminal grooves on the stent surface. We investigated clinical outcomes with this targeted, low-dose, biodegradable polymer, sirolimus-eluting stent compared with XIENCE durable polymer, everolimus-eluting stents in an all-comers population.Methods: The TARGET All Comers study was a prospective, multicentre, open-label randomised non-inferiority trial done at 21 centres in ten European countries. Patients with symptomatic or asymptomatic coronary artery disease and objective evidence of myocardial ischaemia who qualified for percutaneous coronary intervention were randomised 1:1 to undergo implantation of a FIREHAWK or XIENCE. Randomisation was web-based, with random block allocation and stratification by centre and ST elevation myocardial infarction. Outcome assessors were masked to treatment allocation, but treating physicians and patients were not. The primary endpoint was target lesion failure at 12 months, a composite of cardiac death, target vessel myocardial infarction, or ischaemia-driven target lesion revascularisation. The control event rate for XIENCE was assumed to be 7%, the non-inferiority margin was 3.5%, and the primary analysis was in the intention-to-treat population, censoring patients who did not have either an event before 365 days or contact beyond 365 days. Late lumen loss was the primary endpoint of an angiographic substudy designed to investigate the non-inferiority of the FIREHAWK compared with the XIENCE stent. This trial is registered with ClinicalTrials.gov, number NCT02520180.Findings: From Dec 17, 2015, to Oct 14, 2016, 1653 patients were randomly assigned to implantation of the FIREHAWK (n=823) or XIENCE (n=830). 65 patients in the FIREHAWK group and 66 in the XIENCE group had insufficient follow-up data and were excluded from the analyses. At 12 months, target lesion failure occurred in 46 (6·1%) of 758 patients in the FIREHAWK group and in 45 (5·9%) of 764 patients in the XIENCE group (difference 0·2%, 90% CI -1·9 to 2·2, pnon-inferiority=0·004, 95% CI -2·2 to 2·6, psuperiority=0·88). There were no differences in ischaemia-driven revascularisation or stent thrombosis rates at 12 months. 176 patients were included in the angiographic substudy, in which in-stent late lumen loss was 0·17 mm (SD 0·48) in the FIREHAWK group and 0·11 mm (0·52) in the XIENCE group (p=0·48), with an absolute difference of 0·05 mm (95% CI -0·09 to 0·18, pnon-inferiority=0·024).Interpretation: In a broad all-comers population of patients requiring stent implantation for myocardial ischaemia, the FIREHAWK was non-inferior to the XIENCE as assessed with the primary endpoint of target lesion failure at 12 months and in-stent late lumen loss at 13 months. The FIREHAWK is a safe and effective alternative stent to treat patients with ischaemic coronary artery disease in clinical practice.Funding: Shanghai Microport Medical. [ABSTRACT FROM AUTHOR]

Objectives: This study sought to evaluate the long-term clinical outcome of patients with an angiographically intermediate left anterior descending coronary artery (LAD) stenosis in whom the revascularization strategy was based on fractional flow reserve (FFR). Background: When revascularization is based mainly on angiographic guidance, a number of hemodynamically nonsignificant stenoses will be revascularized. Methods: In 730 patients with a 30% to 70% isolated stenosis in the proximal LAD and no significant valvular disease, FFR measurements were obtained to guide treatment strategy. When FFR was ≥0.80, the patients (n = 564) were treated medically (medical group); when FFR was <0.80, the patients (n = 166) underwent a revascularization procedure (revascularization group; 13% coronary artery bypass graft surgery and 87% percutaneous coronary intervention). A 100% long-term clinical follow-up (median follow-up: 40 months) was obtained. The 5-year survival of the medical group was compared with that of a reference population. For each patient, 4 controls were selected from an age- and sex-matched control population. Results: The 5-year survival estimate was 92.9% in the medical group versus 89.6% in the controls (p = 0.74). The mean diameter stenosis was significantly smaller in the medical than in the revascularization group (39 ± 14% vs. 54 ± 13%, p < 0.0001), but there was a large overlap between both groups. The 5-year event-free survival estimates (death, myocardial infarction, and target vessel revascularization) were 89.7% and 68.5%, respectively (p < 0.0001). Conclusions: Medical treatment of patients with a hemodynamically nonsignificant stenosis (FFR ≥0.80) in the proximal LAD is associated with an excellent long-term clinical outcome with survival at 5 years similar to an age- and sex-matched control population. [Copyright &y& Elsevier]

Objectives: The aim of this study was to investigate the correlation between myocardial ischemia detected by myocardial perfusion imaging (MPI) with single-photon emission computed tomography with intracoronary pressure-derived fractional flow reserve (FFR) in patients with multivessel coronary disease at angiography. Background: Myocardial perfusion imaging can underestimate the number of ischemic territories in patients with multivessel disease. However, there are limited data comparing MPI and FFR, a highly accurate functional index of myocardial ischemia, in multivessel coronary disease. Methods: Sixty-seven patients (201 vascular territories) with angiographic 2- or 3-vessel coronary disease were prospectively scheduled to undergo within 2 weeks MPI (rest/stress adenosine) and FFR in each vessel. Results: In 42% of patients, MPI and FFR detected identical ischemic territories (mean number of territories 0.9 ± 0.8 for both; p = 1.00). In the remaining 36% MPI underestimated (mean number of territories; MPI: 0.46 ± 0.6, FFR: 2.0 ± 0.6; p < 0.001) and in 22% overestimated (mean number of territories; MPI: 1.9 ± 0.8, FFR: 0.5 ± 0.8; p < 0.001) the number of ischemic territories in comparison with FFR. There was poor concordance between the ability of the 2 methods to detect myocardial ischemia on both a per-patient (κ = 0.14 [95% confidence interval: −0.10 to 0.39]) and per-vessel (κ = 0.28 [95% confidence interval: 0.15 to 0.42]) basis. Conclusions: Myocardial perfusion imaging with single-photon emission computed tomography has poor concordance with FFR and tends to underestimate or overestimate the functional importance of coronary stenosis seen at angiography in comparison with FFR in patients with multivessel disease. These findings might have important consequences in using MPI to determine the optimal revascularization strategy in patients with multivessel coronary disease. [Copyright &y& Elsevier]

Objectives: We assessed the impact of vessel size on outcomes of stenting with biolimus-eluting degradable polymer stent (BES) and sirolimus-eluting permanent polymer stent (SES) within a randomized multicenter trial (LEADERS). Background: Stenting of small vessels might be associated with higher rates of adverse events. Methods: “All-comer” patients (n = 1,707) were randomized to BES and SES. Post-hoc–stratified analysis of angiographic and clinical outcomes at 9 months and 1 year, respectively, was performed for vessels with reference diameter ≤2.75 mm versus >2.75 mm. Results: Of 1,707 patients, 429 patients in the BES group with 576 lesions and 434 patients in the SES group with 557 lesions had only small vessels treated (50.6% of the patient cohort). In patients with small vessels there was no significant difference in overall major adverse cardiac events (MACE) rate (12.1% vs. 11.8%; p = 0.89) or target lesion revascularization (TLR) rate (9.6% vs. 7.4%; p = 0.26) between BES and SES. The MACE and TLR rates in the small-vessel patient population were higher than in the large-vessel population. The TLR rate was 9.6% versus 2.6%, and MACE rate was 12.1% versus 7.1% for small versus large vessels in the BES arm (TLR: hazard ratio [HR] = 3.724, p = 0.0013; MACE: HR = 1.720, p = 0.0412). In the SES arm, TLR was 7.4% versus 5.1%, and MACE was 11.8% versus 10.3% in small versus large vessels (TLR: HR = 1.435, p = 0.2594; MACE: HR = 1.149, p = 0.5546). Conclusions: Prevalence of small vessel disease is high in an “all-comer” population with higher TLR and MACE rates. The BES and SES seem equivalent in treatment outcomes of small vessels in this “all-comer” patient population. [Copyright &y& Elsevier]

OBJECTIVE -- To evaluate whether in stable angina preference for coronary revascularization by either percutaneous coronary intervention (PCI) or coronary artery bypass surgery (CABG) is influenced by diabetes status and whether this has prognostic implications. RESEARCH DESIGN AND METHODS -- A total of 2,928 consecutive patients with stable angina who were enrolled in the prospective Euro Heart Survey on Coronary Revascularization were studied. Multivariable analyses were applied to evaluate the relation between diabetes, treatment decision, and 1-year outcome. RESULTS -- Diabetes was documented in 587 patients (20%) who had more extensive coronary disease. Revascularization was intended in 74% of patients with diabetes and in 77% of those without diabetes. In patients selected for revascularization, CABG was intended in 35% of diabetic and in 33% of nondiabetic patients. Multivariable analyses did not change these findings, but in some subgroups diabetes influenced treatment decisions. For example, diabetic subjects with mild heart failure had more often intended revascularization (91%) than those without diabetes (67%, P < 0.001). Treatment decisions in patients with more extensive (left main, multivessel, or proximal left anterior descending artery) disease were not influenced by diabetes status. Diabetes was not associated with an increased incidence of all-cause death, nonfatal cerebrovascular accident, or nonfatal myocardial infarction at 1 year, regardless of preferred treatment. The incidence of the combined end points was 7.3% in diabetic and 6.8% in nondiabetic patients (adjusted hazard ratio 1.0 [95% CI 0.7-1.4]). CONCLUSIONS -- In stable angina, treatment decisions regarding revascularization or the choice for CABG or PCI were not influenced by the presence of diabetes. Diabetes was not associated with a poor prognosis. [ABSTRACT FROM AUTHOR]

Abstract: Background: It has been recognized that a clinically significant portion of patients with coronary artery disease (CAD) continue to experience anginal and other related symptoms that are refractory to the combination of medical therapy and revascularization. The Euro Heart Survey on Revascularization (EHSCR) provided an opportunity to assess pharmacological treatment and outcome in patients with proven CAD who were ineligible for revascularization. Methods: We performed a secondary analysis of EHS-CR data. After excluding patients with ST-elevation myocardial infarction and those in whom revascularization was not indicated, 4409 patients remained in the analyses. We selected two groups: (1) patients in whom revascularization was the preferred treatment option (n =3777, 86%), and (2) patients who were considered ineligible for revascularization (n =632, 14%). Results: Patient ineligible for revascularization had a worse risk profile, more often had a total occlusion (59% vs. 37%, p <0.001), were treated more often with ACE-inhibitors (65% vs. 55%, p <0.001) but less likely with aspirin (83% vs. 88%, p <0.001). Overall, they had higher case-fatality at 1-year (7.0% vs. 3.7%, p <0.001). Regarding self-perceived health status, measured via the EuroQol 5D (EQ-5D) questionnaire, these same patients reported more problems on all dimensions of the EQ-5D. Furthermore, in the revascularization group we observed an increase between discharge and 1-year follow up (utility score from 0.85 to 1.00) whereas patients ineligible for revascularization did not improve over time (utility score remained 0.80) Conclusion: In this large cohort of European patients with CAD, those considered ineligible for revascularization had more co-morbidities and risk factors, and scored worse on self-perceived health status as compared to revascularized patients in the revascularization group. With the exception of ACE-inhibitors and aspirin, there were no major differences regarding drug treatment between the two groups. Given these clinically significant observations, there appears to be a role for nurse-led, multidisciplinary, rehabilitation teams that target clinically vulnerable patients whose symptoms remain refractory to standard medical care. [Copyright &y& Elsevier]

Accurate prediction of improvement in left ventricular ejection fraction (LVEF) after revascularisation is critical in the therapeutic decision-making process in patients with chronic ischaemic dysfunction. Positron emission tomography (PET) allows non-invasive evaluation of myocardial blood flow (MBF), metabolic rate of glucose (MRG, absolute and relative) and the water-perfusable tissue fraction (PTF). Each of these indices has been proposed for the prediction of functional recovery. Their relative merits, however, are unknown, because a direct head-to-head comparison of their predictive accuracy in the same patients has not been performed. In this study, MBF, MRG (absolute and relative) and PTF were evaluated in 34 patients with severe ischaemic LV dysfunction (LVEF 32%±9%). MBF and PTF were determined by oxygen-15 labelled water PET, and MRG (absolute and relative) was determined by fluorine-18 fluorodeoxyglucose (FDG) PET during hyperinsulinaemic euglycaemic clamp. LVEF was measured by radionuclide ventriculography before and 4-6 months after surgery. Sensitivities of MBF, PTF, absolute MRG and relative MRG in predicting improvement in LVEF were 80%, 80%, 90% and 100%, respectively. Their specificities were 54%, 67%, 71% and 71%, respectively. The lowest specificity was obtained for MBF, an intermediate specificity was obtained for PTF and the highest specificities were obtained with FDG PET using absolute and relative MRG. It is concluded that metabolic imaging is superior to perfusion-based indexes for assessment of the potential for functional recovery after revascularisation. [ABSTRACT FROM AUTHOR]

: ObjectivesWe tested the hypothesis that the tissue Doppler imaging (TDI)-derived positive preejection velocity (+VIC) can predict the recovery of contractile function after revascularization in patients with a recent myocardial infarction.: BackgroundIn experimental studies, the presence and extent of TDI-derived +VIC correlated with the extent of viable myocardium.: MethodsForty-three patients with a large myocardial infarction and an occluded left anterior descending (n = 38) or dominant right coronary (n = 5) artery were selected. The median duration of occlusion was 24 h. Longitudinal myocardial velocities were recorded at rest by pulsed-wave TDI echocardiography 6 ± 2 h after revascularization. Functional recovery was defined as an increase in segmental chordal shortening ≥10% at three-month follow-up left ventricular angiogram as compared with baseline.: ResultsA good quality TDI signal was obtained in 309 of 324 analyzed segments (95.4%). Severe dysfunction was present in 198 segments of which 126 (64%) showed recovery at three-month follow-up. Sampling of all dysfunctional segments lasted 11 ± 4 min per patient. Sensitivity, specificity, and accuracy of the +VIC to predict segmental recovery were 91%, 71%, and 84%, respectively. The percentage of segments that were dysfunctional at angiography but showed a +VIC correlated with improvement of both global left ventricular ejection fraction (r = 0.60, p = 0.001) and wall motion score index (r = −0.78, p < 0.0001) at follow-up.: ConclusionsAssessment of +VIC by pulsed-wave TDI is a simple and accurate method that predicts recovery of contractile function after revascularization in patients with a recent myocardial infarction. [Copyright &y& Elsevier]

The long-term risk associated with different coronary artery disease (CAD) presentations in women undergoing percutaneous coronary intervention (PCI) with drug-eluting stents (DES) is poorly characterized. We pooled patient-level data for women enrolled in 26 randomized clinical trials. Of 11,577 women included in the pooled database, 10,133 with known clinical presentation received a DES. Of them, 5,760 (57%) had stable angina pectoris (SAP), 3,594 (35%) had unstable angina pectoris (UAP) or non-ST-segment-elevation myocardial infarction (NSTEMI), and 779 (8%) had ST-segment-elevation myocardial infarction (STEMI) as clinical presentation. A stepwise increase in 3-year crude cumulative mortality was observed in the transition from SAP to STEMI (4.9% vs 6.1% vs 9.4%; p <0.01). Conversely, no differences in crude mortality rates were observed between 1 and 3 years across clinical presentations. After multivariable adjustment, STEMI was independently associated with greater risk of 3-year mortality (hazard ratio [HR] 3.45; 95% confidence interval [CI] 1.99 to 5.98; p <0.01), whereas no differences were observed between UAP or NSTEMI and SAP (HR 0.99; 95% CI 0.73 to 1.34; p = 0.94). In women with ACS, use of new-generation DES was associated with reduced risk of major adverse cardiac events (HR 0.58; 95% CI 0.34 to 0.98). The magnitude and direction of the effect with new-generation DES was uniform between women with or without ACS (pinteraction = 0.66). In conclusion, in women across the clinical spectrum of CAD, STEMI was associated with a greater risk of long-term mortality. Conversely, the adjusted risk of mortality between UAP or NSTEMI and SAP was similar. New-generation DESs provide improved long-term clinical outcomes irrespective of the clinical presentation in women. [ABSTRACT FROM AUTHOR]

Although trials comparing antiplatelet strategies after percutaneous coronary intervention report average risks of bleeding and ischemia in a population, there is limited information to guide choices based on individual patient risks, particularly beyond 1 year after treatment. Patient-level data from Patient Related Outcomes With Endeavor vs Cypher Stenting Trial (PROTECT), a broadly inclusive trial enrolling 8,709 subjects treated with drug-eluting stents (sirolimus vs zotarolimus-eluting stent), and PROTECT US, a single-arm study including 1,018 subjects treated with a zotarolimus-eluting stent, were combined. The risk of ischemic events, cardiovascular death/non-periprocedural myocardial infarction (MI)/definite or probable stent thrombosis, and bleeding events, Global Use of Strategies to Open Occluded Arteries moderate or severe bleed, were predicted using logistic regression. At median follow-up of 4.1 years, major bleeding occurred in 260 subjects (2.8%) and ischemic events in 595 (6.3%). Multivariate predictors of bleeding were older age, smoking, diabetes mellitus, congestive heart failure, and chronic kidney disease (all p <0.05). Ischemic events shared all the same predictors with bleeding events and gender, body mass index, previous MI, previous coronary artery bypass graft surgery, ST-segment elevation MI on presentation, stent length, and sirolimus-eluting stent use (all p <0.05). Within individual subjects, bleeding and ischemic risks were strongly correlated; 97% of subjects had a greater risk of ischemic events than bleeding. In conclusion, individual patient risks of ischemia and bleeding are related to many common risk factors, yet the predicted risks of ischemic events are greater than those of major bleeding in the large majority of patients in long-term follow-up. [ABSTRACT FROM AUTHOR]