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Patients with acute STEMI were randomly assigned to undergo infarct-vessel-only PCI or preventive PCI (PCI to noninfarct arteries with stenoses). The rate of the primary outcome of cardiac death, myocardial infarction, or refractory angina was lower with preventive PCI. Patients with acute ST-segment elevation myocardial infarction (STEMI) are effectively treated with emergency angioplasty, hereafter called percutaneous coronary intervention (PCI), to restore blood flow to the coronary artery that is judged to be causing the myocardial infarction (infarct artery, also known as culprit artery). 1 – 5 These patients may have major stenoses in coronary arteries that were not responsible for the myocardial infarction, 6 but the value of performing PCI in such arteries for the prevention of future cardiac events is not known. Some physicians have taken the view that stenoses in noninfarct arteries may cause serious adverse cardiac events that could . . .

In the Fractional Flow Reserve Versus Angiography for Multivessel Evaluation (FAME) study, fractional flow reserve (FFR)-guided percutaneous coronary intervention (PCI) improved outcome compared with angiography-guided PCI for up to 2 years of follow-up. The aim in this study was to investigate whether the favourable clinical outcome with the FFR-guided PCI in the FAME study persisted over a 5-year follow-up. The FAME study was a multicentre trial done in Belgium, Denmark, Germany, the Netherlands, Sweden, the UK, and the USA. Patients (aged ≥18 years) with multivessel coronary artery disease were randomly assigned to undergo angiography-guided PCI or FFR-guided PCI. Before randomisation, stenoses requiring PCI were identified on the angiogram. Patients allocated to angiography-guided PCI had revascularisation of all identified stenoses. Patients allocated to FFR-guided PCI had FFR measurements of all stenotic arteries and PCI was done only if FFR was 0·80 or less. No one was masked to treatment assignment. The primary endpoint was major adverse cardiac events at 1 year, and the data for the 5-year follow-up are reported here. Analysis was by intention to treat. This trial is registered with ClinicalTrials.gov, number NCT00267774. After 5 years, major adverse cardiac events occurred in 31% of patients (154 of 496) in the angiography-guided group versus 28% (143 of 509 patients) in the FFR-guided group (relative risk 0·91, 95% CI 0·75–1·10; p=0·31). The number of stents placed per patient was significantly higher in the angiography-guided group than in the FFR-guided group (mean 2·7 [SD 1·2] vs 1·9 [1·3], p<0·0001). The results confirm the long-term safety of FFR-guided PCI in patients with multivessel disease. A strategy of FFR-guided PCI resulted in a significant decrease of major adverse cardiac events for up to 2 years after the index procedure. From 2 years to 5 years, the risks for both groups developed similarly. This clinical outcome in the FFR-guided group was achieved with a lower number of stented arteries and less resource use. These results indicate that FFR guidance of multivessel PCI should be the standard of care in most patients. St Jude Medical, Friends of the Heart Foundation, and Medtronic.

Coronary artery bypass grafting (CABG) is the standard treatment for revascularisation in patients with left main coronary artery disease, but use of percutaneous coronary intervention (PCI) for this indication is increasing. We aimed to compare PCI and CABG for treatment of left main coronary artery disease. In this prospective, randomised, open-label, non-inferiority trial, patients with left main coronary artery disease were enrolled in 36 centres in northern Europe and randomised 1:1 to treatment with PCI or CABG. Eligible patients had stable angina pectoris, unstable angina pectoris, or non-ST-elevation myocardial infarction. Exclusion criteria were ST-elevation myocardial infarction within 24 h, being considered too high risk for CABG or PCI, or expected survival of less than 1 year. The primary endpoint was major adverse cardiac or cerebrovascular events (MACCE), a composite of all-cause mortality, non-procedural myocardial infarction, any repeat coronary revascularisation, and stroke. Non-inferiority of PCI to CABG required the lower end of the 95% CI not to exceed a hazard ratio (HR) of 1·35 after up to 5 years of follow-up. The intention-to-treat principle was used in the analysis if not specified otherwise. This trial is registered with ClinicalTrials.gov identifier, number NCT01496651. Between Dec 9, 2008, and Jan 21, 2015, 1201 patients were randomly assigned, 598 to PCI and 603 to CABG, and 592 in each group entered analysis by intention to treat. Kaplan-Meier 5 year estimates of MACCE were 28% for PCI (121 events) and 18% for CABG (80 events), HR 1·51 (95% CI 1·13–2·00), exceeding the limit for non-inferiority, and CABG was significantly better than PCI (p=0·0044). As-treated estimates were 28% versus 18% (1·48, 1·11–1·98, p=0·0069). Comparing PCI with CABG, 5 year estimates were 11% versus 9% (1·08, 0·67–1·74, p=0·84) for all-cause mortality, 6% versus 2% (2·87, 1·40–5·89, p=0·0040) for non-procedural myocardial infarction, 15% versus 10% (1·50, 1·04–2·17, p=0·0304) for any revascularisation, and 5% versus 2% (2·20, 0·91–5·36, p=0·08) for stroke. The findings of this study suggest that CABG might be better than PCI for treatment of left main stem coronary artery disease. Biosensors, Aarhus University Hospital, and participating sites.

Fractional flow reserve (FFR) is a measure of the functional significance of a coronary stenosis. In this study, the use of FFR, as compared with angiography alone, in guiding the placement of coronary stents resulted in the use of fewer stents and better clinical outcomes. The use of fractional flow reserve, as compared with coronary angiography alone, in guiding the placement of coronary stents resulted in the use of fewer stents and better clinical outcomes. The presence of myocardial ischemia is an important risk factor for an adverse clinical outcome. 1 – 3 Revascularization of stenotic coronary lesions that induce ischemia can improve a patient's functional status and outcome. 3 – 5 For stenotic lesions that do not induce ischemia, however, the benefit of revascularization is less clear, and medical therapy alone is likely to be equally effective. 6 , 7 With the introduction of drug-eluting stents, the percentage of patients with multivessel coronary artery disease in whom percutaneous coronary intervention (PCI) is performed has increased. 8 , 9 Because drug-eluting stents are expensive and are associated with potential late complications, their appropriate . . .

Microvascular and/or vasospastic anginas are relevant causes of ischemia with no obstructive coronary artery disease (INOCA) in patients after computed tomography coronary angiography (CTCA). Our research has 2 objectives. The first is to undertake a diagnostic study, and the second is to undertake a nested, clinical trial of stratified medicine. A prospective, multicenter, randomized, blinded, sham-controlled trial of stratified medicine (NCT03477890) will be performed. All-comers referred for clinically indicated CTCA for investigation of suspected coronary artery disease (CAD) will be screened in 3 regional centers. Following informed consent, eligible patients with angina symptoms are enrolled before CTCA and remain eligible if CTCA excludes obstructive CAD. Diagnostic study: Invasive coronary angiography involving an interventional diagnostic procedure (IDP) to assess for disease endotypes: (1) angina due to obstructive CAD (fractional flow reserve ≤0.80); (2) microvascular angina (coronary flow reserve <2.0 and/or index of microvascular resistance >25); (3) microvascular angina due to small vessel spasm (acetylcholine); (4) vasospastic angina due to epicardial coronary spasm (acetylcholine); and (5) noncoronary etiology (normal coronary function). The IDP involves direct invasive measurements using a diagnostic coronary guidewire followed by provocation testing with intracoronary acetylcholine. The primary outcome of the diagnostic study is the reclassification of the initial CTCA diagnosis based on the IDP. Stratified medicine trial: Participants are immediately randomized 1:1 in the catheter laboratory to therapy stratified by endotype (intervention group) or not (control group). The primary outcome of the trial is the mean within-subject change in Seattle Angina Questionnaire score at 6 months. Secondary outcomes include safety, feasibility, diagnostic utility (impact on diagnosis and certainty), and clinical utility (impact on treatment and investigations). Health status assessments include quality of life, illness perception, anxiety-depression score, treatment satisfaction, and physical activity. Participants who are not randomized will enter a follow-up registry. Health and economic outcomes in the longer term will be assessed using electronic patient record linkage. CorCTCA will prospectively characterize the prevalence of disease endotypes in INOCA and determine the clinical value of stratified medicine in this population. [Display omitted]

In this trial, fractional flow reserve was used to assess the functional significance of coronary stenoses in patients with clinically stable coronary artery disease. The clinical outcomes were better when this technique was used to direct the use of coronary stenting. Percutaneous coronary intervention (PCI) improves the outcome in patients with acute coronary syndromes. 1 In contrast, for the treatment of patients with stable coronary artery disease, controversy persists regarding the extent of the benefit from PCI, as compared with the best available medical therapy, as an initial management strategy. 2 – 5 The potential benefit of revascularization depends on the presence and extent of myocardial ischemia. 6 – 8 Performing PCI on nonischemic stenoses is not beneficial 9 and is probably harmful. 10 Thus, careful selection of ischemia-inducing stenoses is essential for deriving the greatest benefit from revascularization in patients with stable coronary artery disease. Fractional flow . . .

Guidelines recommend coronary artery bypass graft (CABG) surgery over percutaneous coronary intervention (PCI) for the treatment of 3-vessel coronary artery disease (3-VD). The inferior results of PCI demonstrated by previous large randomized trials comparing PCI and CABG might be explained by the use of suboptimal stent technology and by the lack of fractional flow reserve (FFR) guidance of PCI. The objective of this investigator-initiated, multicenter, randomized clinical trial is to investigate whether FFR-guided PCI with new-generation stents is noninferior to CABG in patients with 3-VD, not including the left main coronary artery. Eligible patients must have ≥50% coronary stenoses in all 3 major epicardial vessels or major side branches. Patients with a nondominant right coronary artery may be included only if the left anterior descending artery and left circumflex have ≥50% stenoses. Consecutive patients who meet all of the inclusion criteria and none of the exclusion criteria will be randomized in a 1:1 fashion to either CABG or FFR-guided PCI. Coronary artery bypass graft will be performed based on the angiogram as per clinical routine. Patients assigned to FFR-guided PCI will have FFR measured in each diseased vessel and only undergo stenting if the FFR is ≤0.80. The primary end point of the study is a composite of major adverse cardiac and cerebrovascular events, including death, myocardial infarction, repeat coronary revascularization, and stroke at 1 year. Key secondary end point will be a composite of death, myocardial infarction, and stroke at 3-year follow-up. Other secondary end points include the individual adverse events, cost-effectiveness, and quality of life at 2-year, 3-year, with up to 5-year follow-up. The FAME 3 study will compare in a multicenter, randomized fashion FFR-guided PCI with contemporary drug-eluting stents to CABG in patients with 3-VD.

Stroke is a rare but potentially catastrophic complication of cardiac catheterization. Although some procedural aspects are known to influence stroke risk, the impact of radial versus femoral access site use is unclear. Early observational studies and limited randomized trial data suggested more frequent embolic events with radial access. Subsequently, larger pooled analyses have shown no clear differences in stroke risk but were limited by low event rates. Recent publication of relevant new data prompted our reevaluation of this concern. Therefore, we conducted a systematic review and meta-analysis to evaluate stroke complicating cardiac catheterization with use of transradial versus transfemoral access. A search of MEDLINE and EMBASE was undertaken using OVID SP with appropriate search terms. RevMan 5.3.5 was used to conduct a random-effects meta-analysis using the inverse variance method for pooling risk ratios (RRs) or the Mantel-Haenszel method for pooling dichotomous data. Pooled data from >24,000 patients in randomized controlled trials and >475,000 patients from observational studies were used. The risk ratio (RR) for (any) stroke, using randomized controlled trial data, was not significant (RR 0.87, 95% CI 0.58-1.29). Using observational data, a significant difference favoring radial access was seen (RR 0.71, 95% CI 0.52-0.98). Radial access site utilization for cardiac catheterization is not associated with an increased risk of stroke events. These data provide reassurance and should remove another potential barrier to conversion to a “default” radial practice among those who are currently predominantly femoral operators.

BackgroundThe relationship between atherosclerosis and endotypes of myocardial ischaemia with no obstructive coronary artery disease (INOCA) is unclear. We investigated potential associations between cumulative atherosclerotic plaque burden quantified using the Gensini score, novel invasive indices of coronary microvascular function (microvascular resistance reserve (MRR); resistive reserve ratio (RRR)) and related INOCA endotypes.MethodsCoronary angiography and invasive coronary function tests were simultaneously acquired in the CorMicA cohort. A comprehensive physiological assessment was performed using both a thermodilution-based diagnostic guidewire and intracoronary acetylcholine provocation testing. Angiograms were examined for luminal stenosis in each segment of the SYNTAX coronary model. Cumulative plaque burden was quantified using the Gensini score, which incorporated both the number of diseased coronary segments and stenosis severity. Results were compared with indices of microvascular function and INOCA endotypes. Angiographic analyses were performed blind to coronary physiology findings.ResultsIn 151 participants (median age 61 years; 73.5% female) without flow-limiting coronary artery disease, medical history included 41.7% smoking, 63.6% hypertension and 19.2% diabetes mellitus. The left anterior descending artery underwent diagnostic guidewire testing in 85.4%, and 55.0% of participants had abnormal coronary flow reserve (CFR) and/or Index of Microcirculatory Resistance (IMR). The median Gensini score was 6.0 (IQR 2.5–11.0). CFR (p=0.012), MRR (p=0.026) and RRR (p=0.026), but not IMR (p=0.445), were univariably associated with raised Gensini scores. These significant effects persisted in multivariable models controlling for potential confounders. Considering INOCA endotypes, Gensini scores differed among participants with microvascular angina (MVA) (7.0 (2.5–11.0)), vasospastic angina (VSA) (4.5 (2.0–10.0)), mixed MVA/VSA (9.0 (5.0–11.5)) and non-cardiac symptoms (3.5 (1.5–8.0)); Kruskal-Wallis p=0.030.ConclusionsReduced CFR, MRR and RRR, and MVA were associated with increased coronary atherosclerotic plaque burden, as evidenced by higher Gensini scores. These novel findings provide a mechanistic link between INOCA and cardiovascular events, reinforcing the importance of antiatherosclerosis therapy in patients with MVA.