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In this placebo-controlled trial, 7119 patients were randomly assigned at 3 months after PCI to either receive ticagrelor alone or continue dual therapy with ticagrelor plus aspirin. The trial evaluated bleeding and ischemic end points at 1 year.

At a median of 2.2 years, patients with stable coronary artery disease and advanced kidney disease who were treated with an invasive strategy of coronary angiography with revascularization if indicated did not have a lower risk of death or MI than those who were treated with a conservative strategy of medical therapy alone.

It is unclear whether radial compared with femoral access improves outcomes in unselected patients with acute coronary syndromes undergoing invasive management. We did a randomised, multicentre, superiority trial comparing transradial against transfemoral access in patients with acute coronary syndrome with or without ST-segment elevation myocardial infarction who were about to undergo coronary angiography and percutaneous coronary intervention. Patients were randomly allocated (1:1) to radial or femoral access with a web-based system. The randomisation sequence was computer generated, blocked, and stratified by use of ticagrelor or prasugrel, type of acute coronary syndrome (ST-segment elevation myocardial infarction, troponin positive or negative, non-ST-segment elevation acute coronary syndrome), and anticipated use of immediate percutaneous coronary intervention. Outcome assessors were masked to treatment allocation. The 30-day coprimary outcomes were major adverse cardiovascular events, defined as death, myocardial infarction, or stroke, and net adverse clinical events, defined as major adverse cardiovascular events or Bleeding Academic Research Consortium (BARC) major bleeding unrelated to coronary artery bypass graft surgery. The analysis was by intention to treat. The two-sided α was prespecified at 0·025. The trial is registered at ClinicalTrials.gov, number NCT01433627. We randomly assigned 8404 patients with acute coronary syndrome, with or without ST-segment elevation, to radial (4197) or femoral (4207) access for coronary angiography and percutaneous coronary intervention. 369 (8·8%) patients with radial access had major adverse cardiovascular events, compared with 429 (10·3%) patients with femoral access (rate ratio [RR] 0·85, 95% CI 0·74–0·99; p=0·0307), non-significant at α of 0·025. 410 (9·8%) patients with radial access had net adverse clinical events compared with 486 (11·7%) patients with femoral access (0·83, 95% CI 0·73–0·96; p=0·0092). The difference was driven by BARC major bleeding unrelated to coronary artery bypass graft surgery (1·6% vs 2·3%, RR 0·67, 95% CI 0·49–0·92; p=0·013) and all-cause mortality (1·6% vs 2·2%, RR 0·72, 95% CI 0·53–0·99; p=0·045). In patients with acute coronary syndrome undergoing invasive management, radial as compared with femoral access reduces net adverse clinical events, through a reduction in major bleeding and all-cause mortality. The Medicines Company and Terumo.

In 7213 patients with an acute coronary syndrome, the rate of major adverse cardiovascular events was not significantly lower with bivalirudin than with heparin. Post-PCI bivalirudin infusion did not reduce the risk of stent thrombosis. The most effective antithrombotic regimen for preventing ischemic complications while limiting bleeding risk in patients with an acute coronary syndrome who are undergoing invasive treatment remains unknown. 1 – 3 Two of the most commonly used antithrombotic regimens worldwide 4 , 5 are unfractionated heparin, an indirect thrombin inhibitor, with or without the concomitant use of a glycoprotein IIb/IIIa inhibitor, and bivalirudin, a direct thrombin inhibitor, with a glycoprotein IIb/IIIa inhibitor added only for periprocedural ischemic complications. Previous studies that have compared these two options among patients who were undergoing invasive treatment for an acute coronary syndrome have provided conflicting results with respect to . . .

The relative safety of drug-eluting stents and bare-metal stents, especially with respect to stent thrombosis, continues to be debated. In view of the overall low frequency of stent thrombosis, large sample sizes are needed to accurately estimate treatment differences between stents. We compared the risk of thrombosis between bare-metal and drug-eluting stents. For this network meta-analysis, randomised controlled trials comparing different drug-eluting stents or drug-eluting with bare-metal stents currently approved in the USA were identified through Medline, Embase, Cochrane databases, and proceedings of international meetings. Information about study design, inclusion and exclusion criteria, sample characteristics, and clinical outcomes was extracted. 49 trials including 50 844 patients randomly assigned to treatment groups were analysed. 1-year definite stent thrombosis was significantly lower with cobalt-chromium everolimus eluting stents (CoCr-EES) than with bare-metal stents (odds ratio [OR] 0·23, 95% CI 0·13–0·41). The significant difference in stent thrombosis between CoCr-EES and bare-metal stents was evident as early as 30 days (OR 0·21, 95% CI 0·11–0·42) and was also significant between 31 days and 1 year (OR 0·27, 95% CI 0·08–0·74). CoCr-EES were also associated with significantly lower rates of 1-year definite stent thrombosis compared with paclitaxel-eluting stents (OR 0·28, 95% CI 0·16–0·48), permanent polymer-based sirolimus-eluting stents (OR 0·41, 95% CI 0·24–0·70), phosphorylcholine-based zotarolimus-eluting stents (OR 0·21, 95% CI 0·10–0·44), and Resolute zotarolimus-eluting stents (OR 0·14, 95% CI 0·03–0·47). At 2-year follow-up, CoCr-EES were still associated with significantly lower rates of definite stent thrombosis than were bare-metal (OR 0·35, 95% CI 0·17–0·69) and paclitaxel-eluting stents (OR 0·34, 95% CI 0·19–0·62). No other drug-eluting stent had lower definite thrombosis rates compared with bare-metal stents at 2-year follow-up. In randomised studies completed to date, CoCr-EES has the lowest rate of stent thrombosis within 2 years of implantation. The finding that CoCr-EES also reduced stent thrombosis compared with bare-metal stents, if confirmed in future randomised trials, represents a paradigm shift. The Cardiovascular Research Foundation.

Since the beginning of the percutaneous coronary intervention (PCI) era, periprocedural myocardial infarction (PMI) has been recognized as a potential source of impaired outcomes in patients undergoing revascularization. Subsequently, several different definitions of PMI have been provided, coming from trial research groups or international consensus. Despite these efforts, the debate over the prognostic value or PMI in terms of mortality risk, as well as its role in defining composite ischemic endpoints in clinical investigations, has been extremely active. Currently, three international definitions of PMI are available: the Universal Definition of Myocardial Infarction (UDMI), the Academic Research Consortium (ARC)-2 definition, and the definition by the Society for Cardiovascular Angiography and Interventions (SCAI). These definitions differ significantly in terms of sensitivity and prognostic relevance, which has led to heterogeneous findings in clinical studies investigating this topic. Thus, this review aims to provide an overview of the main features of these definitions, their association with the risk of mortality, and how different definitions can influence the results of major investigations in the research setting.

Background Diabetic patients undergoing percutaneous coronary intervention (PCI) frequently have complex coronary artery disease (CAD) and suboptimal outcomes with drug-eluting stents (DES). Sirolimus-coated balloons (SCB) have recently been introduced, but comparative data versus DES in diabetic patients with de novo CAD are lacking. Methods The SIMPLE-DM study is a pooled analysis of five observational registries including all-comer diabetic patients undergoing PCI for de novo CAD. Patients in the SCB cohort were treated with the phospholipid nanocarrier Magic Touch SCB, while those in the DES cohort received current-generation DES. Propensity score (PS) adjustment was used to balance clinical and angiographic characteristics. The primary endpoint was the 2-year cumulative incidence of target lesion failure (TLF), defined as the composite of cardiac death, target vessel MI (TV-MI), or target lesion revascularization (TLR). Results A total of 1838 patients were included, 599 treated with SCB-based PCI and 1239 with DES-only PCI. At 2 years, TLF occurred in 9.1% of SCB and 9.9% of DES patients (adj. hazard ratio HR 0.88, 95% confidence interval CI 0.43–1.81, p  = 0.736). No significant differences were found in cardiac death, TV-MI or TLR. SCB-based PCI was associated with more favourable outcomes in patients with chronic kidney disease ( p for interaction = 0.042) and long lesions ( p for interaction = 0.003), whereas DES-only PCI performed better in those with short lesions. Conclusions In diabetic patients undergoing PCI for de novo CAD, an SCB-based strategy was associated with comparable 2-year outcomes to DES-only PCI, with signals of potential benefit in the highest clinical and anatomical risk subsets. Graphical abstract Abbreviations: ACS, acute coronary syndrome; ASTUTE, Amphilimus Italian multicentre registry; BP, biodegradable-polymer; CCS, chronic coronary syndrome; CKD, chronic kidney disease; DES, drug-eluting stent; EASTBOURNE, All-Comers Sirolimus-Coated Balloon European Registry; HR, hazard ratio; IDDM, insulin-dependent diabetes mellitus; PCI, percutaneous coronary intervention; PF, polymer-free; RUDI-FREE, Polymer-free biolimus-eluting stent implantation in all-comers population; SCB, sirolimus-coated balloon; TLF, target lesion failure; TLR, target lesion revascularization; TVF, target vessel failure; TV-MI, target vessel myocardial infarction; ULISSE, ULtimaster Italian multicenter all comerS Stent rEgistry.

Background: Visual angiographic assessment of left main (LM) bifurcation lesions is fraught with major limitations. Bifurcation-dedicated quantitative coronary angiography (Bif-QCA) assessment provides higher accuracy than standard QCA in bifurcation lesions. Fractal laws (e.g., Finet’s and Murray’s laws) can enhance the accuracy of reference diameter calculation when applied to angiography-derived algorithms and may serve as a surrogate for pressure-based assessment.Aims: To investigate the correlation between Bif-QCA, Finet’s law derived Bif-QCA (Finet-QCA) and pressure–wire functional assessment for LM bifurcation stenosis.Methods: Using instantaneous wave-free ratio (iFR) as a reference standard (≤ 0.89), we compared the value of Bif-QCA and Finet-QCA (diameter stenosis ≥ 50%). Moreover, the differences in MEDINA classification according to site-reported visual assessment vs Bif-QCA or Finet-QCA were investigated.Results: Eighty-four patients were included in the analysis, of which 72 (85.7%) presented an abnormal iFR. Bif-QCA derived %DS was moderately correlated with iFR values; however, implementing Finet’s law in the correlation resulted weak. Site-reported MEDINA (visual assessment) resulted in significant higher rate of 1,1,1 and lower rate of 1,0,0 patterns compared to Bif-QCA MEDINA (9.5% vs. 1.2%, p<0.001 and 33.3% vs. 46.4%, p<0.001, respectively) and to Finet-QCA MEDINA (9.5% vs. 2.4%, p<0.001 and 33.3% vs. 40%, p<0.001, respectively).Conclusions: The present study suggested that LM MEDINA bifurcation pattern should be based on QCA analysis rather than visual assessment, both in the context of clinical practice and clinical studies. Compared to conventional Bif-QCA, the implementation of fractal laws (Finet-QCA) did not appear to improve the determination of the reference diameters of the LM shaft.

High urine flow rate (UFR) has been suggested as a target for effective prevention of contrast-induced acute kidney injury (CI-AKI). The RenalGuard therapy (saline infusion plus furosemide controlled by the RenalGuard system) facilitates the achievement of this target. Four hundred consecutive patients with an estimated glomerular filtration rate ≤30 mL/min per 1.73 m2 and/or a high predicted risk (according to the Mehran score ≥11 and/or the Gurm score >7%) treated by the RenalGuard therapy were analyzed. The primary end points were (1) the relationship between CI-AKI and UFR during preprocedural, intraprocedural, and postprocedural phases of the RenalGuard therapy and (2) the rate of acute pulmonary edema and impairment in electrolytes balance. Urine flow rate was significantly lower in the patients with CI-AKI in the preprocedural phase (208 ± 117 vs 283 ± 160 mL/h, P < .001) and in the intraprocedural phase (389 ± 198 vs 483 ± 225 mL/h, P = .009). The best threshold for CI-AKI prevention was a mean intraprocedural phase UFR ≥450 mL/h (area under curve 0.62, P = .009, sensitivity 80%, specificity 46%). Performance of percutaneous coronary intervention (hazard ratio [HR] 4.13, 95% CI 1.81-9.10, P < .001), the intraprocedural phase UFR <450 mL/h (HR 2.27, 95% CI 1.05-2.01, P = .012), and total furosemide dose >0.32 mg/kg (HR 5.03, 95% CI 2.33-10.87, P < .001) were independent predictors of CI-AKI. Pulmonary edema occurred in 4 patients (1%). Potassium replacement was required in 16 patients (4%). No patients developed severe hypomagnesemia, hyponatremia, or hypernatremia. RenalGuard therapy is safe and effective in reaching high UFR. Mean intraprocedural UFR ≥450 mL/h should be the target for optimal CI-AKI prevention.