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In this trial involving patients with three-vessel coronary artery disease, PCI guided by assessment of fractional flow reserve was not noninferior to CABG with respect to the composite end point of death, myocardial infarction, stroke, or repeat revascularization at 1 year. The incidence of this composite end point was higher among those assigned to FFR-guided PCI than among those assigned to CABG.

Bivalirudin, with selective use of glycoprotein (GP) IIb/IIIa inhibitor agents, is an accepted standard of care in primary percutaneous coronary intervention (PPCI). We aimed to compare antithrombotic therapy with bivalirudin or unfractionated heparin during this procedure. In our open-label, randomised controlled trial, we enrolled consecutive adults scheduled for angiography in the context of a PPCI presentation at Liverpool Heart and Chest Hospital (Liverpool, UK) with a strategy of delayed consent. Before angiography, we randomly allocated patients (1:1; stratified by age [<75 years vs ≥75 years] and presence of cardiogenic shock [yes vs no]) to heparin (70 U/kg) or bivalirudin (bolus 0·75 mg/kg; infusion 1·75 mg/kg per h). Patients were followed up for 28 days. The primary efficacy outcome was a composite of all-cause mortality, cerebrovascular accident, reinfarction, or unplanned target lesion revascularisation. The primary safety outcome was incidence of major bleeding (type 3–5 as per Bleeding Academic Research Consortium definitions). This study is registered with ClinicalTrials.gov, number NCT01519518. Between Feb 7, 2012, and Nov 20, 2013, 1829 of 1917 patients undergoing emergency angiography at our centre (representing 97% of trial-naive presentations) were randomly allocated treatment, with 1812 included in the final analyses. 751 (83%) of 905 patients in the bivalirudin group and 740 (82%) of 907 patients in the heparin group had a percutaneous coronary intervention. The rate of GP IIb/IIIa inhibitor use was much the same between groups (122 patients [13%] in the bivalirudin group and 140 patients [15%] in the heparin group). The primary efficacy outcome occurred in 79 (8·7%) of 905 patients in the bivalirudin group and 52 (5·7%) of 907 patients in the heparin group (absolute risk difference 3·0%; relative risk [RR] 1·52, 95% CI 1·09–2·13, p=0·01). The primary safety outcome occurred in 32 (3·5%) of 905 patients in the bivalirudin group and 28 (3·1%) of 907 patients in the heparin group (0·4%; 1·15, 0·70–1·89, p=0·59). Compared with bivalirudin, heparin reduces the incidence of major adverse ischaemic events in the setting of PPCI, with no increase in bleeding complications. Systematic use of heparin rather than bivalirudin would reduce drug costs substantially. Liverpool Heart and Chest Hospital, UK National Institute of Health Research, The Medicines Company, AstraZeneca, The Bentley Drivers Club (UK).

BackgroundIt is still uncertain whether coronary bifurcations with lesions involving a large side branch (SB) should be treated by stenting the main vessel and provisional stenting of the SB (simple) or by routine two-stent techniques (complex). We aimed to compare clinical outcome after treatment of lesions in large bifurcations by simple or complex stent implantation.MethodsThe study was a randomised, superiority trial. Enrolment required a SB≥2.75 mm, ≥50% diameter stenosis in both vessels, and allowed SB lesion length up to 15 mm. The primary endpoint was a composite of cardiac death, non-procedural myocardial infarction and target lesion revascularisation at 6 months. Two-year clinical follow-up was included in this primary reporting due to lower than expected event rates.ResultsA total of 450 patients were assigned to simple stenting (n=221) or complex stenting (n=229) in 14 Nordic and Baltic centres. Two-year follow-up was available in 218 (98.6%) and 228 (99.5%) patients, respectively. The primary endpoint of major adverse cardiac events (MACE) at 6 months was 5.5% vs 2.2% (risk differences 3.2%, 95% CI −0.2 to 6.8, p=0.07) and at 2 years 12.9% vs 8.4% (HR 0.63, 95% CI 0.35 to 1.13, p=0.12) after simple versus complex treatment. In the subgroup treated by newer generation drug-eluting stents, MACE was 12.0% vs 5.6% (HR 0.45, 95% CI 0.17 to 1.17, p=0.10) after simple versus complex treatment.ConclusionIn the treatment of bifurcation lesions involving a large SB with ostial stenosis, routine two-stent techniques did not improve outcome significantly compared with treatment by the simpler main vessel stenting technique after 2 years.Trial registration numberNCT01496638.

IntroductionAn evidence-based selection between fractional flow reserve (FFR) and optical coherence tomography (OCT) to drive percutaneous coronary intervention is still lacking.MethodsPatients enrolled in the Fractional Flow Reserve vs. Optical Coherence Tomography to Guide Revascularization of Intermediate Coronary Stenoses (FORZA) trial and in the OCT-Features Of moRphology, coMposItion anD instABility of culprit and not culprit coronary pLaquE in ACS patient (OCT-FORMIDABLE) registry were included. Target vessel revascularisation (TVR) and major adverse cardiac events (MACE), a composite endpoint of cardiac death, myocardial infarction (MI) and TVR were considered as coprimary endpoints. Phenomapping with clustering was performed: incidence of outcomes according to FFR and OCT was explored.Results405 patients were treated according to OCT and 405 to FFR. Three different clusters were identified. 48% of the patients were included in the first cluster, presenting mainly with stable angina and a relevant burden of risk factors (cardiovascular risk factors, CVRFs). 21% of the patients were included in the second cluster, presenting with ST segment elevation MI (STEMI) and with low rates of CVRFs. 31% of the patients, being admitted mostly for non-STEMI (NSTEMI) and with high rates of CVRFs, were included in the third cluster. FFR and OCT performed similarly in terms of MACE and TVR in the first cluster. In the second cluster, rates of MACE were lower in the OCT arm (3% vs 12%, p 0.04), mainly driven by TVR (2% vs 6%, p 0.18). In the third cluster, rates of TVR were significantly reduced in the OCT arm (6% vs 14%, p 0.037) with a neutral impact on MACE (12% vs 15%, p 0.71).ConclusionsCompared with a functional assessment, an OCT-based approach reduces revascularisation in patients with STEMI/NSTEMI, while FFR proved non-inferior for patients with stable angina.

The sirolimus-eluting stent has shown promise in the prevention of restenosis after balloon dilation of simple coronary lesions. This clinical trial compared the sirolimus-eluting stent with a standard stent in patients with complex coronary lesions. The sirolimus-eluting stent proved to be superior in the prevention of restenosis and neointimal hyperplasia. Superior prevention of restenosis and hyperplasia with the sirolimus-eluting stent. The demonstrated clinical usefulness of the implantation of a coronary stent as the preferred method of percutaneous revascularization is due to improved procedural safety as compared with balloon angioplasty and reduced rates of restenosis. 1 – 7 But despite the use of coronary stents, the frequency of restenosis may be more than 30 percent in several subgroups of patients, including subgroups with diabetes mellitus, small coronary vessels, and long lesions. 8 – 15 During the past two decades, attempts to reduce restenosis after angioplasty with the use of locally delivered or systemic pharmaceutical agents have been largely unsuccessful. 16 – 19 Recently, sirolimus (rapamycin), a cytostatic . . .

Intravascular ultrasound (IVUS) has developed as a preferable choice for optimizing the stenting procedures mainly because it will have good access to vessel size, lesion length, or severity accurately. However, it still remains unclear about the benefits of IVUS guidance in drug-eluting stent (DES) implantation for patients with unprotected left main coronary artery (ULMCA) stenosis. The aim of the present study was to evaluate the clinical outcomes with respect to IVUS-guided DES implantation for these patients. A total of 336 consecutive patients from December 2010 to December 2015 were enrolled in the study. The patients were then randomly assigned into two groups: IVUS-guided group (n=167) and control group (n=169). The primary endpoint was the incidence of composite major adverse cardiac events (MACEs), including cardiac death, myocardial infarction (MI), and target vessel revascularization (TVR). The risk of stent thrombosis (ST) was chosen as the safety endpoint. After a 1-year follow-up, the occurrence of composite MACE in the IVUS-guided group was significantly lower than that in the control group (13.2% vs. 21.9%, p=0.031), which might mainly result from the significant reduction in the risk of cardiac death (1.8% vs. 5.9%, p=0.048). Dramatically, the risk of MI did not differ significantly between the two groups (11.4% vs. 13.6%, p=0.478), though a tended reduction in TVR was observed under IVUS guidance (4.2% vs. 8.9%, p=0.068). There was no statistical significance between the two groups with respect to the risk of target lesion revascularization (IVUS-guided vs. control: 1.2% vs. 3.0%, p=0.239) and ST (IVUS-guided vs. control: 1.2% vs. 3.0%, p=0.246). The possible feasibility of IVUS-guided DES implantation for patients with ULMCA stenosis was supported by the present study. Larger and more powerful randomized trials were still warranted to research the whole benefits of IVUS guidance for these patients.

BackgroundWhether final kissing ballooning (FKB) is mandatory in the 1-stent technique is uncertain.ObjectiveTo evaluate the effect of FKB on long-term clinical outcomes in coronary bifurcation lesions treated with the 1-stent technique.MethodsConsecutive patients undergoing percutaneous coronary intervention using drug-eluting stents for non-left main bifurcation lesions were enrolled from 16 centres in Korea between January 2004 and June 2006. In patients treated with the 1-stent technique major adverse cardiac events (MACE; cardiac death, myocardial infarction (MI), or target lesion revascularisation (TLR)) were compared between those undergoing main vessel stenting only (non-FKB group, n=736) or those undergoing FKB after main vessel stenting (FKB group, n=329). Propensity score-matching analysis was also performed in 222 patient pairs (444 from the non-FKB group and 222 from the FKB group).ResultsDuring follow-up (median 22 months), the FKB group had a higher incidence of MACE (HR 2.58; 95% CI 1.52 to 4.37; p<0.001) and TLR (HR 3.63; 95% CI 2.00 to 6.56; p<0.001), but not of cardiac death or MI. Most TLR occurred in the main vessel (HR 3.39 for the FKB group; 95% CI 1.86 to 6.19; p<0.001). The rate of stent thrombosis was similar in both groups (0.5% in the non-FKB group vs 0.6% in the FKB group, p=0.99). After propensity score matching, the FKB group still had higher rates of MACE and TLR than the non-FKB group (HR 2.13; 95% CI 1.15 to 3.95; p=0.02 and HR 2.84; 95% CI 1.45 to 5.55; p=0.002, respectively).ConclusionsIn patients treated with the 1-stent technique for bifurcation lesions, FKB after main vessel stenting may be harmful mainly due to increased TLR.Trial Registration Numberclinicaltrials.gov number: NCT00851526.

In patients with increased bleeding risk during dual antiplatelet therapy, the biolimus A9–coated BioFreedom, a stainless steel drug-coated stent devoid of polymer, has shown superiority compared to a bare-metal stent. The aim of this study was to investigate whether the polymer-free biolimus A9–coated BioFreedom is noninferior to a modern thin-strut biodegradable polymer cobalt-chromium sirolimus-eluting Orsiro stent in an all-comers patient population treated with percutaneous coronary intervention. The multicenter SORT OUT IX trial (NCT02623140) randomly assigned all-comers patients to treatment with the BioFreedom drug-coated stent or the biodegradable polymer Orsiro stent in 4 Danish University Hospitals. The primary end point target lesion failure is a composite of cardiac death, myocardial infarction (not related to other than index lesion), or target lesion revascularization within 12 months. Clinically driven event detection based on Danish registries will be used and continue through 5 years. Assuming an event rate of 4.2% in each stent group, 1,563 patients in each treatment arm will provide 90% power to detect noninferiority of the drug-coated BioFreedom stent with a noninferiority margin of 2.1%. A total of 3,150 patients have been randomized and enrolled in the study. The SORT OUT IX trial will determine whether the drug-coated BioFreedom stent is noninferior to a modern biodegradable polymer Orsiro stent.

There exist limited data on the relative degree of acute injury and late healing of the radial artery after transradial artery (TRA) percutaneous coronary intervention (PCI) with a 7F sheathless guide catheter compared with a 6F sheath/guide combination. We used ultrahigh-resolution (55 MHz) vascular ultrasound to compare intimal-medial thickening (IMT) and early and late radial artery (RA) injury resulting from a sheathless 7F guide catheter versus a 6F sheath/guide combination for TRA-PCI. Forty-one consecutive consenting patients undergoing elective nonemergent TRA-PCI at a single institution from June 2016 to December 2016 were included. Patients were randomized (stratified by sex) to undergo TRA-PCI using a 7F sheathless guide catheter versus a 6F sheath/6F guide combination. Ultrahigh-resolution vascular ultrasound (55MHz) of the RA access site was performed at 24hours and 90days post–TRA-PCI. The primary outcome of the study was a noninferiority comparison of radial artery IMT thickness at 90days. PCI success rates, fluoroscopy times, number of guides used, and crossover rates to a femoral approach were also compared. Baseline characteristics were similar between groups. Radial arterial IMT (mm) was similar between the 7F sheathless and 6F sheath/guide groups at 24hours (0.27 vs 0.29, respectively; P=.43) and at 90days (0.35 vs 0.34, respectively; P=.96). The P value for the noninferiority testing of a 0.07-mm limit was .002. Limited access site intimal tears were relatively common in both groups at 24hours (4 vs 5, P=.53) but often healed by 90days. Radial artery occlusion was infrequent at 90days (2 vs 1, P=.10), and no frank dissections were noted. PCI success rates (100% vs 95%, P=.59), fluoroscopy times (16 vs 12minutes, P=.17), number of guides used (1.1 vs 1.2, P=.48), and femoral crossover rates (0% vs 0%) were similar between the 2 respective groups. A 7F sheathless approach to TRA-PCI results in no more IMT and early or late RA trauma than a standard 6F sheath/guide combination, rendering the 7F sheathless technique an attractive option for complex TRA-PCI.

Objective We investigated clinical outcomes after treatment of coronary bifurcation lesions with second generation drug eluting stents (DES). Design Post hoc analysis of a randomised, multicentre, non-inferiority trial. Setting Multicentre study. Patients All comers study with minimal exclusion criteria. Interventions Patients were treated with either zotarolimus or everolimus eluting stents. The patient population was divided according to treatment of bifurcation or non-bifurcation lesions and clinical outcomes were compared between groups. Main outcomes measures Clinical outcomes within 2-year follow-up. Results A total of 2265 patients were included in the present analysis. Two-year follow-up data were available in 2223 patients: 1838 patients in the non-bifurcation group and 385 patients in the bifurcation group. At 2-year follow-up the bifurcation and the non-bifurcation lesion groups showed no significant differences in terms of cardiac death (2.3 vs 2.1, p=0.273), target lesion failure (9.7% vs 13.8%, p=0.255), major adverse cardiac events (11.5% vs 15.1%, p=0.305), target lesion revascularisation (4.7% vs 6.0%, p=0.569), and definite or probable stent thrombosis (1.6% vs 1.8%, p=0.419). Conclusions The use of second generation DES for the treatment of coronary bifurcation lesions was associated with similar long term mortality and clinical outcomes compared with non-bifurcation lesions.