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Dual antiplatelet therapy (DAPT) is necessary to prevent thrombosis yet increases bleeding after percutaneous coronary intervention (PCI) with drug-eluting stents (DES). Antiplatelet monotherapy with a potent P2Y12 receptor antagonist may reduce bleeding while maintaining anti thrombotic efficacy compared with conventional DAPT. TWILIGHT is a randomized, double-blind placebo-controlled trial evaluating the comparative efficacy and safety of antiplatelet monotherapy versus DAPT in up to 9000 high-risk patients undergoing PCI with DES. Upon enrollment after successful PCI, all patients will be treated with open label low-dose aspirin (81-100 mg daily) plus ticagrelor (90 mg twice daily) for 3 months. Event-free patients will then be randomized in a double-blind fashion to low-dose aspirin versus matching placebo with continuation of open-label ticagrelor for an additional 12 months. The primary hypothesis is that a strategy of ticagrelor monotherapy will be superior with respect to the primary endpoint of bleeding academic research consortium type 2, 3 or 5, while maintaining non-inferiority for ischemic events compared with ticagrelor plus ASA. TWILIGHT is the largest study to date that is specifically designed and powered to demonstrate reductions in bleeding with ticagrelor monotherapy versus ticagrelor plus ASA beyond 3 months post-procedure in a high-risk PCI population treated with DES. The trial will provide novel insights with respect to the potential role of ticagrelor monotherapy as an alternative for long-term platelet inhibition in a broad population of patients undergoing PCI with DES.

Double kissing (DK) crush approach for patients with coronary bifurcation lesions, particularly localized at distal left main or lesions with increased complexity, is associated with significant reduction in clinical events when compared with provisional stenting. Recently, randomized clinical trial has demonstrated the net clinical benefits by intravascular ultrasound (IVUS)-guided implantation of drug-eluting stent in all-comers. However, the improvement in clinical outcome after DK crush treatment guided by IVUS over angiography guidance for patients with complex bifurcation lesions have never been studied in a randomized fashion. DKCRUSH VIII study is a prospective, multicenter, randomized controlled trial designed to assess superiority of IVUS-guided vs angiography-guided DK crush stenting in patients with complex bifurcation lesions according to DEFINITION criteria. A total of 556 patients with complex bifurcation lesions will be randomly (1:1 of ratio) assigned to IVUS-guided or angiography-guided DK crush stenting group. The primary end point is the rate of 12-month target vessel failure, including cardiac death, target vessel myocardial infarction, or clinically driven target vessel revascularization. The secondary end points consist of the individual component of primary end point, all-cause death, myocardial infarction, and in-stent restenosis. The safety end point is the incidence of definite or probable stent thrombosis. An angiographic follow-up will be performed for all patients at 13 months and clinical follow-up will be continued annually until 3 years after the index procedure. DKCRUSH VIII trial is the first study designed to evaluate the differences in efficacy and safety between IVUS-guided and angiography-guided DK crush stenting in patients with complex true bifurcation lesions. This study will also provide IVUS-derived criteria to define optimal DK crush stenting for bifurcation lesions at higher complexity.

Drug-coated balloon (DCB) technology was developed as an alternative treatment for obstructive coronary artery disease (CAD) and in-stent restenosis (ISR). Management of coronary ISR is clinically challenging and frequently encountered in practice. The Agent DCB uses an inactive excipient to effectively deliver a targeted, therapeutic dose of paclitaxel to the vessel wall. AGENT IDE is a prospective, multicenter, randomized controlled trial to evaluate superiority of the Agent DCB to balloon angioplasty in treating patients with ISR. A total of 480 patients with ISR of a previously treated lesion length <26 mm and reference vessel diameter >2.0 mm to ≤4.0 mm will be initially randomized. Subjects presenting with recent myocardial infarction (MI), complex lesions, or thrombus in the target vessel will be excluded. An adaptive group sequential design with one formal interim analysis for sample size re-estimation will be conducted, and the sample size may be increased to a maximum of 600 subjects. The primary endpoint is the rate of 12-month target lesion failure (TLF; composite of any ischemia-driven revascularization of the target lesion (TLR), target vessel related MI, or cardiac death) and will be tested for superiority in the test arm against the control. Functional status and general health-related quality of life will be measured by changes in the EQ-5D scores. Subjects will be followed for 5 years following the index procedure. This study will prospectively evaluate the safety and efficacy of Agent DCB in patients treated for coronary ISR.

The edge effect (EE) of isolated restenosis at one or both ends of a stent is not reduced by drug-eluting stent (DES). The purpose of the study was to investigate the long-term outcome of 1-year subclinical DES-EE (sDES-EE), which was defined as any reduction in the minimal lumen area (MLA) at stent edge without any evidence of clinical ischemia. A total of 252 patients were enrolled from one of our previous randomized controlled studies, who were detected by optical coherence tomography (OCT) immediately after DES implantation and 1 year later. The primary endpoint was EE-related target lesion failure (EE-TLF) at 5 years. Secondary endpoints were the changes of morphologies and composition of stent edge plaque, and each component of EE-TLF. sDES-EE at 1 year was significantly correlated with EE-TLF at 5 years by binary logistic regression analysis after propensity scoring. The most valuable cutoff value of sDES-EE at 1 year was a 25% MLA reduction at the stent edge, according to receiver operating characteristic analysis, which showed a major increase in lipid normalized total volume (0.99 ± 0.25 mm 3 vs. -0.21 ± 0.06 mm 3 , p  = 0.025) and lipid percent atheroma volume (3.92 ± 1.34% vs. -1.22 ± 0.78%, p  = 0.029). EE-TLF at 5 years was significantly higher in the sDES-EE group than in the non-sDES-EE group (15.6% vs. 4.1%, p  = 0.001). sDES-EE with MLA reduction ≥ 25% at the stent edge at 1 year after PCI was an independent predictor of EE-TLF at 5 years, which was mainly caused by the progression of lipid components measured by OCT. Trial registration ClinicalTrials.gov. Number NCT02140801. Study registration http://www.clinicaltrials.gov . identifier: NCT02140801.

The aim of this study was to investigate the efficacy and safety of paclitaxel-coated balloon (PCB) for the treatment of the bare-metal stent restenosis (BMS-ISR) and drug-eluting stent restenosis (DES-ISR). This study was a prospective, multicenter, randomized (2:1) trial conducted in 208 patients with 213 in-stent restenosis lesions (BMS-ISR: 123 lesions, DES-ISR: 90 lesions) at 13 centers in Japan. Patients were randomly assigned to a PCB group (137 patients with 142 lesions) or a conventional balloon angioplasty (BA) group (71 patients with 71 lesions). The primary end point was target vessel failure at 6-month follow-up. Clinical and angiographic follow-up 6 months after intervention was performed in 207 patients (99.5%) with 208 lesions (97.7%). Target vessel failure was noted in 6.6% of the PCB group and 31.0% of the BA group (P < .001). Recurrent restenosis occurred in 4.3% of the PCB group and 31.9% of the BA group (P < .001). Late lumen loss was lower in the PCB group than in the BA group (0.11 ± 0.33 mm vs 0.49 ± 0.50 mm, P < .001). In PCB-treated lesions, recurrent restenosis occurred in 1.1% of patients with BMS-ISR and in 9.1% of patients with DES-ISR (P = .04). Late lumen loss was lower in patients with BMS-ISR than in patients with DES-ISR (0.05 ± 0.28 mm vs 0.18 ± 0.38 mm, P = .03). This randomized clinical study suggested that PCB provided much better clinical and angiographic outcomes than did conventional BA in patients with BMS-ISR and DES-ISR. Drug-eluting stent restenosis was associated with poorer outcomes compared with BMS-ISR after treatment with PCB.

We sought to compare the long-term safety of two devices with different antiproliferative properties: the Endeavor zotarolimus-eluting stent (E-ZES; Medtronic, Inc) and the Cypher sirolimus-eluting stent (C-SES; Cordis, Johnson & Johnson) in a broad group of patients and lesions. Between May 21, 2007 and Dec 22, 2008, we recruited 8791 patients from 36 recruiting countries to participate in this open-label, multicentre, randomised, superiority trial. Eligible patients were those aged 18 years or older undergoing elective, unplanned, or emergency procedures in native coronary arteries. Patients were randomly assigned to either receive E-ZES and C-SES (ratio 1:1). Randomisation was stratified per centre with varying block sizes of four, six, or eight patients, and concealed with a central telephone-based or web-based allocation service. The primary outcome was definite or probable stent thrombosis at 3 years and was analysed by intention to treat. Patients and investigators were aware of treatment assignment. This trial is registered with ClinicalTrials.gov, number NCT00476957. PROTECT randomised 8791 patients, of whom 8709 provided consent to participate and were eligible: 4357 were allocated to the E-ZES group and 4352 patients to the C-SES group. At 3 years, rates of definite or probable stent thrombosis did not differ between groups (1·4% for E-ZES [predicted: 1·5%] vs 1·8% [predicted: 2·5%] for C-SES; hazard ratio [HR] 0·81, 95% CI 0·58–1·14, p=0·22). Dual antiplatelet therapy was used in 8402 (96%) patients at discharge, 7456 (88%) at 1 year, 3041 (37%) at 2 years, and 2364 (30%) at 3 years. No evidence of superiority of E-ZES compared with C-SES in definite or probable stent thrombosis rates was noted at 3 years. Time analysis suggests a difference in definite or probable stent thrombosis between groups is emerging over time, and a longer follow-up is therefore needed given the clinical relevance of stent thrombosis. Medtronic, Inc.

Background This prospective randomized study compares the efficacy of novel intravascular lithotripsy (IVL) to the standard preparation of calcified coronary lesions based on rotational atherectomy (RA). Methods A total of 50 patients with 52 calcified lesions were enrolled in the study and randomized 1:1 to be treated with IVL or RA followed by drug-eluting stent (DES) implantation. The procedural success was chosen as a primary endpoint and the 12-month late lumen loss (LLL) as measured by quantitative coronarography, the incidence of binary in-stent restenosis (ISR), 12-month major adverse cardiac events (MACE) and target lesion failure (TLF) served as secondary angiographic and clinical endpoints. Results Procedural success was achieved in 21 patients (84.0%) in the IVL group and in 24 patients (96%) in the RA group (p = 0.349). The secondary endpoints, including 12-month LLL (0.12 mm [IQR: − 0.06; 0.68] vs. 0.61 mm [IQR: 0.22; 0.72]; p = 0.084), the incidence of 12-month binary ISR (11.1% vs. 8.0%; p >0.999), MACE (18.5% vs. 8.0%; p = 0.422), TLR (14.8% vs. 8.0%; p = 0.670) or TLF (18.5% vs. 8.0%; p = 0.422) did not show significant differences between the IVL and RA groups. Conclusion Despite different approaches to the treatment of calcified coronary lesions, both therapeutic techniques achieved similar procedural, angiographic and clinical results. (ClinicalTrials.gov NCT04428177).

Background This study aimed to develop and validate a nomogram to predict probability of in-stent restenosis (ISR) in patients undergoing percutaneous coronary intervention (PCI). Methods Patients undergoing PCI with drug-eluting stents between July 2009 and August 2011 were retrieved from a cohort study in a high-volume PCI center, and further randomly assigned to training and validation sets. The least absolute shrinkage and selection operator (LASSO) regression model was used to screen out significant features for construction of nomogram. Multivariable logistic regression analysis was applied to build a nomogram-based predicting model incorporating the variables selected in the LASSO regression model. The area under the curve (AUC) of the receiver operating characteristics (ROC), calibration plot and decision curve analysis (DCA) were performed to estimate the discrimination, calibration and utility of the nomogram model respectively. Results A total of 463 patients with DES implantation were enrolled and randomized in the development and validation sets. The predication nomogram was constructed with five risk factors including prior PCI, hyperglycemia, stents in left anterior descending artery (LAD), stent type, and absence of clopidogrel, which proved reliable for quantifying risks of ISR for patients with stent implantation. The AUC of development and validation set were 0.706 and 0.662, respectively, indicating that the prediction model displayed moderate discrimination capacity to predict restenosis. The high quality of calibration plots in both datasets demonstrated strong concordance performance of the nomogram model. Moreover, DCA showed that the nomogram was clinically useful when intervention was decided at the possibility threshold of 9%, indicating good utility for clinical decision-making. Conclusions The individualized prediction nomogram incorporating 5 commonly clinical and angiographic characteristics for patients undergoing PCI can be conveniently used to facilitate early identification and improved screening of patients at higher risk of ISR.

Thrombus burden and distal embolization are predictive of no-reflow during primary percutaneous coronary intervention (PCI) in patients with acute ST-elevation myocardial infarction (STEMI). We sought to compare the efficacy of pharmacological and catheter-based strategies for thrombus in patients with STEMI and high atherothrombotic burden. Between January 2012 and December 2013, 128 STEMI patients undergoing primary PCI at 5 centers were randomly assigned in a 2 × 2 factorial design to intracoronary (IC) abciximab bolus (via the guide catheter) versus intralesion (IL) abciximab bolus, each with versus without aspiration thrombectomy (AT). Study end points were residual intrastent atherothrombotic burden, defined as the number of cross-sections with residual tissue area >10% as assessed by optical coherence tomography, and indices of angiographic and myocardial reperfusion. Residual intrastent atherothrombotic burden did not significantly differ with IL versus IC abciximab (median [interquartile range] 6.0 [1-15] vs 6.0 [2-11], P = .806) and with AT versus no aspiration (6.0 [1-13] vs 6.0 [2-12], P = .775). Intralesion abciximab administration was associated with improved angiographic myocardial reperfusion in terms of thrombolysis in myocardial infarction (TIMI) flow (3 [3-3] vs 3 [2-3], P = .040), corrected TIMI frame count (12 ± 5 vs 17 ± 16, P = .021), and myocardial blush grade (3 [2-3] vs 3 [2-3], P = .035). In particular, IL abciximab was associated with higher occurrence of final TIMI 3 flow (90% vs 73.8%, P = .032) and myocardial blush grade 3 (71.6% vs 52.4%, P = .039). Conversely, AT had no significant effect on indices of angiographic or myocardial reperfusion. In patients with STEMI and high thrombotic burden, neither IL versus IC abciximab nor AT versus no aspiration reduced postprocedure intrastent atherothrombotic burden in patients with STEMI undergoing primary PCI. However, IL abciximab improved indices of angiographic and myocardial reperfusion compared to IC abciximab, benefits not apparent with AT.

Background Drug-coated balloon (DCB) is a novel and effective device for coronary artery disease patients with in-stent restenosis (ISR). However, the incidence and possible influencing factors associated with binary restenosis have not yet been adequately assessed. Methods The data are extracted from a prospective, multicenter, randomized controlled trial. A total of 211 patients with ISR were enrolled at 13 centers from August 2017 to October 2018 and treated with DCB. At the 9-month coronary angiographic follow-up, patients were divided into restenosis and non-restenosis groups, and demographic data, lesion features, and laboratory tests were retrospectively reviewed. Furthermore, logistic regression analysis was used to identify possible influencing factors. Results All patients successfully underwent treatment, and 166 patients with 190 lesions took part in angiography follow-ups at 9 months. Of these, 41 patients with 44 target lesions developed restenosis following treatment, and the incidence of ISR was 24.7%. There were significant differences in the average length of target lesions and the number of multivessel lesions and fasting plasma glucose (FBG) between the two groups ( p  < 0.05). Demographic data, cardiac risk factors, left ventricular ejection fractions (LVEF), blood routine tests, biochemical tests, and other features of devices and lesions showed no difference. Logistic regression analyses showed that FBG > 6.1 mmol/L (OR: 7.185 95% CI: 2.939–17.567 P  < 0.001) and length of lesion (OR:1.046 95% CI: 1.001–1.093 P  = 0.046) were associated risk factors. Conclusions The longer length of lesions, more target lesions and FBG > 6.1 mmol/L per individual may be characteristics of patients showing ISR following treatment. Studies with larger sample size, and more complete follow-up data are needed in the future to expend on these findings. Trial registration No.: NCT04213378, first posted date (30/12/2019).