Percutaneous coronary intervention for bifurcation coronary lesions using optimised angiographic guidance: the 18th consensus document from the European Bifurcation Club.

The 2023 European Bifurcation Club (EBC) meeting took place in Warsaw in October, and the latest evidence for the use of intravascular ultrasound (IVUS) and optical coherence tomography (OCT) to optimise percutaneous coronary interventions (PCI) on coronary bifurcation lesions (CBLs) was a major focus. The topic generated deep discussions and general appraisal on the potential benefits of IVUS and OCT in PCI procedures. Nevertheless, despite an increasing recognition of IVUS and OCT capabilities and their recognised central role for guidance in complex CBL and left main PCI, it is expected that angiography will continue to be the primary guidance modality for CBL PCI, principally due to educational and economic barriers. Mindful of the restricted access/adoption of intracoronary imaging for CBL PCI, the EBC board decided to review and describe a series of tips and tricks which can help to optimise angiography-guided PCI for CBLs. The identified key points for achieving an optimal angiography-guided PCI include a thorough analysis of pre-PCI images (computed tomography angiography, multiple angiographic views, quantitative coronary angiography vessel estimation), a systematic application of the technical steps suggested for a given selected technique, an intraprocedural or post-PCI use of stent enhancement and a low threshold for bailout use of intravascular imaging.

Bifurcation left main stenting with or without intracoronary imaging: Outcomes from the EBC MAIN trial.

BACKGROUND: The impact of intracoronary imaging on outcomes, after provisional versus dual-stenting for bifurcation left main (LM) lesions, is unknown. OBJECTIVES: We investigated the effect of intracoronary imaging in the EBC MAIN trial (European Bifurcation Club LM Coronary Stent study). METHODS: Four hundred and sixty-seven patients were randomized to dual-stenting or a stepwise provisional strategy. Four hundred and fifty-five patients were included. Intravascular ultrasound (IVUS) or optical coherence tomography (OCT) was undertaken at the operator's discretion. The primary endpoint was death, myocardial infarction or target vessel revascularization at 1-year. RESULTS: Intracoronary imaging was undertaken in 179 patients (39%; IVUS = 151, OCT = 28). As a result of IVUS findings, operators reintervened in 42 procedures. The primary outcome did not differ with intracoronary imaging versus angiographic-guidance (17% vs. 16%; odds ratio [OR]: 0.92 (95% confidence interval [CI]: 0.51-1.63) p = 0.767), nor for reintervention based on IVUS versus none (14% vs. 16%; OR: 0.88 [95% CI: 0.32-2.43] p = 0.803), adjusted for syntax score, lesion calcification and ischemic symptoms. With angiographic-guidance, primary outcome events were more frequent with dual versus provisional stenting (21% vs. 10%; adjusted OR: 2.11 [95% CI: 1.04-4.30] p = 0.039). With intracoronary imaging, there were numerically fewer primary outcome events with dual versus provisional stenting (13% vs. 21%; adjusted OR: 0.56 [95% CI: 0.22-1.46] p = 0.220). CONCLUSIONS: In EBC MAIN, the primary outcome did not differ with intracoronary imaging versus none. However, in patients with angiographic-guidance, outcomes were worse with a dual-stent than provisional strategy When intracoronary imaging was used, there was a trend toward better outcomes with the dual-stent than provisional strategy.

The 17th expert consensus document of the European Bifurcation Club - techniques to preserve access to the side branch during stepwise provisional stenting.

Provisional stenting has become the default technique for the treatment of most coronary bifurcation lesions. However, the side branch (SB) can become compromised after main vessel (MV) stenting and restoring SB patency can be difficult in challenging anatomies. Angiographic and intracoronary imaging criteria can predict the risk of side branch closure and may encourage use of side branch protection strategies. These protective approaches provide strategies to avoid SB closure or overcome compromise following MV stenting, minimising periprocedural injury. In this article, we analyse the strategies of SB preservation discussed and developed during the most recent European Bifurcation Club (EBC) meetings.

Management of life-threatening deformation of obstructive transcatheter mitral valve replacement bioprosthesis with balloon inflation in left ventricular outflow tract: a case report.

Background: Left ventricular outflow track (LVOT) obstruction (LVOTO) is a severe complication of transcatheter mitral valve replacement (TMVR) procedures, with an uncertain prognosis and only few strategies available to prevent its occurrence. TMVR is thus contraindicated in some patients because of a high risk of LVOTO onset. We demonstrate how LVOTO can be managed with a balloon inflation in the LVOT and a D-shaped deformation of the bioprosthetic valve. Case summary: A 64-year-old female presented with acute pulmonary oedema 2 weeks following aortic valve replacement and aorto-coronary bypass surgeries. A concomitant mitral stenosis, secondary to significant calcifications of the mitral annulus, was not treated during the procedure. After surgery, the mitral valvulopathy caused an acute heart failure and TMVR was performed by the heart team. The procedure was complicated by a cardiac arrest secondary to the onset of LVOTO which was managed by a balloon inflation in the LVOT and an alcohol septal ablation. Two-year follow-up shows a favourable outcome of the patient and good function of the prosthetic valve despite its deformation. Discussion: This case highlights the successful management of a LVOTO following valve-in-mitral annular calcification TMVR by balloon inflation in the LVOT. It is strongly recommended to place a 'rescue' guidewire in transaortic position during TMVR in order to manage the potential onset of acute LVOTO.

Impact of technique on bifurcation stent outcomes in the European Bifurcation Club Left Main Coronary Trial.

BACKGROUND: Techniques for provisional and dual-stent left main bifurcation stenting require optimization. AIM: To identify technical variables influencing procedural outcomes and periprocedural myocardial infarction following left main bifurcation intervention. METHODS: Procedural and outcome data were analyzed in 438 patients from the per-protocol cohort of the European Bifurcation Club Left Main Trial (EBC MAIN). These patients were randomized to the provisional strategy or a compatible dual-stent extension (T, T-and-protrude, or culotte). RESULTS: Mean age was 71 years and 37.4% presented with an acute coronary syndrome. Transient reduction of side vessel thrombolysis in myocardial infarction flow occurred after initial stent placement in 5% of procedures but was not associated with periprocedural myocardial infarction. Failure to rewire a jailed vessel during any strategy was more common when jailed wires were not used (9.5% vs. 2.5%, odds ratio [OR]: 6.4, p = 0.002). In the provisional cohort, the use of the proximal optimization technique was associated with less subsequent side vessel intervention (23.3% vs. 41.9%, OR: 0.4, p = 0.048). Side vessel stenting was predominantly required for dissection, which occurred more often following side vessel preparation (15.3% vs. 4.4%, OR: 3.1, p = 0.040). Exclusive use of noncompliant balloons for kissing balloon inflation was associated with reduced need for side vessel intervention in provisional cases (20.5% vs. 38.5%, OR: 0.4, p = 0.013), and a reduced risk of periprocedural myocardial infarction across all strategies (2.9% vs. 7.7%, OR: 0.2, p = 0.020). CONCLUSION: When performing provisional or compatible dual-stent left main bifurcation intervention, jailed wire use is associated with successful jailed vessel rewiring. Side vessel preparation in provisional patients is linked to increased side vessel dissection requiring stenting. Use of the proximal optimization technique may reduce the need for additional side vessel intervention, and noncompliant balloon use for kissing balloon inflation is associated with a reduction in both side vessel stenting and periprocedural myocardial infarction. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov Identifier NCT02497014.

Definitions and Standardized Endpoints for Treatment of Coronary Bifurcations.

The Bifurcation Academic Research Consortium (Bif-ARC) project originated from the need to overcome the paucity of standardization and comparability between studies involving bifurcation coronary lesions. This document is the result of a collaborative effort between academic research organizations and the most renowned interventional cardiology societies focused on bifurcation lesions in Europe, the United States, and Asia. This consensus provides standardized definitions for bifurcation lesions; the criteria to judge the side branch relevance; the procedural, mechanistic, and clinical endpoints for every type of bifurcation study; and the follow-up methods. Considering the complexity of bifurcation lesions and their evaluation, detailed instructions and technical aspects for site and core laboratory analysis of bifurcation lesions are also reported. The recommendations included within this consensus will facilitate pooled analyses and the effective comparison of data in the future, improving the clinical relevance of trials in bifurcation lesions, and the quality of care in this subset of patients.

Treatment of coronary bifurcation lesions, part II: implanting two stents. The 16th expert consensus document of the European Bifurcation Club.

The European Bifurcation Club (EBC) supports a continuous review of the field of coronary artery bifurcation interventions and aims to facilitate a scientific discussion and an exchange of ideas on the management of bifurcation disease. The recent focus of meetings and consensus statements has been on the technical issues in bifurcation stenting, recognising that the final result of a bifurcation procedure and the long-term outcome for our patients are strongly influenced by factors, including preprocedural strategy, stenting technique selection, performance of optimal procedural steps, the ability to identify and correct complications and finally, and most important, the overall performance of the operator. Continuous refinement of bifurcation stenting techniques and the promotion of education and training in bifurcation stenting techniques represent a major clinical need. Accordingly, the consensus from the latest EBC meeting in Brussels, October 2021, was to promote education and training in bifurcation stenting based on the EBC principle. Part II of this 16th EBC consensus document aims to provide a step-by-step overview of the pitfalls and technical troubleshooting during the implantation of the second stent either in the provisional stenting (PS) strategy or in upfront 2-stent techniques (e.g., 2-stent PS pathway and double kissing crush stenting). Finally, a detailed overview and discussion of the numerous modalities available to provide continuous education and technical training in bifurcation stenting techniques are discussed, with consideration of their future application in enhancing training and practice in coronary bifurcation lesion treatment.

Definitions and Standardized Endpoints for Treatment of Coronary Bifurcations.

The Bifurcation Academic Research Consortium (Bif-ARC) project originated from the need to overcome the paucity of standardization and comparability between studies involving bifurcation coronary lesions. This document is the result of a collaborative effort between academic research organizations and the most renowned interventional cardiology societies focused on bifurcation lesions in Europe, the United States, and Asia. This consensus provides standardized definitions for bifurcation lesions; the criteria to judge the side branch relevance; the procedural, mechanistic, and clinical endpoints for every type of bifurcation study; and the follow-up methods. Considering the complexity of bifurcation lesions and their evaluation, detailed instructions and technical aspects for site and core laboratory analysis of bifurcation lesions are also reported. The recommendations included within this consensus will facilitate pooled analyses and the effective comparison of data in the future, improving the clinical relevance of trials in bifurcation lesions, and the quality of care in this subset of patients.

The European bifurcation club Left Main Coronary Stent study: a randomized comparison of stepwise provisional vs. systematic dual stenting strategies (EBC MAIN).

BACKGROUND: Patients with non-left-main coronary bifurcation lesions are usually best treated with a stepwise provisional approach. However, patients with true left main stem bifurcation lesions have been shown in one dedicated randomized study to benefit from systematic dual stent implantation. METHODS AND RESULTS: Four hundred and sixty-seven patients with true left main stem bifurcation lesions requiring intervention were recruited to the EBC MAIN study in 11 European countries. Patients were aged 71 ± 10 years; 77% were male. Patients were randomly allocated to a stepwise layered provisional strategy (n = 230) or a systematic dual stent approach (n = 237). The primary endpoint (a composite of death, myocardial infarction, and target lesion revascularization at 12 months) occurred in 14.7% of the stepwise provisional group vs. 17.7% of the systematic dual stent group (hazard ratio 0.8, 95% confidence interval 0.5-1.3; P = 0.34). Secondary endpoints were death (3.0% vs. 4.2%, P = 0.48), myocardial infarction (10.0% vs. 10.1%, P = 0.91), target lesion revascularization (6.1% vs. 9.3%, P = 0.16), and stent thrombosis (1.7% vs. 1.3%, P = 0.90), respectively. Procedure time, X-ray dose and consumables favoured the stepwise provisional approach. Symptomatic improvement was excellent and equal in each group. CONCLUSIONS: Among patients with true bifurcation left main stem stenosis requiring intervention, fewer major adverse cardiac events occurred with a stepwise layered provisional approach than with planned dual stenting, although the difference was not statistically significant. The stepwise provisional strategy should remain the default for distal left main stem bifurcation intervention. STUDY REGISTRATION: http://clinicaltrials.gov NCT02497014.

Percutaneous coronary intervention for bifurcation coronary lesions: the 15th consensus document from the European Bifurcation Club.

The 15th European Bifurcation Club (EBC) meeting was held in Barcelona in October 2019. It facilitated a renewed consensus on coronary bifurcation lesions (CBL) and unprotected left main (LM) percutaneous interventions. Bifurcation stenting techniques continue to be refined, developed and tested. It remains evident that a provisional approach with optional side branch treatment utilising T, T and small protrusion (TAP) or culotte continues to provide flexible options for the majority of CBL patients. Debate persists regarding the optimal treatment of side branches, including assessment of clinical significance and thresholds for bail-out treatment. In more complex CBL, especially those involving the LM, adoption of dedicated two-stent techniques should be considered. Operators using such techniques have to be fully familiar with their procedural steps and should acknowledge associated limitations and challenges. When using two-stent techniques, failure to perform a final kissing inflation is regarded as a technical failure, since it may jeopardise clinical outcome. The development of novel technical tools and drug regimens deserves attention. In particular, intracoronary imaging, bifurcation simulation, drug-eluting balloon technology and tailored antiplatelet therapy have been identified as promising tools to enhance clinical outcomes. In conclusion, the evolution of a broad spectrum of bifurcation PCI components has resulted from studies extending from bench testing to randomised controlled trials. However, further advances are still needed to achieve the ambitious goal of optimising the clinical outcomes for every patient undergoing PCI on a CBL.

Coronary Access and Percutaneous Coronary Intervention Up to 3 Years After Transcatheter Aortic Valve Implantation With a Balloon-Expandable Valve.

BACKGROUND: Coronary artery disease and aortic stenosis often coexist. Transcatheter aortic valve implantation (TAVI) has emerged as a valid therapeutic option for younger, lower-risk patients who may eventually require coronary artery disease treatment. Thus, post-TAVI coronary access (CA) and percutaneous coronary intervention are expected to increase. The purpose of this study was to retrospectively evaluate patients who were enrolled in the SOURCE 3 (SAPIEN 3 Aortic Bioprosthesis European Outcome) European registry for treatment with the balloon-expandable SAPIEN 3 transcatheter heart valve and underwent CA with or without percutaneous coronary intervention after TAVI. METHODS: Baseline characteristics and clinical outcomes of patients with or without CA up to 3 years after TAVI were compared. A Kaplan-Meier estimate with a univariate model determined the impact of CA on cardiac mortality. RESULTS: Of 1936 TAVI patients (mean age 81.6 years, 52% male), 68 (3.5%) had CA within 3 years (mean 441±332 days) after TAVI. At baseline, the logistic EuroSCORE was similar (20.2% versus 18.3%, P=0.2, CA and non-CA groups, respectively). Higher rates of coronary artery disease (76.5% versus 50.6%, P<0.001), myocardial infarction (20.6% versus 11.5%, P=0.03) and previous coronary artery bypass graft (22.1% versus 11.0%, P=0.01) were present in the CA group. In 100% of patients, CA was successfully achieved. The clinical success of percutaneous coronary intervention was 97.9%. Cardiovascular mortality was numerically higher in patients with CA than in those without CA. CONCLUSIONS: In the large SOURCE 3 European registry, CA was needed at 3-year follow-up after TAVI with a balloon-expandable valve in 3.5% of patients and was successful in all patients. The clinical success of percutaneous coronary intervention was 97.9%. Registration: URL: https://www.clinicaltrials.gov. Unique identifier: NCT02698956.

Balloon-Expandable Versus Self-Expanding Transcatheter Aortic Valve Replacement: A Propensity-Matched Comparison From the FRANCE-TAVI Registry.

BACKGROUND: No randomized study powered to compare balloon expandable (BE) with self expanding (SE) transcatheter heart valves (THVs) on individual end points after transcatheter aortic valve replacement has been conducted to date. METHODS: From January 2013 to December 2015, the FRANCE-TAVI nationwide registry (Registry of Aortic Valve Bioprostheses Established by Catheter) included 12 141 patients undergoing BE-THV (Edwards, n=8038) or SE-THV (Medtronic, n=4103) for treatment of native aortic stenosis. Long term mortality status was available in all patients (median 20 months; interquartile range, 14 to 30). Patients treated with BE-THV (n=3910) were successfully matched 1:1 with 3910 patients treated with SE-THV by using propensity score (25 clinical, anatomical, and procedural variables) and by date of the procedure (within 3 months). The first coprimary outcome was ≥ moderate occurrence of paravalvular regurgitation or in-hospital mortality, or both. The second coprimary outcome was 2-year all-cause mortality. RESULTS: In propensity-matched analyses, the incidence of the first coprimary outcome was higher with SE-THV (19.8%) compared with BE-THV (11.9%; relative risk, 1.68 [95% CI, 1.46-1.91]; P<0.0001). Each component of the outcome was also higher in patients receiving SE-THV: ≥ moderate paravalvular regurgitation (15.5% versus 8.3%; relative risk, 1.90 [95% CI, 1.63-2.22]; P<0.0001) and in hospital mortality (5.6% versus 4.2%; relative risk, 1.34 [95% CI, 1.07-1.66]; P=0.01). During follow up, all cause mortality occurred in 899 patients treated with SE-THV (2-year mortality, 29.8%) and in 801 patients treated with BE-THV (2-year mortality, 26.6%; hazard ratio, 1.17 [95% CI, 1.06-1.29]; P=0.003). Similar results were found using inverse probability of treatment weighting using propensity score analysis. CONCLUSION: The present study suggests that use of SE-THV was associated with a higher risk of paravalvular regurgitation and higher in-hospital and 2-year mortality compared with use of BE-THV. These data strongly support the need for a randomized trial sufficiently powered to compare the latest generation of SE-THV and BE-THV. CLINICAL TRIAL REGISTRATION: https://www.clinicaltrials.gov. Unique identifier: NCT01777828.

Percutaneous coronary intervention for obstructive bifurcation lesions: the 14th consensus document from the European Bifurcation Club.

The European Bifurcation Club recommends an approach to a bifurcation stenosis which involves careful assessment, planning and a sequential provisional approach. In the minority of lesions where two stents are required, careful deployment and optimal expansion are essential to achieve a long-term result.

Joint consensus on the use of OCT in coronary bifurcation lesions by the European and Japanese bifurcation clubs.

Coronary artery bifurcation lesions comprise approximately 15-20% of all percutaneous coronary interventions (PCI) and constitute a complex lesion subgroup. Intravascular optical coherence tomography (OCT) is a promising adjunctive tool for guiding coronary bifurcation with its unrivalled high resolution. Compared to angiography, intravascular OCT has a clear advantage in that it depicts ostial lesion(s) in bifurcation without the misleading two-dimensional appearance of conventional angiography such as overlap and foreshortening. In addition, OCT has the ability to reconstruct a bifurcation in three dimensions and to assess the side branch ostium from 3D reconstruction of the main vessel pullback, which can be applied to ensure the optimal recrossing position of the wire after main vessel stenting. Recently, online co-registration of OCT and angiography became widely available, helping the operator to position a stent in precise landing zones, reducing the risk of geographic miss. Despite these technological advances, the currently available clinical data are based mainly on observational studies with a small number of patients; there is little evidence from randomised trials. The joint working group of the European Bifurcation Club and the Japanese Bifurcation Club reviewed all the available literature regarding OCT use in bifurcation lesions and here provides recommendations on OCT guiding of coronary interventions in bifurcation lesions.

Percutaneous coronary intervention in left main coronary artery disease: the 13th consensus document from the European Bifurcation Club.

The 2017 European Bifurcation Club (EBC) meeting was held in Porto (Portugal) and allowed a multidisciplinary international faculty to review and discuss the latest data collected in the field of coronary bifurcation interventions. In particular, the topic of percutaneous coronary intervention (PCI) on left main coronary artery (LM) disease was highlighted as a contemporary priority. Herein, we summarise the key LM anatomy features, the diagnostic modalities and available data that are relevant for a patient's procedural management. Since the clinical outcomes of patients undergoing PCI on LM disease may depend on both PCI team organisation and PCI performance, the optimal catheterisation laboratory set-up and the rationales for device and technique selection are critically reviewed. The best lesion preparation modalities, the different DES implantation technique choices and the strategies to be considered during PCI on unprotected LM for optimal PCI results are reviewed step by step.

Percutaneous coronary intervention for the left main stem and other bifurcation lesions: 12th consensus document from the European Bifurcation Club.

The European Bifurcation Club (EBC) was initiated in 2004 to support a continuous overview of the field of coronary artery bifurcation interventions and aims to facilitate a scientific discussion and an exchange of ideas on the management of bifurcation disease. The EBC hosts an annual, two-day compact meeting, dedicated to bifurcations, which brings together physicians, pathologists, engineers, biologists, physicists, mathematicians, epidemiologists and statisticians for detailed discussions. Every meeting is finalised with a consensus statement that reflects the unique opportunity of combining the opinion of interventional cardiologists with the opinion of a large variety of other scientists on bifurcation management. A series of consensus sessions dedicated to specific topics, to strengthen the consensus debates and focus the discussions, was introduced at this year's meeting. The sessions comprise an intensive overview of the present literature, a pro and con debate and a voting system, to guide the consensus-building process. The present document represents the summary of the up-to-date EBC consensus and recommendations from the 12th annual EBC meeting in 2016 in Rotterdam.

Bench testing and coronary artery bifurcations: a consensus document from the European Bifurcation Club.

This is a consensus document from the European Bifurcation Club concerning bench testing in coronary artery bifurcations. It is intended to provide guidelines for bench assessment of stents and other strategies in coronary bifurcation treatment where the United States Food and Drug Administration (FDA) or International Organization for Standardization (ISO) guidelines are limited or absent. These recommendations provide guidelines rather than a step-by-step manual. We provide data on the anatomy of bifurcations and elastic response of coronary arteries to aid model construction. We discuss testing apparatus, bench testing endpoints and bifurcation nomenclature.

Temporal Trends in Transcatheter Aortic Valve Replacement in France: FRANCE 2 to FRANCE TAVI.

BACKGROUND: Transcatheter aortic valve replacement (TAVR) is standard therapy for patients with severe aortic stenosis who are at high surgical risk. However, national data regarding procedural characteristics and clinical outcomes over time are limited. OBJECTIVES: The aim of this study was to assess nationwide performance trends and clinical outcomes of TAVR during a 6-year period. METHODS: TAVRs performed in 48 centers across France between January 2013 and December 2015 were prospectively included in the FRANCE TAVI (French Transcatheter Aortic Valve Implantation) registry. Findings were further compared with those reported from the FRANCE 2 (French Aortic National CoreValve and Edwards 2) registry, which captured all TAVRs performed from January 2010 to January 2012 across 34 centers. RESULTS: A total of 12,804 patients from FRANCE TAVI and 4,165 patients from FRANCE 2 were included in this analysis. The median age of patients was 84.6 years, and 49.7% were men. FRANCE TAVI participants were older but at lower surgical risk (median logistic European System for Cardiac Operative Risk Evaluation [EuroSCORE]: 15.0% vs. 18.4%; p < 0.001). More than 80% of patients in FRANCE TAVI underwent transfemoral TAVR. Transesophageal echocardiography guidance decreased from 60.7% to 32.3% of cases, whereas more recent procedures were increasingly performed in hybrid operating rooms (15.8% vs. 35.7%). Rates of Valve Academic Research Consortium-defined device success increased from 95.3% in FRANCE 2 to 96.8% in FRANCE TAVI (p < 0.001). In-hospital and 30-day mortality rates were 4.4% and 5.4%, respectively, in FRANCE TAVI compared with 8.2% and 10.1%, respectively, in FRANCE 2 (p < 0.001 for both). Stroke and potentially life-threatening complications, such as annulus rupture or aortic dissection, remained stable over time, whereas rates of cardiac tamponade and pacemaker implantation significantly increased. CONCLUSIONS: The FRANCE TAVI registry provided reassuring data regarding trends in TAVR performance in an all-comers population on a national scale. Nonetheless, given that TAVR indications are likely to expand to patients at lower surgical risk, concerns remain regarding potentially life-threatening complications and pacemaker implantation. (Registry of Aortic Valve Bioprostheses Established by Catheter [FRANCE TAVI]; NCT01777828).

6- Versus 24-Month Dual Antiplatelet Therapy After Implantation of Drug-Eluting Stents in Patients Nonresistant to Aspirin: Final Results of the ITALIC Trial (Is There a Life for DES After Discontinuation of Clopidogrel).

OBJECTIVES: The aim of this study was to test the hypothesis that 6-month dual antiplatelet therapy (DAPT) is noninferior to 24-month DAPT in aspirin-sensitive patients. BACKGROUND: The ITALIC (Is There a Life for DES After Discontinuation of Clopidogrel) trial showed that rates of bleeding and thrombotic events at 1 year were much the same with 6 versus 12 months of DAPT after percutaneous coronary intervention with second-generation drug-eluting stents. In this report, 2-year follow-up is presented. METHODS: In a multicenter randomized study, patients with confirmed nonresistance to aspirin undergoing drug-eluting stent implantation were allocated to 6 or 24 months of DAPT. The primary endpoint was a composite of death, myocardial infarction, urgent target vessel revascularization, stroke, and major bleeding at 12 months post-percutaneous coronary intervention. The secondary endpoints comprised the same composite endpoint at 24 months and each individual component. RESULTS: Overall, 2,031 patients from 70 centers were screened; 926 were randomized to 6-month and 924 to 24-month DAPT. Noninferiority was demonstrated for 6- versus 12-month DAPT, with an absolute risk difference of 0.11% (95% confidence interval: -1.04% to 1.26%; p = 0.0002). At 2 years, the composite endpoint was unchanged, at 3.5% for 6 months and 3.7% for 24 months (p = 0.79), and rates of myocardial infarction (1.3% vs. 1.0%; p = 0.51), stroke (0.6% vs. 0.8%; p = 0.77), and target vessel revascularization (1.0% vs. 0.3%; p = 0.09) were likewise similar. There was a trend toward higher mortality with longer DAPT (2.2% vs. 1.2%; p = 0.11). Four patients (0.4%) in the 24-month group and none in the 6-month group had major bleeding. CONCLUSIONS: Two-year outcomes in the ITALIC trial confirmed the 1-year results and showed that patients receiving 6-month DAPT after percutaneous coronary intervention with second-generation drug-eluting stent have similar outcomes to those receiving 24-month DAPT.