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Background: The EXCEL trial reported similar five-year rates of the primary composite outcome of death, myocardial infarction (MI), or stroke after percutaneous coronary intervention (PCI) compared with coronary artery bypass grafting (CABG) for treatment of obstructive left main coronary artery disease (LMCAD)., Aims: We sought to determine whether these outcomes remained consistent regardless of geography of enrolment., Methods: We performed a prespecified subgroup analysis based on regional enrolment., Results: Among 1,905 patients randomised to PCI (n=948) or CABG (n=957), 1,075 (56.4%) were recruited at 52 European Union (EU) centres, and 752 (39.5%) were recruited at 67 North American (NA) centres. EU versus NA patients varied according to numerous baseline demographics, anatomy, pharmacotherapy and procedural characteristics. Nonetheless, the relative rates of the primary endpoint after PCI versus CABG were consistent across EU versus NA centres at 30 days and 5 years. However, NA participants had substantially higher late rates of ischaemia-driven revascularisation (IDR) after PCI, driven predominantly by the need for greater target vessel and lesion revascularisation. This culminated in a significant difference in the relative risk of the secondary composite outcome of death, MI, stroke, or IDR at 5 years (p interaction =0.02)., Conclusions: In the EXCEL trial, the relative risks for the 30-day and five-year primary composite outcome of death, MI or stroke after PCI versus CABG were consistent irrespective of geography. However, five-year rates of IDR after PCI were significantly higher in NA centres, a finding the Heart Team and patients should consider when making treatment decisions. ClinicalTrials.gov identifier: NCT01205776.

Aims: Limited data exist regarding procedural and clinical outcomes of percutaneous coronary intervention (PCI) in patients with trifurcation disease of the distal left main (LM) coronary artery. We therefore aimed to examine the procedural methods and early and late outcomes among patients undergoing distal LM trifurcation versus bifurcation PCI in the EXCEL trial., Methods and Results: Patients with distal LM bifurcation disease randomised to PCI with everolimus-eluting stents in the EXCEL trial were categorised into those with and without trifurcation involvement. Angiographic and procedural characteristics in addition to clinical events up to five-year follow-up after PCI were compared. Among 605 patients with site-reported distal LM disease, 61 patients (10.1%) were identified with trifurcation anatomy. The five-year primary composite endpoint of death, myocardial infarction, or stroke occurred in 16.6% of patients with trifurcation disease compared with 22.5% of patients with distal bifurcation disease only (p=0.32). Ischaemia-driven target lesion revascularisation rates were also similar (11.9% vs 12.0%, p=0.94). No significant differences in definite or probable stent thrombosis were observed between treatment groups (1.7% vs 2.3%, p=0.76)., Conclusions: Despite the greater inherent complexity, procedural and long-term clinical outcomes following PCI of distal LM trifurcations with everolimus-eluting stents in a modest-sized cohort from the EXCEL trial were similar compared with treatment of distal LM bifurcation disease without trifurcations. These findings support PCI as a treatment strategy for selected patients with distal LM trifurcation disease. ClinicalTrials.gov Identifier: NCT01205776.

Aims: The impact of final kissing balloon inflation (FKBI) after percutaneous coronary intervention (PCI) of bifurcation lesions on long-term clinical outcomes remains controversial. We sought to determine the impact of FKBI on four-year outcomes after PCI of distal left main (LM) bifurcation lesions., Methods and Results: The EXCEL trial compared PCI with everolimus-eluting stents and coronary artery bypass graft surgery (CABG) in patients with left main (LM) disease. We examined four-year clinical outcomes after PCI of distal LM bifurcation lesions according to use of FKBI. The primary endpoint was the composite rate of death, myocardial infarction (MI), or stroke. The major secondary endpoint was the composite rate of death, MI, stroke, or ischaemia-driven revascularisation (IDR). Among 948 patients randomised to PCI, 759 had distal LM lesions treated, 430 of which were treated with one stent and 329 of which were treated with two or more stents. The four-year rates of the primary and major secondary endpoints were similar with versus without FKBI in both the one-stent and ≥2-stent groups in both unadjusted and adjusted analyses., Conclusions: In the EXCEL trial, the performance of FKBI after PCI of distal LM bifurcation lesions was not associated with improved four-year clinical outcomes regardless of whether one stent or ≥2 stents were implanted.

Aims: Accurate risk prediction in patients undergoing revascularisation is essential. We aimed to assess the predictive performance of Society of Thoracic Surgeons (STS) risk models in patients with left main coronary artery disease (LMCAD) undergoing coronary artery bypass grafting (CABG) or percutaneous coronary intervention with everolimus-eluting stents (PCI-EES)., Methods and Results: The predictive performance of STS risk models for perioperative mortality, stroke and renal failure was evaluated for their discriminative ability (C statistic) and calibration (Hosmer-Lemeshow goodness-of-fit-test; χ2 and p-values) among patients with LMCAD undergoing PCI-EES (n=935) and CABG (n=923) from the randomised EXCEL trial. STS risk scores, in CABG patients, showed good discrimination for 30-day mortality and average discrimination for stroke (C statistic 0.730 and 0.629, respectively) with average calibration. For PCI, STS risk scores had no discrimination for mortality (C statistic 0.507), yet good discrimination (C statistic 0.751) and calibration for stroke. The predictive performance for renal failure was good for CABG (C statistic 0.82), yet poor for PCI (C statistic 0.59)., Conclusions: In selected patients with LMCAD from the EXCEL trial, STS risk models showed good predictive performance for CABG yet lacked predictive performance for PCI for perioperative mortality and renal failure. The STS stroke risk model was surprisingly more discriminating in PCI compared to CABG. Improved and procedure-specific risk prediction instruments are needed to accurately estimate adverse events after LMCAD revascularisation by CABG and PCI. ClinicalTrials.gov Identifier: NCT01205776.

Aims: The impact of an occluded right coronary artery (RCA) in patients with left main coronary artery disease (LMCAD) undergoing revascularisation is unknown. We compared outcomes for patients with LMCAD randomised to percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG) according to the presence of an occluded RCA in the EXCEL trial., Methods and Results: The EXCEL trial randomised 1,905 patients with LMCAD and SYNTAX scores ≤32 to PCI with everolimus-eluting stents versus CABG. Patients were categorised according to whether they had an occluded RCA at baseline, and their outcomes were examined using multivariable Cox proportional hazards regression. The primary endpoint was a composite of death, stroke, or myocardial infarction at three years. Among 1,753 patients with a dominant RCA by core laboratory analysis, the RCA was occluded in 130 (7.4%) at baseline. PCI was attempted in 34 of 65 patients with an occluded RCA (52.3%) and was successful in 27 (79.4% of those attempted; 41.5% of all RCAs recanalised). The RCA was bypassed in 42 of 65 patients with an occluded RCA (64.6%; p=0.0008 versus PCI). The three-year absolute and relative rates of the primary endpoint were similar between PCI and CABG, in patients with or without an occluded RCA (pinteraction=0.92)., Conclusions: In the EXCEL trial, the presence of an occluded RCA at baseline did not confer a worse three-year prognosis in patients undergoing revascularisation for LMCAD and did not affect the relative outcomes of PCI versus CABG in this high-risk patient cohort.

Aims: We sought to compare clinical outcomes and procedural characteristics with transradial access (TRA) versus transfemoral access (TFA) in patients who were treated with PCI for left main (LM) coronary artery disease., Methods and Results: The EXCEL trial was a prospective, international, open-label, multicentre trial that randomised 1,905 patients with LM disease and SYNTAX scores ≤32 to PCI with everolimus-eluting stents versus coronary artery bypass grafting. The present analysis cohort consisted of 931 patients undergoing PCI with TRA or TFA, but not both. The primary endpoint was a composite of death, myocardial infarction (MI), or stroke at three years. Multivariable Cox proportional hazards regression was used to adjust for differences in baseline covariates. PCI in EXCEL was performed exclusively with TRA in 248 (26.6%) patients and with TFA in 683 (73.4%) patients. TRA patients were younger and less likely to have hypertension and chronic kidney disease. The mean number of vessels and lesions treated was higher in TFA patients, although the SYNTAX score was similar in both groups. Patients undergoing TRA and TFA had similar 30-day rates of TIMI major or minor bleeding (2.4% versus 3.8%, respectively, p=0.30). At three years, TRA and TFA patients had similar rates of the primary endpoint (15.7% versus 14.8%, adjusted HR 1.11, 95% CI: 0.73-1.69, p=0.64), as well as the individual rates of death, MI, stroke, ischaemia-driven revascularisation and stent thrombosis., Conclusions: In the EXCEL trial, PCI of LM disease with TRA was associated with comparable early and late clinical outcomes to TFA.

Aims: Coronary artery bypass graft (CABG) surgery is the standard of care for revascularisation of patients with left main coronary artery disease (LMCAD). Recent studies have suggested that percutaneous coronary intervention (PCI) with drug-eluting stents (DES) may provide comparable outcomes in selected patients with LMCAD without extensive CAD. We therefore designed a trial to investigate whether PCI with XIENCE cobalt-chromium everolimus-eluting stents (CoCr-EES) would result in non-inferior or superior clinical outcomes to CABG in selected patients with LMCAD., Methods and Results: The Evaluation of XIENCE versus Coronary Artery Bypass Surgery for Effectiveness of Left Main Revascularization (EXCEL) trial is a prospective, open-label, multicentre, international study of 1,900 randomised subjects. Patients with significant LMCAD with a SYNTAX score ≤32 and local Heart Team consensus that the subject is appropriate for revascularisation by both PCI and CABG are consented and randomised 1:1 to undergo PCI using CoCr-EES or CABG. All patients undergo follow-up for five years. The primary endpoint is the three-year composite rate of death, stroke or myocardial infarction, assessed at a median follow-up of at least three years (with at least two-year follow-up in all patients), powered for sequential non-inferiority and superiority testing., Conclusions: The EXCEL study will define the contemporary roles of CABG and PCI using XIENCE CoCr-EES in patients with LMCAD disease with low and intermediate SYNTAX scores.