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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 pre-specified 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 (pinteraction=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.

Background: There is a paucity of data regarding the effect of inhibition of the renin-angiotensin system on outcomes after percutaneous coronary intervention (PCI) and coronary artery bypass grafting (CABG). We sought to examine long-term outcomes of patients with left main coronary disease (LMCAD) randomized to PCI with fluoropolymer-based cobalt-chromium everolimus-eluting stents or CABG according to treatment at discharge with angiotensin-converting enzyme inhibitors (ACEI) or angiotensin receptor blockers (ARB) in the large-scale, multicenter, randomized EXCEL trial. Methods: EXCEL randomized 1905 patients with LMCAD of low and intermediate anatomical complexity (visually-assessed SYNTAX score ≤32) to PCI (n = 948) versus CABG (n = 957). Patients were categorized according to whether they were treated with ACEI/ARB at discharge; their outcomes from discharge to 5 years were examined using multivariable logistic regression with an offset for follow-up time. Results: Among 1775 patients discharged alive with known ACEI/ARB treatment status, 896 (50.5%) were treated with one of these agents. Among those treated with ACEI/ARB, the 5-year rate of all-cause death was similar after PCI or CABG (10.7% versus 9.8% respectively, adjOR, 0.94; 95% CI, 0.56-1.57) in contrast to patients not treated with ACEI/ARB (15.0% versus 7.8%, respectively, adjOR, 2.20; 95% CI, 1.32-3.67) (Pinteraction = 0.02). Significant interactions between treatment arm (PCI versus CABG) and ACEI/ARB treatment status were also found for cardiovascular death (Pinteraction = 0.03), ischemia-driven revascularization (Pinteraction = 0.03), target vessel revascularization (Pinteraction = 0.007) and target vessel failure (Pinteraction = 0.0009). Conclusion: In the EXCEL trial, the postdischarge rates of death and revascularization after 5 years were similar after PCI and CABG in patients with LMCAD treated with ACEI/ARB at discharge. In contrast, event rates were higher after PCI versus CABG in those not so treated.

Prior studies in patients with noncomplex coronary artery disease have demonstrated the safety of percutaneous coronary intervention (PCI) in the outpatient setting. We sought to examine the outcomes of outpatient PCI in patients with unprotected left main coronary artery disease (LMCAD). In the EXCEL trial, 1905 patients with LMCAD and site-assessed low or intermediate SYNTAX scores were randomized to PCI with everolimus-eluting stents versus coronary artery bypass grafting. The primary end point was major adverse cardiovascular events (MACE; the composite of death, stroke, or myocardial infarction). In this sub-analysis, outcomes at 30 days and 5 years were analyzed according to whether PCI was performed in the outpatient versus inpatient setting. Among 948 patients with LMCAD assigned to PCI, 935 patients underwent PCI as their first procedure, including 100 (10.7%) performed in the outpatient setting. Patients who underwent outpatient compared with inpatient PCI were less likely to have experienced recent myocardial infarction. Distal left main bifurcation disease involvement and SYNTAX scores were similar between the groups. Comparing outpatient to inpatient PCI, there were no significant differences in MACE at 30 days (4.0% vs 5.0% respectively, adjusted OR 0.52 95% CI 0.12 to 2.22; p = 0.38) or 5 years (20.6% vs 22.1% respectively, adjusted OR 0.72, 95% CI 0.40 to 1.29; p = 0.27). Similar results were observed in patients with distal left main bifurcation lesions. In conclusion, in the EXCEL trial, outpatient PCI of patients with LMCAD was not associated with an excess early or late hazard of MACE. These data suggest that outpatient PCI may be safely performed in select patients with LMCAD.

Background We examined guidewire and microcatheter utilization during chronic total occlusion (CTO) percutaneous coronary intervention (PCI). Methods We examined device utilization in 2,968 CTO PCIs performed in 2,936 patients at 19 US and two international center between January 2016 and January 2019. Results The median number of antegrade guidewires used per case declined (5 in 2016 vs 3 in 2019) and was higher in higher complexity lesions (2 in J-CTO 0 vs. 8 in J-CTO 4 or 5 score). In antegrade-only procedures, the most frequently used guidewires were the Pilot 200 (Abbott Vascular, 37%), Fielder XT (Asahi Intecc, 25%) and Gaia third (Asahi Intecc, 18%), while the most commonly used microcatheters were the Turnpike Spiral (Vascular Solutions, 18%) and Turnpike (Vascular Solutions, 16%). Compared with 2012-2015, during 2016-2019 use of novel equipment such as the Gaia guidewires and the Turnpike microcatheters led to decreased use of Confianza Pro 12 (Asahi Intecc) wire and Corsair (Asahi Intecc) family of microcatheters. In retrograde cases, the guidewires most commonly used were the Sion (44%), Pilot 200 (27%) and Fielder FC (26%), while the Corsair/Corsair Pro, Turnpike LP (Vascular Solutions) and Caravel (Asahi Intecc) were the most frequently used microcatheters for collateral crossing (29%, 26% and 22%, respectively). Conclusions The most commonly used guidewires during CTO PCI are polymer-jacketed guidewires and the most commonly used microcatheters are torquable microcatheters.

Objectives The aim of this study was to investigate the incidence and impact on mortality of repeat revascularization after index percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG) for left main coronary artery disease (LMCAD). Background The impact on mortality of the need of repeat revascularization following PCI or CABG in patients with unprotected LMCAD is unknown. Methods All patients with LMCAD and site-assessed low or intermediate SYNTAX (Synergy Between PCI With Taxus and Cardiac Surgery) scores randomized to PCI (n = 948) or CABG (n = 957) in the EXCEL (Evaluation of XIENCE Versus Coronary Artery Bypass Surgery for Effectiveness of Left Main Revascularization) trial were included. Repeat revascularization events were adjudicated by an independent clinical events committee. The effect of repeat revascularization on mortality through 3-year follow-up was examined in time-varying Cox regression models. Results During 3-year follow-up, there were 346 repeat revascularization procedures among 185 patients. PCI was associated with higher rates of any repeat revascularization (12.9% vs. 7.6%; hazard ratio: 1.73; 95% confidence interval: 1.28 to 2.33; p = 0.0003). Need for repeat revascularization was independently associated with increased risk for 3-year all-cause mortality (adjusted hazard ratio: 2.05; 95% confidence interval: 1.13 to 3.70; p = 0.02) and cardiovascular mortality (adjusted hazard ratio: 4.22; 95% confidence interval: 2.10 to 8.48; p Conclusions In the EXCEL trial, repeat revascularization during follow-up was performed less frequently after CABG than PCI and was associated with increased mortality after both procedures. Reducing the need for repeat revascularization may further improve long-term survival after percutaneous or surgical treatment of LMCAD. (EXCEL Clinical Trial; NCT01205776)

The aim of this study was to examine the use of saphenous vein grafts (SVGs) for retrograde crossing during chronic total occlusion (CTO) percutaneous coronary intervention (PCI).The use of SVGs for retrograde crossing during CTO PCI has received limited study.A total of 1,615 retrograde CTO PCIs performed between 2012 and 2019 at 25 centers were examined. Clinical, angiographic, and technical characteristics and procedural outcomes were compared among retrograde cases via SVGs (SVG group) versus other collateral vessels (non-SVG group).Retrograde CTO PCI via SVGs was performed in 189 cases (12%). Patients in the SVG group were older (mean age 70 ± 9 years vs. 64 ± 10 years; p 0.01) and had higher rates of prior myocardial infarction (62% vs. 51%; p 0.01) and prior PCI (81% vs. 70%; p 0.01). They were more likely to have moderate or severe calcification (81% vs. 65%; p 0.01) and moderate or severe tortuosity (53% vs. 44%; p = 0.02) and had similar J-CTO (Multicenter CTO Registry in Japan) scores (3.2 ± 1.0 vs. 3.1 ± 1.1; p = 0.13) but higher PROGRESS-CTO (Prospective Global Registry for the Study of Chronic Total Occlusion Intervention) scores (4.7 ± 1.7 vs. 3.1 ± 1.1; p 0.01). Technical (85% vs. 78%; p = 0.04) and procedural (81% vs. 74%; p = 0.04) success rates were higher in the SVG group, with no difference in in-hospital major adverse events (6.4% vs. 4.4%; p = 0.22). Contrast volume was lower in the SVG group (225 ml [173 to 325 ml] vs. 292 ml [202 to 400 ml]; p 0.01).Use of SVGs for retrograde crossing is associated with higher rates of technical and procedural success and similar rates of in-hospital major adverse cardiac events compared with retrograde CTO PCI via other collateral vessels.

Background Limited study has detailed the late-term safety and efficacy of chronic total coronary occlusion (CTO) revascularization among multiple centers applying modern techniques and with newer-generation drug-eluting stents. Methods Among 20 centers, 222 patients enrolled in the XIENCE coronary stent, performance, and technique (EXPERT) CTO trial underwent CTO percutaneous coronary intervention (PCI) with everolimus-eluting stents (EES). Through planned 4-year follow-up, the primary composite endpoint of major adverse cardiac events (MACE; death, myocardial infarction [MI] and target lesion revascularization) and rates of individual component endpoints and stent thrombosis were determined. Results Demographic, lesion, and procedural characteristics included prior bypass surgery, 9.9%; diabetes, 40.1%; lesion length, 36.1 ± 18.5 mm; and stent length, 51.7 ± 27.2 mm. By 4 years, MACE rates were 31.6 and 22.4% by the pre-specified ARC and per-protocol definitions, respectively. Clinically-indicated target lesion revascularization at 4 years was 11.3%. In landmark analyses of events beyond the first year of revascularization, the annualized rates of target vessel-related MI and clinically-indicated target lesion revascularization were 0.53 and 1.3%, respectively. Through 4 years, the cumulative definite/probable stent thrombosis rate was 1.7% with no events occurring beyond the initial year of index revascularization. Conclusions In a multicenter registration trial representing contemporary technique and EES, these results demonstrate sustained long-term safety and effectiveness of EES in CTO percutaneous revascularization and can be used to inform shared decision making with patients being considered for CTO PCI relative to late safety and vessel patency.

There is limited data on the use of atherectomy during chronic total occlusion (CTO) percutaneous coronary intervention (PCI). We compared the clinical and procedural characteristics and outcomes of CTO PCIs performed with or without atherectomy in a contemporary multicenter CTO PCI registry. Between 2012 and 2018, 3,607 CTO PCIs were performed at 21 participating centers. Atherectomy was used in 117 (3.2%) cases: rotational atherectomy in 105 cases, orbital atherectomy in 8, and both in 4 cases. Patients in whom atherectomy was used, were older (68 ± 8 vs 64 ± 10 years, p0.0001) and had higher Japan-chronic total occlusion score (3.0 ± 1.2 vs 2.4 ± 1.3, p0.0001). CTO PCI cases in which atherectomy was used had similar technical (91% vs 87%, p = 0.240) and procedural (90% vs 85%, p = 0.159) success and in-hospital major adverse cardiac event (4% vs 3%, p = 0.382) rates. However, atherectomy cases were associated with higher rates of donor vessel injury (4% vs 1%, p = 0.031), tamponade requiring pericardiocentesis (2.6% vs 0.4%, p = 0.012) and more often required use of a left ventricular assist device (9% vs 5%, p = 0.031). Atherectomy cases were associated with longer procedural duration (196 [141, 247] vs 119 [76, 180] minutes, p0.0001), and higher patient air kerma radiation dose (3.6 [2.5, 5.6] vs 2.8 [1.6, 4.7] Gray, p = 0.001). In conclusion, atherectomy is currently performed in approximately 3% of CTO PCI cases and is associated with similar technical and procedural success and overall major adverse cardiac event rates, but higher risk for donor vessel injury and tamponade.

Objectives This study examined the frequency and outcomes of radial access for chronic total occlusion (CTO) percutaneous coronary intervention (PCI). Background Radial access improves the safety of PCI, but its role in CTO PCI remains controversial. Methods We compared the clinical, angiographic, and procedural characteristics of 3,790 CTO interventions performed between 2012 and 2018 via radial-only access (RA) (n = 747) radial-femoral access (RFA) (n = 844) and femoral-only access (n = 2,199) access at 23 centers in the United States, Europe, and Russia. Results Patients’ mean age was 65 ± 10 years, and 85% were men. Transradial access (RA and RFA) was used in 42% of CTO interventions and significantly increased over time from 11% in 2012 to 67% in 2018 (p Conclusions Transradial access is increasingly being used for CTO PCI and is associated with similar technical and procedural success and lower major bleeding rates compared with femoral-only access interventions. (Prospective Global Registry for the Study of Chronic Total Occlusion Intervention [PROGRESS CTO]; NCT02061436)

The prognostic impact of high-sensitivity C-reactive protein (CRP) levels in patients with left main coronary artery disease (LMCAD) treated with percutaneous coronary intervention (PCI) and coronary artery bypass grafting (CABG) is unknown. We sought to determine the effect of elevated baseline CRP levels on the 3-year outcomes after LMCAD revascularization and to examine whether CRP influenced the relative outcomes of PCI versus CABG.In the EXCEL trial, patients with LMCAD and Synergy between PCI with Taxus and Cardiac Surgery (SYNTAX) scores ≤32 were randomized to PCI versus CABG. The primary composite outcome of death, myocardial infarction (MI), or stroke was analyzed according to baseline CRP levels.Among 999 patients with available CRP levels, median CRP was 3.10 mg/L (interquartile range 1.12-6.40 mg/L). The rate of the primary composite end point of death, MI, or stroke at 3 years steadily increased with greater baseline CRP levels. The adjusted relationship between the 3-year composite rate of death, MI, or stroke and baseline CRP modeled as a continuous log-transformed variable demonstrated steadily increasing event rates with greater CRP levels (adjusted hazard ratio, 1.26, 95% CI 1.10-1.44, P = .0008). Similarly, patients with CRP ≥10 mg/L had a 3-fold higher risk of the 3-year primary end point compared to patients with lower CRP levels (adjusted hazard ratio 2.92, 95% CI 1.88-4.54, P.0001). The association between an elevated CRP level and the adjusted 3-year risk of the primary composite end point did not differ according to revascularization strategy (PIn patients with LMCAD undergoing revascularization, elevated baseline CRP levels were strongly associated with subsequent death, MI, and stroke at 3 years, irrespective of the mode of revascularization. Further studies are warranted to determine whether anti-inflammatory therapies may improve the prognosis of high-risk patients with LMCAD following revascularization.

Introduction: Chronic total occlusion (CTO) percutaneous coronary intervention (PCI) has been advancing due to improvement of equipment, operator experience, and techniques. Methods: We examined contemporary outcomes of CTO PCI by analyzing the clinical, angiographic, and procedural characteristics of 7,031 CTO interventions performed in 6,984 patients at 35 participating centers between 2012 and 2020. Results: Mean age was 64.5 ± 10 years and 82% of the patients were men. The patients had high prevalence of comorbidities, such as diabetes (42%), prior coronary artery bypass graft surgery (29%), prior myocardial infarction (45%), and prior heart failure (29%). The most common CTO target vessel was the right coronary artery (53%), followed by the left anterior descending artery (26%), and left circumflex artery (20%). The mean J-CTO and PROGRESS scores were 2.41 ± 1.28 and 1.09 ± 1.01, respectively. The overall technical and procedural success rates were 85.9% and 83.8% and the rate of in-hospital major cardiac adverse events (MACE) was 2.06%. Technical success and procedural success rates were lower for higher values of J-CTO and PROGRESS scores, and MACE rate was higher ( Figure 1 ). The final successful crossing strategy was antegrade wire escalation in 53.7%, retrograde in 19.9%, and antegrade dissection reentry in 14.6%. The overall median air kerma radiation dose, contrast volume, procedure and fluoroscopy time were 2.30 (1.30, 3.90) Gray, 225 (160, 305) ml, 115 (75, 170) and 43 (26, 70) minutes, respectively. Conclusions: Using a combination of crossing strategies, high success and acceptable complication rates can be achieved in CTO PCI among various centers and patient populations.

Varying definitions of procedural myocardial infarction (PMI) are in widespread use.This study sought to determine the rates and clinical relevance of PMI using different definitions in patients with left main coronary artery disease randomized to percutaneous coronary intervention (PCI) versus coronary artery bypass grafting (CABG) surgery in the EXCEL (Evaluation of XIENCE versus Coronary Artery Bypass Surgery for Effectiveness of Left Main Revascularization) trial.The pre-specified protocol definition of PMI (PMIPMIThe rates of PMI after PCI and CABG vary greatly with different definitions. In the EXCEL trial, the pre-specified PMI

Objectives: We examined outcomes according to lesion preparation strategy (LPS) in patients with left main coronary artery (LMCA) percutaneous coronary intervention (PCI) in the EXCEL trial. Background: The optimal LPS for LMCA PCI is unclear. Methods: We categorized LPS hierarchically (high to low) as: (a) rotational atherectomy (RA); (b) cutting or scoring balloon (CSB); (c) balloon angioplasty (BAL); and d) direct stenting (DIR). The primary endpoint was 3-year MACE; all-cause death, stroke, or myocardial infarction. Results: Among 938 patients undergoing LMCA PCI, RA was performed in 6.0%, CSB 9.5%, BAL 71.3%, and DIR 13.2%. In patients treated with DIR, BAL, CSB, and RA, respectively, there was a progressive increase in SYNTAX score, LMCA complex bifurcation, trifurcation or calcification, number of stents, and total stent length. Any procedural complication occurred in 10.4% of cases overall, with the lowest rate in the DIR (7.4%) and highest in the RA group (16.1%) (ptrend =.22). There were no significant differences in the 3-year rates of MACE (from RA to DIR: 17.9%, 20.2%, 14.5%, 14.7%; p =.50) or ischemia-driven revascularization (from RA to DIR: 16.8%, 10.8%, 12.3%, 14.2%; p =.65). The adjusted 3-year rates of MACE did not differ according to LPS. Conclusions: The comparable 3-year outcomes suggest that appropriate lesion preparation may be able to overcome the increased risks of complex LMCA lesion morphology.

Objectives The authors sought to determine the extent to which the site of the left main coronary artery (LM) lesion (distal bifurcation versus ostial/shaft) influences the outcomes of revascularization with percutaneous coronary intervention (PCI) versus coronary artery bypass grafting (CABG). Background Among 1,905 patients with LM disease and site-assessed SYNTAX scores of Methods Outcomes from the randomized EXCEL trial were analyzed according to the presence of angiographic core laboratory–determined diameter stenosis ≥50% involving the distal LM bifurcation (n = 1,559; 84.2%) versus disease isolated to the LM ostium or shaft (n = 293; 15.8%). Results At 3 years, there were no significant differences between PCI and CABG for the primary composite endpoint of death, MI, or stroke for treatment of both distal LM bifurcation disease (15.6% vs. 14.9%, odds ratio [OR]: 1.08, 95% confidence interval [CI]: 0.81 to 1.42; p = 0.61) and isolated LM ostial/shaft disease (12.4% vs. 13.5%, OR: 0.90, 95% CI: 0.45 to 1.81; p = 0.77) (pinteraction = 0.65). However, at 3 years, ischemia-driven revascularization occurred more frequently after PCI than CABG in patients with LM distal bifurcation disease (13.0% vs. 7.2%, OR: 2.00, 95% CI: 1.41 to 2.85; p = 0.0001), but were not significantly different in patients with disease only at the LM ostium or shaft (9.7% vs. 8.4%, OR: 1.18, 95% CI: 0.52 to 2.69; p = 0.68) (pinteraction = 0.25). Conclusions In the EXCEL trial, PCI and CABG resulted in comparable rates of death, MI, or stroke at 3 years for treatment of LM disease, including those with distal LM bifurcation disease. Repeat revascularization rates during follow-up after PCI compared with CABG were greater for lesions in the distal LM bifurcation but were similar for disease isolated to the LM ostium or shaft.

Objectives The aim of this study was to determine the techniques and outcomes of hybrid chronic total occlusion (CTO) percutaneous coronary intervention (PCI) in a diverse group of patients and operators on 2 continents. Background CTO PCI has been evolving with constant improvement of equipment and techniques. Methods Contemporary outcomes of CTO PCI were examined by analyzing the clinical, angiographic, and procedural characteristics of 3,122 CTO interventions performed in 3,055 patients at 20 centers in the United States, Europe, and Russia. Results The mean age was 65 ± 10 years, and 85% of the patients were men, with high prevalence of diabetes (43%), prior myocardial infarction (46%), prior coronary artery bypass graft surgery (33%), and prior PCI (65%). The CTO target vessels were the right coronary artery (55%), left anterior descending coronary artery (24%), and left circumflex coronary artery (20%). The mean J-CTO (Multicenter Chronic Total Occlusion Registry of Japan) and PROGRESS CTO (Prospective Global Registry for the Study of Chronic Total Occlusion Intervention) scores were 2.4 ± 1.3 and 1.3 ± 1.0, respectively. The overall technical and procedural success rate was 87% and 85%, respectively, and the rate of in-hospital major complications was 3.0%. The final successful crossing strategy was antegrade wire escalation in 52.0%, retrograde in 27.1%, and antegrade dissection re-entry in 20.9%; >1 crossing strategy was required in 40.9%. Median contrast volume, air kerma radiation dose, and procedure and fluoroscopy time were 270 ml (interquartile range: 200 to 360 ml), 2.9 Gy (interquartile range: 1.7 to 4.7 Gy), 123 min (interquartile range: 81 to 188 min) and 47 min (interquartile range: 29 to 77 min), respectively. Conclusions CTO PCI is currently being performed with high success and acceptable complication rates among various experienced centers in the United States, Europe, and Russia. (Prospective Global Registry for the Study of Chronic Total Occlusion Intervention [PROGRESS CTO]; NCT02061436)

Objectives: The aim of the present study was to assess outcomes after coronary artery bypass grafting surgery (CABG) and percutaneous coronary intervention (PCI) according to sex in a large randomized trial of patients with unprotected left main disease. Background: In the SYNTAX (Synergy Between Percutaneous Coronary Intervention With Taxus and Cardiac Surgery) trial, sex had a significant interaction effect with revascularization strategy, and women had an overall higher mortality when treated with PCI than CABG. Methods: The EXCEL (Evaluation of XIENCE Versus Coronary Artery Bypass Surgery for Effectiveness of Left Main Revascularization) trial was a multinational randomized trial that compared PCI with everolimus-eluting stents and CABG in patients with unprotected left main disease. The primary endpoint was the composite of all-cause death, myocardial infarction, or stroke at 3 years. Results: Of 1,905 patients randomized, 1,464 (76.9%) were men and 441 (23.1%) were women. Compared with men, women were older; had higher prevalence rates of hypertension, hyperlipidemia, and diabetes; and were less commonly smokers but had lower coronary anatomic burden and complexity (mean SYNTAX score 24.2 vs. 27.2, p < 0.001). By multivariate analysis, sex was not independently associated with either the primary endpoint (hazard ratio [HR]: 1.10; 95% confidence interval [CI]: 0.82 to 1.48; p = 0.53) or all-cause death (HR: 1.39; 95% CI: 0.92 to 2.10; p = 0.12) at 3 years. At 30 days, all-cause death, myocardial infarction, or stroke had occurred in 8.9% of woman treated with PCI, 6.2% of women treated with CABG, 3.6% of men treated with PCI, and 8.4% of men treated with CABG (p for interaction = 0.003). The 3-year rate of the composite primary endpoint was 19.7% in women treated with PCI, 14.6% in women treated with CABG, 13.8% in men treated with PCI, and 14.7% in men treated with CABG (p for interaction = 0.06). These differences were driven by higher periprocedural rates of myocardial infarction in women after PCI and in men after CABG. Conclusions: In patients with unprotected left main disease in the EXCEL trial, sex was not an independent predictor of adverse outcomes after revascularization. However, women undergoing PCI had a trend toward worse outcomes, a finding related to associated comorbidities and increased periprocedural complications. Further studies are required to determine the optimal revascularization modality in women with complex coronary artery disease.

Background: The EXCEL (Evaluation of Xience Versus Coronary Artery Bypass Surgery for Effectiveness of Left Main Revascularization) trial compared outcomes in patients with unprotected left...

Coronary perforation is a potential complication of chronic total occlusion (CTO) percutaneous coronary intervention (PCI). We analyzed 2,097 CTO PCIs performed in 2,049 patients from 2012 to 2017. Patient age was 65 ± 10 years, 85% were men, and 36% had prior coronary artery bypass graft surgery. Technical and procedural success were 88% and 87%, respectively. A major periprocedural adverse cardiovascular event occurred in 2.6%. Coronary perforation occurred in 85 patients (4.1%); The frequency of Ellis class 1, 2, and 3 perforations was 21%, 26%, and 52%, respectively. Perforation occurred more frequently in older patients and those with previous coronary artery bypass graft surgery (61% vs 35%, p 0.001). Cases with perforation were angiographically more complex (Multicenter CTO Registry in Japan score 3.0 ± 1.2 vs 2.5 ± 1.3, p 0.001). Twelve patients (14%) with perforation experienced tamponade requiring pericardiocentesis. Patient age, previous PCI, right coronary artery target CTO, blunt or no stump, use of antegrade dissection re-entry, and the retrograde approach were associated with perforation. Adjusted odds ratio for periprocedural major periprocedural adverse cardiovascular events among patients with perforation was 15.04 (95% confidence interval 7.35 to 30.18). In conclusion, perforation occurs relatively infrequently in contemporary CTO PCI performed by experienced operators and is associated with baseline patient characteristics and angiographic complexity necessitating use of advanced crossing techniques. In most cases, perforations do not result in tamponade requiring pericardiocentesis, but they are associated with reduced technical and procedural success, higher periprocedural major adverse events, and reduced procedural efficiency.

We sought to examine the impact of calcific deposits on the outcomes of chronic total occlusion (CTO) percutaneous coronary intervention (PCI). The outcomes of 1,476 consecutive CTO PCIs performed in 1,453 patients (65.5 ± 10 years, 85% male) between 2012 and 2016 at 11 US centers were evaluated. Moderate or severe quantity of calcium was present in 58% of target lesions. Calcified lesions were more tortuous and more likely to have proximal cap ambiguity and interventional collaterals. PCI of moderately/severely calcified CTOs more often required use of the retrograde approach (54% vs 30%, p

The impact of peripheral artery disease (PAD) in patients undergoing chronic total occlusion (CTO) percutaneous coronary intervention (PCI) has received limited study. We reviewed 3999 CTO PCIs performed in 3914 patients between 2012 and 2018 at 25 centers, 14% of whom had a history of PAD. We compared the clinical and angiographic characteristics and procedural outcomes of patients with versus without history of PAD. Patients with PAD were older (67 ± 9 vs 64 ± 10 years, P < .001) and had a higher prevalence of cardiovascular risk factors. They also had more complex lesions as illustrated by higher Japanese CTO score (2.7 ± 1.2 vs 2.4 ± 1.3, P < .001). In patients with PAD, the final crossing technique was less often antegrade wire escalation (40% vs 51%, P < .001) and more often the retrograde approach (23 vs 20%, P < .001) and antegrade dissection/reentry (20% vs 16%, P < .001). Technical success was similar between the 2 study groups (84% vs 87%, P = .127), but procedural success was lower for patients with PAD (81% vs 85%, P = .015). The incidence of in-hospital major adverse cardiac events was higher among patients with PAD (3% vs 2%, P = .046). In conclusion, patients with PAD undergoing CTO PCI have more comorbidities, more complex lesions, and lower procedural success.

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.

BACKGROUND Long-term outcomes after percutaneous coronary intervention (PCI) with contemporary drug-eluting stents, as compared with coronary-artery bypass grafting (CABG), in patients with left main coronary artery disease are not clearly established. METHODS We randomly assigned 1905 patients with left main coronary artery disease of low or intermediate anatomical complexity (according to assessment at the participating centers) to undergo either PCI with fluoropolymer-based cobalt–chromium everolimus-eluting stents (PCI group, 948 patients) or CABG (CABG group, 957 patients). The primary outcome was a composite of death, stroke, or myocardial infarction. RESULTS At 5 years, a primary outcome event had occurred in 22.0% of the patients in the PCI group and in 19.2% of the patients in the CABG group (difference, 2.8 percentage points; 95% confidence interval [CI], −0.9 to 6.5; P=0.13). Death from any cause occurred more frequently in the PCI group than in the CABG group (in 13.0% vs. 9.9%; difference, 3.1 percentage points; 95% CI, 0.2 to 6.1). In the PCI and CABG groups, the incidences of definite cardiovascular death (5.0% and 4.5%, respectively; difference, 0.5 percentage points; 95% CI, −1.4 to 2.5) and myocardial infarction (10.6% and 9.1%; difference, 1.4 percentage points; 95% CI, −1.3 to 4.2) were not significantly different. All cerebrovascular events were less frequent after PCI than after CABG (3.3% vs. 5.2%; difference, −1.9 percentage points; 95% CI, −3.8 to 0), although the incidence of stroke was not significantly different between the two groups (2.9% and 3.7%; difference, −0.8 percentage points; 95% CI, −2.4 to 0.9). Ischemia-driven revascularization was more frequent after PCI than after CABG (16.9% vs. 10.0%; difference, 6.9 percentage points; 95% CI, 3.7 to 10.0). CONCLUSIONS In patients with left main coronary artery disease of low or intermediate anatomical complexity, there was no significant difference between PCI and CABG with respect to the rate of the composite outcome of death, stroke, or myocardial infarction at 5 years. (Funded by Abbott Vascular; EXCEL ClinicalTrials.gov number, NCT01205776.)

BACKGROUND Limited research has detailed the outcomes of chronic total occlusion (CTO) percutaneous coronary intervention (PCI) with independent core laboratory and event adjudication. This study examined procedural, clinical, and patient-reported health status outcomes among patients undergoing CTO PCI with specific focus on outcomes for those treated with zotarolimus-eluting stents (ZES). METHODS Among 500 consecutive patients undergoing attempted CTO PCI, procedural and in-hospital clinical outcomes were examined in addition to the 1-year composite endpoint of death, myocardial infarction, and target lesion revascularization (major adverse cardiac events, MACE). In a pre-specified cohort of 250 patients, health status measures were ascertained at baseline and 1 year. A powered secondary endpoint was 1-year MACE among patients treated with ZES compared with a performance goal. RESULTS Demographic, lesion, and procedural characteristics for the overall population included prior bypass surgery, 29.8%; diabetes, 35.2%; occlusion length >20 mm, 71.3%; J-CTO score, 2.5 ± 1.1; and primary retrograde strategy, 30.8%. Overall guidewire crossing was 90.9%; clinical success following guidewire crossing, 94.3%; and 1-year MACE rate, 12.1%. One-year health status significantly improved from baseline with successful CTO-PCI (angina frequency, 72.7 ± 26.5 at baseline to 96.0 ± 10.8, p

Background The randomized EXCEL (Evaluation of XIENCE versus Coronary ArteryBypass Surgeryfor Effectiveness of Left Main Revascularization) trial reported a similar rate of the 3-year composite primary endpoint ofdeath,myocardial infarction(MI), orstrokein patients with left maincoronary artery disease(LMCAD) and site-assessed low or intermediateSYNTAX scorestreated withpercutaneous coronary intervention(PCI) and coronary artery bypass grafting (CABG). Whether these results are consistent in high-riskpatients with diabetes, who have fared relatively better with CABG in most prior trials, is unknown. Objectives In this pre-specifiedsubgroup analysisfrom the EXCEL trial, the authors sought to examine the effect ofdiabetesin patients with LMCAD treated with PCI versus CABG. Methods Patients (N=1,905) with LMCAD and site-assessed low or intermediate CAD complexity (SYNTAX scores≤32) were randomized 1:1 to PCI with everolimus-elutingstentsversus CABG, stratified by the presence ofdiabetes. The primary endpoint was the rate of a composite of all-causedeath,stroke, or MI at 3 years. Outcomes were examined in patients with (n=554) and without (n=1,350) diabetes. Results The 3-year composite primary endpoint was significantly higher in diabetic compared with nondiabetic patients (20.0% vs. 12.9%; p< 0.001). The rate of the 3-year primary endpoint was similar after treatment with PCI and CABG in diabetic patients (20.7% vs. 19.3%, respectively;hazard ratio: 1.03; 95%confidence interval: 0.71 to 1.50; p=0.87) and nondiabetic patients (12.9% vs. 12.9%, respectively;hazard ratio: 0.98; 95% confidence interval: 0.73 to 1.32; p=0.89). All-cause death at 3 years occurred in 13.6% of PCI and 9.0% of CABG patients (p=0.046), although no significant interaction was present between diabetes status and treatment for all-cause death (p=0.22) or other endpoints, including the 3-year primary endpoint (p=0.82) or the major secondary endpoints of death, MI, or stroke at 30days (p=0.61) or death, MI, stroke, or ischemia-driven revascularization at 3 years (p=0.65). Conclusions In the EXCEL trial, the relative 30-day and 3-year outcomes of PCI with everolimus-eluting stents versus CABG were consistent in diabetic and nondiabetic patients with LMCAD and site-assessed low or intermediateSYNTAX scores.(Evaluation of XIENCE versusCoronary Artery BypassSurgery for Effectiveness of Left MainRevascularization[EXCEL];NCT01205776)

Background: We examined the procedural outcomes of chronic total occlusions (CTO) percutaneous coronary interventions in patients with prior coronary artery bypass graft surgery (CABG). Methods and Results: We compared the clinical, angiographic characteristics and outcomes of 3486 CTO interventions performed in patients with (n=1101) and without (n=2317) prior CABG at 21 centers. Prior CABG patients (32% of total cohort) were older (67±9 versus 63±10 years; P P P P P P P P P =0.287). In-hospital mortality (1% versus 0.4%; P =0.016) and coronary perforation (7.1% versus 3.1%; P P =0.002) and pericardiocentesis (0% versus 1.3%; P Conclusions: In a large multicenter CTO percutaneous coronary interventions registry, prior CABG patients had lower success rate but similar overall risk for complications, although mortality was higher and the incidence of tamponade was lower. Clinical Trial Registration: URL: https://www.clinicaltrials.gov . Unique identifier: NCT02061436.

During chronic total occlusion (CTO) percutaneous coronary intervention (PCI), sometimes non-CTO lesions are also treated.We compared the clinical and procedural characteristics and outcomes of CTO PCIs with and without concomitant treatment of a non-CTO lesion in a contemporary multicenter CTO registry.Of the 3598 CTO PCIs performed at 21 centers between 2012 and 2018, 814 (23%) also included PCI of at least one non-CTO lesion. Patients in whom non-CTO lesions were treated were older (65 ± 10 vs. 64 ± 10 years, p = 0.03), more likely to present with an acute coronary syndrome (32% vs. 23%, p 0.01), and less likely to undergo PCI of a right coronary artery (RCA) CTO (46% vs. 58%, p 0.01). The most common non-CTO lesion location was the left anterior descending artery (31%), followed by the circumflex (29%) and the RCA (25%).Combined non-CTO and CTO-PCI procedures had similar technical (88% vs. 87%, p = 0.33) and procedural (85% vs. 85%, p = 0.74) success and major in-hospital complication rates (3.4% vs. 2.7%, p = 0.23), but had longer procedure duration (131 [88, 201] vs. 117 [75, 179] minutes, p 0.01), higher patient air kerma radiation dose (3.0 [1.9, 4.8] vs. 2.8 [1.5, 4.6] Gray, p 0.01) and larger contrast volume (300 [220, 380] vs. 250 [180, 350] ml, p 0.01).Combined CTO PCI with PCI of non-CTO lesions is associated with similar success and major in-hospital complication rates compared with cases in which only CTOs were treated, but requires longer procedure duration and higher radiation dose and contrast volume.

Aims The prognostic implications of periprocedural myocardial infarction (PMI) after percutaneous coronary intervention (PCI) and coronary artery bypass grafting (CABG) remain controversial. We examined the 3-year rates of mortality among patients with and without PMI undergoing left main coronary artery intervention randomized to PCI with everolimus-eluting stents vs. CABG in the large-scale, multicentre, prospective, randomized EXCEL trial. Methods and results By protocol, PMI was defined using an identical threshold for PCI and CABG [creatinine kinase-MB (CK-MB) elevation >10× the upper reference limit (URL) within 72 h post-procedure, or >5× URL with new Q-waves, angiographic vessel occlusion, or loss of myocardium on imaging]. Cox proportional hazards modelling was performed controlling for age, sex, hypertension, diabetes mellitus, left ventricular ejection fraction, SYNTAX score, and chronic obstructive pulmonary disease (COPD). A total of 1858 patients were treated as assigned by randomization. Periprocedural MI occurred in 34/935 (3.6%) of patients in the PCI group and 56/923 (6.1%) of patients in the CABG group [odds ratio 0.61, 95% confidence interval (CI) 0.40–0.93; P = 0.02]. Periprocedural MI was associated with SYNTAX score, COPD, cross-clamp duration and total procedure duration, and not using antegrade cardioplegia. By multivariable analysis, PMI was associated with cardiovascular death and all-cause death at 3 years [adjusted hazard ratio (HR) 2.63, 95% CI 1.19–5.81; P = 0.02 and adjusted HR 2.28, 95% CI 1.22–4.29; P = 0.01, respectively]. The effect of PMI was consistent for PCI and CABG for cardiovascular death (P interaction = 0.56) and all-cause death (P interaction = 0.59). Peak post-procedure CK-MB ≥10× URL strongly predicted mortality, whereas lesser degrees of myonecrosis were not associated with prognosis. Conclusion In the EXCEL trial, PMI was more common after CABG than PCI, and was strongly associated with increased 3-year mortality after controlling for potential confounders. Only extensive myonecrosis (CK-MB ≥10× URL) was prognostically important.

Background We sought to determine the effect of lesion age on procedural techniques and outcomes of chronic total occlusion (CTO) percutaneous coronary intervention (PCI). Methods We examined the characteristics and outcomes of 394 CTO PCIs with data on lesion age, performed between 2012 and 2016 at 11 experienced US centres. Results Mean patient age was 66 ± 10 years and 85.6% of the patients were men. Overall technical and procedural success rates were 90.1% and 87.5%, respectively. A major adverse cardiovascular event (MACE) occurred in 16 patients (4.1%). Mean and median lesion ages were 43 ± 62 months and 12 months (interquartile range, 3-64 months), respectively. Patients were stratified into tertiles according to lesion age (3-5, 5-36.3, and > 36.3 months). Older lesion age was associated with older patient age (68 ± 8 vs 65 ± 10 vs 64 ± 11 years; P = 0.009), previous coronary artery bypass grafting (62% vs 42% vs 30%; P P = 0.001). Older lesions more often required use of the retrograde approach and antegrade dissection/re-entry for successful lesion crossing. There was no difference in technical (87.8% vs 89.6% vs 93.0%; P = 0.37) or procedural (86.3% vs 87.4% vs 89.0%; P = 0.80) success, or the incidence of MACE (3.1% vs 3.0% vs 6.3%; P = 0.31) for older vs younger occlusions. Conclusions Older CTO lesions exhibit angiographic complexity and more frequently necessitate the retrograde approach or antegrade dissection/re-entry. Older CTOs can be recanalized with high technical and procedural success and acceptable MACE rates. Lesion age appears unlikely to be a significant determinant of CTO PCI success.

We assessed efficacy and safety of chronic total occlusion (CTO) percutaneous coronary intervention (PCI) using antegrade dissection re-entry (ADR).We examined outcomes of ADR among 1313 CTO PCIs performed at 11 US centers between 2012-2015.84.1% of patients were men. Prevalence of prior coronary artery bypass graft surgery was 34.3%. Overall technical and procedural success were 90.1% and 88.7%, respectively. In-hospital major adverse cardiovascular events (MACE) occurred in 31 patients (2.4%). ADR was used in 458 cases (34.9%), and was the first strategy in 169 cases (12.9%). ADR cases were angiographically more complex than non-ADR cases (mean J-CTO score: 2.8±1.2 vs. 2.4±1.2, p0.001). ADR was performed using the CrossBoss catheter in 246 of 458 (53.7%) and the Stingray system in 251 ADR cases (54.8%). Compared with non-ADR cases, ADR cases had lower technical (86.9% vs. 91.8%, p=0.005) and procedural success (85.0% vs. 90.7%, p=0.002), but similar risk for MACE (2.9% vs. 2.2%, p=0.42). ADR was associated with longer procedure and fluoroscopy time, and higher patient air kerma dose and contrast volume (all p0.001). After excluding retrograde cases, ADR and antegrade wire escalation (AWE) had similar technical success (92.7% vs. 94.2%, p=0.43), procedural success (91.8% vs. 94.1%, p=0.23), and MACE (2.1% vs. 0.6%, p=0.12).ADR is used relatively frequently in contemporary CTO PCI, especially for challenging lesions and after failure of other strategies. ADR is associated with similar success rates and risk for complications as compared with AWE, and is important for achieving high procedural success.

Objectives We sought to describe contemporary guidewire and microcatheter utilization for antegrade wire escalation (AWE) during chronic total occlusion (CTO) percutaneous coronary intervention (PCI). Background Equipment utilization for AWE has been variable and evolving over time. Methods We examined device utilization during 694 AWE attempts in 679 patients performed at 15 experienced US centers between May 2012 and April 2015. Results Mean age was 65.6 ± 9.7 years, and 85% of the patients were men. Successful wiring occurred in 436 AWE attempts (63%). Final technical and procedural success was 91% and 89%, respectively. The mean number of guidewire types used for AWE was 2.2 ± 1.4. The most frequently used guidewire types were the Pilot 200 (Abbott Vascular, 56% of AWE procedures), Fielder XT (Asahi Intecc, 45%), and the Confianza Pro 12 (Asahi Intecc, 28%). The same guidewires were the ones that most commonly crossed the occlusion: Pilot 200 (36% of successful AWE crossings), Fielder XT (20%), and Confianza Pro 12 (11%). A microcatheter or over-the-wire balloon was used for 81% of AWE attempts; the Corsair microcatheter (Asahi Intecc) was the most commonly used (44%). No significant association was found between guidewire type and incidence of major adverse cardiac events (MACE). Conclusions Our contemporary, multicenter CTO PCI registry demonstrates that the most commonly used wires for AWE are polymer-jacketed guidewires. "Stiff" and polymer-jacketed guidewires appear to provide high crossing rates without an increase in MACE or perforation, and may thus be considered for upfront use. © 2016 Wiley Periodicals, Inc.

Objectives This study sought to develop a novel parsimonious score for predicting technical success of chronic total occlusion (CTO) percutaneous coronary intervention (PCI) performed using the hybrid approach. Background Predicting technical success of CTO PCI can facilitate clinical decision making and procedural planning. Methods We analyzed clinical and angiographic parameters from 781 CTO PCIs included in PROGRESS CTO (Prospective Global Registry for the Study of Chronic Total Occlusion Intervention) using a derivation and validation cohort (2:1 sampling ratio). Variables with strong association with technical success in multivariable analysis were assigned 1 point, and a 4-point score was developed from summing all points. The PROGRESS CTO score was subsequently compared with the J-CTO (Multicenter Chronic Total Occlusion Registry in Japan) score in the validation cohort. Results Technical success was 92.9%. On multivariable analysis, factors associated with technical success included proximal cap ambiguity (beta coefficient [b] = 0.88), moderate/severe tortuosity (b = 1.18), circumflex artery CTO (b = 0.99), and absence of “interventional” collaterals (b = 0.88). The resulting score demonstrated good calibration and discriminatory capacity in the derivation (Hosmer-Lemeshow chi-square = 2.633; p = 0.268, and receiver-operator characteristic [ROC] area = 0.778) and validation (Hosmer-Lemeshow chi-square = 5.333; p = 0.070, and ROC area = 0.720) subset. In the validation cohort, the PROGRESS CTO and J-CTO scores performed similarly in predicting technical success (ROC area 0.720 vs. 0.746, area under the curve difference = 0.026, 95% confidence interval = −0.093 to 0.144). Conclusions The PROGRESS CTO score is a novel useful tool for estimating technical success in CTO PCI performed using the hybrid approach.

The hybrid algorithm was designed to assist with crossing strategy selection in chronic total occlusion (CTO) percutaneous coronary interventions (PCI) (Figure), however the success of the initially selected strategy has received limited study. We examined the impact of hybrid algorithm

Ostial chronic total occlusions (CTOs) can be challenging to recanalize.We sought to examine the prevalence, angiographic presentation, and procedural outcomes of ostial (side-branch ostial and aorto-ostial) CTOs among 1000 CTO percutaneous coronary interventions (PCIs) performed in 971 patients between 2015 and 2017 at 14 centres in the US, Europe, and Russia.Ostial CTOs represented 16.9% of all CTO PCIs: 9.6% were aorto-ostial, and 7.3% were side-branch ostial occlusions. Compared with nonostial CTOs, ostial CTOs were longer (44 ± 33 vs 29 ± 19 mm, P0.001) and more likely to have proximal-cap ambiguity (55% vs 33%, P0.001), moderate/severe calcification (67% vs 45%, P 0.001), a diffusely diseased distal vessel (41% vs 26%, P 0.001), interventional collaterals (64% vs 53%, P = 0.012), and previous coronary artery bypass graft surgery (CABG) (51% vs 27%, P 0.001). The retrograde approach was used more often in ostial CTOs (54% vs 29%, P0.001) and was more often the final successful crossing strategy (30% vs 18%, P = 0.003). Technical (81% vs 84%, P = 0.280), and procedural (77% vs 83%, P = 0.112) success rates and the incidence of in-hospital major complication were similar (4.8% vs 2.2%, P = 0.108), yet in-hospital mortality (3.0% vs 0.5%, P = 0.010) and stroke (1.2% vs 0.0%, P = 0.030) were higher in the ostial CTO PCI group. In multivariable analysis, ostial CTO location was not independently associated with higher risk for in-hospital major complications (adjusted odds ratio 1.27, 95% confidence intervals 0.37 to 4.51, P = 0.694).Ostial CTOs can be recanalized with similar rates of success as nonostial CTOs but are more complex, more likely to require retrograde crossing and may be associated with numerically higher risk for major in-hospital complications.

Background: Elevated B-type natriuretic peptide (BNP) is reflective of impaired cardiac function and is associated with worse prognosis among patients with coronary artery disease (CAD). We sought to assess the association between baseline BNP, adverse outcomes, and the relative efficacy of percutaneous coronary intervention (PCI) versus coronary artery bypass grafting (CABG) in patients with left main CAD. Methods: The EXCEL trial (Evaluation of XIENCE Versus Coronary Artery Bypass Surgery for Effectiveness of Left Main Revascularization) randomized patients with left main CAD and low or intermediate SYNTAX scores (Synergy Between PCI With TAXUS and Cardiac Surgery) to PCI with everolimus-eluting stents versus CABG. The primary end point was the composite of all-cause death, myocardial infarction, or stroke. We used multivariable Cox proportional hazards regression to assess the associations between normal versus elevated BNP (≥100 pg/mL), randomized treatment, and the 3-year risk of adverse events. Results: BNP at baseline was elevated in 410 of 1037 (39.5%) patients enrolled in EXCEL. Patients with elevated BNP levels were older and more frequently had additional cardiovascular risk factors and lower left ventricular ejection fraction than those with normal BNP, but had similar SYNTAX scores. Patients with elevated BNP had significantly higher 3-year rates of the primary end point (18.6% versus 11.7%; adjusted hazard ratio [HR], 1.62; 95% confidence interval [CI], 1.16–2.28; P =0.005) and higher mortality (11.5% versus 3.9%; adjusted HR, 2.49; 95% CI, 1.48–4.19; P =0.0006), both from cardiovascular and noncardiovascular causes. In contrast, there were no significant differences in the risks of myocardial infarction, stroke, ischemia-driven revascularization, stent thrombosis, graft occlusion, or major bleeding. A significant interaction ( P interaction =0.03) was present between elevated versus normal BNP and treatment with PCI versus CABG for the adjusted risk of the primary composite end point at 3 years among patients with elevated BNP (adjusted HR for PCI versus CABG, 1.54; 95% CI, 0.96–2.47) versus normal BNP (adjusted HR, 0.74; 95% CI, 0.46–1.20). This interaction was stronger when log(BNP) was modeled as a continuous variable ( P interaction =0.002). Conclusions: In the EXCEL trial, elevated baseline BNP levels in patients with left main CAD undergoing revascularization were independently associated with long-term mortality but not nonfatal adverse ischemic or bleeding events. The relative long-term outcomes after PCI versus CABG for revascularization of left main CAD may be conditioned by the baseline BNP level. Clinical Trial Registration: URL: https://www.clinicaltrials.gov . Unique identifier: NCT01205776.

To study outcomes with use of percutaneous mechanical circulatory support (MCS) devices in chronic total occlusion (CTO) percutaneous coronary intervention (PCI).We examined characteristics and outcomes of 1598 CTO-PCIs performed from 2012-2017 at 12 high-volume centers.Patient age was 66 ± 10 years; 86% were men. An MCS device was used electively in 69 procedures (4%) and urgently in 22 procedures (1%). The most commonly used elective MCS device was Impella 2.5 or CP (62%). Compared to patients without elective MCS, patients with elective MCS had higher prevalence of prior heart failure (55% vs 29%; P.001), prior coronary artery bypass graft surgery (49% vs 35%; P=.02), and lower left ventricular ejection fraction (34 ± 14% vs 50 ± 14%; P.001). MCS patients had a higher prevalence of moderate/ severe calcification (88% vs 55%; P.001) and higher J-CTO scores (3.1 ± 1.2 vs 2.6 ± 1.2; P.01), and a greater proportion underwent retrograde crossing attempts (55% vs 39%; P.01). Despite more complex characteristics in MCS patients, technical success rates (88% vs 87%; P=.70) and procedural success rates (83% vs 87%; P=.32) were similar in the two groups. Use of elective MCS was associated with longer procedure and fluoroscopy times, and higher incidences of in-hospital major adverse cardiovascular events (8.7% vs 2.5%; P.01) and bleeding (7.3% vs 1.0%; P.001).Elective MCS was used in 4% of patients undergoing CTO-PCI. Despite more complex clinical and angiographic characteristics, elective use of MCS in high-risk patients is associated with similar technical and procedural success rates, but higher risk of complications, compared to cases without elective MCS.

The frequency and outcomes of patients who underwent chronic total occlusion (CTO) percutaneous coronary intervention (PCI) of more than one CTO during the same procedure have received limited study. We compared the clinical and angiographic characteristics and procedural outcomes of patients who underwent treatment of single versus1 CTOs during the same procedure in 20 centers from the United States, Europe, and Russia. A total of 2,955 patients were included: mean age was 65 ± 10 years and 85% were men with high prevalence of previous myocardial infarction (46%), and previous coronary artery bypass graft surgery (33%). More than one CTO lesions were attempted during the same procedure in 58 patients (2.0%) and 70% of them were located in different major epicardial arteries. Compared with patients who underwent PCI of a single CTO, those who underwent PCI of1 CTOs during the same procedure had similar J-CTO (2.4 ± 1.3 vs 2.5 ± 1.3, p = 0.579) and Prospective Global Registry for the Study of Chronic Total Occlusion Intervention (1.5 ± 1.2 vs 1.3 ± 1.0 p = 0.147) scores. The multi-CTO PCI group had similar technical success (86% vs 87%, p = 0.633), but higher risk of in-hospital major complications (10.3% vs 2.7%, p = 0.005), and consequently numerically lower procedural success (79% vs 85%, p = 0.197). The multi-CTO PCI group had higher in-hospital mortality (5.2% vs 0.5%, p = 0.005) and stroke (5.2%vs 0.2%, p0.001), longer procedure duration (162 [117 to 242] vs 122 [80 to 186] minutes, p0.001) and higher radiation dose (3.6 [2.1 to 6.4] vs 2.9 [1.7 to 4.7] Gray, p = 0.033). In conclusion, staged revascularization may be the preferred approach in patients with1 CTO lesions requiring revascularization, as treatment during a single procedure was associated with higher risk for periprocedural complications.

Background: Distal left main (LM) coronary artery bifurcation disease increases percutaneous coronary intervention (PCI) procedural complexity and is associated with worse outcomes than isolated ostial/shaft disease. The optimal treatment strategy for distal LM disease is undetermined. We sought to determine whether outcomes after PCI of LM distal bifurcation lesions are influenced by treatment with a provisional 1-stent versus planned 2-stent technique, and if so, whether such differences are conditioned by the complexity of the LM bifurcation lesion. Methods and Results: The clinical and angiographic characteristics, procedural methods and outcomes, and clinical events through 3-year follow-up were compared in patients undergoing distal LM PCI with a 1-stent provisional versus planned 2-stent technique in the EXCEL trial (Evaluation of XIENCE Versus Coronary Artery Bypass Surgery for Effectiveness of Left Main Revascularization). Among 529 patients undergoing planned distal LM PCI, 344 (65.0%) and 185 (35.0%) were treated with intended 1-stent provisional and planned 2-stent techniques, respectively. The primary composite end point rate of death, myocardial infarction, or stroke at 3 years was significantly lower in patients treated with the provisional 1-stent versus planned 2-stent method (14.1% versus 20.7%; adjusted hazard ratio, 0.55; 95% CI, 0.35–0.88; P =0.01), driven by differences in cardiovascular death (3.3% versus 8.3%, P =0.01) and myocardial infarction (7.7% versus 12.8%, P =0.06). The 3-year rate of ischemia-driven revascularization of the LM complex was also lower in the provisional group (7.2% versus 16.3%, P =0.001). In 342 patients with distal LM bifurcation disease that did not involve both major side branch vessels, the 3-year primary end point was lower with a provisional 1-stent versus planned 2-stent technique (13.8% versus 23.3%, P =0.04), whereas no significant difference was present in 182 patients with distal LM bifurcation disease that did involve both side branch vessels (14.3% versus 19.2%, P =0.36). Conclusions: Among patients with distal LM bifurcation disease in the EXCEL trial randomized to PCI, 3-year adverse outcomes were worse with planned 2-stent treatment compared with a provisional 1-stent approach, a difference that was confined to patients without major involvement of both LM side branch vessels. Clinical Trial Registration: URL: https://www.clinicaltrials.gov . Unique identifier: NCT01205776.

Objectives This study sought to evaluate procedural and clinical outcomes among patients undergoing chronic total occlusion (CTO) percutaneous coronary intervention (PCI) using contemporary methods and everolimus-eluting stents (EES). Background Limited studies have detailed the procedural and late-term safety and efficacy of CTO revascularization among multiple centers applying modern techniques and with newer-generation drug-eluting stents. Methods Among 20 centers, 250 consecutive patients were enrolled for attempted CTO PCI. Procedural and in-hospital clinical outcomes were examined in addition to the 1-year primary endpoint of death, myocardial infarction, and target lesion revascularization (major adverse cardiac events [MACE]). Results Demographic, lesion, and procedural characteristics included prior bypass surgery: 9.9%; diabetes: 40.1%; lesion length: 36.1 ± 18.5 mm; and stent length: 51.7 ± 27.2 mm. Procedural success, defined as guidewire recanalization with no in-hospital MACE, was 96.4%. Success with antegrade-only methods was 97.9% and 86.2% by retrograde/combined methods, respectively. Compared with a pre-specified performance goal derived from 6 prior CTO drug-eluting stent trials (1-year MACE: 24.4%), treatment with EES was associated with significantly lower composite adverse events for both intent-to-treat (18.5%, 1-sided upper confidence interval: 23.4%, p = 0.025) and per-protocol populations (8.2%, 1-sided upper confidence interval: 12.3%, p Conclusions In a multicenter registration trial representing contemporary technique and EES, favorable procedural success and late-term clinical outcomes support CTO PCI in a patient population with high lesion complexity. (EXPERT CTO: Evaluation of the XIENCE PRIME LL and XIENCE Nano Everolimus Eluting Coronary Stent Coronary Stents, Performance, and Technique in Chronic Total Occlusions; NCT01435031 )

Objectives To examine the impact of transradial access on the procedural outcomes of chronic total occlusion (CTO) percutaneous coronary interventions (PCI). Background The efficacy and safety of transradial access in CTO PCI has received limited study. Methods We compared the technique and outcomes of transradial vs. transfemoral access among 650 CTO PCI cases performed between January 2012 and March 2014 at 6 US centers. Results Most patients were men (87%) with high frequency of diabetes mellitus (42%) and prior coronary artery bypass graft surgery (36%). The CTO target vessel was the right coronary (59%), left anterior descending (20%), or circumflex (17%) artery. TR access was used in 110 (17%) of the 650 cases, as follows: bilateral radial access (63%); bilateral radial access plus unilateral or bilateral femoral access (7%); unilateral radial access plus unilateral or bilateral femoral access (26%); and unilateral radial access (4%). Six and eight French guide catheters were used through the radial and femoral artery, respectively. Compared to transfemoral, transradial cases had similar technical (92.6% vs. 93.0%, P = 0.87) and procedural (91.1% vs. 90.0%, P = 0.95) success and major complication rates (1.7% vs 1.8%, P = 0.99). However, transradial access was associated with higher mean procedure (142 ± 83 vs. 120 ± 60 min, P = 0.008) and fluoroscopy (58 ± 40 vs. 49 ± 31 min, P

Chronic total occlusion percutaneous coronary intervention (CTO PCI) procedural planning involves much thought and deliberation before one actually attempts to cross the CTO lesion in the cardiac catheterization laboratory. Careful preprocedural angiographic assessment is a key to successful CTO PCI. CTO PCI represents the most complex PCI one can perform, and thus operator and staff training as well as the concept of CTO days are all essential for a successful CTO PCI program.

We examined the impact of proximal vessel tortuosity on the outcomes of chronic total occlusion (CTO) percutaneous coronary intervention (PCI).The baseline clinical and angiographic characteristics and procedural outcomes of 1618 consecutive CTO-PCIs performed between 2012 and 2016 at 14 United States centers in 1589 patients were reviewed.Mean patient age was 65.3 ± 10.0 years and 85% were men. Moderate/severe proximal vessel tortuosity was present in 35.7% of target lesions. Compared with non-tortuous lesions, tortuous lesions had longer length (30 mm [interquartile range, 20-50 mm] vs 28 mm [interquartile range, 16-40 mm]; P.001), more proximal cap ambiguity (36% vs 28%; P.01), and more frequent utilization of the retrograde approach (52% vs 37%; P.001). Moderate/severe proximal vessel tortuosity was associated with lower technical success rates (84.1% vs 91.3%; P.001) and procedural success rates (82.3% vs 89.9%; P.001), but similar incidence of major cardiac adverse events (3.0% vs 2.5%; P=.59). Moderate/severe tortuosity was associated with longer procedure time and fluoroscopy time, higher air kerma radiation dose, and larger contrast volume.In a contemporary multicenter registry, moderate/severe proximal vessel tortuosity was present in approximately one-third of target CTO lesions and was associated with more frequent use of the retrograde approach and lower success rates, but similar complication rates.