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Objectives: The aim of this study was to identify independent predictors of procedural success after retrograde chronic total occlusion (CTO) percutaneous coronary intervention (PCI). Background: Retrograde CTO PCI is an established technique, but predictors of success remain poorly understood. Methods: A multivariable logistic regression model was used to analyze potentially important demographic, clinical, anatomical, and technical aspects of retrograde CTO PCI cases uploaded to the multicenter European CTO (ERCTO) Club Registry. Results: In calendar years 2018 and 2019, 2,364 retrograde CTO PCI cases constituted the primary analysis cohort. A primary retrograde strategy was used in 1,953 cases (82.6%), and an initial antegrade approach was converted to retrograde in 411 cases (17.4%). Procedural success was achieved in 1,820 cases (77.0%) and was more likely to occur after a primary retrograde attempt versus conversion from an initial antegrade approach (80.9% vs 58.4%; P < 0.0001). After multivariable analysis, an absence of lesion calcification (OR: 1.86; 95% CI: 1.37-2.51; P < 0.0001), a higher degree of distal vessel opacification (OR: 2.47; 95% CI: 1.72-3.55; P < 0.0001), little or no proximal target vessel tortuosity (OR: 1.84; 95% CI: 1.28-2.64; P = 0.001), Werner collateral connection CC1 (OR: 4.87; 95% CI: 2.90-8.19; P < 0.0001) or CC2 (OR: 5.33; 95% CI: 3.02-9.42; P < 0.0001), and the top tertile of operator volume (>120 cases over 2 years) (OR: 1.88; 95% CI: 1.26-2.79; P = 0.002) were associated with the greatest chance of achieving angiographic success. Conclusions: Less calcification with good distal vessel opacification, little or absent proximal vessel tortuosity, and visible collateral connections, along with high-volume operator status, were all independently predictive of angiographically successful retrograde CTO PCI.

© 2021 The Authors. Published by Elsevier on behalf of the American College of Cardiology Foundation. This is an open access article under the CC-BY-NC-ND license., The authors developed a global chronic total occlusion crossing algorithm following 10 steps: 1) dual angiography; 2) careful angiographic review focusing on proximal cap morphology, occlusion segment, distal vessel quality, and collateral circulation; 3) approaching proximal cap ambiguity using intravascular ultrasound, retrograde, and move-the-cap techniques; 4) approaching poor distal vessel quality using the retrograde approach and bifurcation at the distal cap by use of a dual-lumen catheter and intravascular ultrasound; 5) feasibility of retrograde crossing through grafts and septal and epicardial collateral vessels; 6) antegrade wiring strategies; 7) retrograde approach; 8) changing strategy when failing to achieve progress; 9) considering performing an investment procedure if crossing attempts fail; and 10) stopping when reaching high radiation or contrast dose or in case of long procedural time, occurrence of a serious complication, operator and patient fatigue, or lack of expertise or equipment. This algorithm can improve outcomes and expand discussion, research, and collaboration.

AIMS: Radiation exposure is a limiting factor for percutaneous coronary interventions (PCI) of chronic total coronary occlusion (CTO) lesions. This study was designed to analyze changes in patient radiation dose for CTO-PCI and parameters associated with radiation dose.METHODS AND RESULTS: We analyzed a cohort of 12,136 procedures performed by 23 operators between 2012 and 2017 from the European Registry of CTO-PCI. Radiation exposure was recorded as air kerma (AK) and dose area product (DAP). A dose rate index (DRI) was calculated as AK per fluoroscopy time to normalize for individual differences in fluoroscopy time. The lesion complexity increased from Japanese-CTO (J-CTO) score of 2.19 ± 1.44 to 2.46 ± 1.28, with an increase of retrograde procedures from 31.1% to 40.7%; still, procedural success improved from 87.7% to 92.1%. Fluoroscopy time remained similar, but AK decreased by 14.9%, from 2.35 Gy (interquartile range [IQR], 1.29-4.14 Gy) to 2.00 Gy (IQR, 1.08-3.45 Gy) and DAP decreased by 21.5%, from 130 Gy•cm² (IQR, 70-241 Gy•cm²) to 102 Gy•cm² (IQR, 58-184 Gy•cm²). Radiation exposure was determined by the lesion complexity (J-CTO score) and procedural complexity (antegrade or retrograde). DRI was determined by fluoroscopy frame rate and type of equipment used, but the major influence remained interoperator differences.CONCLUSIONS: Radiation exposure decreased during the observation period despite an increase in lesion and procedural complexity. While many operators already achieved a goal of low radiation exposure, there were considerable interoperator differences in radiation management, indicating further potential for improvement.

BACKGROUND Conflicting evidence exists on the efficacy and safety of bivalirudin administered as part of percutaneous coronary intervention (PCI) in patients with an acute coronary syndrome. METHODS We randomly assigned 7213 patients with an acute coronary syndrome for whom PCI was anticipated to receive either bivalirudin or unfractionated heparin. Patients in the bivalirudin group were subsequently randomly assigned to receive or not to receive a post-PCI bivalirudin infusion. Primary outcomes for the comparison between bivalirudin and heparin were the occurrence of major adverse cardiovascular events (a composite of death, myocardial infarction, or stroke) and net adverse clinical events (a composite of major bleeding or a major adverse cardiovascular event). The primary outcome for the comparison of a post-PCI bivalirudin infusion with no post-PCI infusion was a composite of urgent target-vessel revascularization, definite stent thrombosis, or net adverse clinical events. RESULTS The rate of major adverse cardiovascular events was not significantly lower with bivalirudin than with heparin (10.3% and 10.9%, respectively; relative risk, 0.94; 95% confidence interval [CI], 0.81 to 1.09; P = 0.44), nor was the rate of net adverse clinical events (11.2% and 12.4%, respectively; relative risk, 0.89; 95% CI, 0.78 to 1.03; P = 0.12). Post-PCI bivalirudin infusion, as compared with no infusion, did not significantly decrease the rate of urgent target-vessel revascularization, definite stent thrombosis, or net adverse clinical events (11.0% and 11.9%, respectively; relative risk, 0.91; 95% CI, 0.74 to 1.11; P = 0.34). CONCLUSIONS In patients with an acute coronary syndrome, the rates of major adverse cardiovascular events and net adverse clinical events were not significantly lower with bivalirudin than with unfractionated heparin. The rate of the composite of urgent target-vessel revascularization, definite stent thrombosis, or net adverse clinical events was not significantly lower with a post-PCI bivalirudin infusion than with no post-PCI infusion. (Funded by the Medicines Company and Terumo Medical; MATRIX ClinicalTrials.gov number, NCT01433627.) abstr act

OBJECTIVES This study sought to assess whether transradial access (TRA) compared with transfemoral access (TFA) is associated with consistent outcomes in male and female patients with acute coronary syndrome undergoing invasive management.BACKGROUND There are limited and contrasting data about sex disparities for the safety and efficacy of TRA versus TFA for coronary intervention.METHODS In the MATRIX (Minimizing Adverse Haemorrhagic Events by TRansradial Access Site and Systemic Implementation of angioX) program, 8,404 patients were randomized to TRA or TFA. The 30-day coprimary outcomes were major adverse cardiovascular and cerebrovascular events (MACCE), defined as death, myocardial infarction, or stroke, and net adverse clinical events (NACE), defined as MACCE or major bleeding.RESULTS Among 8,404 patients, 2,232 (26.6%) were women and 6,172 (73.4%) were men. MACCE and NACE were not significantly different between men and women after adjustment, but women had higher risk of access site bleeding (male vs. female rate ratio [RR]: 0.64; p = 0.0016), severe bleeding (RR: 0.17; p = 0.0012), and transfusion (RR: 0.56; p = 0.0089). When comparing radial versus femoral, there was no significant interaction for MACCE and NACE stratified by sex (p(int) = 0.15 and 0.18, respectively), although for both coprimary endpoints the benefit with TRA was relatively greater in women (RR: 0.73; p = 0.019; and RR: 0.73; p = 0.012, respectively). Similarly, there was no significant interaction between male and female patients for the individual endpoints of all-cause death (p(int) = 0.79), myocardial infarction (p(int) = 0.25), stroke (p(int) = 0.18), and Bleeding Academic Research Consortium type 3 or 5 (p(int) = 0.45).CONCLUSIONS Women showed a higher risk of severe bleeding and access site complications, and radial access was an effective method to reduce these complications as well as composite ischemic and ischemic or bleeding endpoints. (C) 2018 by the American College of Cardiology Foundation.

Objectives: The aim was to establish a contemporary scoring system to predict the outcome of chronic total occlusion coronary angioplasty. Background: Interventional treatment of chronic total coronary occlusions (CTOs) is a developing subspecialty. Predictors of technical success or failure have been derived from datasets of modest size. A robust scoring tool could facilitate case selection and inform decision making. Methods: The study analyzed data from the EuroCTO registry. This prospective database was set up in 2008 and includes >20,000 cases submitted by CTO expert operators (>50 cases/year). Derivation (n = 14,882) and validation (n = 5,745) datasets were created to develop a risk score for predicting technical failure. Results: There were 14,882 patients in the derivation dataset (with 2,356 [15.5%] failures) and 5,745 in the validation dataset (with 703 [12.2%] failures). A total of 20.2% of cases were done retrogradely, and dissection re-entry was performed in 9.3% of cases. We identified 6 predictors of technical failure, collectively forming the CASTLE score (Coronary artery bypass graft history, Age (≥70 years), Stump anatomy [blunt or invisible], Tortuosity degree [severe or unseen], Length of occlusion [≥20 mm], and Extent of calcification [severe]). When each parameter was assigned a value of 1, technical failure was seen to increase from 8% with a CASTLE score of 0 to 1, to 35% with a score ≥4. The area under the curve (AUC) was similar in both the derivation (AUC: 0.66) and validation (AUC: 0.68) datasets. Conclusions: The EuroCTO (CASTLE) score is derived from the largest database of CTO cases to date and offers a useful tool for predicting procedural outcome.

To investigate the long-term clinical outcomes of second-generation drug-eluting stent (2G-DES) implantation for the treatment of complex unprotected left main coronary artery (ULMCA) bifurcation lesions with different two-stent techniques.Several two-stent techniques for ULMCA bifurcation lesions have been described. However, a paucity of data exists regarding the optimal strategy, especially in the 2G-DES era.The FAILS-2 registry enrolled 1270 consecutive patients treated for ULMCA stenosis with 2G-DES. We compared long-term outcomes of different two-stent strategies in patients who underwent PCI for complex ULMCA bifurcation disease. The primary endpoints were the incidence of death and major adverse cardiac events (MACE, defined as a composite of all-cause death, myocardial infarction [MI], target-lesion revascularization [TLR], and stent thrombosis [ST]) at long-term follow-up.A total of 238 patients were included in the present analysis. T-stenting strategy was used in 66 patients, mini-crush in 104 patients, and culotte in 68 patients. After a median follow-up of 2.27 years, death rates were comparable for the three techniques (9.3% T-stenting vs 9.0% mini-crush vs 4.5% culotte [P=.48]). MACE rates were also similar between the three groups (22% T-stenting vs 26% mini-crush vs 31% culotte [P=.50]). Finally, we showed no differences in MI, ST, and TLR rates between groups. At multivariate analysis, no significant advantage of one technique over the others was observed.T-stenting, mini-crush, and culotte techniques using 2G-DES for ULMCA bifurcation disease showed similar clinical outcomes at long-term follow-up. MACE rates were mainly driven by in-stent restenosis at the circumflex ostium.

Item does not contain fulltext AIMS: Bioresorbable vascular scaffolds (BVS) represent a novel therapeutic option for the treatment of coronary artery diseases. The objective of this study was to evaluate the feasibility of BVS implantation in complex chronic total occlusions (CTO). METHODS AND RESULTS: The present report is a multicentre registry evaluating results after BVS deployment in challenging CTO lesions, defined as J-CTO score >/=2 (difficult or very difficult). A total of 105 patients were included in the present analysis. The mean J-CTO score was 2.61 (difficult 52.4%, very difficult 47.6%). Device success and procedural success rates were 98.1% and 97.1%, respectively. The retrograde approach was used in 25.7% of cases. After wire crossing, predilatation was performed in all cases with a mean predilatation balloon diameter of 2.73+/-0.43 mm. The mean scaffold length was 59.75+/-25.85 mm, with post-dilatation performed in 89.5% of the cases and a mean post-dilatation balloon diameter of 3.35+/-0.44 mm. Post-PCI minimal lumen diameter was 2.50+/-0.51 mm and percentage diameter stenosis 14.53+/-10.31%. At six-month follow-up, a total of three events were reported: one periprocedural myocardial infarction, one late scaffold thrombosis and one additional target lesion revascularisation. CONCLUSIONS: The present report suggests the feasibility of BVS implantation in complex CTO lesions, given adequate lesion preparation and post-dilatation, with good acute angiographic results and midterm clinical outcomes.

Objectives: Culprit plaque characteristics in young patients who experience an Acute Coronary Syndrome (ACS) evaluated by OCT (Optical Coherence Tomography) have to be defined. The OCT-FORMIDABLE is a multicentre retrospective registry enrolling consecutive patients with ACS who performed OCT in 9 European centres. Methods: Patients were divided in two groups according to age at presentation: juvenile-ACS (age 50 years). Primary end-point was the prevalence of plaque rupture (PR). Secondary end point was the prevalence of thin cap fibro atheroma (TCFA), fibrocalcific and fibrotic plaque. Results: 285 patients were included, 71 (24.9%) in juvenile-ACS group and 215 (75.1%) in not juvenile-ACS group. Younger patients showed a trend for a higher prevalence of TCFA (70 vs. 58%, P = 0.06) and thrombus presence (62 vs. 51%, P = 0.1), while no statistical difference concerning PR (70 vs. 64%, P = 0.29). Of interest patients younger that 35 years showed a higher prevalence of PR compared to patients aged between 35 and 45 or 45 and 50 years (100 vs. 72 vs. 55%, P = 0.03). Culprit plaque in juvenile-ACS group showed more frequently a reduced mean cap thickness (119 +/- 66 vs. 155 +/- 95 nm, P = 0.05) and less frequently fibrotic (32 vs. 57%, P < 0.001) or fibrocalcific (17 vs. 36%, P = 0.003) characteristics. Conclusions:young patients with ACS show a trend for a higher prevalence of culprit PR, a thinner cap and less fibrotic or fibrocalcific components.

Aim. To determine the potential clinical impact of OCT (Optical Coherence Tomography) during primary percutaneous coronary intervention in patients presenting with ACS (Acute Coronary Syndrome). Methods and Results. FORMIDABLE is a multicentre retrospective registry enrolling all patients presenting with ACS and treated with an OCT-guided approach, while the USZ registry enrolled patients treated with a standard angiography guided approach. Multivariate adjustment was performed via a propensity score matching. The number stents useds was the primary outcome, while the incidence of MACE (a composite of death, myocardial infarction, target vessel revascularization, and stent thrombosis) was the secondary endpoint. A total of 285 patients OCT-guided and 1,547 angiography guided patients were enrolled, resulting in 270 for each cohort after propensity score with matching. Two stents were used in 12% versus 34%; 3 stents in 8% versus 38% of the patients (P

Intravascular ultrasound has been used for >20 years to guide percutaneous coronary intervention in different subsets of coronary lesions. During the last decade, the interest in percutaneous coronary intervention for chronic total occlusion (CTO) has increased dramatically, leading to high success rates. Failure of guidewire crossing is the most common reason for failed CTO attempts. Certain angiographic features, such as blunt proximal CTO cap, tortuosity, heavy calcification, and lack of visibility of path in the distal vessel, increase procedural difficulty. A better understanding of the behavior of the guidewire within the CTO segment may represent a key issue to achieve successful outcome. In this respect, intravascular ultrasound imaging might have potential roles in the recanalization of CTOs. In this paper, we focused on the usefulness and the applications of intravascular ultrasound imaging in percutaneous CTO recanalization, underlying its impact on clinical outcome.

BackgroundA lack of clarity exists about the role of complete coronary revascularization in patients presenting with non–ST-segment elevation myocardial infarction.ObjectivesThe aim of our study was to compare long-term outcomes in terms of major adverse cardiovascular and cerebrovascular events of 2 different complete coronary revascularization strategies in patients with non–ST-segment elevation myocardial infarction and multivessel coronary artery disease: 1-stage percutaneous coronary intervention (1S-PCI) during the index procedure versus multistage percutaneous coronary intervention (MS-PCI) complete coronary revascularization during the index hospitalization.MethodsIn the SMILE (Impact of Different Treatment in Multivessel Non ST Elevation Myocardial Infarction Patients: One Stage Versus Multistaged Percutaneous Coronary Intervention) trial, 584 patients were randomly assigned in a 1:1 manner to 1S-PCI or MS-PCI. The primary study endpoint was the incidence of major adverse cardiovascular and cerebrovascular events, which were defined as cardiac death, death, reinfarction, rehospitalization for unstable angina, repeat coronary revascularization (target vessel revascularization), and stroke at 1 year.ResultsThe occurrence of the primary endpoint was significantly lower in the 1-stage group (1S-PCI: n = 36 [13.63%] vs. MS-PCI: n = 61 [23.19%]; hazard ratio [HR]: 0.549 [95% confidence interval (CI): 0.363 to 0.828]; p = 0.004). The 1-year rate of target vessel revascularization was significantly higher in the MS-PCI group (1S-PCI: n = 22 [8.33%] vs. MS-PCI: n = 40 [15.20%]; HR: 0.522 [95% CI: 0.310 to 0.878]; p = 0.01; p log-rank = 0.013). When the analyses were limited to cardiac death (1S-PCI: n = 9 [3.41%] vs. MS-PCI: n = 14 [5.32%]; HR: 0.624 [95% CI: 0.270 to 1.441]; p = 0.27) and myocardial infarction (1S-PCI: n = 7 [2.65%] vs. MS-PCI: n = 10 [3.80%]; HR: 0.678 [95% CI: 0.156 to 2.657]; p = 0.46), no significant differences were observed between groups.ConclusionsIn multivessel non–ST-segment elevation myocardial infarction patients, complete 1-stage coronary revascularization is superior to multistage PCI in terms of major adverse cardiovascular and cerebrovascular events. (Impact of Different Treatment in Multivessel Non ST Elevation Myocardial Infarction [NSTEMI] Patients: One Stage Versus Multistaged Percutaneous Coronary Intervention [PCI] [SMILE]: NCT01478984)

The use of drug-eluting stents (DES) has improved clinical outcomes in percutaneous coronary intervention procedures, but many challenges remain. In two symposia at EuroPCR 2015, the factors necessary to ensure successful chronic total occlusion (CTO) intervention were presented. Good preparation, sufficient operator experience and the correct approach are key to the success of CTO interventions. A live case demonstrated the challenges of these complex cases. Stent choice in CTO interventions is crucial; second-generation DES are associated with lower rates of restenosis and re-occlusion compared with first-generation DES. The Coracto™ DES features unique structural properties and rapidly absorbable polymer, resulting in excellent conformability, efficacy and safety.

Rotational atherectomy (RA) is relatively contraindicated in patients with lesions ≥25 mm of length. Aim of this study was to evaluate RA safety and efficacy in this subset of patients with new technology and devices.From April 2002 to August 2013, the ROTATE registry included all consecutive patients undergoing RA in 8 centres. They were divided into shorter lesion group (SLG, lesions 25 mm) and longer lesion group (LLG, lesions ≥ 25 mm). The angiographic success (AS) was the primary end point. Procedural complications (PC), a composite end point of procedural perforation, slow flow/no flow, and in-hospital major acute cardiovascular events (MACE), were secondary end points, along with death, nonfatal MI, target lesion revascularization, and MACE during follow-up. Sensitivity analysis was performed according to generation of DES. 1186 patients were included: 51.5% in SLG and 48.4% in LLG. Mean age was 70.4 ± 9.3 years, 64.5% were male. AS and PC did not differ between the two groups (93% vs 91%, p = 0.24 and 9.8 vs 9.4%, p = 0.84). During follow-up (27.6 ± 22.9 months), MACE did not differ between the two groups (28% vs 29.1%, p = 0.95). At multivariate analysis chronic kidney disease, male gender increased risk of MACE (HR 1.94, IQR 1.29-2.0, p = 0.01, HR 0.52, IQR 0.34-0.79, p = 0.01) while second-generation DES seemed protective (HR 0.53, IQR 0.31-0.88, p = 0.02). Data were confirmed at sensitivity analysis for second-generation DES (759 pts, 63.9%). No differences were found in this subpopulation between the two groups in term of AS, PC, and long-term MACE (93.6% vs 93.5%, p = 0.28, 11.9% vs 9.4%, p = 0.32 and 25.5% vs 23.9%, p = 0.72, respectively).Treating coronary lesions ≥ 25 mm length with RA does not impact short- and long-term outcome, in particular, in patients with second-generation DES. © 2016 Wiley Periodicals, Inc.

Chronic total occlusions (CTO) are the most challenging lesions treated by interventional cardiologists. A symposium at EuroPCR 2014 discussed factors influencing the success of percutaneous intervention (PCI) in CTO. Current treatment paradigms suggest that one or two vessel disease should be treated by PCI while three-vessel disease requires surgery if complete revascularisation cannot be achieved with PCI. In patients with CTO and multi-vessel disease timing is key, and evidence of ischaemic burden and expected completeness of revascularisation is required before PCI is undertaken. Other factors affecting procedural success include the available equipment and expertise of the operator. Flexiblity in strategy selection is also important as it is frequently necessary to switch strategies during the procedure. The presentation included two live cases that illustrated the complexity of this procedure.

BackgroundThe optimal duration of dual antiplatelet therapy (DAPT) following second-generation drug-eluting stent (DES) implantation is still debated.ObjectivesThe aim of this study was to test the noninferiority of 6 versus 12 months of DAPT in patients undergoing percutaneous coronary intervention with second-generation DES.MethodsThe SECURITY (Second Generation Drug-Eluting Stent Implantation Followed by Six- Versus Twelve-Month Dual Antiplatelet Therapy) trial was a 1:1 randomized, multicenter, international, investigator-driven, noninferiority study conducted from July 2009 to June 2014. Patients with a stable or unstable angina diagnosis or documented silent ischemia undergoing revascularization with at least 1 second-generation DES were eligible. The primary endpoint was a composite of cardiac death, myocardial infarction (MI), stroke, definite or probable stent thrombosis, or Bleeding Academic Research Consortium (BARC) type 3 or 5 bleeding at 12 months. The main secondary endpoint was a composite of cardiac death, MI, stroke, definite or probable stent thrombosis, or BARC type 2, 3, or 5 bleeding at 12 and 24 months.ResultsOverall, 1,399 patients were enrolled in the study and randomized to receive 6 months (n = 682) versus 12 months (n = 717) DAPT. The primary composite endpoint occurred, respectively, in 4.5% versus 3.7% (risk difference 0.8%; 95% confidence interval [CI]: −2.4% to 1.7%; p = 0.469) at 12 months. The upper 95% CI limit was lower than the pre-set margin of 2%, confirming the noninferiority hypothesis (p < 0.05). Moreover, no differences were observed in the occurrence of the secondary endpoint at 12 months (5.3% vs. 4.0%, difference: 1.2%; 95% CI: −1.0 to 3.4; p = 0.273) and between 12 and 24 months (1.5% vs. 2.2%, difference: −0.7%; 95% CI: −2.1 to 0.6; p = 0.289). Finally, no differences were observed in definite or probable stent thrombosis at 12 months (0.3% vs. 0.4%; difference: −0.1%; 95% CI: −0.7 to 0.4; p = 0.694) and between 12 and 24 months of follow-up (0.1% vs. 0%; difference: 0.1%; 95% CI: −0.1 to 0.4; p = 0.305).ConclusionsIn a low-risk population, the noninferiority hypothesis of 6 vs. 12 months DAPT following second-generation DES implantation appears accepted for the incidence of cardiac death, MI, stroke, definite/probable stent thrombosis, and BARC type 3 or 5 bleeding at 12 months. (Second Generation Drug-Eluting Stent Implantation Followed by Six- Versus Twelve-Month Dual Antiplatelet Therapy; NCT00944333)

ObjectivesThis study sought to assess in vivo sex differences in the pathophysiology of ST-segment elevation myocardial infarction (STEMI) and vascular response to primary percutaneous coronary intervention (PCI).BackgroundThere is no consensus on whether differences in the pathophysiology of STEMI and response to primary PCI between women and men reflect biological factors as opposed to differences in age.MethodsIn this prospective, multicenter study, 140 age-matched men and women with STEMI undergoing primary PCI with everolimus-eluting stent were investigated with intravascular optical coherence tomography, histopathology-immunohistochemistry of thrombus aspirates, and serum biomarkers. Primary endpoints were the percentages of culprit plaque rupture at baseline and everolimus-eluting stent strut coverage at 9-month follow-up as determined by optical coherence tomography.ResultsMen and women had similar rates of plaque rupture (50.0% vs. 48.4%; risk ratio [RR]: 1.03; 95% confidence interval [CI]: 0.73 to 1.47; p = 0.56). Nonruptured/eroded plaques comprised 25% of all cases (p = 0.86 in men vs. women). There were no sex differences in composition of aspirated thrombus and immune and inflammatory serum biomarkers. At 9 months, women had similar strut coverage (90.9% vs. 92.5%; difference in medians: RR: 0.2%; 95% CI: –0.4% to 1.3%; p = 0.89) and amount of in-stent neointimal obstruction (10.3% vs. 10.6%; p = 0.76) as men did. There were no sex differences in clinical outcome either at 30-day or 1-year follow-up.ConclusionsIn patients presenting with STEMI undergoing primary PCI, no differences in culprit plaque morphology and factors associated with coronary thrombosis were observed between age-matched men and women. Women also showed similar vascular healing response to everolimus-eluting stents as men did. (Optical Coherence Tomography Assessment of Gender Diversity In Primary Angioplasty: The OCTAVIA Trial [OCTAVIA]; NCT01377207)

Background The impact of coronary artery disease (CAD) extension/complexity on outcomes and on the comparative benefits/risks of zotarolimus-eluting stent (ZES) versus bare-metal stents (BMS) remains unclear in patients at high risk of bleeding or thrombosis or at low restenosis risk. Methods We performed a post-hoc analysis of the ZEUS trial. The impact of coronary anatomic complexity measured by the SYNTAX score on the differences in outcomes following ZES and BMS was assessed at 1 year. Results The mean SYNTAX score was 16.3 ± 13.1 with a median of 12 (IQR: 7 to 22). We stratified patients according to SYNTAX tertiles (0–8: n = 563; >8–19 n = 532; >19: n = 511), and observed that the higher the score, the correspondingly higher was the rate of the primary endpoint of major adverse cardiovascular events (MACE) and other ischemic events, but not bleeding after adjustment. The superior efficacy of ZES versus BMS for MACE was consistent across SYNTAX tertiles (tertile 1: HR 0.71, 95% CI 0.44–1.13; tertile 2: HR 0.71, 95% CI 0.46–1.09; tertile 3: HR 0.83, 95% CI 0.61–1.10) without significant heterogeneity (p for trend = 0.55). This between-groups difference mainly reflected a reduction in MI and TVR without effect on mortality. There was no significant interaction between the SYNTAX score and allocated stent type with respect to ischemic and bleeding endpoints. Conclusions The SYNTAX score was predictor of major adverse cardiovascular events but not bleeding and ZES provided superior efficacy and safety than BMS across the whole spectrum of CAD complexity. SYNTAX score may be routinely used for the assessment of the ischemic risk (but not bleeding) after PCI and should not guide the decision-making for DES versus BMS in patients undergoing PCI.

Aims The differential impact on ischaemic and bleeding events of the type of drug-eluting stent [durable polymer stents [DES] vs. biodegradable polymer stents vs. bioresorbable scaffolds (BRS)] and length of dual antiplatelet therapy (DAPT) remains to be defined. Methods and results Randomized controlled trials comparing different types of DES and/or DAPT durations were selected. The primary endpoint was Major Adverse Cardiovascular Events (MACE) [a composite of death, myocardial infarction (MI), and target vessel revascularization]. Definite stent thrombosis (ST) and single components of MACE were secondary endpoints. The arms of interest were: BRS with 12 months of DAPT (12mDAPT), biodegradable polymer stent with 12mDAPT, durable polymer stent [everolimus-eluting (EES), zotarolimus-eluting (ZES)] with 12mDAPT, EES/ZES with 12 months of DAPT (DAPT > 12 m). Sixty-four studies with 150 arms and 102 735 patients were included. After a median follow-up of 20 months, MACE rates were similar in the different arms of interest. EES/ZES with DAPT > 12 m reported a lower incidence of MI than the other groups, while BRS showed a higher rate of ST when compared to EES/ZES, irrespective of DAPT length. A higher risk of major bleedings was observed for DAPT > 12 m as compared to shorter DAPT. Conclusion Durable and biodegradable polymer stents along with BRS report a similar rate of MACE irrespective of DAPT length. Fewer MI are observed with EES/ZES with DAPT > 12 m, while a higher rate of ST is reported for BRS when compared to EES/ZES, independently from DAPT length. Stent type may partially affect the outcome together with DAPT length.

Transradial access (TRA) is often avoided in favor of the transfemoral access (TFA) during percutaneous coronary interventions of the unprotected left main coronary artery (ULM), due to technical and safety concerns. The aim of this study was to compare the performance of TRA and TFA in the treatment of ULM with second-generation drug-eluting stents. Consecutive patients who underwent percutaneous coronary intervention on ULM with second-generation drug-eluting stents were retrospectively enrolled in the multicenter Failure in Left Main Study With 2nd Generation Stents (FAILS 2) registry. Patients were stratified according to the arterial access. The choice between TRA and TFA was left to each operator's preferences. Bleedings during index hospitalization were the primary end point. Secondary end points were major adverse cardiovascular events (a composite of death, reinfarction, and target lesion revascularization), the single components of major adverse cardiovascular events at follow-up and stent thrombosis. Propensity score matching was executed to account for possible confounding. Overall, 1,247 patients were enrolled (23.2% [289] of female gender, mean age 70.2 ± 10.2 years). Diagnosis at presentation was stable angina in 603 (48.7%) cases, non–ST-segment elevation acute coronary syndrome in 465 (37.3%), ST-segment elevation myocardial infarction in 117 (9.5%). Mean follow-up was 726 ± 654 days. After propensity score with matching, 354 patients were included. The primary end point was significantly reduced in patients treated with TRA (2.0% vs 4.0%, p = 0.042), whereas no differences emerged pertaining the secondary end points, including target lesion revascularization and reinfarction. In conclusion, TRA may reduce in-hospital bleedings in patients undergoing percutaneous treatment of the ULM, without increasing the rate of adverse cardiovascular events at follow-up, and may therefore be safely used in the treatment of the ULM.

Incidence, predictors, and impact on prognosis of target lesion revascularization (TLR) for patients treated with second-generation drug-eluting stents (DESs) on unprotected left main (ULM) remain to be defined. The present study is a multicenter study including patients treated with a second-generation DES on ULM from June 2007 to January 2015. Rate of TLR was the primary end point. All cause death, myocardial infarction, target vessel revascularization, and stent thrombosis were the secondary end points. A total of 1,270 patients were enrolled: after a follow-up of 650 days (230 to 1,170), 47 (3.7%) of them underwent a re–percutaneous coronary intervention TLR on the left main, 22 during a planned angiographic follow-up. Extent of coronary artery disease was similar among groups (median value of Syntax of 27 ± 10 vs 26 ± 9, p = 0.45), as localization of the lesion in the ULM. Of patients reporting with TLR on ULM, 56% presented with a focal restenosis, 33% diffuse and 10% proliferative. At multivariate analysis, insulin-dependent diabetes mellitus increased risk of TLR (hazard ratio [HR] 2.0: 1.1 to 3.6, p = 0.04), whereas use of intravascular ultrasound resulted protective (HR 0.5: 0.3 to 0.9, p = 0.02). At follow-up, rates of cardiovascular death did not differ among the 2 groups (4% vs 4%, p = 0.95). At multivariate analysis, TLR on LM did not increase risk of all cause death (HR 0.4: 0.1 to 1.6, p = 0.22), whereas cardiogenic shock and III tertile of Syntax portended a worse prognosis (HR 4.5: 2.1 to 10.2, p = 0.01 and HR 1.4: 1.1 to 1.6, p = 0.03, respectively). In conclusion, repeated revascularization after implantation of second-generation DES on ULM represents an unfrequent event, being increased in insulin-dependent patients and reduced by intravascular ultrasound. Impact on prognosis remains neutral, being related to clinical presentation and extent of coronary artery disease.

Background This study sought to investigate the optimal percutaneous coronary intervention (PCI) strategy for true unprotected left main coronary artery (ULMCA) bifurcations. Methods The FAILS-2 was a retrospective multi-center study including patients with ULMCA disease treated with second-generation drug-eluting stents. Of these, we compared clinical outcomes of a provisional strategy (PS; n=216) versus an elective two-stent strategy (E2S; n=161) for true ULMCA bifurcations. The primary endpoint was the incidence of major adverse cardiac events (MACEs) at 3-years. We further performed propensity-score adjustment for clinical outcomes. Results There were no significant differences between the groups in terms of patient and lesion characteristics. 9.7% of patients in the PS group crossed over to a provisional two-stent strategy. MACEs were not significantly different between groups (MACE at 3-year; PS 28.1% vs. E2S 28.9%, adjusted p=0.99). The rates of target lesion revascularization (TLR) on the circumflex artery (LCX) were numerically high in the E2S group (LCX-TLR at 3-years; PS 11.8% vs. E2S 16.6%, adjusted p=0.51). Conclusions E2S was associated with a comparable MACE rate to PS for true ULMCA bifurcations. The rates of LCX-TLR tended to be higher in the E2S group although there was no statistical significance. Condensed abstract This study sought to compare the clinical outcomes of a provisional strategy (PS) with an elective two-stent strategy (E2S) for the treatment of true unprotected left main coronary artery bifurcations. 377 Patients (PS 216 vs. E2S 161 patients) were evaluated, and 9.7% in the PS group crossed over to a two-stent strategy. E2S was associated with a similar major adverse cardiac event rate at 3-years when compared to the PS strategy (PS 28.1% vs. E2S 28.9%, p=0.99). However, the left circumflex artery TLR rate at 3-year tended to be higher in the E2S group (PS 11.8% vs. E2S 16.6%, p=0.51).

Summary Background The Minimizing Adverse Haemorrhagic Events by Transradial Access Site and Systemic Implementation of Angiox (MATRIX) programme was designed to assess the comparative safety and effectiveness of radial versus femoral access and of bivalirudin versus unfractionated heparin with optional glycoprotein IIb/IIIa inhibitors in patients with the whole spectrum of acute coronary syndrome undergoing invasive management. Here we describe the prespecified final 1-year outcomes of the entire programme. Methods MATRIX was a programme of three nested, randomised, multicentre, open-label, superiority trials in patients with acute coronary syndrome in 78 hospitals in Italy, the Netherlands, Spain, and Sweden. Patients with ST-elevation myocardial infarction were simultaneously randomly assigned (1:1) before coronary angiography to radial or femoral access and to bivalirudin, with or without post-percutaneous coronary intervention infusion or unfractionated heparin (one-step inclusion). Patients with non-ST-elevation acute coronary syndrome were randomly assigned (1:1) before coronary angiography to radial or femoral access and, only if deemed eligible to percutaneous coronary intervention after angiography (two-step inclusion), entered the antithrombin type and treatment duration programmes. Randomisation sequences were computer generated, blocked, and stratified by intended new or current use of P2Y12 inhibitor (clopidogrel vs ticagrelor or prasugrel), and acute coronary syndrome type (ST-elevation myocardial infarction, troponin-positive, or troponin-negative non-ST-elevation acute coronary syndrome). Bivalirudin was given as a bolus of 0·75 mg/kg, followed immediately by an infusion of 1·75 mg/kg per h until completion of percutaneous coronary intervention. Heparin was given at 70–100 units per kg in patients not receiving glycoprotein IIb/IIIa inhibitors, and at 50–70 units per kg in patients receiving glycoprotein IIb/IIIa inhibitors. Clinical follow-up was done at 30 days and 1 year. Co-primary outcomes for MATRIX access and MATRIX antithrombin type were major adverse cardiovascular events, defined as the composite of all-cause mortality, myocardial infarction, or stroke up to 30 days; and net adverse clinical events, defined as the composite of non-coronary artery bypass graft-related major bleeding, or major adverse cardiovascular events up to 30 days. The primary outcome for MATRIX treatment duration was the composite of urgent target vessel revascularisation, definite stent thrombosis, or net adverse clinical events up to 30 days. Analyses were done according to the intention-to-treat principle. This trial is registered with ClinicalTrials.gov, number NCT01433627. Findings Between Oct 11, 2011, and Nov 7, 2014, we randomly assigned 8404 patients to receive radial (4197 patients) or femoral (4207 patients) access. Of these 8404 patients, 7213 were included in the MATRIX antithrombin type study and were randomly assigned to bivalirudin (3610 patients) or heparin (3603 patients). Patients assigned to bivalirudin were included in the MATRIX treatment duration study, and were randomly assigned to post-procedure infusion (1799 patients) or no post-procedure infusion (1811 patients). At 1 year, major adverse cardiovascular events did not differ between patients assigned to radial access compared with those assigned to femoral access (14·2% vs 15·7%; rate ratio 0·89, 95% CI 0·80–1·00; p=0·0526), but net adverse clinical events were fewer with radial than with femoral access (15·2% vs 17·2%; 0·87, 0·78–0·97; p=0·0128). Compared with heparin, bivalirudin was not associated with fewer major adverse cardiovascular (15·8% vs 16·8%; 0·94, 0·83–1·05; p=0·28) or net adverse clinical events (17·0% vs 18·4%; 0·91, 0·81–1·02; p=0·10). The composite of urgent target vessel revascularisation, stent thrombosis, or net adverse clinical events did not differ with or without post-procedure bivalirudin infusion (17·4% vs 17·4%; 0·99, 0·84–1·16; p=0·90). Interpretation In patients with acute coronary syndrome, radial access was associated with lower rates of net adverse clinical events compared with femoral access, but not major adverse cardiovascular events at 1 year. Bivalirudin with or without post-procedure infusion was not associated with lower rates of major adverse cardiovascular events or net adverse clinical events. Radial access should become the default approach in acute coronary syndrome patients undergoing invasive management. Funding Italian Society of Invasive Cardiology, The Medicines Company, Terumo, amd Canada Research Chairs Programme.

Heavily calcified unprotected left main (ULM) disease continues to be a challenging situation and represent a high-risk subset for interventional cardiologist. To date, there are limited data investigating the results after rotational atherectomy (RA) in this setting. The aim of this study was to investigate the in-hospital and 1-year outcomes after RA of heavily calcified ULM lesions. A retrospective cohort analysis was performed on all calcified patients with ULM (n = 86) enrolled in the multicenter international ROTATE registry (overall patients, n = 962). End points of the study were the in-hospital and 1-year incidence of major adverse cardiovascular events (MACE): a composite of death, myocardial infarction, and target-vessel revascularization in the ULM versus non-ULM group. Patients in the ULM group were older (p = 0.01) and more frequently with diabetes (p = 0.001) compared with the non-ULM group, whereas intravascular ultrasound guidance was higher, even if not systematic, in the ULM group (p

Intravascular ultrasound has been used for >20 years to guide percutaneous coronary intervention in different subsets of coronary lesions. During the last decade, the interest in percutaneous coronary intervention for chronic total occlusion (CTO) has increased dramatically, leading to high success rates. Failure of guidewire crossing is the most common reason for failed CTO attempts. Certain angiographic features, such as blunt proximal CTO cap, tortuosity, heavy calcification, and lack of visibility of path in the distal vessel, increase procedural difficulty. A better understanding of the behavior of the guidewire within the CTO segment may represent a key issue to achieve successful outcome. In this respect, intravascular ultrasound imaging might have potential roles in the recanalization of CTOs. In this paper, we focused on the usefulness and the applications of intravascular ultrasound imaging in percutaneous CTO recanalization, underlying its impact on clinical outcome. (J Am Coll Cardiol Intv 2016;9:1979–91) © 2016 by the American College of Cardiology Foundation