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Introduction: The potential benefit on long term outcomes of Percutaneous Coronary Intervention (PCI) on Unprotected Left Main (ULM) driven by IntraVascular UltraSound (IVUS) remains to be defined., Methods: IMPACTUS LM-PCI is an observational, multicenter study that enrolled consecutive patients with ULM disease undergoing coronary angioplasty in 13 European high-volume centers from January 2002 to December 2015. Major Adverse Cardiovascular Events (MACEs) a composite of cardiovascular (CV) death, target vessel revascularization (TVR) and myocardial infarction (MI) were the primary endpoints, while its single components along with all cause death the secondary ones., Results: 627 patients with ULM disease were enrolled, 213 patients (34%) underwent IVUS-guided PCI while 414 (66%) angioguided PCI. Patients in the two cohorts had similar prevalence of risk factors except for active smoking and clinical presentation. During a median follow-up of 7.5 years, 47 (22%) patients in the IVUS group and 211 (51%) in the angio-guided group underwent the primary endpoint (HR 0.42; 95% CI [0.31-0.58] p < 0.001). After multivariate adjustment, IVUS was significantly associated with a reduced incidence of the primary endpoint (adj HR 0.39; 95% CI [0.23-0.64], p < 0.001), mainly driven by a reduction of TVR (ad HR 0.30, 95% CI [0.15-0.62], p = 0.001) and of all-cause death (adj HR 0.47, 95% CI [0.28-0.82], p = 0.008). IVUS use, age, diabetes, side branch stenosis, DES and creatinine at admission were independent predictors of MACE., Conclusions: In patients undergoing ULM PCI, the use of IVUS was associated with a reduced risk at long-term follow-up of MACE, all-cause death and subsequent revascularization., Competing Interests: Declaration of competing interest None., (Copyright © 2024. Published by Elsevier B.V.)

There is a paucity of data regarding the safety of a 1-month dual antiplatelet therapy (DAPT) after percutaneous coronary intervention (PCI) in patients at high bleeding risk (HBR) presenting with acute coronary syndromes (ACS). We aimed to compare the clinical outcomes of patients at HBR with chronic coronary syndrome (CCS) or ACS treated with PCI using bioresorbable polymer everolimus-eluting stent (BP-EES) followed by 1-month DAPT. Patients at HBR who underwent PCI with BP-EES were prospectively enrolled in 10 Italian centers. All patients were treated with 1-month DAPT. In case of need for anticoagulation, patients received an oral anticoagulant in addition to a P2Y12 inhibitor for 1 month, followed by oral anticoagulation only after that. The primary end point was a composite of cardiac death, myocardial infarction, or definite/probable stent thrombosis at 12 months. Overall, 263 patients (59.4%) with CCS and 180 patients (40.6%) with ACS were enrolled. No significant difference was evident between patients with CCS and ACS for the primary end point (4.3% vs 5.6%, respectively, p = 0.497) and for each isolated component. The risk for Bleeding Academic Research Consortium (BARC) type 1 to 5 or type 3 to 5 bleedings was also similar between patients with CCS and ACS (4.3% vs 5.2%, p = 0.677, and 1.6% vs 2.9%, p = 0.351, respectively). In conclusion, among HBR patients with ACS who underwent PCI with BP-EES, a 1-month DAPT strategy is associated with a similar risk of ischemic and bleeding events compared with those with CCS., Competing Interests: Declaration of Competing Interest Dr. Testa has received consulting fees, personal and institutional honoraria, and has served on the advisory board participation from Abbott, Medtronic, Biotronik, Boston Scientific Corporation, Terumo Lifesciences, Meril, Cardionovum, Concept Medical. Dr. Piccolo has received speaker fees from Abbott Vascular and Biotronik and has served on the advisory board for Daiichi-Sankyo. Dr. De Luca has received speaker fees from AstraZeneca, Daiichi-Sankyo and Sanofi. Dr. Stefanini has received speaker fees from Abbott Vascular, Boston Scientific, and Pfizer (New York, NY, United States)/BMS. The remaining authors have no competing interests to declare., (Copyright © 2023 Elsevier Inc. All rights reserved.)

Background: Data about the long-term performance of new-generation ultrathin-strut drug-eluting stents (DES) in challenging coronary lesions, such as left main (LM), bifurcation, and chronic total occlusion (CTO) lesions are scant., Methods: The international multicenter retrospective observational ULTRA study included consecutive patients treated from September 2016 to August 2021 with ultrathin-strut (<70 µm) DES in challenging de novo lesions. Primary endpoint was target lesion failure (TLF): composite of cardiac death, target-lesion revascularization (TLR), target-vessel myocardial infarction (TVMI), or definite stent thrombosis (ST). Secondary endpoints included all-cause death, acute myocardial infarction (AMI), target vessel revascularization, and TLF components. TLF predictors were assessed with Cox multivariable analysis., Results: Of 1801 patients (age: 66.6 ± 11.2 years; male: 1410 [78.3%]), 170 (9.4%) experienced TLF during follow-up of 3.1 ± 1.4 years. In patients with LM, CTO, and bifurcation lesions, TLF rates were 13.5%, 9.9%, and 8.9%, respectively. Overall, 160 (8.9%) patients died (74 [4.1%] from cardiac causes). AMI and TVMI rates were 6.0% and 3.2%, respectively. ST occurred in 11 (1.1%) patients while 77 (4.3%) underwent TLR. Multivariable analysis identified the following predictors of TLF: age, STEMI with cardiogenic shock, impaired left ventricular ejection fraction, diabetes, and renal dysfunction. Among the procedural variables, total stent length increased TLF risk (HR: 1.01, 95% CI: 1-1.02 per mm increase), while intracoronary imaging reduced the risk substantially (HR: 0.35, 95% CI: 0.12-0.82)., Conclusions: Ultrathin-strut DES showed high efficacy and satisfactory safety, even in patients with challenging coronary lesions. Yet, despite using contemporary gold-standard DES, the association persisted between established patient- and procedure-related features of risk and impaired 3-year clinical outcome., (© 2023 Wiley Periodicals LLC.)

Background: In patients with ST-segment elevation myocardial infarction (STEMI), percutaneous coronary intervention (PCI) of the culprit lesion significantly reduces the risk of cardiovascular death. However, the management of non-culprit lesions in patients with the multivessel disease remains a matter of debate in this setting. It's still unclear if a morphological OCT-guided approach, identifying coronary plaque instability, may provide a more specific treatment compared with a standard angiographic/functional approach., Methods: OCT-Contact is a prospective, multicenter, open-label, non-inferiority randomized controlled trial. Patients with STEMI with successful primary PCI of the culprit lesion will be enrolled after the index PCI. Patients will be deemed eligible if a critical coronary lesion other than the culprit (associated with a diameter of stenosis ≥50%) will be identified during the index angiography. Patients will be randomized in a 1:1 fashion to OCT-guided PCI of non-culprit lesions (Group A) vs. complete PCI (Group B). PCI in group A will be undertaken according to criteria of plaque vulnerability, while in group B the use of fractional flow reserve will be left at the operators' discretion. Major-adverse cardiovascular events (MACE) are a composite of all-cause mortality, non-fatal myocardial infarction (MI) (excluding peri-procedural MI), unplanned revascularization, and NYHA IV heart failure) will be the primary efficacy outcome. Single components of MACE along with cardiovascular mortality will be the secondary endpoints. . Safety endpoints will embrace worsening of renal failure, procedural complications, and bleedings. Patients will be followed for 24 months after randomization., Results: A sample size of 406 patients (203 per group) is required to provide the analysis an 80% power to detect a non-inferiority in the primary endpoint with an alpha error set at 0.05 and a non-inferiority limit of 4%., Conclusions: A morphological OCT-guided approach may be a more specific treatment compared with the standard angiographic/functional approach in non-culprit lesions of STEMI patients.

Background: Comparative data after percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG) for unprotected left main coronary artery (ULMCA) disease according to lesion site (ostial/shaft vs distal) are scant. The aim of this meta-analysis was to investigate outcomes after PCI or CABG for ULMCA disease according to lesion site., Methods: Randomized controlled trials (RCTs) and adjusted observational studies that compared PCI versus CABG in patients with ULMCA disease and reported outcomes according to lesion site were systematically identified. Major adverse cardiovascular events (MACE; a composite of all-cause death, myocardial infarction, stroke, and repeat revascularization) and all-cause death were the co-primary end points. Individual components of MACE were secondary end points. Sensitivity analysis including RCTs only were performed for each outcome., Results: Nine studies (3 RCTs, 6 adjusted observational), encompassing 6296 patients (2274 and 4022 treated for ostial/shaft or distal ULMCA, respectively) were included. At the 5-year follow-up, there were no significant differences between CABG and PCI for MACE, death, or any other secondary outcome for ostial/shaft ULMCA lesions (MACE: hazard ratio [HR], 1.0 [95% confidence interval (CI), 0.79-1.27]; death: HR, 1.10 [95% CI, 0.84-1.46]). For distal ULMCA, PCI was associated with an increased risk of MACE (HR, 1.32; 95% CI, 1.10-1.58), death (HR, 1.56; 95% CI, 1.19-2.04), and revascularization (HR, 2.07; 95% CI, 1.5-2.84). The benefit of CABG for MACE and revascularization was confirmed in the analysis limited to RCTs, whereas the benefit for mortality was not., Conclusions: Among patients with distal ULMCA disease, CABG is associated with lower incidence of MACE and revascularization compared with PCI, whereas no differences in outcomes were observed for ostial/shaft ULMCA disease., (Copyright © 2021 The American Association for Thoracic Surgery. Published by Elsevier Inc. All rights reserved.)

The association of left ventricular ejection fraction (LVEF) with procedural and long-term outcomes after state-of-the-art percutaneous coronary intervention (PCI) of bifurcation lesions remains unsettled. A total of 5,333 patients who underwent contemporary coronary bifurcation PCI were included in the intercontinental retrospective combined insights from the unified RAIN (veRy thin stents for patients with left mAIn or bifurcatioN in real life) and COBIS (COronary BIfurcation Stenting) III bifurcation registries. Of 5,003 patients (93.8%) with known baseline LVEF, 244 (4.9%) had LVEF <40% (bifurcation with reduced ejection fraction [BIFrEF] group), 430 (8.6%) had LVEF 40% to 49% (bifurcation with mildly reduced ejection fraction [BIFmEF] group) and 4,329 (86.5%) had ejection fraction (EF) ≥50% (bifurcation with preserved ejection fraction [BIFpEF] group). The primary end point was the Kaplan-Meier estimate of major adverse cardiac events (MACEs) (a composite of all-cause death, myocardial infarction, and target vessel revascularization). Patients with BIFrEF had a more complex clinical profile and coronary anatomy. No difference in procedural (30 days) MACE was observed across EF categories, also after adjustment for in-study outcome predictors (BIFrEF vs BIFmEF: adjusted hazard ratio [adj-HR] 1.39, 95% confidence interval [CI] 0.37 to 5.21, p = 0.626; BIFrEF vs BIFpEF: adj-HR 1.11, 95% CI 0.25 to 2.87, p = 0.883; BIFmEF vs BIFpEF: adj-HR 0.81, 95% CI 0.29 to 2.27, p = 0.683). BIFrEF was independently associated with long-term MACE (median follow-up 21 months, interquartile range 10 to 21 months) than both BIFmEF (adj-HR 2.20, 95% CI 1.41 to 3.41, p <0.001) and BIFpEF (adj-HR 1.91, 95% CI 1.41 to 2.60, p <0.001) groups, although no difference was observed between BIFmEF and BIFpEF groups (adj-HR 0.87, 95% CI 0.61 to 1.24, p = 0.449). In conclusion, in patients who underwent PCI of a coronary bifurcation lesion according to contemporary clinical practice, reduced LVEF (<40%), although a strong predictor of long-term MACEs, does not affect procedural outcomes., (Copyright © 2022 Elsevier Inc. All rights reserved.)

Background: The safety and efficacy of potent P2Y12 inhibitors (Ticagrelor and Prasugrel) in dual antiplatelet therapy (DAPT) with aspirin in elderly acute coronary syndrome (ACS) patients remains unclear., Methods: All ACS patients aged 75 years and older treated with Percutaneous Coronary Intervention (PCI) from PRAISE dataset were included. The safety and efficacy of Ticagrelor vs Clopidogrel was evaluated with inverse probability of treatment weighting (IPTW). Sensitivity analysis was performed for patients older or equal than 85 years old. All-cause mortality was the primary endpoint, while myocardial infarction (MI), Bleeding Academic Research Consortium (BARC) 3-5 bleedings and Major and Net Adverse Clinical and Cardiac Events (MACE and NACE) were the secondary ones., Results: 4287 patients were included, 3197 treated with Clopidogrel and 1090 with Ticagrelor. After 16 ± 3 months, Ticagrelor showed neutral effect on NACE and mortality (HR 0.98; 0.63-1.52, p = 0.94 and HR 0.38; 0.14-1.04, p = 0,06), reduced risk of MACE and MI (HR 0.82; 0.23-0.91, p = 0.03 and HR 0.43; 0.14-0.89, p = 0.04) and increased risk of BARC 3-5 bleeding (HR 2.14; 1.19-3.85, p = 0.001). In very elderly patients (≥85 years) Ticagrelor decreased risk of MI and increased risk of bleeding (HR 0.69; 0.22-0.95, p = 0.04 and HR 2.36; 1.02-5.52, p = 0.04, all 95%CI) with neutral effect on NACE and MACE., Conclusions: In elderly ACS patients treated with PCI, Ticagrelor was associated with neutral effect on all-cause mortality, lower risk MACE and MI compared with Clopidogrel. Such benefit was counterbalanced by increased risk of major bleedings. These results were consistent among patients aged 85 years and older., (Copyright © 2022 Elsevier B.V. All rights reserved.)

Background It is unknown whether contemporary drug-eluting stents have a similar safety profile in high bleeding risk patients treated with 1-month dual antiplatelet therapy following percutaneous coronary interventions. Methods and Results We performed an interventional, prospective, multicenter, single-arm trial, powered for noninferiority with respect to an objective performance criterion to evaluate the safety of percutaneous coronary interventions with Synergy bioresorbable-polymer everolimus-eluting stent followed by 1-month dual antiplatelet therapy in patients with high bleeding risk. In case of need for an oral anticoagulant, patients received an oral anticoagulant in addition to a P2Y 12 inhibitor for 1 month, followed by an oral anticoagulant only. The primary end point was the composite of cardiac death, myocardial infarction, or definite or probable stent thrombosis at 1-year follow-up. The study was prematurely interrupted because of slow recruitment. From April 2017 to October 2019, 443 patients (age, 74.8±9.2 years; women, 29.1%) at 10 Italian centers were included. The 1-year primary outcome occurred in 4.82% (95% CI, 3.17%-7.31%) of patients, meeting the noninferiority compared with the predefined objective performance criterion of 9.4% and the noninferiority margin of 3.85% ( P noninferiority <0.001) notwithstanding the lower-than-expected sample size. The rates of cardiac death, myocardial infarction, and definite or probable stent thrombosis were 1.88% (95% CI, 0.36%-2.50%), 3.42% (95% CI, 2.08%-5.62%), and 0.94% (95% CI, 0.35%-2.49%), respectively. Conclusions Among high bleeding risk patients undergoing percutaneous coronary interventions with the Synergy bioresorbable-polymer everolimus-eluting stent, a 1-month dual antiplatelet therapy regimen is safe, with low rates of ischemic and bleeding events. Registration URL: https://www.clinicaltrials.gov; Unique identifier: NCT03112707.

Objective: Aim of this study is to evaluate short term safety and efficacy of Impella in high risk percutaneous coronary intervention (HR-PCI) population., Background: While several studies demonstrated the clinical significance of Impella in HR-PCI, few data exist about its impact on short term outcome., Methods: All studies reporting short term outcomes of PCI with any Impella device were included. The primary endpoint was either in-hospital or 30-day mortality, while vascular complications, post-procedural stroke, post-procedural dialysis and bleeding complications were assessed as secondary outcomes., Results: Nine studies with 7448 patients were included. Median age was 69.5 years old (67-73), with a mean ejection fraction of 29.7% (20%-39%) and a Syntax score of 30.2 (25. 5-33, interquartile [IQR]). Impella 2.5 was the most commonly used axial flow pump used to support these PCIs (88.7%). In-hospital death was observed in 5.09% of patients (95% confidence interval [CI] 3.69-6.49, I 2  = 78%), while vascular complications in 2.53% of patients (1.07-4.00, I 2  = 89%) and post-procedural stroke in 2.77% of patients (0.50-6.05, I 2  = 98%). Major bleeding occurred in 5.98% of patients (3.66-8.31, I 2  = 90%) and post-procedural dialysis in 4.44% of patients (1.50-7.37, I 2  = 93% all CI 93%)., Conclusion: Use of Impella in high risk PCI appears to have an acceptable rate of complication, especially regarding vascular complications and major bleedings., (© 2021 Wiley Periodicals LLC.)

Long term survival and its determinants after Percutaneous Coronary Intervention (PCI) on Unprotected Left Main Coronary Artery (ULMCA) remain to be appraised. In 9 European Centers 470 consecutive patients performing PCI on ULMCA between 2002 and 2005 were retrospectively enrolled. Survival from all cause and cardiovascular (CV) death were the primary end points, while their predictors at multivariate analysis the secondary ones. Among the overall cohort 81.5% of patients were male and mean age was 66 ± 12 years. After 15 years (IQR 13 to 16), 223 patients (47%) died, 81 (17.2%) due to CV etiology. At multivariable analysis, older age (HR 1.06, 95%CI 1.02 to 1.11), LVEF < 35% (HR 2.97, 95%CI 1.24 to 7.15) and number of vessels treated during the index PCI (HR 1.75, 95%CI 1.12 to 2.72) were related to all-cause mortality, while only LVEF <35% (HR 4.71, 95%CI 1.90 to 11.66) to CV death. Repeated PCI on ULMCA occurred in 91 (28%) patients during the course of follow up and did not significantly impact on freedom from all-cause or CV mortality. In conclusion, in a large, unselected population treated with PCI on ULMCA, 47% died after 15 years, 17% due to CV causes. Age, number of vessels treated during index PCI and depressed LVEF increased risk of all cause death, while re-PCI on ULMCA did not impact survival., (Copyright © 2021 Elsevier Inc. All rights reserved.)

Optimal dual antiplatelet therapy (DAPT) duration for patients undergoing percutaneous coronary intervention (PCI) for coronary bifurcations is an unmet issue. The BIFURCAT registry was obtained by merging two registries on coronary bifurcations. Three groups were compared in a two-by-two fashion: short-term DAPT (≤ 6 months), intermediate-term DAPT (6-12 months) and extended DAPT (>12 months). Major adverse cardiac events (MACE) (a composite of all-cause death, myocardial infarction (MI), target-lesion revascularization and stent thrombosis) were the primary endpoint. Single components of MACE were the secondary endpoints. Events were appraised according to the clinical presentation: chronic coronary syndrome (CCS) versus acute coronary syndrome (ACS). 5537 patients (3231 ACS, 2306 CCS) were included. After a median follow-up of 2.1 years (IQR 0.9-2.2), extended DAPT was associated with a lower incidence of MACE compared with intermediate-term DAPT (2.8% versus 3.4%, adjusted HR 0.23 [0.1-0.54], p <0.001), driven by a reduction of all-cause death in the ACS cohort. In the CCS cohort, an extended DAPT strategy was not associated with a reduced risk of MACE. In conclusion, among real-world patients receiving PCI for coronary bifurcation, an extended DAPT strategy was associated with a reduction of MACE in ACS but not in CCS patients., (Copyright © 2021 Elsevier Inc. All rights reserved.)

Background: Clinical benefits of FFR (Fraction Flow Reserve) driven CABG (Coronary Artery Bypass Graft) remain to be established., Methods: All randomized controlled trials (RCTs) and observational studies with multivariable adjustement were included. MACE (Major Adverse Cardiac Events) was the primary end point, while its single components (death, myocardial infarction, and total vessel revascularization [TVR]) along with number of anastomoses, on pump procedures and graft occlusion at angiographic follow-up were the secondary ones. Each analysis was stratified for RCTs versus observational studies., Results: Four studies (two RCTs and two observational) were included, enrolling 983 patients, 542 angio-guided and 441 FFR-guided. Mean age was 68.45 years, 79% male, with a mean EuroSCORE I of 2.7. Coronary lesions were located in 37% of patients in the left anterior descending artery, 32% in the circumflex artery, and 26% in the right coronary artery. After a mean follow-up of 40 months, risk of MACE did not differ (OR 0.86 [0.63-1.18]) as that of all cause death (OR 0.86 [0.59-1.25]), MI (OR 0.57 [0.30-1.11]) and TVR (OR 1.10 [0.65-1.85]). FFR-driven CABG reduced on-pump procedures (OR 0.58 [0.35-0.93]) and number of anastomoses (-0.40 [-0.80: -0.01]) while incidence of graft occlusion at follow-up did not differ (OR 0.59 [0.30-1.15], all CI 95%)., Conclusion: Fraction flow reserve driven CABG reduced the number of anastomoses and of on-pump procedures without increasing risk of MACE and without reducing graft occlusion at angiographic follow-up. ID CRD42020211945., (© 2020 Wiley Periodicals LLC.)

Objective: Outcomes of complex percutaneous coronary interventions (PCIs) in older patients are still debated. The aim of the study was to evaluate clinical outcomes of Octogenarian patients treated with ultrathinstents on left main or on coronary bifurcations, compared with younger patients., Methods: All consecutive patients presenting a critical lesion of an unprotected left main (ULM) or a bifurcation and treated with very thin stents were included in the RAIN (veRy thin stents for patients with left mAIn or bifurcatioN in real life) registry and divided into octogenarians group (OG, 551 patients) and nonoctogenarians (NOGs, 2,453 patients). Major adverse cardiovascular event (MACE), a composite end point of all-cause death, nonfatal myocardial infarction (MI), target lesion revascularization (TLR), and stent thrombosis (ST), was the primary endpoint, while MACE components, cardiovascular (CV) death, and target vessel revascularization (TVR) were the secondary ones., Results: Indication for PCI was acute coronary syndrome in 64.7% of the OG versus 53.1% of the NOG. Severe calcifications and a diffuse disease were significantly more in OG. After a follow-up of 15.2 ± 10.3 months, MACEs were higher in the OG than in the NOG patients (OG 19.1% vs. NOG 11.2%, p < .001), along with MI (OG 6% vs. NOG 3.4%, p = .002) and all-cause death (OG 14% vs. NOG 4.3%, p < .001). In contrast, no significant difference was detected in CV-death (OG 5.1% vs. NOG 4%, p = .871), TVR/TLR, or ST. At multivariate analysis, age was not an independent predictor of MACE (OR 1.02 CI 95% 0.76-1.38), while it was for all-cause death, along with diabetes, GFR < 60 ml/min, and ULM disease., Discussion: Midterm outcomes of complex PCI in OG are similar to those of younger patients. However, due to the higher non-CV death rate, accurate patient selection is mandatory., (© 2020 Wiley Periodicals LLC.)

Background: The optimal antithrombotic regimen in patients with a concomitant indication for oral anticoagulation (OAT) presenting with acute coronary syndrome (ACS) or undergoing percutaneous coronary intervention (PCI) remains unclear., Objectives: To perform a network meta-analysis of all randomized controlled trials (RCTs) evaluating different antithrombotic regimens among patients with ACS or undergoing PCI requiring OAT., Methods: Network meta-analysis was performed in a frequentist framework. Antithrombotic regimens were categorized by OAC type (vitamin K antagonist-based [VKA]; non-VKA OAT [NOAC]) and antiplatelet agents (P2Y inhibitor only: dual therapy [DAT]; P2Y plus aspirin: triple therapy [TAT]). Safety outcomes were Thrombolysis in Myocardial Infarction (TIMI) major bleeding and intracranial hemorrhage (ICH). Efficacy outcomes were cardiovascular death, myocardial infarction, stroke and stent-thrombosis (ST)., Results: Five RCTs were included, encompassing 10,797 patients (atrial fibrillation 69-100%, ACS 28-62%, PCI 77-100%). Both VKA and NOAC-based DAT regimens reduced the occurrence of TIMI major bleeding compared to VKA TAT (VKA DAT: RR 0.62, 95% CI 0.39-0.98; NOAC DAT: RR 0.52, 95% CI 0.39-0.70). Nevertheless, only NOAC DAT significantly reduced the occurrence of ICH compared to VKA TAT (RR 0.33, 95% CI 0.17-0.64). Ischemic outcomes were similar among the four treatment regimens. However, numerical, potentially clinically important, higher ST occurrence was observed for NOAC DAT as compared to both VKA TAT (1.50, 95% confidence interval [CI] 0.96-2.33) and NOAC TAT (1.86, 95% CI 0.93-3.73)., Conclusion: DAT regimens present the highest safety profile among antithrombotic strategies, with a NOAC-specific impact on ICH reduction. NOAC DAT might entail clinically important higher ST occurrence, warranting a case-by-case comprehensive evaluation that integrates patient- and procedure-related residual ischemic risk with the patient-specific bleeding risk., (© 2020 Wiley Periodicals LLC.)

Background: The PARIS risk score (PARIS-rs) and percutaneous coronary intervention complexity (PCI-c) predict clinical and procedural residual ischemic risk following PCI. Their accuracy in patients undergoing unprotected left main (ULM) or bifurcation PCI has not been assessed., Methods: The predictive performances of the PARIS-rs (categorized as low, intermediate, and high) and PCI-c (according to guideline-endorsed criteria) were evaluated in 3,002 patients undergoing ULM/bifurcation PCI with very thin strut stents., Results: After 16 (12-22) months, increasing PARIS-rs (8.8% vs. 14.1% vs. 27.4%, p < .001) and PCI-c (15.2% vs. 11%, p = .025) were associated with higher rates of major adverse cardiac events ([MACE], a composite of death, myocardial infarction [MI], and target vessel revascularization), driven by MI/death for PARIS-rs and target lesion revascularization/stent thrombosis for PCI-c (area under the curves for MACE: PARIS-rs 0.60 vs. PCI-c 0.52, p-for-difference < .001). PCI-c accuracy for MACE was higher in low-clinical-risk patients; while PARIS-rs was more accurate in low-procedural-risk patients. ≥12-month dual antiplatelet therapy (DAPT) was associated with a lower MACE rate in high PARIS-rs patients, (adjusted-hazard ratio 0.42 [95% CI: 0.22-0.83], p = .012), with no benefit in low to intermediate PARIS-rs patients. No incremental benefit with longer DAPT was observed in complex PCI., Conclusions: In the setting of ULM/bifurcation PCI, the residual ischemic risk is better predicted by a clinical risk estimator than by PCI complexity, which rather appears to reflect stent/procedure-related events. Careful procedural risk estimation is warranted in patients at low clinical risk, where PCI complexity may substantially contribute to the overall residual ischemic risk., (© 2020 Wiley Periodicals, Inc.)

Background: COronaVIrus Disease 19 (COVID-19) led to the reorganization of Cardiology Units in terms of working spaces and healthcare personnel. In this scenario, both outpatient visits and elective interventional cardiology procedures were suspended and/or postponed. We aimed to report the impact of COVID-19 on interventional coronary and structural procedures in Piedmont, Italy., Methods: The number of coronary angiographies (CAG), percutaneous coronary interventions (PCI), primary PCI (pPCI), transcatheter aortic valve replacements (TAVR) and Mitraclip performed in Piedmont between March 1st and April 20th, 2020 (CoV-time) were collected from each catheterization laboratory and compared to the number of procedures performed the year before in the same months (NoCoV-time)., Results: Procedural data from 18 catheterization laboratories were collected. Both coronary (5498 versus 2888: difference: -47.5%; mean 305.4 VS 160.4; p = 0.002) and structural (84 versus 17: difference: -79.8%; mean 4.7 Vs 0.9; p < 0.001) procedures decreased during CoV-time compared to NoCoV-time. In particular, coronary angiographies (1782 versus 3460), PCI (1074 versus 1983), p PCI (271 versus 410), TAVR (11 versus 72) and Mitraclip (6 versus 12) showed a reduction of 48.5%, 45.7%, 33.7%, 84.7% and 50.0%, respectively (all p for comparison <0.05)., Conclusions: Compared to the same time-period in 2019, both coronary and structural interventional procedures during COVID-19 epidemic suffered a dramatic decrease in Piedmont, Italy. Organizational change and structured clinical pathways should be created, together with awareness campaigns., Competing Interests: Declaration of Competing interest None., (Copyright © 2020 Elsevier B.V. All rights reserved.)

Background: A large trial established the favorable profile of a new polymer-free biolimus A9-eluting stent (PF-BES) with a 1-month dual antiplatelet therapy (DAPT) in high bleeding risk (HBR) patients. This is the first study comparing outcomes for a 1-month versus longer DAPT strategies following PF-BES-percutaneous coronary intervention (PCI)., Methods: All patients undergoing PF-BES-PCI (January 2016 to July 2018) were included in the multicenter CHANCE registry. Patients were stratified according to DAPT strategy at discharge (planned 1-month vs. planned >1-month). Primary outcomes were the 390-day estimates of a patient-oriented and of a device-oriented composite endpoints (POCE: death, myocardial infarction [MI] or target vessel revascularization; DOCE: cardiac death, target vessel-MI or ischemia-driven target lesion revascularization). Landmark analyses from 1-month post-PCI were carried., Results: Following PF-BES-PCI, 328(40.3%) and 485(59.6%) patients were discharged with 1-month and longer DAPT (12 months [6-12]), respectively. Patients with a previous or index MI were less likely to be discharged on 1-month DAPT. Patients prescribed with 1-month DAPT were more likely to be at HBR than those with longer DAPT (90.2% vs. 69.9%, p = .001). No between-groups differences in the primary outcomes (planned 1-month vs. planned >1-month DAPT: POCE 11.9% vs. 13.2%, p = .747; DOCE: 4.8% vs. 8.1%, p = .500) were observed, also after adjusting for confoundings (POCE: adjusted-hazard ratio [adj-HR] 1.26, 95%CI 0.74-2.13; DOCE: adj-HR 1.00, 95%CI 0.49-1.99). Landmark analyses showed similar results., Conclusions: In a large all-comers registry of PF-BES PCI, no interaction of planned DAPT strategy (1-month vs. >1-month) with outcomes was found. This observation warrants investigation in adequately powered randomized studies (ClinicalTrials.gov NCT03622203)., (© 2020 Wiley Periodicals, Inc.)

Aims: To establish the value of the SYNTAX Score-II (SS-II) in predicting long-term mortality of patients treated with left main PCI (LM-PCI) using second-generation drug-eluting stents (DES)., Methods and Results: The SYNTAX score (SS) and the SS-II were calculated in 804 patients included in the FAILS-2 registry (failure in left main study with 2nd generation stents). Patients were classified in low (SS-II ≤33; n = 278, 34.6%), intermediate (SS-II 34-43; n = 260, 32.3%) and high (SS-II ≥44; n = 266, 33.1%) SS-II tertiles. Primary endpoint was all-cause mortality. A significant difference in long-term mortality was noted (5.2 ± 3.6 years): 4.1, 7.5, and 16.7% in low, mid and high SS-II tertiles respectively (p < .001). SS-II score was more accurate in predicting mortality than SS (AUC = 0.73; 95%CI: 0.67-0.79 vs. AUC = 0.55; 95%CI: 0.48-0.63, respectively; p < .001). SS-II led to a reclassification in the risk of all-cause mortality re-allocating 73% of patients from the CABG-only indication to PCI or equipoise PCI-or-CABG indication. Using multiple Cox regression analysis, SS-II (HR: 1.07; 95%CI: 1.05-1.09; p < .001), along with Acute coronary syndrome (ACS) (HR: 1.66; 95%CI: 1.03-2.66; p = .07) and Cardiogenic shock (CS) (HR: 2.82 (95%CI: 1.41-5.64; p = .003) were independent predictors of long-term mortality. SS-II (HR: 1.05; 95%CI: 1.04-1.06; p < .001) along with Insulin dependent Type 2 DM (HR: 1.58, 95%CI: 1.09-2.30.; p < .05), ACS (HR: 1.58, 95%CI: 1.16-2.14; p < .001) and CS (HR: 2.02 95%CI 1.16-3.53; p < .05), were independent predictors of long-term MACE., Conclusion: The SS-II was superior to the SS in predicting outcomes associated with contemporary LM-PCI. In this real-world population, two clinical variables not included in the SS-II, ACS and T2DM, were identified as additional markers of poor outcome., (© 2019 Wiley Periodicals, Inc.)

Objectives: To evaluate the independent clinical impact of stent structural features in a large cohort of patients undergoing unprotected left main (ULM) or coronary bifurcation percutaneous coronary intervention (PCI) with a range of very thin strut stents., Background: Clinical impact of structural features of contemporary stents remains to be defined., Methods: All consecutive patients enrolled in the veRy thin stents for patients with left mAIn or bifurcatioN in real life (RAIN) registry were included. The following stent structural features were studied: antiproliferative drugs (everolimus vs. sirolimus vs. zotarolimus), strut material (platinum-chromium vs. cobalt-chromium), polymer (bioresorbable vs. durable), number of crowns (<8 vs. ≥8) and number of connectors (<3 vs. ≥3). For small diameter stents (≤2.5 mm), struct thickness (74 vs. 80/81 μm) was also tested. Target lesion failure (TLF), a composite of target lesion revascularization and stent thrombosis, was the primary endpoint. Multivariate analysis was performed with Cox regression models., Results: Out of 2,707 patients, 110 (4.1%) experienced a TLF event after 16 months (12-18). After adjustment for confounders, an increased number of connectors (adjusted hazard ratio [adj-HR] 0.62, 95% confidence interval (CI) 0.39-0.99, p = .04) reduced risk of TLF, driven by stents with ≥2.5 mm diameter (HR 0.54, 95% CI 0.32-0.93, p = .02). This independent relationship was lost for stents with diameter <2.5 mm, where only strut thickness appeared to impact. Conversely, no independent relationship of polymer type, number of crowns, and the specific limus-family eluted drug with outcomes was observed., Conclusions: Among a range of contemporary very thin stent models, an increased number of connectors improved device-related outcomes in this investigated high-risk procedural setting., (© 2019 Wiley Periodicals, Inc.)

Background: The optimal approach to guide percutaneous coronary intervention (PCI) has yet to be defined. The aim of this study was to compare functional driven (fractional flow reserve) versus intravascular imaging (intravascular ultrasound, IVUS, and/or optical coherence tomography, OCT) versus standard (coronary angiography only, CA)-guided PCI., Methods: Randomized controlled trials (RCTs) and propensity score weight-matched studies (PSWMs) comparing FFR versus IVUS versus OCT versus CA-guided PCI were included. Major adverse cardiovascular event (MACE; a composite end point of death or myocardial infarction [MI] or revascularization) was the primary endpoint, whereas definite stent thrombosis (ST) and single components of MACE were the secondary ones. Primary analyses were performed including only RCTs, secondary also with PSWMs., Results: Thirty-three studies were included in the analysis, 16 RCTs and 17 PSWMs. After 2 (1-3) years, IVUS performed better for MACE than CA (odds ratio [OR] 0.75 0.52-0.88), whereas there was just a trend for FFR (OR 0.81, 0.64-1.02). These results were mainly driven by reduced risk of all cause death, MI (FFR OR 0.74:0.57-0.99 and IVUS OR 0.82:0.54-0.94) and revascularization. IVUS reduced ST while FFR did not, and at meta-regression analysis, there was a trend for superiority of IVUS versus FFR to reduce subsequent MI in acute coronary syndrome (ACS) patients. The present results were consistent also after adding studies with PSWMs., Conclusions: Functional and intravascular imaging approaches seem to perform similarly in term of clinical outcomes, while both performed better compared with the standard approach. Imaging showed a potential benefit for ACS patients. The present results stress the need for a wider use of functional or imaging driven PCI., (© 2019 Wiley Periodicals, Inc.)

Background: The risk of recurrent ischemia and bleeding after percutaneous coronary intervention (PCI) for acute coronary syndrome (ACS) may vary during the first year of follow-up according to clinical presentation, and medical and interventional strategies., Methods: BleeMACS and RENAMI are 2 multicenter registries enrolling patients with ACS treated with PCI and clopidogrel, prasugrel, or ticagrelor. The average daily ischemic and bleeding risks (ADIR and ADBR) in the first year after PCI were the primary end points. The difference between ADBR and ADIR was calculated to estimate the potential excess of bleeding/ischemic events in a given period or specific subgroup., Results: A total of 19,826 patients were included. Overall, in the first year after PCI, the ADBR was 0.008085%, whereas ADIR was 0.008017% (P = .886). In the first 2 weeks ADIR was higher than ADBR (P = .013), especially in patients with ST-segment elevation myocardial infarction or incomplete revascularization. ADIR continued to be, albeit non-significantly, greater than ADBR up to the third month, whereas ADBR became higher, although not significantly, afterward. Patients with incomplete revascularization had an excess in ischemic risk (P = .003), whereas non-ST-segment elevation ACS patients and those on ticagrelor had an excess of bleeding (P = .012 and P = .022, respectively)., Conclusions: In unselected ACS patients, ADIR and ADBR occurred at similar rates within 1 year after PCI. ADIR was greater than ADBR in the first 2 weeks, especially in ST-segment elevation myocardial infarction patients and those with incomplete revascularization. In the first year, ADIR was higher than ADBR in patients with incomplete revascularization, whereas ADBR was higher in non-ST-segment elevation ACS patients and in those discharged on ticagrelor., (Copyright © 2019 Elsevier Inc. All rights reserved.)

Aims: The impact of the severity of coronary artery disease (CAD) and percutaneous coronary interventions (PCI) on outcomes after transcatheter aortic valve implantation (TAVI) remains a matter of debate. We therefore performed a meta-analysis to evaluate the impact of CAD, of its severity and of PCI on mortality after TAVI., Methods and Results: All published studies evaluating the impact of CAD on 30-day and one-year mortality after TAVI at multivariable analysis were included. The primary endpoint was the impact of CAD severity (assessed with the SYNTAX score [SS]) on one-year mortality by pooling with logarithmic transformation results of multivariable adjusted effect estimates from each individual study. Secondary endpoints were the impact of the presence of CAD on 30-day and one-year mortality at multivariable analysis and the impact of residual SYNTAX score (rSS) on one-year mortality at multivariable analysis. A total of 8,334 patients with a median age of 81.3 (81-82) years and STS score of 6.2% (IQR 6.0-6.7) from 13 studies were included. Patients with an SS >22 showed higher one-year mortality at multivariable analysis (OR 1.71 [1.24-2.36]). The presence of CAD did not impact on 30-day and one-year mortality at multivariable analysis (respectively, OR 1.57 [0.71-3.46] and OR 1.25 [0.74-2.11]). Regarding PCI, patients with rSS <8 showed lower one-year mortality (OR 0.34 [0.012-0.93])., Conclusions: The risk of death after TAVI is closely related to the complexity of CAD. Patients with an SS >22 present higher mortality. SS may represent a useful tool to select patients undergoing TAVI who could benefit from coronary revascularisation. In this regard, reaching an rSS <8 reduced one-year mortality. Randomised controlled trials are needed to confirm these results.

Aims: Instantaneous free-wave ratio (iFR) has been recently demonstrated non-inferior to fractional flow reserve (FFR) to drive coronary revascularization; however, no study has compared iFR versus coronary angiography (CA). We performed a network meta-analysis to evaluate efficacy and safety of iFR- versus CA-guided strategy., Methods and Results: We searched for randomized trials and studies with propensity score matching in The Cochrane Collaboration Central Register of Controlled Trials, EMBASE, and MEDLINE/Pubmed. CA, FFR, and iFR were the three competitive arms, MACE (a composite endpoint of death, myocardial infarction [MI], and target vessel revascularization [TVR]) was the primary endpoint, while its single components the secondary ones. Subgroup analysis was performed for patients presenting with stable coronary artery disease. Eight studies were selected: 4126 patients were evaluated with FFR, 2160 with iFR, and 2214 with CA, acute coronary syndrome (ACS) was the most frequent admission diagnosis. After 12 months, rates of MACE and all-cause death did not differ between groups (respectively OR 1.04 and OR 0.86 for iFR vs FFR). Both FFR and iFR reduced TVR compared to CA (respectively OR 0.68 and OR 0.70). In patients with stable CAD both FFR and iFR reduced risk of subsequent MI compared to CA (respectively OR 0.66 and OR 0.79)., Conclusion: Compared to CA alone, both FFR and iFR are safe and effective in guiding coronary revascularization at 12 months. In patients with stable CAD, both FFR and iFR-guided revascularization reduce the risk of subsequent MI at 12 months., (© 2018 Wiley Periodicals, Inc.)

Background: Covered stent (CS) implantation is considered a useful device in the setting of Grade III Coronary Perforation (G3CP), one of the most harmful PCI complication. However, data regarding efficacy of this device and clinical outcomes are still limited., Methods and Results: From 1993 to 2015, among 97,779 patients from 9 European centres undergoing PCI, 224 patients had G3CP (0.23%), and 102 patients were managed with CS implantation (96 with PTFE, 6 with pericardium). Device oriented composite endpoint (DOCE), a composite of cardiac death, target lesion revascularization, and stent thrombosis (ST) in-hospital and at long term follow-up were evaluated. G3-CP perforations were successfully sealed with CS in 88 patients (86.3%) with need of intraprocedural pericardiocentesis in one-third of cases. Protamine as heparin reversal agent was administered in 36 (35%) of cases. The cumulative incidence of in-hospital DOCE were 16.6% (17/102): death 14.7%, TLR 2.9%, ST 3.9%. At long-term follow-up (mean 42 ± 38 months), DOCE rates occurred in 19.7%: death 7.4%, TLR 11%, and ST 6.2%. Indication to Dual Antiplatelet Therapy (DAPT) was lifelong in 20% of cases, 1 to 6 months in 22.5% and 12-months in 57.5% without differences in long-term DOCE before and after DAPT interruption (8.0 vs. 6.6%, respectively, P = 0.20)., Conclusions: Use of CS was successful in sealing grade 3 coronary artery perforations in the majority of cases. Beside the high rate of clinical events at short and long-term, ST remains the leading cause of device failure., (© 2018 Wiley Periodicals, Inc.)

Background: Treatment of patients with ULMCA (unprotected left main coronary artery disease) with percutaneous coronary intervention (PCI) has been compared with coronary artery bypass graft (CABG), without conclusive results., Methods: All randomized controlled trials (RCTs) and observational studies with multivariate analysis comparing PCI and CABG for ULMCA were included. Major cardiovascular events (MACEs, composite of all-cause death, MI, definite or probable ST, target vessel revascularization and stroke) were the primary end points, whereas its single components were the secondary ones, along with stent thrombosis, graft occlusion and in-hospital death and stroke. Subgroup analyses were performed according to Syntax score., Results: Six RCTs (4717 patients) and 20 observational studies with multivariate adjustment (14 597 patients) were included. After 5 (3-5.5) years, MACE rate was higher for PCI [odds ratio (OR) 1.10, 95% confidence interval (CI) 1.07-1.14], without difference in death, whereas more relevant risk of MI was because of observational studies. Coronary stenting increased risk of revascularization (OR 1.52; 95% CI 1.34-1.72). At meta-regression, performance of PCI was improved by use of intra-coronary imaging and worsened by first generation stents, whereas two arterial grafts increased benefit of CABG. For patients with Syntax score less than 22, MACE rates did not differ, whereas for higher values, CABG reduced MACE because of lower risk of revascularization. Incidence of graft occlusion was 3.24% (2.25-4.23), whereas 2.13% (1.28-2.98: all CI 95%) of patients experienced stent thrombosis., Conclusion: Surgical revascularization reduces risk of revascularization for ULMCA patients, especially for those with Syntax score greater than 22, with a higher risk of in-hospital death. Intra-coronary imaging and use of arterial grafts improved performance of revascularization strategies.

Objectives: 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., Background: 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., Methods: 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., Results: 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., Conclusion: 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.

Objective: To evaluate the outcome of patients undergoing PCI for unprotected left main coronary artery (ULMCA) disease with different drug-eluting stent (DES) types., Background: Published literature suggests that second-generation DES options have differing vascular responses and outcomes, but there is a paucity of data in real-life patients in the LM setting., Methods: This is a retrospective, multicenter study, including patients treated with a second-generation DES for ULMCA disease between 2007 and 2015. The primary endpoint was target-lesion revascularization (TLR). Secondary endpoints were major adverse cardiac events, myocardial infarction (MI), and stent thrombosis (ST)., Results: A total of 1209 patients were enrolled; 840 patients (69.5%) received an everolimus-eluting stent (EES), 133 patients (11.0%) received a zotarolimus-eluting stent (ZES), and 236 patients (19.5%) received a biodegradable polymer, biolimus-eluting stent (BP-BES). During a mean follow-up of 722 ± 640 days, TLR occurred in 47 patients (3.8%). At univariate analysis, EES patients had a lower TLR rate (3.6% vs 4.5% in ZES vs 4.2% in BP-BES), which was statistically significant at multivariate analysis (hazard ratio, 0.50; 95% confidence interval, 0.27-0.93; P=.03). No differences in major adverse cardiac events, death, MI, or ST were observed between groups., Conclusion: The safety profile of the stents used was comparable over the follow-up period. However, EES patients had lower restenosis rates, with a reduced need for repeat PCI.

Aims: The long-term impact of beta blockers on prognosis in patients treated with contemporary therapies for coronary artery disease remains to be defined., Methods and Results: All observational studies evaluating the impact of beta blockers in patients treated with coronary revascularization and contemporary therapies and adjusted with multivariate analysis were included. All-cause death was the primary endpoint, while Major Adverse Cardiac Events (MACE) (composite endpoint of all-cause death or myocardial infarction, MI) and MI were secondary endpoints. A total of 26 studies were included, with 863 335 patients. After 3 (1-4.3) years, long-term risk of all-cause death was lower in patients on beta blockers [odds ratio, OR 0.69 (0.66-0.72)], both for Acute Coronary Syndrome (ACS) [OR 0.60 (0.56-0.65)], and stable angina patients [OR 0.84 (0.78-0.91)], independently from ejection fraction [OR 0.64 (0.42-0.98) for reduced ejection fraction and OR 0.79 (0.69-0.91) for preserved ejection fraction]. The risk of long-term MACE was lower but NS for ACS patients treated with beta blockers [OR 0.83 (0.69-1.00)], as in stable angina. Similarly, risk of MI did not differ between patients treated with beta blockers or without beta blockers [OR 0.99 (0.89-1.09), all 95% confidence intervals]. Using meta-regression analysis, the benefit of beta blockers was increased for those with longer follow-up. The number needed to treat was 52 to avoid one event of all-cause death for ACS patients and 111 for stable patients., Conclusion: Even in percutaneous coronary intervention era, beta blockers reduce mortality in patients with coronary artery disease, confirming their protective effect, which was consistent for both ACS and stable patients indifferently of preserved or reduced ejection fraction.

Background: Chronic kidney disease (CKD) is associated with increased risk of mortality. We examined the impact of moderate and severe CKD at presentation on short- and long-term mortality among unselected patients with ST-segment elevation myocardial infarction (STEMI) treated with primary percutaneous coronary intervention (PPCI)., Methods: The study cohort consists of 501 patients (pts), enrolled from October 2005 to December 2012. The median follow-up was 46.52±25.58 months (range 8-99). A severe CKD (estimated Glomerular Filtration Rate [eGFR] <30 mL/min/1.73 m2) was detected in 16 pts (3.19%), a moderate CKD (eGFR 30-59 mL/min/1.73 m2) in 110 (21.96%) and a normal kidney function (eGFR >60 mL/min/1.73 m2) in 375 (74.85%)., Results: The crude in-hospital mortality rate resulted significantly higher in pts with severe and moderate CKD compared to pts with normal renal function (50% and 19.08% versus 2.93%, P<0.0001), as well as the long-term mortality rate (57.14% and 46.34% versus 8.77%, P<0.0001). After adjustment for confounding variables, severe and moderate CKD resulted the main independent predictors of in-hospital (odds ratio [OR]=21.815, P<0.0001 for severe CKD and OR= 4.203, P=0.002 for moderate CKD) and long-term (hazard ratio [HR]= 5.272, P=0.001; HR= 1.978, P=0.006) mortality., Conclusions: CKD is a frequent condition in patients with STEMI treated with PPCI and it is associated to an excess of mortality, resulting the main independent negative prognostic predictor.

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)., (Copyright © 2017 Elsevier B.V. All rights reserved.)

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., (Copyright © 2017 Elsevier Inc. All rights reserved.)

Aims: Given the different pathogenesis, use of drug eluting stent (DES) in patients with Spontaneous Coronary Artery Dissection SCAD may delay the healing of the dissected vessel. Aim of our study was to compare the safety and the efficacy of DES vs. bare metal stent (BMS) in a cohort of patients who underwent stenting for SCAD., Methods and Results: Consecutive patients with SCAD between January 1995 and August 2014 were retrospectively identified in 12 centers and included. Major Adverse Cardiac Events (MACE) was the primary end point. A total of 238 SCAD patients were identified: of them 108 patients underwent PCI with DES or BMS. Overall 24 patients (22.2%) suffered an intra-procedural complication without any differences between the 2 groups. At median follow-up of 1201days (Inter Quartile Range 541-2760), incidence of the primary endpoint showed a trend towards less events in the DES-treated patients (38.7% vs. 25.9% p=0.14) mainly driven by the benefit of DES in terms of TVR (17.6% vs. 4%, p=0.08), mortality (16.8% vs. 9.3%, p=0.4), and MI rate (16% vs. 8.4%, p=0.33). STEMI at presentation (HR 6.4, CI 95% 1.29-31.9, p=0.02) but not kind of stent (HR 0.97, CI 95% 0.2-4.7, p=0.9) emerged as independently related to prognosis at multivariable analysis., Conclusions: In SCAD patients use of DES seems to be as safe as BMS with trend of better efficacy in the long term., (Copyright © 2017 Elsevier B.V. All rights reserved.)

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., (Copyright © 2017 Elsevier Inc. All rights reserved.)

The optimal antiaggregant therapy after coronary stenting in patients receiving oral anticoagulants (OACs) is currently debated. MEDLINE and Cochrane Library were searched for studies reporting outcomes of patients who underwent PCI and who were on triple therapy (TT) or dual-antiplatelet therapy (DAPT) with aspirin and clopidogrel or dual therapy (DT) with OAC and clopidogrel. Major bleeding was the primary end point, whereas all-cause death, myocardial infarction (MI), stent thrombosis, and stroke were secondary ones. Results were reported for all studies and separately for those deriving from randomized controlled trials or multivariate analysis. In 9 studies, 1,317 patients were treated with DAPT and 1,547 with TT. DAPT offered a significant reduction of major bleeding at 1 year for overall studies and for the subset of observational works providing adjusted data (odds ratio [OR] 0.51, 95% confidence interval [CI] 0.39 to 0.68, I2 60% and OR 0.36, 95% CI 0.28 to 0.46) compared to TT. No increased risk of major adverse cardiac events (MACE: death, MI, stroke, and stent thrombosis) was reported (OR 0.71, 95% CI 0.46 to 1.08), although not deriving from randomized controlled trials or multivariate analysis. Six studies tested OAC and clopidogrel (1,263 patients) versus OAC, aspirin, and clopidogrel (3,055 patients) with a significant reduction of bleeding (OR 0.79, 95% CI 0.64 to 0.98), without affecting rates of death, MI, stroke, and stent thrombosis (OR 0.90, 95% CI 0.69 to 1.23) also when including clinical data from randomized controlled trials or multivariate analysis. In conclusion, compared to TT, both aspirin and clopidogrel and clopidogrel and OAC reduce bleeding. No difference in major adverse cardiac events is present for clopidogrel and OAC, whereas only low-grade evidence is present for aspirin and clopidogrel., (Copyright © 2015 Elsevier Inc. All rights reserved.)

Objectives: To assess sex differences in clinical presentation, in-hospital and long-term outcome in ST-elevated myocardial infarction (STEMI) patients undergoing primary PCI (PPCI)., Background: Several studies have shown higher rates of mortality in women. These differences are not always confirmed after adjusting for confounding variables., Methods: From January 2007 to December 2011, 325 consecutive patients (23.1% females and 76.9% males) were prospectively treated and retrospectively analyzed. Primary outcome was in-hospital and long-term mortality., Results: Women were older (71.8±11.7 vs. 62.5±12.6years; p<0.0001), presented more renal failure (45.3% vs. 20.8%; p<0.0001) and severe haemodynamic impairment (9.3% vs. 3.6%; p=0.04). In-hospital overall mortality (14.7% vs. 4.8%; p=0.003) and cardiac death (12% vs. 2%; p=0.002) were significantly higher in women. The multivariate analysis identified age (OR 1.07; 95% CI: 1.01-1.13), resuscitated cardiac arrest (CCA) and cardiogenic shock (CS) (OR 15.31; 95% CI: 4.30-61.75), renal failure (OR 0.20; 95% CI: 0.06-0.68), but not sex (OR 1.49; 95% CI: 0.53-4.22) as independent prognostic factors of in-hospital mortality. During a median follow-up of 46.5months (IQR range 32.7-63.1months), long-term overall mortality (24.2% vs. 11.0%; p=0.007) and cardiac death (4.8% vs. 1.7%; p=0.02) were significantly higher in women. The multivariate analysis identified age (HR 1.06; 95% CI: 1.02-1.11), previous AMI (HR 3.9; 95% CI: 1.63-9.35), renal failure (HR 5.21; 95% CI: 2.12-12.85), technical success (HR 0.35; 95% CI: 0.14-0.84) but not sex (HR 0.90; 95% CI: 0.42-1.94) as independent prognostic factors of long-term mortality., Conclusions: Worse clinical presentation rather than sex may explain the excess of mortality in women with STEMI undergoing PPCI., (Copyright © 2015 Elsevier Inc. All rights reserved.)

Introduction: The increasing use of primary percutaneous coronary intervention (pPCI) has improved clinical outcome in ST-segment elevation myocardial infarction (STEMI) patients, but the impact of sex on early and mid-term outcomes remains to be defined., Methods: Medline, Cochrane Library, Biomed Central, and Google Scholar were searched for articles describing differences in baseline, periprocedural, and midterm outcomes after pPCI, by sex. The primary end point was all-cause mortality at early and mid-term follow-up. Secondary endpoints included in-hospital bleeding and stroke., Results: Sixteen studies were included. Women were older, had more frequent hypertension, diabetes mellitus, and hypercholesterolemia, as well as longer ischemia time and more shock at presentation. Men were more likely to have had a previous myocardial infarction. Female sex emerged as independently associated to early mortality (OR 1.1; 95%CI, 1.02-1.18) but not to mid-term mortality (OR, 1.01; 95%CI, 0.99-1.03). The pooled analysis showed a significantly higher risk of in hospital stroke (OR, 1.69; 95%CI, 1.11-2.56) and major bleeding (OR, 2.04; 95%CI, 1.51-2.77) in women., Conclusions: As compared to men, women undergoing pPCI have more bleedings and strokes, and a worse early, but not mid-term mortality. These findings may allow a better risk stratification of pPCI patients., (© 2015, Wiley Periodicals, Inc.)

Aims: To establish the cardioprotective effect of remote ischaemic preconditioning (RIPC) in patients undergoing percutaneous coronary intervention (PCI)., Methods and Results: Pubmed (MEDLINE), Cochrane and Embase were systematically searched for randomised controlled trials of RIPC in patients undergoing PCI. Periprocedural myocardial infarction (PMI) was the primary endpoint (defined as troponin elevation >3 times upper reference limit) and C-reactive protein (CRP) was a secondary endpoint. Five studies with 731 patients were included. The median age of the patients was 62 (59-68) years old, 25% were female (23-33), 29% (25-33) had diabetes mellitus, and 26.5% (19-31) presented with multivessel disease. RIPC significantly reduced the incidence of PMI (odds ratio: 0.58 [0.36, 0.93]; I2 43%), with a greater benefit when performed using the lower limb (0.21 [0.07-0.66]) compared to the upper limb (0.67 [0.46-0.99]). This reduction was enhanced for patients with multivessel disease (beta -0.05 [-0.09;-0.01], p=0.01) and with type C lesion (beta -0.014 [-0.04;-0.010], p=0.01) and did not vary according to age, female gender, diabetes mellitus, use of beta-blockers and of angiotensin converting enzyme inhibitors. Absolute risk difference was -0.10 [-0.19, -0.02], with a number needed to treat of 10 [6-50] patients to avoid one event. CRP -0.69 [-1.69, 0.31] was not significantly reduced by RIPC., Conclusions: RIPC reduced the incidence of PMI following PCI, especially when performed in the lower limb and for patients with multivessel disease and complex lesions.

Background: Patients on chronic hemodialysis (HD) are recognized as a high-risk group for adverse events after percutaneous coronary intervention, and whether drug-eluting stents (DES) are associated with improved outcomes over bare metal stents (BMS) is still uncertain. The purpose of this study was to assess the efficacy of DES compared with BMS at short- and long-term follow-up (FU) in an unselected sample of HD patients., Methods and Results: In the time period 2005-2010, consecutive patients on chronic HD treated with percutaneous coronary intervention (PCI) and stent implantation were retrospectively selected and analyzed. A total of 169 patients were selected, 77 treated exclusively with BMS and 92 exclusively with DES. Baseline clinical characteristics were similar in the 2 groups as well as the number of treated vessels, treated lesions, and the stent per patient ratio. At longest available FU, no difference between the 2 study groups was found in terms of cardiac death (18.2% vs 16.3%, P=0.83), myocardial infarction (2.5% vs 8.6%, P=0.09), cerebrovascular accidents (0% vs 1.1%, P=0.98), and target vessel revascularization (TVR) (9.1% vs 16.3%, P=0.17). Major adverse cardiac and cerebrovascular events-free survival at 1,500 days in the BMS and DES groups was 57.6% and 50.9% (P=0.11), respectively., Conclusions: PCI in patients on chronic HD treatment is associated with a high incidence of adverse events at FU, mainly represented by death. In our study, the use of DES was not associated with a reduction of target lesion revascularization (TLR) and TVR., (© 2013, Wiley Periodicals, Inc.)