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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.)

Aims: To assess the long-term outcomes of patients treated with sirolimus-eluting Stentys stent in a real-life setting., Background: Few data regarding the safety and effectiveness of self-apposing sirolimus-eluting Stentys stent are available., Methods: 278 patients (30% stable coronary artery disease, 70% acute coronary syndromes, and 54% on unprotected left main) treated with sirolimus eluting Stentys stent were retrospectively included in the self-aPposing, bAlloon-delivered, siRolimus-eluting stent for the Treatment of the coronary Artery disease multicenter registry. Major adverse cardiovascular events (MACE, a composite of cardiac death, myocardial infarction, target lesion revascularization, stent thrombosis) were the primary end-point, single components of MACE were the secondary ones., Results: After 13 months (interquartile range 5-32), MACE was 14%. Stent thrombosis occurred in 3.9% of the patients (2.5% definite stent thrombosis and 1.4% probable stent thrombosis), 66% of them presenting with ST-segment elevation myocardial infarction (STEMI) at admission. Cardiovascular death, target lesion revascularization and myocardial infarction was 4.7%, 8.3%, and 7.2%, respectively. At multivariate analysis, risk of MACE was increased by diabetes (hazard ratios 4.76; P = 0.002) but was not affected by the indication leading to sirolimus-eluting Stentys stent implantation (marked vessel tapering vs. coronary ecstasies, hazard ratios 0.74, P = 0.71)., Conclusion: Sirolimus-eluting Stentys stent may represent a potential solution for specific coronary anatomies such as bifurcation, ectasic, or tapered vessels. Risk of stent thrombosis appears related to clinical presentation with STEMI and to anatomic features, stressing the importance of the use of intracoronary imaging for self-expandable stents implantation.

Introduction: Percutaneous coronary intervention (PCI) for complex lesions, including unprotected left main (ULM) and bifurcations, is gaining a relevant role in treating coronary artery disease with good outcomes, also thanks to new generation stents. The daily risk of adverse cardiovascular events and their temporal distribution after these procedures is not known., Methods: All consecutive patients presenting with a critical lesion of ULM or bifurcation treated with very thin struts stents, enrolled in the RAIN-Cardiogroup VII study, were analyzed. The daily risk of major acute cardiovascular events (MACE), target lesion revascularization (TLR) and stent thrombosis (ST) and their temporal distribution in the first year of follow-up was the primary endpoint. Differences among subgroups (ULM, patient presentation, kind of stent polymer) were the secondary endpoint., Results: 2745 patients were included, mean age 68 ± 11 years, 33.3% diabetics, 54.5% had an acute coronary syndrome (ACS); 88.5% of treated lesions were bifurcations, 27.2% ULM. Average daily risk was 0.022% for MACE, 0.005% for TLR and 0.004% for ST, in the first year. Bimodal distribution of adverse events, especially TLR, with an early peak in the first 50 days and a late one after 150 days, was observed. Patients with ULM presented a significantly higher daily risk of events, and ACS patients presented higher MACE risk. No difference emerged according to the type of stent polymer., Conclusions: The daily risk of adverse events in the first year after complex PCI in our study is acceptably low. PCI on ULM carries a higher risk of complications., (Copyright © 2019 Elsevier B.V. All rights reserved.)

Objectives: To compare the effectiveness and safety of self-expandable, sirolimus-eluting Stentys stents (SES) and second-generation drug-eluting stents (DES-II) for the treatment of the unprotected left main (ULM)., Background: SES may provide a valuable option to treat distal ULM, particularly when significant caliber gaps with side branches are observed., Methods: Patients from the multicenter SPARTA (clinicaltrials.gov: NCT02784405) and FAILS2 registries were included. Propensity-score with matching was performed to account for the lack of randomization. Primary end-point was the rate of major adverse cardiovascular events (MACE, a composite of all cause death, myocardial infarction, target lesion revascularization [TLR], unstable angina and definite stent thrombosis [ST]). Single components of MACE were the secondary end-points., Results: Overall, 151 patients treated with SES and 1270 with DES-II were included; no differences in MACE rate at 250 days were observed (9.8% vs. 11.5%, P = 0.54). After propensity score with matching, 129 patients treated with SES and 258 with DES-II, of which about a third of female gender, were compared. After a follow-up of 250 days, MACE rate did not differ between the two groups (9.9% vs. 8.5%, P = 0.66), as well as the rate of ULM TLR (1.6% vs. 3.1%, P = 0.36) and definite ST (0.8% vs. 1.2%, P = 0.78). These results were consistent also when controlling for the treatment with provisional vs. 2-stents strategies for the ULM bifurcation., Conclusion: SES use for ULM treatment was associated with a similar MACE rate compared to DES-II at an intermediate-term follow-up. SES might represent a potential option in this setting., (© 2018 Wiley Periodicals, Inc.)

Background: In the recent years percutaneous treatment of the left main stem (LM) has gained a precise role as a result of consistent scientific evidence vs. coronary artery bypass. A self-apposing stent offers an improved adaptation to the vessel wall, especially in case of tapered vessels; aim of this study was to investigate the role of a novel self-apposing, sirolimus-eluting stent (Stentys, France) for the treatment of LM coronary artery disease., Methods and Results: MATISSE is a retrospective, multicenter registry, which enrolled 151 patients treated with the device at 17 international centers. Primary study endpoint was the occurrence of major adverse cardiovascular events (MACE), a composite endpoint of cardiac death, target lesion revascularization (TLR) and target-vessel myocardial infarction, at 9months clinical follow-up. Secondary endpoints included procedural success, the single determinants of MACE and stent thrombosis. Lesions were located in distal LM bifurcation in 84% of the patients. Procedural success was achieved in 150 patients. The average follow-up length was 348±52days. MACE occurred in 14 (9.3%) patients with 2 (1.3%) cardiac deaths. TLR occurred in 8 patients (5.3%). There were 2 cases of definite stent thrombosis, 1 acute and 1 very late., Conclusions: A self-apposing stent, when used for LM PCI in a real world, high risk population, showed good immediate procedural results with low rates of adverse events at mid-term follow-up., (Copyright © 2018 Elsevier Inc. 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.)

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.)

Aims: The intermediate-term incidence of strut malapposition (SM) and uncovered struts (US), and the degree of neointimal thickness (NIT) according to stent type have not been characterized., Methods and Results: All studies of >50 patients in which optical coherence tomography was performed between 6 and 12 months after stent implantation were included. The incidences of SM and US were the co-primary end points, while NIT was the secondary end point. A total of 458 citations were initially appraised at the abstract level, and 11 full-text studies (280 652 analysed struts, 921 patients) were assessed. The 6-12 months incidences of SM and US were 5.0 and 7.8%, respectively, and the mean NIT was 206 μm. Biolimus-eluting stents (BES) and bioresorbable vascular scaffolds (BVS) had the highest SM rates (2.7 and 3.8%, respectively), while everolimus-eluting stents (EES) and fast-release zotarolimus-eluting stents (ZES) had the lowest SM rates (0.9 and 0.1%, respectively). BES and sirolimus-eluting stents (SES) had the highest US rates (7.7 and 8.8%, respectively), while bare metal stents (BMS) and ZES had the lowest US rates (0.3 and 0.3%, respectively). BMS had the greatest NIT (340 μm), while SES, EES, and BES had the least NIT., Conclusion: Second-generation drug-eluting stents (DES) have better intermediate-term strut apposition and coverage than first-generation DES, BVS, and BMS. EES demonstrate the overall best combination of healing with suppression of neointimal hyperplasia at 6-12 months. Further studies with clinical correlation are warranted to determine the implications of these findings., (Published on behalf of the European Society of Cardiology. All rights reserved. © The Author 2016. For permissions please email: journals.permissions@oup.com.)

Percutaneous coronary intervention (PCI) of unprotected left main disease (ULM) with drug-eluting stents (DES) is hampered by lack of information on long-term (≥10 years) safety data. All patients treated with PCI on ULM in 9 international centers with at least 10 years follow-up were enrolled. Baseline and procedural features were recorded. Repeat PCI (re-PCI) on ULM at 10 years was the primary end point. Secondary end points included major adverse cardiac events and its components (cardiac and noncardiac death, myocardial infarction, re-PCI not on ULM, and stent thrombosis). Sensitivity analysis was performed according to the presence of isolated ULM disease: 284 patients were enrolled. A total of 70 patients (21%) performed a re-PCI on ULM, 39 in the first year, and 31 between 1 and 10 years (only 5 overall performed for acute coronary syndrome). Patients with re-PCI on ULM did not show differences in baseline and procedural features, or experience higher rates of cardiovascular death (12% vs 11%, p 0.65), myocardial infarction (11% vs 6%, p 0.56), or of re-PCI on non-ULM disease (31% vs 27%, p 0.76) compared with those without re-PCI on ULM. At Kaplan-Meier analysis, patients with PCI in other coronary vessels were at higher risk of major adverse cardiac events, driven by target vessel revascularization (20.4% vs 32.9%, p 0.009), as confirmed at multivariate analysis (stenosis other than LM; hazard ratio 2, 1.4 to 2.7, all CI 95%). In conclusion, despite of using first-generation stents, PCI on ULM is safe, with low rates of recurrent events due to index revascularization. Progression of atherosclerotic lesions on other coronary vessels represents the only independent predictive factor for prognosis., (Copyright © 2016 Elsevier Inc. All rights reserved.)

The purpose of the study was to evaluate the optimal duration of dual antiplatelet therapy (DAPT) after percutaneous coronary intervention, especially in the era of second-generation drug-eluting stents (DES). The work was conducted from November 2014 to April 2015. All randomized controlled trials comparing short (<12 months) versus long (≥12 months) DAPT in patients treated with second-generation DES were analyzed. Sensitivity analyses were performed for length of DAPT and type of DES. All-cause death was the primary end point, whereas cardiovascular death, myocardial infarction (MI), stent thrombosis (ST), and major bleeding were secondary end points. Results were pooled and compared with random-effect models and meta-regression analysis. Eight randomized controlled trials with 18,810 randomized patients were included. The studies compared 3 versus 12 months of DAPT (2 trials), 6 versus 12 months (3 trials), 6 versus 24 months (1 trial), 12 versus 24 months (1 trial), and 12 versus 30 months (1 trial). Comparing short versus long DAPT, there were no significant differences in all-cause death (odds ratio [OR] 0.87; 95% confidence interval [CI] 0.66 to 1.44), cardiovascular death (OR 0.95; 95% CI 0.65 to 1.37), and ST (OR 1.20; 95% CI 0.79 to 1.83), and no differences were present when considering everolimus-eluting and fast-release zotarolimus-eluting stents separately. Shorter DAPT was inferior to longer DAPT in preventing MI (OR 1.35; 95% CI 1.03 to 1.77). Conversely, major bleeding was reduced by shorter DAPT (OR 0.60; 95% CI 0.42 to 0.96). Baseline features did not influence these results in meta-regression analysis. In conclusion, DAPT for ≤6 months is reasonable for patients treated with everolimus-eluting and fast-release zotarolimus-eluting stents, with the benefit of less major bleeding at the cost of increased MI, with similar survival and ST rates. An individualized patient approach to DAPT duration should take into account the competing risks of bleeding and ischemic complications after present-generation DES., (Copyright © 2016 Elsevier Inc. All rights reserved.)

Aims: There is uncertainty on which stenting approach confers the best long-term outlook for unprotected left main (ULM) bifurcation disease., Methods and Results: This is a non-randomized, retrospective study including all consecutive patients with 50% stenosis of the left main involving at least 1 of the arteries stemming from the left main treated with drug-eluting stents (DES) in 9 European centers between 2002 and 2004. Patients were divided into two groups: those treated with provisional stentings vs. those treated with two stent strategy. The outcomes of interest were 10-year rates of target lesion revascularization (TLR), major adverse cardiac events (MACE), and their components (cardiovascular death, myocardial infarction [MI], or repeat revascularization), along with stent thrombosis (ST). A total of 285 patients were included, 178 (62.5%) in the provisional stenting group and 87 (37.5%) in the two stent group. After 10 years, no differences in TLR were found at unadjusted analysis (19% vs 25%, p>0.05) nor after propensity score matching (25% vs 28%, p>0.05). Similar rates of MACE (60% vs 66%, p>0.05), death (34% vs 43%, p>0.05), MI (9% vs 14%, p>0.05) and ST were also disclosed at propensity-based analysis., Conclusion: Even after 10 year follow-up, patients treated with provisional stenting on left main showed comparable rates of target lesion revascularization compared to two stent strategy., (Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.)

Aims The intermediate-term incidence of strut malapposition (SM) and uncovered struts (US), and the degree of neointimal thickness (NIT) according to stent type have not been characterized. Methods and results All studies of >50 patients in which optical coherence tomography was performed between 6 and 12 months after stent implantation were included. The incidences of SM and US were the co-primary end points, while NIT was the secondary end point. A total of 458 citations were initially appraised at the abstract level, and 11 full-text studies (280 652 analysed struts, 921 patients) were assessed. The 6-12 months incidences of SM and US were 5.0 and 7.8%, respectively, and the mean NIT was 206 mm. Biolimus-eluting stents (BES) and bioresorbable vascular scaffolds (BVS) had the highest SM rates (2.7 and 3.8%, respectively), while everolimus-eluting stents (EES) and fast-release zotarolimus-eluting stents (ZES) had the lowest SM rates (0.9 and 0.1%, respectively). BES and sirolimus-eluting stents (SES) had the highest US rates (7.7 and 8.8%, respectively), while bare metal stents (BMS) and ZES had the lowest US rates (0.3 and 0.3%, respectively). BMS had the greatest NIT (340 mm), while SES, EES, and BES had the least NIT. Conclusion Second-generation drug-eluting stents (DES) have better intermediate-term strut apposition and coverage than first- generation DES, BVS, and BMS. EES demonstrate the overall best combination of healing with suppression of neointimal hyperplasia at 6-12 months. Further studies with clinical correlation are warranted to determine the implications of these findings. [ABSTRACT FROM AUTHOR]