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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.

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 <0.001). No difference was reported between ULM versus non-ULM groups in terms of in-hospital MACE (5.8% vs 8%). At 1 year, MACE rate was higher in ULM versus non-ULM (26.4% vs 14.9%, p = 0.002) mostly driven by target-vessel revascularization (20.3% vs 12.7%, p = 0.05). Even definite/probable stent thrombosis rate was higher in the ULM group (3.9% vs 0.8%). All these events were subacute and 2/3 (75%) were fatal. In conclusion, our multicenter experience shows that RA followed by stent implantation in patients with heavily calcified ULM narrowing is feasible and associated with good in-hospital results. Patient (age and diabetes) and procedural aspects (relatively low intravascular ultrasound guidance) may affect the worse subacute mid-term prognosis in the more complex ULM group.

The use of drug-eluting stent (DES) instead of bare-metal stent (BMS) in patients at high stent thrombosis or bleeding risk as well as in those at low restenosis risk (ie, uncertain DES candidates) remains a matter of debate. Zotarolimus-Eluting Endeavor Sprint stent (E-ZES) (Santa Rosa, CA) is a hydrophilic polymer-based second-generation device with unique drug fast-release profile, which may allow for a shorter dual antiplatelet therapy (DAPT) duration without safety concerns. The primary objective is to assess whether E-ZES implantation followed by a shorter than currently recommended course of DAPT will decrease the incidence of 12-month major adverse cardiovascular events as compared with BMS in undefined DES recipients. Actual duration of DAPT regimen will be dictated by patients' characteristics and not by stent type and, as such, can be as short as 30 days after intervention in both stent groups. The ZEUS study is an open-label randomized clinical trial conducted at 20 clinical sites in Italy, Switzerland, Portugal, and Hungary. With 1,600 individuals, this study will have 85% power to detect a 33% difference in the primary end point consisting of the composite of death, nonfatal myocardial infarction, or target vessel revascularization. The ZEUS trial aims to assess whether the use of E-ZES, followed by a DAPT duration regimen based on patients' characteristics and not by stent type, is superior to conventional BMS implantation in undefined DES recipients who qualify for the presence of high thrombosis, bleeding, or low restenosis risk criteria.

Whether duration of chronic total occlusion (CTO) affects lesion and procedural characteristics remains largely unknown. To investigate whether CTO duration influences lesion characteristics and revascularization success. EuroCTO Registry data on patients who had CTO percutaneous coronary intervention between January 2015 and April 2017 were analyzed. Three groups were created based on occlusion age: 3 to 6 months ( = 1415), 7 to 12 months ( = 973), > 12 months ( = 1656). Patients with greater CTO duration were older (63.0 (56.0-70.0); 63.0 (56.0-71.0); 66.0 (59.0-73.0) years respectively; < 0.001), had more 3-vessel disease (32.2%; 30.9%; 46.1% respectively; < 0.001) and more frequent prior coronary artery bypass grafting (8.2%; 9.9%; 29.4% respectively; < 0.001). In multivariate analysis, occlusion duration was associated with moderate/severe calcification (OR = 1.52; 95% CI: 1.28-1.80; < 0.001), lesion length > 20 mm (OR 1.77; 95% CI 1.49-2.10; < 0.001), and collateral circulation Werner type 2 (OR = 1.20; 95% CI: 1.01-1.43; = 0.041). The CTO duration was associated with lower procedural success (OR for success 0.60; 95% CI: 0.46-0.79; < 0.001). In multivariate analysis in-hospital adverse events did not differ according to duration of CTO. Coronary artery CTO duration is associated with greater extent of calcification, lesion length, development of collateral circulation and, most importantly, with lower procedural success.

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.

Device loss or entrapment during percutaneous coronary interventions (PCI) is a rare circumstance whose incidence has decreased over time mainly because of device improvements. Nevertheless, they still represent fearful complications also and above all because the operators may be unfamiliar with rescue and retrieval techniques. The devices that most frequently experience loss or entrapment are stents, followed by angioplasty balloons, burrs for rotational atherectomy, guidewires and microcatheters. In this review we will illustrate the risk factors for device loss and the main retrieval techniques, as described in the literature or stemmed from our experience as high-volume PCI center.

Coronary chronic total occlusions (CTO) are a frequent finding in patients undergoing coronary angiography. However, a low percentage of patients is still referred for percutaneous coronary intervention. The main reasons lie in the skepticism concerning the real benefit and high technical complexity of these interventions. In recent years, thanks to the growing operators' experience and the introduction of new techniques and materials, the procedural success has increased with relatively low complication rates. There is growing evidence in recent literature that percutaneous recanalization improves symptoms and quality of life, increases ejection fraction and prolongs survival. Appropriate patient selection alone may involve a real clinical benefit in case of percutaneous CTO treatment. The key to procedural success is to use the right method and the knowledge of dedicated techniques and devices: CTO recanalization should be performed by experienced operators, and non-CTO interventionalists should approach these procedures only after specific training.

Safety and efficacy of bioresorbable vascular scaffolds (BRS) and the role of postdilatation on outcome in acute coronary syndrome (ACS) patients compared with those of everolimus-eluting stents (EES) remain unknown. The aim of the study is to compare the safety and efficacy of BRS with EES in ACS and to investigate the role of BRS postdilatation. Consecutive ACS patients undergoing BRS implantation in 8 centers were com-pared with those with EES before and after propensity score matching. Major adverse cardiac event (MACE), myocardial infarction, and target lesion revascularization (TLR) were the primary endpoint. Sensitivity analysis was performed according to postdilatation after BRS implantation. We enrolled 303 BRS and 748 EES patients; 215 from each group were com-pared after matching, and 117 (55.2%) BRS patients were treated with postdilatation. After a median follow-up of 24.0 months, MACE rates were higher in BRS patients than in EES patients (9.3% vs. 4.7%, p < 0.001), mainly driven by TLR (6.1% vs. 1.9%, p < 0.001). Stent thrombosis increased in the BRS group (2.8% vs. 0.9%, p = 0.01). How-ever, after sensitivity analysis, MACE rates in BRS patients with postdilatation were signifi-cantly lower than in those without, comparable to EES patients (6.0% vs. 12.6% vs. 4.7%, p < 0.001). The same trend was observed for TLR (3.4% vs. 8.4% vs. 1.9%, p < 0.001). Stent thrombosis rates were higher in both the BRS groups than in EES patients (2.6% vs. 3.2% vs. 0.9%, p = 0.045). Postdilatation appears effective when using BRS in ACS patients. MACE rates are comparable to those of EES, although scaffold thrombosis is not negligible. Randomized prospective studies are required for further investigation.

BackgroundThe role of planned angiographic control (PAC) over a conservative management driven by symptoms and ischaemia following percutaneous coronary intervention (PCI) of the unprotected left main (ULM) with second-generation drug-eluting stents remains controversial. PAC may timely detect intrastent restenosis, but it is still unclear if this translated into improved prognosis.Methods and analysisPULSE is a prospective, multicentre, open-label, randomised controlled trial. Consecutive patients treated with PCI on ULM will be included, and after the index revascularisation patients will be randomised to PAC strategy performed with CT coronary after 6 months versus a conservative symptoms and ischaemia-driven follow-up management. Follow-up will be for at least 18 months from randomisation. Major adverse cardiovascular events at 18 months (a composite endpoint including death, cardiovascular death, myocardial infarction (MI) (excluding periprocedural MI), unstable angina, stent thrombosis) will be the primary efficacy outcome. Secondary outcomes will include any unplanned target lesion revascularisation (TLR) and TLR driven by PAC. Safety endpoints embrace worsening of renal failure and bleeding events. A sample size of 550 patients (275 per group) is required to have a 80% chance of detecting, as significant at the 5% level, a 7.5% relative reduction in the primary outcome.Trial registration numberNCT04144881