Search

Diabetes mellitus (DM) accounts for >25% of all percutaneous coronary interventions. In patients with DM, drug-eluting stent implantation is associated with a reduced risk of restenosis and target lesion revascularization. However, concern has been raised about the incidence of late and very late stent thrombosis and the increased mortality rate, mostly after thienopyridine withdrawal. We evaluated the long-term prognostic effect of thienopyridine discontinuation after drug-eluting stent implantation on the subsequent occurrence of stent thrombosis and all-cause death among a cohort of high-risk "de novo" diabetic patients. From May 2002 to December 2005, 542 consecutive patients with DM underwent drug-eluting stent implantation at 2 hospitals in Milan, Italy. For study purposes, only the 217 patients who had not previously undergone percutaneous or surgical revascularization were considered in the final analysis. The follow-up time was curtailed at 3.5 years. Detailed information about dual antiplatelet therapy (DAT) were collected for all patients included. Of the 217 patients, 15 died (6.9%); in 9 cases, the cause of death was cardiac (4.1%). The incidence of cumulative stent thrombosis was 4.6% (10 patients); 3 stent thromboses were early (1.38%), 5 late (2.3%), and only 2 were very late (0.9%). Of the 10 cases of stent thrombosis, 5 were definite and 5 were probable. Most (80%) of the stent thromboses occurred within the first 6 months during DAT. The median duration of DAT was 420 days (interquartile range 350 to 859). DAT discontinuation was the only independent predictor of the follow-up events (hazard ratio 20.42, 95% confidence interval 4.99 to 83.62). In conclusion, DM remains an independent adverse factor on clinical outcome. In this setting, prolonged DAT, even beyond that recommended in the guidelines, might be beneficial. [ABSTRACT FROM AUTHOR]

In this study we randomly compared the estradiol eluting stent (17-beta-E) with phosphorylcholine (PC)-coated stents in native coronary arteries. The incidence of angiographic restenosis was 23% in the 17-beta-E group and 31% in the PC group (p = 0.34). The major adverse cardiovascular event rates were also similar in the 2 groups (17% in the 17-beta-E group vs 22% in the PC group, p = 0.47). The mid-term clinical and angiographic outcomes did not indicate superiority of the 17-beta-E eluting stent over the control PC stent. [ABSTRACT FROM AUTHOR]

The technique of "T" stenting, which incorporates wiring both the branches of a bifurcation lesion, dilating a balloon in the main branch during stent deployment in the side branch followed by deployment of stent in the main branch, provides excellent immediate results in terms of technical and procedural success. However, further innovations are mandated to optimize the long-term outcome, which with a restenosis rate of 63%, can be described as not encouraging. [ABSTRACT FROM AUTHOR]

Data deriving from patients who underwent TAVR between 2007 and 2017 in 13 Italian centers were prospectively collected. Patients were stratified in those with normal LVEF and reduced LVEF. The latter was further classified according to ischemic or nonischemic etiology. The primary end point was a composite of all-cause death and rehospitalizations; the secondary end points were the isolated composers of the primary end point and cardiac death. Overall, 2,626 patients were included in the analysis: 68.1% with normal LVEF and 31.9% with reduced LVEF. At 8 years, reduced LVEF was significantly associated with the primary end point (adjusted hazard ratio 1.17, 95% confidence interval 1.06 to 1.29). Consistent findings were evident for the composite end point. No differences in these trends were found at the 30-day landmark analyses. Compared with nonischemic etiology, ischemic reduced LVEF was associated with an increased risk of cardiac death (adjusted hazard ratio 1.43, 95% confidence interval 1.02 to 2.02). In conclusion, patients with reduced LVEF who underwent TAVR are exposed to a progressively increased risk of death and rehospitalizations, even at very long-term follow-up., Competing Interests: Declaration of competing interest CG, MA, and MDC received speaker fees from Medtronic; FB received consultant/proctor fees from Medtronic; MM received consultant fees from Abbott, Boston, Kardia and Medtronic; TP received lectures fees from Medtronic, Edwards and Abbott. The remaining authors have no competing interest to declare., (Copyright © 2024 Elsevier Inc. All rights reserved.)

Transcatheter mitral edge-to-edge repair (TEER) with transcatheter devices has become a mainstay in the minimally invasive treatment of patients with severe mitral regurgitation at increased surgical risk. Despite its apparently favorable risk profile, there is uncertainty on the risk and features of cerebrovascular accidents (CVAs) early and long after transcatheter mitral valve repair. We aimed to appraise the incidence and predictors of CVA in patients who underwent TEER. We explicitly queried the data set of an ongoing multicenter prospective observational study dedicated to TEER with MitraClip (Abbott Vascular, Santa Clara, California). The incidence of CVAs after TEER was formally appraised, and we explored potential predictors of such events. Descriptive, bivariate, and diagnostic accuracy analyses were performed. Of 2,238 patients who underwent TEER, CVAs occurred in 33 patients (1.47% [95% confidence interval 1.02% to 2.06%]), including 6 (0.27% [0.10% to 0.58%]) in-hospital strokes and 27 events after discharge (0.99% [0.66% to 1.44%]), over a median follow-up of 14 months. Most CVAs were major ischemic strokes during and after the in-hospital phase. Overall, CVAs were more common in patients with atrial fibrillation (p = 0.018), renal dysfunction (p = 0.032), higher EuroSCORE II (p = 0.033), and, as expected, higher CHA2DS2-VASc score (p = 0.033), despite the limited prognostic accuracy of the score. Notably, the occurrence of CVA did not confer a significantly increased risk of long-term (p = 0.136) or cardiac death (p = 0.397). The incidence of CVA in patients who underwent TEER is low, with most events occurring after discharge and being associated with preexisting risk features. These findings, although reassuring on the safety of TEER, call for proactive antithrombotic therapy whenever CVA risk is increased before and after TEER., Competing Interests: Declaration of competing interest Dr. Adamo has received speaker fees from speaker fees from Abbott Structural Heart. Giuseppe Biondi-Zoccai has consulted for aleph, Amarin, Balmed, Cardionovum, Crannmedical, Endocore Lab, Eukon, Guidotti, Innovheart, Meditrial, Menarini, MicroPort, Opsens Medical, Terumo, and Translumina outside the present work. The remaining authors have no competing interests to declare., (Copyright © 2024 The Author(s). Published by Elsevier Inc. All rights reserved.)

Atrial functional mitral regurgitation (aFMR) has a peculiar pathophysiology that may have distinctive outcomes. We investigated the impact of transcatheter edge-to-edge repair in aFMR compared with other FMR etiologies. The GIOTTO (GIse registry Of Transcatheter treatment of MR) is a multicenter, prospective study enrolling patients with symptomatic MR treated with MitraClip up to 2020. We categorized patients with FMR as aFMR, ischemic FMR (iFMR), and nonischemic ventricular FMR (niFMR). The clinical end points were defined according to the Mitral Valve Academic Research Consortium. Of 1,153 patients, 6% had aFMR, 47% iFMR, and 47% niFMR. Patients with aFMR were older, mostly women, and had a higher atrial fibrillation rate. They had better left ventricular ejection fraction and smaller left ventricular volumes, with no difference in mitral effective regurgitant orifice area. The acute device and procedural success rates were similar among the groups. At the longest available follow-up (median 478 days, interquartile range 91 to 741 days), the rate of MR ≥2+ was similar among the groups. Patients with aFMR had a lower rate of cardiovascular death and heart failure than patients with iFMR (hazard ratio [HR] 0.43, p = 0.02) and niFMR (HR 0.45, p = 0.03). The aFMR etiology remained independently associated with the composite outcome, together with postprocedural MR ≤1+ (HR 0.63, p <0.01) and peripheral arteriopathy (HR 1.82, p = 0.003). The results of this GIOTTO subanalysis suggested that aFMR is less prevalent and associated with better outcomes compared with other causes of FMR treated by transcatheter edge-to-edge repair. Postprocedural MR >1+, peripheral vasculopathy, non-aFMR were independent predictors of worse outcomes., Competing Interests: Declaration of Competing Interest Drs. Giuseppe Tarantini, Bedogni, Grasso, Paolo Denti (PD), Tamburino, Petroni, Montorfano declared speaker fees from Abbott Vascular. The remaining authors have no competing interest to declare., (Copyright © 2023 The Author(s). Published by Elsevier Inc. All rights reserved.)

Limited data are available about the impact of permanent pacemaker (PPM) implantation on long-term survival in patients with a bicuspid aortic valve (BAV) and severe aortic stenosis (AS) treated with transcatheter aortic valve replacement (TAVR). We aimed to evaluate the long-term clinical outcomes of patients with BAV with AS who underwent periprocedural PPM implantation after TAVR with a self-expandable prosthesis. Data from patients with BAV and severe AS who underwent TAVR between April 2009 and January 2022 and followed in the framework of the One Hospital ClinicalService-CoreValve Project were collected. Patients were categorized in 2 groups according to PPM implantation after TAVR ("PPM" group) or not ("no PPM" group). The coprimary end points were all-cause death and a composite of cardiac mortality, rehospitalization because of cardiac causes, stroke, and myocardial infarction. Overall, 106 patients were considered (74 in the "no PPM" group and 32 in the "PPM" group). No statistically significant difference was found between the groups in terms of follow-up and baseline characteristics. Patients in the PPM group were more likely to show baseline conduction abnormalities (p = 0.023). Patients in the PPM group were more often treated with older generation prosthesis than those in the no PPM group (28.1% vs 5.4%, respectively, p = 0.013). At 2 years of follow-up, all-cause death in the no PPM and PPM groups occurred in 20.0% and 10.0% of patients, respectively (hazard ratio 0.37, 95% confidence interval 0.08 to 1.67). Similarly, no difference was evident for the composite end point between the 2 groups (no PPM vs PPM: 8 [14.6%] vs 6 [19.3%], hazard ratio 1.67, 95% CI 0.58 to 4.81). In conclusion, patients with severe AS and BAV treated with TAVR complicated by PPM implantation are not exposed to an increased risk of major adverse events at 2 years of follow-up., Competing Interests: Declaration of Competing Interest Dr. Matteo Montorfano received consultant fees from Abbott, Boston, Kardia, and Medtronic. The remaining authors have no competing interest to declare., (Copyright © 2023 Elsevier Inc. All rights reserved.)

Direct oral anticoagulants (DOACs) represent the cornerstone therapy for cardioembolic events prevention in patients with nonvalvular atrial fibrillation (NVAF). In practice, the choice of one DOAC over another is guided by the decision-making process of the physician, which considers specific patient and drug characteristics. This study aimed to evaluate the clinical features and long-term outcomes of a real-world population treated with DOACs, where the use of the 4 different DOACs is quite equal. We conducted a retrospective observational, single-center, multidisciplinary study enrolling consecutive NVAF patients treated with one of the 4 DOACs. From an initial number of 753 patients, we excluded 72 patients because of loss to follow-up, at the end we enrolled 681:174 (23%) treated with dabigatran, 175 (23%) with apixaban, 190 (25%) with rivaroxaban, and 214 (29%) with edoxaban. Patients treated with apixaban were significantly older, more women represented (p <0.001), and with a higher cardioembolic and bleeding risk (p <0.001). Dabigatran was preferred in patients with liver failure (p = 0.008), whereas Apixaban and Edoxaban were chosen in chronic kidney disease (p = 0.002). At 3-year follow-up, 20 patients (2.7%) experienced a systemic thromboembolic event without significant differences in the 4 DOACs. In the same period, an International Society of Thrombosis and Hemostasis classification major bleeding event occurred in 26 patients (3.6%), more statistically correlated to edoxaban (6.1%) (p = 0.038). Thromboembolic events or major bleeding were higher in the edoxaban group (10%) compared with the others (p = 0.014). In our single-center real-world experience, the choice of the DOAC for a patient with NVAF was tailored to specific clinical features and drug pharmacokinetics of the patient. As a result, a small number of adverse events were observed., Competing Interests: Declaration of Competing Interest The authors have no competing interests to declare., (Copyright © 2023 Elsevier Inc. All rights reserved.)

Despite the growing experience with MitraClip in the broad spectrum of mitral regurgitation (MR), limited data are available regarding the independent prognostic role on survival of different mitral regurgitation etiology subtypes. We sought to evaluate the impact of flail leaflet etiology in a large series of patients with primary MR (PMR) who underwent MitraClip treatment. The study included 588 patients with significant PMR from the multicenter GIOTTO (Italian Society of Interventional Cardiology [GIse] registry Of Transcatheter treatment of mitral valve regurgitaTiOn), stratified into 2 groups according to MR etiology: flail + (n = 300) and flail - (n = 288). The primary end point was a composite of cardiac death and first rehospitalization for heart failure (HF). To account for the baseline differences, patients were propensity score-matched 1:1. Flail leaflet etiology was present in about a half of the patients. Acute technical success was achieved in 98% of the overall cohort, with no significant differences between the study groups (p = 0.789). At the 2-year Kaplan-Meier analysis, the primary end point occurred in 13% of flail + patients compared with 23% in flail - (p = 0.009). The flail + group presented lower rates of both cardiac death and rehospitalization for HF, whereas a similar overall death rate was observed between the groups. A multivariate Cox regression analysis identified flail leaflet etiology as an independent predictor of favorable outcome in terms of the primary end point (hazard ratio 0.141, 95% confidence interval 0.049 to 0.401, p <0.001). After propensity score matching, flail + patients had confirmed lower rates of cardiac mortality and rehospitalization for HF but similar rates of overall death. In conclusion, flail leaflet-related etiology was common in patients with PMR who underwent MitraClip treatment and was an independent predictor of midterm favorable clinical outcomes., Competing Interests: Declaration of Competing Interest Drs. Grasso, Adamo, Denti, Giordano, Bartorelli, Montorfano, Petronio, Tamburino, and Bedogni received consultation and speakers fees from Abbott Vascular outside the submitted work. The remaining authors have no conflicts of interest to declare., (Copyright © 2023 Elsevier Inc. All rights reserved.)

During transcatheter edge-to-edge repair (TEER), the reduction of functional mitral regurgitation (FMR) severity, compared with baseline evaluation, is not uncommon. Because the procedural strategies are mainly guided by the location and severity of the regurgitant jets, intraprocedural downgrading (ID) of regurgitation severity could affect the procedural strategy and the results. The aim of this study was to evaluate the prevalence of ID during TEER and to compare early and midterm outcomes in patients with and without ID. All patients with moderate-to-severe or severe FMR who underwent TEER in San Raffaele Hospital between 2018 and 2020 were evaluated in this single-center, retrospective study. ID was defined as mild (1+) or moderate (2+) regurgitation degree during intraprocedural evaluation. The outcomes, assessed at discharge and at 2 years of follow-up, were all-cause mortality, heart failure hospitalization, and recurrence of mitral regurgitation >2+. The final study cohort included 55 patients: 42% presented with ID. At discharge, 85.5% of patients achieved regurgitation reduction to 2+ or less: 100% in patients with ID versus 75% in patients without ID, p <0.009. At 2 years, no significant difference in the incidence of all-cause mortality, heart failure hospitalization, and the recurrence of mitral regurgitation >2+ between patients with ID or without ID was found. In conclusion, ID is frequent during TEER in FMR. No baseline characteristics were found to identify this group of patients. In patients with ID, the combination of live intraprocedural imaging and baseline ambulatory assessment of regurgitant jets seems effective in the procedural guiding to achieve a successful and durable mitral repair., (Copyright © 2022 Elsevier Inc. All rights reserved.)

Despite being highly effective in reducing residual mitral regurgitation and improving outcomes, mitral valve transcatheter edge-to-edge repair (MV-TEER) may be associated with high postprocedural residual mitral gradient (rMG). Conflicting results have been reported regarding the relation between rMG and adverse events. This study aimed to evaluate the predictors and the impact of elevated rMG after MV-TEER on clinical events in patients with functional mitral regurgitation (FMR) at 2 years follow-up. We selected a cohort of 864 patients with FMR who were treated with MV-TEER enrolled in the multicentre Italian Society of Interventional Cardiology (GISE) registry of transcatheter treatment of mitral valve regurgitation (GIOTTO). Patients were stratified into tertiles according to rMG. The primary clinical end point was a composite of all-cause death and hospitalization because of heart failure at 2-year follow-up. Overall, 269 patients (31.5%) with an rMG &lt;3 mm Hg, 259 (30.3%) with an rMG ≥3/&lt;4 mm Hg, and 326 (38.2%) with an rMG ≥4 mm Hg were considered. At multivariate logistic regression, ischemic FMR etiology, baseline MG, and the number of implanted clips were independent predictors of an rMG ≥4 mm Hg. Clinical follow-up was available in 570 patients (63.2%). Patients with an rMG ≥4 mm Hg experienced higher rates of the composite end point than patients of the other tertiles (51.1%, vs 42.3% vs 40.8% log-rank test: p = 0.033). In multivariate Cox's regression, both rMG ≥4 mm Hg (hazard ratio 1.54, 95% confidence interval 1.14 to 2.08) and residual mitral regurgitation ≥2+ (hazard ratio 1.36, 95% confidence interval 1.01 to 1.83) were independent predictors of adverse events at 2-year follow-up. In conclusion, we demonstrated that real-world patients who underwent MV-TEER who show an rMG ≥4 mm Hg are at higher risk of death or hospitalization because of heart failure during a 2-year follow-up. Further studies will be needed to confirm our results., (Copyright © 2022 Elsevier Inc. All rights reserved.)

Chronic kidney disease (CKD) is strongly related to outcomes in cardiovascular diseases. Limited data are available regarding the independent prognostic role of CKD after transcatheter mitral valve repair with MitraClip. We sought to evaluate the real impact of CKD in a large series of patients with heart failure (HF) and secondary mitral regurgitation (SMR) who underwent MitraClip treatment. The study included 565 patients with severe SMR from a multicenter international registry. Patients were stratified into 3 groups according to estimated glomerular filtration rate (eGFR) assessment before MitraClip implantation: normal eGFR (≥60 ml/min/1.73 m 2 ) (n = 196), mild-to-moderate CKD (30 to 59 ml/min/1.73 m 2 ) (n = 267), and severe CKD (<30 ml/min/1.73 m 2 ) (n = 102). The primary end point was a composite of overall death and the first rehospitalization for HF, the secondary end points were overall death, cardiac death, and first rehospitalization for HF. CKD was present in about 2/3 of patients. At 5-year Kaplan-Meier analysis, primary clinical end point occurred in 60% of patients with normal eGFR, compared with 73% cases in patients with mild-to-moderate CKD and 91% in patients with severe CKD (p <0.001). Long-term overall death rate significantly decreased with increasing eGFR, and cardiac death and rehospitalization for HF rates. Multivariate Cox regression analysis identified severe CKD as the strongest independent predictor of adverse outcome (hazard ratio 2.136, 95% confidence interval 1.164 to 3.918, p = 0.014). In conclusion, CKD affected about 2/3 of patients who underwent MitraClip treatment for severe SMR, and it was a strong and independent predictor of 5-year adverse outcomes., Competing Interests: Disclosures The authors have no conflicts of interest to declare., (Copyright © 2022 Elsevier Inc. All rights reserved.)

Limited data are available about the association between coronary artery calcification and chronic kidney disease severity on clinical outcomes after percutaneous coronary intervention (PCI). This study aimed to assess the association between coronary artery calcification and chronic kidney disease severity on clinical outcomes after PCI. We identified 1,391 patients treated with drug-eluting stent for unprotected left main distal bifurcation lesions (ULMD), including 604 without calcified lesions (noncalcified left main group) and 787 with calcified ULMD (calcified left main group) in Japan and Italy. We divided the calcified group into the following 2 groups: estimated glomerular filtration rate (eGFR) ≥30 (n = 687) and <30 (n = 100) and compared the clinical outcomes. The primary end point was target lesion failure (TLF) at 3 years. TLF was defined as a composite of cardiac death, target lesion revascularization, and myocardial infarction. TLF occurred more frequently in the calcified group (adjusted hazard ratio 1.36, 95% confidence interval 1.08 to 1.71, p = 0.01), especially in calcified ULMD with eGFR <30 (adjusted hazard ratio relative to the other 2 groups 2.59, 95% confidence interval 1.60 to 4.18, p <0.001). In conclusion, the calcified ULMD treated with PCI was associated with poorer clinical outcomes than noncalcified ULMD, especially in those with eGFR <30., Competing Interests: Disclosures The authors have no conflicts of interest to declare., (Copyright © 2022 Elsevier Inc. All rights reserved.)

Ellis grade III coronary artery perforations (G3-CAP) remain a life-threatening complication of percutaneous coronary intervention (PCI), with high morbidity and mortality and lack of consensus regarding optimal treatment strategies. We reviewed all PCIs performed in 10 European centers from 1993 to 2019 recording all G3-CAP along with management strategies, in-hospital and long-term outcome according to Device-related perforations (DP) and Guidewire-related perforations (WP). Among 106,592 PCI (including 7,773 chronic total occlusions), G3-CAP occurred in 311 patients (0.29%). DP occurred in 194 cases (62.4%), more commonly in proximal segments (73.2%) and frequently secondary to balloon dilatation (66.0%). WP arose in 117 patients (37.6%) with chronic total occlusions guidewires involved in 61.3% of cases. Overall sealing success rate was 90.7% and usually required multiple maneuvers (80.4%). The most commonly adopted strategies to obtain hemostasis were prolonged balloon inflation (73.2%) with covered stent implantation (64.4%) in the DP group, and prolonged balloon inflation (53.8%) with coil embolization (41%) in the WP group.  Procedural or in-hospital events arose in 38.2% of cases: mortality was higher after DP (7.2% vs 2.6%, p = 0.05) and acute stent thrombosis 3-fold higher (3.1% vs 0.9%, p = 0.19). At clinical follow-up, median 2 years, a major cardiovascular event occurred in one-third of cases (all-cause mortality 8.2% and 7.1% respectively, without differences between groups). In conclusion, although rare and despite improved rates of adequate perforation sealing G3-CAP cause significant adverse events. DP and WP result in different patterns of G3-CAP and management strategies should be based on this classification., (Copyright © 2020 Elsevier Inc. All rights reserved.)

The impact of chronic kidney disease (CKD) on clinical outcomes after percutaneous coronary intervention for unprotected left main distal bifurcation lesions in patients with diabetes mellitus (DM) is not fully understood in drug eluting stent era. We identified 512 consecutive DM patients who underwent percutaneous coronary intervention for unprotected left main distal bifurcation lesions at New Tokyo Hospital, San Raffaele Scientific Institute and EMO-GVM Centro Cuore Columbus between January 2005 and December 2015. We analyzed according to estimated glomerular filtration rate (eGFR). Each group was defined as follows; no CKD (60 ≤ eGFR), mild CKD (45 ≤ eGFR < 60), moderate CKD (30 ≤ eGFR < 45), and severe CKD (15 ≤ eGFR < 30). The primary end point was target lesion failure (TLF) at 3 years. TLF was defined as a composite of cardiac death, target lesion revascularization, and myocardial infarction. The rate of TLF was significantly higher in the severe CKD group than that in the other groups (Adjusted HR of severe CKD relative to the others 3.64, [1.86 to 7.11], p < 0.001). Cardiac mortality was significantly higher in the severe CKD group than that in the other groups (Adjusted HR of severe CKD relative to the others 6.43, [2.19 to 18.9], p = 0.001). Target lesion revascularization rate was comparable in 4 groups (Adjusted HR of severe CKD relative to the others 1.71, [0.60 to 4.82], p = 0.31). In conclusions, in DM patients, those with severe CKD was extremely associated with worse clinical outcomes., (Copyright © 2020 Elsevier Inc. All rights reserved.)

The durability of chronic total occlusion (CTO) percutaneous coronary intervention (PCI) is uncertain. We aimed to compare the long-term outcomes of CTO PCI with those of complex non-CTO PCI. We built a single-center registry including all patients who underwent CTO and complex non-CTO PCI between 2012 and 2017. Complex non-CTO PCI was defined as: 3 vessels treated, ≥3 stents implanted, total stent length >60 mm, saphenous vein graft intervention, 2-stent bifurcation intervention, left main PCI, protected PCI, or rotational/laser atherectomy. The primary endpoint was target-lesion failure, a composite of cardiac death, myocardial infarction, and target-lesion revascularization. A total of 2,396 patients were included (n=609 CTO PCI, n=1,787 complex non-CTO PCI). Patients who underwent CTO PCI were younger and had higher prevalence of cardiovascular comorbidities. CTO PCI patients exhibited worse procedural metrics and success rate (74% vs 98%, p <0.001). They also suffered a higher incidence of coronary perforation (3.5% vs 2.0%, p = 0.04) and cardiac tamponade (0.8% vs 0.1%, p = 0.001). However, there was no difference in the overall incidence of in-hospital major adverse cardiac and cerebrovascular events (4.1% vs 5.0%, p = 0.40). At 36 months, there were no differences in the incidence of target-lesion failure (10.1% vs 9.9%, p = 0.91) or its individual components, between the CTO and complex non-CTO group. This finding was confirmed on multivariable analysis. In conclusion, CTO PCI is associated with lower success rates and higher risk for coronary perforation and tamponade compared with complex non-CTO PCI. The incidence of other in-hospital and long-term adverse events is similar and reasonably low., (Copyright © 2019 Elsevier Inc. All rights reserved.)

A high prevalence of mitral annular calcium (MAC) is expected in patients undergoing transcatheter aortic valve implantation (TAVI); however, data regarding the prevalence of MAC and impact on risk of cardiovascular events are lacking. To determine the prevalence of MAC and its association with clinical outcomes in patients undergoing TAVI, we retrospectively analyzed 424 patients who underwent transfemoral TAVI from 2007 to 2015 and whose preoperative computed tomography images were available for assessment of MAC. Severe circumferential MAC (SC-MAC) was defined as calcification involving at least the whole posterior annulus alone or with the attachment of the anterior leaflet. Clinical outcomes were examined according to Valve Academic Research Consortium-2 criteria up to 2 years. SC-MAC was found in 17.7% of patients. Patients with SC-MAC were more likely to be female, with a higher prevalence of atrial fibrillation and peripheral artery disease. There were no differences between the groups regarding age, functional class, prevalence of diabetes, kidney disease, and operative risk. Female gender and peripheral artery disease were independent predictors of SC-MAC. SC-MAC did not appear to be associated with periprocedural and 30-day outcomes. At 2 years' follow-up, patients with SC-MAC had significantly higher cardiovascular and all-cause mortality rates. SC-MAC was an independent predictor of cardiovascular mortality during follow-up. In conclusion, SC-MAC is a frequent finding in the TAVI population and appears to be an independent predictor of cardiovascular mortality at 2 years' follow-up., (Copyright © 2017 Elsevier Inc. All rights reserved.)

There is limited evidence to support decision-making regarding discharge antiplatelet therapy after transcatheter aortic valve implantation (TAVI). The aim of this study was to assess the outcome of patients discharged on single-antiplatelet therapy (SAPT) or dual-antiplatelet therapy (DAPT) after TAVI. Consecutive patients were identified by retrospective review of a dedicated TAVI database of a single high-volume center in Milan, Italy, from January 2009 to May 2015. Our primary end point was the rate of net adverse clinical events defined as a composite of all-cause mortality, major bleeding requiring hospitalization, cerebrovascular accidents, redo-TAVI or surgical aortic valve replacement, and valve thrombosis. A total of 439 patients were included in the final analysis; 108 patients were discharged on SAPT and 331 on DAPT. Reasons for discharge SAPT included high risk of bleeding (n = 33; 31%), postprocedural bleeding (n = 42; 39%), thrombocytopenia (n = 20; 18%), vascular complications (n = 13; 12%). The mean length of DAPT was 5.2 ± 2.7 months. Patients discharged in SAPT had a higher incidence of life-threatening bleeding during the index hospitalization. At follow-up, no differences were observed in the incidence of net adverse clinical event, all-cause or cardiovascular mortality, and cerebrovascular events. A similar rate of valve thrombosis was reported in both groups. In conclusion, prescribing only SAPT after TAVI in selected patients was not associated with an increased risk of events and may be an acceptable alternative to DAPT in elderly patients at high risk of bleeding., (Copyright © 2017 Elsevier Inc. All rights reserved.)

This study investigates clinical outcomes after drug-coated balloon (DCB) treatment for in-stent restenosis (ISR) based on the angiographic result achieved after predilatation and before DCB treatment. Among ISR lesions treated with DCBs, 166 lesions with angiography immediately after predilatation were analyzed. The lesions were divided into 2 groups according to angiographic results after predilatation: (1) "adequate" defined as the presence of Thrombolysis In Myocardial Infarction 3 flow, residual stenosis ≤30%, and no major dissections (n = 98 lesions) or (2) "inadequate" (n = 68 lesions). The reference vessel diameters were larger (2.88 ± 0.39 vs 2.64 ± 0.52 mm, p = 0.001) and lesion lengths shorter in the adequate group (15.4 ± 11.2 vs 19.7 ± 13.9 mm, p = 0.04). During a median follow-up of 808 days, the cumulative target lesion revascularization (TLR) rate was lower in the adequate group (20.3% vs 35.5% at 2 years; p = 0.04). Multivariate analysis indicated that an angiographically inadequate result before DCB treatment was an independent predictor of TLR, even after adjusting for reference vessel diameter and lesion length (hazard ratio 1.99, 95% confidence interval 1.02 to 3.87, p = 0.04). In conclusion, angiographic results after lesion preparation appear to be a good predictor of TLR after DCB treatment for ISR., (Copyright © 2016 Elsevier Inc. All rights reserved.)

Balloon predilation is historically considered a requirement before performing transcatheter aortic valve implantation (TAVI). As the procedure has evolved, it has been questioned whether it is actually needed, but data are lacking on mid-term outcomes. The aim of this study was to evaluate the effect of balloon predilation before TAVI. A total of 517 patients who underwent transfemoral TAVI from November 2007 to October 2015 were analyzed. The devices implanted included the Medtronic CoreValve (n = 216), Medtronic Evolut R (n = 30), Edwards SAPIEN XT (n = 210), and Edwards SAPIEN 3 (n = 61). Patients were divided into 2 groups depending on whether pre-implantation balloon aortic valvuloplasty (pre-BAV) was performed (n = 326) or not (n = 191). Major adverse cardiac and cerebrovascular events (MACCE) were primarily evaluated. Propensity score matching was used to adjust for differences in baseline characteristics and potential confounders (n = 113 pairs). In the overall cohort, patients without pre-BAV had a significantly higher MACCE rate at 30 days, driven by a higher incidence of stroke (0.3% pre-BAV vs 3.7% no-pre-BAV, p <0.01). MACCE and mortality at 1 year were, however, similar in both groups. Independent predictors of MACCE at 1 year included serum creatinine, NYHA class 3 to 4, logistic European System for Cardiac Operative Risk Evaluation, and postdilation. Of note, the postdilation rate was higher in the no-pre-BAV group (21.5% pre-BAV vs 35.6% no-pre-BAV, p <0.001). After propensity score matching, there were no differences in MACCE between the 2 groups. In conclusion, this study showed that, in selected patients and with specific transcatheter valves, TAVI without pre-BAV appears to be associated with similar mid-term outcomes compared with TAVI with pre-BAV, but it may increase the need for postdilation., (Copyright © 2016 Elsevier Inc. All rights reserved.)

Transcatheter aortic valve implantation (TAVI) is now the treatment of choice for patients with symptomatic aortic stenosis who are inoperable or with high surgical risk. Data with regards to contemporary clinical practice and long-term outcomes are sparse. To evaluate temporal changes in TAVI practice and explore procedural and long-term clinical outcomes of patients in a contemporary "real-world" population, outcomes of 829 patients treated from November 2007 to May 2015, at the San Raffaele Scientific Institute, Milan, Italy, were retrospectively analyzed. Median follow-up was 568 days, with the longest follow-up of 2,677 days. Overall inhospital mortality was 3.5%. During the study period, there was a trend toward treating younger, lower risk patients. Overall mortality rates were 3.5% (30 days), 14% (1 year), 22% (2 years), 29% (3 years), 37% (4 years), 47% (5 years), 53% (6 years), and 72% (7 years). The survival probability at 5 years was significantly higher in patients treated through the transfemoral (TF) route compared to other vascular access sites (log rank p <0.001). Non-TF vascular access and residual paravalvular leak ≥2 (after TAVI) were identified as independent predictors for both all-cause and cardiovascular mortality. No patient required further aortic valve intervention for TAVI prosthesis degeneration. In conclusion, there is a trend toward treating younger, lower-risk patients. Non-TF vascular access approach and ≥2 PVL after TAVI were identified as independent predictors for both overall and cardiovascular mortality with no cases of prosthesis degeneration suggesting acceptable durability., (Copyright © 2016 Elsevier Inc. All rights reserved.)

Data on transcatheter aortic valve implantation (TAVI) for severe bicuspid aortic valve (BAV) stenosis and how this compares to that for tricuspid aortic valve (TAV) stenosis are limited. Twenty-one consecutive patients with BAV were treated with the Edwards or CoreValve bioprosthesis from November 2007 to December 2012 at San Raffaele Scientific Institute and Clinical Institute S. Ambrogio, Milan, Italy. Results were compared with a cohort of patients with TAV (n=447) treated with the same bioprostheses over the same period. Procedural 1- and 12-month outcomes were examined as defined by the Valve Academic Research Consortium criteria. Patients with BAV were younger (76.7±7.1 vs 79.8±7.4 years, p=0.06) and with a larger aortic annulus (25.0±1.8 vs 23.6±2.1 mm, p=0.01). Device success (85.7% vs 94.4%, p=0.10) was lower in patients with BAV. Although the 30-day composite safety end point (23.8% vs 21.0%, p=0.76) was similar between the 2 groups, mortality rate at 30 days was higher (14.2% vs 3.6%, p=0.02) in the BAV group. Cardiovascular mortality at 1 year did not differ significantly between the 2 groups (10.5% vs 7.4%, p=0.62). In conclusion, transcatheter aortic valve implantation in high surgical risk patients with severe BAV stenosis appears to be feasible with mid-term cardiovascular mortality similar to that for patients with TAV. Early survival and device success, however, were lower for patients with BAV demonstrating that further studies are required to identify which subset of patients with BAV is best suited for transcatheter treatment., (Copyright © 2014 Elsevier Inc. All rights reserved.)

Conduction disorders and permanent pacemaker implantation are common complications in patients who undergo transcatheter aortic valve implantation (TAVI). The aim of this study was to assess the incidence and clinical significance of new bundle branch block in patients who underwent TAVI with the Medtronic CoreValve Revalving System (MCRS) or the Edwards SAPIEN valve (ESV). Data from 238 patients with no previous pacemaker implantation, left bundle branch block (LBBB) or right bundle branch block at baseline electrocardiography who underwent TAVI with either MCRS (n = 87) or ESV (n = 151) bioprostheses from 2007 to 2011 were analyzed. New-onset LBBB occurred in 26.5% patients (n = 63): 13.5% with the ESV (n = 20) and 50.0% with the MCRS (n = 43) (p = 0.001). Permanent pacemaker implantation was required in 12.7% of patients (n = 8) because of complete atrioventricular block (ESV n = 2, MCRS n = 4), LBBB and first degree atrioventricular block (MCRS n = 1) and new-onset LBBB associated with sinus bradycardia (MCRS n = 1). At discharge, LBBB persisted in 8.6% of ESV patients (n = 13) and 32.2% of MCRS patients (n = 28) (p = 0.001). On multivariate analysis, the only predictor of LBBB was MCRS use (odds ratio 7.2, 95% confidence interval 2.9 to 17.4, p <0.001). Persistent new-onset LBBB at discharge was not associated with overall (log-rank p = 0.42) or cardiovascular (log-rank p = 0.46) mortality. New-onset right bundle branch block was documented in 4.6% of patients (n = 11), with no statistically significant differences between the ESV and MCRS. In conclusion, new-onset LBBB is a frequent intraventricular conduction disturbance after TAVI with a higher incidence with the MCRS compared with the ESV. LBBB persists in most patients, but in this cohort, it was not a predictor of overall or cardiovascular mortality or permanent pacemaker implantation., (Copyright © 2013 Elsevier Inc. All rights reserved.)

Saphenous vein grafts (SVGs) are prone to an aggressive atherosclerotic process, and the efficacy of drug-eluting stents (DES) in treating this is still debated. In recent years, second-generation DES have been increasingly used in SVG intervention. The main objective of this study was to compare midterm clinical outcomes between first- and second-generation DES in SVGs because data regarding the use of second-generation DES in SVG are lacking. Patients treated with first-generation DES (127 patients with 143 lesions) and those treated with second-generation DES (84 patients with 100 lesions) were included in the study. Major adverse cardiac events, defined as the composite of all-cause death, myocardial infarction, and target vessel revascularization, as well as target vessel revascularization and target lesion revascularization separately, were evaluated at 30-day, 12-month, and 18-month follow-up. Baseline characteristics were similar between the 2 groups. Older grafts were treated with second-generation DES (11.6 ± 5.3 vs 14.3 ± 6.0 years, p = 0.001). Stent length was longer in the first-generation group (34.1 ± 25.1 vs 30.5 ± 19.4 mm, p = 0.006), and maximum balloon diameter was smaller in the second-generation group (3.42 ± 0.42 vs 3.30 ± 0.41 mm, p = 0.003). Embolic protection device use was higher in the second-generation DES group (55.2% vs 72.0%, p = 0.012). At 18-month follow-up, rates of major adverse cardiac events, target vessel revascularization, and target lesion revascularization for the first- and second-generation groups were 24.4% versus 20.2% (p = 0.479), 18.1% versus 14.2% (p = 0.465), and 15.0% versus 10.7% (p = 0.373), respectively. In conclusion, second-generation DES are at least comparable with first-generation DES with regard to clinical outcomes at midterm follow-up., (Copyright © 2013 Elsevier Inc. All rights reserved.)

Patients who undergo transcatheter aortic valve implantation are generally discharged on dual-antiplatelet therapy. However, many of these patients also have indications for anticoagulant therapy, and it is unclear what the best antithrombotic strategy is in these cases. Data from 360 patients who underwent transcatheter aortic valve implantation were retrospectively analyzed, of whom 60 (16.7%) had indications for anticoagulant treatment, mainly because of atrial fibrillation. The antithrombotic regimen was decided according to clinical evaluation of thrombotic and hemorrhagic risk; most of these patients (n = 43) were discharged with warfarin plus a single antiplatelet drug. Their outcomes were compared to those in a group with no indications for anticoagulation (n = 300) treated with dual-antiplatelet therapy. During the follow-up period (median 11 months), 53 patients (15%) died; mortality was not associated with antithrombotic regimen. The incidence of cerebral events or intracranial hemorrhage (4.6% and 1.1%, respectively) was low in the study population, and no significant differences were detected between groups; the bleeding rate was also unaffected by antithrombotic therapy. In conclusion, when anticoagulation is indicated after transcatheter aortic valve implantation, many variables must be taken into account. The most frequent scenario in this study was patients in atrial fibrillation, most of whom were discharged with warfarin plus a single antiplatelet medication. When bleeding was a concern, especially in the absence of coronary disease, warfarin alone was prescribed. These results suggest that this approach is safe, but data from larger, randomized studies are needed., (Copyright © 2013 Elsevier Inc. All rights reserved.)

Percutaneous coronary intervention (PCI) to aorto-ostial (AO) lesions is technically demanding and associated with high revascularization rates. The aim of this study was to assess outcomes after bare metal stent (BMS) compared to drug-eluting stent (DES) implantation after PCI to AO lesions. A retrospective cohort analysis was conducted of all consecutive patients who underwent PCI to AO lesions at 2 centers. Angiographic and clinical outcomes in 230 patients with DES from September 2000 to December 2009 were compared to a historical control group of 116 patients with BMS. Comparison of the baseline demographics showed more diabetics (32% vs 16%, p = 0.001), lower ejection fractions (52.3 ± 9.7% vs 55.0 ± 11.5%, p = 0.022), longer stents (17.55 ± 7.76 vs 14.37 ± 5.60 mm, p <0.001), and smaller final stent minimum luminal diameters (3.43 ± 0.53 vs 3.66 ± 0.63 mm, p = 0.001) in the DES versus BMS group. Angiographic follow-up (DES 68%, BMS 66%) showed lower restenosis rates with DES (20% vs 47%, p <0.001). At clinical follow-up, target lesion revascularization rates were lowest with DES (12% vs 27%, p = 0.001). Cox regression analysis with propensity score adjustment for baseline differences suggested that DES were associated with a reduction in target lesion revascularization (hazard ratios 0.28, 95% confidence interval 0.15 to 0.52, p <0.001) and major adverse cardiac events (hazard ratio 0.50, 95% confidence interval 0.32 to 0.79, p = 0.003). There was a nonsignificantly higher incidence of Academic Research Consortium definite and probable stent thrombosis with DES (n = 9 [4%] vs n = 1 [1%], p = 0.131). In conclusion, despite differences in baseline characteristics favoring the BMS group, PCI with DES in AO lesions was associated with improved outcomes, with lower restenosis, revascularization, and major adverse cardiac event rates., (Copyright © 2011 Elsevier Inc. All rights reserved.)

Poor long-term outcomes after percutaneous coronary intervention (PCI) in chronic total occlusion (CTO) of saphenous vein grafts (SVGs) have been reported. However, limited data are available evaluating the use of modern techniques in this group. The aim of the present study was to assess the efficacy and long-term outcomes of PCI in SVG CTO with the routine use of embolic protection devices and drug-eluting stents. A retrospective cohort analysis was conducted of all consecutive patients undergoing PCI to SVG CTO from May 2002 to July 2009 at 2 centers. The indication for PCI was the presence of angina or silent ischemia with evidence of inducible ischemia after functional testing in the territory supplied by the SVG, despite optimal medical therapy. We identified 34 patients with SVG CTO. Of the 34 patients, 23 (68%) underwent successful SVG recanalization with stent implantation. An embolic protection device was used in 78% and 95% of stents implanted were drug-eluting stents. No in-hospital major adverse cardiac events occurred in the successful PCI group; one myocardial infarction occurred in the unsuccessful group. At follow-up (median 18.0 months, interquartile range 10.4 to 48.3), 1 case of myocardial infarction had occurred in the successful group. The in-stent restenosis rate was 68% (n = 13), of which 77% were focal, with target vessel revascularization in 61%. In conclusion, despite the relatively low procedural success rates, the clinical outcomes after successful PCI to SVG CTO with modern techniques were favorable. The repeat revascularization rates were high; however, graft patency was achievable in most after reintervention., (Copyright © 2010 Elsevier Inc. All rights reserved.)

To characterize in-stent restenosis after the implantation of sirolimus-eluting stents (SES), paclitaxel-eluting stents (PES), tacrolimus-eluting stents (TES), and zotarolimus-eluting stents (ZES), 25 patients treated with drug-eluting stents (DES; 9 PES, 10 SES, 4 TES, and 2 ZES) and 19 with bare-metal stents (BMS) underwent directional coronary atherectomy for in-stent restenosis 4 to 36 months after implantation. Restenosis after DES implantation was more frequently focal and associated with smaller specimens compared to that after BMS implantation. Light and confocal microscopy were used. Histologic features were similar in DES and BMS. In-stent restenotic lesions were composed mainly of neointima containing proteoglycan-rich smooth muscle cells and fibrolipidic regions. Small inflammatory infiltrates were observed, mostly in patients with unstable angina; CD18- and/or CD3(+) cells were detected in patients with BMS and DES. Different smooth muscle cell phenotypes were observed: synthetic was more frequent with BMS and PES, intermediate with ZES, contractile or intermediate with SES, and contractile with TES. The mean proliferation index was low and comparable among stent types; cyclins B1 and D1 were expressed in all DES. In conclusion, intra-DES and intra-BMS restenotic tissue was composed mainly of smooth muscle cells with different phenotypes, proliferating at a low rate. The different smooth muscle cell phenotypes within the stent types might suggest different mechanisms of restenosis.

Prolonged periods of dual antiplatelet therapy (DAT), i.e., aspirin plus a thienopyridine, are currently recommended to prevent late drug-eluting stent (DES) thrombosis. The aim of our study was to determine the risk and predictors of bleeding and compliance associated with such prolongation of DAT. In this observational study we examined 2,355 consecutive patients undergoing successful DES implantation at 4 hospitals in Italy from June 2002 to December 2004. Bleeding events occurring on DAT and warfarin or in the first 30 days after stent implantation were excluded. Median duration of DAT was 209 days (interquartile range 178 to 444) and only 158 patients (6.7%) prematurely discontinued DAT. The overall bleeding rate was 1.9% (45), with major bleeding in 19 (0.8%) and minor bleeding in 26 (1.1%). Independent predictors of bleeding were DAT (hazard ratio 19.8, 95% confidence interval [CI] 3.69 to 106.34, p <0.001) and age >65 years (hazard ratio 2.15, 95% CI 1.16 to 4.00, p = 0.02). In patients on DAT, the incidence rate (30 days to 18 months) of any bleeding event was 2.57 per 100 person-years (95% CI 1.85 to 3.48) and major bleeding was 1.10 per 100 person-years (95% CI 0.65 to 1.74). In conclusion, DAT after DES implantation is well tolerated and associated with a very low risk of major bleeding.

Despite encouraging results from randomized trials, concerns exist about long-term results of sirolimus-eluting stent implantation. We sought to determine whether in-stent restenosis occurring >1 year ("late") after sirolimus-eluting stent implantation is a real clinical entity. We analyzed data on all sirolimus-eluting stents implanted in our institution before March 2003. During the study period 928 lesions in 433 patients were treated. Angiographic follow-up was performed in 306 patients (70.6%) with 679 lesions (73.2%). Angiography after 1 year was performed only in symptomatic patients. We considered restenosis "early" if it occurred during the first year and late if after 1 year. Late restenosis required demonstration of a widely patent stent at 6 to 9 months, with repeat angiography after 1 year demonstrating restenosis. Restenosis occurred in 160 lesions overall (23.5%). Of the 31 (4.6%) that were documented after 1 year, 13 were excluded from analysis due to absence of 6- to 9-month angiography; the remaining 18 (2.6%, 1.7 to 4.2) fulfilled our criteria for late restenosis (median time of documentation 607 days, interquartile range 511 to 923). In conclusion, late restenosis is an infrequent but real entity; its existence implies we should not discount the possibility of restenosis as the cause of symptoms that develop >1 year after sirolimus-eluting stent implantation.

Nitroprusside (NTP) is used for the treatment of slow coronary flow (SCF) after coronary interventions. The wide variation in dosage, route, and timing of its administration in the reported studies prevents an objective assessment of its efficacy. We report the incidence and response to a standardized NTP protocol of SCF after successful stent implantation. Selective intracoronary administration of incremental doses (initial bolus of 80 microg incremented by 40 microg) of NPT was assessed in 21 patients who developed SCF in a series of 2,212 consecutive patients who underwent successful stent placement from January to October 2005. SCF was observed only in patients treated for acute myocardial infarction (AMI; 11.5%, 12 of 105) or saphenous vein graft (SVG) stenosis (8.2%, 9 of 109). An intracoronary bolus of nitroglycerin did not restore normal Thrombolysis In Myocardial Infarction (TIMI) flow in any patient. The first 80-microg dose of NTP restored normal TIMI flow in 58% of patients (7 of 12) with AMI and in 44% of patients (4 of 9)with SVG stenosis. The maximal dose (120/160 microg) restored normal TIMI flow in all remaining patients with AMI but in only 1 additional patient with SVG stenosis. At the end of the procedure, the percent decrease in corrected TIMI frame count was significantly larger in patients with AMI (-44+/-10%) than in those with SVG stenosis (-24+/-16%, p=0.02). In a large consecutive series of successful stent procedures, SCF was found only in patients with ST-elevation AMI (11.5%) or with a stenosed SVG (8.2%). In conclusion, the standardized protocol of intracoronary NTP administration succeeded in normalizing SCF in all patients with AMI but in only 5 of 9 patients with SVG stenosis. This latter subgroup requires other therapeutic strategies.

Late loss is becoming an important end point to compare drug-eluting stents; however, little is known about its pattern of distribution. We analyzed the pattern of late loss distribution in sirolimus-eluting stents (SESs) and paclitaxel-eluting stents (PESs) in a consecutive cohort of patients. From a cohort of 529 patients treated with drug-eluting stents in 1 year, we selected all patients who underwent angiographic follow-up. Three hundred fifty-nine patients with 592 de novo lesions received SESs (286 lesions) or PESs (306 lesions). Late loss and binary angiographic restenosis were analyzed. Binary restenosis occurred in 56 lesions (19.6%) treated with SESs compared with 53 (17.3%) treated with PESs (p = 0.48). The 2 late loss distributions were skewed to the right and were not normally distributed (p <0.001 for SES, p = 0.003 for PES). Late loss was significantly lower in the SES group (p = 0.03), with a median value of 0.29 mm (interquartile range -0.09 to 0.66) versus 0.41 mm (-0.02 to 0.85) in the PES group. When analyzing only restenotic lesions, late loss had a normal distribution in the SES and PES groups (p = 0.96 and 0.44, respectively) and was similar in the 2 groups (1.75 +/- 0.51 vs 1.82 +/- 0.62, p = 0.48). When evaluating nonrestenotic lesions, late loss was also normally distributed in the 2 groups (p = 0.75 for SES, p = 0.73 for PES) but was significantly lower (p = 0.002) after SES implantation (0.14 +/- 0.39) than after PES implantation (0.27 +/- 0.44). In conclusion, SESs and PESs have a bimodal pattern of late loss distribution. The observed difference in late loss between SES and PES seems to be partly explained by the decrease in late loss after SES implantation in nonrestenotic lesions (where SES approaches "zero late loss"). Thus, late loss may not be a reliable marker of the true efficacy of these devices due to its complex and nongaussian distribution.

Percutaneous coronary intervention in a patient's last remaining coronary conduit is perceived to be high risk, although there are no published data on outcomes in this lesion cohort. We report our experience with 16 patients who underwent intervention in their sole remaining vessel between 1998 and 2005. All patients had previously undergone coronary artery bypass grafting, had a history of myocardial infarction, had impaired left ventricular systolic function, and were symptomatic with unstable angina or minimal effort angina. There was 1 periprocedural death 10 hours after the procedure, and another patient died 4 months after the procedure. At 6-month follow-up, 2 patients had undergone target lesion revascularization. There was a significant and sustained improvement in symptom status, with 75% of patients being asymptomatic or in Canadian Cardiovascular Society class I after 6 months. Given the complexity of the patients and lesions treated in this cohort, periprocedural and long-term outcomes are acceptable with a notable improvement in symptomatic status. In conclusion, these data support percutaneous intervention as a realistic treatment option for this often highly symptomatic and difficult-to-treat patient cohort.

Randomized trials have shown that implantation of sirolimus-eluting stents (SESs) and paclitaxel-eluting stents (PESs) reduce the incidence of major adverse cardiac events (MACEs) compared with bare metal stents. We compared the impact of SESs and PESs on clinical outcome in medically treated diabetic patients with multivessel stents. In this study, the in-hospital and 9-month clinical outcomes of 260 consecutive diabetic patients who underwent implantation of SESs (147 patients) or PESs (113 patients) were compared. MACEs were defined as death, nonfatal myocardial infarction, and clinically driven target vessel revascularization. The baseline demographic and angiographic characteristics were well matched. An average of 3.0 +/- 1.3 versus 2.8 +/- 1.2 lesions were treated in the SES and PES groups, respectively (p = 0.34), with a mean stented length per patient of 73 +/- 43 versus 61 +/- 36 mm (p = 0.08). No significant difference was observed between the SES and PES groups for in-hospital (6.1% vs 3.5%, p = 0.34) or 9-month MACE (24.5% vs 19.5%, p = 0.34) rates or for subacute (1.4% vs 0.9%, p = 0.72) or late (0.7% vs 0.9%, p = 0.85) stent thrombosis. Insulin-requiring diabetic patients treated with SESs and PESs also had similar demographic and angiographic characteristics and rates of in-hospital (4.7% vs 7.7%, p = 0.57) and 9-month (28.0% vs 38.4%, p = 0.44) MACEs. Insulin-dependent diabetes was the only independent predictor of MACEs (odds ratio 2.68, 95% confidence interval 1.46 to 4.89, p = 0.001). In conclusion, our results demonstrated a relatively high incidence of MACEs in a diabetic population with multivessel disease, despite treatment with drug-eluting stents. In addition, we could not find any clear advantage of 1 type of stent versus the other.

In patients with in-stent restenosis (ISR) inside bare metal stents, drug-eluting stents reduce the recurrence of restenosis compared with balloon angioplasty. However, few data are available about this therapeutic modality in the case of diffuse restenosis. The aim of this study was to evaluate the immediate and mid-term outcome of sirolimus- and paclitaxel-eluting stent implantation in diffuse ISR and determine the predictors of clinical and angiographic restenosis recurrence. A series of 161 consecutive patients with 194 diffuse ISR lesions (>10 mm) treated with drug-eluting stent implantation were evaluated. Major adverse cardiac events were defined as death, myocardial infarction, and the need for target lesion revascularization. During a mean follow-up of 8.2 +/- 3.4 months, the cumulative incidence of major adverse cardiac events was 19% in the SES group and 24% in the PES group (p = 0.56). Angiographic follow-up was performed in 80% of the lesions. The overall restenosis rate was 22% and was not significantly different between lesions treated with sirolimus-eluting (20%) or paclitaxel-eluting (25%, p = 0.55) stents. The incidence of restenosis was higher in diabetics (32%) than in nondiabetics (16%, odds ratio 2.5, 95% confidence interval 1.1 to 5.5, p = 0.02). By multivariate analysis, diabetes was confirmed to be the only independent predictor of recurrent restenosis (odds ratio 3.53, 95% confidence interval 1.39 to 9.02, p = 0.008). In conclusion, drug-eluting stent implantation for diffuse ISR is associated with acceptable clinical and angiographic results. The association of diffuse restenosis and diabetes mellitus is an unfavorable condition leading to a high risk of recurrence.

We investigated early and mid-term clinical and angiographic outcomes of patients who had de novo ostial left anterior descending coronary artery (LAD) lesions that were treated with drug-eluting stents (DESs) or bare metal stents (BMSs). We identified 43 consecutive patients who underwent percutaneous intervention for isolated de novo ostial LAD lesions with implantation of DESs and compared them with 43 patients who had similar lesions that were treated with BMSs. All stents were successfully implanted. There were no significant differences with respect to major in-hospital complications between the 2 groups. One patient in the BMS group died during hospitalization. Non-Q-wave myocardial infarction occurred in 2 patients (4.7%) in the DES and in 1 patient (2.3%) in the BMS group. At 9-month follow-up, 3 patients (7%) in the DES group and 11 (25.6%) in the BMS group underwent target lesion revascularization (p = 0.038); major adverse cardiac events were less frequent in the DES than in the BMS group (9.3% vs 32.6%, p = 0.015). Angiographic follow-up was available in 82% of patients in the DES group and 75% of those in the BMS group (p = 0.6) and showed lower binary restenotic rates (5.7% vs 31.3%, p = 0.01) and smaller late loss (0.30 +/- 0.81 vs 1.23 +/- 0.93 mm, p = 0.0001) in the DES group. In conclusion, DES implantation in de novo ostial LAD lesions appears safe and effective and is associated with a significant decrease in restenotic rates compared with historical experience with BMSs.

We compared the clinical efficacy of paclitaxel-eluting stents (PESs) and sirolimus-eluting stents (SESs) in a contemporary cohort of patients who had complex lesions. We collected data on 9-month outcomes in 529 patients (281 in the PES group and 248 in the SES group) whose de novo lesions were treated with drug-eluting stents. The end point was per-patient in-hospital and follow-up major adverse cardiac events, which were defined as a composite of death, myocardial infarction, and target vessel revascularization, including target lesion revascularization. There were no in-hospital deaths or repeat revascularizations; however, 5.7% of the PES group and 2% of the SES group developed a myocardial infarction (p = 0.04). At a median follow-up of 10.6 months, the rate of major adverse cardiac events was similar between groups (18.1% vs 21%, adjusted hazard ratio 0.85, 95% confidence interval 0.57 to 1.25), without any difference in the occurrence of death or myocardial infarction. Diabetes and total stent length were independent predictors of major adverse cardiac events. Propensity analysis confirmed the similarity between devices (hazard ratio 0.87, 95% confidence interval 0.62 to 1.25). Most restenoses were focal and only 2 patients required surgical revascularization. In conclusion, implantation of drug-eluting stents in complex lesions was associated with favorable results and most patients remained free from surgical revascularization at follow-up. Overall, the 2 available stent platforms had similar performance characteristics.

Although predictors of acute intraprocedural stent thrombosis (IPST) in the drug-eluting stent era have been proposed, external validation is lacking. We thus analyzed the occurrence of IPST in the RECIPE study and found that, among 1,320 patients who underwent drug-eluting stent implantation, IPST occurred in 6 (0.5%), with in-hospital major adverse events in 4 (67%). IPST was predicted by number and total length of implanted stents, baseline minimal lumen diameter, and, in a pooled analysis that incorporated values from the present study and a previous study, use of elective glycoprotein IIb/IIIa inhibitors. Such results may provide useful information to guide prevention of this complication.

Sixty in-stent restenotic lesions were treated with sirolimus-eluting stent implantation and retrospectively compared with a group of matched lesions treated with cutting balloon angioplasty. The results indicate a good safety profile of the procedure and a 57% reduction in the incidence of recurrent restenosis in comparison with cutting balloon angioplasty.

Stainless steel (SS) and carbon-coated (CC) stents were randomly compared in 347 patients (520 lesions). No differences were observed in in-hospital major adverse cardiac events: 2.8% in the CC group and 4.5% in the SS group (p = 0.286). The 6-month follow-up showed similar rates of binary restenosis (31.8% in the CC group vs 35.9% in the SS group; p = 0.448) and of cumulative major adverse cardiac events (30.5% in the CC group vs 32.7% in the SS group; p = 0.675). In unselected patients and lesions, carbon coating does not provide significant improvements over SS stents with the same design.

We sought to determine the incidence of coronary perforations, predisposing factors, and in-hospital and late outcome of patients with coronary perforations. Perforations occurred in 0.84% of treated lesions and more frequently in patients with complex lesions after atheroablative procedures and who underwent intravascular ultrasound guided lumen optimization. The incidence of adverse events, emergency coronary artery bypass grafting and death significantly decreased over time.