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Whether an eruptive or noneruptive target lesion calcified nodule (CN) portends worse acute and long-term clinical outcomes after stenting has not been established. The authors sought to compare acute and long-term clinical outcomes in eruptive CN vs noneruptive CN morphology. Using optical coherence tomography, an eruptive CN was defined as an accumulation of small calcium fragments protruding and disrupting the overlying fibrous cap, typically with small amount of thrombus. A noneruptive CN was defined as an accumulation of small calcium fragments with a smooth intact fibrous cap without an overlying thrombus. The primary endpoint was target lesion failure (TLF) including cardiac death, target vessel myocardial infarction, or clinically driven target lesion revascularization in patients with ≥6-month follow-up. Among 3,231 patients with evaluable pre- and postintervention OCT, 236 patients had lesions with CNs (7.3%). After eliminating 4 secondary lesions and 6 patients without ≥6-month follow-up, 126 (54.8%) lesions with eruptive CNs and 104 (45.2%) lesions with noneruptive CNs formed the current report. Compared with noneruptive CNs, eruptive CNs were independently associated with greater stent expansion (89.2% ± 18.7% vs. 81.5% ± 18.9%; P = 0.003) after adjusting for morphologic and procedural factors. At 2 years, eruptive CNs trended toward more TLF compared with noneruptive CNs (Kaplan-Meier estimates, 19.8% vs 12.5%; P = 0.11) and significantly more target lesion revascularization (18.3% vs 9.6%; P = 0.04). In the adjusted model, eruptive CNs were independently associated with 2-year TLF (HR: 2.07; 95% CI: 1.01-4.50; P = 0.048). Compared with noneruptive CN morphology, lesions with an eruptive CN appearance on optical coherence tomography had a worse poststent long-term clinical outcome despite better acute stent expansion. [Display omitted] [ABSTRACT FROM AUTHOR]

There are scarce data about the incidence and impact on clinical outcomes of target lesion revascularization (TLR) after percutaneous coronary intervention (PCI) for unprotected left main distal bifurcation lesions (ULMD) in current generation drug eluting stent (cDES) era. We evaluated the incidence and impact on clinical outcomes of TLR after PCI using cDES for ULMD. We identified 720 patients treated with cDES for ULMD at New Tokyo Hospital (Matsudo, Japan), San Raffaele Scientific Institute and EMO-GVM Centro Cuore Columbus (Milan, Italy) between January 2005 and December 2015. We divided those patients in 2 groups; TLR group (n = 107), no TLR group (n = 613). The TLR group was comprised patients undergoing a repeat revascularization by PCI or coronary artery bypass grafting of the target lesion. Analysis using propensity score adjustment was also performed. The primary endpoint was cardiac mortality. Additionally, we analyzed the impact of TLR for each main branch (MB) or side branch on cardiac mortality using multivariate Cox regression analysis. Cardiac mortality was significantly higher in TLR group than in no TLR group (adjusted HR 1.96; 95 % CI, 1.50–3.62; p = 0.032). Cardiac mortality was also significantly higher in TLR group after propensity score adjustment. TLR for MB was identified as an independent predictor of cardiac death on multivariate Cox regression analysis. The TLR, especially the TLR for MB, after PCI even with cDES for ULMD, was strongly associated with worse cardiac mortality. [Display omitted] [ABSTRACT FROM AUTHOR]

Percutaneous coronary intervention (PCI) is increasingly performed for symptom relief and survival benefit, particularly in patients presenting with acute coronary syndromes. It remains controversial whether prior PCI, and specifically when index PCI is performed on previously treated lesion(s), affects peri-procedural and in-hospital mortality. We queried an institutional PCI registry for all unique patients undergoing PCI during a 4-year period and classified them as having had or not prior PCI. If prior PCI had occurred, we further defined index PCI as a target lesion (TLR) PCI or non-TLR PCI, according to lesion(s) treated during the prior PCI. Multivariable analysis was performed to identify predictors of in-hospital mortality. Prior PCI was an independent predictor of in-hospital survival or lower mortality (HR 0.41 [0.22–0.76], P = 0.004), together with lower age (per 5 years, HR 0.73 [0.66–0.82], P < 0.001) and elective PCI (HR 0.63 [0.58–0.70], P < 0.0001). Among prior PCI patients, TLR PCI was associated with higher mortality (HR 3.03 [1.05–8.33]. P = 0.045), while elective PCI status was associated with lower mortality (HR 0.10 [0.01–0.80], P = 0.03). This excess mortality was only present in non-elective PCI cases (P INT = 0.02). We conclude that PCI mortality risk is decreased in patients with prior PCI, particularly when index PCI is performed electively on a lesion not previously treated. • In-hospital mortality of patients undergoing PCI is affected predominantly by age and clinical presentation. • Prior PCI is associated with lower in-hospital mortality during index PCI TLR-PCI is associated with increased in-hospital mortality when performed in ACS setting. [ABSTRACT FROM AUTHOR]

The optimal endpoint after balloon angioplasty remains poorly defined. This study aimed to characterize post-balloon angioplasty anatomical and physiological indexes by quantitative flow ratio (QFR) and to compare their prognostic impacts on long-term clinical outcomes. This retrospective study included 106 lesions from 106 patients who underwent percutaneous coronary interventions with drug-coated-balloon (n = 69) or plain-old-balloon-angioplasty (n = 37). Analyses measured minimum lumen diameter (MLD) and percent diameter stenosis (%DS) as anatomical indexes; QFR of target vessel (QFR-vessel) and QFR-gradient (ΔQFR between proximal and distal segments of the lesion) as physiological indexes. Primary endpoint was target lesion revascularization (TLR) after the index procedure. TLR occurred in 21 (20 %) lesions. TLR group showed significantly smaller QFR-vessel (0.79 ± 0.12 vs. 0.85 ± 0.12, p = 0.03), as well as greater QFR-gradient (0.12 ± 0.07 vs. 0.04 ± 0.03, p < 0.0001) at post-procedure compared with non-TLR group. The percentage of angiographically significant dissection was also more frequently observed in TLR group compared with non-TLR group (47.6 % vs. 14.1 %, p < 0.0001 for log-rank). In the multivariate analysis, angiographically significant dissection and QFR-gradient at post-procedure was significantly associated with TLR. In the receiver-operating characteristics curve analysis, the area under the curve for predicting post-procedural TLR was significantly greater for QFR-gradient than for MLD and residual %DS (p < 0.0001 for MLD and p = 0.0003 for residual %DS at post-procedure). The best cut-off value of post-procedural QFR-gradient for predicting TLR was 0.08. Post-procedural QFR-gradient across the lesion was a statistically independent and stronger predictor of TLR, compared with anatomical indexes. [Display omitted] • Post-procedural QFR after POBA or DCB was a predictor of subsequent TLR. • Per-lesion QFR analysis was a stronger predictor, compared with per-vessel analysis. • The best cut-off value of post QFR-gradient for predicting TLR was 0.08. • QFR analysis may help identify the optimal endpoint of balloon angioplasty. [ABSTRACT FROM AUTHOR]

Symptomatic central venous obstruction (CVO) is sometimes observed in patients undergoing hemodialysis. Angioplasty is generally performed for salvage purposes, and stent implantation is performed as a last resort to prevent permanent venous occlusion. However, published reports about the clinical outcomes of stenting for CVO have been limited by the small number of included patients and the relatively old generation of analyzed stents. This study aimed to clarify the safety and efficacy of endovascular therapy (EVT) using stents for symptomatic CVO in contemporary practice. This retrospective review was performed between May 2012 and August 2021. We retrospectively analyzed consecutive 31 lesions (31 patients, 64 ± 10.7 years old) treated with a vascular stent for elastic recoil after balloon angioplasty or recurrent stenosis <3 months after angioplasty. The primary outcome was primary patency, defined as freedom from target lesion revascularization. The secondary outcome was assisted primary patency, defined as freedom from permanent occlusion of the target stents. In all cases, stents were successfully deployed on the target lesions. No EVT-related complications were observed. Self-expandable and balloon-expandable stents were used in 26 and 5 lesions, respectively. The median follow-up period was 18 months (interquartile range, 7–40). Kaplan-Meier analysis revealed that the primary patency rates were 66.1 % at 6 months, 61.7 % at 12 months, and 38.4 % at 24 months after EVT. The assisted primary patency rate was 70.3 % 24 months after EVT. In the multivariate analysis, younger age was the only independent predictor of target lesion revascularization (hazard ratio: 0.92, 95 % CI: 0.85–0.99, p = 0.04). Stent implantation for CVO that is resistant to standard angioplasty seems safe and effective. [Display omitted] • Endovascular therapy with stents for central venous obstruction in patients receiving hemodialysis is safe. • Midterm patency rates seem acceptable in contemporary practice. • Young age is a predictor of clinically driven, target lesion revascularization. [ABSTRACT FROM AUTHOR]

In-stent restenosis (ISR) remains a significant challenge in interventional cardiology despite advancements in stent technology. Drug-coated balloons (DCBs), which deliver antiproliferative agents directly to the vessel wall, have emerged as a promising alternative to plain balloon angioplasty for ISR treatment. This meta-analysis evaluates the efficacy of DCBs compared to plain balloon angioplasty in patients with coronary ISR. A comprehensive search of PubMed and Embase was conducted on June 27, 2024. The search identified randomized controlled trials comparing DCBs and plain balloon angioplasty for ISR treatment. Six trials involving 1,322 patients met the inclusion criteria. Quality was assessed with the Cochrane Risk of Bias tool. Data extraction and statistical analysis were performed using RevMan software, assessing heterogeneity with the I2 statistic and publication bias using funnel plots. The analysis showed that DCBs significantly reduced late in-stent and in-segment luminal loss (P < 0.001) and target lesion revascularization (P = 0.02) compared to plain balloon angioplasty. Major adverse cardiovascular events and the combined endpoint of target lesion revascularization, myocardial infarction, and death also showed highly significant improvements with DCB treatment (P < 0.00001 and P = 0.0002, respectively). However, no significant effect was observed on myocardial infarction and mortality rates. DCBs significantly reduce in-stent late luminal loss, target lesion revascularization, and major adverse cardiovascular events compared to plain balloon angioplasty. [ABSTRACT FROM AUTHOR]

Paclitaxel-eluting devices (PED) reduce restenosis and target lesion revascularization (TLR) in femoropopliteal intervention. Recent data suggest a two-fold increased long-term mortality in patients treated with PED. The aim of our study is to evaluate if endovascular therapy (EVT) with PED increases mortality risk in patients with symptomatic lower limb peripheral artery disease (PAD) compared to non-eluting devices (NED). The study is a retrospective, single-center registry on patients undergoing EVT for PAD from January 2009 to June 2018. Propensity score analysis on logistic regression model for independent predictors of long-term mortality was used to match PED and NED patients. Mortality was assessed at 2, 5 and 7 years in the entired matched population and in a sub-group of patients ≤75 years. During the study period, 1294 patients, 718 NED and 576 PED, met the inclusion/exclusion criteria and entered in the study. Propensity score matching analysis identified 854 matched patients, 414 PED and 440 NED. The population was mainly characterized by diabetic patients with CLI (80%) and high prevalence of CAD (30%), heart failure (15%) and renal insufficiency (20%). Mean follow-up length was 58 ± 34 months, (median 52.5). Mortality was 18% in NED vs 12% in PED patients at two years (p = 0.01), 36% vs 30% at 5 years (p = 0.03) and 41% vs 39% at seven years (p = 0.2) respectively. In patients ≤75 years, mortality at 7-year was 28% in PED vs 36% in NED, p = 0.07. These results suggest a reduced mortality at 2 and 5 years with PED as compare to NED treatment in a real-world CLI scenario. At 7-year follow-up, the advantage was numerically evident only in patients ≤75 years. • Angioplasty of lower limb arteries is associated with a high incidence of restenosis. • Paclitaxel-eluting devices reduce restenosis and target lesion revascularization in lower limb ischemia. • Recent data are conflicting about long-term mortality in patients treated with PED. • In real world scenario paclitaxel-eluting devices reduce major limb adverse events and mortality at 2 and 5 years follow-up. [ABSTRACT FROM AUTHOR]

Measurement of the coronary artery calcification score using multidetector computed tomography (MDCT) is a useful noninvasive test for the diagnosis of coronary artery disease. However, whether pre-intervention assessment of the target vessel coronary artery calcification (TV-CAC) score is associated with stent expansion failure and future target lesion revascularization (TLR), remains unknown. This study aimed to determine the association between the TV-CAC score measured by MDCT and stent expansion rate in patients who underwent IVUS-guided PCI for stable angina. We conducted a retrospective observational study including 135 consecutive patients (186 target lesions) who underwent MDCT and were scheduled for the first PCI. The patients were divided into 2 groups based on the median value of the TV-CAC score. The primary outcome was the stent expansion rate measured by IVUS after stent implantation. The secondary outcome was TLR within 1 year. Stent expansion rate was associated with the TV-CAC score (p < 0.001). According to the ROC curve analysis, the TV-CAC score had the largest area under the curve (AUC) for the stent expansion area of 0.90 (AUC = 0.893, p < 0.001). The TV-CAC score was a positive predictor for stent expansion rate of <90% (odds ratio: 7.54, p < 0.001). Mediation analysis showed that stent under-expansion was a mediator of the association between high TV-CAC and TLR. Our study demonstrates that pre-intervention assessment of TV-CAC using MDCT is a predictor of stent expansion. The TV-CAC score might predict the complexity and help in the PCI operative strategy. • The present study showed that high TV-CAC assessed using the multidetector computed tomography is a predictor of stent under-expansion. • Stent under-expansion is a mediator of the association between high TV-CAC score and in-stent restenosis. • Assessing the TV-CAC score before PCI might be clinically useful to reduce future TLR due to stent under-expansion. [ABSTRACT FROM AUTHOR]

Purpose: To analyze the difference in morphological patterns between in-stent restenosis (ISR) lesions of overlapping segments and ISR lesions of non-overlapping segments with second- and third-generation drug-eluting stents (DESs) using optical frequency domain imaging (OFDI).Methods: We analyzed 23 consecutive ISR lesions after second- or third-generation DES implantation using OFDI.Results: A total of 18 men and 5 women (median age, 68.0 years; interquartile range, 51.0-74.0 years) were included in the analysis. Fourteen and nine patients underwent second- and third-generation DES implantation, respectively. The median ISR detection timepoint was 10.0 months after implantation (interquartile range, 9.0-34.0 months). In 9 out of 23 lesions, ISR was found in the stent overlap area (overlapping segment group); the remaining 14 cases were categorized as the non-overlapping segment group. In OFDI analysis, homogeneous, layered, and heterogeneous patterns were found in 22%, 55%, and 22%, respectively, of lesions in the overlapping segment group and 14%, 50%, and 35%, respectively, of lesions in the non-overlapping segment group. There was no difference in the distribution of restenotic tissue structure patterns between the groups (p = .756).Conclusions: Morphological assessments of ISR tissue using OFDI showed no difference between the overlapping and non-overlapping segment groups with second and third-generation DESs in this hypothesis generating study. [ABSTRACT FROM AUTHOR]

There are little clinical data on imaging-guided percutaneous coronary intervention (PCI) 1 year after the biodegradable-polymer sirolimus-eluting stents (BP-SES) implantation, when the polymer disappears. We retrospectively analyzed 2455 patients who underwent successful PCI with BP-SES or durable-polymer everolimus-eluting stents (DP-EES) between September 2011 and March 2021, and compared 2-year clinical outcomes of BP-SES (n = 459) with DP-EES (n = 1996). The outcome measures were target lesion revascularization (TLR) and major adverse cardiac events (MACE), defined as a composite of cardiac death, myocardial infarction, target vessel revascularization, and stent thrombosis. Multivariate analysis using the Cox proportional hazard model and inverse probability weighting (IPW) analysis based on the propensity score were used to evaluate the clinical outcomes. The 2-year cumulative incidences of TLR (BP-SES: 4.9% vs. DP-SES: 6.1%, p = 0.304) and MACE (10.3% vs. 12.5%, p = 0.159) were similar between the two groups. Multivariable and IPW analysis revealed the risks of TLR (p = 0.388 and p = 0.500) and MACE (p = 0.139 and p = 0.083) also had no significant difference. There was a significant interaction between none/mild and moderate/severe calcification with respect to MACE and TLR (adjusted p for interaction = 0.036 and 0.047, respectively). The risk of MACE was significantly lower in BP-SES than in DP-EES in lesions with none/mild calcification (adjusted hazard ratio [aHR]: 0.53; 95% confidence interval [CI]: 0.30–0.91), while it was similar in those with moderate/severe calcification (aHR: 0.95; 95% CI: 0.58–1.55). Compared with DP-EES, BP-SES demonstrated durable 2-year clinical outcomes. However, BP-SES showed better clinical performance than DP-EES for lesions with none/mild calcification. [Display omitted] • There are little clinical data of BP-SES on intravascular imaging-guided PCI beyond 1 year, when the polymer disappears. • BP-SES demonstrated comparable 2-year clinical outcomes after intravascular imaging device-guided PCI with DP-EES. • BP-SES also showed a lower risk of major adverse cardiac event in lesions with none/mild calcification than DP-EES. [ABSTRACT FROM AUTHOR]

Despite the development of new therapies for the treatment of femoropopliteal disease, nitinol stents remain a mainstay of therapy following balloon angioplasty. Consequently, femoropopliteal in-stent restenosis (FP-ISR) remains an important clinical problem. Interventions used to treat de novo lesions of the femoropopliteal segment have been used to treat ISR lesions, with disappointing outcomes. Early interventions focused on repeat balloon angioplasty, cryoplasty, and various debulking therapies. Recently, treatment has shifted towards the use of stent-grafts, drug-eluting therapies, and combination therapies. This review analyzes the evidence behind each treatment modality and provides insight into future directions for optimal endovascular management of FP-ISR. [ABSTRACT FROM AUTHOR]

Objectives This study sought to investigate the impact of nonemergent, uncomplicated target lesion revascularization (TLR) on the risk of long-term mortality after percutaneous coronary intervention (PCI). Background Restenosis requiring TLR after PCI is generally considered a benign event. Methods The study pooled patient - level data from 21 randomized trials. Subjects dying the same day as or the day after the TLR procedure as well as those with myocardial infarction (MI) the day before, the same day as or the day after TLR were excluded. The primary endpoint of the study was all-cause mortality. Results The dataset included 32,524 patients who were stratified according to whether repeat TLR was performed during follow-up. During a median follow-up of 37 months, 2,330 (7.2%) patients underwent a nonemergent, uncomplicated TLR procedure. After adjusting for potential confounders, TLR was an independent predictor of mortality (hazard ratio: 1.23, 95% confidence interval: 1.04 to 1.45; p = 0.02). Patients undergoing nonemergent, uncomplicated TLR had significantly higher rates of non–procedure-related MI compared with those without TVR. Among patients undergoing elective TLR, MI occurring after TLR was an independent predictor of mortality (hazard ratio: 3.82; 95% confidence interval: 2.44 to 5.99; p < 0.0001). Conclusions Nonemergent, uncomplicated TLR after PCI is an independent predictor of long-term mortality, an association in part explained by higher rates of MI occurring after TLR. Efforts aimed at reducing TLR risk may translate into prognostic benefits including reduced rates of MI and survival. [ABSTRACT FROM AUTHOR]

Objectives The present study aimed to analyze the incidence of SF and its correlation with clinical events after DES implantation and the outcome of re-intervention for symptomatic in-stent restenosis (ISR) induced by stent fracture (SF). Background SF is associated with a high rate of clinical events after the implantation of drug-eluting stents (DES). However, the chronological rate of SF and the effect of SF on clinical outcomes from a large patient population remain underreported. Methods A total of 6,555 patients with 16482 DES in 10751 diseased vessels and surveillance angiography between November 2003 and January 2014 were prospectively studied. The primary endpoints included the incidence of SF, in-stent restenosis (ISR), target lesion revascularization (TLR), and definite stent thrombosis (ST) at the end of follow-up before and after propensity score matching. Clinical outcomes after TLR were also followed up. Results The SF rate was detected in 803 (12.3%) patients, 3,630 (22.0%) stents, and 1,852 (17.2%) diseased vessels. SF increased over time. SF was associated with higher unadjusted rates of ISR (42.1%), TLR (24.8%, n = 379), and definite ST (4.6%) compared with stents without fracture (10.7%, 6.6%, and 1.03%, all p < 0.001), and the differences remained significant after propensity score matching (all p < 0.05). There was no significant difference in any-cause or cardiac mortality between patients with and without SF. After 1,523 days of follow-up since the first surveillance angiography, repeat ISR was detected in 90 of 379 (23.8%) stents after reintervention, and 6 (7.5%) stents required repeat TLR. Conclusions SF is more frequently observed after DES implantation. TLR was required in almost one-fourth of fractured stents. Increased events in the SF group did not translate into a difference in mortality compared with the non-SF group. Reintervention was associated with acceptable clinical results. [ABSTRACT FROM AUTHOR]

Objectives: We aim to evaluate the long-term efficacy of two different paclitaxel-coated balloons (PCBs) for the treatment of coronary in-stent restenosis (ISR).Methods: Between February 2011 and February 2012, all consecutive patients with ISR lesions treated with the SeQuent® Please (B. Braun, Melsungen, Germany) PCB or with the DIOR® (Eurocor GmbH, Bonn, Germany) PCB at our institution were prospectively included and followed up for 36months by clinical observation. The primary endpoint was the clinically driven target lesion revascularization (TLR) rate at 36months.Results: 65 patients with 74 ISR lesions were included. 43 ISR lesions were treated with the SeQuent® Please PCB and 31 with the DIOR® PCB. Baseline clinical, lesion characteristics and procedural data did not significantly differ between the groups. The TLR rate was significantly lower in patients treated with the SeQuent® Please PCB compared with the DIOR® PCB (4.7% vs. 22. 6%, p=0.03) at 36months.Conclusions: This registry suggests that there are differences in terms of TLR between two clinically available PCBs. The SeQuent® Please PCB demonstrated lower TLR rate compared to the DIOR® PCB at 36months follow up. [ABSTRACT FROM AUTHOR]

Background Data about paclitaxel-eluting balloon (PCB) angioplasty to treat drug-eluting stents (DES) in-stent restenosis (ISR) were mainly collected in selected patient populations in the setting of randomized trials. The main goal of this prospective registry was to confirm the positive findings of these studies in an unselected population in clinical practice. Methods Consecutive patients with DES-ISR treated by PCB angioplasty were recruited in this prospective real-world registry. The primary endpoint was clinically driven target-lesion revascularization (TLR) at 9 months. Secondary endpoints included acute technical success, in-hospital outcomes, 9-month major adverse cardiac events (MACE) a composite of death, myocardial infarction (MI) and TLR and the occurrence of target vessel revascularization. Results A total of 206 patients (67.7 ± 10.2 years, 80.6% male, 41.3% diabetics) with 210 lesions were recruited. Unstable coronary artery disease was present in 55.3% of patients. The time from DES implantation to DES-ISR was 3.0 ± 2.4 years. Quantitative analyses revealed that patterns of treated DES-ISR were focal in 55.7% and diffuse in 44.3%. The reference diameter was 2.76 ± 0.64 mm. The 9-month follow-up rate was 90.8% (187/206). At 9 months, the TLR rate was 7.0% (13/187) whereas the rates for MACE, MI and cardiac death were 10.7% (20/187), 4.8% (9/187) and 2.1% (4/187) respectively. Results were consistent in patients with paclitaxel and non-paclitaxel-eluting stents (PES) ISR. Conclusion This large prospective registry demonstrated acceptable rates of TLR and MACE at 9 months after treatment of DES-ISR by PCB angioplasty. PCB angioplasty was equally effective in patients with PES-ISR and non PES-ISR. [ABSTRACT FROM AUTHOR]

Background: Evidence from large, randomized, controlled peripheral artery disease trials reporting long-term outcomes using drug-coated balloons (DCBs) is limited. Previously, the DCB showed favorable 1-year outcomes compared with conventional percutaneous transluminal angioplasty (PTA), yet durability of the treatment effect with DCBs remains unknown.Objectives: This study sought to investigate the longer-term outcomes of a paclitaxel-eluting DCB compared to PTA for femoropopliteal lesions.Methods: We enrolled 331 patients with symptomatic (Rutherford 2 to 4) femoropopliteal lesions up to 18 cm in length. Patients were randomly assigned in a 2:1 ratio to treatment with DCB or PTA. The 24-month assessments included primary patency, freedom from clinically driven target lesion revascularization (CD-TLR), major adverse events, and quality of life and functional outcomes as assessed by the EuroQOL-5D quality-of-life questionnaire, walking impairment questionnaire, and 6-min walk test.Results: At 24 months, patients treated with DCB showed significantly higher primary patency when compared with PTA (78.9% vs. 50.1%; p < 0.001). The rates of CD-TLR were 9.1% and 28.3% (p < 0.001) for the DCB and PTA groups, respectively. The overall mortality rate in the DCB group was 8.1% versus 0.9% in the PTA group (p = 0.008). There were no device- or procedure-related deaths and no major amputations in either group through 24-month follow-up. The rate of vessel thrombosis was low (1.5% DCB vs. 3.8% PTA; p = 0.243), with no new events reported between 1 and 2 years. Both groups showed similar functional improvement at 2 years, although DCB patients achieved this level of function with 58% fewer reinterventions.Conclusions: The 24-month outcomes from the trial demonstrate a durable and superior treatment effect of DCB versus PTA with significantly higher primary patency, lower CD-TLR, and similar functional status improvement with fewer repeat interventions. (Randomized Trial of IN.PACT Admiral Drug Eluting Balloon vs Standard PTA for the Treatment of SFA and Proximal Popliteal Arterial Disease [INPACT SFA I]; NCT01175850; and IN.PACT Admiral Drug-Coated Balloon vs. Standard Balloon Angioplasty for the Treatment of Superficial Femoral Artery [SFA] and Proximal Popliteal Artery [PPA] [INPACT SFA II]; NCT01566461). [ABSTRACT FROM AUTHOR]

Objectives This study sought to assess the incidence and clinical impact of stent fracture (SF) after the PROMUS Element platinum-chromium everolimus-eluting stent (PtCr-EES). Background SF remains an unresolved, clinically relevant issue, even in the newer-generation drug-eluting stent era. Methods From March 2012 to August 2013, 816 patients with 1,094 lesions were treated only with PtCr-EES and 700 patients (85.7%) with 898 lesions undergoing follow-up angiography within 9 months after the index procedure were analyzed. SF was defined as complete or partial separation of the stent, as assessed by plain fluoroscopy, intravascular ultrasound, or optical coherence tomography during the follow-up. We assessed the rate of SF and the cumulative incidence of clinically driven target lesion revascularization and definite stent thrombosis within 9 months after the index procedure. Results SF was observed in 16 of 898 lesions (1.7%) and 16 of 700 patients (2.2%). Lesions with in-stent restenosis at baseline (odds ratio [OR]: 14.2, 95% confidence intervals [CI]: 5.09 to 39.7; p < 0.001) or hinge motion (OR: 4.31, 95% CI: 1.12 to 16.5; p = 0.03), and total stent length (per 10-mm increase; OR: 1.32, 95% CI: 1.12 to 1.57; p = 0.001) were predictors of SF. Cumulative incidence of clinically driven target lesion revascularization within 9-months was numerically higher in the SF group than that in the non-SF group (18.7% vs. 2.3%). Cumulative incidence of definite stent thrombosis within 9 months after the index procedure was similar between the SF and non-SF groups (0.0% vs. 0.23%). Conclusions SF after PtCr-EES occurs in 1.7% of lesions and appears to be associated with clinically driven target lesion revascularization. [ABSTRACT FROM AUTHOR]

Objective The aim of this study was to compare the safety and efficacy of the everolimus-eluting stents (EES) with the paclitaxel-eluting stent (PES) and sirolimus-eluting stent (SES) for the treatment of bare-metal in-stent restenosis. Background The optimal treatment for bare-metal in-stent restenosis remains controversial. Methods The study cohort comprised 322 consecutive patients (543 lesions) who presented with bare-metal in-stent restenosis to our institution and underwent coronary artery stent implantation with EES (114 patients; 181 lesions), PES (65 patients; 116 lesions) and SES (143 patients; 246 lesions). The analyzed clinical parameters were the 1-year rates of death, Q-wave myocardial infarction (MI), target lesion revascularization (TLR), target vessel revascularization (TVR), definite stent thrombosis (ST) and major adverse cardiac events (MACE) defined as the composite of death, MI, or TLR at 1-year. Results The three groups were well matched for the conventional risk factors except for age and chronic kidney disease. The 1-year analyzed clinical parameters were similar in the three groups: death (EES = 3.5%, PES = 4.6%, SES = 4.2%; p = 0.94), MI (EES = 3.5%, PES = 6.3%, SES = 2.1%; p = 0.31), TLR (EES = 9.8%, PES = 9.5%, SES = 5.7%; p = 0.42), TVR (EES = 14.3%, PES = 11.1%, SES = 11.3%; p = 0.74), definite ST (EES = 0.9%, PES = 3.1%, SES = 3.5%; p = 0.38) and MACE (EES = 14.0%, PES = 15.4%, SES = 10.5%; p = 0.54). Male gender (hazard ratio = 0.47; 95% confidence interval = 0.25–0.88) and number of treated lesions (hazard ratio = 1.47; 95% confidence interval = 1.06–2.05) were found to be independent predictors of MACE. Conclusion The results of the present study indicate that EES may provide similar safety and efficacy as first generation DES for the treatment of patients presenting with bare-metal in-stent restenosis. [ABSTRACT FROM AUTHOR]

Clinically driven target lesion revascularization (CD-TLR) frequently occurs after endovascular therapy (EVT) in patients with chronic limb-threatening ischemia (CLTI). The total thrombus-formation analysis system (T-TAS) can quantitatively evaluate thrombogenicity. Therefore, we aimed to elucidate the association of the T-TAS parameters with CD-TLR. We analyzed 34 patients with CLTI and 62 patients without CLTI who had undergone EVT. Blood samples collected on the day of EVT were used in the T-TAS to compute the thrombus formation area under the curve for the first 10 minutes for the platelet chip tested at a flow rate of 24 μL/min (PL 24 -AUC 10) and area under the curve for the first 30 minutes for the atheroma chip tested at a flow rate of 10 μL/min (AR 10 -AUC 30). After EVT, clinical follow-up was performed, and the presence of CD-TLR was assessed. During the follow-up period (median, 574 days), 10 patients (29%) in the CLTI group and 11 (18%) in the non-CLTI group had required CD-TLR. In the CLTI group, the patients with CD-TLR had had a higher AR 10 -AUC 30 vs those without (median, 1694 [interquartile range, 1657-1799] vs median, 1561 [interquartile range, 1412-1697]; P =.01). In contrast, the PL 24 -AUC 10 showed no significant differences when stratified by CD-TLR in either group. For the CLTI patients, multivariable Cox regression analysis using propensity score matching revealed that the AR 10 -AUC 30 was an independent predictor of CD-TLR even after adjusting for baseline demographics, lesion characteristics, and anticoagulant use (hazard ratio, 2.04; 95% confidence interval, 1.18-3.88; P =.01; per 100-unit increase). In contrast, for those without CLTI, neither the AR 10 -AUC 30 nor the PL 24 -AUC 10 was significantly associated with CD-TLR. Receiver operating characteristics curve analysis identified an AR 10 -AUC 30 level of 1646 as an optimal cutoff value to predict for CD-TLR (AUC, 0.85; sensitivity, 0.93; specificity, 0.56). For patients with CLTI, but not for those without CLTI, the AR 10 -AUC 30 showed potential to predict for CD-TLR. This finding suggests that hypercoagulability might play a predominant role in the progression of CLTI and that anticoagulant therapy might be useful in preventing revascularization. [ABSTRACT FROM AUTHOR]

Abstract: Background: Randomized controlled trials have demonstrated that second-generation drug-eluting stents (DESs) for the treatment of obstructive coronary artery disease are associated with comparable, if not improved, clinical outcomes as compared to those of their first-generation counterparts. The aim of this study was to compare the long-term clinical outcomes associated with first- versus second-generation DESs for the treatment of coronary bifurcation lesions. Methods and Materials: This was a retrospective study of consecutive de novo bifurcation lesions, excluding those at the left main, treated with either second-generation DES (everolimus-eluting or resolute zotarolimus-eluting stents) between October 2006 and October 2011 (199 bifurcation lesions in 192 patients) or first-generation DES (sirolimus-eluting or paclitaxel-eluting stents) between April 2002 and December 2005 (289 bifurcation lesions in 273 patients). Results: Second-generation DES use in this setting was associated with less major adverse cardiac events (MACE) (23.1% vs. 14.4%, p=0.02) as well as lower target vessel revascularization (TVR) rates (15.5% vs. 8.3%, p=0.01) at 2-year follow-up. Target lesion revascularization, both per patient (12.6% vs. 7.4%, p=0.02) and per bifurcation (11.8% vs. 7.0%, p=0.03), was also improved with second-generation DES over the same follow-up period. Propensity-score adjusted analysis suggested that second-generation DES was associated with a lower incidence of MACE (HR, 0.53; 95% CI, 0.33–0.85; p=0.01) and TVR (HR, 0.44; 95% CI, 0.24–0.83; p=0.01). Conclusions: Our results suggest that the use of second-generation DES for the treatment of bifurcation lesions is associated with better clinical outcomes as compared to first-generation DES, largely due to a lower need for repeat revascularization. [Copyright &y& Elsevier]

Objectives: This study sought to investigate the role of drug-eluting balloons (DEB) alone or in combination with drug-eluting stents (DES) in the treatment of diffuse de novo coronary artery disease (CAD) (>25 mm). Background: The use of DEB in diffuse CAD, either alone or in combination with DES, offers an alternative to stenting alone. Data regarding DEB in this context are limited. Methods: We retrospectively evaluated all patients treated with DEB for diffuse CAD between June 2009 and October 2012. Endpoints analyzed were major adverse cardiac events, defined as all-cause death, myocardial infarction, and target vessel revascularization (TVR), as well as TVR and target lesion revascularization separately. Results were compared with those obtained from a cohort of patients with similar characteristics treated with DES alone. Results: A total of 69 patients (93 lesions) were treated with DEB ± DES, and 93 patients with DES alone (93 lesions). A high proportion of patients were diabetic (46.4% vs. 44.1%, p = 0.77). Of the DEB-treated lesions, 56.0% were treated with DEB alone, 7.4% with DEB and DES as bail out, and 36.6% with DES and DEB as part of a hybrid approach for very long disease. Outcome rates with DEB ± DES were comparable to those with DES alone at 2-year follow-up (major adverse cardiac events = 20.8% vs. 22.7%, p = 0.74; TVR = 14.8% vs. 11.5%, p = 0.44; target lesion revascularization = 9.6% vs. 9.3%, p = 0.84). Conclusions: DEB may have a role in the treatment of diffuse de novo CAD, either alone in smaller vessels or in combination with DES in very long disease. [Copyright &y& Elsevier]

Abstract: Background: In the treatment of bifurcation lesions, routine stenting of both branches has thus far failed to demonstrate a clear clinical advantage over a provisional one-stent strategy. On the other hand, large scale data evaluating different stent types for clinical outcomes after one-stent treatment with final kissing inflation (FKI) of bifurcation lesions is also limited. This prospective study evaluated the clinical and angiographic outcomes of paclitaxel-eluting stents (PES) vs. sirolimus-eluting stents (SES) in single crossover main branch stenting followed by FKI in patients with bifurcation lesions. Methods: We randomized 800 patients with single bifurcation lesions to PES (n=400) and SES (n=400) groups. Results: Crossover rates to the two-stent strategy were low in both groups (PES 1.5%, SES 2.8%; p=0.23). At 1year, there was no significant difference in the primary endpoint of this study, target lesion revascularization rate (PES 3.8%, SES 3.2%, hazard ratio 0.83; 95% confidence interval 0.39 to 1.76; p=0.62). Stent thrombosis occurred in only 1 case in the SES group after 282days. At 9months, a total of 593 patients underwent quantitative coronary measurement. The main branch restenosis rate in the PES group was significantly higher than that of the SES group (PES 12.2%, SES 5.5%; p=0.004), however both groups exhibited similar high side branch restenosis rates (PES 17.2%, SES 19.3%; p=0.6). Conclusions: In patients with bifurcation lesions, a single stent strategy using PES and SES with FKI indicated similar 1year clinical outcomes and safety profiles. [Copyright &y& Elsevier]

Abstract: Background: Target lesion revascularization (TLR) with primary percutaneous transluminal angioplasty (PTA) versus cryoplasty (CRYO) in the treatment of de novo femoropopliteal disease has not been well defined in randomized trials. Methods: In this prospective, 2-center randomized trial of PTA vs CRYO of femoropopliteal arteries, the primary endpoint of TLR was evaluated at 6 months. Secondary endpoints included the rate of bail out stenting because of suboptimal acute angiographic results (defined as a residual narrowing of ≥30% or type C or higher dissection) and target vessel revascularization (TVR). Major adverse events including death and amputations were recorded. A two sample t test was used to compare the two groups on the continuous variables. For categorical variables, cross tabular analysis was conducted with nonparametric tests (Chi Square and Fisher''s Exact) used to test for significant differences. Results: A total of 40 patients were included in the study. Of these 20 patients (24 vessels) were included in the PTA arm and 20 patients (26 vessels) in the CRYO arm. CRYO was performed at a predefined automated pressure of 8 atm. PTA was performed at a mean pressure of 9.57±1.34 atm (P=.001 compared to CRYO). TLR (10.5% vs. 15%, P=NS) and TVR (10% vs 25%, P=NS) were statistically similar between the PTA arm compared to the CRYO arm respectively. Bail out stenting was performed in 10/24 (41.7%) of vessels in the PTA arm and 10/26 (38.5%) of patients in the CRYO arm (P=NS). Conclusion: In this pilot randomized study of de novo femoropopliteal lesions, CRYO and PTA had the same TLR and TVR at 6 months in treating femoropopliteal de novo lesions. Also, bail out stenting was statistically similar between the 2 groups. Larger studies are needed to confirm these results. [Copyright &y& Elsevier]

Objectives: This study sought to compare the 1-year safety and efficacy of Cypher Select or Cypher Select Plus (Cordis Corporation, Bridgewater, New Jersey) sirolimus-eluting stents (SES) with the treatment of bare-metal stents (BMS) and drug-eluting stent (DES) in-stent restenosis (ISR) in nonselected, real-world patients. Background: There is paucity of consistent data on DES for the treatment of ISR, especially, DES ISR. Methods: The e-SELECT (Multicenter Post-Market Surveillance) registry is a Web-based, multicenter and international registry encompassing virtually all subsets of patients and lesions treated with at least 1 SES during the period from 2006 to 2008. We enrolled in this pre-specified subanalysis all patients with at least 1 clinically relevant BMS or DES ISR treated with SES. Primary endpoint was major adverse cardiac events and stent thrombosis rate at 1 year. Results: Of 15,147 patients enrolled, 1,590 (10.5%) presented at least 1 ISR (BMS group, n = 1,235, DES group, n = 355). Patients with DES ISR had higher incidence of diabetes (39.4% vs. 26.9%, p < 0.001), renal insufficiency (5.8% vs. 2.3%, p = 0.003), and prior coronary artery bypass graft (20.5% vs. 11.8%, p < 0.001). At 1 year, death (1.4% for BMS vs. 2.1% for DES, p = 0.3) and myocardial infarction (2.4% for BMS and 3.3% for DES, p = 0.3) rates were similar, whereas ischemia-driven target lesion revascularization and definite/probable late stent thrombosis were higher in patients with DES ISR (6.9% vs. 3.1%, p = 0.003, and 1.8% vs. 0.5%, p = 0.04, respectively). Conclusions: Use of SES for either BMS or DES ISR treatment is safe and associated with low target lesion revascularization recurrence and no apparent safety concern. [ABSTRACT FROM AUTHOR]

Objectives: These studies sought to evaluate the clinical outcomes of the slow-release Taxus paclitaxel-eluting stent (PES) versus an otherwise identical bare-metal stent (BMS). Background: Prior studies were not individually powered to generate reliable estimates of low-frequency safety endpoints or to characterize the long-term safety and efficacy profile of PES. Methods: The completed 5-year databases from the prospective, randomized, double-blind TAXUS I, II, IV, and V trials were pooled for a patient-level analysis. Results: The study population comprised 2,797 randomized patients (1,400 PES and 1,397 BMS). At the end of the 5-year study period, PES compared with BMS significantly reduced the rate of ischemia-driven target lesion revascularization (12.3% vs. 21.0%, p < 0.0001), with consistent reductions across high-risk subgroups and in patients with and without routine angiographic follow-up. There were no significant differences between the stent types in the 1-year or cumulative 5-year rates of death or myocardial infarction (MI). However, cardiac death or MI between 1 and 5 years was increased with PES (6.7% vs. 4.5%, p = 0.01), as was stent thrombosis (protocol definition: 0.9% vs. 0.2%, p = 0.007; ARC definition: 1.4% vs. 0.9%, p = 0.18). Conclusions: In this pooled patient-level analysis from the prospective, randomized, double-blind TAXUS trials, PES compared with BMS resulted in a durable 47% reduction in the 5-year rate of ischemia-driven target lesion revascularization in simple and complex lesions, with nonsignificant differences in the cumulative 5-year rates of death or MI. Between 1 and 5 years, however, the rates of cardiac death or MI and protocol-defined stent thrombosis were increased with PES. [ABSTRACT FROM AUTHOR]

Objectives: The aim of this study was to assess the long-term safety and efficacy of the CYPHER (Cordis, Johnson and Johnson, Bridgewater, New Jersey) sirolimus-eluting coronary stent (SES) in percutaneous coronary intervention (PCI) for ST-segment elevation myocardial infarction (STEMI). Background: Concern over the safety of drug-eluting stents implanted during PCI for STEMI remains, and long-term follow-up from randomized trials are necessary. TYPHOON (Trial to assess the use of the cYPHer sirolimus-eluting stent in acute myocardial infarction treated with ballOON angioplasty) randomized 712 patients with STEMI treated by primary PCI to receive either SES (n = 355) or bare-metal stents (BMS) (n = 357). The primary end point, target vessel failure at 1 year, was significantly lower in the SES group than in the BMS group (7.3% vs. 14.3%, p = 0.004) with no increase in adverse events. Methods: A 4-year follow-up was performed. Complete data were available in 501 patients (70%), and the survival status is known in 580 patients (81%). Results: Freedom from target lesion revascularization (TLR) at 4 years was significantly better in the SES group (92.4% vs. 85.1%; p = 0.002); there were no significant differences in freedom from cardiac death (97.6% and 95.9%; p = 0.37) or freedom from repeat myocardial infarction (94.8% and 95.6%; p = 0.85) between the SES and BMS groups. No difference in definite/probable stent thrombosis was noted at 4 years (SES: 4.4%, BMS: 4.8%, p = 0.83). In the 580 patients with known survival status at 4 years, the all-cause death rate was 5.8% in the SES and 7.0% in the BMS group (p = 0.61). Conclusions: In the 70% of patients with complete follow-up at 4 years, SES demonstrated sustained efficacy to reduce TLR with no difference in death, repeat myocardial infarction or stent thrombosis. (The Study to Assess AMI Treated With Balloon Angioplasty [TYPHOON]; NCT00232830) [ABSTRACT FROM AUTHOR]

The introduction of the drug-eluting stent (DES) proved to be an important step forward in reducing rates of restenosis and target lesion revascularization after percutaneous coronary intervention. However, the rapid implementation of DES in standard practice and expansion of the indications for percutaneous coronary intervention to high-risk patients and complex lesions also introduced a new problem: DES in-stent restenosis (ISR), which occurs in 3% to 20% of patients, depending on patient and lesion characteristics and DES type. The clinical presentation of DES ISR is usually recurrent angina, but some patients present with acute coronary syndrome. Mechanisms of DES ISR can be biological, mechanical, and technical, and its pattern is predominantly focal. Intravascular imaging can assist in defining the mechanism and selecting treatment modalities. Based upon the current available evidence, an algorithm for the treatment approaches to DES restenosis is proposed. [ABSTRACT FROM AUTHOR]

Objectives: The ENDEAVOR IV (Randomized Comparison of Zotarolimus-Eluting and Paclitaxel-Eluting Stents in Patients with Coronary Artery Disease) trial evaluated the safety and efficacy of the zotarolimus-eluting stent (ZES) compared with the paclitaxel-eluting stent (PES). Background: First-generation drug-eluting stents have reduced angiographic and clinical restenosis, but long-term safety remains controversial. A second-generation drug-eluting stent, which delivers zotarolimus, a potent antiproliferative agent, via a biocompatible phosphorylcholine polymer on a cobalt alloy thin-strut stent has shown promising experimental and early clinical results. Methods: This is a prospective, randomized (1:1), single-blind, controlled trial comparing outcomes of patients with single de novo coronary lesions treated with ZES or PES. The primary end point was noninferiority of 9-month target vessel failure defined as cardiac death, myocardial infarction, or target vessel revascularization. Results: Among a total of 1,548 patients assigned to ZES (n = 773) or PES (n = 775), at 9 months, ZES was noninferior to PES with rates of target vessel failure 6.6% versus 7.1%, respectively (pnoninferiority ≤ 0.001). There were fewer periprocedural myocardial infarctions with ZES (0.5% vs. 2.2%; p = 0.007), whereas at 12 months, there were no significant differences between groups in rates of cardiac death, myocardial infarction, target vessel revascularization, or stent thrombosis. Although incidence of 8-month binary angiographic in-segment restenosis was higher in patients treated with ZES versus PES (15.3% vs. 10.4%; p = 0.284), rates of 12-month target lesion revascularization were similar (4.5% vs. 3.2%; p = 0.228), especially in patients without planned angiographic follow-up (3.6% vs. 3.2%; p = 0.756). Conclusions: These findings demonstrate that ZES has similar clinical safety and efficacy compared with PES in simple and medium complexity single de novo coronary lesions. (ENDEAVOR IV Clinical Trial; NCT00217269) [Copyright &y& Elsevier]

Abstract: Background: The paclitaxel drug-eluting stent (Taxus, Boston Scientific) is FDA approved for treatment of coronary artery disease in simple, noncomplex coronary lesions. In this registry, we sought to investigate the procedural success and long-term outcomes of patients receiving the Taxus stent in the setting of acute ST-elevation myocardial infarction (STEMI) in a busy single-center interventional program. Methods: This is a single-center retrospective analysis of prospectively collected in-hospital data with postdischarge follow-up achieved by phone calls and review of medical records. Data were audited by an independent monitor, and outcomes were adjudicated by an experienced interventional cardiologist. All patients with STEMI over the period of 2 years (2005 and 2006) with native de novo lesions who received the Taxus stent were included. Patients receiving bare metal stents were excluded. The primary outcome was the combined end point of cardiac death, recurrent nonfatal MI, and target lesion revascularization (TLR) on follow-up. Results: Of 198 patients included in this study, follow-up data were obtained in 172 (86.9%) patients. The mean age was 63±14.9 years. There were 59.1% males. Patients had the following cardiac risk factors: diabetes 20.7%, hypertension 60.6%, hyperlipidemia 87.8%, and current smoking 48%. In-hospital complications included death 5.1%, acute closure with stent thrombosis 1%, vascular complications 2.9%, and cardiogenic shock 6.6%. The mean follow-up period (days) was 317.3±239.3. The primary end point of cardiac death, nonfatal MI, and TLR was met in 12.4%. Individual end points on follow-up were cardiac death 2.5%, total death 4.9%, TLR 8.1%, target vessel revascularization 19.9%, stroke 1.2%, nonfatal MI 5%, and acute stent thrombosis 5.5% (definite 4.3%, probable 0.6%, possible 0.6%; Academic Research Consortium definition). Conclusion: The use of the Taxus stent in acute STEMI is associated with a low postdischarge combined end point of cardiac death, nonfatal MI, and TLR and a definite/probable 4.9% in-stent thrombosis rate, which is within the reported range of data published in “real-world” registry. [Copyright &y& Elsevier]

Objectives: We investigated the impact of sex on outcomes after percutaneous coronary intervention (PCI) with drug-eluting stent (DES). Background: Women have a higher risk of adverse outcomes after PCI than do men. However, long-term outcomes of women after contemporary PCI with DES have not been fully investigated. Methods: We performed a retrospective cohort study of 4,936 consecutive patients (28.2% women) who underwent PCIs between 2000 and 2004, before and after introduction of DES (bare-metal stent [BMS] group: n = 2,131, DES group: n = 2,805), to assess the impact of sex on long-term PCI outcomes and to compare outcome after PCI of women between the DES and BMS eras. Results: Compared with men, women undergoing PCIs were 5 years older and more frequently have comorbidities such as diabetes mellitus and hypertension. In patients treated throughout the BMS and DES eras, there were no differences by sex for risk of all-cause death, myocardial infarction, or target vessel revascularization 3 years after procedure. The procedural complexity was higher in the DES era, nevertheless, risk for target vessel revascularization and major adverse cardiac event at 3 years were significantly lower in women treated with DES than in women treated with BMS (adjusted hazard ratio [HR] for target vessel revascularization: 0.52 [95% confidence interval (CI): 0.36 to 0.75], adjusted HR for major adverse cardiac event: 0.63 [95% CI: 0.48 to 0.83]). Conclusions: Although women had worse baseline characteristics, no differences in 3-year outcomes were observed between men and women. Compared with BMS use, DES use has decreased revascularization rate equally in women and men. [Copyright &y& Elsevier]

Abstract: Background: Previous studies have demonstrated similar efficacy of the drug-eluting stent (DES) in patients with and without calcified lesions. However, most of the randomized trials have excluded patients with severe calcified lesions. This study aimed to examine the impact of lesion calcium on clinical and angiographic outcome after sirolimus-eluting stent (SES) implantation in real-world patients. Methods: Consecutive 380 patients with 556 lesions treated with SES were enrolled. Lesions were divided into Calc lesions (moderate or sever calcification; 195 lesions) and non-Calc lesions (none or mild calcification; 361 lesions) according to the lesion calcium. Quantitative coronary angiography (QCA) parameters, binary restenosis rate (%restenosis), target lesion revascularization (TLR) rate, and major adverse cardiac events (MACE) during follow-up were compared between the two groups. All patients were contacted at 1, 6, and 12 months after the procedure. Results: Lesion success rate was similar in the two groups. %Restenosis (9.2% vs. 3.6%; P<.05) and TLR (7.3% vs. 2.8%; P<.05) were significantly higher in Calc lesions. Stent thrombosis was observed in 0.7% of overall lesions with no difference between the two groups. The MACE rate in Calc patients (13.8%) was significantly higher than in non-Calc patients (6.1%). By multivariate analysis, hemodialysis (HD) and requirement of rotational atherectomy (RA) were predictive factors of TLR in the Calc lesions. Conclusions: Coronary lesions with calcification comprise a high-risk cohort and are associated with a higher TLR and binary restenosis rates in real-world patients treated with SES. Moreover, patients with calcified lesions and on HD are associated with higher MACE rate. [Copyright &y& Elsevier]

Abstract: Objective: The drug-eluting stent (DES) has been proven its efficacy in randomized trials. But the difference of efficacy between sirolimus-eluting stents (SES) and paclitaxel-eluting stents (PES) in unselected patients is in controversy. Therefore, we investigated the clinical and angiographic outcomes of these two types of the DES. Methods: All consecutive patients treated with DES from March 2003 to March 2004 at two centers were analyzed. Results: We analyzed 440 patients with 519 lesions who were treated with the two types of DES (SES 353 lesions/296 patients, PES 166 lesions/144 patients). PES group had more acute myocardial infarction (AMI) patients. Angiographically, the number of stents per lesion, maximal deployment pressure, stent diameter and the percent residual stenosis after procedure were different between the two groups. Angiographic follow-up was available in 103 patients (71.5%) in the PES group and 208 patients (70.3%) in the SES group. PES showed the higher binary restenosis rate (PES 17.9%, SES 4.5%, p <0.0001) and the larger late loss (PES 0.60×0.83 mm vs. SES 0.16×0.40 mm, p <0.001) than SES. PES was the predictor of binary restenosis at six months (OR 4.67, CI 2.20–9.91). At one year follow-up, PES also had more cardiac events (composites of death of all cause, MI, and target lesion revascularization) than SES (PES 13.9% vs. SES 6.1%, p <0.001). PES was a significant predictor of cardiac events at one year (OR 2.47, CI 1.23–4.95). Conclusion: SES showed better clinical and angiographic outcomes compared to PES in a daily routine practice of coronary intervention in Koreans. [Copyright &y& Elsevier]

: ObjectivesWe sought to investigate the success rate and the acute and 12-month clinical outcome of percutaneous coronary intervention (PCI) for chronic total occlusion (CTO) in the contemporary era.: BackgroundThe technique of PCI involving CTO has improved over time. However, limited data on acute and follow-up results in patients treated with PCI on CTO in recent years are available.: MethodsFour hundred nineteen consecutive patients scheduled for PCI of CTO of ≥30 days of duration were enrolled in 29 centers; 390 CTOs were confirmed in 376 patients in an independent core laboratory. The end points were technical and procedural success, in-hospital and 12-month major adverse cardiac events (MACE) occurrence, and 12-month symptomatic status.: ResultsTechnical and procedural success was obtained in 77.2% and 73.3% of lesions, respectively. In-hospital major adverse cardiac events occurred in 5.1% of patients. Multivariate analysis identified CTO length >15 mm or not measurable, moderate to severe calcifications, duration ≥180 days, and multivessel disease as significant predictors of PCI failure. At 12 months, patients with a successful procedure experienced a lower incidence of cardiac deaths or myocardial infarction (1.05% vs. 7.23%, p = 0.005), a reduced need for coronary artery bypass surgery (2.45% vs. 15.7%, p < 0.0001), and were more frequently free of angina (88.7% vs. 75.0%, p = 0.008) compared with patients who had an unsuccessful procedure.: ConclusionsSuccessful PCI was achieved in a high percentage of CTOs with a low incidence of complications. At one-year follow-up, patients with successful PCI of a CTO had a significantly better clinical outcome than those whose PCI was unsuccessful. [Copyright &y& Elsevier]

: ObjectivesThis study reports the outcome of patients who failed intracoronary radiation therapy (IRT) for the treatment of in-stent restenosis (ISR).: BackgroundIntracoronary radiation therapy has demonstrated a reduction in the recurrence rate of restenosis for patients with ISR. However, 10% to 30% of these patients require repeat intervention to the irradiated site.: MethodsOf 961 patients who were assigned to gamma or beta radiation for the treatment of diffuse ISR, we evaluated the outcome of 282 (29%) consecutive patients who failed IRT and compared them with the 679 (71%) patients who had successful IRT. For patients who failed radiation, the mean time to the first target vessel revascularization (TVR) was 173 ± 127 days after the index procedure and the total duration of follow-up was 494 ± 304 days.: ResultsPatients who failed IRT were younger (60 ± 10 vs. 63 ± 11 years, p = 0.002) and had a higher incidence of restenting (51% vs. 41%, p = 0.003). The majority (55%) of the restenotic lesions after IRT failure were focal (≤10 mm), with a mean lesion length of 11.9 ± 1.9 mm. Of the 257 patients who had subsequent TVR after failed IRT, 68 (26%) underwent coronary artery bypass grafting and 189 (74%) underwent percutaneous coronary intervention using balloon in 61%, restenting in 26%, atheroablation in 11%, and the cutting balloon in 2% of cases. At six months, 6% of patients died, 1% had Q-wave MI, 17% had repeat TVR, and the overall rate of major adverse cardiac events was 21%.: ConclusionsThe predominant angiographic pattern of lesions in patients who failed IRT is focal restenosis, with these lesions responding well to conventional revascularization methods. [Copyright &y& Elsevier]

: ObjectivesWe sought to evaluate clinical restenosis in a large population of patients who had undergone coronary stent placement.: BackgroundOne-year success after coronary stenting is limited mainly by restenosis of and requirement for repeat revascularization of the treated lesion.: MethodsWe studied 6,186 patients (6,219 lesions) pooled from several recently completed coronary stent trials. Clinical restenosis was defined using three different definitions: target lesion revascularization (TLR) beyond 30 days, target vessel revascularization (TVR) beyond 30 days, and target vessel failure (TVF), defined as TVR, any death, or myocardial infarction (MI) of the target vessel territory after hospital discharge.: ResultsBy one year, 638 (12.2%) patients had TLR, 748 (14.3%) had TVR, and 848 (16.0%) had TVF, more than two-thirds higher than the rate of these end points at six months. The severity of angiographic restenosis (≥50% follow-up diameter stenosis [DS]) in 419 of 1,437 (29%) patients undergoing routine angiographic follow-up correlated directly with the likelihood of TLR (73% vs. 26% for >70% DS compared with <60% DS). Smaller pretreatment minimum lumen diameter (MLD), smaller final MLD, longer stent length, diabetes mellitus, unstable angina, and hypertension were independent predictors of TLR. Prior MI and current smoking were negative predictors.: ConclusionsAt one year after stenting, most clinical restenosis reflected TLR, which was predicted by the same variables previously associated with an increased risk of angiographic restenosis. The lower absolute rate of clinical restenosis relative to angiographic restenosis was due to infrequent TLR in lesions with less severe (<60% DS) angiographic renarrowing. [Copyright &y& Elsevier]

: ObjectivesThe aim of this study was to evaluate the clinical, angiographic, and technical factors related to successful stenting of diseased saphenous vein grafts (SVGs) using a novel filter-based distal protection device.: BackgroundProtection of the distal microvasculature with a balloon occlusion and aspiration system has been shown to reduce atherothrombotic embolization and peri-procedural myocardial infarction (MI) after percutaneous coronary intervention (PCI) in SVGs. The safety, efficacy, and technical factors relating to procedural success with filter-based distal protection devices are unknown.: MethodsPercutaneous coronary intervention was performed in 60 lesions in 48 patients undergoing SVG intervention with the FilterWire EX distal protection system in a phase I experience at six sites. A larger phase II study was then performed in 248 lesions in 230 SVGs at 65 U.S. centers.: ResultsCumulative adverse events to 30 days occurred in 21.3% of patients in phase I, including a 19.1% rate of MI. Numerous anatomic, device-specific, and operator-related contributors to these adverse events were identified, resulting in significant changes to the protocol and instructions for use. Subsequently, despite similar clinical and angiographic characteristics to the phase I patients, the 30-day adverse event rate in phase II was reduced to 11.3% (p = 0.09), due primarily to a lower incidence of peri-procedural Q-wave and non–Q-wave MI.: ConclusionsDistal protection during SVG PCI with the FilterWire EX is associated with a low rate of peri-procedural adverse events compared to historical controls. A unique set of anatomic, technical, and operator-related issues exist with distal filters which, if ignored, may reduce their effectiveness. [Copyright &y& Elsevier]

: ObjectivesThe aim of this study was to evaluate a possible relationship between homocysteine levels on admission and late outcome after successful percutaneous coronary intervention (PCI).: BackgroundIncreasing evidence suggests that mild to moderate elevation of total plasma homocysteine is a graded and potentially modifiable risk factor for cardiovascular disease and death that appears to be largely independent of other traditional risk factors.: MethodsA total of 549 patients were included after successful PCI of at least one coronary stenosis (≥50%). End points were cardiac death, nonfatal myocardial infarction (MI), target lesion revascularization (TLR), and a composite of major adverse cardiac events (MACE). The relationship between homocysteine levels and study endpoints was assessed.: ResultsAfter a median (± SD) follow-up of 58 ± 20 weeks, 6 patients died of cardiac death, 14 were diagnosed with a new MI, and 71 underwent repeat TLR. A graded relationship between homocysteine levels (quartiles) and freedom from MACE was found (p = 0.01). Homocysteine levels (± SD) were associated with cardiac death (14.9 ± 1.7 μmol/l vs. 9.6 ± 4.3 μmol/l, p < 0.005), TLR (10.7 ± 4.4 μmol/l vs. 9.5 ± 4.3 μmol/l, p < 0.05), and overall MACE (11.0 ± 4.4 μmol/l vs. 9.4 ± 4.3 μmol/l, p < 0.005). These findings remained unchanged after adjustment for potential confounders.: ConclusionsPlasma homocysteine is an independent predictor of mortality, nonfatal MI, TLR, and overall adverse late outcome after successful coronary angioplasty. [Copyright &y& Elsevier]

: ObjectivesThe rationale of this study was to identify risk factors that predict early thrombotic events and angiographic restenosis after stenting in small coronary arteries.: BackgroundRates of cardiac complications and restenosis after percutaneous coronary intervention are higher in patients with small versus large coronary arteries. Because of discordant results, randomized studies comparing stent placement with balloon angioplasty could not establish the best interventional approach to use in this high-risk subset of patients. This study of predictive factors, with special focus on stent design, may provide particular help in this regard.: MethodsClinical, lesion-related, and procedural data of a large and unselected population of 3,156 consecutive patients were analyzed in a logistic regression model for both early and late complications. Repeat angiography at six months was performed in 80.8% of eligible patients.: ResultsThe strongest risk factors for early thrombotic events (cumulative incidence of 4.2%) were the presence of an acute coronary syndrome and reduced left ventricular function. The stent design had no influence on early thrombotic complications. Restenosis (overall rate of 38.4%) was predominantly influenced by procedure-related variables, including the stent design and stented segment length. The incidence of restenosis varied from 29.6% to 55.8%, depending on the stent design used.: ConclusionsClinical factors known before the procedure are predominant risk factors for early thrombotic complications, underscoring the need for potent antiplatelet regimens in these patients. In contrast, our findings suggest a major impact of procedural factors, including the choice of stent type, on restenosis. [Copyright &y& Elsevier]

Background: Patients treated for lesions in the proximal left anterior descending coronary artery (P-LAD) have worse outcome after balloon angioplasty as compared to patients treated for lesions in the distal left anterior descending coronary artery (D-LAD). We sought to examine if this discrepancy was still observed after stenting. Methods: A total of 676 consecutive patients with a symptomatic monovessel disease in the LAD artery who underwent angioplasty with stenting were prospectively entered into a dedicated database. Among this cohort, 322 lesions were located in P-LAD and 354 in D-LAD. Patients with total occlusion, acute myocardial infarction (MI) or restenosis were excluded. Results: Procedural characteristics were similar in the two groups. Procedural success was high with the same rates of in-hospital death and Q-wave MI for patients treated in P-LAD and D-LAD. At 1 year, the rate of target lesion revascularization (TLR) was 13.9% in the P-LAD group and 16.3% in the D-LAD group (P=.79), and the rate of event-free survival was 81.9% and 81% (P=.67), respectively. The treatment of ostial lesions (n=23) was not related to worse outcome. In multivariate analysis, lesion location was not a predictor of major adverse cardiac events (MACE). Conclusion: This study shows that stenting of lesions in the P-LAD is as effective and safe as treatment of lesions located in D-LAD. Therefore, when stenting is feasible, the location of the lesion in the LAD is not predictive of worse outcome and, consequently, should not be taken into account in the choice of the revascularization strategy. [Copyright &y& Elsevier]

: ObjectivesThe purpose of this study was to examine the effect of intracoronary radiation therapy (IRT) in diabetic patients with in-stent restenosis (ISR).: BackgroundDiabetic patients are at an increased risk for restenosis, repeat revascularization procedures and late mortality after percutaneous coronary interventions and stenting. Intracoronary radiation therapy, utilizing both gamma and beta-emitters, has been shown to reduce the rate of ISR.: MethodsThe study group consisted of 749 consecutive patients with ISR who were treated with either IRT or placebo in randomized trials and registries at our center. Diabetic patients (252 radiation and 51 placebo) were compared with nondiabetic patients (371 radiation and 75 placebo).: ResultsIn-hospital outcomes were similar between diabetic and nondiabetic patients treated with and without radiation. At six-month clinical and angiographic follow-up, there was a significant reduction in the binary restenosis (63.8% vs. 15.7%, p < 0.0001), target lesion revascularization (66.7% vs. 17.6%, p < 0.0001) and target vessel revascularization (TVR) (70.6% vs. 22.9%, p < 0.0001) rates in diabetic patients treated with radiation compared to placebo. Comparisons between the placebo arms detected a trend towards higher restenosis (63.8% vs. 48.4% p = 0.13) and TVR (70.6% vs. 56.0%, p = 0.14) in diabetic versus nondiabetic patients. In contrast, diabetic and nondiabetic patients treated with IRT experienced similar restenosis (15.6% vs. 10.7% p = 0.33) and TVR (22.9% vs. 28.2% p = 0.41) rates.: ConclusionsIn diabetic patients with ISR, intracoronary radiation significantly reduced the recurrence of ISR compared to placebo. Additionally, similar rates of restenosis and revascularization procedures were achieved in irradiated diabetic and nondiabetic patients. In view of these results, IRT should be considered as a valuable therapeutic alternative in all diabetic patients with ISR. [Copyright &y& Elsevier]

: ObjectivesThe study assessed the influence of lesion length and reference vessel diameter (RVD) on recurrent restenosis after gamma intracoronary radiation therapy (ICRT) for in-stent restenosis (IRS).: BackgroundIntracoronary radiation therapy reduces angiographic and clinical restenosis in patients with ISR. The impact of ICRT on challenging subgroups, such as long lesions and small vessels, has not been established.: MethodsSix-month quantitative coronary angiography and clinical follow-up were conducted to evaluate the influence of lesion length and RVD in patients with ISR treated with ICRT who were enrolled in gamma radiation trials. Angiographic binary restenosis (>50% diameter stenosis) and clinical events were assessed in 311 patients treated with gamma ICRT and 105 patients who received placebo.: ResultsBaseline demographic, angiographic and procedural details were similar in the two treatment groups. The ICRT group had reduced binary restenosis in vessels of all sizes (30% vs. 66%, p < 0.001), with the most benefit seen in small vessels. A trend toward reduced restenosis with ICRT was found across all lesion lengths. At six months, major adverse cardiac events (MACE) were reduced in the ICRT group compared to placebo (34% vs. 71%, p < 0.0001), driven by reduced target vessel revascularization (27% vs. 71%, p < 0.0001). The independent predictors of angiographic restenosis include ICRT (OR [odds ratio] 0.16; CI [confidence interval] 0.10 to 0.28, p < 0.001), lesion length (OR 1.03; CI 1.01 to 1.05, p = 0.004) and RVD (OR 0.40; CI 0.23 to 0.67, p < 0.001).: ConclusionsIntracoronary radiation therapy, compared to placebo, results in a significant reduction of angiographic restenosis across all vessel sizes, with a trend toward reduction of angiographic restenosis across all lesion lengths; this effect is seen predominantly in small vessels and diffuse lesions. [Copyright &y& Elsevier]

Patients with chronic kidney disease (CKD) have a greater risk of peripheral arterial disease (PAD). Although individual studies have documented an association between CKD and/or end-stage renal disease (ESRD) and adverse outcomes in patients undergoing PAD interventions in an era of technological advances in peripheral revascularization, the magnitude of the effect size is unknown. Therefore, we performed a meta-analysis to compare the outcomes of PAD interventions for patients with CKD/ESRD with those patients with normal renal function, stratified by intervention type (endovascular vs surgical), reflecting contemporary practice. Five databases were analyzed from January 2000 to June 2019 for studies that had compared the outcomes of lower extremity PAD interventions for patients with CKD/ESRD vs normal renal function. We included both endovascular and open interventions, with an indication of either claudication or critical limb ischemia. We analyzed the pooled odds ratios (ORs) across studies with 95% confidence intervals (CIs) using a random effects model. Funnel plot and exclusion sensitivity analyses were used for bias assessment. Seventeen observational studies with 13,140 patients were included. All included studies, except for two, had accounted for unmeasured confounding using either multivariable regression analysis or case-control matching. The maximum follow-up period was 114 months (range, 0.5-114 months). The incidence of target lesion revascularization (TLR) was greater in those with CKD/ESRD than in those with normal renal function (OR, 1.68; 95% CI, 1.25-2.27; P =.001). The incidence of major amputations (OR, 1.97; 95% CI, 1.37-2.83; P <.001) and long-term mortality (OR, 2.28; 95% CI, 1.45-3.58; P <.001) was greater in those with CKD/ESRD. The greater TLR rates with CKD/ESRD vs normal renal function were only seen with endovascular interventions, with no differences for surgical interventions. The differences in rates of major amputations and long-term mortality between the CKD/ESRD and normal renal function groups were statistically significant, regardless of the intervention type. Patients with CKD/ESRD who have undergone lower extremity PAD interventions had worse outcomes than those of patients with normal renal function. When stratifying our results by intervention (endovascular vs open surgery), greater rates of TLR for CKD/ESRD were only seen with endovascular and not with open surgical approaches. Major amputations and all-cause mortality were greater in the CKD/ESRD group, irrespective of the indication. Evidence-based strategies to manage this at-risk population who require PAD interventions are essential. [ABSTRACT FROM AUTHOR]