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Abstract: Objective: Although cardiovascular risk factors have been strongly linked to carotid intimal-media thickness, their association with plaque progression towards instability is poorly understood. We evaluated a large database of endarterectomy specimens removed from symptomatic and asymptomatic patients to determine the correlation between major cardiovascular risk factors and carotid plaque morphology. Methods: Incidence of thrombotic, vulnerable and stable plaques together with the degree of plaque inflammatory infiltration was evaluated in 457 carotid atherosclerotic lesions. Clinical records were reviewed in all cases for risk factors profile. Results: Thrombotic plaques were more frequently observed in patients affected by stroke (66.9%) as compared to TIA (36.1%) and asymptomatic patients (26.8%, p <0.001). Out of 457 carotid plaques removed during carotid endarterectomy, 181 (39.6%) were represented by thrombotic plaques, 72 (15.8%) by vulnerable plaques (thin cap fibroateroma) and 204 (44.6%) by stable plaques. At the multivariate analysis, a strong association was observed between hypertension, low HDL-cholesterol (HDL-C) and ratio of total to HDL-C >5 with vulnerable and thrombotic carotid plaques. Hypertension (p =0.001), hypercholesterolemia (p =0.05) and low HDL-C (p =0.001) significantly also correlated with the presence of high inflammatory infiltrate of the plaque. When multivariate analysis was restricted to asymptomatic patients, hypertension (p =0.009, OR 2.29), low HDL-cholesterol (p =0.01 OR 2.21) and the ratio of total to HDL-C >5 (p =0.03, OR 2.07) were confirmed to be the risk factors most significantly associated to unstable plaques. The relative risk to carry an unstable plaque for asymptomatic patients with high Framingham Risk Score as compared with those with low risk score was 2.06 (95% C.I., 1.26–3.36). Conclusions: The present histopathological study identifies risk factors predictive of increased risk of carotid plaque rupture and thrombosis. Asymptomatic patients with high risk factors profile may constitute a specific target to reduce the likelihood of cerebrovascular accidents even in the presence of non-flow-limiting plaque. [Copyright &y& Elsevier]

Abstract: Background: Paclitaxel-eluting stents (PES) have been proved effective in randomized trials enrolling highly selected patients. Yet, given the uncertainty concerning results of PES implantation in very high-risk patients and lesions, we designed a prospective multicenter registry, the Taxus in Real-life Usage Evaluation (TRUE) Study. Study design, patient characteristics and in-hospital outcomes: Consecutive patients undergoing PES implantation were enrolled provided that the target lesion treated with PES was an unprotected left main (ULM), a true bifurcation, a chronic total occlusion (CTO), a long lesion (>28 mm), located in a small vessel (<2.75 mm), or the patient had diabetes mellitus. Clinical events will be adjudicated at 1, 7 and 12 months, with 4- to 8-month angiographic follow-up. The primary end-point will be the 7-month occurrence of major adverse cardiovascular events (MACE, i.e. the composite of cardiac death, non-fatal myocardial infarction [MI], coronary artery bypass grafting [CABG] and percutaneous target vessel revascularization [TVR]). To date, patient enrolment has been completed reaching the target of 1065 subjects. These included 322 (30.2%) diabetics, 115 (10.8%) subjects undergoing PES implantation for ULM, 229 (21.5%) in a bifurcation, 191 (17.9%) in a CTO, 430 (40.4%) in a small vessel, and 289 (27.1%) in a long lesion. An average of 1.5±0.6 vessels and 2.0±1.0 lesions were treated per patient, with 2.0±1.2 PES implanted per patient, and a 46±30 mm total PES length per patient. In-hospital MACE occurred in 39 (3.7%) patients, with 2 (0.2%) cardiac deaths, 32 (3.0%) MI, 5 (0.5%) TVR, no CABG, and 4 (0.4%) acute stent thromboses. Implications: Despite the availability of randomized trials, only carefully designed and prospective registries can provide timely and accurate assessment of the risk–benefit profile of PES in very high-risk patients. Indeed, the TRUE Study, including as much as 115 ULM and 229 bifurcation interventions, should give important insights into the outcome of PES in such an unprecedented and challenging context. [Copyright &y& Elsevier]

The impact of the use of sirolimus-eluting stents (SESs) in the treatment of in-stent restenosis in previously irradiated sites has not been adequately evaluated. Fifteen consecutive patients who underwent percutaneous coronary interventions using SESs in lesion sites previously intervened with intracoronary radiation therapy were identified. All stents were implanted successfully, and there were no major in-hospital complications. At 30-day follow-up, there was 1 case of subacute thrombosis that led to target lesion revascularization (TLR). At 6 months, 2 patients underwent TLR because of recurrent angina with angiographic restenosis, and 1 patient underwent target vessel revascularization distally to the SES site; no other major adverse cardiac events occurred at long-term follow-up (mean 17 ± 8 months). [Copyright &y& Elsevier]

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. [Copyright &y& Elsevier]

This article presents a letter to the editor in response to the article "Treatment of in-stent restenosis--back to the future?" by E. Camenzind, published in the November 16, 2006 issue.

Background: Identifying sex-related differences/variables associated with 30 day/1 year mortality in patients with chronic limb-threatening ischemia (CLTI). Methods: Multicenter/retrospective/observational study. A database was sent to all the Italian vascular surgeries to collect all the patients operated on for CLTI in 2019. Acute lower-limb ischemia and neuropathic-diabetic foot are not included. Follow-up: One year. Data on demographics/comorbidities, treatments/outcomes, and 30 day/1 year mortality were investigated. Results: Information on 2399 cases (69.8% men) from 36/143 (25.2%) centers. Median (IQR) age: 73 (66–80) and 79 (71–85) years for men/women, respectively (p < 0.0001). Women were more likely to be over 75 (63.2% vs. 40.1%, p = 0.0001). More men smokers (73.7% vs. 42.2%, p < 0.0001), are on hemodialysis (10.1% vs. 6.7%, p = 0.006), affected by diabetes (61.9% vs. 52.8%, p < 0.0001), dyslipidemia (69.3% vs. 61.3%, p < 0.0001), hypertension (91.8% vs. 88.5%, p = 0.011), coronaropathy (43.9% vs. 29.4%, p < 0.0001), bronchopneumopathy (37.1% vs. 25.6%, p < 0.0001), underwent more open/hybrid surgeries (37.9% vs. 28.8%, p < 0.0001), and minor amputations (22% vs. 13.7%, p < 0.0001). More women underwent endovascular revascularizations (61.6% vs. 55.2%, p = 0.004), major amputations (9.6% vs. 6.9%, p = 0.024), and obtained limb-salvage if with limited gangrene (50.8% vs. 44.9%, p = 0.017). Age > 75 (HR = 3.63, p = 0.003) is associated with 30 day mortality. Age > 75 (HR = 2.14, p < 0.0001), nephropathy (HR = 1.54, p < 0.0001), coronaropathy (HR = 1.26, p = 0.036), and infection/necrosis of the foot (dry, HR = 1.42, p = 0.040; wet, HR = 2.04, p < 0.0001) are associated with 1 year mortality. No sex-linked difference in mortality statistics. Conclusion: Women exhibit fewer comorbidities but are struck by CLTI when over 75, a factor associated with short- and mid-term mortality, explaining why mortality does not statistically differ between the sexes. [ABSTRACT FROM AUTHOR]

Objectives: The purpose of the present report was to evaluate clinical and angiographic outcomes of drug-eluting stent (DES) implantation in saphenous vein graft (SVG) lesions. Background: The safety and efficacy of DES implantation for the treatment SVG lesions remains uncertain. Methods: We evaluated in-hospital and six-month outcomes in 61 consecutive patients treated with DES in SVG lesions from March 2002 to March 2004 (DES group), as compared to 89 consecutive patients treated with bare-metal stents (BMS) in the 24 months immediately before the introduction of DES (BMS group). Major adverse cardiac events (MACE) including death, myocardial infarction, target lesion revascularization (TLR), and target vessel revascularization (TVR) were recorded in-hospital and at six-month follow-up. Results: The rate of in-hospital MACE was similar between the two groups (6.6% vs. 5.6%, p = 1.0). Cumulative MACE at six months was 11.5% in the DES group and 28.1% in the BMS group (p = 0.02). The DES group had a significantly lower incidence of in-segment restenosis (10.0% vs. 26.7%, p = 0.03), TLR (3.3% vs. 19.8%, p = 0.003), and TVR (4.9% vs. 23.1%, p = 0.003). By Cox regression analysis, diabetes (hazard ratio [HR]: 3.03; 95% confidence interval [CI]: 1.33 to 6.90; p = 0.008), usage of BMS (HR: 2.53; 95% CI: 1.07 to 5.97; p = 0.03), and age of SVG (HR: 1.10; 95% CI: 1.02 to 1.19; p = 0.02) were identified as predictors of MACE at six-month follow-up. Conclusions: Compared to BMS implantation, DES implantation in SVG lesions appears safe with favorable and improved mid-term outcomes. [Copyright &y& Elsevier]

Abstract: Thienopyridines and aspirin are beneficial in patients undergoing bare-metal stent implantation, and aspirin and clopidogrel treatment have also been proved effective after drug-eluting stent (DES) implantation. However, despite the common substitution of clopidogrel with ticlopidine because of cost or patient intolerance, there are no data on the comparison of ticlopidine vs. clopidogrel after DES implantation. We hereby compare ticlopidine vs. clopidogrel after paclitaxel-eluting stent implantation in subjects enrolled in the prospective multicenter Taxus in Real-life Usage Evaluation (TRUE) Study. Across the 505 analyzed patients (112 treated with ticlopidine and 393 with clopidogrel), similar rates of early and mid-term (7 months) adverse thrombotic events were found with either antiplatelet regimen, with the notable exception of 2 cases of late stent thrombosis in patients who had prematurely withdrawn ticlopidine treatment just 3 months after the procedure. These findings thus support the overall safety and effectiveness of ticlopidine after DES implantation, and also confirm the increased risk of late thrombosis when premature withdrawal of thienopyridines occurs. [Copyright &y& Elsevier]

Objectives: The goal of this study was to compare angiographic, intravascular imaging, and functional parameters, as well as the clinical outcomes of patients treated with drug-eluting balloon (DEB) plus bare-metal stent (BMS) versus BMS versus drug-eluting stent (DES) for ST-segment elevated acute myocardial infarction (STEMI). Background: Concerns remain regarding the long-term safety of DES in STEMI. DEB could provide an attractive alternative in order to achieve potentially similar effectiveness but limiting the long-term hazards related to late-acquired stent malapposition and thus stent thrombosis. Methods: In this randomized, international, 2-center, single-blinded, 3-arm study, STEMI patients were randomly assigned to group A: BMS; group B: DEB plus BMS; or group C: DES after successful thrombus aspiration. The primary endpoint was 6-month angiographic in-stent late-luminal loss. Secondary endpoints were in-stent binary restenosis, major adverse cardiac events (MACE: cardiac death, myocardial infarction, target vessel revascularization). In a subgroup of patients, stent (mal)apposition (by optical coherence tomography) and endothelial function (by acetylcholine infusion) was assessed. Results: Overall, 150 patients were randomized. Procedural success was achieved in 96.7%. In groups A, B, and C, respectively, late-luminal loss was 0.74 ± 0.57 mm, 0.64 ± 0.56 mm, and 0.21 ± 0.32 mm (p < 0.01); binary restenosis was 26.2%, 28.6%, and 4.7% (p = 0.01); and MACE rates were 23.5%, 20.0%, and 4.1% (p = 0.02), respectively. The median percentage [25th to 75th interquartile range] of uncovered and malapposed stent struts per lesion was 0 [0 to 0.35], 2.84 [0 to 6.63], and 5.21 [3.25 to 14.5] (p < 0.01). Significant paradoxical vasoconstriction was seen in groups B and C. Conclusions: In STEMI patients, DEB followed by BMS implantation failed to show angiographic superiority to BMS only. Angiographic results of DES were superior to both BMS and DEB. Moreover, DEB before implantation induced more uncovered and malapposed stent struts than BMS, but less than after DES. (Drug-Eluting Balloon in Acute Myocardial Infarction [DEB-AMI]; NCT00856765) [Copyright &y& Elsevier]

Abstract: Background: Stent thrombosis (ST) and restenosis are concerns after percutaneous coronary intervention (PCI). Limited information exists concerning clinical and angiographic outcomes following multiple stent insertion. We therefore present the long-term outcome from drug-eluting stent (DES) insertion and correlate this with the Syntax score. Methods and Results: Between April 2002 and 2006, all patients that underwent multilesion PCI (defined as ≥4 DES) were included for analysis, and follow-up commenced from the point where the fourth stent was inserted. Three hundred and seventy-four patients were identified, comprising 1972 lesions; 99% had clinical (30±16 months), and 72% had angiographic follow-up. The mean number of stents implanted was 5.7±1.9 and with length of 137±50 mm and Syntax Score of 24±8. The Syntax score (SS) did not predict major adverse cardiac events (MACE) at long-term follow-up, which occurred in 33% in the low SS (<22), 34% intermediate SS (22–32) and 40% in the high SS (>33); P=ns. However, the number of stents implanted correlated with events [MACE: 12% (4 DES), 35% (4–6 DES), 61% (>6 DES)]. There were 11 (2.9%) definite and probable ST: four acute and subacute, three late, and four very late. Conclusions: This study demonstrates an acceptable occurrence of myocardial infarction, death, repeat revascularisation, and ST in patients with multivessel de novo lesions, which had better correlation with the number of DES inserted than the Syntax score. [Copyright &y& Elsevier]

Despite the increasing use of transradial techniques for cardiac percutaneous procedures, none of the strategies commonly utilized for hemostasis has been able to reduce the occurrence of radial artery occlusion (RAO). The aim of this study was to evaluate the occurrence of 24-hour RAO and the rate of bleeding of a novel hemostatic device for radial closure after percutaneous interventions, in adjunct to short-time compression. Once the radial access was obtained, patients were randomized to 3 different strategies of radial closure: a short compression with the QuikClot® Interventional™ pad (Z-Medica Corporation, Wallingford, CT, USA) (15 minutes, group 1), a short compression (15 minutes, group 2), and a conventional prolonged compression (2 hours, group 3) both without QuikClot® utilization. Fifty patients in group 1, 20 in group 2, and 50 in group 3 were enrolled. The three groups were homogenous for baseline and procedural characteristics. None of patients in group 1 developed RAO, 1 (5%) occurred in group 2, and 5 (10%) in group 3 (P = 0.05). Active bleeding after compression removal occurred in 10 patients (20%) in group 1, 18 (90%) in group 2, and 1 (2%) in group 3 (P < 0.001). Among patients in group 1, at univariate analysis, the predictors of acute bleeding resulted in chronic therapy with clopidogrel (Odds Ratio 28.78, 95% Confidence Intervals 4.79-172.82, P < 0.001) and high levels of activated clotting time (ACT) at the time of sheath removal (OR 1.02, 95% CI 1.00-1.03, P = 0.009). At ROC analysis, the cutoff value of ACT for the risk of bleeding with a sensitivity of 80% and specificity of 75% was 287 seconds. Early sheet removal and short-time compression with QuikClot® Interventional™ can reduce the rate of RAO after diagnostic or interventional procedures especially in patients not on double antiplatelet therapy. (J Interven Cardiol 2011;24:65-72) [ABSTRACT FROM AUTHOR]

Background: Investigation of the correlation between bifurcation angles and outcomes is limited with discordant results. The aim of this study is to investigate left main (LM) and non-left main (N-LM) bifurcation angles and their modification after percutaneous coronary intervention (PCI). Measurement of all three angles adds to our understanding of bifurcation anatomy and the resultant effect of different stenting techniques. Methods and Results: All three bifurcation angles were described according to the European Bifurcation Club definition: the A (proximal bifurcation angle), the B (distal bifurcation angle) and the C (main branch angle). Measurements were performed in 75 LM and 140 N-LM bifurcations. In LM bifurcations baseline mean values of C, A, and B were 151°± 28°, 131°± 32°, and 78 ± 28°, respectively. In bifurcations with 2 stents the B significantly decreased by a mean of 10° (P = 0.003) and A increased by 10° (P = 0.006). Crush stenting significantly decreased B (A – 14°; P = 0.020) and increased A (A + 21°; P = 0.005), particularly non-true bifurcations. In N-LM bifurcations mean values for C, A, and B were 156°± 19°, 144°± 22°, and 60°± 20°, respectively. Similar to LM bifurcations, the B became narrower mainly at the expense of the A, which became wider. In both types of bifurcations the greatest variation in A and B was found following 2-stent techniques performed in T-shaped (≥70°) bifurcations. Conclusions: In both LM and N-LM bifurcations we found a significant difference in A and B pre- and post-PCI. This difference was driven by the 2-stent technique and was most evident with a baseline bifurcation angle ≥70°. The Crush technique caused the largest angle variation post-procedure, particularly in non-true LM bifurcations. (J Interven Cardiol 2010;23:382–393) [ABSTRACT FROM AUTHOR]

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. [Copyright &y& Elsevier]

Several randomized trials have shown that sirolimus-eluting stents and paclitaxel-eluting stents (PES) are effective in reducing restenosis in respect to bare-metal stents, including the subset of small vessels. The objective of this study was to evaluate “real world” angiographic and clinical outcomes of a large series of patients enrolled in the TRUE registry and treated with PES for both small vessel and very small vessel lesions. A consecutive series of 675 patients (926 lesions) with reference vessel diameter <2.75 mm measured by quantitative coronary angiography analysis were analyzed. The primary end point was the rate of angiographic in-stent restenosis and 1-year major adverse cardiac events. In this study 390 lesions were identified as small vessel (reference vessel diameter ≥2.25 and <2.75 mm) and 536 lesions as very small vessel (reference vessel diameter <2.25 mm). Overall in-stent restenosis was 15.5% (n = 96). Compared with small vessel, the very small vessel lesions had more in-stent restenosis (21.7% vs 11.4%, p <0.001) and in-segment restenosis (29.3% vs 22.5%, p = 0.055). The majority of the restenotic lesions (n = 125) were focal (57%, n = 71). At 1 year, cardiac death was 1.6% (n = 11), acute myocardial infarction 0.5% (n = 4.), and the target lesion revascularization 12.8% (n = 86). Cumulative major adverse cardiac events rate was 17.3% (n = 119). The rate of definite and probable stent thrombosis was 0.9% (n = 8). In conclusion, in comparison with historical bare-metal stent controls, this large series of small vessel lesions treated with PES confirms previous results reporting the efficacy of PES in small vessels. The rate of subacute and late stent thrombosis was low in this subgroup of patients. [Copyright &y& Elsevier]

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. [Copyright &y& Elsevier]

Objectives: This study was designed to compare the outcomes of paclitaxel-eluting stents (PES) and sirolimus-eluting stents (SES) in a contemporaneous cohort of real-world patients. Background: A number of randomized comparisons of PES and SES have shown unequivocal advantages for SES in angiographic end points such as late loss. However, the data on clinical outcomes are less consistent. Methods: All consecutive patients successfully treated with only SES or PES in de novo native vessel lesions between March 2003 and March 2005 were analyzed. Our end points were major adverse cardiac events (MACE), a composite of death, myocardial infarction (MI), target vessel revascularization (TVR), and target lesion revascularization (TLR). We also analyzed late loss and angiographic restenosis. Results: There were 609 patients (1,064 lesions) treated with PES and 674 patients (1,205 lesions) treated with SES. Diabetes mellitus was present in 26.8% of patients and multivessel disease in 75% of patients. Bifurcations made up 16.3% of lesions, chronic occlusions 9.5%, left main 4.8%, and American Heart Association/American College of Cardiology type B2/C 75.4%. Despite a higher late loss in the PES group (p = 0.0001), there were no differences in angiographic restenosis (PES 18% vs. SES 17.8%, p = 0.95), TLR (PES 11.9% vs. SES 11%, p = 0.47), or MACE (PES 21.3% vs. SES 21.1%, p = 0.95). The relative risk of MACE for the PES group was 1.02 (95% confidence interval [CI] 0.78 to 1.33). Multivariable analysis confirmed the lack of association of stent type with MACE (odds ratio 1.03 [95% CI 0.77 to 1.38], p = 0.83) and TLR (odds ratio 1.08 [95% CI 0.81 to 1.44], p = 0.61). Conclusions: In this complex cohort, both stent platforms demonstrated similar clinical outcomes despite different late loss. [Copyright &y& Elsevier]

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. [Copyright &y& Elsevier]

Abstract: Drug-eluting stents have been unequivocally demonstrated to reduce in-stent restenosis when compared to bare metal stents, with resultant lower rates of repeat revascularization. Comparative data are now emerging which compare the performance of sirolimus- and paclitaxel-eluting stents to each other rather than to bare metal stents. In this article, we review these data with the aim of placing the studies in context thereby providing an overall view of this rapidly developing field as it stands at present. [Copyright &y& Elsevier]

Objectives: We sought to determine if the angiographic pattern of in-stent restenosis in drug-eluting stents (DES) maintains its prognostic importance. Background: The pattern of restenosis in the bare-metal stent era had a significant impact on therapeutic outcomes. Methods: We identified a total of 250 consecutive restenotic lesions in 203 patients (66.4% sirolimus-eluting stents and 33.6% paclitaxel-eluting stents). We divided these lesions into two groups: focal, defined as ≤10 mm, 163 lesions (65.2%); and nonfocal, which were diffuse, proliferative, or obstructive, 87 lesions (34.8%). The end points analyzed were angiographic restenosis and target lesion revascularization (TLR). Results: Diabetes was the only clinical variable associated with the pattern of restenosis (28.8% focal compared with 52.9% diffuse; p = 0.0001). Angiographic follow-up of the treatment of restenosis was available in 61.2% of the lesions and was similar between the two groups. The rate of angiographic restenosis was 17.8% in the focal group and 51.1% in the nonfocal group (p = 0.0001). The incidence of TLR also increased with the type of restenosis treated (9.8% and 23%, respectively; p = 0.007). An adjusted multivariate analysis revealed that the pattern of restenosis remained associated with both the occurrence of restenosis and TLR (odds ratio [OR] 5.1 [95% confidence interval (CI) 1.1 to 23], p = 0.03; and OR 3.61 [95% CI 1.2 to 10.9], p = 0.02; respectively). Conclusions: Similar to bare-metal stent data, the angiographic pattern of restenosis following DES implantation is prognostically important. Diabetes is a significant predictor of the pattern of restenosis in the DES era. [Copyright &y& Elsevier]

Objectives: The purpose of this study was to evaluate predictors of an adverse outcome after “crush” bifurcation stenting. Background: The “crush” technique is a recently introduced strategy with limited data regarding long-term outcomes. Methods: We identified 231 consecutive patients treated with drug-eluting stent implantation with the “crush” technique for 241 de novo bifurcation lesions. Clinical follow-up was obtained in 99.6%. Results: The in-hospital major adverse cardiac event (MACE) rate was 5.2%. At 9 months, 10 (4.3%) patients had an event consistent with possible post-procedural stent thrombosis. Survival free of target lesion revascularization (TLR) was 90.3%; the only independent predictor of TLR was left main stem (LMS) therapy (odds ratio [OR] 4.97; 95% confidence interval [CI] 2.00 to 12.37, p = 0.001). Survival free of MACE was 83.5% and independent predictors of MACE were LMS therapy (OR 3.79; 95% CI 1.76 to 8.14, p = 0.001) and treatment of patients with multivessel disease (OR 4.21; 95% CI 0.95 to 18.56, p = 0.058). Angiographic follow-up was obtained in 77% of lesions at 8.3 ± 3.7months. The mean late loss of the main vessel and side branch were 0.30 ± 0.64 mm and 0.41 ± 0.67 mm, respectively, with binary restenosis rates of 9.1% and 25.3%. Kissing balloon post-dilation significantly reduced the side branch late lumen loss (0.24 ± 0.50 mm vs. 0.58 ± 0.77 mm, p < 0.001). Conclusions: The crush technique of bifurcation stenting with drug-eluting stents is associated with favorable outcomes for most lesions; however, efficacy appears significantly reduced in LMS bifurcations, and further research is needed before the technique can be routinely recommended in this group. Furthermore, the incidence of possible stent thrombosis is of concern and requires further investigation. Kissing balloon post-dilatation is mandatory to reduce side branch restenosis. [Copyright &y& Elsevier]

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. [Copyright &y& Elsevier]

Objectives: The purpose of this research was to evaluate the long-term outcomes after implantation of drug-eluting stents (DES) in bifurcation lesions with the "crush" technique. Background: The long-term outcome of "crush" stenting technique has yet to be determined. Methods: We identified 181 consecutive patients who were treated with DES with the "crush" stent technique from April 2002 to April 2004. Based on the usage of final kissing balloon post-dilation (FKB), the patients were divided into an FKB group (n = 116) and a non-FKB group (n = 65). Results: Clinical follow-up at nine months was available in all patients, and angiographic follow-up in 80% of patients. Three cases (1.7%) of intraprocedural stent thrombosis and five (2.8%) cases of postprocedural stent thrombosis occurred. Restenosis rate of the main branch in the entire cohort lesions was 11.5%. Restenosis rate of the side branch was lower in the FKB group than that in the non-FKB group (11.1% vs. 37.9%, p < 0.001). The target lesion revascularization (TLR) rate for all patients was 14.9%. The lack of FKB was a predictor for TLR (hazard ratio [HR] 4.17; 95% confidence interval [CI] 1.30 to 14.3, p = 0.02). Diabetes was also a predictor for TLR (HR 1.79; 95% CI 1.14 to 2.80, p = 0.01). Premature discontinuation of dual antiplatelet therapy (odds ratio [OR] 16.8; 95% CI 1.31 to 159.5, p = 0.03) and age (OR 1.10; 95% CI 1.00 to 1.21, p = 0.048) was associated with the occurrence of postprocedural stent thrombosis. Conclusions: Compared to the absence of FKB, the "crush" stenting technique with FKB appears to be associated with more favorable long-term outcomes. When utilizing the "crush" stenting technique, FKB is mandatory. [ABSTRACT FROM AUTHOR]

Objectives: The purpose of this research was to evaluate the long-term outcomes after implantation of drug-eluting stents (DES) in bifurcation lesions with the “crush” technique. Background: The long-term outcome of “crush” stenting technique has yet to be determined. Methods: We identified 181 consecutive patients who were treated with DES with the “crush” stent technique from April 2002 to April 2004. Based on the usage of final kissing balloon post-dilation (FKB), the patients were divided into an FKB group (n = 116) and a non-FKB group (n = 65). Results: Clinical follow-up at nine months was available in all patients, and angiographic follow-up in 80% of patients. Three cases (1.7%) of intraprocedural stent thrombosis and five (2.8%) cases of postprocedural stent thrombosis occurred. Restenosis rate of the main branch in the entire cohort lesions was 11.5%. Restenosis rate of the side branch was lower in the FKB group than that in the non-FKB group (11.1% vs. 37.9%, p &#60; 0.001). The target lesion revascularization (TLR) rate for all patients was 14.9%. The lack of FKB was a predictor for TLR (hazard ratio [HR] 4.17; 95% confidence interval [CI] 1.30 to 14.3, p = 0.02). Diabetes was also a predictor for TLR (HR 1.79; 95% CI 1.14 to 2.80, p = 0.01). Premature discontinuation of dual antiplatelet therapy (odds ratio [OR] 16.8; 95% CI 1.31 to 159.5, p = 0.03) and age (OR 1.10; 95% CI 1.00 to 1.21, p = 0.048) was associated with the occurrence of postprocedural stent thrombosis. Conclusions: Compared to the absence of FKB, the “crush” stenting technique with FKB appears to be associated with more favorable long-term outcomes. When utilizing the “crush” stenting technique, FKB is mandatory. [Copyright &y& Elsevier]

Objectives: We sought to determine the safety and efficacy of using multiple overlapping drug-eluting stents (DES) in patients with diffuse left anterior descending coronary artery (LAD) disease. Background: Diffuse LAD disease represents a therapeutic challenge. Results after coronary artery bypass surgery are suboptimal, whereas the use of bare metal stents is limited by high rates of restenosis. The introduction of DES prompted treatment of long diffuse disease with multiple overlapping stents. Methods: All consecutive patients with de novo diffuse LAD disease treated with more than 60-mm long DES from April 2002 to March 2004 were analyzed. Results: The study population consisted of 66 patients. Thirty-nine patients were treated with sirolimus-eluting stents (SES), average length 84 ± 22 mm, and 27 patients with paclitaxel-eluting stents (PES), average length 74 ± 14 mm. The number of stents implanted per patient was 2.8 ± 0.7, whereas the mean total stent length for the LAD treatment was 80 ± 20 mm. Angiographic as well as procedural success was achieved in 95% of cases. Eleven (16.6%) patients had in-hospital non-Q-wave myocardial infarction (five SES and six PES), and one patient developed intraprocedural stent thrombosis. All patients had clinical follow-up, and 52 patients (79%) had an angiographic follow-up at six months. Hierarchical major adverse cardiac event rate was 15% (7.5% for SES and 7.5% for PES). No patients died, one patient had non-Q-wave myocardial infarction (non-index vessel), and 10 patients (15%) underwent target vessel revascularization. Conclusions: The implantation of multiple overlapping DES in patients with a diffusely diseased LAD is relatively safe and associated with good midterm clinical outcomes. [Copyright &y& Elsevier]

Context Traditionally, stent thrombosis has been regarded as a complication of percutaneous coronary interventions during the first 30 postprocedural days. However, delayed endothelialization associated with the implantation of drug-eluting stents may extend the risk of thrombosis beyond 30 days. Data are limited regarding the risks and the impact of this phenomenon outside clinical trials. Objective To evaluate the incidence, predictors, and clinical outcome of stent thrombosis after implantation of sirolimus-eluting and paclitaxel-eluting stents in routine clinical practice. Design, Setting, and Patients Prospective observational cohort study conducted at 1 academic hospital and 2 community hospitals in Germany and Italy. A total of 2229 consecutive patients underwent successful implantation of sirolimus-eluting (1062 patients, 1996 lesions, 2272 stents) or paclitaxel-eluting (1167 patients, 1801 lesions, 2223 stents) stents between April 2002 and January 2004. Interventions Implantation of a drug-eluting stent (sirolimus or paclitaxel). All patients were pretreated with ticlopidine or clopidogrel and aspirin. Aspirin was continued indefinitely and clopidogrel or ticlopidine for at least 3 months after sirolimus-eluting and for at least 6 months after paclitaxel-eluting stent implantation. Main Outcome Measures Subacute thrombosis (from procedure end through 30 days), late thrombosis (>30 days), and cumulative stent thrombosis. Results At 9-month follow-up, 29 patients (1.3%) had stent thrombosis (9 [0.8%] with sirolimus and 20 [1.7%] with paclitaxel; P = .09). Fourteen patients had subacute thrombosis (0.6%) and 15 patients had late thrombosis (0.7%). Among these 29 patients, 13 died (case fatality rate, 45%). Independent predictors of stent thrombosis were premature antiplatelet therapy discontinuation (hazard ratio [HR], 89.78; 95% CI, 29.90-269.60; P<.001), renal failure (HR, 6.49; 95% CI, 2.60-16.15; P<.001), bifurcation lesions (HR, 6.42; 95% CI, 2.93-14.07; P<.001), diabetes (HR, 3.71; 95% CI, 1.74-7.89; P = .001), and a lower ejection fraction (HR, 1.09; 95% CI, 1.05-1.36; P<.001 for each 10% decrease). Conclusions The cumulative incidence of stent thrombosis 9 months after successful drug-eluting stent implantation in consecutive “real-world” patients was substantially higher than the rate reported in clinical trials. Premature antiplatelet therapy discontinuation, renal failure, bifurcation lesions, diabetes, and low ejection fraction were identified as predictors of thrombotic events. [ABSTRACT FROM AUTHOR]

Objectives: The purpose of the present report was to evaluate clinical and angiographic outcomes of drug-eluting stent (DES) implantation in saphenous vein graft (SVG) lesions. Background: The safety and efficacy of DES implantation for the treatment SVG lesions remains uncertain. Methods: We evaluated in-hospital and six-month outcomes in 61 consecutive patients treated with DES in SVG lesions from March 2002 to March 2004 (DES group), as compared to 89 consecutive patients treated with bare-metal stents (BMS) in the 24 months immediately before the introduction of DES (BMS group). Major adverse cardiac events (MACE) including death, myocardial infarction, target lesion revascularization (TLR), and target vessel revascularization (TVR) were recorded in-hospital and at six-month follow-up. Results: The rate of in-hospital MACE was similar between the two groups (6.6% vs. 5.6%, p = 1.0). Cumulative MACE at six months was 11.5% in the DES group and 28.1% in the BMS group (p = 0.02). The DES group had a significantly lower incidence of in-segment restenosis (10.0% vs. 26.7%, p = 0.03), TLR (3.3% vs. 19.8%, p = 0.003), and TVR (4.9% vs. 23.1%, p = 0.003). By Cox regression analysis, diabetes (hazard ratio [HR]: 3.03; 95% confidence interval [CI]: 1.33 to 6.90; p = 0.008), usage of BMS (HR: 2.53; 95% CI: 1.07 to 5.97; p = 0.03), and age of SVG (HR: 1.10; 95% CI: 1.02 to 1.19; p = 0.02) were identified as predictors of MACE at six-month follow-up. Conclusions: Compared to BMS implantation, DES implantation in SVG lesions appears safe with favorable and improved mid-term outcomes. [ABSTRACT FROM AUTHOR]

Between April 2002 and May 2004, 174 consecutive patients who underwent percutaneous coronary intervention of bifurcational lesions with sirolimus-eluting stents were identified. Two strategies were used: stenting only 1 branch (group 1S, n = 57) or stenting both branches (group 2S, n = 117). The incidence of major adverse cardiac events was evaluated in the hospital and at 9-month follow-up. There were no statistically significant differences between the 2 groups with regard to the incidence of target lesion revascularization (5.4% vs 8.9%, p = 0.76), target vessel revascularization (5.4% vs 11.1%, p = 0.51), and cumulative major adverse cardiac events (18.9% vs 23.3%, p = 0.76) at 9 months. [Copyright &y& Elsevier]

This observational study evaluated the clinical and angiographic outcomes of patients with aorto-ostial coronary artery disease treated with sirolimus-eluting stents (SESs) or with bare metal stents (BMSs).The safety and effectiveness of SESs for the treatment of aorto-ostial lesions have not been demonstrated.We identified 82 consecutive patients who underwent percutaneous coronary interventions in 82 aorto-ostial lesions using the SES (32 patients) or BMS (50 patients) and compared the two groups of patients. The incidence of major adverse cardiac events (MACE), including death or Q-wave myocardial infarction (MI), target lesion revascularization (TLR), and target vessel revascularization (TVR), were recorded in-hospital and at a 10-month follow-up.All stents were implanted successfully. There were no statisticallysignificant differences regarding major in-hospital complications between the two groups. At 10-month follow-up, two (6.3%) patients in the SES group and 14 (28%) patients in the BMS group underwent TLR (p = 0.01); MACE were less frequent in the SES group compared to the BMS group (19% vs. 44%, p = 0.02). Angiographic follow-up showed lower binary restenosis rates (11% vs. 51%, p = 0.001) and smaller late loss (0.21 ± 0.31 mm vs. 2.06 ± 1.37 mm, p < 0.0001) in the SES group.The main finding of our study is that, compared to the BMS, implantation of the SES in aorto-ostial lesions appears safe and effective, with no increase in major in-hospital complications and a significant improvement in restenosis and late event rates at 10-month follow-up. [Copyright &y& Elsevier]