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Objectives: To investigate the long-term prognostic implications of complete versus incomplete revascularization in multivessel coronary artery disease (MVD) patients undergoing percutaneous coronary intervention (PCI) with drug-eluting stent (DES). Background: Coronary artery bypass grafting (CABG) in patients with MVD provides better outcomes when complete revascularization is achieved. There is a paucity of data on the outcomes of complete versus incomplete revascularization of MVD patients undergoing PCI, and currently there is no data available with DES. Methods: Patients with MVD undergoing PCI with DES (sirolimus- or paclitaxel-eluting stent) were included. Comparisons of long-term outcomes between completely versus incompletely revascularized patients were made. The primary outcome measure was the composite of cardiac death, nonfatal myocardial infarction (MI), or any revascularization. Secondary endpoints were the components of the composite endpoint. Results: A total of 508 patients were considered for this analysis: 212 (41.7%) and 296 (58.3%) had complete and incomplete revascularization, respectively. The median follow-up was 27.0 (interquartile range: 23.0–37.1) months. After adjusting for baseline characteristics, the hazard ratio (HR, 95% confidence interval) for complete revascularization was 0.43 (0.29–0.63, P < 0.0001) for the primary composite endpoint. Complete revascularization was associated with better outcomes for components of the composite endpoint: 0.37 (0.15–0.92, P = 0.03) for cardiac death, 0.34 (0.16–0.75 P = 0.008) for the composite of cardiac death or MI and 0.45 (0.29–0.69, P = 0.0003) for any repeat revascularization. This association was confirmed in a propensity-matched population. Conclusions: Complete revascularization with DES of MVD patients is associated with lower rates of long-term adverse events. © 2008 Wiley-Liss, Inc.

Recent studies of drug-eluting stents (DES) use in routine clinical practice have led to concern regarding their long-term safety and to questions about the adequacy of current antiplatelet therapy guidelines. This study sought to derivate a risk score for predicting stent thrombosis after drug-eluting stenting. The large single center DES Real-world Incremental Value in the erA of percutaneous revascularizaTION (DERIVATION) database, collecting data about 1,377 patients of any age undergoing PCI with DES as treatment for symptomatic coronary artery disease, was use for this purpose. Logistic regression and bootstrap procedure were used to select correlates of stent thrombosis that were subsequently weighted and integrated into an integer scoring system. Five variables selected from the initial multivariate model were weighted proportionally to their respective odds ratio for stent thrombosis [baseline left ventricular ejection fraction

OBJECTIVE: This is a multicentre, open label, prospective non-randomized registry, with 9-month angiographic follow-up, conducted to evaluate the safety and effectiveness of drug-eluting stents (DES) when used in high restenosis risk patients from the real world. METHODS: From June 2004 to February 2005, a total of 1622 consecutive patients were enrolled to the Sicilian DES Registry, according to specific inclusion criteria. Both paclitaxel-eluting and sirolimus-eluting stents were used. The analysis was performed on 1472 patients because 150 patients were excluded from the study. The primary endpoint was to evaluate the rate of major adverse cardiac events (MACE) within 9 months after DES implantation. Major adverse cardiac events were defined as cardiac death, non-Q-wave or Q-wave myocardial infarction (MI) and target vessel revascularization (TVR). The secondary endpoints were procedural success, angiographic binary restenosis and stent thrombosis within 9 months post-procedure. RESULTS: Patients were more frequently male; 472 (32.1%) were diabetics, of whom 130 (27.5%) were treated with insulin. Mean ejection fraction of the left ventricle was 51.5 ± 8.7%. Multivessel disease was found and treated in 627 patients (42.6%). A total of 2439 lesions were treated with DES. Final angiographic success was achieved in 2422 (99.3%) lesions. Procedural success was achieved in 1422 (96.6%) patients. The 9-month cumulative incidence of MACE was 7.3% with 0.8% of cardiac deaths, 0.8% non-fatal MI, 7.9% TVR. Binary restenosis was observed in 101 patients (8.3%). Stent thrombosis was documented in 11 patients (0.8%). CONCLUSIONS: Drug-eluting stents appear to be safe and associated with a low incidence of MACE at 9-month follow-up, even in patients selected for their complexity. © 2008 Italian Federation of Cardiology.

Background: Percutaneous coronary intervention (PCI) of coronary bifurcation lesions remains a subject of debate. Many studies have been published in this setting. They are often small scale and display methodological flaws and other shortcomings such as inaccurate designation of lesions, heterogeneity, and inadequate description of techniques implemented. Methods: The aim is to propose a consensus established by the European Bifurcation Club (EBC), on the definition and classification of bifurcation lesions and treatments implemented with the purpose of allowing comparisons between techniques in various anatomical and clinical settings. Results: A bifurcation lesion is a coronary artery narrowing occurring adjacent to, and/or involving, the origin of a significant side branch. The simple lesion classification proposed by Medina has been adopted. To analyze the outcomes of different techniques by intention to treat, it is necessary to clearly define which vessel is the distal main branch and which is (are) the side branche(s) and give each branch a distinct name. Each segment of the bifurcation has been named following the same pattern as the Medina classification. The classification of the techniques (MADS: Main, Across, Distal, Side) is based on the manner in which the first stent has been implanted. A visual presentation of PCI techniques and devices used should allow the development of a software describing quickly and accurately the procedure performed. Conclusion: The EBC proposes a new classification of bifurcation lesions and their treatments to permit accurate comparisons of well described techniques in homogeneous lesion groups. (c) 2008 Wiley-Liss, Inc. Udgivelsesdato: 2007-Nov-5

Aims Recanalisation rates of coronary chronic total occlusions (CTO) remain sub-optimal. The retrograde technique was recently introduced to improve success rates. Methods and results From February 2005 until December 2007, 175 patients were treated with this technique in seven European centres by highly experienced operators: in 84 (48%) as primary strategy, in 41 (23.5%) immediately after antegrade failure and in 50 (28.5%) as a repeat procedure after previous antegrade failure. Baseline characteristics revealed a mean age 61.4 +/- 10.8 years with 29.5% and 39% of patients having diabetes and a prior history of MI, respectively. The mean occlusion duration was 50.8 months (determined in 32% of patients). The target vessel was: LAD 21%, LCX 6.3%, RCA 71.4%. Epicardial collaterals were accessed in 20.6% and septal in 79.4% of the patients. Overall success rate was 83.4%. In 80.6% a wire crossed the collaterals and successfully delivered distal to the occlusion; success rate in this group was 91.5%. The technique implemented in the retrograde facilitated successful recanalisation was: retrograde wire/balloon crossing in 28%, CART in 34% and marker wire/"knuckle" technique in 48%. There was a great diversity between centres referring to the retrograde technique used. According to the initial strategy success rates were: primary 89.3%, immediately after antegrade failure 65.9% and repeat procedure after antegrade failure in 88%. In patients with failure to cross the collaterals success rate was 50%. Septal rupture/haematoma occurred in 6.9% of the patients, periprocedural myocardial infarction (CK-MB rise) in 4% and TIA in 0.6% and wire entrapment in 0.6%. Mean fluoroscopy time was 59.3 mn and the mean contrast used was 420.9 ml. Drug eluting stents were implanted in all successfully recanalised vessels. Conclusions There is great diversity amongst European centres with respect to how the retrograde strategy has been adopted and adapted. The retrograde approach was used with high degree of success and safety and can thus be regarded as a valid contributor to the armamentarium of the modern day interventional cardiologist.

OBJECTIVE - It is still controversial whether sirolimus-eluting stent (SES) and paclitaxel-eluting stent (PES) are equally effective in patients with diabetes. In these patients, multiple individual variables may be responsible for neointimal hyperplasia, thus making difficult the comparison of the two drug-eluting stents (DES). RESEARCH DESIGN AND METHODS - We designed a prospective, randomized study to compare the efficacy in prevention of restenosis of SES and PES, both implanted in the same diabetic patient with multiple de novo coronary artery lesions undergoing elective percutaneous coronary intervention. We enrolled 60 patients with diabetes with at least two significant de novo angiographic stenoses in different coronary segments. The primary end point was in-stent late luminal loss (LLL) at 8-month angiographic follow-up. RESULTS - A total of 120 lesions were successfully treated with the randomly assigned DES (SES, n=60; PES, n=60). In-stent LLL was lower in the SES than in the PES group (0.26 ± 0.4 vs. 0.50 ± 0.6 mm; P = 0.01). Coronary lesions treated with SES presented a reduced in-stent LLL in 40 (68%) patients, while PES resulted in a lower in-stent LLL in 19 (32%) patients (P = 0.0002). At multivariable analysis, the type of DES implanted was the only independent predictor of in-stent LLL (odds ratio 2.3 [95% CI 1.1-5.0]; P = 0.03). CONCLUSIONS - SES directly compared with PES in the same diabetic patient is associated with a decrease in the extent of in-stent LLL at 8 months, suggesting a reduced risk of restenosis. © 2008 by the American Diabetes Association.

Aims. Radiation exposure is a limiting factor for percutaneous coronary interventions (PCI) of chronic total coronary occlusion (CTO) lesions. This study was designed to analyze changes in patient radiation dose for CTO-PCI and parameters associated with radiation dose. Methods and Results. We analyzed a cohort of 12,136 procedures performed by 23 operators between 2012 and 2017 from the European Registry of CTO-PCI. Radiation exposure was recorded as air kerma (AK) and dose area product (DAP). A dose rate index (DRI) was calculated as AK per fluoroscopy time to normalize for individual differences in fluoroscopy time. The lesion complexity increased from Japanese-CTO (J-CTO) score of 2.19 +/- 1.44 to 2.46 +/- 1.28, with an increase of retrograde procedures from 31.1% to 40.7%; still, procedural success improved from 87.7% to 92.1%. Fluoroscopy time remained similar, but AK decreased by 14.9%, from 2.35 Gy (interquartile range [IQR], 1.29-4.14 Gy) to 2.00 Gy (IQR, 1.08-3.45 Gy) and DAP decreased by 21.5%, from 130 Gy.cm(2) (IQR, 70-241 Gy.cm(2)) to 102 Gy.cm(2) (IQR, 58-184 Gy.cm(2)). Radiation exposure was determined by the lesion complexity (J-CTO score) and procedural complexity (antegrade or retrograde). DRI was determined by fluoroscopy frame rate and type of equipment used, but the major influence remained interoperator differences. Conclusions. Radiation exposure decreased during the observation period despite an increase in lesion and procedural complexity. While many operators already achieved a goal of low radiation exposure, there were considerable interoperator differences in radiation management, indicating further potential for improvement.

OBJECTIVE: To evaluate the long-term follow up of patients at high risk for coronary restenosis. BACKGROUND: Drug-eluting stents (DES) have been proven to reduce restenosis and reintervention compared with bare-metal stents (BMS). Although the safety of DES is not different from that of BMS in the short-to-medium term, concern has arisen about the potential for late stent thrombosis related to delayed endothelialization of the stent struts. METHODS: Among 495 patients who underwent percutaneous coronary intervention between June 2004 and March 2005, we retrospectively identified a subset of 150 patients (30%) at high risk for coronary restenosis on the basis of angiographic characteristics who were treated with DES. We assessed the incidence of major adverse cardiac events (MACE) during a 2-year follow-up period. The risk of MACE was estimated by computing the hazard ratio and the 95% confidence interval using the Cox regression method. RESULTS: At baseline, 31% of the patients had diabetes mellitus, 43% had previous myocardial infarction (MI), and 12% had ST-elevation acute MI as the cause of admission. The most frequent selection criteria observed were the presence of a long lesion (73% of patients) and the execution of multivessel angioplasty (43% of patients). Overall, 284 lesions were treated (1.9 lesions/patient) and 318 stents were implanted (2 stents/patient). Two-year cumulative incidence of the combined endpoint of death or MI, target vessel revascularization (TVR), MACE and target lesion revascularization were 7.3%, 10%, 16% and 7.3%, respectively. Significant predictors of MACE at 2 years were total occlusion, number of lesions treated and age. Significant predictors of TVR at 2 years were bypass graft treatment, total occlusion, number of stents implanted and number of lesions treated. Stent thrombosis occurred in 3 patients (2%). CONCLUSION: In these real-world patients at high risk for coronary restenosis, the use of DES was associated with a low incidence of cardiac events.

OBJECTIVES: We sought to evaluate clinical and angiographic outcomes of percutaneous coronary intervention (PCI) in patients receiving both bare-metal stents (BMS) and drug-eluting stents (DES). BACKGROUND: Few data are available about the safety and efficacy of the practice namely called "hybrid PCI". METHODS: One hundred and eighty-six patients, 502 de novo lesions, received during PCI both BMS (n ≤ 266) and DES (316), with a mean of 3.1 ± 1.2 stents/patient. Cumulative major adverse cardiac events were analyzed at 24 ± 22 months. RESULTS: Clinical follow up was carried out in 100 of eligible patients. Angiographic follow up at 8.6 ± 4.4 months was achieved in 70.4 of patients, 71.6 of stents and 72.5 of lesions. Binary restenosis was 12.9 vs. 20.6 (p ≤ 0.034) in DES vs. BMS, respectively; late loss was significantly higher in BMS than in DES (0.67 ± 0.73 vs. 0.35 ± 0.71 mm; p < 0.001). DES showed less lumen loss and binary restenosis rates than BMS in B2/C lesions (p < 0.001 and 0.007, respectively), while any significant difference was detected in A/B1 lesions (p ≤ 0.27 and 0.76, respectively). CONCLUSIONS: The simultaneous use of DES and BMS is safe and provides similar results for the 2 stents only in simple lesions. In complex lesions, BMS offer restenosis and a target lesion revascularization rates significantly higher than with DES.

OBJECTIVE: We sought to evaluate the impact on long-term clinical outcomes of different types of drug-eluting stents (DES) in elderly patients. BACKGROUND: Elderly patients constitute a fast-growing portion of cardiovascular patients, however, they are not adequately represented in clinical trials. Moreover, few data comparing different type of DES in elderly patients are available. METHODS: From a total of 2,330 consecutive patients treated at our institution with DES, we selected 207 elderly patients (≥ 75 years of age) who underwent, from May 2002 to December 2006, sirolimus-eluting stent (SES group, 116 patients [pts], 56%) or paclitaxel-eluting stent (PES group, 91 pts, 43.9%) implantation. We evaluated the 24-month incidence of major adverse cardiac events (MACE). RESULTS: Higher rates of hypertension (78.4% vs. 90.1%; p = 0.01), diabetes (37.9 vs. 45.1; p = 0.01) and previous coronary artery bypass grafts (10.3% vs. 19.4%; p = 0.04) in the PES group were observed, whereas in the SES group, there were more smokers (26.6% vs. 12.1%; p = 0.007) and a higher incidence of previous myocardial infarction (MI) (50% vs. 35.2%; p = 0.02). Procedural success and in-hospital MACE were similar in both groups. At follow up, there was a higher incidence of MACE (22.4% vs. 10.9%; p = 0.04) and target lesion revascularization (7.1% vs. 3.0%; p = 0.02) in the SES group compared to the PES group. The incidence of cardiac death and MI were comparable between the two groups, as well as the rate of stent thrombosis. After adjustment for clinical and angiographic characteristics, no significant differences in outcomes were observed between SES and PES. CONCLUSIONS: In this real-word experience, no significant differences were found in the safety and efficacy profiles between SES and PES use in elderly patients.