Abstract Objectives The aim of this study was to assess the impact of operator experience on prognosis after left main coronary artery (LM) percutaneous coronary intervention (PCI). Background LM PCI ...can be technically challenging and potentially risky considering the amount of supplied myocardium. Methods Consecutive patients who underwent unprotected LM PCI at a single institution were included and compared according to whether the primary operator was an experienced, high-volume LM operator (defined as an operator who performed at least 15 LM PCIs per year for at least 3 consecutive years) or not. Kaplan-Meier estimates and Cox proportional hazards models are presented. Results From January 2004 to December 2011, a total of 1,948 patients underwent unprotected LM PCI by 25 operators. Of these, 7 operators (28%) were considered experienced, and 18 (72%) were considered less experienced, with an overall mean experience of 12.0 ± 11.5 LM PCIs per year. LM PCI was performed in 1,422 patients (73%) by experienced operators and in 526 patients (27%) by less experienced operators. Patients treated by experienced operators had more complex and extensive coronary artery disease. Unadjusted and adjusted risks for cardiac death were lower for patients who were treated by experienced operators, both at 30-day (unadjusted hazard ratio HR: 0.23; 95% confidence interval CI: 0.09 to 0.60; p = 0.003; adjusted HR: 0.22; 95% CI: 0.09 to 0.59; p = 0.003) and 3-year (unadjusted HR: 0.53; 95% CI: 0.32 to 0.89, p = 0.02; adjusted HR: 0.49; 95% CI: 0.29 to 0.84; p = 0.009) follow-up. Discrimination improved when operator experience was added to Cox proportional hazards models containing the SYNTAX (Synergy Between PCI With Taxus and Cardiac Surgery) score (integrated discriminatory index = 0.004, p = 0.03) or SYNTAX score II (integrated discriminatory index = 0.007, p = 0.02). No significant interaction was detected between operator experience and distal bifurcation LM lesion, 2-stent bifurcation stenting, and intravascular ultrasound use (p > 0.10 for all). Conclusions Patients who underwent LM PCI by high-volume and experienced operators had better short- and long-term prognoses. Operator experience is an important factor in a complex intervention such as LM PCI.
Objectives This study sought to evaluate the safety and efficacy of rosuvastatin in preventing contrast-induced acute kidney injury (CI-AKI) in patients with diabetes mellitus (DM) and chronic kidney ...disease (CKD). Background CI-AKI is an important complication after contrast medium injection. While small studies have shown positive results with statin therapy, the role of statin therapy in prevention of CI-AKI remains unknown. Methods We randomized 2,998 patients with type 2 DM and concomitant CKD who were undergoing coronary/peripheral arterial angiography with or without percutaneous intervention to receive rosuvastatin, 10 mg/day (n = 1,498), for 5 days (2 days before, and 3 days after procedure) or standard-of-care (n = 1,500). Patients' renal function was assessed at baseline, 48 h, and 72 h after exposure to contrast medium. The primary endpoint of the study was the development of CI-AKI, which was defined as an increase in serum creatinine concentration ≥0.5 mg/dl (44.2 μmol/l) or 0.25% above baseline at 72 h after exposure to contrast medium. Results Patients randomized to the rosuvastatin group had a significantly lower incidence of CI-AKI than controls (2.3% vs. 3.9%, respectively; p = 0.01). During 30 days' follow-up, the rate of worsening heart failure was significantly lower in the patients treated with rosuvastatin than that in the control group (2.6% vs. 4.3%, respectively; p = 0.02). Conclusions Rosuvastatin significantly reduced the risk of CI-AKI in patients with DM and CKD undergoing arterial contrast medium injection. (Rosuvastatin Prevent Contrast Induced Acute Kidney Injury in Patients With Diabetes TRACK-D; NCT00786136 )
Abstract Objectives The aim of this study was to investigate the hypothesis that a novel biodegradable polymer–coated, cobalt-chromium (CoCr), sirolimus-eluting stent (BP-SES) is noninferior in ...safety and efficacy outcomes compared with a durable polymer (DP)-SES. Background No randomized trials have the compared safety and efficacy of BP-SES versus DP-SES on similar CoCr platforms, thereby isolating the effect of the polymer type. Methods In this prospective, single-blind, randomized trial conducted at 32 Chinese sites, 2,737 patients eligible for coronary stenting were treated with BP- or DP-SES in a 2:1 ratio. The primary endpoint was 12-month target lesion failure (TLF), a composite of cardiac death, target vessel myocardial infarction, or clinically indicated target lesion revascularization. Secondary endpoints included TLF components, and definite/probable stent thrombosis. Results At 12 months, the difference in the primary endpoint of TLF between BP-SES (6.3%) and DP-SES (6.1%) groups was 0.25% (95% confidence interval: −1.67% to 2.17%, p for noninferiority = 0.0002), demonstrating noninferiority of BP-SES to DP-SES. Individual TLF components of cardiac death (0.7% vs. 0.6%, p = 0.62), target vessel myocardial infarction (3.6% vs. 4.3%, p = 0.39), and clinically indicated target lesion revascularization (2.6% vs. 2.2%, p = 0.50) were similar, as were low definite/probable stent thrombosis rates (0.4% vs. 0.6%, p = 0.55). Conclusions In this large-scale real-world trial, BP-SES was noninferior to DP-SES for 1-year TLF. (Evaluate Safety and Effectiveness of the Tivoli ® DES and the Firebird ® DES for Treatment of Coronary Revascularization; NCT01681381 )
Abstract Objectives This study sought to evaluate the long-term prognostic capacity of the SYNTAX (Synergy Between Percutaneous Coronary Intervention With Taxus and Cardiac Surgery) score II (SS-II) ...and compare it with other risk scores among patients undergoing left main percutaneous coronary intervention (LM-PCI). Background Recently, the SS-II was developed in an attempt to individualize and help the decision-making process between PCI and coronary artery bypass graft (CABG) surgery in the management of complex coronary artery disease (CAD). However, there is a paucity of data regarding the utility of SS-II in patients undergoing LM-PCI. Methods Data from 1,528 consecutive patients from a single center undergoing unprotected LM-PCI were prospectively collected. The SS-II and other scores were then derived using patients’ baseline clinical characteristics. Patients were stratified according to tertiles of SS-II for PCI: SS-II ≤21 (n = 508), SS-II >21 and ≤28 (n = 480), and >28 (n = 540). Predictive capability for long-term mortality was compared between angiographic scores and scores combining both angiographic and clinical variables. Results At a mean follow-up of 4.4 years, mortality in the first, second, and third SS-II tertiles was 1.8%, 3.5%, and 9.4%, respectively (p < 0.0001). Multivariate analysis showed SS-II to be a strong independent predictor of mortality (hazard ratio: 1.76, 95% confidence interval: 1.10 to 2.82; p = 0.02) after LM-PCI. When compared with the angiographic SS, scores combining both clinical and angiographic variables, such as the SS-II, were superior in terms of long-term prognostication. Conclusions Results of this large series of consecutive patients who underwent unprotected LM-PCI suggested that the SS-II has better long-term prognostic power in terms of mortality compared with the original purely angiographic SS.
Abstract Objectives This study sought to investigate long-term clinical outcomes following coronary artery bypass graft (CABG) and percutaneous coronary intervention (PCI) in patients with ...unprotected left main disease (ULMD). Background PCI has been increasingly used as an alternative mode of revascularization for ULMD. However, there are limited data comparing clinical outcomes between CABG surgery and PCI. Methods Between 2004 and 2010, 4,046 consecutive patients with ULMD were treated with either CABG surgery (n = 2,604) or PCI (n = 1,442) with drug-eluting stents. The primary outcome was 3-year all-cause mortality and the secondary outcome was the composite of death, nonfatal myocardial infarction, or nonfatal stroke. Results The unadjusted 3-year all-cause mortality was higher in the PCI group as compared with the CABG group (3.8% vs. 2.5%; log-rank p = 0.03), although there was no significant difference in the composite outcome (7.5% vs. 9.4%; log-rank p = 0.07). After adjustment for differences in baseline risk factors, PCI was associated with significantly higher risk of all-cause mortality (hazard ratio HR: 1.71; 95% confidence interval CI: 1.32 to 2.21; p < 0.001) but similar risk of the composite outcome (HR: 0.94; 95% CI: 0.82 to 1.09; p = 0.43). These differences were not statistically significant among patients with low or intermediate SYNTAX (Synergy Between PCI With Taxus and Cardiac Surgery) score (≤32) or diabetes; however, PCI was associated with an increased risk among those with high SYNTAX score (>32), with HRs of 3.10 (95% CI: 1.84 to 5.22; p < 0.001) for all-cause mortality and 1.82 (95% CI: 1.36 to 2.45; p < 0.001) for the composite outcome. CABG was associated with lower risk of repeat revascularization but higher risk of stroke in each clinically relevant subgroup. Conclusions In this single-center observational study among patients with ULMD, CABG was associated with improved long-term outcomes, especially in patients with more complex disease.
Comparison Between the NERS (New Risk Stratification) Score and the SYNTAX (Synergy Between Percutaneous Coronary Intervention With Taxus and Cardiac Surgery) Score in Outcome Prediction for ...Unprotected Left Main Stenting Shao-Liang Chen, Jack P. Chen, Gary Mintz, Bo Xu, Jing Kan, Fei Ye, Junjie Zhang, Xuewen Sun, Yawei Xu, Qing Jiang, Aiping Zhang, Gregg W. Stone The NERS (New Risk Stratification) score was generated from a multicenter trial of patients undergoing stenting of unprotected left main coronary artery stenosis. In contrast to the SYNTAX (Synergy between Percutaneous Coronary Intervention with Taxus and Cardiac Surgery) score, the NERS scoring system encompasses clinical, angiographic, and procedural variables. Although predictive accuracies for both systems were similar in low-risk individuals, in the higher-risk cohort, a NERS score ≥25 was more predictive than a higher-risk SYNTAX score. Moreover, NERS score ≥25 emerged as the only independent predictor of cumulative major adverse cardiac events and stent thrombosis.
Transcatheter aortic valve replacement (TAVR) is traditionally performed under cardiac imaging guidance. In the early TAVR experience, intra-procedural transoesophageal echocardiography (TOE) is ...recommended to guide device deployment, in the context of general anaesthesia (GA). Intra-procedural TOE imaging is particularly useful during TAVR deployment as a contrast-saving strategy for patients with renal impairment. Evidence has emerged recently demonstrating that in selected patients, transthoracic echocardiography (TTE) can be used to provide intra-procedural guidance for TAVR. Additionally, there is a growing body of evidence supporting the performance of TAVR using fluoroscopy alone, without additional cardiac imaging. This article aims to provide a contemporary review of the various procedural imaging approaches for TAVR guidance, comparing the relative strengths and weaknesses of each approach ( Table 1 ).
This prospective, single-center, observational study evaluated prognostic value of clinical SYNTAX score (CSS) on 2-year outcomes in patients with acute coronary syndrome (ACS) who underwent ...percutaneous coronary intervention (PCI). The SYNTAX score (SS) is a scoring system based on the complexity and severity of coronary lesions and is thought to be a prognostic tool to predict long-term outcomes. However, SS was a sole angiographic grading tool only with no consideration for clinical factors. There are few studies investigating the prognostic value of CSS in patients with ACS who underwent PCI. From January 2013 to December 2013, 6,099 consecutive patients with ACS admitted to FuWai hospital and underwent PCI were enrolled in this study. Based on CSS, patients were divided into low CSS group (CSS ≤ 6.5; 2,012 patients), mid-CSS group (6.5 < CSS < 13.8; 2,056 patients), and high CSS group (CSS ≥ 13.8; 2,031 patients). At 2-year follow-up, rates of cardiac death and major adverse cardiac events (MACE) were significantly higher in the high CSS group. Compared with baseline SS, CSS demonstrated significantly improved performance for 2-year cardiac death (receiver-operating characteristic curve C-statistic: 0.74 vs 0.62, p <0.001) but not for MACE (receiver-operating characteristic curve C-statistic: 0.60 vs 0.59, p = 0.29). By multivariable analysis, the CSS combined with PCI history and hypertension were strong predictors for cardiac death and CSS, intra-aortic balloon pump support, diabetes, and successful PCI were independent predictors for MACE. In conclusion, compared with the anatomic SS, CSS was suitable in risk stratifying and predicting 2-year clinical outcome among ACS population.
Objectives This study sought to compare clinical outcomes and angiographic findings using the Resolute zotarolimus-eluting stent (R-ZES) (Medtronic, Santa Rosa, California) versus the Taxus Liberte ...paclitaxel-eluting stent (PES) (Boston Scientific, Natick, Massachusetts) in an all-comer Chinese population. Background Concerns regarding restenosis risk led to new-generation drug-eluting stents (DES) designed for use in patients with complex clinical or lesion characteristics. In-stent late lumen loss (LLL) is a measure of restenosis risk. Methods Patients with an indication for treatment with a DES were randomized in a 1:1 ratio to placement of at least 1 R-ZES or PES with minimal exclusions. The primary endpoint was angiographic in-stent LLL at 9 months post-procedure. Clinical endpoints at 12 months are compared between the 2 stents. Results A total of 198 patients received a R-ZES, and 202 patients received a PES. Most patients were male; 25.8% and 29.2% of R-ZES and PES patients, respectively, had diabetes. Over 70% of lesions in both cohorts were American College of Cardiology/American Heart Association lesion classification Type B2 and C (B2/C). In-stent LLL was 0.16 ± 0.38 mm for R-ZES and 0.33 ± 0.52 mm for PES at 9 months (p < 0.001; 95% confidence interval CI: −0.26 to −0.08). The rates of clinically driven target lesion revascularization were 1.5% for R-ZES and 7.0% for PES (p = 0.011). The rate of target lesion failure was 5.6% for R-ZES and 11% for PES (p = 0.068). Conclusions In an all-comers Chinese population, 9-month in-stent LLL was significantly less with R-ZES compared with PES, which was reflected in lower revascularization rates at 12 months for the R-ZES patients. Results are consistent with previous clinical trials of the R-ZES in all-comer populations. (Resolute Zotarolimus-Eluting Stent Versus the Taxus Liberte Paclitaxel-Eluting Stent for Percutaneous Coronary Intervention in China R-China RCT; NCT01334268 ).
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