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Percutaneous revascularization of saphenous vein grafts (SVGs) remains a challenging task. Drug-eluting stents (DESs) have been shown to decrease the incidence of restenosis in de novo native coronary artery lesions. However, their clinical value in SVGs remains to be established. We compared long-term clinical outcomes of percutaneous coronary intervention with DESs and bare metal stents (BMSs) for de novo lesions in SVGs. In a large prospective, multicenter registry, 360 patients underwent stenting of a de novo lesion in SVGs using BMSs (288 patients) or DESs (72 patients). Incidence of major adverse cardiac events (MACEs), including all-cause mortality, reinfarction, and target vessel revascularization, was recorded at a 12-month follow-up. Compared with the DES group, patients receiving BMSs were more likely to be men, to have chronic renal insufficiency or higher Charlson scores, but less likely to have undergone previous percutaneous coronary intervention. Incidence of MACEs at 12-month follow-up was similar in the 2 groups (17.8% in DES group vs 20.3% in BMS group, respectively, p = 0.460). Cox regression analysis identified age, chronic renal failure, cardiogenic shock at presentation, and ostial location of stenosis as independent predictors of long-term MACEs. In conclusion, our data suggest that rates of 12-month MACEs associated with the use of DESs and BMSs are similar in patients undergoing treatment of de novo lesions in SVGs.

Background: The long-term effectiveness of drug-eluting stents (DES) in unselected diabetics in routine practice is currently unclear., Methods and Results: To evaluate the long-term effectiveness of bare metal stents and DES in a real-world setting of diabetic patients, we analyzed 2-year follow-up data from all diabetic patients with de novo lesions enrolled in a prospective Web-based multicenter registry (Registro Regionale Angioplastiche dell'Emilia-Romagna; study period, 2002 to 2004) comprising all 13 hospitals performing percutaneous coronary interventions in the Emilia-Romagna region of Italy. Among the 1648 eligible patients treated with either bare metal stents alone (n=1089) or DES alone (n=559), 27% were insulin dependent and 83% had multivessel coronary disease. At 2 years, use of DES was associated with lower crude incidence of major adverse cardiac advents (all-cause mortality, nonfatal myocardial infarction, and target vessel revascularization) compared with bare metal stents (22.5% versus 28.1%; P=0.01). After propensity score adjustment, only target vessel revascularization appeared significantly lower in the DES group (11.6% versus 15.0%; hazard ratio, 0.66; 95% confidence interval, 0.46 to 0.96; P=0.041). Two-year angiographic stent thrombosis occurred in 1.5% DES patients and 0.7% of the bare-metal-stents patients (P=0.18). At Cox regression analysis, predictors of 2-year major adverse cardiac advents were left ventricular ejection fraction <35%, Charlson comorbidity index, insulin-dependent diabetes, and total lesion length., Conclusions: In this large, real-world, diabetic population, the use of DES was associated with a moderate reduction in the 2-year risk of target vessel revascularization, a benefit that was limited to non-insulin-dependent diabetic patients. Larger long-term studies are needed to clarify the long-term effectiveness and safety of such devices in diabetic patients.

Background: The long-term safety and efficacy of drug-eluting stents (DES) have been questioned recently., Methods and Results: Between July 2002 and June 2005, 10,629 patients undergoing elective percutaneous coronary intervention with either DES (n=3064) or bare-metal stents (BMS, n=7565) were enrolled in a prospective registry comprising 13 hospitals. We assessed the cumulative incidence of major adverse cardiac events (death, acute myocardial infarction, and target-vessel revascularization) and angiographic stent thrombosis during 2-year follow-up. A propensity score analysis to adjust for different baseline clinical, angiographic, and procedural characteristics was performed. The 2-year unadjusted cumulative incidence of major adverse cardiac events was 17.8% in the DES group and 21.0% in the BMS group (P=0.003 by log-rank test). Angiographic stent thrombosis was 1.0% in the DES group and 0.6% in the BMS group (P=0.09). After adjustment, the 2-year cumulative incidence of death was 6.8% in the DES group and 7.4% in the BMS group (P=0.35), whereas the rates were 5.3% in DES and 5.8% in BMS for acute myocardial infarction (P=0.46), 9.1% in DES and 12.9% in BMS for target-vessel revascularization (P<0.00001), and 16.9% in DES and 21.8% in BMS for major adverse cardiac events (P<0.0001). Independent predictors of target-vessel revascularization in the DES group were diabetes mellitus (hazard ratio 1.36, 95% confidence interval 1.06 to 1.76), renal failure (hazard ratio 1.69, 95% confidence interval 1.06 to 2.69), and reference vessel diameter (hazard ratio 0.64, 95% confidence interval 0.45 to 0.93)., Conclusions: In this large real-world population, the beneficial effect of DES in reducing the need for new revascularization compared with BMS extends to 2 years without evidence of a worse safety profile.

Background: The impact of the use of drug-eluting stents in percutaneous coronary intervention (PCI) on cardiac care is still uncertain. We examined the influence of systemic factors, such as hospital ownership status, organizational characteristics and payment structure, on the use of drug-eluting stents in PCI and the effect on cardiac surgery volume., Methods: We conducted a cross-sectional analysis of drug-eluting stent use in 12 993 patients undergoing PCI with stenting (drug-eluting or bare-metal) and time-series regression analyses of the monthly number of cardiac surgery and PCI procedures performed using data collected from 1998 to 2004 at 13 public and private hospitals in the Emilia-Romagna region of Italy., Results: Public hospitals used drug-eluting stents more selectively than private hospitals, targeting the new device to patients at high risk of adverse events. The time-series regression analyses showed that the number of PCI procedures performed per year increased during this period, both in public (slope coefficient 36.4, 95% confidence interval [CI] 30.2 to 43.1) and private centres (slope coefficient 6.4, 95% CI 3.1 to 9.2 ). Concurrently, there was a reduction in the number of isolated coronary artery bypass graft (CABG) surgeries, although the degree of change was higher in public than in private hospitals (coefficient -16.1 v. -6.2 respectively ). The number of CABG procedures associated with valve surgery decreased in public hospitals (coefficient -5.0, 95% CI -6.1 to -3.8) but increased in private hospitals (coefficient 4.1, 95% CI 2.0 to 6.1)., Interpretation: Public and private hospitals behaved differently in adopting drug-eluting stents and in using PCI with drug-eluting stents as a substitute for surgical revascularization.

Objectives: We compared the clinical outcome of sirolimus-eluting stents (SES) and paclitaxel-eluting stents (PES) in a real-world scenario., Background: In selected patients, SES has been associated with lower late luminal loss than PES. Whether this emerging biological difference could translate into different clinical efficacy in daily practice is presently unknown., Methods: This analysis included 1,676 consecutive patients with de novo coronary lesions treated solely with drug-eluting stents (SES = 992; PES = 684). All patients were enrolled in a dynamic prospective registry comprising 13 hospitals. We assessed the cumulative incidence of major adverse cardiac events (MACE), defined as death, myocardial infarction (MI), and target vessel revascularization (TVR) during follow-up., Results: Overall, 29% of the patients had diabetes, 23% had prior MI, and 9% had poor left ventricular function. ST-segment elevation MI was diagnosed at admission in 12%. Multivessel intervention was performed in 16%. At 1-year follow-up, SES was associated with a reduced incidence of MACE (9.2% SES vs. 14.1% PES; p = 0.007) and TVR (5.0% SES vs. 10.0% PES; p = 0.0008) compared to PES. A propensity analysis with many clinical and angiographic variables was carried out to adjust for baseline differences. In this analysis, SES was associated with a 44% risk reduction of MACE (hazard ratio 0.56, 95% confidence interval 0.39 to 0.78) and a 55% reduction of TVR (hazard ratio 0.45, 95% confidence interval 0.29 to 0.70). This result was consistent across most subgroups tested. Similar rates of death and MI were observed in the 2 treatment groups., Conclusions: In this large real-world population, SES improved 1-year clinical results as compared to PES.

Objectives: To explore how the adoption of medical innovations challenges tax-financed health systems, drawing from the case of sirolimus eluting stents, a promising and costly innovation for percutaneous coronary interventions., Methods: The coverage decisions for the new stents adopted in Emilia-Romagna, an Italian region, are described. The innovation was adopted through a process combining the development of clinical guidelines targeting their use to selected clinical indications, negotiation with the manufacturer for reducing price, and the organization of a registry for monitoring its patterns of utilization and assessing its effectiveness., Results: Overall, 17% of the 6276 patients included in the registry over a 12-month period had the new stent. Wide differences between published trials on sirolimus eluting stents and actual clinical practice emerged. The new stents were frequently (23%) used in combination with traditional bare metal stents, and for indications (acute myocardial infarction and multivessel coronary disease) never included in clinical experiments (25% and 8% of the cases, respectively). Patients' outcomes were also different, the overall rate of major adverse cardiac events being relatively higher (12%) than that shown in clinical trials., Conclusions: The actions undertaken for the new stents allowed a timely, and at the same time targeted and monitored, adoption of the innovation. This experience highlights how policy decisions related to new medical products could benefit from the availability of clinical databases providing key information on how innovations are actually used and on their impact on clinical practice.

We evaluated the clinical effect of selective use of sirolimus-eluting stents (SESs) in real-world, high-risk patients. A total of 4,237 consecutive patients who underwent percutaneous coronary intervention (SES, n = 872, bare metal stents [BMSs], n = 3,365) was enrolled in a prospective regional survey. A prespecified high-risk subset of patients was selected on the basis of clinical and angiographic characteristics. A propensity score analysis was performed to compare patients who received SESs with those who received BMSs. Patients in the SES group more often had diabetes and more frequently had previous myocardial infarction or coronary revascularization, type C lesions, and multivessel procedures. Patients who presented with acute myocardial infarction were treated more often with BMSs. At 9 months, the use of SESs was associated with fewer major adverse cardiac events (death, myocardial infarction, or target lesion revascularization; hazard ratio 0.56, 95% confidence interval 0.37 to 0.85) and target lesion revascularizations (hazard ratio 0.43, 95% confidence interval 0.20 to 0.91). This decrease was more evident in a prespecified high-risk subgroup of patients (major adverse cardiac events, 8.0% SES vs 15.6% BMS, hazard ratio 0.45, 95% confidence interval 0.29 to 0.72). We conclude that selective SES use in real-world patients who have high-risk clinical and angiographic characteristics is associated with significant decreases in major adverse cardiac events and repeat revascularizations compared with BMS use.

Objectives: To assess the impact of the availability of drug-eluting stents (DES) in April 2002 in Emilia-Romagna (a four-million resident Italian region), on the rate of use of revascularization procedures. DES are expected to influence the rate of use of coronary artery bypass graft (CABG) and percutaneous coronary interventions (PCI). However, to date, little empirical information is available on the actual impact of this innovation on clinical practice., Methods: A time series regression analysis of the monthly number of procedures (PCI and CABG) performed between January 1998 and March 2003., Results: DES availability was associated with statistically significant changes in the use of revascularization procedures, although the size of the effect was always small or moderate. PCI increased only by 0.36 more procedures per month (approximately four per year), whereas more evident was the concurrent reduction of isolated CABG (4.15 fewer per month, that is fifty fewer per year). Overall, considering all the surgical revascularizations (i.e., CAGB both isolated and associated with other interventions), there was a reduction of 2.52 procedures per month (thirty less per year)., Conclusions: Despite DES being at a very early stage of their diffusion process, our results indicate that they are already having an impact, although moderate, on the use of revascularization procedures. If these findings will be confirmed, they will have a substantial influence on the patterns of care for patients with coronary artery disease and relevant policy implications for health services.

Abstract: Background: The study compares five-year clinical outcomes of CABG vs PCI in a real world population of diabetic patients with multivessel coronary disease since it is not clear whether to prefer surgical or percutaneous revascularization. Methods: Between July 2002 and December 2008, 2885 multivessel coronary diabetic patients underwent revascularization (1466 CABG and 1419 PCI) at hospitals in Emilia-Romagna Region, Italy and were followed for 1827±617days by record linkage of two clinical registries with the regional administrative database of hospital admissions and the mortality registry. Five-year incidences of MACCE (mortality, acute myocardial infarction [AMI], stroke, and repeat revascularization [TVR]) were assessed with Kaplan–Meier estimates, Cox proportional hazards regression and cumulative incidence functions of death and TVR, to evaluate the competing risk of AMI on death and TVR. The same analyses were applied to the propensity score matched subgroup of patients undergoing CABG or PCI with DES and with complete revascularization. Results: PCI had higher mortality for all causes (HR: 1.8, 95% CI 1.4–2.2 p<0.0001), AMI (HR: 3.3, 95% CI 2.4–4.6 p<0.0001) and TVR (HR: 4.5, 95% CI 3.4–6.1 p<0.0001). No significant differences emerged for stroke (HR: 0.8, 95% CI 0.5–1.2 p=0.26). The higher incidence of AMI caused higher mortality in PCI group. Results did not change comparing CABG with PCI patients receiving complete revascularization or DES only. Conclusions: Diabetics show a higher incidence of MACCE with PCI than with CABG: thus diabetes and its degree of control should be considered when choosing the type of revascularization. [Copyright &y& Elsevier]

Abstract: Background: The long-term effectiveness of drug eluting stents (DESs) in a real-world setting of female patients is currently unclear. Methods and results: We analyzed long-term follow-up (up to 3 years) data from all female patients with de novo lesions enrolled in a prospective web-based multicenter registry (REAL Registry; study period, July 2002–June 2006) including all 15 hospitals performing PCI in the Emilia-Romagna region of Italy. Among the 3549 women without ST elevation myocardial infarction, 2434 were treated with BMSs alone and 1115 with DESs alone. At 3 years, use of DESs was associated with a lower propensity score adjusted incidence of MACE [cardiac mortality, non-fatal myocardial infarction and target vessel revascularization (TVR); 19.5% vs. 24.4%; HR 0.75, p =0.006)] and TVR (11.6% vs. 15.6%; HR 0.68, p =0.004) compared with BMSs. No difference was apparent in terms of adjusted 3-year cardiac mortality or myocardial infarction. Nevertheless, after the first 6months of follow-up, a non significantly increased risk of myocardial infarction and stent thrombosis was found in the DES group. Conclusions: In this real-world female registry, the use of DESs was associated with a 3-year reduction of TVR and MACE in comparison with the use of BMSs. However, the observed (non-significant) increment of late AMI makes performing larger studies to clarify the long-term safety of DESs mandatory. [Copyright &y& Elsevier]