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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 P 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.

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.

OBJECTIVE To describe a multicenter experience with patent foramen ovale (PFO) and atrial septal defect (ASD) device closure for presumed paradoxical emboli in children and young adults ( PATIENTS AND METHODS Medical records were reviewed of patients who had device closure of an ASD or PFO, who were younger than 35 years, and who had a history of presumed paradoxical embolus between January 1999 and August 2005 at Mayo Clinic, Rochester, Minn, University of Parma, Parma, Italy, and Loyola University Medical Center, Maywood, Ill. RESULTS Forty-five patients fulfilled the inclusion criteria. Median patient age was 29.0 years (range, 5.0-34.9 years), and 23 patients (51%) were male. Clinical diagnoses included the following: stroke, 30 (67%); transient ischemic attack, 13 (29%); myocardial infarction, 1 (2%); and renal infarct, 1 (2%). Overall, 42 patients (93%) had a PFO, and 3 (7%) had an ASD. Seventeen patients had known cardiovascular disease risk factors: tobacco use (10 patients), hypercoagulable states (7 patients), systemic hypertension (3 patients), and hyperlipidemia (2 patients). No major procedural complications occurred. Median follow-up evaluation was performed at 5.3 months (range, 2.5-40.0 months). Forty-four patients (98%) had no recurrent neurologic events and no residual atrial shunt by contrast transthoracic echocardiography. CONCLUSIONS Cryptogenic ischemic events occur in young patients and have serious sequelae. The potential for paradoxical embolization through a PFO or an ASD should be assessed in all such patients. In our short-term follow-up, device closure was a safe alternative therapeutic option for children and young adults with presumed paradoxical emboli.

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.

Background: Limited data are available for sirolimus eluting stent (SES) implantation in patients with ST-segment elevation myocardial infarction (STEMI). Aim: to confirm the safety and effectiveness of SES in patients with STEMI in a real-world scenario (multicentric registry). Methods: From July 2002 to June 2004, clinical and angiographic data of 1617 patients with STEMI treated with primary percutaneous coronary intervention (PCI) have been collected. Patients were prospectively followed for the occurrence of major adverse cardiac events (MACE): death, reinfarction and target vessel revascularization (TVR). Results: Overall, 205 patients received SES (12.5%, SES group) and 1412 received bare metal stent (87.5%, BMS group) in the infarct related artery. Compared with the BMS group, SES patients were younger, had more often diabetes mellitus, anterior localization and less cardiogenic shock at admission. The angiographic characteristics in the SES group showed longer lesions and smaller diameter of vessels. After a median follow-up of 396 days, there was no significant difference in the rate of stent thrombosis (1% in the SES group vs 1.5% in the BMS group, p=ns). The incidence of MACE was significantly lower in the SES group compared to BMS group (HR 0.62 [95% CI: 0.4–0.95]; p=0.03), principally due to the lower rate of TVR (HR 0.41 [95% CI: 0.2–0.85]; p=0.01). Conclusions: Utilization of SES in the setting of primary PCI for STEMI, in our “real world” registry, was safe and improved the 1-year clinical outcome compared to BMS reducing the need of TVR.

The study reports the results of directional atherectomy with an 8Fr guiding catheter-compatible atherectomy catheter in a series of 31 in-stent restenotic lesions. This preliminary experience indicates a favorable safety profile, with events limited to non-Q-wave myocardial infarction occurring in 3.6% of patients. The secondary end point regarding the incidence of angiographic restenosis at 6 months showed a high restenosis rate (65%).

The role of coronary artery disease (CAD) in hypertrophic cardiomyopathy (HC) has not been thoroughly clarified. To assess the clinical and prognostic significance of these 2 coexistent diseases, 96 patients with HC (62 men, mean age 45 years) who underwent coronary arteriography and 2-dimensional echocardiography were studied. Significant stenosis (greater than 70%) of 1 or more coronary arteries was detected in 11 patients, all aged greater than 45 years. This group, compared with the other group without significant CAD (n = 85), was characterized by an older age (59 +/- 7 vs 42 +/- 15 years; p less than 0.05), a greater prevalence of previous myocardial infarction (24 vs 0%; p less than 0.001), complex ventricular arrhythmias (100 vs 50%; p less than 0.05), non-obstructive forms (82 vs 46%; p less than 0.05), dilated (45 vs 7%; p less than 0.02) and hypocontractile left ventricle (36 vs 6%; p less than 0.01) and higher mortality (36 vs 8%; p less than 0.05) during a mean follow-up of 3.6 years. It is concluded that CAD associated with HC is a complex clinical syndrome, difficult to diagnose clinically, that can reliably be recognized by coronary angiography. CAD seems to play an important role in modifying the pathophysiology, the natural history and the prognosis of HC.