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BACKGROUND: The Placement of Aortic Transcatheter Valves (PARTNER) trial showed that among high-risk patients with aortic stenosis, the 1-year survival rates are similar with transcatheter aortic-valve replacement (TAVR) and surgical replacement. However, longer-term follow-up is necessary to determine whether TAVR has prolonged benefits. METHODS: At 25 centers, we randomly assigned 699 high-risk patients with severe aortic stenosis to undergo either surgical aortic-valve replacement or TAVR. All patients were followed for at least 2 years, with assessment of clinical outcomes and echocardiographic evaluation. RESULTS: The rates of death from any cause were similar in the TAVR and surgery groups (hazard ratio with TAVR, 0.90; 95% confidence interval [CI], 0.71 to 1.15; P=0.41) and at 2 years (Kaplan-Meier analysis) were 33.9% in the TAVR group and 35.0% in the surgery group (P=0.78). The frequency of all strokes during follow-up did not differ significantly between the two groups (hazard ratio, 1.22; 95% CI, 0.67 to 2.23; P=0.52). At 30 days, strokes were more frequent with TAVR than with surgical replacement (4.6% vs. 2.4%, P=0.12); subsequently, there were 8 additional strokes in the TAVR group and 12 in the surgery group. Improvement in valve areas was similar with TAVR and surgical replacement and was maintained for 2 years. Paravalvular regurgitation was more frequent after TAVR (P

Objectives. We examined the relations of elevated creatine kinase (CK) and its myocardial band isoenzyme (CK-MB) to clinical outcomes after percutaneous coronary intervention (PCI) in patients enrolled in Integrilin (eptifibatide) to Minimize Platelet Aggregation and Coronary Thrombosis-II (trial) (IMPACT-II), a trial of the platelet glycoprotein IIb/IIIa inhibitor eptifibatide. Background. Elevation of cardiac enzymes often occurs after PCI, but its clinical implications are uncertain. Methods. Patients undergoing elective, scheduled PCI for any indication were analyzed. Parallel analyses investigated CK (n = 3,535) and CK-MB (n = 2,341) levels after PCI (within 4 to 20 h). Clinical outcomes at 30 days and 6 months were stratified by postprocedure CK and CK-MB (multiple of the site’s upper normal limit). Results. Overall, 1,779 patients (76%) had no CK-MB elevation; CK-MB levels were elevated to 1 to 3 times the upper normal limit in 323 patients (13.8%), to 3 to 5 times normal in 84 (3.6%), to 5 to 10 times normal in 86 (3.7%), and to >10 times normal in 69 patients (2.9%). Elevated CK-MB was associated with an increased risk of death, reinfarction, or emergency revascularization at 30 days, and of death, reinfarction, or surgical revascularization at 6 months. Elevated total CK to above three times normal was less frequent, but its prognostic significance paralleled that seen for CK-MB. The degree of risk correlated with the rise in CK or CK-MB, even for patients with successful procedures not complicated by abrupt closure. Conclusions. Elevations in cardiac enzymes, including small increases (between one and three times normal) often not considered an infarction, are associated with an increased risk for short-term adverse clinical outcomes after successful or unsuccessful PCI.

ObjectivesThe goal of this study was to examine the impact of reasons for surgical inoperability on outcomes in patients undergoing transcatheter aortic valve replacement (TAVR).BackgroundPatients with severe aortic stenosis may be deemed inoperable due to technical or clinical reasons. The relative impact of each designation on early and late outcomes after TAVR is unclear.MethodsPatients were studied from the inoperable arm (cohort B) of the randomized PARTNER (Placement of Aortic Transcatheter Valve) trial and the nonrandomized continued access registry. Patients were classified according to whether they were classified as technically inoperable (TI) or clinically inoperable (CLI). Reasons for TI included porcelain aorta, previous mediastinal radiation, chest wall deformity, and potential for injury to previous bypass graft on sternal re-entry. Reasons for CLI were systemic factors that were deemed to make survival unlikely.ResultsOf the 369 patients, 23.0% were considered inoperable for technical reasons alone; the remaining were judged to be CLI. For TI, the most common cause was a porcelain aorta (42%); for CLI, it was multiple comorbidities (48%) and frailty (31%). Quality of life and 2-year mortality were significantly better among TI patients compared with CLI patients (mortality 23.3% vs. 43.8%; p < 0.001). Nonetheless, TAVR led to substantial survival benefits compared with standard therapy in both inoperable cohorts.ConclusionsPatients undergoing TAVR based solely on TI have better survival and quality of life improvements than those who are inoperable due to clinical comorbidities. Both TI and CLI TAVR have significant survival benefit in the context of standard therapy. (THE PARTNER TRIAL: Placement of AoRTic TraNscathetER Valve Trial; NCT00530894)

To determine the efficacy of repeat percutaneous transluminal coronary angioplasty, 74 patients were studied who underwent a third angioplasty for a second restenosis of one coronary artery segment. The procedure was successful in 93% of patients. Procedural complications included emergency bypass surgery (three patients) and in-hospital death (two patients). At late follow-up (mean 18 months, range 7 to 49), 30 patients (43%) had a third restenosis treated with either a fourth angioplasty (16 patients), coronary bypass surgery (11 patients) or medical management (1 patient). Thirty-nine patients (57%) had no restenosis on the basis of follow-up angiography or absence of symptoms previously attributed to restenosis. Factors associated with a third restenosis included a shorter time interval (

Blockade of the platelet GP IIb/IIIa receptor by the monoclonal antibody c7E3 during high-risk coronary intervention reduced the 30-day endpoint of death, MI, or urgent revascularization by 35% in the EPIC trial, but was accompanied by an increase in the rate of major bleeding. In EPIC, heparin was administered as non-weight adjusted bolus doses to a therapeutic activated clotting time (ACT): bleeding increased with maximal in-lab ACT and relative heparin dose. To evaluate the safety and efficacy of weight-adjusted heparin dosing during c7E3 administration (0.25mg/kg bolus, 10mcg/min infusion×12hrs). 103 pts undergoing coronary intervention were randomized to 1 of 2 regimens of heparin in a blinded fashion: 100U/kg bolus+additional doses to achieve ACT>300sec (Standard Dose, n=51), or 70U/kg bolus without ACT adjustment (Low Dose, n=52). ACT values immediately prior to intervention (median and interquartile range) and bleeding complications (unrelated to CABG) during the first 36hrs (compared to 708 EPIC pts receiving same c7E3 dose). femoral hematoma>5cm in size, and in-hospital death or MI were:EPIC Non Wt-AdjustedStandard Wt-AdjustedLow Wt-AdjustedHeparinHeparinHeparinACT (sec)398330257(25th, 75th)(356,468)(308,374)(229,288)Major bleeds7.8%1.9%2.0%Minor bleeds17.9%7.7%7.8%HematomaN/A15.4%3.9%Transfusions15.5%7.7%2.0%Thus, reduced weight-adjusted heparin dosing with c7E3 antiplatelet therapy during coronary intervention in this pilot study did not increase ischemic events, and at the same time appeared to decrease bleeding complications. Weight-adjusted heparin strategies will be further tested in a large-scale, randomized trial (EPILOG).

Stent platform characteristics, including material and design, influence both periprocedural and late performance. Recent reports have suggested susceptibility of novel thin-strut coronary stents to incur longitudinal stent deformation during or following deployment. This analysis focuses on the ION

Jorg Hausleiter, Adnan Kastrati, Julinda Mehilli, Helmut Schuhlen, Franz Dotzer, Christoph Goos, Gisela Pogatsa-Murray, Michael Vogeser, Martin Breuer, Josef Dirschinger, Albert Schomig, The OSIRIS Study Group, German Heart Center Munich, Munich, Germany, 1. Medizinische Klinik, Klinikum rechts der Isar, Munich, GermanySirolimus coated stents are a promising new therapy for restenosis in de-novo coronarylesions. Except for the promising results achieved with brachytherapy, the treatment ofrecurrent in-stent-restenosis (ISR) remains a challenging clinical issue. Given the effi-cacy of systemic administration of Sirolimus to prevent neointimal hyperplasia in animalmodels and to halt and even reverse the progression of allograft vasculopathy, it seemsreasonable to consider this drug as a good option for oral treatment to prevent recurrentISR. This randomized, double-blind, placebo-controlled study is aimed at evaluating theefficacy of 2 different regimens of oral Sirolimus in patients with ISR treated with repeatPTCA. We enrolled 300 patients with ISR in native coronary arteries who were randomlyassigned to one of three treatment arms: usual-dose Sirolimus, high-dose Sirolimus andplacebo. All patients in the two treatment arms received Sirolimus loading two days priorto and the day of intervention followed by maintenance therapy for 7 days. The differencebetween usual- and high-dose arms was in the amount of pre-treatment, 8 mg in theusual-dose Sirolimus arm and 24 mg in the high-dose Sirolimus arm. The maintenancetherapy after intervention consisted of 2mg/d for 7 days in both arms. Angiographicbinary restenosis at 6-months angiography was the primary end point of the study. Sam-ple size was estimated to give sufficient power to the trial for detecting a 25 and 50%reduction of the binary restenosis with the two Sirolimus doses. Angiographic and 1-yearclinical follow-up is in progress and will be completed in January 2004. The final studyresults will be presented.

Over a five-month period, 83 consecutive patients undergoing elective Palmaz-Schatz stent placement in a target vessel of greater than 3.2 mm in diameter were evaluated for early hospital discharge without anticoagulation. Thirty-nine patients failed to meet angiographic or clinical criteria due to the presence of dissection (11 patients), TIMI flow15%, one who lacked apposition in an aneurysmal segment, one with an angiographically occult dissection and one who achieved