Diagnostic accuracy of exercise electrocardiogram in patients with left anterior hemi-block

BACKGROUND: Left anterior hemiblock (LAHB) is the most frequent conduction abnormality, but its impact on the diagnostic accuracy of the exercise ECG has not been studied. The aim of our study was to determine the diagnostic accuracy of ST depression for predicting ischaemia in the presence of LAHB. PATIENTS: Consecutive patients with known or suspected coronary heart disease undergoing exercise ECG and 99mTc-sestamibi single photon emission computed tomography (SPECT) were included in the analysis. Patients with left bundle branch block, with changes in QRS morphology related to myocardial infarction, and patients who had undergone pharmacological stress testing were excluded. RESULTS: Of 1532 patients assessed, 567 patients qualified for the analysis. In 69 patients with LAHB, ECG stress testing had lower sensitivity (38% vs 86%) and lower negative predictive value (82% vs 92%) than in patients with normal baseline ECG. The reduction of sensitivity appeared to be similar in patients with isolated LAHB (n=43), in patients with right bundle branch block (n=39), and with bifascicular block (n=26). In contrast, the positive predictive value of the test was excellent. CONCLUSION: The diagnostic accuracy of the exercise ECG for prediction of ischaemia is reduced in patients with LAHB.

Biolimus-eluting stent with biodegradable polymer versus sirolimus-eluting stent with durable polymer for coronary revascularisation (LEADERS): a randomised non-inferiority trial

BACKGROUND: A novel stent platform eluting biolimus, a sirolimus analogue, from a biodegradable polymer showed promising results in preliminary studies. We compared the safety and efficacy of a biolimus-eluting stent (with biodegradable polymer) with a sirolimus-eluting stent (with durable polymer). METHODS: We undertook a multicentre, assessor-blind, non-inferiority study in ten European centres. 1707 patients aged 18 years or older with chronic stable coronary artery disease or acute coronary syndromes were centrally randomised by a computer-generated allocation sequence to treatment with either biolimus-eluting (n=857) or sirolimus-eluting (n=850) stents. The primary endpoint was a composite of cardiac death, myocardial infarction, or clinically-indicated target vessel revascularisation within 9 months. Analysis was by intention to treat. 427 patients were randomly allocated to angiographic follow-up, with in-stent percentage diameter stenosis as principal outcome measure at 9 months. The trial is registered with ClinicalTrials.gov, number NCT00389220. FINDINGS: We analysed all randomised patients. Biolimus-eluting stents were non-inferior to sirolimus-eluting stents for the primary endpoint at 9 months (79 [9%] patients vs 89 [11%], rate ratio 0.88 [95% CI 0.64-1.19], p for non-inferiority=0.003, p for superiority=0.39). Frequency of cardiac death (14 [1.6%] vs 21 [2.5%], p for superiority=0.22), myocardial infarction (49 [5.7%] vs 39 [4.6%], p=0.30), and clinically-indicated target vessel revascularisation (38 [4.4%] vs 47 [5.5%], p=0.29) were similar for both stent types. 168 (79%) patients in the biolimus-eluting group and 167 (78%) in the sirolimus-eluting group had data for angiographic follow-up available. Biolimus-eluting stents were non-inferior to sirolimus-eluting stents in in-stent percentage diameter stenosis (20.9%vs 23.3%, difference -2.2% [95% CI -6.0 to 1.6], p for non-inferiority=0.001, p for superiority=0.26). INTERPRETATION: Our results suggest that a stent eluting biolimus from a biodegradable polymer represents a safe and effective alternative to a stent eluting sirolimus from a durable polymer in patients with chronic stable coronary artery disease or acute coronary syndromes. FUNDING: Biosensors Europe SA, Switzerland.

Drug-eluting or bare-metal stents for large coronary vessel stenting? The BASKET-PROVE (PROspective Validation Examination) trial: study protocol and design

BACKGROUND: Based on a subgroup analysis of 18-month BAsel Stent Kosten Effektivitäts Trial (BASKET) outcome data, we hypothesized that very late (> 12 months) stent thrombosis occurs predominantly after drug-eluting stent implantation in large native coronary vessel stenting. METHODS: To prove or refute this hypothesis, we set up an 11-center 4-country prospective trial of 2260 consecutive patients treated with > or = 3.0-mm stents only, randomized to receive Cypher (Johnson ; Johnson, Miami Lakes, FL), Vision (Abbott Vascular, Abbott Laboratories, IL), or Xience stents (Abbott Vascular). Only patients with left main or bypass graft disease, in-stent restenosis or stent thrombosis, in need of nonheart surgery, at increased bleeding risk, without compliance/consent are excluded. All patients are treated with dual antiplatelet therapy for 12 months. The primary end point will be cardiac death/nonfatal myocardial infarction after 24 months with further follow-up up to 5 years. RESULTS: By June 12, 229 patients (10% of the planned total) were included with a baseline risk similar to that of the same subgroup of BASKET (n = 588). CONCLUSIONS: This study will answer several important questions of contemporary stent use in patients with large native vessel stenting. The 2-year death/myocardial infarction-as well as target vessel revascularization-and bleeding rates in these patients with a first- versus second-generation drug-eluting stent should demonstrate the benefit or harm of these stents compared to cobalt-chromium bare-metal stents in this relevant, low-risk group of everyday patients. In addition, a comparison with similar BASKET patients will allow to estimate the impact of 12- versus 6-month dual antiplatelet therapy on these outcomes.

Starting a carotid artery stenting program is safe

BACKGROUND: Little is known on the performance of newly initiated carotid artery stenting (CAS) programs. The safety of the procedure is being questioned following the publication of the EVA-3S trial, a study criticized for the limited interventional experience required to enroll patients. METHODS: Within a newly started academic CAS program, patient data and outcomes were collected prospectively. The outcomes of the first 100 consecutive patients treated are reported. A CAS-fellowship-trained interventionalist was involved in all procedures. All patients underwent clinical assessment by a neurologist before and after the procedure, and serial ECG and cardiac enzymes were routinely obtained. Primary outcome measures included 30-day major adverse events (MAE), defined as death, stroke, or myocardial infarction, while on follow-up deaths and ipsilateral strokes were added. RESULTS: Between July 2003 and November 2006, 92 patients had a single internal carotid artery treated, while 7 underwent staged bilateral CAS. In one patient, the procedure was aborted prior to lesion treatment. The 30-day MAE rate per procedure was 1.9% (one major and one minor stroke). By a mean follow-up of 16 months (range 2-42 months), one patient had died of refractory heart failure, while one patient had a minor ipsilateral stroke and three had minor contralateral strokes, corresponding to total MAE per patient of 4%. The rate of any stroke or death was 7%. The rate of restenosis >or=50% per lesion by ultrasound was 3.8%. CONCLUSION: This single center experience suggests that it is safe to start a CAS program following dedicated fellowship.