Further information: Intervention for Unstable Coronary Artery Disease (see p1005) from Cardiovascular Medicine, 3rd Edn* Percutaneous Coronary

Although atorvastatin is currently administered 3–7 days prior to percutaneous coronary intervention (PCI), the Naples II study [1] was conducted to determine if a single, high-loading 80 mg dose of atorvastatin administered within 24 hr prior to a procedure for PCI could reduce the incidence of periprocedural elevation of the cardiac enzyme creatine kinase-myocardial isoenzyme (CK-MB), an indicator of myocardial infarction (MI). The Naples II trial was a two-center, prospective, randomized study that enrolled 668 statin-naïve patients. Of that total, 338 were assigned to receive 80 mg atorvastatin and 330 were in the no-statin control group. The primary end point of this study was CK-MB elevation more than three times upper-known limit (UKL) alone or associated with chest pain or ST-segment or T-wave abnormalities, while the secondary end-points included the rate of cTnl elevation more than three times ULN and the composite of all in-hospital events, i.e. death, MI, and repeated revascularization.

In the atorvastatin group, periprocedural MI was 9.5%, and it was 15.8% in the control group (odds ratio [OR], 0.56; 95% confidence interval [CI], 0.35–0.89; P=0.014). Median CK-MB peak after PCI was 2.10 ng/ml (interquartile range [IR] 1.00–12.50 ng/ml) in the atorvastatin group and 3.20 ng/ml (IR 1.37–16.07 ng/ml) in the control group (P=0.014). Cardiac troponin I elevation >3X ULN was 26.6 % in the atorvastatin group and 39.1 % in the control group (OR, 0.56; 95% CI, 0.40–0.78; P<0.001). The results of the study confirmed the effectiveness of the single high-loading 80 mg dose of atorvastatin when administered 24 hr before PCI, showing the cardioprotective effect of a statin independent from cholesterol reduction. Thus, for the statin-naive patient, the need to postpone PCI is unnecessary when atorvastatin is administered.

In an accompanying editorial [2], the author expressed his opinion that although the Naples II study confirmed the major benefit of a 24-hr pre-procedural administration of 80 mg atorvastatin, one drawback to the study was that it was not powered to assess long-term, hard end-points. For the clinician’s use of the Naples II trial data, he opined that the overall result showed that all patients should be treated with a high dose of a potent statin. For patients who were not statin-naive, the clinician should consider a high-dose reloading of a potent statin at least 12 hr prior to PCI.

[1] Briguori C, Visconti G, Focaccio A, et al. Novel approaches for preventing or limiting events (Naples) II Trial. JACC 2009;54:2157-63

[2] Tsimikas S. High-dose statins prior to percutaneous coronary intervention. JACC 2009;54:2164-6

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Further information: Atrial Fibrillation and Flutter (see p1955) from Cardiovascular Medicine, 3rd Edn*

This study [1] was a prospective, multicenter, randomized trial designed to compare catheter ablation with antiarrhythmic drug therapy (ADT) in an effort to find the best control of recurrent atrial fibrillation (AF). Patients who have AF have increased risk of stroke, heart failure (HF), and impaired quality of life. ADT has long been the common treatment, but an ineffective one that subjected patients to adverse effects, with recurrence likely within 6 to 12 months. In this study, catheter ablation was evaluated as the alternate treatment to ADT.

Enrollment to the study was conducted from October 25, 2004 to October 11, 2007 in 19 hospitals, and 167 patients were enrolled who were refractory to at least one antiarrhythmic drug and had had at least three reoccurrences of AF within 6 months. Patients were randomized at a 2:1 ratio to either catheter ablation (n=106) or ADT (n=61), with the primary outcome being the time to protocol-defined treatment failure. The evaluation period lasted 9 months, and data showed that only 16% of patients in the ADT arm were free of recurrence of AF, while 63% in the catheter ablation group remained free. Hazard ratio of catheter ablation to ADT was 0.30 (95% confidence interval [CI], 0.19–0.47; P<0.001). Major 30-day treatment-related adverse events occurred in five of 57 patients (or 8.8%) in the ADT arm, contrasting with five of 103 patients (4.9%) in the catheter ablation arm. Because the study showed that patients treated with catheter ablation had an early and sustained reduction in symptom frequency and in the severity of symptoms, this result corresponded with an improvement in quality of life.

[1] Wilber DJ, Pappone C, Neuzil P, et al. Comparison of antiarrhythmic drug therapy and radiofrequency catheter ablation in patients with paroxysmal atrial fibrillation (ThermoCool AF Trial). JAMA 2010;803:333-40

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Further information: Pathophysiology and Clinical Recognition of Heart Failure (see p1379) from Cardiovascular Medicine, 3rd Edn*

In heart failure (HF), sudden cardiac death (SCD) causes 50% of all deaths, yet it is difficult to predict the heart failure patients who are at risk of SCD. Investigators conducted a post-hoc, nested case-control study of patients enrolled from April 2003 to December 2004 in the MUerte Súbita en Insuficiencia Cardíaca (MUSIC) registry [1]. The registry consisted of a three-year enrollment of ambulatory patients in the New York Heart Association functional class II to III. The patients had a left ventricular ejection fraction less than or equal to 45%, and data were consistently collected that included electrical, clinical, echocardiographic, and demographic information. The purpose of the study was to determine whether increased sST2 (an interleukin-1 receptor family member) concentrations, which have been predictive of the mortality rate for patients with acute coronary syndromes, could also be predictive for HF patients at risk of SCD. At the 3-year follow-up, 36 patients had died of SCD.

The concentrations of sST2 were greater in the deceased patients than in the 63 control patients (0.23 ng/ml [interquartile range 0.16–0.43 ng/ml] vs. 0.12 ng/ml [interquartile range 0.06–0.23 ng/ml], P=0.001) and were predictive of experiencing SCD (+0.1 ng/ml, odds ratio: 1.39, 95% confidence interval: 1.09–1.78, P=0.006). When N-terminal pro-B-type natriuretic peptide (NT-proBNP), an already established HF marker, and sST2 concentrations were both considered, only 4% of patients experienced SCD for neither sST2 nor NT-proBNP above characteristic cut-off points (0.15 ng/ml and 2,000 ng/l, respectively), 34% for either biomarker, and 71% for both biomarkers above (P<0.001 for trend). This study, the first to show that elevated sST2 concentrations may predict SCD, also provides complementary data to NT-proBNP, but future studies need to be conducted to determine if sST2 concentrations alone serve as a biomarker for SCD.

[1] Pascual-Figal DA, Ordonez-Llanos J, Tornel PL, et al. Soluble ST2 for predicting sudden cardiac death in patients with chronic heart failure and left ventricular systolic dysfunction (MUSIC). J Am Coll Cardiol 2009;54:2174-9

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