Final 5-Year Follow-Up of a Randomized Controlled Trial of Everolimus- and Paclitaxel-Eluting Stents for Coronary Revascularization in Daily Practice: The COMPARE Trial (A Trial of Everolimus-Eluting Stents and Paclitaxel Stents for Coronary Revascularization in Daily Practice).

OBJECTIVES: This study sought to report the 5-year outcomes of everolimus-eluting stents (EES) and paclitaxel-eluting stents (PES) in an all-comers population undergoing percutaneous coronary intervention (PCI). BACKGROUND: The medium-term 1 and 2-year results of the prospective randomized COMPARE trial (A Trial of Everolimus-Eluting Stents and Paclitaxel-Eluting Stents for Coronary Revascularization in Daily Practice) showed superior clinical outcomes with EES compared with PES in an all-comers PCI population. Whether this benefit is sustained over longer-term follow-up is unknown. Furthermore, systematic long-term follow-up data on these metallic drug eluting stents with durable polymers are scarce. METHODS: We randomly assigned 1,800 patients undergoing PCI to EES or PES. The pre-specified composite primary endpoint was death, myocardial infarction (MI), or target vessel revascularization (TVR). RESULTS: Follow-up at 5 years was completed in 1,791 (99.5%) patients. Treatment with EES compared with PES led to a relative risk reduction of the primary endpoint by 27% (18.4% vs. 25.1%, p = 0.0005), driven by lower rates of MI (7.0% vs. 11.5%, p = 0.001) and TVR (7.4% vs. 11.4%, p = 0.003), but not with mortality (9.0% vs. 10.3%, relative risk 0.88, p = 0.36). Moreover, patients treated with EES compared with PES had lower rates of definite/probable stent thrombosis at 5 years (3.1% vs. 5.9%, p = 0.005). The hazard curves for TVR, MI, and stent thrombosis diverge over the first 3 years and, subsequently, progress in parallel. CONCLUSIONS: The early- and medium-term superiority of EES over PES measured both by safety and efficacy endpoints is sustained at 5 years in this all-comer population. (A Trial of Everolimus-Eluting Stents and Paclitaxel-Eluting Stents for Coronary Revascularization in Daily Practice [COMPARE]; NCT01016041).

Combining magnetic resonance viability variables better predicts improvement of myocardial function prior to percutaneous coronary intervention.

OBJECTIVE: To optimize the predictive value of cardiac magnetic resonance imaging (MRI) for improvement of myocardial dysfunction prior to percutaneous coronary intervention (PCI). METHODS: We performed cardiac MRI in 72 patients (male 87%, age 60 years) before and 6 months after successful PCI (43/72) or unsuccessful PCI (29/72) of a chronic total coronary occlusion (CTO). Before PCI, 5 viability parameters were evaluated: transmural extent of infarction (TEI), contractile reserve during dobutamine, end diastolic wall thickness, unenhanced rim thickness and segmental wall thickening of the unenhanced rim (SWTur). Multivariate analysis was performed and based on the regression coefficient (RC) a predictive score was constructed. Diagnostic performance to predict improvement in myocardial function for each parameter and for the viability score was determined. RESULTS: The predictive value of a combination of contractile reserve, SWTur and TEI was incremental to TEI alone (AUROC 0.91 vs. 0.77; p<0.001). A viability score of ≥ 5 based on contractile reserve (RC=4), SWTur (RC=1) and TEI (RC=2) was 91% sensitive and 84% specific in predicting improvement of myocardial function. CONCLUSION: Combining viability parameters results in a better prediction of improvement of dysfunctional myocardial segments after a successful PCI.

Integration of multislice computed tomography with magnetic navigation facilitates percutaneous coronary interventions without additional contrast agents.

OBJECTIVES: We hypothesized that percutaneous coronary intervention (PCI) without additional contrast agents can be performed by directly integrating multislice computed tomography coronary angiography (CTCA) within the magnetic navigation system (MNS). BACKGROUND: Increasingly, CTCA is being used in the diagnostic work-up of patients with coronary disease. Its inherent 3-dimensional information should be exploited, as it potentially offers advantages over 2-dimensional radiography in guiding invasive diagnostic and therapeutic interventions. METHODS: CTCA-derived centerlines from 15 patients were coregistered and overlaid on real-time fluoroscopic images employing the MNS. Vessels were manually wired with a magnetically enabled guidewire assisted by variable local magnetic fields. Fractional flow reserve (FFR) determined the lesion severity, and the dimensions were quantified by intravascular ultrasound (IVUS). Locations of the IVUS catheter probe along the lesion were incorporated in software to facilitate stenting without contrast agents. RESULTS: The average crossing and fluoroscopic times were 105.3 +/- 35.5 s and 83.4 +/- 38.6 s, respectively, with no contrast agents used in 11 of 15 patients (73.3%). Contrast agents were used in only 1 of 10 patients (10%) in whom an IVUS was performed. In 4 patients, apart from a "blinded" safety check angiogram, the entire PCI (lesion crossing, stent sizing, positioning, and deployment) was performed without additional contrast agents following the coregistration of the IVUS probe position in the MNS. CONCLUSIONS: The integration of pre-procedural CTCA within the MNS can facilitate PCI without additional contrast agents.