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The majority of the methodological developments in the field of cluster RCTs have been published in the more specialized fields of statistics and epidemiology. While statisticians and epidemiologists have the greatest need for this information, it is important that generic health services and primary care researchers have access to the principal findings of this research if they are to plan and conduct cluster RCTs appropriately.

We have outlined here the primary implications of adopting a cluster design and have highlighted that methods, some of which are easy to apply, do exist whereby cluster RCTs can be analysed appropriately. While we have identified a range of plausible methods, however, the choice of method and its actual implementation and interpretation should not be considered lightly, and expert statistical advice should be sought early in the planning of such studies. It should also be noted that the analysis options described are only appropriate for a completely randomized trial design with a continuous outcome. While the general approach to the analysis of binary data will be similar, whether cluster or individual level, the specifics of the analysis will be different. Similarly, more complex designs, such as stratified or matched designs, will require more sophisticated analysis strategies. 2

When planning a cluster RCT, it is important to think about the analysis strategy at the design phase as the choice of analysis approach may impact on the design of the trial. For example, to ensure that robust multilevel modelling can be undertaken, it is necessary that both sufficient clusters are recruited to the study and sufficient number of patients are available per cluster. 17

Considerable debate surrounds the choice of unit of analysis in cluster randomized trials. 2 , 18 Some authors stress that analysis should only be undertaken at the level of randomization; for example if a trial is randomized by practice, it should only be analysed by practice. Murray 2 argues that this emphasis on the unit of analysis may be misplaced and that attention should be focused rather on the appropriate specification of the model for the analysis, where the model selected should be well matched to the underlying structure of the data.

In conclusion, this study has demonstrated that adjustment for clustering can be applied to real-life data in a relatively straightforward manner, if advice and relevant software are available, and we encourage more routine adoption of appropriate analytical techniques.

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We would like to thank Ruth Thomas, lead researcher on the URGE study, for access to the study data. The research was funded by the Changing Professional Practice in Europe Group (a concerted action funded from the EU BIOMED-2 programme). The Health Services Research Unit is funded by the Chief Scientist Office of the Scottish Executive Health Department and is part of the MRC Health Services Research Collaboration. The views expressed are not necessarily those of the funding bodies.

Table 35 summarizes the relative clinical contraindications to the use of DES.

The optimal duration of DAPT after DES implantation is not known. Convincing data exist only for continuation up to 6 months [ 237 ]. Possibly, under some circumstances or with some DES, DAPT for 3 months could be sufficient but the evidence is not robust [ 219 ]. Recent evidence shows that (very) late stent thrombosis results from delayed hypersensitivity to components of the drug-polymer-device combination that causes necrotizing vasculitis and late malapposition [ 238 ]. Diabetics may require a longer duration of DAPT.

For situations listed in Table 35 , a number of alternative approaches have been tested. The Genous bio-engineered BMS carries a layer of murine, monoclonal, antihuman CD34 antibody, aimed at capturing circulating endothelial CD34+ progenitor cells, possibly increasing the rate of healing. The single-centre pilot TRIAS RCT did not confirm initial promising results in patients at high risk of coronary restenosis [ 239 ].

The rationale of using drug-eluting balloons is based on the concept that with highly lipophilic drugs, even short contact times between the balloon and the vessel wall are sufficient for effective drug delivery. Using a paclitaxel-eluting balloon, three RCTs have targeted in-stent restenosis following BMS implantation: PACCOCATH-I and -II [ 174 , 175 ] and PEPCAD-II [ 240 ]. As with DES, one cannot assume a class effect for all drug-eluting balloons. In the randomized PEPCAD III study, the combination of a drug-eluting balloon with cobalt chromium stent implantation was inferior to SES for de novo indications.

Although some brands already provide a biodegradable polymer, current DES remain permanent implants that cannot be extracted like pacemakers or artificial heart valves. Furthermore, stents force the cardiac surgeons to anastomose bypass grafts more distally. Stents create disruptive artefacts on cardiac CT and magnetic resonance images. Therefore, fully biodegradable stents are in development [ 241 ].

Whereas angiography depicts only a two-dimensional lumen silhouette, IVUS allows tomographic assessment of lumen area, plaque size, and distribution. IVUS is a valuable adjunct to angiography, providing further insights into both diagnosis and therapy, including stent implantation. Interventional cardiologists have learnt much from IVUS, but it has been difficult to demonstrate that this knowledge acquired routinely translates into reduced MACE. Multiple studies have addressed the potential of IVUS to reduce restenosis and adverse events after BMS implantation, but conflicting results were obtained with the largest of these trials showing no difference between groups with or without IVUS guidance. For DES, it was recently shown that the threshold of stent expansion predictive of late events including restenosis and stent thrombosis is lower than for BMS (5.0–5.5mm 2 ). In a retrospective analysis of a multicentre registry comparing PCI with surgery for unprotected LM, IVUS-guided stent implantation was associated with a significant mortality reduction at 3 years [ 242 ]. No properly designed RCT has compared the clinical value of IVUS-guided stent implantation in the DES era.

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