PMC:6019327 / 585675-598939 JSONTXT

{"target":"https://pubannotation.org/docs/sourcedb/PMC/sourceid/6019327","sourcedb":"PMC","sourceid":"6019327","source_url":"https://www.ncbi.nlm.nih.gov/pmc/6019327","text":"Types of Clinical Trials, Strengths, and Weaknesses\n\nMortality Trials\nLarge, randomized, controlled multicenter trials are considered the “gold standard” for many therapies in cardiovascular medicine. They are most likely to provide an unbiased understanding of the outcomes of specific aspects of ablative intervention. Although AF is associated with increased mortality and morbidity from stroke, HF, and recurrent hospitalization, most of the AF ablation literature is focused on AF recurrence and symptomatic improvement. It remains unclear whether ablation can affect AF burden sufficiently to have a positive outcome with respect to mortality and stroke endpoints. Trials powered to demonstrate a benefit for ablation with regard to these “hard” endpoints require large numbers of patients with extensive follow-up and its accompanying expense; however, the need for such trials cannot be understated. The CABANA trial was powered to examine stroke and mortality outcomes of AF ablation compared with pharmacological rate and rhythm control strategies. CABANA, which recently completed enrollment, requires a minimum of 5 years of follow-up; thus, results will not be available until 2018. In the meantime, EAST is a study that is currently enrolling and is designed to compare standard care vs a strategy of early rhythm control with ablation and/or AADs with endpoints including a composite outcome of cardiovascular death, stroke, and hospitalization due to worsening of HF or acute coronary syndrome. Although it is unclear whether these trials will demonstrate a mortality benefit of AF ablation, both are designed to examine a host of prespecified secondary endpoints. Secondary endpoints such as HF hospitalizations are especially important for patients with uncontrolled rates and HF with preserved EF or tachycardia-induced cardiomyopathy. Finally, because both trials will include larger numbers of patient ablations with more novel technologies such as cryoablation and CFS than have been available in any other study to date, significant advances in the understanding of ablation procedure with these systems should be possible. Nevertheless, it remains imperative to continue with designs of large mortality trials that reflect shifting global ablation techniques, technologies, and patient selection. There are currently 45 trials that meet the search criteria of “ablation mortality AF” on ClinicalTrials.gov; however, fewer than 10 have mortality as part of the primary endpoint.\n\nStroke and Thromboembolism Trials\nReductions in stroke and thromboembolism remain the most important goals of AF treatment. It is unclear, however, if elimination of or reductions in AF will necessarily reduce the associated risk of stroke, and whether such outcomes exceed those possible with NOAC agents. Although an increased risk of stroke appears to be associated with brief episodes of AF detected by implanted cardiac devices, multiple large randomized trials have demonstrated that there might be no temporal relationship between AF episodes and AF thromboembolic events. This possibility has cast significant doubt regarding the direct causal role that AF plays in stroke. On the other hand, some cohort studies of AF ablation have reported a lower risk of stroke postablation compared with matched, nonablated AF populations. The impact of AF ablation on stroke and thromboembolism is an important topic of future study and will likely require a combination of very large studies with long durations of follow-up akin to CABANA and EAST. The OCEAN study is currently getting started, and will examine the optimal strategy for ongoing antithrombotic therapy 1 year after successful ablation in a moderate-risk profile population with a primary endpoint of overt and covert stroke. It is important to stress that until the results of these trials are known, the current recommendations are to continue anticoagulation indefinitely in patients with CHA2DS2-VASc ≥2, regardless of the success of the ablation procedure.\nPeriprocedural stroke reduction is an important topic that is actively being studied, with various strategies of anticoagulation, particularly continuous administration of VKA and non-VKA oral anticoagulants through the ablation procedure.834, 841,842 In addition, concomitant LAA occlusion is being tested. In percutaneous procedures, there are few if any studies powered for stroke alone; most primarily evaluate AF recurrence.\nFinally, multiple studies have demonstrated small ACE on MR brain imaging after ablation.724,728,1207 The clinical significance of such ACE lesions is not known, and many will resolve to the point of being undetectable after weeks or months. The impact on cognitive function, if any, is not clear. At this point, there are no mandates for performing periprocedural brain imaging for novel technologies to evaluate the incidence of silent cerebral embolism, in large part because of its unknown clinical significance and the cost and burden of MRI on patients. However, further evaluation of the significance of such findings remains an important area of study.\nScreening substudies could be reasonable for high-risk devices and should be combined with clinical neurological and cognitive assessments. These silent cerebral emboli are to be distinguished from covert embolic strokes secondary to long-term AF, which have been linked with long-term cognitive decline, and are much larger than the silent emboli seen peri-procedurally.1385,1386,1387,1388\n\nMulticenter Outcome Studies\nThere has been a proliferation of multicenter, randomized studies primarily geared toward the outcome of AF recurrence in the last several years. Many of these studies have had the appropriate size and power to make some important statements on the appropriate techniques for AF ablation. Because of the endpoint of AF recurrence, these studies can be performed with smaller sample sizes and shorter follow-up periods compared with mortality- or stroke-driven trials. A number of randomized trials have demonstrated the superiority of AF ablation over AADs in drug-refractory patients. First-line catheter ablation has shown mixed results over first-line drug therapy in the MANTRA-PAF and RAAFT-2 studies.378,379 STAR AF 2, Adenosine Following Pulmonary Vein Isolation to Target Dormant Conduction Elimination (ADVICE), FIRE AND ICE, and TOCCASTAR are just a few examples of multicenter randomized studies that have included hundreds of patients per study and added important contributions to the daily practice of AF ablation.245,265,378,379,489,655 STAR AF 2, for example, challenged the long-held belief that additional ablation beyond PVI is important for ablation of persistent AF and has launched a new search for alternative targets to CFAE and empiric lines. It remains possible that incomplete ablation in these arenas is more problematic than the ablation format itself. As reported recently, the FIRE AND ICE trial has shown an equivalence of evolving cryoablation technologies to traditional RF. The ADVICE trial showed that systematic use of adenosine to search for dormant conduction can improve durability of PVI and associated 1-year outcome, although studies reported earlier in this document raise questions about the overall utility of adenosine or isoproterenol. There are many more studies planned to examine various aspects of AF ablation, primarily around the comparison of techniques in certain patient populations to improve ablation outcomes. As expected, a criticism of all such trials is that the technology and techniques are outdated prior to trial completion. STAR AF 2 did not use CFS and FIRE AND ICE used a mixture of first- and second-generation CB technologies. Therefore, ongoing trials comparing the most up-to-date technologies will always be required. Larger-scale surgical ablation trials are lacking, and the consensus group believes that the development of well designed, highly agile, large-scale multicenter surgical trials with similar monitoring regimens need to be encouraged and performed. As with catheter-based studies and registries, the use of patient-reported outcome measures as part of the study endpoints is highly recommended.\n\nIndustry-Sponsored Device Approval Studies\nThere have been a number of prospective randomized studies performed to evaluate the safety and efficacy of investigational devices used for AF ablation. These studies, such as THERMOCOOL IDE and STOP AF, have all provided important, high-quality data demonstrating the superiority of catheter ablation over drug therapy in drug refractory patients.462,684 Now that the utility of ablation over drug therapy in such patients has been accepted, many of the current studies are focused on comparing new technologies against approved devices in a noninferiority design. Although these studies are important from a safety and efficacy perspective and are often mandated by health approval bodies such as the FDA, the incremental yield in knowledge could be limited. Prespecified subgroup analyses, or the use of novel endpoints. could therefore be important to determine whether incremental value is added by the newer technology. TOCCASTAR, for example, demonstrated statistical noninferiority of CF-driven RF ablation to traditional RF. However, only in a post-hoc analysis did the trial show that optimal CF was associated with better outcomes, findings which should be viewed with caution due to the limitations of post hoc analyses. Testing of the durability of lesion sets such as PVI either after delayed waiting, drug (adenosine) challenge, or repeat electrophysiology study after 3 months might also help assess comparative efficacy more accurately. Industry must also look to see whether safety and efficacy parameters demonstrated in PAF also apply to nonparoxysmal populations. Several industry-sponsored studies are either being planned or are in progress to assess outcomes in this challenging population.\n\nRegistry Studies\nAF ablation registries offer a unique opportunity to collect data from large numbers of patients to examine outcomes. In particular, registries might help assess how ablation is being performed in the “real world” compared with controlled clinical trials that are often performed on a highly selected patient population in very experienced centers. The Definition of real world remains problematic, however, because recent studies have shown reasonable congruence between the outcomes of RCTs and registries. Registries are well suited to determining early complication rates of ablation, particularly for less common ones such as PV stenosis, esophageal injury, or mortality. Appropriateness of patient selection and outcomes in patient subgroups that are underrepresented in studies, such as women or patients with underlying structural heart disease, can also be assessed in sizable registries. The collection of this kind of information, by itself, makes registries worthwhile if they can be performed with sufficient representation of a majority of centers. Still, well-controlled efforts such as the STS database have shown an evenhanded approach to collecting this kind of material. Worldwide surveys of AF ablation have been published, and ongoing efforts are being made to harmonize various centers or national databases to pool ablation information. Many countries are now setting up provincial or national registries to examine the use and outcomes of AF ablation. In the United States, for example, the older Safety of Atrial Fibrillation Ablation Registry Initiative registry project was discontinued, but another started by the National Cardiovascular Data Registry (NCDR) has been launched nationally, with voluntary participation. The HRS is also collaborating with the AHA to develop an additional AF ablation registry. Surgical data are currently being collected in the STS database; however, although data on safety and outcome are available, lesion-specific information for surgical ablation remains preliminary. Collection of longitudinal data, particularly longer-term outcomes, can be limited by a lack of patient follow-up at the same center and a lack of consistent monitoring protocols. The need for informed consent to collect follow-up data also remains an obstacle to obtaining outcome data. The burden of data entry can also lead to inadequate reporting, and the cost of auditing data can be very expensive and tedious. The purpose of establishing a registry and the realistic goals of data collection must be stated outright upon establishment, because the opportunity and financial costs could be alternatively spent on well-designed clinical trials. Comparison of performance among sites, for example, must be based on the stated purposes and strengths of the registry. If the main purpose is to report acute complications, then long-term outcomes cannot be compared. Comparisons must also be corrected for patient characteristics, referral patterns to the institution, and community-based versus advanced academic practices. Finally, once the stated goals of the registry are accomplished, there should be specific timeframes for termination of the registry to avoid indefinite data collection with no specific stated 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