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Review in depth

Coronary artery disease and transcatheter aortic valve replacement: current treatment paradigms Jean-Michel Paradisa,b, Benoit Labbéa and Josep Rodés-Cabaua Aortic stenosis is the most common form of valvular heart disease in the elderly population and is often diagnosed in individuals who also have coronary artery disease. Surgical aortic valve replacement has been the standard of care for the treatment of aortic stenosis during the past decades, but the availability of transcatheter aortic valve replacement has now allowed different options for high or extreme surgical risk patients. The management of coronary artery disease in patients undergoing transcatheter aortic valve replacement remains a controversial issue, as available studies in the literature have generated conflicting results. This review offers a comprehensive portrait of coronary artery disease management in the presence of concomitant

Introduction In the elderly population, aortic stenosis (AS) is the most common form of valvular heart disease and is often diagnosed in individuals who also have coronary artery disease (CAD) [1,2]. Both conditions share risk factors such as age, smoking, and hypertension, and the pathophysiologic process involving degenerative calcification is found in both elastocalcinosis and atherosclerosis [3,4]. CAD affects over 50% of patients over 70 years of age with AS and over 65% of patients over 80 years of age with AS [5]. Coronary artery bypass grafting (CABG) in addition to surgical aortic valve replacement (SAVR) during the same surgical procedure has been considered the standard treatment option for patients with AS and CAD. Nevertheless, over the past 10 years, the availability of transcatheter aortic valve replacement (TAVR) has allowed different options for many patients, especially those considered at high surgical risk. This review will offer a comprehensive portrait of CAD in the presence of concomitant AS and propose treatment approaches for patients presenting both diseases.

Prevalence of coronary artery disease and aortic sclerosis

The prevalence of CAD increases with the presence of valve calcification and age [1,2,6]. In an elderly population, a significant link between aortic valve calcification and the presence of significant CAD was found [6]. Furthermore, in patients undergoing surgical valve replacement, CABG was found to be necessary in 30.2% of patients between 51 and 60 years of age, in 41.2% patients between 61 and 70 years, and in over 50% of patients over 71 years, as reported by a large Swedish 0954-6928 Copyright © 2015 Wolters Kluwer Health, Inc. All rights reserved.

aortic stenosis and proposes treatment approaches for patients presenting both diseases. Coron Artery Dis 26:272–278 Copyright © 2015 Wolters Kluwer Health, Inc. All rights reserved. Coronary Artery Disease 2015, 26:272–278 Keywords: aortic stenosis, coronary artery disease, coronary revascularization, percutaneous coronary intervention, transcatheter aortic valve replacement a

Quebec Heart and Lung Institute, Quebec, Quebec, Canada and Cardiovascular Research Foundation, New York, New York, USA

b

Correspondence to Jean-Michel Paradis, MD, Quebec Heart and Lung Institute, 2725 Chemin Sainte-Foy, Quebec, Quebec, Canada G1V 4G5 Tel: + 1 418 656 8711; fax: + 1 418 656 4581; e-mail: [email protected]

surgical registry [7]. Post-mortem and pathologic studies have correlated those findings. Indeed, 100% of patients over 65 years of age with mitral annular calcification or aortic valve calcification post mortem were observed to have coronary calcific deposits in one study [8]. Foam cells were found on the endothelium of aortic valve cusps and on coronary arteries of young patients in pathological studies, suggesting that early CAD and AS share a common pathophysiological process [3,9]. Therefore, the presence of aortic valve calcification can serve as a window to atherosclerosis of the coronary arteries [6].

Coronary arterial disease symptoms in presence of aortic stenosis

Angina is a poor indicator of the presence of CAD in patients with AS. In fact, in both diseases, angina is the most common presenting symptom. In patients with AS, the sensitivity and specificity of angina in identifying the presence of CAD are 68 and 46%, respectively. Notably, the prevalence of CAD is comparable either in the presence or in the absence of angina [1]. About 50% of patients with angina and AS show significant CAD during angiography [10]. Diminished coronary arterial flow (CFR) due to an insufficient supply of oxygen under conditions of high demand has been suggested to explain the presence of angina in AS without CAD. The 2014 American College of Cardiology/American Heart Association guidelines on the management of patients with valvular heart disease therefore recommend to proceed with coronary angiography before aortic valve replacement in symptomatic men over 35 years of age, in all asymptomatic men over 45 years of age, in premenopausal women over 35 years of age with a CAD risk DOI: 10.1097/MCA.0000000000000210

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CAD and transcatheter aortic valve replacement Paradis et al. 273

factor, in all women over 55 years of age or postmenopausal women, and in patients with known CAD or two or more risk factors [11]. Coronary arterial flow in aortic stenosis

Coronary flow reserve is a useful concept that represents a combined measure of blood flow through major epicardial coronary arteries and smaller vessels from the microcirculation. It can be defined as the maximal increase in myocardial blood flow from its usual resting level at a known perfusion pressure while the vasculature is optimally dilated. Patients with AS often have altered CFR, even when their coronaries are angiographically normal [12]. Dysfunction of the coronary circulation and the presence of epicardial coronary lesions may not be visible angiographically and may still lead to abnormal CFR by an unknown mechanism. This seems to be a crucial factor in explaining why AS leads to left ventricular dysfunction and myocardial ischemia. Interestingly, there is a better correlation between CFR and hemodynamic indexes of AS severity such as transvalvular pressure gradient and valve area than with left ventricular mass, consequently questioning the belief that concentric left ventricular hypertrophy causes most of the CFR reductions in patients with AS. The major factor could instead be the excessively high left ventricular workload generated by AS [13]. Myocardial microcirculation impairment has also been shown to be caused by long-term pressure load, therefore offering another possible explanation for the CFR reduction in patients with severe AS [14]. Evaluation of myocardial ischemia remains a controversial issue in AS [15]. Notably, exercise testing is contraindicated in patients with symptomatic severe AS. Fractional flow reserve measurement during coronary angiography has been shown to improve outcomes of percutaneous coronary intervention (PCI) [16]. It can therefore be a precious tool in evaluating CAD in the presence of AS, as demonstrated in a very small case series showing the benefits and safety of fractional flow reserve in this particular population [17]. Dipyridamole myocardial perfusion tomography has also proven to be a precise and safe tool to evaluate CAD in patients with AS [18]. Outcomes of surgical aortic valve replacement in patients with coronary arterial disease

The 2014 American College of Cardiology/American Heart Association Guidelines on the management of patients with valvular heart disease recommend that patients with significant CAD (≥70% luminal diameter reduction) with planned aortic valve replacement should also undergo CABG [11]. This class 1 recommendation results from the previous demonstration that concomitant CAD in patients undergoing valve replacement increases mortality [19,20]. Nonetheless, CABG combined with AVR, as compared with AVR alone, has been linked to a

higher postoperative risk of mortality in large studies [21–23]. Although these results question the benefit of concomitant CABG, the fact that patients undergoing both procedures have a higher risk profile seems to explain the increased risk. Indeed, Beach et al. [23] showed that when patients were propensity matched according to their comorbidities at baseline, survival through a follow-up to 10 years was similar whether the patients had isolated AS or AS with concomitant CAD. Percutaneous coronary intervention in the presence of severe aortic stenosis

Few studies have looked at PCI outcomes in patients with AS, as the surgical approach has been the preferred treatment in this population. A recent observational study led by Goel et al. [24] compared PCI outcomes of over 250 patients with severe AS. These patients were propensity matched to a cohort of individuals without AS who had PCI under comparable clinical conditions. Thirty-day mortality and short-term complications after PCI were similar in both groups. During the mean followup of 3.7 years, 29% underwent SAVR and 71% of those patients concomitantly underwent CABG. Using SAVR as a time-dependent covariate, multivariable analysis identified low left ventricular ejection fraction, type II diabetes, chronic obstructive pulmonary disease, and chronic kidney disease as being predictors of long-term mortality in patients with AS undergoing PCI. Still, these results suggest that PCI can be considered for patients with AS without increasing mortality. Limitations to this study include its single-center observational design and the fact that over 75% of PCIs were performed using bare metal stents, therefore restraining the scope of this study. Coronary arterial disease and transcatheter aortic valve replacement

As reported by The Euro Heart Survey published in 2003 [25], up to one-third of patients who could benefit from AVR were actually not being treated surgically because of an elevated surgical risk. Prohibitive or high surgical risk patients with severe symptomatic AS now have alternative treatment options. Different factors may be taken into account in determining surgical risk, such as renal failure, respiratory conditions, and associated CAD, especially in an aged population. Indeed, patients undergoing TAVR have been reported to have a high prevalence of CAD in numerous studies and registries (from 34.3% up to 74.9%) [4,6,26–42]. Studies available in the literature have generated conflicting conclusions with regard to the impact of CAD on the outcomes of TAVR. In a study reporting outcomes of the early experience with TAVR, Dewey et al. [20] observed an overall mortality that was significantly higher in patients with CAD, making them 10 times more at risk of dying during the first month following the intervention. Some influential limitations may have led to

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such conclusions. Notably, CAD was defined only as previous revascularization and populations were unmatched, probably creating differences in risk profiles. A recent prospective study evaluating 445 patients undergoing TAVR also reported that the severity of CAD was associated with a two-fold increased risk for cardiovascular death at 1 year [43]. In this cohort, the SYNTAX score was used to determine whether patients were considered at high risk (score > 22). This anatomic score evaluates the severity and complexity of CAD and is a known long-term predictor of outcomes in patients undergoing PCI [44]. Patients with significant CAD underwent TAVR with prior or concomitant PCI in this study, but most patients with higher SYNTAX scores had received less complete revascularization and had higher rSS scores (residual SYNTAX score). Therefore, the severity of CAD appears to negatively impact TAVR outcomes, and the anatomical complexity of the disease leads to a higher risk of death. Other studies have concluded differently on the impact of CAD in patients undergoing TAVR. In fact, another study in which patients had been stratified according to the extent of CAD demonstrated survival rates that were similar across the Duke Myocardial Jeopardy Score quintiles [45]. Some patients had undergone PCI before TAVR and the sample size was small, therefore limiting the extent of the conclusions of this trial. More recent studies have concluded that survival after TAVR is not modified by the presence of CAD. A metaanalysis regrouping the results of seven observational studies reported that CAD did not modify TAVR outcomes (including death) after a median follow-up of over a year [46]. Another study that enrolled 240 high-risk patients with severe AS demonstrated similar survival rates in patients with or without CAD at 30 days [47]. Among patients with CAD who underwent TAVR, clinical judgment was used to decide which patients would undergo PCI in this study. At 30 days and at 1 year, the survival rates were similar in the cohort with CAD and in the cohort without any CAD. This trial supports the selective revascularization strategy as only 17% of patients with CAD underwent PCI before TAVR. Of course, the short follow-up period and the small heterogeneous population limit the conclusions made. The paper by Van Mieghem and colleagues also supports the proposition that complete revascularization is not a prerequisite for TAVR. Indeed, in this study including 263 consecutive patients undergoing TAVR, 47% of patients were identified as having significant CAD before TAVR and only 20% of TAVR patients with incomplete revascularization at baseline underwent complete revascularization after evaluation by the heart team. Interestingly, revascularization status (complete vs. incomplete revascularization) had no effect on survival rates and on combined Valve Academic Research Consortium endpoints during the median follow-up of 16 months [48]. This

study not only promotes the selective revascularization strategy but also the importance of the heart team in the decision-making process. Recently published data from a large Italian registry using the CoreValve showed that patients with prior CABG or PCI did not suffer from more major adverse cerebrovascular and cardiac events and had similar mortality rates at 19 months of follow-up after TAVR [49]. This study was a nonrandomized report of over 600 consecutive patients and did not include prespecified methods of CAD evaluation, therefore limiting the extent of the conclusions made. Nevertheless, myocardial infarction was significantly more frequent during follow-up in patients who had not undergone revascularization before TAVR compared with patients who had undergone partial or complete revascularization. Notably, myocardial injury during uncomplicated TAVR has previously been associated with higher cardiac mortality at follow-up and a lesser improvement in the left ventricular ejection fraction [50]. Rates of periprocedural MI after TAVR have been reported by numerous studies to range between 0 and 4.6% [26–30]. Comparison between studies is limited because of a nonuniform method of defining MI using cardiac biomarkers, and more research is required to determine the true impact of MI after TAVR. Coronary angiography should be a part of the pre-TAVR assessment process and is recommended [51]. However, up to date, there is no consensus on the best way to manage CAD in patients with severe AS undergoing TAVR. Proceeding with PCI for all high-risk patients with CAD implicates risks such as a higher bleeding propensity due to the mandatory dual antiplatelet therapy after PCI and renal failure due to the increased contrast exposure. In contrast, the TAVR procedure implicates rapid ventricular pacing and can result in periods of hypotension, therefore exposing patients with untreated CAD to myocardial ischemia. It is unclear whether a selective revascularization strategy can offer a better balance between the risks and benefits. For now, the small number of studies addressing this delicate question makes it difficult to conclude on the best timing or on the optimal strategy for revascularization. Timing of percutaneous coronary intervention in patients with aortic stenosis undergoing transcatheter aortic valve replacement

The ideal timing (before, concomitant, or after) to proceed with revascularization in patients undergoing TAVR is still under investigation. PCI before TAVR could potentially reduce the procedural risks and limit the possibility of requiring revascularization after TAVR. The concomitant approach could offer considerable advantages such as patient convenience, optimal resource utilization, and a single need for arterial access. The rationale behind proceeding with PCI after TAVR is

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CABG, coronary artery bypass grafting; CAD, coronary arterial disease; PCI, percutaneous coronary intervention; SAVR, surgical aortic valve replacement; TA, transapical; TAVR, transcutaneous aortic valve replacement.

Treatment of significant CAD by PCI immediately after TA-TAVR is feasible and safe 3 years Immediately after TA-TAVR PCI after TAVR Pasic et al. [57]

419 patients total, 46 patients with PCI immediately after TAVR

30 days 14 days before TAVR (mean) or immediately before TAVR 21 patients with PCI before TAVR, seven patients with PCI concomitant with TAVR, and 197 patients with isolated TAVR Conradi et al. [56]

Up to 2 years 36 ± 26 days before TAVR (mean) or immediately before TAVR

PCI concomitant with TAVR and before TAVR are both feasible and safe alternatives Mid-term survival is not modified by complete or incomplete revascularization Proceeding with PCI concomitant with TAVR is safe and feasible The concomitant strategy leads to a higher risk for renal failure

Up to 3 years 10 days before TAVR (median)

Abdel-Wahab et al. [54] 55 patients with PCI + TAVR, 70 patients with isolated TAVR PCI concomitant with TAVR Wenaweser et al. [55] 23 patients with PCI before TAVR, 36 patients with PCI concomitant with TAVR

Up to 6 years 82 ± 93 days before TAVR (mean) Wendt et al. [53]

184 patients with SAVR + CABG, 59 patients with PCI + TAVR

Treating CAD with PCI before TAVR in a selective manner is safe and results in similar outcomes to that seen in non-CAD patients PCI before TAVR compared with SAVR + CABG results in similar inhospital mortality rates PCI before TAVR is safe and feasible 12.9 months 27 days before TAVR (median) 191 patients total, 113 patients with CAD PCI before TAVR Gasparetto et al. [52]

Main conclusions Follow-up Timing of PCI Study groups Study

Table 1

Main studies on timing of percutaneous coronary intervention in patients with aortic stenosis undergoing transcatheter aortic valve replacement

CAD and transcatheter aortic valve replacement Paradis et al. 275

to reduce the risk for intraprocedural complications of PCI by treating AS, which can be considered the most proximal coronary artery stenosis and is therefore capable of decreasing the oxygen supply of the myocardium. All these different strategies have been studied over the past 10 years and have been reviewed in the following sections. Presented studies are summarized in Table 1. Percutaneous coronary intervention before transcatheter aortic valve replacement

The PUREVALVE registry is one of the largest prospective studies that addressed the safety of proceeding with PCI before TAVR. In this registry, 191 consecutive patients were recruited, and 113 of them had at least one significant coronary stenosis or had undergone previous PCI or CABG [52]. In this CAD group, PCI before TAVR was judged to be clinically relevant for 39 patients. The PCI was performed at a median of 27 days before TAVR. Thirty-day overall mortality in the CAD group was comparable to that in patients free from CAD, suggesting that a selective revascularization strategy applied before TAVR could be a safe and effective treatment approach. In another study, the 30-day mortality rate of 59 high-risk patients who had undergone prior PCI within 12 months of TAVR was similar to that in a group of 184 propensity score-matched high-risk patients treated by SAVR and CABG [53]. Finally, Abdel-Wahab et al. [54] compared 55 patients treated with PCI 10 days before TAVR with 70 patients treated with TAVR alone. Mortality and serious outcomes including major vascular complications and bleeding were comparable at 6 months of follow-up, again indicating the effectiveness and safety of performing PCI before TAVR. Percutaneous coronary intervention concomitant with transcatheter aortic valve replacement

Few studies have looked at the possibility of combining PCI and TAVR during the same procedure. The BERNTAVI registry included 256 patients recruited prospectively. In this trial, CAD was defined by a history of PCI or CABG or at least one significant greater than 50% lesion [55]. Among the 165 patients with CAD, 23 had undergone staged PCI at a mean of 34 days before TAVR and 36 had undergone single-stage intervention. Main outcomes including major strokes, Valve Academic Research Consortium combined safety endpoints, and death were similar on using either TAVR alone or with a concomitant PCI strategy. The small number of patients included and the observational design limit the conclusions made, but the study suggests that concomitant PCI and TAVR could be a safe treatment approach. Another retrospective small case series including 28 high-risk patients judged to be inoperable compared the staged PCI before TAVR strategy and the single-stage procedure [56]. In this report, the overall 30-day mortality was 7.1% in the one-step procedure, which is similar to the

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rates reported in numerous studies and registries, suggesting the safety of this treatment method. Percutaneous coronary intervention after transcatheter aortic valve replacement

Only one retrospective study has directly evaluated the use of PCI immediately after TAVR [57]. Among patients who underwent transapical TAVR in this study, 46 underwent PCI in a single stage after placement of the valve. The follow-up of 36 months showed that this approach was safe and feasible according to the authors. Nonetheless, this strategy poses certain risks, including the possibility that cannulation of the coronary arteries may be challenging and that catheter manipulation may dislodge the newly implanted bioprosthetic transcatheter valve [58,59]. There is still very limited experience with this treatment strategy and its larger-scale applicability certainly remains to be proven. Our approach

Weighting the risks and benefits of proceeding with revascularization along with TAVR still remains a challenge and will require further research before a standardized approach can be suggested by a learned society. In our center, anatomical considerations with regard to the coronary arteries and patient comorbidities are carefully reviewed to determine whether the patient can benefit from a revascularization. Of course, as recommended, every TAVR candidate undergoes a coronary angiography during the evaluation process. The heart team tends to favor a PCI before TAVR strategy for patients in whom a lesion is identified on the left-main or proximal left-anterior descending artery, if there is clinical or measured evidence of ischemia, if a lesion is affecting a vessel perfusing a significant territory, or in the presence of hemodynamic instability (Table 2). We usually proceed with PCI about 1 month before TAVR. For patients with distal lesions, with lesions located in small vessels, with chronic total occlusion or if there is a significant risk of dialysis following complex anticipated PCI, the heart team favors proceeding with TAVR alone, without any PCI.

transcatheter aortic Valve implantaTION trial: a randomized controlled trial (ACTIVATION) is evaluating the safety and impact of PCI before TAVR. In this European study, 310 patients have been randomized and amenable patients are subjected to either TAVR alone or PCI before TAVR. Another large ongoing randomized study is the Placement of AoRTic TraNscathetER Valves (PARTNER 2A) trial, which is comparing the use of TAVR and SAVR in an intermediate-risk population with AS. A subgroup of patients with significant CAD requiring revascularization has been randomized to surgical treatment with SAVR and CABG or to TAVR and PCI at a timing left to the discretion of the treating physician. Finally, the SUrgical Replacement And Transcatheter Aortic Valve Implantation (SURTAVI) trial is evaluating the safety and efficacy of TAVR compared with SAVR in intermediate-risk patients using the Medtronic CoreValve System. If concomitant revascularization is deemed necessary, patients will be randomized to either undergo CABG during SAVR, or PCI before TAVR. These studies will hopefully help to clarify the best strategy and timing of revascularization to be used in patients with severe AS. Pending questions

The novelty of the use of transcatheter technologies leaves many questions yet to be answered, especially with regard to CAD management in this setting. Among those interrogations, establishing the severity at which CAD when left untreated can negatively affect outcomes of TAVR is still unknown. The impact of using bare metal stents or drug-eluting stents for revascularization in patients with planned TAVR has not yet been addressed in a comparative study. Stent choice could impact bleeding complications during TAVR, especially as a high proportion of patients with AS have concomitant atrial fibrillation and also require anticoagulation [60], therefore possibly reducing the benefit of revascularization. Whether PCI should be conducted in a single stage or as a multiple-step process in patients requiring TAVR is also unknown. The previously mentioned ongoing clinical trials should offer answers to some of those questions, but further research is definitely warranted.

Ongoing trials

Three ongoing randomized controlled trials are addressing the issue of management of CAD in patients undergoing TAVR. Important features of these trials are listed in Table 3. The percutaneous intervention prior to Table 2

Conclusion

Patients with severe AS have a high rate of concomitant CAD, as both diseases share many risk factors. Up to recent years, SAVR combined with CABG has been the

Approach to treatment of obstructive CAD in patients with planned TAVR for severe AS at the Quebec Heart and Lung Institute

TAVR alone

PCI before TAVR

Distal lesion Small artery (< 2.5 mm) Risk of dialysis after complex anticipated PCI of a lesion other than LM or pLAD Chronic total occlusion

Lesion located in the LM or pLAD Clinical or measured evidence of ischemia Acute coronary syndrome, hemodynamic instability, or dynamic ST changes Lesion of an artery perfusing a significant territory

AS, aortic stenosis; CAD, coronary arterial disease; LM; left main; PCI, percutaneous coronary intervention; pLAD, proximal left-anterior descending artery; TAVR, transcutaneous aortic valve replacement.

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CAD and transcatheter aortic valve replacement Paradis et al. 277

Table 3

Major ongoing randomized trials evaluating the treatment of CAD in patients with severe AS undergoing TAVR ACTIVATION trial

PARTNER 2A trial

SURTAVI trial

Study design Estimated enrollment Objective

Prospective randomized controlled study 310 patients

Prospective randomized controlled study 2000 patients

Prospective randomized controlled study 2500 patients

To verify whether revascularization of significant CAD by PCI before TAVR can reduce mortality and rehospitalization compared with no revascularization

To determine the safety and efficacy of TAVR, estimated using the Medtronic CoreValve System, compared with SAVR in intermediate surgical risk patients. Patients recruited were further randomized to SAVR + CABG or TAVR + PCI when significant CAD was identified during the initial assessment

Primary outcomes Follow-up

30-day and 1-year mortalities. Rehospitalization

To determine the safety and efficacy of TAVR, estimated from the Edwards SAPIEN XT THV with the NovaFlex delivery system, compared with SAVR in intermediate surgical risk patients. Patients recruited were further randomized to SAVR + CABG or TAVR + PCI when significant CAD was identified during the initial assessment, with timing of PCI left to the discretion of the treating physician Nonhierarchical composite of death and disabling stroke Up to 5 years

1 year

All-cause mortality. Disabling stroke Up to 5 years

ACTIVATION, percutaneous intervention prior to transcatheter aortic Valve implantaTION; AS, aortic stenosis; CABG, coronary artery bypass grafting; CAD, coronary arterial disease; PARTNER 2A, Placement of AoRTic TraNscathetER Valves; PCI, percutaneous coronary intervention; SAVR, surgical aortic valve replacement; SURTAVI, SUrgical Replacement And Transcatheter Aortic Valve Implantation; TAVR, transcutaneous aortic valve replacement.

gold standard for the treatment of AS and CAD. TAVR is now an alternative to open surgery for patients at a high risk or for those deemed inoperable. Thus, treatment of CAD by PCI in this population is of interest. The best revascularization strategy as well as the optimal timing for PCI has yet to be determined, as most of the literature has been observational, and multiple treatment paradigms have been attempted on small populations. Ongoing large-scale randomized studies should offer better insight into the appropriate management of CAD in TAVR candidates. These efforts will hopefully allow physicians to offer patients the most appropriate treatment. In the meantime, a decision-making process based on the heart team approach is undoubtedly instrumental in the management of complex and multifaceted patients with AS and CAD.

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Acknowledgements Conflicts of interest

Dr Rodés-Cabau has received consulting fees from Edwards Lifesciences and St. Jude Medical. For the remaining authors, there are no conflicts of interest.

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Coronary artery disease and transcatheter aortic valve replacement: current treatment paradigms.

Aortic stenosis is the most common form of valvular heart disease in the elderly population and is often diagnosed in individuals who also have corona...
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