Severe Aortic Stenosis and CAD in the TAVR Era
Severe Aortic Stenosis and CAD in the TAVR Era
The ongoing ACTIVATION trial (Percutaneous coronary intervention prior to transcatheter aortic valve implantation: a randomized controlled trial), which is randomizing patients with CAD to pre-TAVR PCI and no pre-TAVR PCI, will help answer the question of whether pre-TAVR PCI has favorable impact on outcomes after TAVR. Other ongoing randomized trials such as SURTAVI (Surgical Replacement and Transcatheter Aortic Valve Implantation) and PARTNER II are including patients with severe AS and significant CAD requiring revascularization. The SURTAVI trial is designed to compare TAVR with the CoreValve system (Medtronic, Minneapolis, Minnesota) with SAVR in intermediate risk patients (STS risk score 4 to 10). Similarly, the PARTNER II trial has been designed to compare TAVR with the Edwards Sapien XT valve (Edwards Lifesciences, Irvine, California) with SAVR in intermediate-risk (STS score 4 and higher) patients. In both these ongoing randomized TAVR studies, patients with concomitant severe CAD will be randomized for percutaneous or surgical treatments. It is important to note that management strategies (i.e., TAVR with or without PCI) will be compared with SAVR with or without CABG. These are not trials to compare the PCI with CABG, but they are trials to compare percutaneous strategy for the treatment of AS and CAD with surgical strategies. The decisions with regard to targets for revascularization are defined before randomization for each strategy. Revascularization before randomization in the study will be discouraged unless patients present with acute coronary syndrome (non–ST-segment elevation MI or ST-segment elevation MI) requiring urgent PCI. Such patients can still be randomized to SAVR or TAVR arm depending on stent type and required duration of dual antiplatelet therapy. The need for revascularization in stable CAD patients will be determined by the heart team on an individual basis. Aforementioned factors with regard to DES use will need to be considered while considering elective PCI. Complex CAD such as unprotected left main trunk and multivessel CAD with SYNTAX score ≥33 will be excluded in both trials. Completeness of revascularization might differ in the 2 arms. For example, a chronic total occlusion of a well-collateralized right coronary artery will likely be left alone in the TAVR arm; however, a bypass graft if feasible during SAVR will be performed. Data from ongoing studies should provide valuable information with regard to the impact of CAD on TAVR outcomes and the role of revascularization with PCI and its timing in patients undergoing TAVR.
Future Directions
The ongoing ACTIVATION trial (Percutaneous coronary intervention prior to transcatheter aortic valve implantation: a randomized controlled trial), which is randomizing patients with CAD to pre-TAVR PCI and no pre-TAVR PCI, will help answer the question of whether pre-TAVR PCI has favorable impact on outcomes after TAVR. Other ongoing randomized trials such as SURTAVI (Surgical Replacement and Transcatheter Aortic Valve Implantation) and PARTNER II are including patients with severe AS and significant CAD requiring revascularization. The SURTAVI trial is designed to compare TAVR with the CoreValve system (Medtronic, Minneapolis, Minnesota) with SAVR in intermediate risk patients (STS risk score 4 to 10). Similarly, the PARTNER II trial has been designed to compare TAVR with the Edwards Sapien XT valve (Edwards Lifesciences, Irvine, California) with SAVR in intermediate-risk (STS score 4 and higher) patients. In both these ongoing randomized TAVR studies, patients with concomitant severe CAD will be randomized for percutaneous or surgical treatments. It is important to note that management strategies (i.e., TAVR with or without PCI) will be compared with SAVR with or without CABG. These are not trials to compare the PCI with CABG, but they are trials to compare percutaneous strategy for the treatment of AS and CAD with surgical strategies. The decisions with regard to targets for revascularization are defined before randomization for each strategy. Revascularization before randomization in the study will be discouraged unless patients present with acute coronary syndrome (non–ST-segment elevation MI or ST-segment elevation MI) requiring urgent PCI. Such patients can still be randomized to SAVR or TAVR arm depending on stent type and required duration of dual antiplatelet therapy. The need for revascularization in stable CAD patients will be determined by the heart team on an individual basis. Aforementioned factors with regard to DES use will need to be considered while considering elective PCI. Complex CAD such as unprotected left main trunk and multivessel CAD with SYNTAX score ≥33 will be excluded in both trials. Completeness of revascularization might differ in the 2 arms. For example, a chronic total occlusion of a well-collateralized right coronary artery will likely be left alone in the TAVR arm; however, a bypass graft if feasible during SAVR will be performed. Data from ongoing studies should provide valuable information with regard to the impact of CAD on TAVR outcomes and the role of revascularization with PCI and its timing in patients undergoing TAVR.
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