Ravinder Singh Rao, Akshay Prashanth Giri, Lakshmi Durga Kumaraguruparan, Kailash Chandra, Prashant Vardhney, Narayan Sharma, Vinod Kumar Balakrishnan, Sadhanandham Shanmugasundaram, Sankaran Ramesh, Jayanty Satyanarayana Murthy, Sadagopan Thanikachalam, Nagendra Boopathy Senguttuvan
In this small, retrospective, two-center cohort, concomitant PCI at the time of TAVR was not associated with an observed excess of bleeding or vascular complications compared with TAVR alone. These findings are hypothesis-generating and support the feasibility of a concomitant strategy in carefully selected patients at experienced, high-volume centers; they do not establish safety equivalence.
BACKGROUND: Severe aortic stenosis (AS) and coronary artery disease frequently coexist, yet the optimal management strategy for patients undergoing TAVR with concomitant CAD remains debated. Our study compared safety outcomes and procedural characteristics of concomitant TAVR and PCI versus TAVR alone in a two-center Indian population with severe AS.
METHODS: This retrospective, multi-center, case-control study included 30 consecutive patients undergoing planned concomitant TAVR and PCI and 30 age-, sex-, and valve-type-matched TAVR-alone controls identified from the same study period. PCI was performed for angiographically confirmed proximal coronary stenosis ≥70% or as deemed appropriate according to the study protocol. The primary outcome was VARC-3 defined any bleeding or vascular complication through hospital dischargeSecondary outcomes included in-hospital and 30-day mortality, myocardial infarction, stroke, acute kidney injury, pacemaker implantation, fluoroscopy time, and contrast volume.
RESULTS: Thirty concomitant TAVR-PCI patients and 30 matched TAVR-alone controls were included. The primary outcome occurred in 3 patients (10.0%) versus 2 patients (6.7%; p>0.99), with a risk difference of 3.3 percentage points (95% CI, -12.7 to 19.7). No major or life-threatening bleeding events occurred. Fluoroscopy time (38.6±23.2 vs. 26.8±10.0 min; p<0.01) and contrast volume (166.7±65.5 vs. 99.6±37.7 mL; p<0.001) were higher with concomitant PCI. No in-hospital or 30-day deaths or myocardial infarctions occurred in either group.
CONCLUSION: In this small, retrospective, two-center cohort, concomitant PCI at the time of TAVR was not associated with an observed excess of bleeding or vascular complications compared with TAVR alone. These findings are hypothesis-generating and support the feasibility of a concomitant strategy in carefully selected patients at experienced, high-volume centers; they do not establish safety equivalence.