Incidence and Prognostic Implications of Thrombocytopenia in Patients Undergoing Transcatheter versus Surgical Aortic Valve Replacement - A Sub-Analysis from the PARTNER IIA Randomized Trial
Pablo Coder1, Matthew T. Finn1, Aakriti Gupta1, Aaron Crowley2, Jacob Cleman1, Susheel Kodali1, Hasan Jilaihawi3, Raj Makkar4, Danny Dvir5, Philippe Genereux2, Augusto Pichard6, James McCAbe5, Howard Herrman7, Zachary Gertz8, Brian Lindman9, Brian O"Neiil10, Vinod Thourani6, Michael Mack11, Craig R. Smith1, Martin B. Leon1, Ajay J. Kirtane1.
1Columbia Univeristy Medical Center, New York, NY, USA, 2Cardiovascular Research Foundation, New York, NY, USA, 3New York University, New York, NY, USA, 4Ceders Sinai, Los Angeles, CA, USA, 5University of Washington, Seattle, WA, USA, 6Medstar Washington Hospital Center, Washington, DC, USA, 7Univesity of Pennsylvania, Philadelphia, PA, USA, 8Virginia Commonwealth, Richmond, VA, USA, 9Vanderbilt, Nashville, TN, USA, 10Temple University, Philadelphia, PA, USA, 11Baylor Scott and White, Plano, TX, USA.
Although thrombocytopenia after transcatheter aortic valve replacement (TAVR) or surgical aortic valve replacement (SAVR) has been observed in practice, data assessing its frequency and prognostic implications are limited. We sought to evaluate outcomes of TAVR and SAVR patients with new-onset thrombocytopenia in a large randomized trial.
Platelet levels were systematically collected from patients in the PARTNER IIA trial (TAVR vs. SAVR in intermediate risk patients with severe aortic stenosis) at baseline, <48 hours post-procedure, discharge and 30-days. Thrombocytopenia was categorized as none/mild: ≥100x109/L or moderate/severe <100 x109/L based on labs within 48 hours post-procedure. Patients with moderate/severe thrombocytopenia at baseline were excluded. The primary outcome was all-cause mortality at 30-days. Secondary outcomes included cardiovascular death, life-threatening bleeding, and stroke at 30-days and 1-year.
A total of 1,841 patients undergoing TAVR or SAVR were analyzed. New-onset moderate/severe thrombocytopenia was lower after TAVR compared to SAVR (21.8% vs. 44.9%, P<0.001). Patients treated with TAVR or SAVR having post-procedural thrombocytopenia demonstrated nearly complete recovery of platelet levels by 30-days, with platelet levels below 100x109/L at both time points occurring in only 1.7% of TAVR and 0.7% of SAVR patients. There was no significant difference in all-cause mortality at 30-days and 1-year post-procedure between patients with moderate/severe thrombocytopenia after TAVR vs. SAVR (30-days HR 1.56, 95% CI 0.7-3.3, P=0.3 and 1-year HR 1.34, 95% CI 0.9-2.1 P =0.2, table 1). However, life-threatening bleeding was lower at 30-days in TAVR compared to SAVR in patients with moderate/severe thrombocytopenia (RR 0.29 95% CI 0.2 - 0.4 P <0.001).
CONCLUSIONS: Post-TAVR and SAVR thrombocytopenia rates are high and are associated with increased life-threatening bleeding in SAVR compared with TAVR patients, but without differences in all-cause mortality between the groups. Following both TAVR and SAVR, platelet counts recovered in nearly all patients by 30-days.
|TAVR Mod-Sev ThrombocytopeniaN= 207||TAVR None-Mild Thrombocytopenia N= 741||TAVR P Value||SAVR Mod-Sev Thrombocytopenia N = 401||SAVR None-Mild Thrombocytopenia N= 492||SAVR P Value||Mod-Sev TAVR vs. Mod-Sev SAVR P value||Relative Risk (95% CI)|
|All Cause Death||5.8%||2.3%||0.009||3.8%||3.5%||0.82||0.3||1.56 (0.7 - 3.3)|
|Cardiovascular Death||5.3%||1.8%||0.004||3.0%||2.2%||0.48||0.1||1.79 (0.8 - 4.1)|
|All Stroke||7.3%||5.3%||0.27||7.8%||4.7%||0.06||0.8||0.94 (0.5 - 1.8)|
|Life Threatening Bleeding||18.4%||8.1%||<0.001||50.2%||43.9%||0.07||<0.001||0.29 (0.2 - 0.4)|
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