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Mauri et al. Mini-invasive Surg 2022;6:49 https://dx.doi.org/10.20517/2574-1225.2022.34 Page 5 of 13

Table 2. Rates of death from any cause, death from cardiovascular causes, myocardial infarction, major stroke, and major bleeding
events divided by surgical risk and type of prosthetic valve
Incidence (%)
High-risk patients PARTNER trial CoreValve US pivotal trial
Death from any cause at 30 days 5% 3.3%
Death from any cause at 1 year 30.7% 14.2%
Death from cardiovascular causes at 30 days 4.5% 3.1%
Death from cardiovascular causes at 1 year 20.5% 10.4%
Myocardial infarction at 30 days 0% 0.8%
Myocardial infarction at 1 year 0.6% 1.9%
Major stroke at 30 days 5% 3.9%
Major stroke at 1 year 7.8% 5.8%
Major bleeding events at 30 days 16.8% 28.1%
Major bleeding events at 1 year 22.3% 29.5%
Intermediate-risk patients PARTNER 2 trial SURTAVI trial
Death from any cause at 30 days 3.9% 2.2%
Death from any cause at 2 years 16.7% 11.4%
Death from cardiovascular causes at 30 days 3.3% 2%
Death from cardiovascular causes at 2 years 10.1% 7.7%
Myocardial infarction at 30 days 1.2% 0.9%
Myocardial infarction at 2 years 3.6% 2.8%
Major stroke at 30 days 5.5% 3.4%
Major stroke at 2 years 9.5% 6.2%
Major bleeding events at 30 days 10.4% 12.1%
Major bleeding events at 2 years 17.3% -
Low-risk patients PARTNER 3 trial Evolut low risk trial
Death from any cause at 30 days 0.4% 0.5%
Death from any cause at 1 year 1% 2.4%
Death from cardiovascular causes at 30 days 0.4% 0.5%
Death from cardiovascular causes at 1 year 0.8% 1.7%
Myocardial infarction at 30 days 1% 0.9%
Myocardial infarction at 1 year 1.2% 1.7%
Major stroke at 30 days 0.6% 3.4%
Major stroke at 1 year 1.2% 4.1%
Major bleeding events at 30 days 3.6% 2.4%
Major bleeding events at 1 year 7.7% 3.2%

Column 1: Balloon-expandable valves; Column 2: self-expandable valves.

Moreover, the BRAVO-3 trial (bivalirudin versus heparin anticoagulation in transcatheter aortic valve
replacement) showed no benefit on thromboembolic events in patients undergoing TAVR with the
administration of clopidogrel before or after the procedure; furthermore, pretreatment was associated with
[23]
more vascular complications .

Recently, the randomized clinical trial POPular-TAVI (aspirin with or without clopidogrel after
transcatheter aortic valve implantation - Cohort A) confirmed that aspirin alone reduced bleeding
compared with aspirin plus clopidogrel in 665 patients not requiring OAC (RR: 0.57; 95%CI: 0.42-0.77; P =
0.001) . In addition, SAPT was non-inferior to DAPT with respect to the composite of cardiovascular
[24]
death, ischemic stroke or MI (RR: 0.98; 95%CI for noninferiority, -4.7 to 4.3; P = 0.004). These data support