Thread by @lamelaspablo

#WeeklyCardioReview PARTNER 3 and Evolut Low Risk TAVR #NeverTooLate. Includes a home-made meta-analysis at the end. Time to re-think the standard for treating AS?

PARTER 3: 1000 pts, mean STS 1.9%, death/stroke/rehosp 1 year lower in TAVR HR 0.54; 95% CI, 0.37 to 0.79; P=0.001. At 30 days lower rate of stroke P=0.02 and death or stroke P=0.01 and new AF P<0.001.
@NEJM nejm.org/doi/10.1056/NE… @tavrkapadia @djc795 @J_M_McCabe @EdwardsLifesci

shorter index hospitalization and lower risk of a poor treatment outcome (death or a low KCCQ score at 30 days (P<0.001). No significant between-group differences in major vascular complications, new permanent pacemaker insertions, or moderate/severe paravalvular regurgitation.

Population: STS<4 (85% STS 1 to 3), Transfemoral feasible with S3. Frail, biscuspids and other anatomical excluded. Severe LV function also excluded despite of STS (further benefit from TAVR?), Most common reason for exclusion was severe LVOT calcium in 38%, poor TF access 7%

Procedural: 1 (0.2%) conversion to SAVR (coronary compromise), S3 26 in 45%, cutdown in 1%, 33% with general anesthesia (too much?), conversion to GA 1%, Predilatation 57%, 90% postdilatations, 7% PCI. SAVR: mini sternotomy 24%, 80% had a #23 or larger, 12% CABG

Small (2 mmHg mean gradients) but statistically significant superiority of gradients with SAVR. This is not aligned with prior literature, likely explained by larger SAVR prosthesis implanted (80% #23 or more).

Methodological point: this is not an issue of this trial, is a global issue of nosology/cause of death. In SAVR someone died from respiratory failure day 14 and counted as non-CV death (no more details). Think patient would have died anyway without SAVR? (real non-CV death?)

Evolut Low-Risk trial: 1,403 with Corevalve-Evolut R-Evolut Pro (1/3 each approx), STS<3. 24mo death/disabling stroke 5.3% TAVR and 6.7% SAVR, noninferiority p >0.999). 30d lower disabling stroke, bleeding complications, acute kidney injury, and AF.

30-day TAVR with higher moderate or severe aortic regurgitation (3.5% vs 0.5%) and pacemaker implantation (19% vs 6.7%, 12 mo). 12mo TAVR lower aortic-valve gradients and lower patient-prosthesis mismatch 1.8% vs 8.2%.

Meta-analysis of PARTER 3 (ITT) + Evolut Low risk (as-treated) (with some rounding, Evolut didnt report absolute events):
1-Year mortality: OR 0.65 (0.37-1.13, p=0.12)
1-Year CV Mortality: OR 0.55 (0.30-1.02, p=0.06)
1-Year Disabling Stroke: OR 0.33 (0.15-0.86, p=0.02)

Research in context: These results are aligned with the intermediate-risk RCTs showing lower CV-death and stroke in the transfemoral subgroup meta-analyses (the two most patient-important outcomes) quality of life, bleeding, AF. S3 lower PPM and PVL, but similar gradients to SAVR

SAVR likely remain the standard for low-risk (STS) and higher anatomical risk (Bicuspids, high-risk of coronary obstruction, non-transfemoral, etc). We have excellent 5+ years durability data, do we need to wait 10/15+ years? maybe not IMHO ncbi.nlm.nih.gov/pubmed/30859731

@J_M_McCabe @PPibarot @philgenereux @gabrielsteg @willsuh76 @Almanfi_Cardio @CardiacConsult @mirvatalasnag @MustafaAhmedMD @MarcVorpahl @ekgpdx @lblitzmd @JLVelianou @cardiacpolymath @mmamas1973 @rahatheart1 @SVRaoMD @DocSavageTJU @fischman_david @GreggWStone @djc795