Evidence map›Paper›PMID 31215985›Full record

Trial reportJAMA cardiology2019

Comparison of Outcomes After Transcatheter vs Surgical Aortic Valve Replacement Among Patients at Intermediate Operative Risk With a History of Coronary Artery Bypass Graft Surgery: A Post Hoc Analysis of the SURTAVI Randomized Clinical Trial.

Michael J Reardon, Robin H Heijmen, Nicolas M Van Mieghem, Mathew R Williams, Steven J Yakubov, Daniel Watson, Neal S Kleiman, John Conte, Atul Chawla, David Hockmuth and 5 more

Registry-linked trialAbstract readComparative StudyEquivalence TrialMulticenter Study
In one paragraph

Trial report in JAMA cardiology, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01586910 (Surgical Replacement and Transcatheter Aortic Valve Implantation), which is not on this map. Cited by 7 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed, 1 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT01586910 naactive not recruitingnot on this map

Surgical Replacement and Transcatheter Aortic Valve Implantation (SURTAVI)

TypeinterventionalSponsorMedtronic CardiovascularRan2012 to 2026Enrolled1,746ConditionsSevere Aortic StenosisArmsMedtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI), Surgical Aortic Valve Replacement (SAVR), Medtronic CoreValve® Evolut R System Transcatheter Aortic Valve Implantation (TAVI)
3 · Its place in the literature

Who cites it

7 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Article
  3. Review
  4. Review
  5. Review
  6. Article
  7. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

15 authors.

Michael J ReardonHouston Methodist DeBakey Heart and Vascular Center, Houston, Texas.
Robin H HeijmenSt Antonius Hospital, Nieuwegein, the Netherlands.
Nicolas M Van MieghemErasmus University Medical Center, Rotterdam, the Netherlands.
Mathew R WilliamsNYU Langone Medical Center, New York, New York.
Steven J YakubovOhioHeath Riverside Methodist Hospital, Columbus, Ohio.
Daniel WatsonOhioHeath Riverside Methodist Hospital, Columbus, Ohio.
Neal S KleimanHouston Methodist DeBakey Heart and Vascular Center, Houston, Texas.
John ConteThe Johns Hopkins University, Baltimore, Maryland.
Atul ChawlaIowa Heart Center, Des Moines.
David HockmuthIowa Heart Center, Des Moines.
George PetrossianSt Francis Hospital, Roslyn, New York.
Newell RobinsonSt Francis Hospital, Roslyn, New York.
A Pieter KappeteinMedtronic, Minneapolis, Minnesota.
Shuzhen LiMedtronic, Minneapolis, Minnesota.
Jeffrey J PopmaBeth Israel Deaconess Medical Center, Boston, Massachusetts.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Importance: Surgical aortic valve replacement (SAVR) has increased risk for patients with aortic stenosis (AS) and a history of coronary artery bypass graft (CABG) surgery. Transcatheter aortic valve replacement (TAVR) may be an alternative. Objective: To compare TAVR with SAVR outcomes in patients at intermediate operative risk with prior CABG surgery. Design, Setting, and Participants: In this post hoc analysis of the Surgical Replacement and Transcatheter Aortic Valve Implantation (SURTAVI) noninferiority randomized clinical trial, patients with severe, symptomatic AS at intermediate operative risk were enrolled from 87 centers across the United States, Europe, and Canada from June 2012 to June 2016 and followed-up with up to July 2017. Those with a history of CABG surgery were considered for analysis. Data were analyzed from September to December 2017. Interventions: A total of 1746 patients were enrolled and randomized 1:1 to self-expanding TAVR or SAVR. An implant was attempted in 1660 patients, of whom 273 had prior CABG surgery, including 136 who underwent attempted TAVR and 137 who underwent attempted SAVR. Main Outcomes and Measures: The primary outcome was all-cause mortality or disabling stroke at 1-year follow-up. Efficacy outcomes included quality of life, measured using the Kansas City Cardiomyopathy Questionnaire at 30 days, 6 months, and 1 year, and distance walked in 6 minutes, measured using the 6-minute walk test at 30 days and 1 year. Results: Of the 136 patients in the TAVR cohort, 111 (81.6%) were male, and the mean (SD) age was 76.9 (6.5) years; of the 137 in the SAVR cohort, 117 (85.4%) were male, and the mean (SD) age was 76.6 (6.5) years. The mean (SD) Society of Thoracic Surgeons Predicted Risk of Mortality score was 5.0% (1.6%) in the TAVR cohort and 5.2% (1.7%) in the SAVR cohort. All-cause mortality or disabling stroke at 1-year follow-up was 8.9% (95% CI, 5.2-15.2) in the TAVR cohort and 6.7% (95% CI, 3.5-12.8) in the SAVR cohort (log-rank P = .53). Compared with patients receiving SAVR, the mean (SD) Kansas City Cardiomyopathy Questionnaire summary score was significantly better among patients receiving TAVR at 30 days (81.4 [19.2] vs 69.7 [22.6]; P < .001); treatments were similar at 1 year (85.7 [14.6] vs 82.8 [18.4]; P = .19). Compared with patients in the SAVR cohort, those in the TAVR cohort showed greater mean (SD) improvement in distance walked at 1 year (48.3 [120.6] m vs 16.8 [88.7] m; P = .04). Conclusions and Relevance: Both TAVR and SAVR were safe for intermediate-risk patients with AS and prior CABG surgery. The transcatheter approach facilitated faster improvement in quality of life and better exercise capacity at 1-year follow-up. Trial Registration: ClinicalTrials.gov identifier: NCT01586910.

Indexed as

Coronary Artery BypassAgedAged, 80 and overAortic ValveAortic Valve StenosisCohort StudiesFemaleHeart Valve Prosthesis ImplantationHumansMaleRisk AssessmentTranscatheter Aortic Valve ReplacementTreatment Outcome

Identifiers

PMID31215985
PMCPMC6584891

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.