{'fraction_non_alphanumeric': 0.04491823638998137, 'fraction_numerical': 0.032084454564272405, 'mean_word_length': 5.017434620174346, 'pattern_counts': {'":': 0, '<': 4, '<?xml version=': 0, '>': 1, 'https://': 0, 'lorem ipsum': 0, 'www.': 0, 'xml': 0}, 'pii_count': 0, 'substrings_counts': 0, 'word_list_counts': {'cursed_substrings.json': 0, 'profanity_word_list.json': 0, 'sexual_word_list.json': 0, 'zh_pornsignals.json': 0}}
In severe aortic stenosis, TAVR was noninferior to conventional surgery for death or disabling stroke at 2 years

Question In patients with severe aortic stenosis and at intermediate surgical risk, is transcatheter aortic valve replacement (TAVR) noninferior to surgical aortic valve replacement (SAVR) for death or disabling stroke at 2 years? Methods Design Randomized controlled trial (Placement of Aortic Transcatheter Valves [PARTNER 2] trial). ClinicalTrials.gov NCT01314313. Allocation Unclear allocation concealment.* Blinding Blinded* (stroke assessment). Follow-up period 2 years. Setting 57 centers in Canada and the USA. Patients 2032 patients (mean age 82 y, 55% men) who had severe aortic stenosis, cardiac symptoms, and intermediate surgical risk (Society of Thoracic Surgeons [STS] score 4%, or <4% in patients with relevant coexisting conditions not included in the STS model). Intervention TAVR using the balloon-expandable SAPIEN XT heart-valve system (n =1011) or SAVR (n =1021). Outcomes Primary outcome was a composite of death or disabling stroke (modified Rankin Scale score 2 out of 6 at 90 d after stroke). Other clinical outcomes included any stroke, any neurologic event, rehospitalization, myocardial infarction, major vascular complication, life-threatening or disabling bleeding, acute kidney injury, new atrial fibrillation, new permanent pacemaker implantation, endocarditis, aortic valve reintervention, or coronary obstruction. 2000 patients were needed to determine noninferiority of TAVR vs SAVR for the primary outcome at 2 years (risk ratio upper 95% CI <1.20, primary outcome rate 30% per group, 80% power). Patient follow-up 90% for vital status (intention-to-treat analysis). Main results 96% of patients in the TAVR group and 92% in the SAVR group had a valve implanted. TAVR was noninferior to SAVR for the composite primary outcome at 2 years; groups did not differ for components of the composite outcome (Table). TAVR decreased life-threatening or disabling bleeding (17% vs 47%, P <0.001), acute kidney injury (3.8% vs 6.2%, P =0.02), and new atrial fibrillation (11% vs 27%, P <0.001), and increased major vascular complications (8.6% vs 5.5%, P =0.006), compared with SAVR at 2 years; groups did not differ for other clinical outcomes. Conclusion In patients with severe aortic stenosis and at intermediate surgical risk, transcatheter aortic valve replacement was noninferior to surgical aortic valve replacement for death or disabling stroke at 2 years. TAVR vs SAVR in patients with severe aortic stenosis and at intermediate surgical risk Outcomes Event rates At 2 y TAVR SAVR RRR (95% CI) Death or disabling stroke 19% 21% 9.9% (8 to 25) All-cause death 17% 18% 7.3% (12 to 24) Disabling stroke 6.2% 6.4% 6.8% (32 to 34) SAVR = surgical aortic valve replacement; TAVR = transcatheter aortic valve replacement; other abbreviations defined in Glossary. RRR and CI calculated from hazard ratios and SAVR Kaplan-Meier rate estimates in article. Based on Kaplan-Meier estimates. Disabling stroke = modified Rankin Scale score 2 out of 6 at 90 d after stroke. P =0.001 for noninferiority. Commentary PARTNER 1 and other trials (1-3) showed that TAVR was noninferior to surgery at 1 to 5 years in high-risk surgical patients. TAVR was also noninferior to surgery in PARTNER 2 in patients defined as being at intermediate surgical risk; however, this cohort remains among the highest-risk patients with aortic stenosis who are candidates for surgery. PARTNER 2 did not comprise the middle ground between low- and high-risk patients but rather a subset of higher-risk patients. TAVR is an excellent treatment for high-risk surgical patients with severe aortic stenosis. In the subgroup of patients in PARTNER 2 who had TAVR using a transfemoral approach, TAVR reduced death or disabling stroke compared with SAVR (hazard ratio 0.79, 95% CI 0.62 to 1.00). This possible superiority needs to be substantiated in an appropriately powered study. The midterm (5-y) clinical outcomes and durability of TAVR, based on mortality and echocardiographic evaluation of the SAPIEN transcatheter valve placed in PARTNER 1, did not differ from SAVR (3). That said, long-term assessment (>10-y follow-up) of clinical outcomes and structural integrity of TAVR, including data on newer-generation valves, is needed before concluding that this procedure is equivalent to surgically placed tissue valves. As we await results from ongoing clinical trials, data from PARTNER 2, which used a balloon-expandable transcatheter valve, should not be extrapolated to other transcatheter valves. Evaluation of patients for TAVR and performance of TAVR are best accomplished by a multidisciplinary heart team, allowing for appropriately selected patients to derive maximum benefit from this powerful new technology.