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"Cohen, David J"
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Transcatheter Aortic-Valve Replacement for Asymptomatic Severe Aortic Stenosis
Among patients with asymptomatic severe aortic stenosis, early TAVR was superior to clinical surveillance in reducing the incidence of death, stroke, or unplanned hospitalization for cardiovascular causes.
Journal Article
Transcatheter Aortic-Valve Replacement in Low-Risk Patients at Five Years
A previous analysis in this trial showed that among patients with severe, symptomatic aortic stenosis who were at low surgical risk, the rate of the composite end point of death, stroke, or rehospitalization at 1 year was significantly lower with transcatheter aortic-valve replacement (TAVR) than with surgical aortic-valve replacement. Longer-term outcomes are unknown.
We randomly assigned patients with severe, symptomatic aortic stenosis and low surgical risk to undergo either TAVR or surgery. The first primary end point was a composite of death, stroke, or rehospitalization related to the valve, the procedure, or heart failure. The second primary end point was a hierarchical composite that included death, disabling stroke, nondisabling stroke, and the number of rehospitalization days, analyzed with the use of a win ratio analysis. Clinical, echocardiographic, and health-status outcomes were assessed through 5 years.
A total of 1000 patients underwent randomization: 503 patients were assigned to undergo TAVR, and 497 to undergo surgery. A component of the first primary end point occurred in 111 of 496 patients in the TAVR group and in 117 of 454 patients in the surgery group (Kaplan-Meier estimates, 22.8% in the TAVR group and 27.2% in the surgery group; difference, -4.3 percentage points; 95% confidence interval [CI], -9.9 to 1.3; P = 0.07). The win ratio for the second primary end point was 1.17 (95% CI, 0.90 to 1.51; P = 0.25). The Kaplan-Meier estimates for the components of the first primary end point were as follows: death, 10.0% in the TAVR group and 8.2% in the surgery group; stroke, 5.8% and 6.4%, respectively; and rehospitalization, 13.7% and 17.4%. The hemodynamic performance of the valve, assessed according to the mean (±SD) valve gradient, was 12.8±6.5 mm Hg in the TAVR group and 11.7±5.6 mm Hg in the surgery group. Bioprosthetic-valve failure occurred in 3.3% of the patients in the TAVR group and in 3.8% of those in the surgery group.
Among low-risk patients with severe, symptomatic aortic stenosis who underwent TAVR or surgery, there was no significant between-group difference in the two primary composite outcomes. (Funded by Edwards Lifesciences; PARTNER 3 ClinicalTrials.gov number, NCT02675114.).
Journal Article
Five-Year Outcomes of Transcatheter or Surgical Aortic-Valve Replacement
Intermediate-risk patients with aortic stenosis were randomly assigned to undergo either transcatheter or surgical aortic-valve replacement. At 5 years, there was no significant difference between the two groups in the incidence of death or disabling stroke. The incidence of aortic regurgitation was higher with transcatheter AVR.
Journal Article
Five-Year Follow-up after Transcatheter Repair of Secondary Mitral Regurgitation
Transcatheter repair of secondary mitral regurgitation was associated with a lower rate of hospitalization for heart failure and lower all-cause mortality than medical therapy at 5 years of follow-up.
Journal Article
Pharmacomechanical Catheter-Directed Thrombolysis for Deep-Vein Thrombosis
Patients with proximal deep-vein thrombosis were assigned to undergo anticoagulation either alone or combined with pharmacomechanical thrombolysis. After 6 to 24 months, there was no significant between-group difference in the incidence of the post-thrombotic syndrome.
Journal Article
Relation of Frailty to Outcomes After Transcatheter Aortic Valve Replacement (from the PARTNER Trial)
Transcatheter aortic valve replacement (TAVR) is an effective treatment for severe symptomatic aortic stenosis (AS) in patients who are inoperable or at high risk for surgery. However, the intermediate- to long-term mortality is high, emphasizing the importance of patient selection. We, therefore, sought to evaluate the prognostic value of frailty in older recipients of TAVR, hypothesizing that frail patients would experience a higher mortality rate and a higher likelihood of poor outcome 1 year after TAVR. This substudy of the Placement of Aortic Transcatheter Valves trial was conducted at 3 high-enrolling sites where frailty was assessed systematically before TAVR. In total, 244 patients received TAVR at the participating sites. Frailty was assessed using a composite of 4 markers (serum albumin, dominant handgrip strength, gait speed, and Katz activity of daily living survey), which were combined into a frailty score. The cohort was dichotomized at median frailty score. Outcomes measures were the time to death from any cause for >1 year of follow-up and poor outcome at 1 year. Poor outcome was defined as (1) death, (2) Kansas City Cardiomyopathy Questionnaire overall summary (KCCQ-OS) score <60, or (3) decrease of ≥10 points in the KCCQ-OS score from baseline to 1 year. At 1 year, the Kaplan-Meier–estimated all-cause mortality rate was 32.7% in the frail group and 15.9% in the nonfrail group (log-rank p = 0.004). At 1 year, poor outcome occurred in 50.0% of the frail group and 31.5% of the nonfrail group (p = 0.02). In conclusion, frailty was associated with increased mortality and a higher rate of poor outcome 1 year after TAVR.
Journal Article
Transcatheter or Surgical Aortic-Valve Replacement in Intermediate-Risk Patients
In a randomized trial involving more than 2000 patients, transcatheter aortic-valve replacement was noninferior to surgical replacement in the primary end point of death from any cause or disabling stroke at 2 years.
Transcatheter aortic-valve replacement (TAVR) is a new therapy for patients with severe aortic stenosis who are not candidates for surgery
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or who are at high risk for complications due to surgery.
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The acceptance of the use of TAVR in high-risk patients was based on evidence from clinical trials
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that used early-generation TAVR devices; these procedures were associated with considerable procedure-related complications.
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Recently, increased operator experience and enhanced transcatheter valve systems have led to a worldwide trend to use TAVR in patients who are at low or intermediate risk.
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This trend has been evaluated in small . . .
Journal Article
Twelve or 30 Months of Dual Antiplatelet Therapy after Drug-Eluting Stents
Patients who had received a drug-eluting stent and then dual antiplatelet therapy for 12 months were randomly assigned to 18 more months of therapy or aspirin alone. Continued therapy resulted in lower rates of stent thrombosis and major adverse cardiovascular events but more bleeding.
Millions of patients worldwide undergo coronary stenting each year for the treatment of ischemic heart disease.
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Although drug-eluting stents reduce the rate of restenosis as compared with bare-metal stents, there is concern that drug-eluting stents may be associated with a risk of stent thrombosis beyond 1 year after treatment.
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Stent thrombosis is rare, yet it is frequently associated with myocardial infarction and may be fatal.
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Furthermore, ischemic events, such as myocardial infarction, stroke, or death from cardiovascular causes, that are unrelated to the treated coronary lesion may also occur beyond 1 year.
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The use of dual antiplatelet therapy . . .
Journal Article