Grundmann D, Rudolph T, Adam M
… +30 more, Kellner C, Bleiziffer S, Braun D, Tamm AR, Meertens M, Renker M, Gmeiner J, Sedaghat A, Leistner D, Hamm CW, Wienemann H, Zapustas N, Juri B, Salem M, Benetti-Lehmann R, Dreger H, Gossling A, Nahif A, Blankenberg S, Reichenspurner H, Schofer N, Schaefer A, Popara J, Sudo M, Geyer M, Vorpahl M, Frank D, Potratz M, Kim W, Seiffert M
BACKGROUND: Access-related vascular and bleeding complications during transcatheter aortic valve implantation (TAVI) are associated with significant morbidity and mortality. Ultrasound-guided (USG) puncture may reduce th...BACKGROUND: Access-related vascular and bleeding complications during transcatheter aortic valve implantation (TAVI) are associated with significant morbidity and mortality. Ultrasound-guided (USG) puncture may reduce the incidence of these adverse events, particularly in large-bore arterial access. However, large-scale data on this approach are limited, and it has not yet been fully implemented into standard clinical practice. We compared access-related vascular and bleeding complications in USG versus fluoroscopy-guided access from a large multicenter TAVI registry. METHODS: The PULSE registry (Plug- or Suture-Based Vascular Closure After TAVI) retrospectively evaluated data of 9295 patients who underwent transfemoral TAVI at 10 high-volume German heart centers (2016-2021). USG and fluoroscopy-guided access were performed in 1992 (21.4%) and 7303 (78.6%) patients, respectively. Propensity score matching (1:1) yielded 895 matched pairs. The primary end point, a composite of minor and major vascular complications or bleeding type II-IV, was assessed according to Valve Academic Research Consortium definitions. RESULTS: Patients in the USG and fluoroscopy-guided groups (median age, 81.9 [78.3-85.0] years; 47.8% female patients) showed well-balanced baseline characteristics. The overall risk profile was comparable (median EuroSCORE II: 3.2 versus 3.5; SD, 0.007 [-0.086 to 0.099]). The composite primary end point occurred less frequently in the USG group (11.7% versus 16.0%; odds ratio, 0.7; =0.01), driven by lower rates of procedural bleeding (5.4% versus 9.2%; odds ratio, 0.56; =0.002) and with lower rates of endovascular treatment (0.7% versus 2.5%; =0.005). CONCLUSIONS: In patients with transfemoral TAVI, USG access demonstrated lower rates of access-related vascular complications and type II-IV bleeding compared with fluoroscopy-guided access. Implementing USG puncture as the standard of care may improve access-related outcomes after TAVI.
Obtaining informed consent for clinical trial participation in acute myocardial infarction presents unique ethical and logistical challenges because of the patient distress, sedation, and the urgency of treatment. Tradit...Obtaining informed consent for clinical trial participation in acute myocardial infarction presents unique ethical and logistical challenges because of the patient distress, sedation, and the urgency of treatment. Traditional consent procedures often conflict with the narrow enrollment windows, prompting the use of legally authorized representatives and short- and long-form consent models. Although these approaches enable faster trial enrollment, they may compromise patient autonomy, introduce selection bias, or create postenrollment ethical dilemmas. This review explores the complexities of informed consent in acute myocardial infarction research, evaluating the advantages and limitations of existing strategies, including legally authorized representative consent, 2-step consent processes, and alternatives such as deferred and verbal consent. It also examines international variations in regulatory oversight and presents emerging solutions, such as preemptive consent, opt-out models, electronic platforms, and registry-based trials, to streamline the enrollment without delaying care. Ultimately, consent regulations should be re-evaluated and potentially relaxed to better support timely research. A thoughtful reassessment of consent frameworks is essential to ethically and effectively advance acute myocardial infarction research in time-sensitive settings.
BACKGROUND: There is heterogeneity in coronary artery disease (CAD) severity among individuals with severe aortic stenosis (AS), but whether this differentially influences prognosis is unknown. METHODS: Patients with sev...BACKGROUND: There is heterogeneity in coronary artery disease (CAD) severity among individuals with severe aortic stenosis (AS), but whether this differentially influences prognosis is unknown. METHODS: Patients with severe AS in the PARTNER 1, 2, and 3 trials and registries (Placement of Aortic Transcatheter Valves) were stratified by obstructive CAD (coronary stenosis ≥50%, prior myocardial infarction, or revascularization) or no obstructive CAD (all stenoses <50%). Multivariable Cox proportional-hazards models examined the association between CAD severity groups and clinical outcomes. The primary composite end point was death, heart failure hospitalization, or stroke at 5 years. Interaction between sex and CAD severity was evaluated. RESULTS: Among 7505 patients with severe AS, 2062 (27.5%) had no obstructive CAD and were more likely to be women (60.5%) with fewer CAD risk factors. After multivariable adjustment, the primary end point was significantly lower among patients with no obstructive CAD compared with those with obstructive CAD (adjusted hazard ratio, 0.92 [CI, 0.84-1.00]; =0.04), irrespective of AS treatment. However, there were significant differences by sex (=0.0002). Men with no obstructive CAD had a 16% lower event rate compared with men with obstructive CAD (adjusted hazard ratio, 0.84 [CI, 0.73-0.96]; =0.01). In contrast, women with no obstructive CAD did not have a significantly lower rate of death, stroke, or heart failure hospitalization compared with women with obstructive CAD (adjusted hazard ratio, 0.95 [CI, 0.85-1.07]; =0.41). Women with no obstructive CAD had a more advanced heart failure phenotype and higher event rates compared with men with no obstructive CAD. CONCLUSIONS: Obstructive CAD was associated with a higher risk of long-term adverse events after treatment for severe AS, but there was a significant sex disparity in clinical outcomes among men and women with no obstructive CAD. Further study is needed to optimize the evaluation and management of women with severe AS.
BACKGROUND: Acute decompensated aortic stenosis is an increasingly common condition associated with a high rate of morbidity, mortality, and health care resource utilization. Among patients with acute decompensated aorti...BACKGROUND: Acute decompensated aortic stenosis is an increasingly common condition associated with a high rate of morbidity, mortality, and health care resource utilization. Among patients with acute decompensated aortic stenosis, this study aimed to assess the impact of time to transcatheter aortic valve implantation (TAVI) on outcomes, hypothesizing that longer durations are associated with worse outcomes. METHODS: Using a single-center registry, patients with their first presentation of acute decompensated aortic stenosis who underwent an urgent TAVI during their index admission were included. Time to TAVI was defined as the number of days between hospital admission and TAVI. The primary composite outcome was heart failure hospitalization or all-cause mortality. The secondary composite outcome was heart failure hospitalization or cardiovascular mortality. RESULTS: A total of 276 patients were included in this study: age 84 (79-88) years, male sex 63.7%, patients requiring cardiopulmonary organ support 3.6%, aortic valve area 0.7 (0.5-0.8) cm, and left ventricular ejection fraction 55 (37-57)%. Baseline characteristics were similar between patients stratified according to the median time to TAVI (22 [13-32] days). Over a follow-up of 4.6 (3.6-5.7) years, the primary and secondary outcomes occurred in 58% and 35% of patients, respectively. After adjusting for comorbidities, mean gradient, and cardiopulmonary organ support, time to TAVI was associated with both the primary (hazard ratio for every 5 days, 1.09 [95% CI, 1.04-1.16]; =0.001) and secondary outcomes (hazard ratio for every 5 days, 1.08 [95% CI, 1.01-1.16]; =0.023). CONCLUSIONS: In patients with acute decompensated aortic stenosis, longer time to TAVI was associated with an increased risk of adverse events at mid-term follow-up.
Ulacia Flores P, Cieza T, Ouarrak S
… +11 more, Ruhl A, Mengi S, De Larochellière R, Garcia-Labbé D, Déry JP, Poulin A, Larose É, Noël B, Nguyen CM, Paradis JM, Bertrand OF
BACKGROUND: Physiology assessment of coronary lesion prepercutaneous coronary intervention (PCI) using hyperemic and nonhyperemic pressure ratios is useful to determine if a lesion requires treatment. Whether the physiol...BACKGROUND: Physiology assessment of coronary lesion prepercutaneous coronary intervention (PCI) using hyperemic and nonhyperemic pressure ratios is useful to determine if a lesion requires treatment. Whether the physiology after PCI is superior to angiography guidance only is unknown. The study sought to investigate whether post-PCI physiology improves clinical outcomes compared with standard angiographic guidance. METHODS: All-comers patients referred for diagnostic angiography and possible PCI were recruited in a high-volume tertiary care hospital. After uncomplicated PCI, patients were randomized to angiography guidance or target vessel physiology, including nonhyperemic pressure ratio (resting distal coronary pressure to aortic pressure ratio and diastolic pressure ratio) and fractional flow reserve. The primary outcome was the rate of target vessel failure, including cardiac death, myocardial infarction, and target vessel revascularization at 18 months post-PCI. Angina score, medications, and quality of life were also assessed. RESULTS: Two hundred twenty-one patients were randomized in the angiography group (110 patients, 166 lesions) and the physiology group (111 patients, 159 lesions). Immediate post-PCI physiology results were deemed suboptimal in 22 (17%) cases, and operators performed further optimization steps. Final post-PCI results were resting distal coronary pressure to aortic pressure ratio of 0.95±0.04, the diastolic pressure ratio of 0.94±0.06, and the fractional flow reserve of 0.90±0.07. Ultimately, 9 lesions (7%) remained with fractional flow reserve values ≤0.80. At 18-month follow-up, target vessel failure was 17.4% in the angiography group and 18% in the physiology group (=0.88). Rates of cardiac death (1% versus 0%; =0.32), myocardial infarction (13% versus 11%; =0.66), and target vessel revascularization (4% versus 7%; =0.24) remained similar in both groups. No difference in angina score, medication, or quality of life was found. CONCLUSIONS: In all-comers patients undergoing uncomplicated PCI, routine post-PCI physiology assessment was not associated with clinical benefit compared with standard angiographic guidance. Further study is required to determine how post-PCI physiology guidance can be helpful in selected lesions. REGISTRATION:URL: https://clinicaltrials.gov/; Unique identifier: NCT04929496.
Phichaphop A, Sorajja P, Enriquez-Sarano M
… +12 more, Fukui M, Okada A, Margonato D, Abed M, Nishihara T, Koike H, Walser-Kuntz E, Lesser JR, Cheng VY, Bapat VN, Hamid N, Cavalcante JL
BACKGROUND: Although pretranscatheter aortic valve replacement-computed tomography angiography (TAVR-CTA) has shown a good correlation with invasive coronary angiography (ICA) for ruling out obstructive coronary artery d...BACKGROUND: Although pretranscatheter aortic valve replacement-computed tomography angiography (TAVR-CTA) has shown a good correlation with invasive coronary angiography (ICA) for ruling out obstructive coronary artery disease (CAD), its clinical effectiveness and safety as a gatekeeper for ICA pre-transcatheter aortic valve replacement (pre-TAVR) remain unclear. This study aims to determine whether routine TAVR-CTA, without premedication, could safely defer and guide the need for ICA pre-TAVR. METHODS: Patients who underwent TAVR evaluation with either TAVR-CTA or ICA to determine CAD between 2017 and 2022 were included. Patients with prior coronary artery bypass grafts were excluded, and the remaining patients were divided into CAD screening with TAVR-CTA or ICA groups. The primary outcome was symptom-driven revascularization at 1 year post-TAVR. RESULTS: Among 1165 patients (median age, 81 years; 46% women), 464 were in TAVR-CTA group and 701 were in the ICA group. Prevalence of CAD was similar (37% versus 41%; =0.2). A total of 53% of patients were exempted from ICA after TAVR-CTA, given the absence of proximal obstructive CAD, whereas 17% had inconclusive TAVR-CTA interpretation, 15% desired for ICA despite CAD exclusion by TAVR-CTA, and 14% had obstructive CAD requiring further ICA. Elevated coronary artery calcium score and the presence of stents were associated with need for ICA after TAVR-CTA. TAVR-CTA revealed a per-patient sensitivity of 89%, specificity of 75%, positive predictive value of 69%, and negative predictive value of 91% for identifying obstructive CAD. Importantly, symptom-driven revascularization, acute coronary syndrome, and unplanned ICA at 1 year after TAVR were all low and not different between TAVR-CTA versus ICA (0.8% versus 1.8%, =0.158; 1.6% versus 1.7%, =0.846; 2.7% versus 2.8%, =0.767; respectively). CONCLUSIONS: In comparison with routine ICA pre-TAVR, integration of TAVR-CTA in our program resulted in up to 53% of patients exempted from ICA, while maintaining patient safety. This approach could have important clinical implications to improve patient access, experience, value, and throughput.
BACKGROUND: Valve-in-valve transcatheter aortic valve replacement (ViV-TAVR) provides an alternative treatment for high-risk patients with failed surgical bioprosthetic aortic valves. However, limited data exist on ViV-T...BACKGROUND: Valve-in-valve transcatheter aortic valve replacement (ViV-TAVR) provides an alternative treatment for high-risk patients with failed surgical bioprosthetic aortic valves. However, limited data exist on ViV-TAVR outcomes in patients with small aortic annuli, particularly among the relatively small-statured Japanese population. METHODS: We analyzed data from the J-TVT (Japan Transcatheter Valve Therapy) registry, which included all TAVR institutions across Japan, with data collected from July 2018, when ViV-TAVR was approved, through December 2022. A small aortic annulus was defined as an aortic annulus area of ≤314 mm², measured using preoperative computed tomography for ViV-TAVR. Prosthesis-patient mismatch (PPM) was defined as an indexed effective orifice area <0.85 cm²/m², assessed using echocardiography within 30 days after ViV-TAVR. The composite end point was evaluated at 30 days and 1 year. RESULTS: Among 47 800 individuals, 1029 underwent ViV-TAVR, resulting in a final sample of 405 patients. The mean indexed effective orifice area was 0.83 cm²/m² in the small annulus group (n=225) and 0.94 cm²/m² in the nonsmall group (n=180), with PPM rates of 59.2% and 44.4%, respectively. Small annuli were independently associated with PPM (odds ratio, 1.9 [95% CI, 1.26-2.87]; =0.002). No differences in 30-day and 1-year outcomes were observed between groups. Among the 225 patients with small annuli, the mean indexed effective orifice area was 0.76 cm/m in the balloon-expandable valve group (n=61) and 0.86 cm/m in the supraannular self-expanding valve group (n=164), with PPM rates of 67.2% and 56.1%, respectively. No differences in outcomes were noted based on the type of valve implanted. CONCLUSIONS: ViV-TAVR for small aortic annuli in Japanese patients was associated with an increased risk of PPM; however, no differences in clinical outcomes were observed according to aortic annulus size or valve type. Due to the small size of our sample, further research is required to validate these findings.
Scala A, Erriquez A, Cocco M
… +13 more, Verardi FM, Caglioni S, Marchini F, Guiducci V, Casella G, Ruozzi M, Arioti M, Pompei G, Picchi A, Colaiori I, Serenelli M, Campo G, Biscaglia S
Marquard JM, Engstrøm T, Kelbæk H
… +17 more, Beske RP, Islam U, Høfsten DE, Holmvang L, Pedersen F, Terkelsen CJ, Høj Christiansen E, Tilsted HH, Glinge C, Jabbari R, Eftekhari A, Raungaard B, Clemmensen P, Bøtker HE, Jensen LO, Køber L, Lønborg JT
Circ Cardiovasc Interv
· 2025 Jun · PMID 40391569
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BACKGROUND: Primary percutaneous coronary intervention (PCI) with stenting is recommended in ST-segment-elevation myocardial infarction. Immediate stenting may cause distal embolization, microvascular damage, and flow di...BACKGROUND: Primary percutaneous coronary intervention (PCI) with stenting is recommended in ST-segment-elevation myocardial infarction. Immediate stenting may cause distal embolization, microvascular damage, and flow disturbances, leading to adverse outcomes. We report the 10-year clinical outcomes of deferred stenting versus conventional PCI in patients with ST-segment-elevation myocardial infarction. METHODS: We conducted a 10-year follow-up study of the open-label, randomized DANAMI-3-DEFER trial (Third Danish Study of Optimal Acute Treatment of Patients With STEMI - Deferred Stent Implantation Versus Conventional Treatment), conducted in 4 PCI centers in Denmark. Patients with ST-segment-elevation myocardial infarction and acute chest pain <12 hours were randomized to deferred stenting >24 hours after the index procedure or conventional PCI with immediate stenting. In the deferred group, immediate stable Thrombolysis in Myocardial Infarction flow II to III was established, and intravenous administration of either a glycoprotein IIb/IIIa antagonist or bivalirudin for >4 hours after the index procedure was recommended. The primary outcome was a composite of hospitalization for heart failure or all-cause mortality. Key secondary outcomes included individual components of the primary outcome and target vessel revascularization. RESULTS: Of 1215 patients, 603 were randomized to deferred stenting and 612 to conventional PCI. After 10 years, deferred stenting did not significantly reduce the primary composite outcome (hazard ratio, 0.82 [95% CI, 0.67-1.02]; =0.08). In the deferred group, 124 (24%) died versus 150 (25%) in the conventional PCI group (hazard ratio, 0.95 [95% CI, 0.75-1.19]). Hospitalization for heart failure was lower in patients treated with deferred stenting compared with conventional PCI (odds ratio, 0.58 [95% CI, 0.39-0.88]). Target vessel revascularization was similar in both groups (odds ratio, 1.20 [95% CI, 0.81-1.79]). CONCLUSIONS: Deferred stenting did not reduce all-cause mortality or the composite primary outcome after 10 years but reduced hospitalization for heart failure compared with conventional PCI. REGISTRATION:URL: https://www.clinicaltrials.gov; Unique identifier: NCT01435408.
Kandzari DE, Mahfoud F, Townsend RR
… +9 more, Kario K, Weber MA, Schmieder RE, Tsioufis K, Pocock S, Liu M, DeBruin V, Brar S, Böhm M
Circ Cardiovasc Interv
· 2025 Jul · PMID 40391448
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BACKGROUND: Six-month results from the SPYRAL HTN-ON MED trial (SPYRAL HTN-ON MED Study of Renal Denervation With the Symplicity Spyral Multi-Electrode Renal Denervation System) demonstrated that renal denervation (RDN)...BACKGROUND: Six-month results from the SPYRAL HTN-ON MED trial (SPYRAL HTN-ON MED Study of Renal Denervation With the Symplicity Spyral Multi-Electrode Renal Denervation System) demonstrated that renal denervation (RDN) reduced office blood pressure (BP), and not 24-hour ambulatory systolic BP, compared with sham control in hypertensive patients. In this prespecified analysis of the ON MED trial, long-term changes in BP, antihypertensive drug use, and safety outcomes through 24 months are compared between RDN and sham control groups. METHODS: SPYRAL HTN-ON MED is a prospective, randomized, sham-controlled, blinded trial enrolling 337 patients globally from 56 clinical centers. Eligible patients had an office systolic BP of 150 to 180 mm Hg, a diastolic BP ≥90 mm Hg, and a 24-hour ambulatory systolic BP of 140 to 170 mm Hg. Patients were randomized to RDN or a sham control procedure and were prescribed a stable regimen of 1 to 3 antihypertensive medications through 6 months. After 6 months, patients and physicians were unblinded with permitted changes to antihypertensive therapy, and control patients were permitted to cross over. Crossover patients had their last observations carried forward as part of the control group. Statistical analyses were conducted on the population as randomized. RESULTS: At 24 months, the RDN group experienced significantly greater mean reductions in ambulatory systolic BP (-12.1±15.3 mm Hg [n=176] versus -7.0±13.1 mm Hg [n=33]; difference: -5.7 mm Hg; =0.039) and office systolic BP (-17.4±16.1 mm Hg [n=187] versus -9.0±19.4 mm Hg [n=35]; difference: -8.7 mm Hg; =0.0034) compared with sham controls. At 24 months, antihypertensive medications increased significantly more in the sham group (1.7 versus 2.7) compared with the RDN group (1.8 versus 2.4; =0.046). Sensitivity analyses accounting for missing sham patient BP values due to crossover yielded consistent results in favor of RDN for 24-hour ambulatory (=0.023) and office systolic BP (<0.0001). Clinically adverse events were rare, with no instances of renal artery stenosis through 24 months. CONCLUSIONS: RDN produced significantly greater ambulatory and office systolic BP reductions at 24 months compared with sham control, despite higher antihypertensive medication use in the control group. REGISTRATION:URL: https://clinicaltrials.gov; Unique identifier: NCT02439775.
BACKGROUND: A functionally significant myocardial bridge (MB) is an important cause of angina with nonobstructive coronary arteries. However, distinguishing a functionally significant versus incidental MB remains challen...BACKGROUND: A functionally significant myocardial bridge (MB) is an important cause of angina with nonobstructive coronary arteries. However, distinguishing a functionally significant versus incidental MB remains challenging. Resting and hyperemic intracoronary functional indices are available, but no studies have compared their diagnostic performance in MBs. METHODS: We prospectively studied 64 patients with angina and nonobstructive coronary arteries, all of whom had an MB confirmed by intravascular ultrasound. We evaluated the diagnostic performance of instantaneous wave-free ratio (iFR) and resting full-cycle ratio (RFR) under dobutamine stress, with dobutamine diastolic fractional flow reserve (dFFR) as a reference standard. Dobutamine iFR and dobutamine RFR were assessed in the first 18 patients, while only dobutamine RFR was assessed in the remaining 46. dobutamine dFFR ≤0.76 was considered indicative of a functionally significant MB. RESULTS: There was a strong correlation between dobutamine iFR (=0.67, <0.001) and dobutamine RFR (=0.80, <0.001) with dobutamine dFFR. Receiver operating characteristics curve analysis to identify the cutoff for dobutamine dFFR ≤0.76 was 0.81 for dobutamine iFR (area under the curve 0.961) and 0.76 for dobutamine RFR (area under the curve 0.996). The diagnostic accuracy of dobutamine iFR was 94.4%, with a sensitivity of 100% and specificity of 85.7%. For dobutamine RFR, the diagnostic accuracy was 96.9%, with a sensitivity of 95.8% and specificity of 100%. CONCLUSIONS: In patients with angina and nonobstructive coronary arteries and an MB confirmed by intravascular ultrasound, dobutamine iFR and dobutamine RFR may serve as alternatives to dobutamine dFFR in identifying a functionally significant MB, with dobutamine RFR having superior diagnostic accuracy.
BACKGROUND: The effects of the aspirin-free strategy on bleeding and cardiovascular events were unknown in patients with high bleeding risk (HBR), with or without acute coronary syndrome (ACS), undergoing percutaneous co...BACKGROUND: The effects of the aspirin-free strategy on bleeding and cardiovascular events were unknown in patients with high bleeding risk (HBR), with or without acute coronary syndrome (ACS), undergoing percutaneous coronary intervention. METHODS: We conducted a subgroup analysis stratified by ACS among patients with HBR in the STOPDAPT-3 trial (Short and Optimal Duration of Dual Antiplatelet Therapy-3), which randomly compared no-aspirin (prasugrel monotherapy) with dual antiplatelet therapy (DAPT) in patients with ACS and HBR. RESULTS: There were 3258 patients with HBR, including 1803 ACS and 1455 non-ACS patients. The effects of no-aspirin compared with DAPT at 1 month after percutaneous coronary intervention were not significant for major bleeding regardless of ACS or non-ACS (7.3% versus 7.9%; hazard ratio [HR], 0.91 [95% CI, 0.65-1.28], and 3.1% versus 2.9%; HR, 1.06 [95% CI, 0.58-1.93]; interaction=0.66). There was a numerically higher risk in the no-aspirin group relative to the DAPT group for a composite of cardiovascular death, myocardial infarction, definite stent thrombosis, or ischemic stroke in patients with ACS, but not in patients with non-ACS (7.9% versus 5.8%; HR, 1.39 [95% CI, 0.97-1.99], and 2.4% versus 3.0%; HR, 0.78 [95% CI, 0.41-1.47]; interaction=0.12). There was a significant treatment-by-subgroup interaction for myocardial infarction (1.6% versus 0.3%; HR, 4.57 [95% CI, 1.31-15.89], and 1.4% versus 1.8%; HR, 0.78 [95% CI, 0.34-1.77]; interaction=0.02). CONCLUSIONS: The aspirin-free strategy compared with the DAPT strategy failed to reduce major bleeding in patients with HBR irrespective of ACS. There was a signal of the excess risk of the aspirin-free strategy relative to the DAPT strategy for cardiovascular events, myocardial infarction in particular, in patients with ACS, but not in patients with non-ACS. The aspirin-free strategy may be considered as a potential treatment option after percutaneous coronary intervention in patients with non-ACS. REGISTRATION:URL: https://www.clinicaltrials.gov; Unique identifier: NCT04609111.
BACKGROUND: The clinical significance of elevated baseline natriuretic peptide level and prior heart failure hospitalization (HFH) within the prior year in mitral transcatheter edge-to-edge repair outcomes is unclear. Th...BACKGROUND: The clinical significance of elevated baseline natriuretic peptide level and prior heart failure hospitalization (HFH) within the prior year in mitral transcatheter edge-to-edge repair outcomes is unclear. This analysis examined the impact of BNP (B-type natriuretic peptide) or NT-proBNP (N-terminal pro-B-type natriuretic peptide) and prior HFH on outcomes in patients with severe secondary mitral regurgitation. METHODS: The COAPT trial (Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients With Functional Mitral Regurgitation) was a randomized controlled trial of subjects assigned to mitral valve transcatheter edge-to-edge repair with the MitraClip device versus guideline-directed medical therapy alone. COAPT patients were grouped by BNP/NT-proBNP levels and prior HFH within 1 year: (1) Mild heart failure (HF): no prior HFH with BNP/NT-proBNP<median; (2) Moderate HF: prior HFH with BNP/NT-proBNP<median or no prior HFH with BNP/NT-proBNP≥median; and (3) Severe HF: prior HFH and BNP/NT-proBNP≥median. The primary measures were 2-year rates of death or HFH. RESULTS: Of 572 patients, mild, moderate, and severe HF were present in 125 (21.9%), 288 (50.3%), and 159 (27.8%) patients, respectively. With guideline-directed medical therapy alone, the 2-year rates of death or HFH in mild, moderate, and severe HF were 56.4%, 60.5%, and 84.1%, respectively (=0.001). These rates were 48.7% and 73.4% among patients with moderate HF and a prior HFH only versus elevated BNP/NT-proBNP≥median only (=0.003). Mitral transcatheter edge-to-edge repair reduced death/HFH compared with guideline-directed medical therapy alone regardless of HF severity (=0.50). CONCLUSIONS: In patients with HF with severe secondary mitral regurgitation enrolled in the COAPT trial, 2-year rates of death/HFH were increased with an elevated baseline BNP/NT-proBNP≥median, and more so if HFH within 1 year prior had occurred. Treatment with mitral transcatheter edge-to-edge repair reduced all-cause mortality and HFH consistently in mild, moderate, and severe HF. REGISTRATION:URL: https://www.clinicaltrials.gov; Unique identifier: NCT01626079.