AIMS:Intracoronary imaging modalities such as intravascular ultrasound (IVUS) and optical coherence tomography (OCT) have been shown to improve outcomes following percutaneous coronary intervention (PCI) by reducing death, myocardial infarction, and stent failure. This is supported by a recent large-scale meta-analysis. Uptake remains highly variable, however, in part due to concerns over up-front costs. Our objective was to establish the cost-effectiveness of the routine use of both IVUS and OCT in patients undergoing PCI including the most up-to-date clinical data. METHODS AND RESULTS:Procedural costs of PCI with and without intracoronary imaging were established. Costs were obtained using figures from primary data collection and previously published literature. Outcome measures were established from a contemporary literature review, including a recent large-scale meta-analysis. We developed a Markov model to compare angiography-guided PCI with IVUS- and OCT-guided PCI. The primary outcomes were quality-adjusted life years, discounted costs, and incremental cost-effectiveness ratio (ICER). In the base case, intracoronary imaging is highly cost-effective compared with angiography alone over a lifetime horizon. Both IVUS and OCT conferred a survival benefit of 0.061 quality-adjusted life years. The ICER for IVUS was €6802 ($7361) and for OCT was €8947 ($9682). Results were robust to extensive sensitivity analyses. CONCLUSION:Our study suggests that the routine use of intracoronary imaging during PCI is likely to be a cost-effective strategy. Our results may help to inform cardiologists, guideline writers, and financial decision-makers in healthcare sectors regarding the widespread adoption of intracoronary imaging.
Hypertension represents the leading risk factor for death globally, affecting one in two adults. Despite dozens of inexpensive medications and lifestyle changes that effectively lower blood pressure (BP), hypertension control rates remain poor. Renal denervation (RDN) is a procedural therapy indicated as an adjunctive treatment for high BP. FDA approval in late 2023 followed the publication of a series of rigorous, second-generation, randomized clinical trials that demonstrated safety and efficacy of the procedure. Two catheters employing radiofrequency (Spyral) and ultrasound (Paradise) are currently approved to ablate renal sympathetic nerves. In randomized sham-controlled trials, RDN lowered BP in patients with mild-to-moderate and true resistant hypertension, and in patients both on and off antihypertensive medication. When evaluating patients for RDN, shared decision-making is a critical element, which should include potential benefits and that a minority may not respond to the therapy. There is only one constant predictor of magnitude of response: magnitude of baseline SBP, which is one reason why guidelines recommend prioritization of patients with resistant hypertension, together with patients whose BP cannot be effectively managed with medication. Before referring patients to a trained interventionalist, it is important to optimize medical therapy and adherence, and confirm uncontrolled hypertension out-of-office. Patients should be screened for primary aldosteronism and for other secondary causes of hypertension if clinically indicated, though sleep apnea is not a contraindication to RDN. A team approach is advised, with hypertension specialists and interventionalists collaborating. Data from global registries will augment our knowledge and guide future implementation.
INTRODUCTION:Catheter-based interventions (CBI) have yielded promising data in selected patients with acute pulmonary embolism (PE). Despite growing clinical use, high-quality comparative evidence on the efficacy and safety of CBI, especially in relation to standard anticoagulation or systemic thrombolysis, is limited. As new randomized controlled trials (RCTs) rapidly accumulate, this living evidence synthesis will aim to systematically and continuously evaluate the comparative efficacy and safety of reperfusion strategies vs standard of care in patients with high- and intermediate-risk acute PE. METHODS:This living systematic review and meta-analysis will include RCTs comparing reperfusion strategies to standard of care in adult patients with high- or intermediate-risk PE. The primary analysis will pertain to trials that are powered and designed to assess hard clinical outcomes, such as death and hemodynamic deterioration. A secondary analysis will include additional studies reporting clinical outcomes, including those primarily evaluating hemodynamic or surrogate outcomes. Analyses will be stratified by PE severity (high- and intermediate-risk) and also conducted using a frequentist network meta-analysis framework. The review is ongoing, with new eligible trials added prospectively. RESULTS:As of the initial search on 28 May 2025, 23 RCTs are included. Thirteen additional ongoing trials were identified for future inclusion, including trials with clinical outcomes such as PEITHO-3, HI-PEITHO, PEERLESS II, PE-TRACT, and PRAGUE-26 for intermediate-risk PE, and CATCH-PE II, PERSEVERE, and TORPEDONL for high-risk PE. CONCLUSION:This living meta-analysis will offer continuously updated, comparative evidence on reperfusion strategies for acute PE, with a focus on informing the role of catheter-based interventions in clinical decision-making. REGISTRATION:PROSPERO: CRD420251207053. Available from https://www.crd.york.ac.uk/PROSPERO/view/CRD420251207053.
Percutaneous mechanical aspiration has emerged as a novel, catheter-based strategy for the management of right-sided infective endocarditis, particularly in patients with a suboptimal response to antimicrobials or in those considered high risk for surgery. Initially developed for thrombus extraction, percutaneous mechanical aspiration has been increasingly used to achieve source control by debulking large vegetations. Despite growing clinical adoption and support from societal statements and guidelines, there have been no randomized controlled trials evaluating its safety or efficacy in right-sided infective endocarditis. Current evidence is derived from retrospective case series, registries, and administrative data sets, all limited by heterogeneity in patient populations, procedural techniques, and outcome definitions. Nevertheless, recent data from multicenter registries demonstrate promising procedural success and feasibility in select patients. In response to expanding use and persistent knowledge gaps, this American Heart Association Science Advisory aimed to (1) define the rationale and evolving indications for percutaneous mechanical aspiration in right-sided infective endocarditis, (2) summarize the available clinical evidence and technical considerations, (3) provide expert consensus on patient selection and procedural planning, and (4) identify priorities for future prospective investigation.
Background High-risk pulmonary embolism (PE), defined as PE causing hemodynamic instability, remains associated with high acute mortality and currently warrants acute treatment with systemic thrombolysis. Mechanical thrombectomy can be considered where thrombolysis is inappropriate, as an alternative, or in addition to, but more prospective data are needed. This analysis evaluates the safety, effectiveness, functional, and quality of life (QoL) outcomes in high-risk PE patients who were treated using mechanical thrombectomy with computer-assisted vacuum thrombectomy (CAVT) devices. Methods Among the first 595 patients enrolled in the prospective, international STRIKE-PE study, 48 were identified as having high-risk PE. Outcomes included change in right-to-left ventricular ratio from baseline to 48-hour follow-up, 48-hour composite major adverse events (MAE), additional safety end points, and 90-day changes in functional and QoL assessments. Results Mean right-to-left ventricular ratio decreased from 1.50 ± 0.36 to 1.02 ± 0.18 (P < .001). One study-defined MAE (major bleeding) occurred. One all-cause mortality and 1 symptomatic PE recurrence occurred within 30 days. Borg scale at rest improved from baseline to discharge (P < .001) and discharge to 90 days (P = .045). Borg scale after 6-minute walk test, 6-minute walk test distance, EQ-5D-5L index value, EuroQoL Visual Analog Scale, and Pulmonary Embolism QoL score improved (all P < .001). New York Heart Association class returned to pre-PE baseline. Six patients received systemic thrombolysis (1 periprocedure and 5 postprocedure); majority of patients received none. Conclusions CAVT for high-risk PE was feasible and associated with a low incidence of MAE and a low 30-day mortality rate. CAVT treatment facilitated improvements in hemodynamic status and RV strain. Dyspnea, distance walked, functional status, and QoL significantly improved.
BACKGROUND:Pulmonary embolism (PE) can be a life-threatening condition. Endovascular treatment is emerging as a promising treatment to restore hemodynamic stability and reverse right ventricular (RV) dysfunction in PE; however, more studies are needed to elucidate the effects on the right ventricle after endovascular treatment. This analysis reports the effects of computer assisted vacuum thrombectomy on RV function. METHODS:Eligible patients for the single-arm, prospective, international, multicenter STRIKE-PE (A Prospective, Multicenter Study of the Indigo Aspiration System Seeking to Evaluate the Long-Term Safety and Outcomes of Treating Pulmonary Embolism) cohort study are adults with acute PE with symptoms for ≤14 days and an RV/left ventricular ratio of ≥0.9 who are treated with computer assisted vacuum thrombectomy. Reported here are periprocedural and RV outcomes of the initial 300 patients of STRIKE-PE, to provide insights into effects on RV function after computer assisted vacuum thrombectomy. RESULTS:Patients were classified with high-risk (5.7%), intermediate-high-risk (84.7%), or intermediate-low-risk (9.7%) PE. Median thrombectomy time was 30 minutes. Mean on-table systolic pulmonary artery pressure decreased from 51.7 mm Hg to 41.3 mm Hg, a 19.1% reduction (P<0.001). The change in mean RV/left ventricular ratio from baseline to 48 hours postprocedure (primary effectiveness end point) was a decrease from 1.40 to 0.99, a 26.8% reduction (P<0.001). Clinical parameters and echocardiographic measures of right heart strain improved from baseline to 48 hours postprocedure (P<0.001). The rate of composite major adverse events within 48 hours postprocedure (primary safety end point) was 2.0%. Median Borg dyspnea scale at rest decreased from 4.0 at baseline to 0.5 at discharge (P<0.001). CONCLUSIONS:This interim analysis demonstrates that computer assisted vacuum thrombectomy safely and expeditiously improves hemodynamic status, RV function, and perceived dyspnea. REGISTRATION: URL:https://clinicaltrials.gov; Unique Identifier: NCT04798261.
ImportanceThe differences between the use of fractional flow reserve (FFR) or instantaneous wave-free ratio (iFR) in the long term are unknown.ObjectiveTo compare long-term outcomes of iFR- and FFR-based strategies to guide revascularization.Design, Setting, and ParticipantsThe DEFINE-FLAIR multicenter study randomized patients with coronary artery disease to use either iFR or FFR as a pressure index to guide revascularization. Patients from 5 continents with coronary artery disease and angiographically intermediate severity stenoses who underwent hemodynamic interrogation with pressure wires were included. These data were analyzed from March, 13, 2014, through April, 27, 2021.MAIN OUTCOME MEASURESFive-year major adverse cardiac events (MACE) (a composite of all-cause death, nonfatal myocardial infarction, and unplanned revascularization), as well as the individual components of the combined end point.ResultsAt 5 years of follow-up, no significant differences were found between the iFR (mean age [SD], 65.5 [10.8] years; 962 male [77.5%]) and FFR (mean age [SD], 65.2 [10.6] years; 929 male [74.3%]) groups in terms of MACE (21.1% vs 18.4%, respectively; hazard ratio [HR], 1.18; 95% CI, 0.99-1.42; P = .06). While all-cause death was higher among patients randomized to iFR, it was not driven by myocardial infarction (6.3% vs 6.2% in the FFR study arm; HR, 1.01; 95% CI, 0.74-1.38; P = .94) or unplanned revascularization (11.9% vs 12.2% in the FFR group; HR, 0.98; 95% CI, 0.78-1.23; P = .87). Furthermore, patients in whom revascularization was deferred on the basis of iFR or FFR had similar MACE in both study arms (17.9% in the iFR group vs 17.5% in the FFR group; HR, 1.03; 95% CI, 0.79-1.35; P = .80) with similar rates of the components of MACE, including all-cause death. On the contrary, in patients who underwent revascularization after physiologic interrogation, the incidence of MACE was higher in the iFR group (24.6%) compared with the FFR group (19.2%) (HR, 1.36; 95% CI, 1.07-1.72; P = .01).Conclusions and relevanceAt 5-year follow up, an iFR based–strategy was not statistically different than an FFR strategy to guide revascularization in terms of MACE, nonfatal myocardial infarction, and unplanned revascularization.Trial RegistrationClinicalTrials.gov Identifier: NCT02053038
Renal denervation has recently emerged as a novel approach to improving blood pressure control, particularly in patients with uncontrolled or resistant hypertension. Although a substantial body of evidence has accumulated regarding the procedure's efficacy and safety, considerable variation exists across studies in the primary measures used to assess treatment response. The degree of response also differs widely among individuals, highlighting the importance of identifying factors associated with enhanced or limited responses to the procedure. In this review, we summarize the currently available evidence on response parameters and predictors of response to renal denervation and offer perspectives for future research.
Background:When cardiac implantable electronic device infection occurs, standard therapy is usually total system extraction. Transvenous lead extraction is preferable to open heart surgical extraction, unless contraindicated because of the presence of very large vegetations on the intravenous leads according to the European Society of Cardiology guidelines. Extraction of transvenous leads with vegetations risks distal embolism resulting in obstruction and/or infection in the pulmonary arteries. Catheter aspiration of vegetations or thrombi has been performed prior to transvenous lead extraction using a partial veno-venous extracorporeal bypass circuit. We report the use of a single-access aspiration system using the Inari FlowTriever 24 French system to debulk a defibrillator lead before percutaneous extraction. Case summary:A 79-year-old male presented with fever 18 years after his first implantable cardioverter defibrillator implant and 9 years after his most recent pulse generator change. Two large vegetations were identified on his transvenous defibrillator lead on the atrial aspect, near the tricuspid annulus, which were aspirated using the Inari Medical 24Fr FlowTriever aspiration catheter. We describe anatomical considerations during the approach and a technique to localize the vegetations based on a combination of fluoroscopy and transoesophageal echocardiogram guidance. Discussion:This case demonstrates the safe and effective use of the Inari Medical 24Fr FlowTriever aspiration catheter in debulking a defibrillator lead before transvenous lead extraction. This method uses a single venous puncture and is not dependent on extracorporeal bypass. Apart from reducing complexity, this technique may be advantageous in patients where anticoagulation needs to be minimised.
Recent advances in therapy and the promulgation of multidisciplinary pulmonary embolism teams show great promise to improve management and outcomes of acute pulmonary embolism (PE). However, the absence of randomized evidence and lack of consensus leads to tremendous variations in treatment and compromises the wide implementation of new innovations. Moreover, the changing landscape of health care, where quality, cost, and accountability are increasingly relevant, dictates that a broad spectrum of outcomes of care must be routinely monitored to fully capture the impact of modern PE treatment. We set out to standardize data collection in patients with PE undergoing evaluation and treatment, and thus establish the foundation for an expanding evidence base that will address gaps in evidence and inform future care for acute PE. To do so, >100 international PE thought leaders convened in Washington, DC, in April 2022 to form the Pulmonary Embolism Research Collaborative. Participants included physician experts, key members of the US Food and Drug Administration, patient representatives, and industry leaders. Recognizing the multidisciplinary nature of PE care, the Pulmonary Embolism Research Collaborative was created with representative experts from stakeholder medical subspecialties, including cardiology, pulmonology, vascular medicine, critical care, hematology, cardiac surgery, emergency medicine, hospital medicine, and pharmacology. A list of critical evidence gaps was composed with a matching comprehensive set of standardized data elements; these data points will provide a foundation for productive research, knowledge enhancement, and advancement of clinical care within the field of acute PE, and contribute to answering urgent unmet needs in PE management. Evidence produced through the Pulmonary Embolism Research Collaborative, as it is applied to data collection, promises to provide crucial knowledge that will ultimately produce a robust evidence base that will lead to standardization and harmonization of PE management and improved outcomes.
BACKGROUND: Prior clinical trials have demonstrated the efficacy of ultrasound-facilitated catheter-directed thrombolysis (USCDT) for the treatment of acute intermediate-risk pulmonary embolism (PE) using reduced thrombolytic doses and shorter infusion durations. However, utilization and safety of such strategies in broader PE populations remain unclear. The KNOCOUT PE (The EKoSoNic Registry of the Treatment and Clinical Outcomes of Patients With Pulmonary Embolism) registry is a multicenter international registry designed to study the treatment of acute PE with USCDT, with focus on safety outcomes. METHODS: The KNOCOUT PE prospective cohort included 489 patients (64 sites internationally) with acute intermediate-high or high-risk PE treated with USCDT between March 2018 and June 2020. Principal safety outcomes were independently adjudicated International Society on Thrombosis and Haemostasis major bleeding at 72 hours post-treatment and mortality within 12 months of treatment. Additional outcomes included change in right ventricular/left ventricular ratio and quality of life measures over 12 months. RESULTS: Mean alteplase (r-tPA [recombinant tissue-type plasminogen activator]) infusion duration was 10.5 hours. Mean total r-tPA dose was 18.1 mg, with 31.0% of patients receiving ≤12 mg. Major bleeding events within 72 hours occurred in 1.6% (8/489) of patients. One patient experienced worsening of a preexisting subdural hematoma after USCDT and therapeutic anticoagulation, which ultimately required surgery. All-cause mortality at 30 days was 1.0% (5/489). Improvement in PE quality of life score was observed with a 41.1% (243/489, 49.7%) and 44.2% (153/489, 31.3%) mean relative reduction by 3 and 12 months, respectively. CONCLUSIONS: In a prospective observational cohort study of patients with intermediate-high and high-risk PE undergoing USCDT, mean r-tPA dose was 18 mg, and the rates of major bleeding and mortality were low. REGISTRATION: URL: https://www.clinicaltrials.gov ; Unique identifier: NCT03426124.
Background Use of intravascular ultrasound (IVUS) during percutaneous coronary intervention (PCI) is associated with improved clinical outcomes over angiography alone. Despite this, the adoption of IVUS in clinical practice remains low.Aims To examine the cost-effectiveness of IVUS-guided PCI compared to angiography alone in patients with acute coronary syndromes (ACS).Methods and results A 1-year decision tree and lifetime Markov model were constructed to compare the cost-effectiveness of IVUS-guided PCI to angiography alone for two hypothetical adult populations consisting of 1000 individuals: ST-elevation myocardial infarction (STEMI) and unstable angina/non-ST-elevation myocardial infarction (UA/NSTEMI) patients undergoing drug-eluting stent (DES) implantation. The United Kingdom (UK) healthcare system perspective was applied using 2019/20 costs. All-cause death, myocardial infarction (MI), repeat PCI, lifetime costs, life expectancy, and quality-adjusted life-years (QALYs) were assessed. Over a lifetime horizon, IVUS-guided PCI was cost-effective compared to angiography alone in both populations, yielding an incremental cost-effectiveness ratio of 3649 pound and 5706 pound per-patient in STEMI and UA/NSTEMI patients, respectively. In the 1-year time horizon, the model suggested that IVUS was associated with reductions in mortality, MI, and repeat PCI by 51%, 33%, and 52% in STEMI and by 50%, 29%, and 57% in UA/NSTEMI patients, respectively. Sensitivity analyses demonstrated the robustness of the model with IVUS being 100% cost-effective at a willingness to pay threshold of 20 pound 000 per QALY-gained.Methods and results A 1-year decision tree and lifetime Markov model were constructed to compare the cost-effectiveness of IVUS-guided PCI to angiography alone for two hypothetical adult populations consisting of 1000 individuals: ST-elevation myocardial infarction (STEMI) and unstable angina/non-ST-elevation myocardial infarction (UA/NSTEMI) patients undergoing drug-eluting stent (DES) implantation. The United Kingdom (UK) healthcare system perspective was applied using 2019/20 costs. All-cause death, myocardial infarction (MI), repeat PCI, lifetime costs, life expectancy, and quality-adjusted life-years (QALYs) were assessed. Over a lifetime horizon, IVUS-guided PCI was cost-effective compared to angiography alone in both populations, yielding an incremental cost-effectiveness ratio of 3649 pound and 5706 pound per-patient in STEMI and UA/NSTEMI patients, respectively. In the 1-year time horizon, the model suggested that IVUS was associated with reductions in mortality, MI, and repeat PCI by 51%, 33%, and 52% in STEMI and by 50%, 29%, and 57% in UA/NSTEMI patients, respectively. Sensitivity analyses demonstrated the robustness of the model with IVUS being 100% cost-effective at a willingness to pay threshold of 20 pound 000 per QALY-gained.Conclusions From a UK healthcare perspective, an IVUS-guided PCI strategy was highly cost-effective over angiography alone amongst ACS patients undergoing DES implantation due to the medium- and long-term reduction in repeat PCI, death, and MI. Graphical Abstract
Background Catheter-based radiofrequency renal denervation (RF RDN) has recently been approved as an adjunctive treatment for hypertensive patients without adequate blood pressure control. This study assessed the cost-effectiveness of RF RDN in the United States based on contemporary clinical evidence. Methods A decision-analytic Markov model projected costs, quality-adjusted life years (QALY), and clinical events for an active cohort treated with RF RDN and a control cohort treated with standard-of-care (defined as 1, 2, or 3 antihypertensive medications). Cohort demographics and therapy effect were derived from the SPYRAL HTN-ON MED study demonstrating an absolute 9.9 mm Hg reduction in office systolic blood pressure and 4.9 mm Hg reduction compared with sham control. Clinical event risk reduction from blood pressure lowering was based on a meta-regression of 47 hypertension trials. The incremental cost-effectiveness ratio was evaluated against willingness-to-pay thresholds of $50,000 per QALY (high value) and $150,000 per QALY (intermediate value). Extensive scenario and sensitivity analyses were conducted to assess robustness of the findings. Results RF RDN yielded a significant risk reduction in clinical events (0.80 for stroke, 0.88 for myocardial infarction, and 0.85 for cardiovascular death over 10 years). Over lifetime, RF RDN added 0.34 QALY at an additional cost of $11,275, leading to an incremental cost-effectiveness ratio of $32,732 per QALY. The cost-effectiveness of RF RDN was robust across a broad range of scenarios and sensitivity analyses. Conclusions Based on a lifetime projection, catheter-based RF RDN is a cost-effective, high-value intervention for hypertensive patients with uncontrolled hypertension.
BACKGROUND:The randomized, sham-controlled RADIANCE-HTN (A Study of the Recor Medical Paradise System in Clinical Hypertension) SOLO, RADIANCE-HTN TRIO, and RADIANCE II (A Study of the Recor Medical Paradise System in Stage II Hypertension) trials independently met their primary end point of a greater reduction in daytime ambulatory systolic blood pressure (SBP) 2 months after ultrasound renal denervation (uRDN) in patients with hypertension. To characterize the longer-term effectiveness and safety of uRDN versus sham at 6 months, after the blinded addition of antihypertensive treatments (AHTs), we pooled individual patient data across these 3 similarly designed trials. METHODS:Patients with mild to moderate hypertension who were not on AHT or with hypertension resistant to a standardized combination triple AHT were randomized to uRDN (n=293) versus sham (n=213); they were to remain off of added AHT throughout 2 months of follow-up unless specified blood pressure (BP) criteria were exceeded. In each trial, if monthly home BP was >= 135/85 mm Hg from 2 to 5 months, standardized AHT was sequentially added to target home BP <135/85 mm Hg under blinding to initial treatment assignment. Six-month outcomes included baseline- and AHT-adjusted change in daytime ambulatory, home, and office SBP; change in AHT; and safety. Linear mixed regression models using all BP measurements and change in AHT from baseline through 6 months were used. RESULTS:Patients (70% men) were 54.1 +/- 9.3 years of age with a baseline daytime ambulatory/home/office SBP of 150.5 +/- 9.8/151.0 +/- 12.4/155.5 +/- 14.4 mm Hg, respectively. From 2 to 6 months, BP decreased in both groups with AHT titration, but fewer uRDN patients were prescribed AHT (P=0.004), and fewer additional AHT were prescribed to uRDN patients versus sham patients (P=0.001). Whereas the unadjusted between-group difference in daytime ambulatory SBP was similar at 6 months, the baseline and medication-adjusted between-group difference at 6 months was -3.0 mm Hg (95% CI, -5.7, -0.2; P=0.033), in favor of uRDN+AHT. For home and office SBP, the adjusted between-group differences in favor of uRDN+AHT over 6 months were -5.4 mm Hg (-6.8, -4.0; P<0.001) and -5.2 mm Hg (-7.1, -3.3; P<0.001), respectively. There was no heterogeneity between trials. Safety outcomes were few and did not differ between groups. CONCLUSIONS:This individual patient-data analysis of 506 patients included in the RADIANCE trials demonstrates the maintenance of BP-lowering efficacy of uRDN versus sham at 6 months, with fewer added AHTs. REGISTRATION:URL: https://www.clinicaltrials.gov; Unique identifiers: NCT02649426 and NCT03614260.
Background Over the past decade, major society guidelines have recommended the use of newer P2Y 12 inhibitors over clopidogrel for those undergoing percutaneous coronary intervention for acute coronary syndrome. It is unclear what impact these recommendations had on clinical practice. Methods and Results All percutaneous coronary intervention procedures (n=534 210) for acute coronary syndrome in England and Wales (April 1, 2010, to March 31, 2022) were retrospectively analyzed, stratified by choice of preprocedural P2Y 12 inhibitor (clopidogrel, ticagrelor, and prasugrel). Multivariable logistic regression models were used to examine odds ratios of receipt of ticagrelor and prasugrel (versus clopidogrel) over time, and predictors of their receipt. Overall, there was a significant increase in receipt of newer P2Y 12 inhibitors from 2010 to 2020 (2022 versus 2010: ticagrelor odds ratio, 8.12 [95% CI, 7.67–8.60]; prasugrel odds ratio, 6.14 [95% CI, 5.53–6.81]), more so in ST‐segment–elevation myocardial infarction than non–ST‐segment–elevation acute coronary syndrome indication. The most significant increase in odds of receipt of prasugrel was observed between 2020 and 2022 ( P <0.001), following a decline/plateau in its use in earlier years (2011–2019). In contrast, the odds of receipt of ticagrelor significantly increased in earlier years (2012–2017, P trend <0.001), after which the trend was stable ( P trend =0.093). Conclusions Over a 13‐year‐period, there has been a significant increase in use of newer P2Y 12 inhibitors, although uptake of prasugrel use remained significantly lower than ticagrelor. Earlier society guidelines (pre‐2017) were associated with the highest rates of ticagrelor use for non–ST‐segment–elevation acute coronary syndrome and ST‐segment–elevation myocardial infarction cases while the ISAR‐REACT 5 (Prospective, Randomized Trial of Ticagrelor Versus Prasugrel in Patients With Acute Coronary Syndrome) trial and later society guidelines were associated with higher prasugrel use, mainly for ST‐segment–elevation myocardial infarction indication.
BACKGROUND:Catheter-based renal sympathetic denervation (RDN) reduced blood pressure (BP) in multiple randomized sham-controlled trials of patients with uncontrolled hypertension (HTN). We tested proof-of-concept for a more selective treatment strategy, exclusively targeting these areas to improve the efficiency of the procedure. METHODS:The SPYRAL DYSTAL Pilot study was designed to mirror the SPYRAL HTN-OFF MED Pivotal study, enabling comparison with a propensity score adjusted active-control group. Patients were antihypertensive medication-free for one month before undergoing BP assessment. Those with office BP of 150-180/>90 mmHg and with an ambulatory systolic BP of 140-170 mmHg were selected to undergo open label treatment, delivering energy only to the distal main renal arteries and first order branches. Patients from DYSTAL were compared with patients who underwent maximized RF RDN treatment in the prior randomized OFF MED trial at 3 months. After 3 months, patients resumed antihypertensive medications as indicated. Safety and efficacy outcomes were assessed post hoc through 12 months. RESULTS:The SPYRAL DYSTAL Pilot study treated 56 HTN patients. Baseline office systolic BP (OSBP) and 24-h ambulatory systolic BP (ASBP) were similar between DYSTAL and OFF MED patient groups. The number of ablations (32.3 ± 8.0 vs 46.6 ± 15.3, p < 0.001), procedure time (67 ± 21 min vs 99 ± 36 min; p < 0.001), and contrast volume (173 ± 77 cc vs 208 ± 96 cc; p = 0.014) were significantly lower with the simplified treatment strategy. OSBP and ASBP changes compared with baseline were -9.0 and -1.4 mmHg at 3 months, -20.3 and -13.9 mmHg at 6 months, and -20.3 and -16.6 mmHg at 12 months, respectively. During the medication up-titration phase, BP reductions among DYSTAL patients were similar to reductions observed in OFF MED through 12 months, with comparable number of drugs (1.4 and 1.5 medications, respectively (P=NS)). Two adverse events related to guidewire placement were reported. CONCLUSION:In this pilot study, focusing ablation treatment on the distal main and proximal branch renal arteries was performed, resulting in fewer RF lesions, and reduced contrast volume and procedure time. Whether BP reductions are similar between a selective vs. maximized RDN approach requires further prospective study.