Practice Patterns and Trends in the Use of Medical Therapy in Patients Undergoing Percutaneous Coronary Intervention in Ontario

Background Clinical guidelines emphasize medical therapy as the initial approach to the management of patients with stable coronary artery disease (CAD). However, the extent to which medical therapy is applied before and after percutaneous coronary intervention (PCI) in contemporary clinical practice is uncertain. We evaluated medication use for patients with stable CAD undergoing PCI, and assessed whether the COURAGE study altered medication use in the Canadian healthcare system. Methods and Results A population‐based cohort of 23 680 older patients \u3e65 years old) with stable CAD undergoing PCI in Ontario between 2003 and 2010 was assembled. Optimal medical therapy (OMT) was defined as prescription for a β‐blocker, statin, and either angiotensin‐converting enzyme inhibitor or angiotensin II receptor blocker in the 90 days before PCI, and the same medications plus thienopyridine 90 days following PCI. Prior to PCI, 8023 (33.9%) patients were receiving OMT, 11 891 (50.2%) were on suboptimal therapy, and 3766 (15.9%) were not prescribed any medications of interest. There was significant improvement in medical therapy following PCI (OMT: 11 149 [47.1%], suboptimal therapy: 11 591 [48.9%], and none: 940 [4.0%], PPP\u3c0.001). Conclusions OMT was prescribed in about 1 in 3 patients prior to PCI and less than half after PCI. In contrast to the anticipated impact of COURAGE, we found lower rates of medication use in PCI patients after its publication

Comparing Trajectory of Surgical Aortic Valve Replacement in the Early vs. Late Transcatheter Aortic Valve Replacement Era

Background: Traditionally, the only effective treatment for aortic stenosis was surgical aortic valve replacement (SAVR). Transcatheter aortic valve replacement (TAVR) was approved in the United States in late 2011 and provided a critical alternative therapy. Our aims were to investigate the trends in the utilization of SAVR in the early vs. late TAVR era and to assess SAVR and TAVR outcomes.Methods: Using the 2011–2017 National Inpatient Sample database, we identified hospitalizations for patients with a most responsible diagnosis of aortic stenosis during which an aortic valve replacement (AVR) was performed, either SAVR or TAVR. Patients' sociodemographic and clinical characteristics, procedure complications, length of stay, and mortality were analyzed. Multivariable analyses were performed to identify predictors of in-hospital mortality. Piecewise regression analyses were performed to assess temporal trends in SAVR and TAVR utilization.Results: A total of 542,734 AVR procedures were analyzed. The utilization of SAVR was steady until 2014 with a significant downward trend in the following years 2015–2017 (P = 0.026). In contrast, a steady upward trend was observed in the TAVR procedure with a significant increase during the years 2015–2017 (P = 0.006). Higher in-hospital mortality was observed in SAVR patients. The mortality rate declined from 2011 to 2017 in a significantly higher proportion in the TAVR compared with the SAVR group.Conclusion: Utilization of SAVR showed a downward trend during the late TAVR era (2015–2017), and TAVR utilization demonstrated a steady upward trend during the years 2011–2017. Higher in-hospital mortality was recorded in patients who underwent SAVR

Financial Incentives for Transcatheter Aortic Valve Implantation in Ontario, Canada: A Cost-Utility Analysis

Background Transcatheter aortic valve implantation (TAVI) is a minimally invasive therapy for patients with severe aortic stenosis, which has become standard of care. The objective of this study was to determine the maximum cost-effective investment in TAVI care that should be made at a health system level to meet quality indicator goals. Methods and Results We performed a cost-utility analysis using probabilistic patient-level simulation of TAVI care from the Ontario, Canada, Ministry of Health perspective. Costs and health utilities were accrued over a 2-year time horizon. We created 4 hypothetical strategies that represented TAVI care meeting =1 quality indicator targets, (1) reduced wait times, (2) reduced hospital length of stay, (3) reduced pacemaker use, and (4) combined strategy, and compared these with current TAVI care. Per-person costs, quality-adjusted life years, and clinical outcomes were estimated by the model. Using these, incremental net monetary benefits were calculated for each strategy at different cost-effectiveness thresholds between $0 and$100 000 per quality-adjusted life year. Clinical improvements over the current practice were estimated with all comparator strategies. In Ontario, achieving quality indicator benchmarks could avoid ˜26 wait-list deaths and 200 wait-list hospitalizations annually. Compared with current TAVI care, the incremental net monetary benefit for this strategy varied from $10 765 (±$8721) and $17 221 (±$8977). This would translate to an annual investment of between ˜$14 to ˜$22 million by the Ontario Ministry of Health to incentivize these performance measures being cost-effective. Conclusions This study has quantified the modest annual investment required and substantial clinical benefit of meeting improvement goals in TAVI care

Bias estimation in study design: a meta-epidemiological analysis of transcatheter versus surgical aortic valve replacement

Background: Paucity of RCTs of non-drug technologies lead to widespread dependence on non-randomized studies. Relationship between nonrandomized study design attributes and biased estimates of treatment effects are poorly understood. Our purpose was to estimate the bias associated with specific nonrandomized study attributes among studies comparing transcatheter aortic valve implantation with surgical aortic valve replacement for the treatment of severe aortic stenosis. Results: We included 6 RCTs and 87 nonrandomized studies. Surgical risk scores were similar for comparison groups in RCTs, but were higher for patients having transcatheter aortic valve implantation in nonrandomized studies. Nonrandomized studies underestimated the benefit of transcatheter aortic valve implantation compared with RCTs. For example, nonrandomized studies without adjustment estimated a higher risk of postoperative mortality for transcatheter aortic valve implantation compared with surgical aortic valve replacement (OR 1.43 [95% CI 1.26 to 1.62]) than high quality RCTs (OR 0.78 [95% CI 0.54 to 1.11). Nonrandomized studies using propensity score matching (OR 1.13 [95% CI 0.85 to 1.52]) and regression modelling (OR 0.68 [95% CI 0.57 to 0.81]) to adjust results estimated treatment effects closer to high quality RCTs. Nonrandomized studies describing losses to follow-up estimated treatment effects that were significantly closer to high quality RCT than nonrandomized studies that did not. Conclusion: Studies with different attributes produce different estimates of treatment effects. Study design attributes related to the completeness of follow-up may explain biased treatment estimates in nonrandomized studies, as in the case of aortic valve replacement where high-risk patients were preferentially selected for the newer (transcatheter) procedure

Intracoronary imaging in PCI for acute coronary syndrome: Insights from British Cardiovascular Intervention Society registry.

While previous studies have demonstrated the superiority of ICI-guided PCI over an angiography-based approach, there are limited data on all-comer ACS patients. This study aimed to identify the characteristics and in-hospital outcomes of patients undergoing intracoronary imaging (ICI) guided percutaneous coronary intervention (PCI) for acute coronary syndrome (ACS). All patient undergoing PCI for ACS in England and Wales between 2006 and 2019 were retrospectively analyzed and stratified according to ICI utilization. The outcomes assessed were in-hospital all-cause mortality and major adverse cardiovascular and cerebrovascular events (MACCE) using multivariable logistic regression models. 598,921 patients underwent PCI for ACS, of which 41,716 (7.0 %) had ICI which was predominantly driven by IVUS use (5.6 %). ICI use steadily increased from 1.4 % in 2006 to 13.5 % in 2019. Adjusted odds of mortality (OR 0.69, 95%CI 0.58-0.83) and MACCE (OR 0.77, 95%CI 0.73-0.83) were significantly lower in the ICI group. The association between ICI and improved outcomes varied according to vessel treated with both left main stem (LMS) and LMS/left anterior descending (LAD) PCI associated with significantly lower odds of mortality (OR 0.34, 95%CI 0.27-0.44, OR 0.51 95%CI 0.45-0.56) and MACCE (OR 0.44 95%CI 0.35-0.54, OR 0.67 95%CI 0.62-0.72) respectively. Although ICI use has steadily increased, less than one in seven patients underwent ICI-guided PCI. The association between ICI use and improved in-hospital outcomes was mainly observed in PCI procedures involving LMS and LAD. [Abstract copyright: Copyright © 2023 The Authors. Published by Elsevier Inc. All rights reserved.

Temporal Changes in Mortality After Transcatheter and Surgical Aortic Valve Replacement: Retrospective Analysis of US Medicare Patients (2012–2019)

BACKGROUND: The treatment of aortic stenosis is evolving rapidly. Pace of change in the care of patients undergoing transcatheter aortic valve replacement (TAVR) and surgical aortic valve replacement (SAVR) differs. We sought to determine differences in temporal changes in 30‐day mortality, 30‐day readmission, and length of stay after TAVR and SAVR. METHODS AND RESULTS: We conducted a retrospective cohort study of patients treated in the United States between 2012 and 2019 using data from the Medicare Data Set Analytic File 100% Fee for Service database. We included consecutive patients enrolled in Medicare Parts A and B and aged ≥65 years who had SAVR or transfemoral TAVR. We defined 3 study cohorts, including all SAVR, isolated SAVR (without concomitant procedures), and elective isolated SAVR and TAVR. The primary end point was 30‐day mortality; secondary end points were 30‐day readmission and length of stay. Statistical models controlled for patient demographics, frailty measured by the Hospital Frailty Risk Score, and comorbidities measured by the Elixhauser Comorbidity Index (ECI). Cox proportional hazard models were developed with TAVR versus SAVR as the main covariates with a 2‐way interaction term with index year. We repeated these analyses restricted to full aortic valve replacement hospitals offering both SAVR and TAVR. The main study cohort included 245 269 patients with SAVR and 188 580 patients with TAVR, with mean±SD ages 74.3±6.0 years and 80.7±6.9 years, respectively, and 36.5% and 46.2% female patients, respectively. Patients with TAVR had higher ECI scores (6.4±3.6 versus 4.4±3) and were more frail (55.4% versus 33.5%). Total aortic valve replacement volumes increased 61% during the 7‐year span; TAVR volumes surpassed SAVR in 2017. The magnitude of mortality benefit associated with TAVR increased until 2016 in the main cohort (2012: hazard ratio [HR], 0.76 [95% CI, 0.67–0.86]; 2016: HR, 0.39 [95% CI, 0.36–0.43]); although TAVR continued to have lower mortality rates from 2017 to 2019, the magnitude of benefit over SAVR was attenuated. A similar pattern was seen with readmission, with a lower risk of readmission from 2012 to 2016 for patients with TAVR (2012: HR, 0.68 [95% CI, 0.63–0.73]; 2016: HR, 0.43 [95% CI, 0.41–0.45]) followed by a lesser difference from 2017 to 2019. Year over year, TAVR was associated with increasingly shorter lengths of stay compared with SAVR (2012: HR, 1.91 [95% CI, 1.84–1.98]; 2019: HR, 5.34 [95% CI, 5.22–5.45]). These results were consistent in full aortic valve replacement hospitals. CONCLUSIONS: The rate of improvement in TAVR outpaced SAVR until 2016, with the recent presence of U‐shaped phenomena suggesting a narrowing gap between outcomes. Future longitudinal research is needed to determine the long‐term implications of lowering risk profiles across treatment options to guide case selection and clinical care