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Comparing Effect Estimates in Randomized Trials and Observational Studies From the Same Population: An Application to Percutaneous Coronary Intervention.

ABSTRACT: Background To understand when results from observational studies and randomized trials are comparable, we performed an observational emulation of a target trial designed to ask similar questions as the VALIDATE (Bivalirudin Versus Heparin in ST-Segment and Non-ST-Segment Elevation Myocardial Infarction in Patients on Modern Antiplatelet Therapy) randomized trial. The VALIDATE trial compared the effect of bivalirudin and heparin during percutaneous coronary intervention on the risk of death, myocardial infarction, and bleeding across Sweden. Methods and Results We specified the protocol of a target trial similar to the VALIDATE trial, then emulated the target trial in the period before the VALIDATE trial took place using data from the SWEDEHEART (Swedish Web System for Enhancement and Development of Evidence-Based Care in Heart Disease Evaluated According to Recommended Therapies) registry-the same registry in which the trial was undertaken. The target trial emulation and the VALIDATE trial both estimated little or no effect of bivalirudin versus heparin on the risk of death or myocardial infarction by 180 days (target trial emulation risk ratio for death, 1.21 [95% CI, 0.88 - 1.54]; VALIDATE trial hazard ratio for death, 1.05 [95% CI, 0.78 - 1.41]). The observational data, however, could not capture less severe cases of bleeding, resulting in an inability to define a bleeding outcome like the trial, and could not accurately estimate the comparative risk of death by 14 days, which may be the result of intractable confounding early in follow-up or the inability to precisely emulate the trial's eligibility criteria. Conclusions Using real-world data to emulate a target trial can deliver accurate effect estimates. Yet, even with rich observational data, it is not always possible to estimate the short-term effect of interventions or the effect on outcomes for which data are not routinely collected.

SUBMITTER: Matthews AA

PROVIDER: S-EPMC8483524 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:Background Bifurcation lesions account for 20% of all percutaneous coronary interventions and represent a complex subset which are associated with lower procedural success and higher rates of restenosis. The ideal bifurcation technique, however, remains elusive. Methods and Results Extensive search of the literature was performed to pull data from randomized clinical trials that met predetermined inclusion criteria. Conventional meta-analysis produced pooled relative risk (RR) and 95% CI of 2-stent technique versus provisional stent on prespecified outcomes. Both frequentist and Bayesian network meta-analyses were performed to compare bifurcation techniques. A total of 8318 patients were included from 29 randomized clinical trials. Conventional meta-analysis showed no significant differences in all-cause mortality, cardiac death, major adverse cardiac events, myocardial infarction, stent thrombosis, target lesion revascularization, and target vessel revascularization between 2-stent techniques and provisional stenting. Frequentist network meta-analysis revealed that double kissing crush was associated with lower cardiac death (RR, 0.57; 95% CI, 0.38-0.84), major adverse cardiac events (RR, 0.50; 95% CI, 0.39-0.64), myocardial infarction (RR, 0.60; 95% CI, 0.39-0.90), stent thrombosis (RR, 0.50; 95% CI, 0.28-0.88), target lesion revascularization, and target vessel revascularization when compared with provisional stenting. Double kissing crush was also superior to other 2-stent techniques, including T-stent or T and protrusion, dedicated bifurcation stent, and culotte. Conclusions Double kissing crush was associated with lower risk of cardiac death, major adverse cardiac events, myocardial infarction, stent thrombosis, target lesion revascularization, and target vessel revascularization compared with provisional stenting and was superior to other 2-stent techniques. Superiority of 2-stent strategy over provisional stenting was observed in subgroup meta-analysis stratified to side branch lesion length ≥10 mm.

Project description:BACKGROUND:Same-day discharge (SDD) after elective percutaneous coronary intervention is safe, less costly, and preferred by patients, but it is usually performed in low-risk patients, if at all. To increase the appropriate use of SDD in more complex patients, we implemented a "patient-centered" protocol based on risk of complications at Barnes-Jewish Hospital. METHODS AND RESULTS:Our objectives were as follows: (1) to evaluate time trends in SDD; (2) to compare (a) mortality, bleeding, and acute kidney injury, (b) patient satisfaction, and (c) hospital costs by SDD versus no SDD (NSDD); and (3) to compare SDD eligibility by our patient-centered approach versus Society for Cardiovascular Angiography and Interventions guidelines. Our patient-centered approach was based on prospectively identifying personalized bleeding, mortality, and acute kidney injury risks, with a personalized safe contrast limit and mitigating those risks. We analyzed Barnes-Jewish Hospital's National Cardiovascular Data Registry CathPCI Registry data from July 1, 2009 to September 30, 2015 (N=1752). SDD increased rapidly from 0% to 77% (P<0.001), independent of radial access. Although SDD patients were comparable to NSDD patients, SDD was not associated with adverse outcomes (0% mortality, 0% bleeds, and 0.4% acute kidney injury). Patient satisfaction was high with SDD. Propensity score-adjusted costs were $7331 lower/SDD patient (P<0.001), saving an estimated $1.8 million annually. Only 16 patients (6.95%) met the eligibility for SDD by Society for Cardiovascular Angiography and Interventions guidelines, implying our patient-centered approach markedly increased SDD eligibility. CONCLUSIONS:With a patient-centered approach, SDD rapidly increased and was safe in 75% of patients undergoing elective percutaneous coronary intervention, despite patient complexity. Patient satisfaction was high, and hospital costs were lower. Patient-centered decision making to facilitate SDD is an important opportunity to improve the value of percutaneous coronary intervention.

Project description:Despite the widespread use of percutaneous coronary intervention (PCI), the appropriateness of these procedures in contemporary practice is unknown.To assess the appropriateness of PCI in the United States.Multicenter, prospective study of patients within the National Cardiovascular Data Registry undergoing PCI between July 1, 2009, and September 30, 2010, at 1091 US hospitals. The appropriateness of PCI was adjudicated using the appropriate use criteria for coronary revascularization. Results were stratified by whether the procedure was performed for an acute (ST-segment elevation myocardial infarction, non-ST-segment elevation myocardial infarction, or unstable angina with high-risk features) or nonacute indication.Proportion of acute and nonacute PCIs classified as appropriate, uncertain, or inappropriate; extent of hospital-level variation in inappropriate procedures.Of 500,154 PCIs, 355,417 (71.1%) were for acute indications (ST-segment elevation myocardial infarction, 103,245 [20.6%]; non-ST-segment elevation myocardial infarction, 105,708 [21.1%]; high-risk unstable angina, 146,464 [29.3%]), and 144,737 (28.9%) for nonacute indications. For acute indications, 350,469 PCIs (98.6%) were classified as appropriate, 1055 (0.3%) as uncertain, and 3893 (1.1%) as inappropriate. For nonacute indications, 72,911 PCIs (50.4%) were classified as appropriate, 54,988 (38.0%) as uncertain, and 16,838 (11.6%) as inappropriate. The majority of inappropriate PCIs for nonacute indications were performed in patients with no angina (53.8%), low-risk ischemia on noninvasive stress testing (71.6%), or suboptimal (?1 medication) antianginal therapy (95.8%). Furthermore, although variation in the proportion of inappropriate PCI across hospitals was minimal for acute procedures, there was substantial hospital variation for nonacute procedures (median hospital rate for inappropriate PCI, 10.8%; interquartile range, 6.0%-16.7%).In this large contemporary US cohort, nearly all acute PCIs were classified as appropriate. For nonacute indications, however, 12% were classified as inappropriate, with substantial variation across hospitals.

Project description:BackgroundNew research in interventional cardiology has shown the demand for percutaneous coronary interventions (PCI) to have increased tremendously. Effective treatment with a lower hospital cost has been the aim of several PCI capable centers. This study aimed to compare the adverse clinical outcomes associated with same day discharge versus overnight stay in the hospital following PCI in a population of randomized patients with stable coronary artery disease (CAD).MethodsThe National Library of Medicine (MEDLINE/PubMed), the Cochrane Registry of Randomized Controlled Trials and EMBASE databases were searched (from March to June 2016) for randomized trials comparing same-day discharge versus overnight stay in the hospital following PCI. Main endpoints in this analysis included adverse cardiovascular outcomes observed during a 30-day period. Statistical analysis was carried out by the RevMan 5.3 software whereby odds ratios (OR) and 95% confidence intervals (CIs) were calculated with respect to a fixed or a random effects model.ResultsEight randomized trials with a total number of 3081 patients (1598 patients who were discharged on the same day and 1483 patients who stayed overnight in the hospital) were included. Results of this analysis showed that mortality, myocardial infarction (MI) and major adverse cardiac events (MACEs) were not significantly different between same day discharge versus overnight stay following PCI with OR: 0.22, 95% CI: 0.04-1.35; P = 0.10, OR: 0.68, 95% CI: 0.33-1.41; P = 0.30 and OR: 0.45, 95% CI: 0.20-1.02; P = 0.06 respectively. Blood transfusion and re-hospitalization were also not significantly different between these two groups with OR: 0.64, 95% CI: 0.13-3.21; P = 0.59 and OR: 1.53, 95% CI: 0.88-2.65; P = 0.13 respectively. Similarly, any adverse event, major bleeding and repeated revascularization were also not significantly different between these two groups of patients with stable CAD, with OR: 0.42, 95% CI: 0.05-3.97; P = 0.45, OR: 0.73, 95% CI: 0.15-3.54; P = 0.69 and OR: 0.67, 95% CI: 0.14-3.15; P = 0.61 respectively.ConclusionIn terms of adverse cardiovascular outcomes, same day discharge was neither superior nor inferior to overnight hospital stay following PCI in those patients with stable CAD. However, future research will have to emphasize on the long-term consequences.

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Comparing Effect Estimates in Randomized Trials and Observational Studies From the Same Population: An Application to Percutaneous Coronary Intervention.

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