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Endpoint selection for noninferiority percutaneous coronary intervention trials: a methodological description.

ABSTRACT: BACKGROUND:The objective of this review is to provide a practical update on endpoint selection for noninferiority (NI) studies in percutaneous coronary intervention studies. METHODS:A PubMed search was conducted for predefined terms to explore the use of NI designs and intrapatient comparisons to determine their current importance. Sample size calculations for the most frequently used endpoints with NI hypotheses were done to increase statistical awareness. RESULTS:Reported NI trials, with the most frequently chosen clinical endpoint of major adverse cardiac events (MACE), had NI margins ranging from 1.66% to 5.00%, resulting in patient populations of 400-1500 per treatment group. Clinical study endpoints comprising of MACE complemented with rates of bleeding complications and stent thrombosis (ST) are suggested to conduct a statistically and clinically meaningful NI trial. Study designs with surrogate endpoints amenable to intrapatient randomizations, are a very attractive option to reduce the number of necessary patients by about half. Comparative clinical endpoint studies with MACE and ST/bleeding rates to study a shortened dual antiplatelet therapy (DAPT) in coronary stent trials are feasible, whereas ST as the sole primary endpoint is not useful. CONCLUSIONS:Expanded composite clinical endpoints (MACE complemented by ST and bleeding rates and intrapatient randomization for selected surrogate endpoints) may be suitable tools to meet future needs in device approval, recertification and reimbursement.

SUBMITTER: Waliszewski M

PROVIDER: S-EPMC7074513 | biostudies-literature | 2020 Jan-Dec

REPOSITORIES: biostudies-literature

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Endpoint selection for noninferiority percutaneous coronary intervention trials: a methodological description.

Waliszewski Matthias M Rosenberg Mark M Rittger Harald H Breul Viktor V Krackhardt Florian F

Therapeutic advances in cardiovascular disease 20200101

<h4>Background</h4>The objective of this review is to provide a practical update on endpoint selection for noninferiority (NI) studies in percutaneous coronary intervention studies.<h4>Methods</h4>A PubMed search was conducted for predefined terms to explore the use of NI designs and intrapatient comparisons to determine their current importance. Sample size calculations for the most frequently used endpoints with NI hypotheses were done to increase statistical awareness.<h4>Results</h4>Reported ...[more]

PMID: 32168991

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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:BackgroundPercutaneous mechanical circulatory support devices (pMCSDs) are increasingly used on the assumption (but without solid proof) that their use will improve prognosis. A meta-analysis was undertaken according to the PRISMA guidelines to evaluate the benefits of pMCSDs in patients undergoing high-risk percutaneous coronary intervention (hr-PCI).MethodsWe searched PubMed, EMbase, Cochrane Library, Clinical Trial.gov, and other databases to identify eligible studies. Relative risks (RRs) and 95% confidence intervals (CIs) were calculated for 30-day and 6-month all-cause mortality rates, reinfarction, and other adverse events using a random effect model.ResultsSixteen randomized controlled trials (RCTs) were included in this study. In the pooled analysis, intra-aortic balloon pump (IABP) was not associated with a decrease in 30-day and 6-month all-cause mortality (RR 1.01 95% CI 0.61-1.66; RR 0.88 95% CI 0.66-1.17), reinfarction (RR 0.89 95% CI 0.69-1.14), stroke/transient ischemic attack (TIA) (RR 1.75 95% CI 0.47-6.42), heart failure (HF) (RR 0.54 95% CI 0.11-2.66), repeat revascularization (RR 0.73 95% CI 0.25-2.10), embolization (RR 3.00 95% CI 0.13-71.61), or arrhythmia (RR 2.81 95% CI 0.30-26.11). Compared with IABP, left ventricular assist devices (LVADs) were not associated with a decrease in 30-day and 6-month all-cause mortality (RR 0.96 95% CI 0.71-1.29; RR 1.23 95% CI 0.88-1.72), reinfarction (RR 0.98 95% CI 0.68-1.42), stroke/TIA (RR 0.45 95% CI 0.1-1.95), acute kidney injury (AKI) (RR 0.83 95% CI 0.38-1.80), or arrhythmia (RR 1.52 95% CI 0.71-3.27), but LVADs were associated with a decrease in repeat revascularization (RR 0.26 95% CI 0.08-0.83). However, LVADs significantly increased the risk of bleeding compared with IABP (RR 2.85 95% CI 1.72-4.73).ConclusionsNeither LVADs nor IABP improves short or long-term survival in hr-PCI patients. LVADs are more likely to reduce repeat revascularization after PCI, but to increase the risk of bleeding events than IABP.

Project description:Appropriate Use Criteria for Coronary Revascularization were developed to critically evaluate and improve patient selection for percutaneous coronary intervention (PCI). National trends in the appropriateness of PCI have not been examined.To examine trends in PCI utilization, patient selection, and procedural appropriateness following the introduction of Appropriate Use Criteria.Multicenter, longitudinal, cross-sectional analysis of patients undergoing PCI between July 1, 2009, and December 31, 2014, at hospitals continuously participating in the National Cardiovascular Data Registry CathPCI registry over the study period.Proportion of nonacute PCIs classified as inappropriate at the patient and hospital level using the 2012 Appropriate Use Criteria for Coronary Revascularization.A total of 2.7 million PCI procedures from 766 hospitals were included. Annual PCI volume of acute indications was consistent over the study period (377,540 in 2010; 374,543 in 2014), but the volume of nonacute PCIs decreased from 89,704 in 2010 to 59,375 in 2014. Among patients undergoing nonacute PCI, there were significant increases in angina severity (Canadian Cardiovascular Society grade III/IV angina, 15.8% in 2010 and 38.4% in 2014), use of antianginal medications prior to PCI (at least 2 antianginal medications, 22.3% in 2010 and 35.1% in 2014), and high-risk findings on noninvasive testing (22.2% in 2010 and 33.2% in 2014) (P?<?.001 for all), but only modest increases in multivessel coronary artery disease (43.7% in 2010 and 47.5% in 2014, P?<?.001). The proportion of nonacute PCIs classified as inappropriate decreased from 26.2% (95% CI, 25.8%-26.6%) to 13.3% (95% CI, 13.1%-13.6%), and the absolute number of inappropriate PCIs decreased from 21,781 to 7921. Hospital-level variation in the proportion of PCIs classified as inappropriate persisted over the study period (median, 12.6% [interquartile range, 5.9%-22.9%] in 2014).Since the publication of the Appropriate Use Criteria for Coronary Revascularization in 2009, there have been significant reductions in the volume of nonacute PCI. The proportion of nonacute PCIs classified as inappropriate has declined, although hospital-level variation in inappropriate PCI persists.

Project description:Inconsistent results exist regarding the treatment effectiveness of immediate versus deferred percutaneous coronary intervention (PCI) in patients with acute coronary syndrome (ACS). This meta-analysis aimed to evaluate the efficacy and safety of immediate versus deferred PCI in ACS patients. PubMed, EMBASE, and Cochrane Library electronic databases were systematically searched from their inception up to August 2019. Random-effects models were employed to calculate pooled relative risks (RRs) and weight mean differences (WMDs) with 95% confidence intervals (CIs). A total of 10 randomized controlled trials (RCTs) that recruited 3350 patients were selected for inclusion in the final meta-analysis. Four trials included patients with non-ST elevation ACS (NSTEACS), whereas the remaining six trials included patients with ST elevation myocardial infarction (STEMI). There were no significant differences between immediate versus deferred PCI for the risk of major adverse cardiovascular events (NSTEACS patients: RR, 0.76, 95%CI, 0.33-1.75, P = 0.513; STEMI patients: RR, 1.24, 95%CI, 0.80-1.92, P = 0.335), myocardial infarction (NSTEACS patients: RR, 0.88, 95%CI, 0.27-2.81, P = 0.826; STEMI patients: RR, 0.86, 95%CI, 0.43-1.74, P = 0.678), all-cause mortality (NSTEACS patients: RR, 0.85, 95%CI, 0.38-1.88, P = 0.686; STEMI patients: RR, 1.16, 95%CI, 0.82-1.66, P = 0.407), target vessel revascularisation (NSTEACS patients: RR, 1.26, 95%CI, 0.29-5.43, P = 0.756; STEMI patients: RR, 1.01, 95%CI, 0.51-1.97, P = 0.988), or major bleeding (NSTEACS patients: RR, 0.99, 95%CI, 0.64-1.54, P = 0.972; STEMI patients: RR, 0.90, 95%CI, 0.45-1.77, P = 0.753). Although patients who underwent immediate PCI may experience increased incidences of cardiac death (RR, 1.19, 95%CI, 0.69-2.07, P = 0.525) and no or slow reflow (RR, 1.60, 95%CI, 0.91-2.84, P = 0.105), these increases were not statistically significant. We noted that immediate versus deferred PCI was associated with a reduced incidence of myocardial brush grade 3 (RR, 0.70, 95%CI, 0.56-0.88, P = 0.002); however, no significant differences were observed between immediate and deferred PCI for TIMI III flow (RR, 0.98, 95%CI, 0.93-1.03, P = 0.453), complete ST-segment resolution (RR, 0.93, 95%CI, 0.75-1.17, P = 0.548), and ejection fraction (WMD, -1.05, 95%CI, -2.58 to 0.49, P = 0.182). The findings of this study suggested that deferred PCI did not yield significant benefits for clinical endpoints. Further large-scale RCTs should be conducted to verify the findings of this study.

Dataset Information

Endpoint selection for noninferiority percutaneous coronary intervention trials: a methodological description.

Publications

Endpoint selection for noninferiority percutaneous coronary intervention trials: a methodological description.

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