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Comparison between patients included in randomized controlled trials of ischemic heart disease and real-world data. A
Peter Nørkjær Laursen1, Lene Holmvang1, Jacob Lønborg1
1Department of Cardiology, The Heart Centre, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark.
Insights
Patients undergoing percutaneous coronary intervention (PCI) in randomized controlled trials (RCTs) had lower mortality than non-participants. These findings highlight that RCT results for PCI may not represent the general ischemic heart disease population.
Area of Science:
- Cardiology
- Clinical Trials
- Public Health
Background:
- Ischemic heart disease (IHD) is a leading cause of mortality worldwide.
- Percutaneous coronary intervention (PCI) is a common revascularization procedure for IHD.
- Randomized controlled trials (RCTs) are crucial for evaluating PCI efficacy, but their generalizability is debated.
Purpose of the Study:
- To compare mortality rates between patients with IHD undergoing PCI who were included in RCTs versus those not included.
- To assess if the indication for PCI influences the representativeness of RCT participants.
Main Methods:
- A cohort study comparing RCT participants and non-participants with IHD undergoing PCI in Denmark (2011-2015).
- Utilized unselected national registry data for patient identification.
- Primary endpoint was all-cause mortality.
Main Results:
- 30% of patients (10,317) were RCT participants; 70% (23,644) were non-participants.
- Non-participants had significantly higher mortality rates compared to trial participants (HR: 2.03, 95% CI: 1.88-2.19).
- This mortality difference persisted across all indications for PCI.
Conclusions:
- RCT participants undergoing PCI are not representative of the general IHD patient population regarding clinical characteristics and mortality.
- Results from RCTs on PCI should be cautiously extrapolated to the broader patient population.
- The disparity in outcomes between trial participants and non-participants is independent of the PCI indication.
Background:
The objective was to compare patients with ischemic heart disease (IHD) undergoing percutaneous coronary intervention (PCI) who were included in randomized controlled trials (RCTs) (trial participants) with patients who were not included (nonparticipants) on a trial-by-trial basis and according to indication for PCI.
Methods:
In this cohort study, we compared patients with IHD who were randomized in RCTs in relation to undergoing PCI in Denmark between 2011 and 2015 were considered as RCT-participants in this study. The RCT-participants were compared with contemporary nonparticipants with IHD undergoing PCI in the same period, and they were identified using unselected national registry data. The primary end point was all-cause mortality.
Results:
A total of 10,317 (30%) patients were included in 10 relevant RCTs (trial participants), and a total of 23,644 (70%) contemporary patients did not participate (nonparticipants). In all the included RCTs, nonparticipants had higher hazard ratios for mortality compared to trial participants (P < .001). Among all patients treated with PCI, the pooled estimates showed a significantly higher mortality rate for nonparticipants compared to trial participants (hazard ratio: 2.03, 95% CI: 1.88-2.19) (P < .001). When patients were stratified according to indication for PCI, the pooled estimates showed a significantly lower mortality rate for trial participants compared to nonparticipants in all strata (P for all < .001).
Conclusions:
Trial participants in recently performed RCTs including patients undergoing PCI were not representative of the general population of patients with IHD treated with PCI according to clinical characteristics and mortality. The difference in mortality was found irrespective of the indication for PCI. Thus, results from RCTs including patients undergoing PCI should be extrapolated with caution to the general patient population.
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