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Treatment and prognosis after the implementation of primary percutaneous coronary intervention as the standard treatment for ST-elevation myocardial infarction

Lars Jakobsen

Summary

The efficacy of primary percutaneous coronary intervention (PPCI) has been documented in a number of randomised controlled trials (RCT) comparing PPCI to thrombolysis. However, translating RCT results into real-world settings is a challenge because the external validity of the trials may be impaired if the participants and/or the offered care are not representative of routine clinical practices. Traditionally, women, older patients, and patients with low socioeconomic status (SES) are underrepresented in RCTs addressing acute coronary syndromes.

 The aims of this thesis were to compare patient characteristics, treatment, and outcome after PPCI between real-world patients and those in an RCT population (study 1), and to compare patient characteristics, treatment, and outcome after PPCI according to sex, age, and SES in real-world patients (studies 2, and 3).

In study 1, we included 1320 real-world patients treated with PPCI and 686 patients treated with PPCI in the DANAMI-2 trial. Compared with the DANAMI-2 population, real-world patients had a higher baseline risk of adverse outcome and a higher cumulative risk of the composite endpoint of mortality, reinfarction, and stroke after 2 years (adjusted hazard ratio (HR)=1.7 (1.2– 2.3)). The results for the real-world patients eligible according to the DANAMI-2 criteria were comparable to the results from the DANAMI-2 trial. 

Study 2 included 7385 patients treated with PPCI and 42,965 matched general population controls. Women had a more adverse baseline risk profile than men. The cumulative risks of the composite endpoint after 2 years was 20.0% for women compared to 14.0% for men (adjusted HR=1.14 (0.99–1.30)). When comparing patients and controls after 90 days, the mortality among 76 the PPCI patients was comparable to the mortality in the matched general population independent of sex and age. 

We included the 7385 patients treated with PPCI in study 3. They were divided into high- and low-SES groups according to income, education, and employment status. Overall, low-SES patients had a more adverse baseline risk profile than high-SES patients. Compared to high-SES patients, low-SES patients had a higher cumulative risk of major adverse cardiac events (MACE) when using income and employment status as the indicator of SES. After adjustment for patient characteristics, the differences were substantially attenuated (maximum follow-up HR=1.16 (1.00– 1.35) and HR=1.14 (0.97–1.35)). With education as the indicator of SES, no differences were seen in the crude HRs of the composite endpoint between the two groups. 

In conclusion, our studies indicate that it has been possible to achieve trial results in realworld settings; and that women, older patients, and low-SES patients have the same prognosis as their counterparts after adjustment for differences in baseline characteristics.