The results of the FREEDOM (Future Revascularization Evaluation in Patients With Diabetes Mellitus: Optimal Management of Multi-vessel Disease) trial have shown a lower rate of events in patients with diabetes and stable multivessel disease who were randomized to undergo myocardial revascularization surgery, compared to those who underwent angioplasty. Surgery even showed a mortality reduction that was on the significance limit (p = 0.049).
While randomized trials with strict protocols have great inherent validity, the application of their results in the real world may be more difficult (e.g., in the early morning and along acute coronary syndrome).
The objective of this work was to assess the impact of revascularization type (angioplasty with drug-eluting stents or surgery) in patients with diabetes and multivessel disease undergoing acute coronary syndrome, obviously excluding those with ST-segment elevation.
Researchers assessed a database from British Columbia including all patients with diabetes who underwent revascularization between 2007 and 2014 (n = 4661; 2947 of these patients experienced non-ST-elevation ACS).
The primary endpoint was the typical composite of death, infarction, and stroke (major adverse cardiac or cerebrovascular events [MACCE]), using multivariable adjustment and a propensity score model.
At 30-days post-revascularization, event rates were lower for ACS patients who underwent surgery (odds ratio [OR]: 0.49; 95% confidence interval [CI]: 0.34 to 0.71), whereas there were no differences in strategy for stable patients in that period of time.
At a mean follow-up of 3.3 years (from 31 days to 5 years), the benefit of surgery was no longer affected by the type of presentation. Events were lower with surgery both for ACS patients (OR: 0.67; 95% CI: 0.55 to 0.81) and stable patients (OR: 0.55; 95% CI: 0.40 to 0.74).
Patients with diabetes and multivessel disease who experience non-ST-elevation acute coronary syndrome present less combined events with surgery vs. angioplasty.
In the long-term follow-up, all components of the primary endpoint had significantly lower rates with surgery, including a 52% relative reduction in all-cause mortality.
Patients in this cohort were older, had more comorbidities, and worse ventricular function that the FREEDOM population, but they also had lower rates of 3-vessel lesions (43% vs. 83%).
However, comparing this trial with the FREEDOM trial, in which randomization balanced all differences, seems whimsical.
In this work, there were significant clinical and angiographic differences between both treatment strategies. The fact that patients who underwent angioplasty in a real-world setting would be older, present more comorbidities, have lower ejection fraction, etc., was foreseeable. Authors used several statistical tools to balance out these differences, but definitive conclusions will obviously be hard to reach without a randomized trial.
Original title: Surgical Versus Percutaneous Coronary Revascularization in Patients with Diabetes and Acute Coronary Syndromes.
Reference: Krishnan Ramanathan et al. J Am Coll Cardiol 2017;70:2995-3006.
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