Preventive Coronary Stents: Not There Yet

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The PREVENT trial on stenting stable plaques deemed vulnerable by imaging criteria suggests a benefit over medical therapy alone. John Mandrola, MD, finds it provocative but not yet ready to act on.

The surprise came because many thousands of patients have been randomized in trials of PCI as an add-on to medical therapy and the results have been clear: PCI improves outcomes inbut adds no benefit over meds in stable patients. More than 80% of patients enrolled in PREVENT had stable coronary disease.

Patients were 65 years of age on average, 73% were men, and approximately one third of them also had PCI of a non-target lesion. In the PCI arm, 9% of patients crossed over to medical therapy alone and 1% of those in the medical arm received preventive PCI.At 2 years, a primary outcome event occurred in three patients in the PCI arm and 27 patients in the control arm.=·.0003). Converting to relative risk yields a hazard ratio of 0.11 .

Longer follow-up exposes the fragility of that result. As the number of events accrued, the difference in events lessened. At 4 and 7 years, the lower rates of the primary outcome in the PCI arm no longer met statistical significance. If the treatment was as good as an 89% lower hazard rate would suggest, you'd expect more events to strengthen, not weaken, confidence in the treatment effect.

Another factor favoring the lower rate of cardiac events in the PCI arm was that far more of these patients were taking P2Y12 inhibitors at 2 years: 79% vs 42% of the medical therapy group. While I wish the journal editors and reviewers disallowed the enthusiastic conclusion of the authors, trials like PREVENT should be published.

Finally, I worry that the enthusiasm from the ACC meeting could induce expanding use of PCI. It should not.

Source: Healthcare Press (healthcarepress.net)

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