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Observational studies and the biologic plausibility linking coronary obstruction to angina have stimulated the use of percutaneous coronary intervention (PCI) in patients with angina and severe obstruction. Until now, no randomized studies have examined this link. In this first, blinded, sham-controlled, randomized study, investigators examined effects of PCI in 200 patients with stable chronic ischemic symptoms who were receiving intensive medical therapy (NCT02062593).
All patients had severe (≥70%) stenosis in a major epicardial coronary artery and underwent an intensive 6-week medication optimization period, including up-titration from about 1 to 3 medications, with multiple weekly physician consultations. Afterwards they were randomized in the catheterization laboratory to PCI or a sham procedure.
Six weeks later, the groups showed no significant differences on the primary endpoint, incremental improvement in exercise treadmill time (PCI, 28 seconds; sham surgery, 12 seconds). Groups also did not differ in improvements in time to 1-mm ST depression, peak oxygen uptake, Seattle Angina Questionnaire physical function or angina frequency, and quality-of-life score. PCI was associated with a small, significantly greater improvement in ischemia, as measured by wall-motion index score on dobutamine stress echocardiography (difference, –0.09).
Al-Lamee R et al. Percutaneous coronary intervention in stable angina (ORBITA): A double-blind, randomised controlled trial. Lancet 2017 Nov 2; [e-pub]. (http://dx.doi.org/10.1016/S0140-6736(17)32714-9)
Brown DL and Redberg RF.Last nail in the coffin for PCI in stable angina? Lancet 2017 Nov 2; [e-pub]. (http://dx.doi.org/10.1016/S0140-6736(17)32757-5)
Comment
Outcomes from this fascinating trial are surprising to interventionalists but are not “unbelievable,” as suggested in the New York Times. In my view, they emphasize the great benefits of antianginal medication, which should continue to be first-line therapy. This small (though well-done) study enrolled very stable patients with angina lasting ~9 months, employed very intensive medical optimization, but had only 6 weeks of follow-up. As the authors note, the findings do not imply that patients should never undergo PCI for stable angina and do not apply to acute coronary syndromes, for which PCI has well-proven benefits.
Will I think twice before stenting the next proximal left anterior descending artery with 80% stenosis? Yes. Will I never stent such a patient? No. Should the guidelines be changed (as editorialists suggest)? Not yet.