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• Percutaneous Coronary Intervention
• Comparison of Revascularization Procedures in Coronary Artery Disease
• Cardiogenic Shock

NEW YORK, NY — A new analysis is calling into question the de facto rationale for many of the revascularization procedures taking place today, at least in patients with stable coronary artery disease^[1]. In a meta-analysis of more than 5000 patients, PCI was no better than medical therapy in patients with documented ischemia by stress testing or fractional flow reserve (FFR).

“Cardiology has a long history of finding a marker of a bad outcome and treating that marker of that bad outcome as if it were the cause of the bad outcome,” senior author on the study, Dr David Brown (State University of New York [SUNY]–Stony Brook School of Medicine), told heartwire . In the case of proceeding to PCI on the basis of documented ischemia, that stems from evidence that patients with ischemia have a worse prognosis than patients who don’t.”It has gotten to the point that a positive stress test [is the gateway] to doing an intervention, even if the ischemia is not in the same ischemic territory as the vessel being treated,” he said. “The medical/industrial complex in cardiology is now focused on finding and treating ischemia, and I think that’s not justified, and these data suggest that that’s not justified.”

Brown and colleagues, with first author Dr Kathleen Stergiopoulus (SUNY–Stony Brook School of Medicine), reviewed the literature for randomized clinical trials of PCI and medical therapy for stable CAD conducted over the past 40 years, ultimately including five trials of 5286 patients. These were a small German trial published in 2004, plus MASS II , COURAGE , BARI 2D , and FAME 2 . In all, 4064 patients had myocardial ischemia documented by exercise, nuclear or echo stress imaging, or FFR.

Over a median follow-up of five years, mortality, nonfatal MI, unplanned revascularization, and angina were no different between patients treated medically vs those treated with PCI.

Odds Ratio, PCI vs Medical Therapy

Outcome	Odds ratio	95% CI
Death	0.90	0.71–1.16
Nonfatal MI	1.24	0.99–1.56
Unplanned revascularization	0.64	0.35–1.17
Angina	0.91	0.57–1.44

“These findings are unique in that this is the first meta-analysis to our knowledge limited to patients with documented, objective findings of myocardial ischemia, almost all of whom underwent treatment with intracoronary stents and disease-modifying secondary-prevention therapy,” Stergiopoulus et al write.

The findings, they continue, “strongly suggest that the relationship between ischemia and mortality is not altered or ameliorated by catheter-based revascularization of obstructive, flow-limiting coronary stenosis.”

To heartwire , Brown pointed out that their analysis could not separate out patients who had small amounts of ischemia from those with larger ischemic territories. “Maybe that’s where the differentiating factor will be,” he acknowledged, adding that the 8000-patient ISCHEMIA trial, still ongoing, will hopefully yield some insights.

Current practice, however, is to check for ischemia and to proceed with catheterization and, usually, revascularization when ischemia is confirmed by stress testing or during FFR. “But if that doesn’t improve outcomes, why are we doing it?” Brown asked. “We think that needs to be rethought.”

Commenting on the study for heartwire , Dr Peter Berger(Geisinger Health System, Danville, PA) pointed out: “There is no question that PCI is more effective than medical therapy for relief of symptoms: the more severe the angina and the more active the patient, the greater the superiority of PCI.” And, as Berger noted, most of the studies included in this analysis documented ischemia but did not report on the frequency or severity of angina at baseline.

That said, “Patients with minimal angina—and certainly those with silent ischemia but no angina—are unlikely to have a significantly greater reduction of symptoms with PCI, and PCI is rarely beneficial in such patients.”

Moreover, Berger continued, it has been clearly established that PCI does not reduce the risk of death or MI in most such patients.

“I very much agree with the authors, however, that just because more severe ischemia has been shown to be associated with a worse long-term prognosis, reducing the ischemic burden ought not be assumed to reduce the likelihood of death or MI. In most such patients, it does not.”

Stergiopoulos and Brown had no disclosures. Disclosures for the coauthors are listed in the paper.