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Complete PCI after STEMI: OK to Delay

SAN FRANCISCO — Complete revascularization appeared to hold about the same benefit for ST-segment myocardial infarction (STEMI) in multivessel disease whether the second stage was immediate or at a second admission soon thereafter, a COMPLETE trial substudy showed.

A strategy of routine staged percutaneous coronary intervention (PCI) of all angiographically significant lesions reduced risk of cardiovascular death or new MI over a median 3 years compared with culprit lesion-only stenting by:

  • 23% if the second stage was done during the index hospitalization at a median of 1 day after treating the culprit lesion (P=0.047)
  • 31% if the second stage was done up to 45 days after discharge (median 23, P=0.032)

Adding in ischemia-driven revascularization yielded similar results, and both these co-primary outcomes showed no significant interaction between timing and the advantage over not treating non-culprit lesions, reported David Wood, MD, of the University of British Columbia in Vancouver, at the Transcatheter Cardiovascular Therapeutics annual meeting.

Primary results reported at the 2019 European Society of Cardiology meeting in Paris showed that the upfront approach to complete PCI conferred a 26% relative reduction in cardiovascular death or MI, and 49% fewer such events combined with ischemia-driven revascularization.

Landmark analysis showed the curves separating after 45 days, with greater magnitude of benefit than seen in the earliest period after revascularization.

“The benefit occurs late,” Wood said at a TCT press conference. “This is like diabetics getting coronary artery bypass graft surgery — the fact that what you do now, achieving a residual SYNTAX score of zero in over 90% of patients, resonates 1, 2, 3 years down the road.”

While either timing is “fine,” commented Marie-Claude Morice, MD, of the Institut Cardiovasculaire Paris Sud, “personally if I was a patient, I would like to have everything fixed as early as possible as opposed to coming back for the second hospitalization. But, there is no price to pay for delay.”

“The implications are truly staggering — not just for patients,” Wood agreed. In his region of British Columbia, adding even a conservative estimate of 1,200 second admissions for complete revascularization in the 45 days post-STEMI “the logistics of that in our socialized medicine system are important. … Logistically in the U.S. and the U.K., you cannot come back for a second procedure before 30 days for remuneration either for the physician or the institution.”

ICD codes may need to change to accommodate this revascularization planning and strategy, suggested TCT press conference moderator Roxana Mehran, MD, of Mount Sinai Hospital in New York City.

There are implications for quality metrics, too, commented Dharam Kumbhani, MD, of UT Southwestern Medical Center in Dallas, and a discussant for the study at the TCT press conference.

“Let’s say you bring somebody back at day 45 and you’ve just done the index vessel. And let’s say they have no symptoms. So now the quality metrics are going to look at this patient and say prior-MI. When you bring that patient back in at day 45, he is actually asymptomatic, he may not have a positive stress,” he said. “On the face of it, then that may look to be an unnecessary PCI.”

COMPLETE included 4,041 STEMI patients successfully treated with PCI for the culprit lesion at 140 centers in 31 countries who were then randomized within 72 hours to either another PCI for non-culprit lesions or no further revascularization. Cardiogenic shock was excluded.

Enrollment was stratified by intended timing of non-culprit-lesion PCI, which operators had specified before the patient’s randomization. One-third of the complete revascularization group had their second PCI after hospital discharge.

The threshold for angiographic significance of non-culprit lesions was 70% stenosis on visual estimation, or as little as 50% stenosis if accompanied by a low fractional flow reserve.

Both groups got guideline-recommended medical therapy, including dual antiplatelet therapy with aspirin and ticagrelor (Brilinta) for at least 1 year.

TCT session discussion panelist Anthony Gershlick, MBBS, of the University of Leicester in England, cautioned about overinterpreting the findings given that selection of timing was not randomized. Since physicians had a say in which patients they would do early versus later, it could be that they decided to treat sicker patients earlier, he said.

Shamir Mehta, MD, of McMaster University in Hamilton, Ontario, countered that given how similar the event rate was between the two complete revascularization groups, there was unlikely to be significant bias there.

Wood also pointed out that anatomic and clinical factors were similar between timing groups.

COMPLETE was supported by Canadian Institutes of Health Research, Canadian Network and Center for Trials Internationally, Population Health Research Institute, and unrestricted grants from AstraZeneca and Boston Scientific.

Wood disclosed no relevant relationships with industry.