番茄社区

BOSTON -- For multivessel coronary artery disease, percutaneous coronary intervention (PCI) pulled even, statistically speaking, with surgery for outcomes after a median of nearly 12 years of follow-up in the Korean BEST trial, but it appeared unlikely to change minds on relative merits of the two approaches.

The primary composite endpoint of death from any cause, myocardial infarction, or target-vessel revascularization occurred in 34.5% of PCI-treated patients and 30.3% of those who received coronary artery bypass grafting (CABG; HR 1.18, 95% CI 0.88-1.56).

There were also no significant differences in a safety composite of death, myocardial infarction, or stroke, or all-cause mortality alone, at a median 11.8 years of follow-up, reported Jung-Min Ahn, MD, of Asan Medical Center in Seoul, during the Transcatheter Cardiovascular Therapeutics (TCT) meeting hosted by the Cardiovascular Research Foundation (CRF). The results were simultaneously published in .

"This extended follow-up study was important for long-term insights for how to decide revascularization strategy in patients with multivessel disease," Ahn said at a press conference for the late-breaking clinical trial session.

"Still, bypass surgery is the gold standard for the treatment of multivessel disease patients," he added. "Some patients want to avoid major bypass surgery. If they have suitable anatomy for PCI, then I think based on this trial PCI would be the reasonable alternative to the bypass surgery if PCI was performed with current generation drug-eluting stents under image guidance."

That message was seconded by TCT press conference panelist Carlo Di Mario, MD, PhD, of Careggi University Hospital in Florence, Italy. "With the exception of diabetes and extremely diffuse disease, there are no signals in favor of CABG versus PCI for mortality and stroke, the two truly hard endpoints. There is an advantage in terms of less target-lesion revascularization -- in my view a small price to pay."

In the trial, secondary endpoints favored CABG with a relative 86% lower risk of spontaneous myocardial infarction (3.8% vs 7.1%, P=0.03) and a 92% lower likelihood of any repeat revascularization (12.7% vs 22.6%, P<0.001).

Prior multivessel disease studies have shown better outcomes with CABG over PCI in the short term (at 1 year with fractional flow reserve-guided use of current-generation stents in the ) and through 5 years (in a diabetes population with first-generation drug-eluting stents in ) and 10 years (with first-generation drug-eluting stents in for three-vessel disease).

, which randomized patients to second-generation everolimus-eluting stents versus CABG, showed higher risk of the primary endpoint with PCI at 2 years (11.0% vs 7.9%, P=0.32 for noninferiority).

With regard to the long-term results, press conference panelist Eric A. Cohen, MD, of the Schulich Heart Program at Sunnybrook Health Sciences Centre in Toronto, noted, "I don't think statistically there's anything here clearly inconsistent with other findings. The fact that at 10 years these findings look slightly more favorable or less detrimental for PCI might reflect the higher use of intravascular imaging, the single stent platform, and completeness of revascularization being relatively higher [compared with prior trials]."

The extended clinical follow-up portion of the trial included data on 865 patients of the originally enrolled 880 (out of a planned 1,776 due to slow enrollment) who were followed for a minimum of 8 years and up to 13.7 years. Complete revascularization had been achieved in 50.9% of PCI patients and 71.5% of CABG patients.

Completeness of revascularization "is an issue that favors bypass surgery," noted Di Mario. "I agree 50% doesn't look so high, despite being higher than other previous CABG versus PCI trials."

Ahn said that a subgroup analysis pointed to no interaction between complete and incomplete revascularization for the primary endpoint. A landmark analysis at 5 years of follow-up showed similar findings to the overall analysis for the primary and safety endpoints as well.

But the picture might be different in a trial that was performed now, Di Mario suggested. "Now that CTO [chronic total occlusion] techniques have improved, probably this percentage [complete revascularization] is likely to reach the surgical level."

However, what Ahn called an "interesting hypothesis-generating analysis" suggested that intravascular ultrasound (IVUS) guidance, used in about 72% of PCI cases in the trial, had a substantial impact on the outcomes. With IVUS, the primary endpoint rate was 22.8%, on par with CABG's 24.0%, whereas it was 44.3% for PCI without IVUS. All-cause mortality occurred in 11.6% of IVUS-guided PCI cases, similar to the 15.7% with CABG, but 24.5% with PCI sans IVUS.

Noting that the repeat revascularization difference between strategies was "essentially nullified" with IVUS, press conference moderator Gary Mintz, MD, of the CRF and MedStar Cardiovascular Research Network in Washington, D.C., said, "It's sort of time to compare modern PCI versus modern surgery, rather than just letting people do whatever they want."

Ori Ben-Yehuda, MD, of the CRF Clinical Trials Center in New York City, another press conference moderator, also noted that "modern PCI" often does not mean IVUS guidance in real-world practice. "My take-away is that individual patient decision making, and particularly having the patient as an advocate for themselves, is very important here, where outcomes are very similar over time."

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