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Redo PCI or CABG, Left Main Patients Pay a Price: EXCEL

Repeat revascularization was more frequent after left main percutaneous coronary intervention (PCI) than coronary artery bypass surgery (CABG), but raised the mortality risk after both procedures in a secondary EXCEL analysis.

The 3-year rate of any repeat revascularization was 12.9% after PCI and 7.6% after CABG (hazard ratio [HR], 1.73; 95% CI, 1.28 – 2.33).

“It’s a real difference and shouldn’t be minimized. About one in 20 patients will need an additional repeat revascularization after PCI, compared with surgery,” study author Gregg Stone, MD, Icahn School of Medicine at Mount Sinai in New York City, told theheart.org | Medscape Cardiology. “Surgery is a more durable procedure in that regard and patients need to be informed of that by heart team discussions.”

That said, Stone highlighted other differences between the two strategies, including more bleeding and atrial fibrillation after surgery and better early quality of life after PCI. There’s also an early myocardial infarction (MI) benefit with PCI but a late MI benefit with surgery, which “is probably a more important difference between the two, as opposed to the difference in repeat revascularization,” he added.

Although the increased need to perform repeat vascularization after PCI is not unexpected, the analysis of 346 repeat revascularizations in 185 patients provides more details on the timing and prognosis of these procedures in left main disease.

The need for repeat revascularization was independently associated with 3-year all-cause mortality (adjusted HR, 2.05; 95% CI, 1.13 – 3.70) and cardiovascular mortality (adjusted HR, 4.22; 95% CI, 2.10 – 8.48) for both PCI and CABG (P for interaction = .85 for both outcomes).

The increase in mortality risk, however, was smaller than that for MI (adjusted HR, 4.03; 95% CI, 2.43 – 6.67) or stroke (adjusted HR, 16.62; 95% CI, 9.97 – 27.69).

The risk for death peaked in the 30 days after redo revascularization and then declined during follow-up. Nearly all of the deaths were cardiovascular (74/128).

The incidence of repeat left main PCI was only 17.5%, whereas the left main was the most common site for redo revascularization in the CABG group.

Repeat revascularization of the index target vessel and target lesion — but not of other lesions — were both strongly associated with increased all-cause and cardiovascular mortality, the authors reported January 15 in JACC: Cardiovascular Interventions.

“It just continues to show that no matter what intervention we use, we haven’t achieved perfection yet, and the opportunities for improvement and decision making between a PCI and a CABG is still up in the air,” Richard J. Shemin, MD, chief of cardiac surgery, UCLA Medical Center, Los Angeles, told theheart.org | Medscape Cardiology. “And there’s some evidence to suggest coronary bypass might be better in terms of mortality and the need for repeat revascularization.”

Enhancing Durability

“Measures to reduce the need for repeat revascularization including improved stent platforms and implantation technique, use of pan-arterial bypass grafting and aggressive risk factor control with guideline-directed medical therapy may improve prognosis after both PCI and CABG,” the authors conclude.

In a linked editorial, David O. Williams, MD, and Pinak B. Shah, MD, both with Brigham and Women’s Hospital and Harvard Medical School, Boston, say intravascular imaging should be “mandatory for all complex PCI,” but that intravascular ultrasound was used in only 77.2% of cases in EXCEL.

“There are also data suggesting careful image guidance during complex PCI is associated with a mortality benefit,” they write. “In a similar fashion, arterial revascularization (especially with a mammary artery graft to the LAD) and complete revascularization during CABG needs to be achieved.”

“Surgeons need to be intellectually challenged to not take the easy way out and just do a saphenous vein graft,” Shemin agreed. “And because we are dealing with an underlying progressive disease, continued medical and preventive measures to prevent atherosclerosis are key.”

Higher body mass index, insulin-treated diabetes, and hemodynamic support during the procedure were associated with a higher risk for repeat revascularization after PCI, whereas statin use at discharge was protective.

Younger age, female sex, and peripheral vascular disease were independent predictors of repeat revascularization after CABG.

Most redo procedures were performed by PCI in both groups. However, repeat revascularization by CABG was more common during follow-up in patients randomized to initial PCI vs CABG (3.3% vs 0.8%; P = .0002) and was significantly associated with increased all-cause mortality.

“This observation suggests that CABG should be reserved for repeat revascularization procedures that are not amenable to repeat PCI, irrespective of the initial revascularization approach,” the authors write.

The editorialists point out that more than half of EXCEL patients with one repeat revascularization went on to have another. Overall, 55.1% of patients underwent one repeat revascularization, 22.2% underwent two redos, and 22.7% underwent more than two redos.

Although enhancing the durability of the initial revascularization is an important goal, “one might also conclude that a safer and potentially more durable treatment specifically developed for recurrent lesions is as equally an important objective,” they opine.

5-Year Kerfuffle

As previously reported, the EXCEL trial’s 5-year analysis showed no significant difference between PCI and CABG for the primary end point of all-cause death, MI, or stroke.

However, recent allegations that key MI data were withheld have called into question the final conclusion of relative parity, and led the European Association for Cardio-Thoracic Surgery (EACTS) to withdraw support for the left main portion of the 2018 EACTS-European Society of Cardiology (ESC) clinical guidelines based on 3-year EXCEL outcomes.

This week, the Society of Thoracic Surgeons (STS) joined EACTS and the American Association for Thoracic Surgery in calling for independent reanalysis of the EXCEL data.

“Any final conclusions drawn from the EXCEL trial will not only affect the actions of physicians, surgeons, regulatory agencies, and third-party payers but, more importantly, they will seriously impact the health and wellbeing of our patients and their families for years to come,” the statement says.

“Given such potentially profound consequences, the Society believes that the final interpretation regarding the outcomes of the EXCEL study should wait until an independent analysis of all aspects of the EXCEL study has been performed.”

EXCEL was sponsored by Abbott Vascular. Stone reports speaker honoraria from Terumo and Amaranth and serving as a consultant to Reva. Coauthor conflict of interest disclosures are listed in the paper. Shemin reported no relevant conflicts of interest.

J Am Coll Cardiol Intv. Published online January 15, 2020. Abstract, Editorial

Follow Patrice Wendling on Twitter: @pwendl. For more from theheart.org | Medscape Cardiology, join us on Twitter and Facebook.




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