Meta-analysis Upholds Complete PCI in STEMI, as Thoughts Turn to Timing, Costs

NATIONAL HARBOR, MD—Complete coronary revascularization in patients with acute myocardial infarction and multivessel disease is associated with a significant reduction in the risk of major adverse cardiovascular events, including a reduction in the risk of cardiovascular mortality, when compared with culprit-lesion-only PCI, according to an updated meta-analysis presented at CRT 2020.

In the new analysis, which includes the COMPLETE study published last summer, a comprehensive revascularization approach was associated with a 39% reduction in MACE (HR 0.61; 95% CI 0.46-0.82), apparently driven by fewer repeat revascularizations (HR 0.43; 95% CI 0.31-0.59).

Lead investigator Mahmoud Barbarawi, MD (Hurley Medical Center/Michigan State University, Flint), said the study also showed complete revascularization to be safe, with investigators seeing no increased risk of major bleeding or contrast-induced nephropathy.

Calling the meta-analysis well conducted, Valeria Paradies, MD (Maasstad Hospital, Rotterdam, the Netherlands), who cochaired the session, said one major limitation is that it included studies performed across a wide time period. Moreover, some of the studies, such as COMPARE-ACUTE, used physiology-based measures such as fractional flow reserve (FFR) to guide revascularization of nonculprit lesions, while others did not.

“There’s such wide variability [of the studies],” she told TCTMD. Nonetheless, given the strength of COMPLETE, as well as this meta-analysis, “we do know now we have to aim for complete revascularization,” she said.

Twelve Studies Spanning Wide Time Period

PCI is the mainstay of patients with acute coronary syndrome, especially STEMI, but a large percentage of patients with STEMI also present with multivessel coronary disease, which has led to questions about whether to treat the culprit lesion alone or also revascularize the more-stable lesions. The COMPLETE trial was the largest study performed to date looking at this question and clarified much of that uncertainty. After a median of 3 years, complete revascularization was associated with a significant reduction in cardiovascular mortality and MI, as well as a significant reduction in the risk of cardiovascular death, MI, or ischemia-driven revascularization.

The updated meta-analysis includes 7,592 patients drawn from COMPLETE, COMPARE-ACUTE, CvLPRIT, DANAMI3-PRIMULTI, and PRAGUE-13, among others. The studies, with the exception of HELP-AMI, which was published in 2004, were all published over the last 10 years.

Abdul Ihdayhid, MBBS, PhD (Monash Heart, Melbourne, Australia), the session cochair, questioned the absence of an MI benefit despite the significant 26% reduction in cardiovascular mortality. “In COMPLETE, there was a pretty good reduction in hard endpoints that was clearly driven by MI,” he said, referring to the statistically significant 32% MI reduction in COMPLETE.

“It’s a good question,” Barbarawi acknowledged in an interview with TCTMD. “There were less MIs in the patients who underwent complete revascularization, but the reduction wasn’t significant.” The reduction in cardiovascular mortality across these 12 studies “may be driven mainly by [less] heart failure and repeat revascularization,” he said. 

Paradies was unconvinced, telling TCTMD she doesn’t believe complete revascularization following PCI of the culprit lesion would translate into a mortality benefit. In COMPLETE, she said, there was no survival advantage, whether it was all-cause or cardiovascular mortality. 

Commenting on the different studies included in the meta-analysis, Ihdayhid pointed out that the timing of the second staged revascularization procedure varied in the different trials. In PRAMI, preventive PCI was performed during the index procedure, while the COMPLETE investigators showed that the same benefit of complete revascularization in STEMI patients was observed whether patients were treated during the index hospitalization or several weeks after discharge. 

“Timing is an issue now,” said Ihdayhid. “What do we do now?”

Both Barbarawi and Paradies said their centers typically perform complete revascularization during the index hospitalization, performing the second procedure within 24 to 72 hours, but COMPLETE changed the game by showing that the second procedure can be done several weeks later. Barbarawi said a cost-effectiveness analysis is now needed to determine the advantages of sending the patient home and bringing them back for the second PCI or performing the procedure while they’re hospitalized.

“We can wait for a few weeks for complete revascularization,” he told TCTMD. “You don’t need to just keep the patient [in the hospital]. It’s very important to study the cost-effectiveness because we’re keeping the patients for a long time and the cost of hospitalization is significant, especially in the United States.”