Meta-analysis Supports Benefit of Complete Revascularization in STEMI
For STEMI patients with multivessel disease, complete revascularization during the index procedure appears to lower MACE risk. The difference is driven by reductions in recurrent MI and repeat revascularization, according to a meta-analysis published online June 2, 2015, ahead of print in Heart.
The findings suggest a “paradigm shift” away from the idea that there are more ischemic complications with complete revascularization, study author Eliano P. Navarese, MD, PhD, of Heinrich Heine University Düsseldorf (Düsseldorf, Germany), told TCTMD in a telephone interview. This new take, he added, should soon be recognized by guidelines committees.
Dr. Navarese and colleagues pooled data from 7 trials—including CvLPRIT and PRAMI—randomizing a total of 1,303 STEMI patients with multivessel disease to either complete (n = 637) or “noncomplete” (n = 666) revascularization during the index procedure. The noncomplete group encompassed culprit-only PCI and staged procedures. Median follow-up was 12 months.
The meta-analysis’ primary endpoint was MACE, whose components varied among studies but typically included death, recurrent MI, and repeat revascularization. Complete revascularization carried lower risks of MACE, recurrent MI, and repeat revascularization (table 1). Rates of cardiovascular and all-cause mortality did not differ between groups.
Findings were similar after adjustment for variation in the length of follow-up between studies and when comparing complete with culprit-only revascularization. Pitting complete revascularization during the index procedure against staged procedures, however, revealed no differences in clinical outcomes.
Results Challenge Guidelines
Current European and US guidelines advocate culprit-vessel–only PCI in hemodynamically stable STEMI patients, and the US document even contains a class III recommendation (indicating harm) against complete revascularization. But those recommendations are based largely on observational data.
Since the guidelines were released, the PRAMI and CvLPRIT trials have shown improved outcomes with a complete approach, causing the American College of Cardiology to pull back somewhat on its stance against complete revascularization by withdrawing one of its “Choosing Wisely” recommendations.
But Dr. Navarese contends that there is enough evidence to change the guidelines, citing the consistency between the current meta-analysis and a prior one he and his colleagues published in 2011.
“With recent advancements in the procedural strategies, having evolved from balloon angioplasty to new-generation DES and novel antithrombotic and antiplatelet regimens, coupled with increasing operator experience, complete [multivessel PCI] is now proven to be feasible and safe during STEMI,” the authors write. “Staged or deferred intervention, on the other hand, may not achieve a similar magnitude of the effect, as the majority of adverse events occur during the early phase after STEMI.”
The results of the meta-analysis “assume particular relevance in STEMI,” they continue. “[I]ndeed, they substantiate the assertion that the other nonculprit lesions can serve as prothrombotic milieu during the acute phase and, if untreated, present as new MI becoming culprit themselves, eventually leading to increased ischemic burden and worse clinical outcomes.”
Outcomes ‘Too Good to Be True’
But Sripal Bangalore, MD, MHA, of NYU Langone Medical Center (New York, NY), questioned the magnitude of the some of the observed differences, calling the reduction in recurrent MI and the trend toward a reduction in cardiovascular death “too good to be true.”
“With only 1,300 patients from 7 randomized trials, the analysis is underpowered for hard events, such as death or MI,” he told TCTMD in an email. “We showed that the traditional meta-analysis is problematic as it does not take into consideration the power to detect a difference.”
Using more robust techniques that account for accumulated sample size, “we showed that the current body of data is robust enough to show reduction in MACE driven by reduction in repeat revascularization, without firm evidence for death or MI,” Dr. Bangalore said. Those findings are confirmed by more recent trials, including DANAMI3-PRIMULTI and PRAGUE-13, he added.
More information on complete revascularization is forthcoming when the 3,900-patient COMPLETE trial concludes, Dr. Bangalore said. But in the meantime, he continued, “randomized trials at least point at no harm with complete revascularization with suggestion of a benefit. This may be one more area where the guideline committee got it wrong based on observational studies.”
Dr. Bangalore suggested that it might be time for change in that “the guidelines should be more open for complete revascularization (perhaps class IIB). However…, we still haven’t reached a stage where [it] should be a class I indication.”
Kowalewski M, Schulze V, Berti S, et al. Complete revascularization in ST-elevation myocardial infarction and multivessel disease: meta-analysis of randomised controlled trials. Heart. 2015;Epub ahead of print.
- Drs. Bangalore and Navarese report no relevant conflicts of interest.