PRAGUE-13 Finds No Advantage to Complete Revascularization After Primary PCI

PARIS, France—On the heels of studies finding complete revascularization superior to culprit-only PCI in STEMI patients with multivessel disease, data from PRAGUE-13 presented May 19, 2015, at EuroPCR suggest that the 2 strategies produce equivalent results.

The CvLPRIT and PRAMI trials both drew headlines for their support of complete revascularization, as did the more recently reported DANAMI3-PRIMULTI, which employed FFR guidance for PCI.

For PRAGUE-13, Ota Hlinomaz, MD, PhD, of St. Anne University Hospital (Brno, Czech Republic) tested 2 management strategies in 214 STEMI patients with at least 1 significant stenosis (≥ 70%) in a nonculprit artery who were enrolled between 2009 and 2013. The patients, deemed suitable for either strategy by an interventional cardiologist, were randomized to:

• Complete revascularization (n = 106): PCI of all significant stenoses in non-infarct coronary arteries (staged PCI performed between days 3 and 40 after the index procedure)
• Conservative management (n = 108): standard guideline-based medical therapy given after primary PCI in the culprit lesion

Baseline characteristics were similar between groups, and patients were “low risk” overall, said Dr. Hlinomaz. Mean ejection fraction at discharge was 48.7% and the mean time from symptom onset to primary PCI was 229 minutes. Only 6.1% of patients had nonculprit artery stenosis of 95% or higher, and the average nonculprit stenosis was 80%.

Results Consistent Over Long Term

Median follow-up duration was 38 months. Kaplan-Meier estimated risk of the primary composite endpoint (all-cause mortality, nonfatal MI, and stroke) did not differ between the complete and conservative arms through approximately 6 years. Long-term rates of the composite endpoint, all-cause mortality, and nonfatal MI were similar between the 2 groups. There were 3 cases of stroke, all in patients treated conservatively (table 1).

Four periprocedural MIs occurred in the complete revascularization group, though all affected patients had “good prognosis,” Dr. Hlinomaz noted.

The strategies also compared well for all secondary endpoints apart from crossover to another treatment group, which as expected was less common in patients randomized to receive complete revascularization vs those assigned to conservative management (HR 0.25; 95% CI 0.09-0.68). No nonculprit lesions progressed to MI during follow-up, and progression of such lesions was “very rare,” Dr. Hlinomaz reported.

Why PRAGUE-13 Stands Apart

PRAGUE-13 diverges from PRAMI and CvLPRIT, he said, by excluding patients with angina more than one month before primary PCI. Patients were more selected in the current trial, which also notably used few DES. In addition, in PRAMI and CvLPRIT the percentages of nonculprit lesions treated during primary PCI were 100% and 60%, respectively, meaning that it was “almost impossible to diagnose periprocedural MI,” Dr. Hlinomaz noted.

“In conclusion, this trial found no difference—not even a trend—favoring staged multivessel PCI over culprit-only primary PCI in STEMI,” he emphasized. “Larger trials are needed to clarify the [best] revascularization strategy in STEMI patients with multivessel disease.”

After the presentation, panelist Thomas Engstrøm, MD, PhD, DMSci, of Rigshospitalet (Cophenhagen, Denmark), asked for further clarification on how PRAGUE-13 differs from PRAMI. In addition to the inability to detect periprocedural MI in the complete revascularization arm of PRAMI, another influence may be the degree of stenosis in nonculprit lesions, Dr. Hlinomaz said. In PRAGUE-13, he reported, such lesions were less severe.

Source: 
Hlinomaz O. Multivessel coronary disease diagnosed at the time of primary PCI for STEMI: complete revascularization versus conservative strategy: the PRAGUE 13 trial. Presented at: EuroPCR; May 19, 2015; Paris, France.

Disclosures:

• Dr. Hlinomaz reports no relevant conflicts of interest.

Related Stories:

• CvLPRIT: Complete Revascularization Halves MACE Risk in STEMI Patients
• PRAMI: Strong Showing for Complete Revascularization in Acute STEMI Patients
• Trials Prompt Interventionalists to Reconsider Complete Revascularization for STEMI