PARIS — Repeat revascularizations almost derailed a contemporary cath lab strategy of using SYNTAX II scores for patients with 3-vessel disease, a study suggests.
The novel workflow involved using instantaneous wave-free ratio (iFR) and fractional flow reserve (FFR) assessment to determine the right patients who will subsequently receive the Synergy stent with intravascular ultrasound (IVUS) optimization.
Thirty-day rates of adverse outcomes — including death, stroke, myocardial infarction, and repeat revascularization — were no different between patients who got percutaneous coronary intervention (PCI) in the SYNTAX II trial in comparison to their historical peers in the preceding investigation, SYNTAX I (2.9% versus 4.4%, log-rank P=0.35).
Yet when repeat revascularization was clarified to include only clinically indicated re-interventions, an advantage indeed emerged for the SYNTAX II cohort (0.4% versus 4.4%, log-rank P<0.001), according to Patrick W. Serruys, MD, PhD, of Imperial College, London, at his late-breaking trial presentation at EuroPCR.
The reduction in adverse events was driven by fewer instances of myocardial infarction (0.2% versus 4.1%, P<0.001) and stent thrombosis (0.4% versus 2.5%, P=0.019).
A landmark trial from 2008, SYNTAX I originally suggested better outcomes after coronary artery bypass grafting (CABG) in lieu of PCI. Since then, advancements in cardiovascular imaging and stent technology had given hope that contemporary practice in the cath lab can do better.
SYNTAX II today therefore “is not a study about physiological assessment, nor is it a study about IVUS nor stents. It’s a study putting it all together in one strategy,” Serruys emphasized.
Altogether, “iFR, FFR, and IVUS-guided PCI for multivessel coronary artery disease with the Synergy stent and the SYNTAX II strategy resulted in lower myocardial infarction and stent thrombosis rates at 30 days when compared to the control of the SYNTAX I trial,” he concluded.
Why more repeat revascularizations in SYNTAX II, then?
Counting just 5 such cases in the SYNTAX I PCI arm (1.6%), as opposed to 12 in the new group (2.6%), Serruys said that 7 of the latter re-interventions could be attributed to “strategy failures” such as stent thrombosis or failed index PCI — that left 5 unnecessary revascularizations that he dubbed “re-touching.”
“Remember I created the term ‘oculostenotic reflex.’ I think we have a new oculostenotic reflex,” Serruys warned, which “lead to an artificially high repeat revascularization rate associated with the new stent.”
“Today, for reasons sometimes economical, we have a large number of staged procedures,” he added. “We know when we put the patient on the table a second and a third time for financial reasons, societal reasons, reimbursement. And that’s not good medicine.”
Serruys continued: “Ideally, as a patient you would like to go on the table one time and be finished. That’s what a surgeon can do.”
The present study found that “staged procedures were frequently used and had to be adjudicated for the exclusion of possible repeat revascularization. That, for the trialists, is a major issue for the future,” the presenter commented.
The prospective study included 450 patients from an all-comers population whose SYNTAX II scores indicated a strategy of CABG or PCI (the gray area) or PCI alone. They were compared with a control group from SYNTAX I, a cohort of patients whose SYNTAX scores rested in the gray area or leaned towards PCI alone.
Upcoming 12-month results will provide a “better understanding” of the SYNTAX II strategy, Serruys noted.
The study was supported by Boston Scientific and Philips Volcano.
Serruys PW “iFR / FFR and IVUS-guided percutaneous coronary revascularisation with new-generation DES in patients with de novo three-vessel disease: 30-day outcomes of the SYNTAX II trial” EuroPCR 2016.