RIGA, Latvia -- Percutaneous coronary intervention (PCI) with cutting balloon pre-treatment of lesions may be a good therapeutic option for left main artery stenosis, a transoceanic team of investigators affirmed.
RIGA, Latvia, July 30 -- Percutaneous coronary intervention (PCI) with cutting balloon pre-treatment of lesions may be a good therapeutic option for left main artery stenosis, a transoceanic team of investigators affirmed.
In a randomized study comparing intravascular ultrasound-guided PCI with either paclitaxel-eluting stents or bare-metal stents, both were safe and effective, reported Andrejs Erglis, M.D., Ph.D., of the Pauls Stradins Clinical University Hospital, and colleagues here and in Melbourne, Australia.
In addition, drug-eluting stents produced slightly better outcomes in large diameter vessels at six months, the investigators wrote in the Aug. 7 edition of the Journal of the American College of Cardiology.
"No serious procedure-related complications were observed, and intermediate-term outcomes were favorable," they said.
The finding that drug-eluting stents may offer an edge warrants further investigation in a randomized trial the authors said. But that doesn't mean that drug-eluting stents are ready to supplant coronary artery bypass graft for this indication any time soon, commented Gregg W. Stone, M.D., of Columbia University Medical Center in New York, and colleagues.
"Numerous unanswered questions must be addressed before that bridge can be crossed," they wrote in an accompanying editorial.
Those questions include whether the use of cutting balloon predilation and intravascular ultrasound are necessary for the success of PCI, identification of the best technique for managing complex disease at the distal left main bifurcation, and whether specialized drug-eluting stents might indeed be more effective than bare-metal models, he wrote.
Dr. Erglis and colleagues randomly assigned 103 patients with unprotected left main coronary artery disease to receive PCI under ultrasound guidance with either a paclitaxel-eluting stent (53 patients) or the bare-metal variety (50 patients).
All patients were pre-treated with a cutting balloon along the entire length of the lesion, with balloon inflation performed three times with increasing pressure throughout the lesion. All patients had successful stent implantation.
At six months, the authors found that 11 patients in the bare-metal stent group (22%) had binary restenosis, compared with only three patients (6%) in the drug-eluting stent group (P=0.021).
On intravascular ultrasound evaluation, they found that the percentage of neointimal volume obstruction at six months was significantly better among the drug-eluting stent group, at 16.60% + 17.25% compared with 25.20% + 22.02% for the bare-metal stent group.
Patients who received drug-coated stents also did better clinically, with an 87% cardiac event-free survival rate at six months, compared with 70% of the patients in the bare-metal group (P=0.036).
"The availability of drug-eluting stents has prompted the question: should we use drug-eluting stents in all left main coronary artery cases?" they wrote.
They noted that some answers may be provided by the Synergy Between PCI and Taxus and Cardiac Surgery (SYNTAX) study, a prospective multi-center trial currently underway.
The authors acknowledged that the study was significantly limited by the open-label, single center design, small sample size, and short follow-up period.