PRAGUE-19 Registry: Bioresorbable Scaffolds an Option for Certain STEMI Patients
PARIS, France—Implantation of bioresorbable vascular scaffolds (BVS) appears feasible and safe in select patients with acute ST-segment elevation myocardial infarction (STEMI), according to early registry results presented Wednesday, May 22, at EuroPCR 2013.
While BVS are safe and effective in treating chronic, stable CAD, their use has not been fully described in the highly thrombogenic setting of primary PCI for STEMI, explained Petr Widimský, MD, DSc, of Charles University (Prague, Czech Republic). STEMI patients with a low Killip class may represent the ideal treatment setting for BVS, he said, in that such individuals are younger, have less calcified arteries, and may stand to gain long-term benefits from stent reabsorption.
For the single-center PRAGUE-19 registry, Dr. Widimský and colleagues prospectively examined outcomes of 87 consecutive STEMI patients who underwent emergent coronary angiography between December 16, 2012, and May 15, 2013. The current report represents 5-month follow-up out of a planned 3-years’ duration.
One-Quarter Suitable for BVS
BVS implantation was the default treatment, though due to prespecified inclusion and exclusion criteria, both angiographic and clinical, the procedure was ultimately attempted in only 22 patients (25%). “Clinical exclusion criteria were based on high probability of 3-year survival,” Dr. Widimský noted.
The remaining 51% received another type of stent, while 24% underwent balloon angioplasty without stenting, thrombus aspiration, or both. Reasons for not using BVS varied; the most common were PCI performed without stenting (32%), vessel too large for commercially available BVS (20%), Killip class III to IV (20%), and artery calcifications or tortuosity (9%).
A total of 27 BVS were successfully implanted in 21 patients. In the 1 unsuccessful BVS procedure, the device could not be delivered to a patient whose left circumflex artery had sharp take-off and so a BMS was used instead. Nineteen of 21 patients had ideal procedural outcomes, with TIMI 3 flow, no residual stenosis, and no dissection. The other 2 patients had TIMI 2 flow after treatment. There were no reinfarctions during index hospital stay.
Early Safety Confirmed
By 5 months, there were no deaths, strokes, or cases of clinical restenosis. One reinfarction occurred due to BVS thrombosis at 3 days after the patient had discontinued ticagrelor.
“BVS implantation in acute STEMI is feasible and safe,” Dr. Widimský concluded, adding that long-term follow-up will clarify the future role of BVS for this indication.
Since the time of the study, he reported, the available size of BVS has expanded and expiration times have lengthened such that now the devices can potentially be used in up to 33% of STEMI patients. This population would substantially grow if a 4.0-mm diameter size became available.
Following the presentation, an audience member asked about the aggressiveness of predilatation. The choice of “strategy was left to the operators,” Dr. Widimský replied, adding that most cases involved predilatation.
Session co-chair Ron Waksman, MD, of Washington Hospital Center (Washington, DC), asked why some patients did not receive any stents at all. “This is a mixture of different cases,” Dr. Widimský explained. “In this group, you have a few cases of failed PCI.” Others involved severe or multivessel disease with challenging anatomy, he said.
Co-chair Antonio L. Bartorelli, MD, of Centro Cardiologico Monzino, IRCCS (Milan, Italy), expressed concerns about no flow and slow flow. “The need for preparation of the lesion is something that should be taken into account when you’re treating an acute MI. [Typically,] I’m more interested in salvaging the muscle than thinking about the long-term [effect] on the vessel. This is something that should be considered when we are treating these kinds of patients.”
Widimský P. Bioresorbable stents in acute STEMI. Presented at: EuroPCR. May 22, 2013. Paris, France.
- Dr. Widimský reports serving as a consultant to Abbott Vascular, AstraZeneca, Bayer Healthcare Pharmaceuticals, Boehringer Ingelheim, Boston Scientific, Daiichi Sankyo, Eli Lilly, Medtronic, and Sanofi.