Chinese Stent at 3 Years; Remodeling With ‘Uncaging’ DES; BASILICA Concerns

Innovations in coronary revascularization and transcatheter aortic valve replacement (TAVR) reported at the PCR e-Course appeared to be panning out in the short-term.

Two novel stents designed to address adverse event risks with current-generation drug-eluting stents (DES) produced favorable outcomes after percutaneous coronary intervention (PCI).

In addition, the risk of coronary obstruction in TAVR could be mitigated by the BASILICA (bioprosthetic or native aortic scallop intentional laceration to prevent iatrogenic coronary artery obstruction) technique — albeit with some caveats.

The three studies below were presented during the virtual meeting, held in lieu of the EuroPCR live event due to COVID-19 risk.

Firehawk DES

A biodegradable sirolimus-eluting polymer stent was still on par with the durable-polymer Xience after 3 years, according to the TARGET All Comers trial.

Incidence of target lesion failure at 3 years (counting cardiac death, target vessel MI, and ischemia-driven target lesion revascularization) reached 11.9% with the Firehawk stent vs 11.5% with a Xience stent implanted instead (HR 1.03, 95% CI 0.77-1.38), reported Alexandra Lansky, MD, of Yale School of Medicine.

Investigators had previously reported non-inferiority of the Firehawk (from Chinese company MicroPort) to Xience at 12 months. Now, on landmark analysis, there appeared to be no difference from 1 year to 3 years between groups, according to Lansky.

Moreover, the two DES shared similar rates of the patient-oriented composite endpoint (25.2% vs 23.7%) and stent thrombosis (2.1% vs 2.5%).

“The safety and efficacy of the Firehawk was maintained at 3 years,” Lansky concluded. “Whether a clinical benefit of the Firehawk exists compared to Xience will require longer follow-up, which is planned to 5 years.”

Lansky highlighted the Firehawk’s numerical advantage in stent thrombosis. “Biodegradable polymer DES may be safer than durable polymer DES in the long term,” she suggested.

The trial was performed in an all-comers population with no lesion or vessel limitations. Ultimately, 1,656 patients with symptomatic coronary artery disease were randomized to either stent at 20 participating centers in Europe. Mean age of the cohort was 65 years, with 77% being men.

DynamX Bioadaptor

PCI with a novel “uncaging” platform resulted in few target lesion failure events and was associated with positive remodeling out to 12 months, according to an observational study.

In the year following DynamX bioadaptor placement in 50 patients with single de novo coronary artery lesions, no target vessel MI, target lesion revascularization, or bioadaptor thrombosis occurred, although there were two cardiac deaths, according to the presentation by Stefan Verheye, MD, PhD, of Antwerp Cardiovascular Center in Belgium.

On quantitative coronary angiography, late lumen loss averaged 0.12 mm (median 0.05 mm). On intravascular ultrasound, there was no change from post-procedure in lumen area but a significant 3% increase in mean vessel area, Verheye said.

The DynamX metallic stent with a drug-eluting bioresorbable polymer was designed to offer similar acute performance as a second-generation DES. After polymer degradation over 6 months, uncaging elements in the links disengage to adapt to vessel physiology and theoretically reduce long-term adverse events.

Verheye called the DynamX “a fundamental innovation in device design” that showed promise in “mitigating the 2-3% annualized event rates beyond year 1” typically seen with second-generation DES.

Only longer-term follow-up will tell if that will be the reality.

BASILICA Technique

The risk of coronary obstruction during transcatheter aortic valve replacement (TAVR) was mitigated by the BASILICA technique, registry data showed, though stroke could be a safety concern.

Combined death, major stroke, or coronary obstruction at 30 days occurred in 12.3% of 129 people who had TAVR with BASILICA lacerations. This was significantly lower than the 35.6% observed in 59 matched controls receiving non-BASILICA TAVR who were considered at risk for coronary obstruction (P<0.001), according to Danny Dvir, MD, of MedStar Washington Hospital Center in Washington, D.C.

TAVR with BASILICA yielded less coronary obstruction (4.5% vs 32.2%, P<0.001) and fewer deaths as well (6% vs 18.9%, P=0.026). However, major stroke favored the conventional approach without laceration (7.5% vs 0%, P=0.051).

Double BASILICA, wherein operators perform both left- and right-sided leaflet lacerations, was associated with a 9% rate of stroke and found to be the only independent predictor for the composite outcome, Dvir said.

“BASILICA could potentially be the preferred therapy in patients at risk for isolated single vessel obstruction in [TAVR]. The optimal therapy for patients at risk for double coronary obstruction is yet to be determined,” he concluded.

At 12 months, mortality again favored recipients of single BASILICA (89.8% vs 75% double vs 70% controls, P<0.001). Similarly, this group fared the best in terms of 12-month survival free from stroke or coronary obstruction (85.1% vs 62.5% vs 57.1%, P<0.001).

Data for the study came from the Valve-in-Valve International Data registry. Dvir’s group identified BASILICA TAVR cases and matched them to controls from the total 2,915 valve-in-valve cases.

The BASILICA cohort averaged 75.7 years of age, and 38.6% were men.

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    Nicole Lou is a reporter for MedPage Today, where she covers cardiology news and other developments in medicine. Follow

Disclosures

Lansky disclosed receiving research support and personal fees from Microport.

Verheye disclosed receiving personal fees from Biotronik, Elixir Medical, and Neovasc.

Dvir reported consulting to Medtronic, Edward Lifesciences, Abbott, and Jena.