RESPECT final analysis: PFO closure reduces risk for recurrent stroke

WASHINGTON — Final results of the RESPECT trial showed that percutaneous patent foramen ovale closure reduced the risk for recurrent stroke compared with guideline-directed medical therapy alone over a mean follow-up of 6 years.

The new data, presented at TCT 2016, come on the heels of FDA approval of the device studied (Amplatzer PFO Occluder, St. Jude Medical). In late October, the FDA approved the device for prevention of recurrent stroke in patients with a patent foramen ovale (PFO) and cryptogenic stroke.

RESPECT was a randomized, event-driven, open-label trial with blinded endpoint adjudication. Patients were randomly assigned 1:1 to receive PFO closure or guideline-directed medical management alone. Patients assigned PFO closure received the implant within 21 days of randomization and received 1 month of aspirin and clopidogrel followed by aspirin only through 6 months; thereafter, medical management was at the physician’s discretion.

A total of 980 patients were enrolled from 2003 to 2011 at 69 sites in the United States and Canada. All patients had confirmed PFO and cryptogenic stroke within the last 9 months.

In the intention-to-treat population, early- and medium-term results in RESPECT showed point estimates in favor of PFO closure, but did not reach statistical significance, David E. Thaler, MD, PhD, chairman of neurology, Tufts University School of Medicine, said during a presentation here. RESPECT protocol required follow-up until an FDA regulatory decision. Following an FDA advisory panel meeting in May, the agency requested an analysis of long-term outcomes using updated data. Thaler presented the final analyses at TCT 2016.

According to findings presented, the rate of technical success was 99.1%, and procedural success was 96.1%. Mean follow-up was 6 years in the device group (total, 3,141 patient-years) and 5.5 years in the medical therapy group (total, 2,669 patient-years).

The primary endpoint was a composite of recurrent nonfatal or fatal ischemic stroke and early post-randomization death within 45 days during long-term follow-up. The researchers’ calculated a relative risk reduction with PFO closure vs. medical management of 45% (HR = 0.55; 95% CI, 0.305-0.999) for ischemic stroke, 62% (HR = 0.38; 95% CI, 0.18-0.79) for stroke without a known mechanism and 58% (HR = 0.42; 95% CI, 0.21-0.83) for recurrent ischemic stroke in an age-censored analysis of patients aged younger than 60 years.

“These analyses support the hypothesis that PFO closure is preventing PFO-related recurrent strokes,” Thaler said. “PFO closure cannot prevent strokes from non-PFO-related causes.”

Data and Safety Monitoring Board-adjudicated procedure- or device-related serious adverse events revealed no intraprocedural strokes, device embolization, device thrombosis or device erosion. The rate of major vascular complications with PFO closure was 0.9%, while 0.4% of patients required device explants.

“For patients with cryptogenic stroke and PFO, closure with the Amplatzer PFO Occluder is an appropriate treatment option that reduces the risk for recurrent stroke,” Thaler said. “Collaboration between a cardiologist and neurologist is important for proper patient selection.”

Reference s :

Thaler DE, et al. First Report Investigations 3. Presented at: TCT Scientific Symposium; Oct. 29-Nov. 2, 2016; Washington, D.C.

Disclosure : Thaler reports financial ties with St. Jude Medical.