P-007 Comparison of SOLITAIRE flow restoration device and the MERCI retriever among acute ischemic stroke patients with atrial fibrillation in the SWIFT multicenter, randomized trial: Abstract P-007 Table 1
Authors: Saver J , Jahan R , Levy E , Jovin T , Baxter B , Nogueira R , Clark W , Budzik R , Zaidat O ,   for the SWIFT Trialists
Published: July 2012

Background

In the SWIFT randomized trial, neurothrombectomy with SOLITAIRE Flow Restoration device (SOLITAIRE) compared with the MERCI Retriever was superior in achieving the primary endpoint, successful recanalization without use of rescue therapy or symptomatic intracranial hemorrhage (SRNH), and was associated with improved outcomes on secondary clinical endpoints, including reduced mortality and higher rates of good neurological outcome at 3 months. Both treatment arms were generally well-matched on baseline characteristics, but an imbalance in the frequency of atrial fibrillation was noted. To minimize potential confounding by this imbalance, we undertook an analysis of trial primary and secondary outcomes confined to the subset of patients in SWIFT with atrial fibrillation.

Methods

Multicenter RCT with blinded primary endpoint ascertainment. Key entry criteria: age 22–85; NIHSS 8–29; within 8 h of onset; ineligible or failed IV TPA; intracranial ICA, M1, M2, BA, or VA occlusion.

Results

The total SWIFT study population, enrolled at 18 sites, comprised 144 patients, including 31 roll-in phase SOLITAIRE patients and 113 randomized patients, 58 SOLITAIRE, 55 MERCI. Among these patients, randomized patients, SOLITAIRE and MERCI treatment arms were comparable on 27 baseline demographic and medical history variables, including age, NIHSS, and onset to treatment time, but differed in history of atrial fibrillation (p=0.02). History of atrial fibrillation was present in 75/144 (52.1%) trial patients, including 12/31 (38.7%) roll-in SOLITAIRE patients, 26/58 (44.8%) randomized SOLITAIRE patients and 37/55 (67.3%) randomized MERCI patients. Outcome findings among the patients with atrial fibrillation are shown in the Abstract P-007 table 1.

Abstract P-007 Table 1OutcomeRoll-In SOLITAIRE (n=12)Randomized SOLITAIRE (n=26)Randomized MERCI® (n=37)Superiority p valueSuccessful recanalization without SICH*36.4% (4/11)66.7% (16/24)25.0% (9/36)0.003Successful recanalization—core lab40.0% (4/10)73.9% (17/23)34.3% (12/35)0.007Successful recanalization—site assessed66.7% (8/12)91.3% (21/23)41.7% (15/36)0.0001Use of rescue therapy33.3% (4/12)19.2% (5/26)40.5% (15/37)0.10Successful recan after rescue rx—per sites91.7% (11/12)95.7% (22/23)62.2% (23/37)0.005Device or procedure-related SAEs**33.3% (4/12)19.2% (5/26)45.9% (17/37)0.035SICH0.0% (0/12)0.0% (0/26)16.2% (6/37)0.038Independent outcome (mRS 0–2) at 90 d30.0% (3/10)32.0% (8/25)15.2% (5/33)0.20Good neurological outcome at 90 d60.0% (6/10)56.0% (14/25)18.2% (6/33)0.005Mortality by 90 days16.7% (2/12)15.4% (4/26)54.1% (20/37)0.003

Conclusions

Among patients with atrial fibrillation, the SOLITAIRE Flow Restoration device was superior to the MERCI Retriever in achieving successful recanalization free of symptomatic hemorrhagic transformation, reduced mortality, and more frequent good final neurologic outcomes.

Competing interests

J Saver: Covidien. R Jahan: Covidien. E Levy: Covidien. T Jovin: Covidien. B Baxter: Covidien. R Nogueira: Covidien. W Clark: Covidien. R Budzik: Covidien. O Zaidat: Covidien. For the SWIFT Trialists: Covidien.