To the editor:
We appreciate the opportunity to revise our manuscript. I am pleased to say that
we have been able to address all of the reviewer’s comments. Please see our
reply below, which details our rationale and actions taken to address each
comment. Please do not hesitate to contact me with any further questions.
Best,
Diana Sobieraj
Reviewer: Anthony Bavry
1. The authors conducted a rigorous systematic review on the use of these
devices. Unfortunately, this review is not the first. In fact at least 4 high quality
reviews have recently been published on the topic including one in this journal
(see Tamhane et al. BMC Cardiovascular Disorders 2010). I was surprised
that the authors did not even acknowledge these previous report or try to
explain how theirs added to what is already known.
Thank you for this comment. We have added a paragraph to the discussion
section to acknowledge previously conducted systematic reviews as well as to
describe how our systematic review adds to the current literature. The following
was added to the discussion, paragraph 6: “Previous systematic reviews have
attempted to address this topic. However, only four of 11 which were identified
through our systematic literature search comprehensively included devices from
all three device categories including catheter aspiration devices, mechanical
thrombectomy, and embolic protection. Albeit comprehensive in the devices
evaluated, only the meta-analysis by Bavry and colleagues, published in 2008,
attempted to evaluate a duration of follow-up beyond 30 days for final health
outcomes, including stroke, MACE, and its components. However, this analysis
did not include safety outcomes and since then, additional RCTs have been
published, which are included in our analyses.”
Reviewer: Ole Fröbert
1. Why is the review restricted to studies with <5% of the study population
receiving PCI of saphenous veins when this is the primary indication for distal
protection devices? Please explain in the manuscript.
Thank you for this comment. Distal embolic protection devices are recommended
to be used in patients undergoing PCI of saphenous vein grafts due to previously
demonstrated ability to reduce MACE. However, use of embolic protection
devices in STEMI has been less well supported mainly because of underpowered
clinical trials that evaluated intermediate markers. More recently, larger
randomized controlled trials (RCTs) of patients with STEMI have evaluated
MACE as an end point and followed patients beyond hospital discharge (typically
3 to 12 months) but have given conflicting results. Therefore, of primary interest
to the systematic review was the use of these devices in native vessels. We have
added this to the introduction, second paragraph, sentences 3-5. We have added
clarification into the methods section as well, study selection section, last
sentence.
2. Please define STSR (ST-segment resolution?) when used the first time.
Thank you for this comment. We define ST-segment resolution as STSR with first
use, methods section, key questions, key question1.
3. Discussion, p. 13. Please rephrase: (although the trended in the right
direction).
Thank you for this comment. That was re-phrased to state “although there was a
trend in the right direction”
4. Discussion, bottom p13: “However, STSR, MBG-3, TIMI-3, no reflow, and
distal embolization were favorably impacted by catheter aspiration devices
compared to standard PCI. As such, more research is needed to truly determine
the balance of benefits to harms but this strategy looks promising.”- what does
“this strategy” refer to? All in combination?
Thank you for this comment. We have clarified this sentence as we are referring
to the use of catheter aspiration devices. The sentence now states “As such,
more research is needed to truly determine the balance of benefits to harms but
use of catheter aspiration devices looks promising.”
5. Discussion p. 16: “Such trials should have adequate representation of
Interventional cardiologists from the United States and include both tertiary
academic medical centers and large community based hospitals.”
- BMC Cardiovascular Disorders is an international medical journal. Please
rephrase.
Thank you for this comment. We have revised the sentence to state “Such trials
should have international representation of interventional cardiologists and
include both tertiary academic medical centers and large community based
hospitals.”
6. In order to update the reader and demonstrate that there is light at the end of
the tunnel it would improve the manuscript if the ongoing large RCTs within the
area are mentioned. Particularly the 5000 patients Scandinavian TASTE trial (Am
Heart J. 2010, 160:1042-1048.) and the 4000 patients primarily Canadian TOTAL
study (ClinicalTrials.gov Identifier: NCT01149044).
Thank you for this suggestion. We have text to the discussion to inform the
reader of upcoming relevant research which may fill some of the research gaps
which we have identified. The following has been added to the discussion, last
paragraph, third sentence: “At least two such trials are currently ongoing,
Thrombus Aspiration in STEMI in Scandinavia (TASTE) and a Trial of Routine
Aspiration Thrombectomy with PCI versus PCI alone in Patients with STEMI
Undergoing Primary PCI (TOTAL). Both trials plan to have a longer duration of
follow-up, with the TASTE trial following patients for 10 years and TOTAL up to 1
year.”