NO REFLOW: A Prospective Randomized Trial of Intracoronary vs' Guiding Catheter Infusion of Nitrates

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NO REFLOW A Prospective Randomized Trial of
Intracoronary vs. Guiding Catheter Infusion of
Nitrates vs. Calcium Channel Blockers in Patients
with No Reflow after Primary PCI in STEMI
1Junbo Ge, 1Dong Huang, 1Juying Qian, 2Huigen
Jin, 1Jianying Ma, 2Zongjun Liu, 1Feng Zhang,
1Xiangfei Wang, 1Lei Ge
1Department of Cardiology, Zhongshan Hospital,
Fudan University, Shanghai, China 2Department of
Cardiology, Putuo District Center Hospital,
Shanghai, China
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Disclosure Statement of Financial Interest

• I DO NOT have a financial interest/arrangement or
  affiliation with one or more organizations that
  could be perceived as a real or apparent conflict
  of interest in the context of the subject of this
  presentation.

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Background

• No-reflow is a frequent phenomenon during primary
  PCI for AMI and associated with a poor clinical
  outcome.
• The present pharmacological management involves
  the use of different vasodilators including
  nitrates, verapamil, adenosine and nicorandil.
• No randomized trial has been conducted to compare
  head-to-head any of these agents, or to determine
  the appropriate dosage.

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Objective

• The prospective, randomized, multi-center study
  was designed to compare angiographic and clinical
  outcomes in AMI patients undergoing primary PCI
  with no-reflow phenomenon using three different
  vasodilators diltiazem, verapamil and
  nitroglycerin.

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Trial Design
STE-AMI
primary PCI
TIMI grade lt3
Randomized 111
Diltiazem (4002000µg)
Verapamil (2001000µg)
Nitroglycerin (2001000µg)

• Primary endpoint Angiographic coronary flow
  after drugs were given post-PCI.
• Secondary endpoint (1) LVEF, NT-proBNP at 1 and
  30 days post-PCI (2) Incidence of MACE (death,
  MI and target vessel revascularization) at 30
  days post-PCI.

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Methods

• In a consecutive series of 608 primary PCI for
  AMI, no-reflow phenomenon (TIMI flow gradelt3) was
  observed in 102 patients (17). All lesions in
  the infarction-related-coronary (IRC) were
  treated by stents.
• The 102 patients were randomised to one of three
  investigational vasodilators groups
  intracoronary infusion of diltiazem (n34),
  verapamil (n34) and nitroglycerin (n34). The
  drugs were given via guiding-catheter (GC group,
  n24) or an infusion microcatheter distal to the
  angioplasty site (MC group, n78).

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Methods

• Angiographic IRC flow outcome measured by blinded
  angiographic readers included
• TIMI flow grade TFG (TIMI study group, NEJM
  1985)
• Corrected TIMI frame count CTFC (Gibson,
  Circulation 1996)
• LVEF assessed by echocardiography and NT-proBNP
  levels were measured at 1 and 30 days post-PCI.

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Results

• There were no statistically significant
  differences in demographic data of patients,
  procedural characteristics and the baseline IRC
  flow post-stenting in the three groups
• The average intracoronary infusion drug dose was
  diltiazem 1.0mg, verapamil 0.4mg and
  nitroglycerin 0.4mg

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Baseline Characteristics (1)
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Baseline Characteristics (2)
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Procedural Characteristics (1)
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Procedural Characteristics (2)
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Results--TIMI flow grade in MC group
Plt0.05
(TFG)
Plt0.05
Plt0.05
Plt0.05
Plt0.05
2.9
3.0
2.5
1.5
1.6
1.5
14
Results--CTFC in MC group
Plt0.05
(Frames)
Plt0.05
Plt0.05
Plt0.05
Plt0.05
72
69
68
39
26
26
15
Results--TIMI flow grade in GC group
Plt0.05
(TFG)
Plt0.05
Plt0.05
Plt0.05
Pgt0.05
2.5
2.3
1.8
1.1
1.3
1.5
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Results--CTFC in GC group
Plt0.05
(Frames)
Plt0.05
Plt0.05
Plt0.05
Pgt0.05
69
68
71
37
41
53
17
Flow improvement in MC vs. GC group
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Safety
()
Plt0.05
Plt0.05
19
Follow up--LVEF
()
Pgt0.05
Pgt0.05
Pgt0.05
20
Follow up--NT-proBNP
(pg/ml)
Plt0.05
Plt0.05
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Follow up--MACE
()
Pgt0.05
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Conclusions

• The intracoronary infusion of diltiazem or
  verapamil can reverse no-reflow phenomenon more
  effectively than infusion of nitroglycerin during
  primary PCI for STEAMI.
• Administration of the vasodilators
  superselectively via microcatheter to the related
  territory is more effective than via
  guiding-catheter.
• The efficacy of diltiazem and verapamil is
  similar but diltiazem seems to be safer.

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Thank you