|
Hypothesis:
Pretreatment with intragraft verapamil will reduce the incidence
and severity of the no reflow phenomenon in patients undergoing
percutaneous coronary intervention (PCI) in saphenous vein grafts
(SVGs).
Entry
Criteria: 1.
PCI of SVG.
2.
Systolic blood pressure >95 mmHg off pressors.
3.
TIMI >1 in SVG.
Study
Design:
Patients will be randomly assigned to receive verapamil 200 mcg
intra-graft through the guiding catheter or nothing prior to wiring
the vessel. On even calender days, patients get verapamil. On odd
days, patients get usual care with no vasodilator pretreatment.
Primary
Endpoint:
The primary study endpoint is the development of transient or persistent
slow (decrease of flow by >1 TIMI grade) or no reflow during
the SVG PCI.
Secondary
Endpoints:
1.
Final TIMI flow and frame count.
2.
Use of additional vasodilators during PCI.
3.
CK, CK-MB 6-12 hours after PCI.
4.
In-hospital clinical events: QMI, NQMI, death, stroke, hospital
days..
Sample
Size: 1.
We expect that roughly 30% of patients undergoing SVG PCI will develop
transient or persistent slow or no reflow.
2.
To detect a 50% decrease in the incidence of decreased TIMI flow
with a two-tailed a of 0.05 and a b of 0.20, 162 patients per group
will be randomized (using z statistic for proportions of dichotomous
variables).
VAPOR
Data Sheet
Patient Name: Hospital
Number: Hospital:
Date: Verapamil
(even days) or Usual Care (odd days)
Attending: Interventional
Fellow:
Age: Sex:
M F Race:
Past Medical
History:
Treated Diabetes:
N Y
Hypertension: N Y
Prior MI: None Old Recent
(1-3 weeks) Evolving (<1 week) Acute
Prior MI involving
SVG: None Old Recent (1-3 weeks) Evolving (<1 week) Acute
LVEF (%):
Age of SVG (years):
Medications
(circle): ASA Plavix Nitrates CCB ACEI Statin
Procedure: Elective Urgent Emergent
Indication: Angina Unstable
angina NQMI ST elevation AMI Other:
SVG target: LAD Diagonal OM RCA/PDA
Lesion location: Ostial Body Anastamosis
Cath Lab Meds: ReoPro Aggrastat Integrilin
Heparin dose
(total):
Highest ACT
(sec): Lowest ACT (sec):
Procedures: PTCA Stent RA AngioJet IVUS IABP Pacing
Stent types: Number
of Stents: Total length of Stents (mm):
Pre TIMI Flow: Pre
TIMI Frame Count:
Post TIMI Flow: Post
TIMI Frame Count:
Transient or
No Reflow: N Y
Additional Vasodilator
Use: None Adenosine Nicardipine Diltiazem Verapamil
Contrast type: Omnipaque Isovue Hypaque Visipaque Hexabrix
Total Contrast
(cc): Total Fluoro (min):
In-Lab Events: None Death CVA Hypotension Arrhythmia
Follow-Up:
Enzymes 6-12
hours later: CK: CK-MB:
In-Hosp Events: None QMI NQMI Death CVA
CCU Days:
Hospital Days:
|
