Is Verapamil In TransRadial Interventions OmittabLe?

State Health Center, Hungary591 enrolled

Overview

Background Verapamil is traditionally applied prophylactically in transradial procedures to prevent radial artery spasm. However, verapamil may have side effects and is contraindicated in some clinical settings. Methods: During an investigator-initiated, randomized, double-blind trial, we evaluate the need for preventive verapamil administration. After vascular access is established, patients receive either 5 mg verapamil (n=297) or placebo (n=294). We compare the rate of access site conversions as primary end point using a superiority margin of 5%. Occurrence of code breaks (composite of conversions and unplanned use of verapamil), overall verapamil use, procedural and fluoroscopic times, contrast volume, and subjective pain are investigated as secondary end points.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Masking

DOUBLE

Enrollment

591

Conditions

Coronary Disease Verapamil Toxicity

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * patients undergoing transradial coronary angiography and/or percutaneous coronary intervention * successful cannulation of the radial artery Exclusion Criteria: * reduced left ventricular systolic function (LVEF\<35%) * significant aortic stenosis * bradycardia (\<50/min.) * myocardial infarction complicated by cardiogenic shock and/or high grade AV block

Outcomes

Primary Outcomes

Rate of Access Site Conversions

Time frame: Occurrence of access site conversion will be assessed within 1 minute after completion of coronary angiography or intervention.

Secondary Outcomes

Rate of Code Breaks

Code break: a composite of access site conversion and unplanned use of vasodilators.

Time frame: Occurrence of code breaking will be assessed within 1 minute after completion of coronary angiography or intervention.

Rate of Vasodilator Use

Time frame: Vasodilator use will be assessed within 1 minute after completion of coronary angiography or intervention.

Procedural Time

Time frame: Procedural time will be assessed within 1 minute after completion of coronary angiography or intervention.

Fluoroscopic Time

Time frame: Fluoroscopic time will be assessed within 1 minute after completion of coronary angiography or intervention.

Contrast Volume

Time frame: The amount of contrast medium will be assessed within 1 minute after completion of coronary angiography or intervention.

Subjective Pain

Analysis of the rates of signiﬁcant pain deﬁned as pain score ≥4 on a semiquantitative scale ranging from 1 to 6.

Time frame: Subjective pain will be assessed within 1 minute after completion of coronary angiography or intervention.