Comparison of a drug-eluting balloon first and then bare metal stent with a drug-eluting stent for treatment of de novo lesions: study protocol of a randomized controlled trial

Table 1 Schedule of events

	Baseline	Post-procedure	Follow-up
			30 days± 2 weeks	3 ± 1 months	9 ± 2 months	12 ± 2 months
Medical/clinical history (age, sex, risk factors, clinical diagnosis, angina status, cardiac history)	X				X
Informed consent^a	X
Inclusion/exclusion criteria	X
Brief physical examination	X				X
Vital status	X		X		X	X
Weight, height	X
Twelve-lead ECG^b	X
Angiogram	X				X ^c
Complete blood count	X		X		X	X
Electrolytes, LFT	X		X		X	X
Creatinine, BUN	X		X		X	X
hs-CRP	X		X		X	X
Fasting plasma triglycerides, HDL, total cholesterol	X		X		X	X
Fasting glucose level^d	X		X		X	X
HgbA1C^e	X		X		X	X
Pregnancy test (if applicable)	X
Medications	X		X	X	X	X
CK, CK-MB, Troponin I^f	X	X
proBNP	X		X			X

BUN, blood urea nitrogen; CK, creatine kinase; LFT, liver function test; HDL, high-density lipoprotein; Hgb, hemoglobin; hs-CRP, high-sensitivity C-reactive protein; proBNP, pro-brain natriuretic peptide. ^aThe informed consent may be signed either prior to the diagnostic angiogram or after the diagnostic angiogram. ^bAdditional electrocardiograms (ECGs) will be performed at 60 ± 30 minutes post procedure. ECG at follow-up visits will only be obtained when clinically indicated, such as recurrent chest pain, ischemia, or significant arrhythmias, heart failure or other signs or symptoms of clinical instability. ^cRoutine follow-up angiography will be recommended at 9 months, but it can be performed at 9 ± 2 --> 9 ± 3 months. Unscheduled angiograms ≥6 months after the index procedure will be considered as the 9-month follow-up angiogram in final analysis. ^dMeasurement may be made later, before discharge, when the patient is in a fasting state. ^eFor patients with diagnosed diabetes mellitus. ^fCardiac enzymes should be followed up for at least 24 hours in patients indicated clinically, such as recurrent chest pain, ischemia, or significant arrhythmias, heart failure or other signs or symptoms of clinical instability. Otherwise the decision is up to the operator. If follow-up is made, enzymes must be followed every 8 hours for at least 24 hours post index procedure.

ISSN: 1745-6215