Drug coated balloon versus drug eluting stent in primary percutaneous coronary intervention: a feasibility study.

• Register: German Clinical Trials Register
• Last refreshed on: 8 April 2024
• Main ID: DRKS00011630
• Date of registration: 13/02/2017
• Prospective Registration: No
• Primary sponsor: Clinical hospital center Rijeka
• Public title: Drug coated balloon versus drug eluting stent in primary percutaneous coronary intervention: a feasibility study.
• Scientific title: Drug coated balloon versus drug eluting stent in primary percutaneous coronary intervention: a feasibility study. - DCB vs. DES in pPCI: a feasibility study.
• Date of first enrolment: 01/03/2014
• Target sample size: 75
• Recruitment status: Complete
• URL: http://drks.de/search/en/trial/DRKS00011630
• Study type: interventional
• Study design: Allocation: Randomized controlled study; Masking: Blinded (masking used); Control: active; Assignment: parallel; Study design purpose: treatment
• Phase: 1-2

Countries of recruitment

Croatia

Contacts

• Name: David Gobic
• Affiliation: Clinical hospital center Rijeka

• Name: David Gobic
• Affiliation: Clinical hospital center Rijeka

Key inclusion & exclusion criteria

Inclusion criteria: Inclusion criteria were: 1) STEMI presenting less than 12 hours from symptoms onset; 2) de novo lesion: coronary artery occlusion or critical stenosis; 3) coronary artery diameter from 2.5 to 4.0 mm.
Exclusion criteria: Exclusion criteria were: 1) stroke within the last six months; 2) likelihood of survival less than one year; 3) pregnancy or breastfeeding; 4) The Modification of Diet in Renal Disease (MDRD) derived eGFR <30 ml/min/1,73 m2; 5) in stent restenosis; 6) extensive coronary disease needing additional revascularization; 7) PCI or coronary artery bypass graft (CABG) surgery within the last six months; 8) severe coronary artery tortuosity; 9) hypersensitivity, allergies and other contraindications to acetylsalicylic acid, clopidogrel, heparin, paclitaxel or eptifibatide; 10) allergies to iodine-containing contrast medium; 11) leucocytes count <3,5 x 10^9/L and platelets count <75 x 10^9/L or >650 x 10^9/L.

Age minimum: 18 Years
Age maximum: None
Gender: All

Health Condition(s) or Problem(s) studied

I21

Acute myocardial infarction

Intervention(s)

Group 1: Drug coated balloon (DCB) application in culprit coronary artery lesion
Group 2: Drug eluting stent (DES) implantation in culprit coronary artery lesion

Primary Outcome(s)

Major adverse cardiac events (MACEs) were followed during hospital stay: cardiovascular death, reinfarction, target lesion revascularization (TLR) and stent thrombosis. Patients were evaluated for BARC-defined
(Bleeding Academic Research Consortium) bleeding adverse events. Left ventricular ejection fraction (LVEF) was evaluated by transthoracic echocardiography (TTE) at discharge. In time intervals of one month and six months after STEMI, patients were classified into four subgroups according to severity of angina based on the Canadian Cardiovascular Society (CCS) classification. The arterial blood pressure, heart rate and BMI were measured and ECG performed. MACEs and BARC complications were noted. Additionally, six months after the procedure, laboratory tests (haemoglobin and haematocrit levels, leucocyte and platelet count, glucose, urea and creatinine levels, total cholesterol and hsCRP levels) and treadmill stress test were performed. LVEF was evaluated at six months by TTE. Follow-up coronary angiography was performed in all patients after six months. Angiographic parameters were measured
and evaluated off-line by an independent investigator using Syngo quantification software (Siemens Healthcare, Erlangen, Germany).

Source(s) of Monetary Support

Clinical hospital center Rijeka

Ethics review

Status: Approved
Approval date: 16/09/2013
Contact:

Clinical hospital center Rijeka Ethical Committee

0038551658111

Results

• Date Completed: 31/01/2015
• URL: http://drks.de/search/en/trial/DRKS00011630#studyResults