balloon elution and late loss optimization (bello) study

Conditions: Coronary Artery Disease

Summary: prospective multicentre randomized (1:1) investigator initiated study, in which consecutive patients undergoing percutaneous revascularization of small coronary vessels will be assigned to one of the two study arms: 1. treatment arm: in.pact falcon™ paclitaxel drug-eluting balloon (deb) dilatation and provisional spot bare-metal stenting (bms). 2. control arm: paclitaxel-eluting stent (pes) implantation as per standard practice. eligible subjects with coronary artery disease in a small vessel (reference diameter\<2.8mm) will be consecutively screened and enrolled based on the inclusion and exclusion criteria the objective of the study is to assess the non-inferiority of the deb to the pes as regards to primary endpoint of mean late lumen loss (lll) at 6 months, defined as the difference between postprocedural minimum luminal (mld) diameter and follow-up mld, as assessed by quantitative coronary angiography and is based on the following assumptions: 1. the means of lll in the 2 groups are precisely equal 2. a standard deviation in lll of 0.5mm in both groups as demonstrated in the isar-smart 3 and pepcad ii trials 3. a non-inferiority margin of 0.25mm between groups is clinically unimportant based on these assumptions: 1. null hypothesis (n0): mean lll in deb group is ≥0.25mm than that in the pes group (i.e. pes is superior to deb) 2. alternative hypothesis 1 (h1): mean lll between deb and pes is \<0.25mm (i.e. deb is non-inferior to pes) 3. alternative hypothesis 2 (h2): mean lll between deb and pes \<0 (i.e. deb is superior to pes) based on the above calculations, a sample size of 77 patients will be required in each group to show non-inferiority of deb vs. pes with an α error of 0.025 (one-sided z test) and a power of 80%. to account for a 20% rate of withdrawal, lost to follow-up or not presenting for follow-up angiography, a total of 182 patients (91 in each group) will be randomized.


Eligibility criteria:
inclusion criteria: * age \> 18 years. * patient providing written informed consent. * patients with stable angina pectoris (canadian cardiovascular society \[ccs\] 1, 2 3) or unstable angina pectoris with documented ischemia (ccs 4, braunwald class ib-c, iib-c or iiib-c), or patients with documented silent ischemia. * patients who are eligible for coronary revascularization (angioplasty and/or cabg). * female patients with child bearing potential must have a negative pregnancy test within one week before treatment and must use adequate contraception. angiographic inclusion criteria: * native coronary artery. * de novo lesion. * reference vessel diameter \< 2.8mm by visual estimate. * target lesion with a visually estimated stenosis \>50%. * target lesion length \< 25mm by visual estimate. * a maximum of 2 epicardial vessels requiring revascularization. * a maximum of 2 target lesions can be included (in the case of treatment of more than one lesion, the treatment selected will remain the same). exclusion criteria: * patients unable to give informed consent. * patients enrolled in another study with any investigational drug or device within the past 30 days. * patients scheduled for a major surgical intervention within 6 months of enrolment in the study. * patients with acute (\< 24h) or recent (≤ 48 hours) myocardial infarction. * patients with a contraindication to an emergency coronary bypass surgery. * any individual who may refuse a blood transfusion. * patients with serum creatinine \>2.0mg/dl or \>180umol/l. * patients with severe congestive heart failure. * patients who had a cerebral stroke \<6 months prior to the index procedure. * ef (ejection fraction) \< 30%. * patients with any known allergy, hypersensitivity or intolerance to acetylsalicylic acid (asa), clopidogrel or ticlopidine, paclitaxel. * any known allergy to contrast medium that cannot be pre-treated. angiographic exclusion criteria: * \>2 epicardial vessels requiring revascularization. * target lesion distance from the ostium of left anterior descending coronary artery (lad)/left circumflex coronary artery (lcx)/right coronary artery (rca) is \< 5 mm. * target lesion is located in either a venous or arterial graft. * target vessel contains a previously implanted stent. * angiographic evidence of thrombus at the target site. * chronic total occlusions. * restenotic lesions. * bifurcation lesions which the operator decides a 2-stent technique as intention-to-treat is required or bifurcations with side branches ≥ 2.5mm. * failure to successfully treat non-target lesions within the target vessel (non-target lesions must be treated prior the target lesion). * greater than 2 non-target lesions treated during the index procedure. * previous percutaneous coronary intervention (pci) within the last 3 months.

Keywords: paclitaxel ptca drug-eluting balloon provisional spot stenting coronary artery disease late lumen loss minimal lumen diameter coronary artery disease in a small vessel