Paclitaxel Eluting Balloon Versus Drug Eluting Stent in Native Coronary Artery Stenoses of Diabetic Patients (PEPCAD IV)

Inclusion Criteria:

• History of diabetes mellitus of at least 3 yrs prior to enrollment. Diabetes mellitus may be treated either orally or s.c.
• Stable blood glucose level for the 6 months preceding enrollment as reflected by HbA1c concentrations measured exclusively ≤ 8 %
• Patients with stable angina pectoris (CCS class 1-3) or with unstable angina pectoris (Braunwald class 1-2, A-C) or documented ischemia or with documented silent ischemia
• Patients eligible for coronary revascularization by means of PCI
• Women of childbearing potential may not be pregnant nor have the desire to becoming pregnant during the first year following the study procedure. Hence, patients will be advised to use an adequate birth control method up to and including 6 months follow-up
• Patients who are mentally and linguistically able to understand the aim of the study and to show sufficient compliance in following the study protocol
• Patients must agree to undergo the 9 months angiographic follow-up
• Patients must agree to undergo the 3 year clinical follow-up
• De-novo native coronary artery stenosis (reference diameter: ≥2.5 mm and ≤ 3.5 mm, length of stenosis: ≥ 10 mm and ≤ 20 mm)
• Target lesion is ≥ 3 mm distant from a major side branch (> 2.0 mm in diameter) and ≥ 3 mm form a previously deployed stent of any type (including active and passive coatings, bare metal stents)
• The target lesion must be treated with a single stent only (multiple stenting shifts the patient to the intention-to-treat group)
• Single or multi-vessel coronary artery disease

Exclusion Criteria:

• Patients with acute (< 24 h) or recent (48 hours) myocardial infarction
• Patients with unstable angina pectoris (Braunwald class 3)
• Patients with severe congestive heart failure
• Patients with severe heart failure NYHA IV
• Patients with severe valvular heart disease
• Women who are pregnant or lactating
• Patients with another coronary stent implanted previously into the target vessel, drug eluting stents less than 9 months and bare metal stents or stents with passive coatings less than 3 months before the PEPCAD IV DM PCI
• Patients with bleeding diathesis in whom anticoagulation or anti-platelet medication is contraindicated
• Patients who had a cerebral stroke < 6 months prior to the procedure
• Patient participates in other clinical trials involving any investigational device or drug
• Untreated hyperthyroidism
• Patient has presence or history of severe renal failure (GFR<30ml/min) and is therefore not eligible for angiography. Patient's serum creatinine levels must be documented
• Post transplantation of any organ or immune suppressive medication
• Other disease to jeopardize follow-up (e.g., malignancy)
• Addiction to any drug or to alcohol
• Patients with any type of surgery during the week preceding the interventional procedure.
• Therapy with anticoagulants
• Poorly controlled diabetes mellitus as reflected by an HbA1c ≥ 8% during the six months prior to enrollment in PEPCAD IV DM
• Patient has a history of peptic ulcer or gastric/intestinal bleeding during the past 6 months.
• Evidence of extensive thrombosis within target vessel before the intervention
• Side branch > 2 mm in diameter originating from the lesion
• Stent within the same vessel less than 3 mm distant from target lesion
• Multi-lesion percutaneous coronary intervention within one vessel (PCI of a total of two lesions one each in a different vessels is permitted)
• Target lesion located in any type of coronary bypass (i.e., venous graft, arterial bypass) or graft/native artery connection
• Coronary artery occlusions of any type (e.g., acute or chronic)
• In-stent restenosis
• In-segment restenosis of the native vessel within 4 mm adjacent to the target lesion