Please select the eligibility criteria that correspond to the clinical trial below.
Title: Comparison of Biolimus Eluted From an Erodable Stent Coating With Bare-Metal Stents in Acute ST-Elevation Myocardial Infarction and In Vivo 3-Vessel Assessment of Time-Related Changes of Culprit and Non-Culprit Lesions by IVUS/OCT in AMI
Brief Summary: Stent study:

Treatment of patients with acute myocardial infarction with drug eluting stents (DES) is effective but there remain concerns regarding the long-term safety and adverse effects on the adjacent arterial wall. The biolimus-eluting Biomatrix stent addresses the issues by incorporating modifications as a biodegradable polymer and a drug application solely to the abluminal stent surface. While clinical data about the biolimus-eluting stent show a favorable safety and efficacy profile, they require confirmation in a dedicated randomised trial in the subset of patients with STEMI. Therefore, the study is designed to compare the safety and efficacy of biolimus-eluting Biomatrix stent as compared to a bare metal stent of otherwise identical design in a prospective, multicenter, randomized, controlled superiority trial in patients with acute ST-elevation myocardial infarction.

Stent and Plaque Imaging Substudy:

In a substudy of the above mentioned stent trial, the investigators will perform a prospective, multicenter, longitudinal cohort study of 100 consecutive STEMI patients undergoing urgent coronary angiography and will employ high-resolution Optical Coherence Tomography (OCT) imaging technology and intra-vascular ultrasound and virtual histology (IVUS-VH) of the culprit STEMI lesions pre- and postprocedural as well as at a 13 months follow up. Assessment of vascular wall responses, including volumetric measurements of vessel, stent, lumen, peri-stent plaque, and intimal hyperplasia, indices of remodeling, stent expansion, and stent-vessel wall apposition in response to biolimus-eluting and bare-metal stent implantation will be performed. Moreover, IVUS, IVUS-VH and OCT will be performed in all three epicardial vessels in order to quantify and map the number, frequency and distribution of ruptured plaques at baseline and follow-up and quantify the morphological changes of ruptured and vulnerable plaques at baseline and follow-up and quantify the morphological changes over time in response to standard medical treatment. Therefore, new insight regarding the frequency, distribution, composition and evolution of coronary artery plaques and their prognostic impact on patients clinical outcome can be expected from the present study. Since patients suffer from a recurrent ischemic event rate of 5-10% during the first year, these findings may have important therapeutic implications for the medical treatment of affected patients to further reduce the risk of recurrence and improve prognosis.


Options:
A: Inclusion Criteria:

* Must have clinical symptoms consistent with AMI (e.g., angina or anginal equivalent)lasting \>20 minutes but \<12 hours in duration;
* ST-segment elevation of \>1 mm in \>2 contiguous leads, or (presumably new) left bundle branch block, or true posterior MI with ST depression of \>1 mm in \>2 contiguous anterior leads;
* The patient or guardian agrees to the study protocol and the schedule of clinical and angiographic follow-up, and provides informed, written consent.

Exclusion Criteria:

* The patient has a known hypersensitivity or contraindication to any of the following medications:

  * Heparin, pork or pork products
  * Both abciximab and eptifibatide
  * Aspirin
  * Both Clopidogrel and Ticlopidine
  * Bivalirudin
  * Paclitaxel or Taxol
  * The polymer components of the TAXUS™ stent (SIBS)
  * Stainless steel and/or
  * Contrast media;
* Prior administration of thrombolytic therapy, bivalirudin, GP IIb/IIIa inhibitors, low molecular weight heparin or fondaparinux for this admission. Patients receiving prior unfractionated heparin may be enrolled, and treated per randomization;
* Current use of coumadin;
* Systemic (intravenous) Paclitaxel or Taxol use within 12 months;
* Female of childbearing potential, unless a recent pregnancy test is negative, who possibly plans to become pregnant any time after enrollment into this study;
* History of bleeding diathesis or known coagulopathy (including heparin-induced thrombocytopenia), or will refuse blood transfusions;
* History of intra-cerebral mass, aneurysm, arteriovenous malformation, or hemorrhagic stroke;
* Stroke or transient ischemic attack within the past 6 months, or any permanent residual neurologic defect;
* Gastrointestinal or genitourinary bleeding within the last 2 months, or major surgery within six weeks;
* Recent history or known current platelet count \<100,000 cells/mm3 or Hgb \<10 g/dL;
* Extensive peripheral vascular disease, such that emergent angiography and intervention in the opinion of the investigator is likely to be difficult or complicated;
* An elective surgical procedure is planned that would necessitate interruption of thienopyridines during the first six months post enrollment;
* Non-cardiac co-morbid conditions are present with life expectancy \<1 year or that may result in protocol non-compliance;
* Patients who are actively participating in another drug or device investigational study, which have not completed the primary endpoint follow-up period;
* Previous enrollment in this trial;
* Patients who underwent coronary stent implantation within the past 30 days.
B: Inclusion Criteria:

1. Be aged \>=18 years at the time of randomization.
2. Have symptoms which include at least 10 minutes of angina or anginal equivalent that the investigator believes has a high likelihood of being ischemic in origin within the 24 hours prior to randomization consistent with a diagnosis of Unstable Angina/Non-ST Elevation Myocardial Infarction (UA/NSTEMI) (patients with symptoms atypical for cardiac ischemia should not be enrolled).
3. Meet at least one of the following criteria for UA/NSTEMI:

   1. All of the following four features: \*Age \>= to 65 years; \*aspirin taken within the last 7 days; \*two or more episodes of angina in the last 24 hours; \*three or more of the following risk factors: hypertension, high cholesterol, family history, diabetes, current smoker OR
   2. ECG changes: New or presumably new ST-segment depression \>=0.1 MV (\>=1mm), or transient (\<30 minutes) ST-segment elevation \>=0.1MV (\>=1mm) in at least 2 contiguous leads, OR
   3. Abnormal cardiac enzymes within the 24 hours before enrollment defined as elevated troponin I, T or creatine phosphokinase-MB isoenzyme (CPK-MB) level greater than the site's upper limit of normal (ULN) OR
   4. History of coronary artery disease with documentation of one of the following: \*prior angiography (coronary stenosis of \>50%); \*prior PCI or Coronary Artery Bypass Grafting (CABG); \*prior definite, documented myocardial infarction.
4. Provide written informed consent before initiation of any study related procedures.

Exclusion Criteria:

1. Anticipated inability to perform angiography within 72 hours of randomization and anticipated inability to perform any intervention required (PCI or CABG) within the index hospitalization.
2. ST segment elevation of \>1 mm in 2 contiguous ECG leads lasting for \>30 minutes, or new left bundle branch block, or a clinical syndrome consistent with acute evolving transmural MI requiring immediate thrombolytic or interventional reperfusion therapy.
3. Cardiogenic shock (systolic blood pressure \<80 mmHg for \>30 minutes not responding to intravenous fluids, or requiring intravenous pressor agents or an intra-aortic balloon pump).
4. Bleeding diathesis or any history of hemorrhagic stroke or other intra-cerebral bleed, cerebral arteriovenous malformation, cerebral aneurysm or prior ischemic stroke within the last 2 years, or any prior stroke with residual neurologic deficit. Gastrointestinal or genitourinary bleeding within the last 2-weeks.
5. Platelet count \<100,000 cells/mm3 at baseline, or history of heparin induced thrombocytopenia
6. Patients on warfarin or phenprocoumon, unless they can be safely discontinued and the baseline INR is \< 1.5 times control.
7. Allergy to pork or pork products.
8. Patients who have been started on and received 2 or more doses of low molecular weight heparin for the current admission prior to randomization (patients who have received one dose of low molecular weight heparin may still be enrolled.
9. Patients who have been started on bivalirudin in the 6 hours prior to randomization
10. Thrombolytic therapy or abciximab use within the last 24 hours.
11. Treatment with a GPIIb/IIIa inhibitor at the time of randomization, which cannot be discontinued.
12. Patients on Arixtra (fondaparinux).
13. Absolute contraindication or allergy to:

    * any one of enoxaparin, unfractionated heparin, bivalirudin or aspirin
    * both abciximab and eptifibatide
    * both eptifibatide and tirofiban
    * iodinated contrast which cannot be pre-medicated
14. Contraindications to angiography, including but not limited to severe peripheral vascular disease.
15. Angina from secondary causes.
16. Pregnancy or nursing mothers. Women of child bearing potential must have a negative urine or serum pregnancy test prior to enrollment.
17. Calculated serum creatinine clearance \< 30 mL/min (Determined by the Cockcroft Gault formula: ((140-age in yrs) x weight in kg)/(814.464 x Creatinine in mmol/l) or /(72 x \[Creatinine in mg/dL\]). For women, multiply by 0.85.
18. Previous enrollment in this study.
19. Patients currently enrolled in another investigational drug study that has not completed the follow-up phase.
C: Inclusion Criteria:

* elective PCI
* ability and willingness to provide written informed consent

Exclusion Criteria:

* ST-elevation myocardial infarction in the previous 48 hours
* moderate to severe renal failure (defined as creatinine clearance of 30-60 ml/min and \<30ml/min respectively)
* known or presumed hypersensitivity to heparin, antiplatelet drugs and hypersensitivity to contrast dye incontrollable with premedication
D: Inclusion Criteria:

* Age equal or more than 18 years
* Chest pain \> 10 minutes
* Primary pci
* ST-segment elevation of \> 1 mm in \> 2 contiguous leads, or (presumably new) left bundle branch block, or true posterior MI with ST depression of \> 1 mm in \> 2 contiguous anterior leads
* Presence of at least one acute infarct artery target vessel with one or more coronary artery stenoses in a native coronary artery from 2.25-4 mm in diameter that can be covered with 1-multiple stents

Exclusion Criteria:

* Female of childbearing potential (age 50 and last menstruation within the last 12 months), who did not underwent tubal ligation, ovariectomy or hysterectomy
* Known intolerance to aspirin, clopidogrel, heparin, stainless steel, biolimus or contrast material
* Inability to provide informed consent
* Currently participating in another trial before reaching first endpoint
* Mechanical complication of acute myocardial infarction
* Acute myocardial infarction secondary to stent thrombosis
* Planned surgery within 6 months of PCI unless dual antiplatelet therapy is maintained throughout the perisurgical period
* Noncardiac comorbid conditions are present with life expectancy 1 year or that may result in protocol malcompliance
* History of bleeding diathesis or known coagulopathy
* Use of Coumadin
* Additional for Imaging Substudy:

  * Age \> 90 years
  * Hemodynamic instability
  * Renal failure
  * OCT/IVUS technically not feasible
  * Any patient in whom angiography demonstrates the infarct lesion to be at the site of a previously implanted stent

Answer: D