A Clinical Evaluation of Everolimus Eluting Coronary Stents in the Treatment of Patients With ST-segment Elevation Myocardial Infarction: EXAMINATION Study

• All cause and cardiac mortality [ Time Frame: at 1 year and yearly up to 5 years ] [ Designated as safety issue: Yes ]
• Recurrent myocardial infarction [ Time Frame: at 1 year and yearly up to 5 years ] [ Designated as safety issue: No ]
• Target lesion revascularization [ Time Frame: at 1 year and yearly up to 5 years ] [ Designated as safety issue: No ]
• Target vessel revascularization [ Time Frame: at 1 year and yearly up to 5 years ] [ Designated as safety issue: No ]
• Stent thrombosis [ Time Frame: at 1 year and yearly up to 5 years ] [ Designated as safety issue: Yes ]
• Clinical device success [ Time Frame: Procedure moment ] [ Designated as safety issue: No ]
  Successful delivery and deployment of the first inserted stent and a final diameter stenosis after stenting ≤ 50% by QCA or visual assessment.
• Clinical procedure success [ Time Frame: procedure moment ] [ Designated as safety issue: Yes ]
  Successful delivery and deployment of study stent in the target lesion and successful removal of the stent delivery system with a final diameter stenosis after stenting ≤ 50% by QCA or visual assessment without the occurrence of serious cardiac events important for ischemia during hospitalization, with a maximum of seven days after the initial procedure.
• Major and minor bleeding [ Time Frame: at 1 year and yearly up to 5 years ] [ Designated as safety issue: Yes ]

• All cause and cardiac mortality [ Time Frame: at 1 year and yearly up to 5 years ] [ Designated as safety issue: Yes ]
• Recurrent myocardial infarction [ Time Frame: at 1 year and yearly up to 5 years ] [ Designated as safety issue: No ]
• Target lesion revascularization [ Time Frame: at 1 year and yearly up to 5 years ] [ Designated as safety issue: No ]
• Target vessel revascularization [ Time Frame: at 1 year and yearly up to 5 years ] [ Designated as safety issue: No ]
• Stent thrombosis [ Time Frame: at 1 year and yearly up to 5 years ] [ Designated as safety issue: Yes ]
• Clinical device success [ Time Frame: Procedure moment ] [ Designated as safety issue: No ]
• Clinical procedure success [ Time Frame: procedure moment ] [ Designated as safety issue: Yes ]
• Major and minor bleeding [ Time Frame: at 1 year and yearly up to 5 years ] [ Designated as safety issue: Yes ]

This study is a prospective, randomized controlled, single blind, two-arm, multi center clinical evaluation. A total of 1500 patients will be enrolled in the study.

Patient randomization will be to one of the two treatment arms: Everolimus arm or Non drug eluting stent arm. The objective of this study is to assess the safety and performance of the Everolimus Eluting Coronary Stent System versus a modified cobalt chromium balloon expandable stent in the setting of primary percutaneous coronary intervention for treatment of patients presenting with ST-segment elevation myocardial infarction.

Primary PCI, with or without stenting, has been shown to result in superior long-term outcome when compared to thrombolytic therapy in patients with acute myocardial infarction (MI).

Recently, several studies showed that both sirolimus- and paclitaxel-eluting stents are more effective in reducing restenosis and the frequency of repeat interventions than bare metal stents, which rapidly resulted in an unrestricted use of drug-eluting stents, also in patients with ST segment elevation MI (STEMI). , , , Shortly after the introduction of the sirolimus-eluting stent in April 2002 the first studies appeared, hypothesizing that the therapeutic range of sirolimus-eluting stents could be extended to patients presenting with MI. When compared to bare metal stents, sirolimus-eluting stents were associated with less restenosis and target vessel revascularization (TVR) up until one year of follow-up. , At present, it is unclear whether this also holds for paclitaxel-eluting stents.4,

Everolimus is a sirolimus analogue, an effective anti-proliferative agent that inhibits growth factor-stimulated cell proliferation by causing cell cycle arrest in the late G1 stage in the cell cycle.

The objective of this study is to assess the safety and performance of the Everolimus Eluting Coronary Stent System versus a modified cobalt chromium balloon expandable stent in the setting of primary percutaneous coronary intervention for treatment of patients presenting with ST-segment elevation myocardial infarction.

This study is a prospective, randomized controlled, single blind, two-arm, multi center clinical evaluation. A total of 1500 patients will be enrolled in the study.

The primary endpoint is the combined endpoint of Composite endpoint of all-cause death, any myocardial infarction and any revascularization at 1 year (patient oriented endpoint suggested by the ARC definitions).

The following secondary endpoints will be examined:

• All cause and cardiac mortality at 1 year and yearly up to 5 years.
• Recurrent myocardial infarction at 1 year and yearly up to 5 years.
• Target lesion revascularization at 1 year and yearly up to 5 years.
• Target vessel revascularization at 1 year and yearly up to 5 years.
• Stent thrombosis (according to the new definitions proposed by the Academic Research Consortium) at 1 year and yearly up to 5 years.
• Clinical device success
• Clinical procedure success.
• Major and minor bleeding at 1 year and yearly up to 5 years.

• Drug: Everolimus Eluting Coronary Stent System
  Everolimus Eluting Coronary Stent System (Everolimus Arm) implantation
  Other Name: N/H
• Device: cobalt chromium balloon expandable stent ( non drug eluting stent Arm)
  cobalt chromium balloon expandable stent ( non drug eluting stent Arm)implantation
  Other Name: N/H.

• Experimental: Everolimus Arm
  Everolimus Eluting Coronary Stent System
  Intervention: Drug: Everolimus Eluting Coronary Stent System
• Active Comparator: non drug eluting stent Arm
  cobalt chromium balloon expandable stent
  Intervention: Device: cobalt chromium balloon expandable stent ( non drug eluting stent Arm)

• Sabate M, Cequier A, Iñiguez A, Serra A, Hernandez-Antolin R, Mainar V, Valgimigli M, Tespili M, den Heijer P, Bethencourt A, Vazquez N, Gómez-Hospital JA, Baz JA, Martin-Yuste V, van Geuns RJ, Alfonso F, Bordes P, Tebaldi M, Masotti M, Silvestro A, Backx B, Brugaletta S, van Es GA, Serruys PW. Everolimus-eluting stent versus bare-metal stent in ST-segment elevation myocardial infarction (EXAMINATION): 1 year results of a randomised controlled trial. Lancet. 2012 Aug 31. [Epub ahead of print]
• Sabaté M, Cequier A, Iñiguez A, Serra A, Hernández-Antolín R, Mainar V, Valgimigli M, Tespili M, den Heijer P, Bethencourt A, Vázquez N, Brugaletta S, Backx B, Serruys P. Rationale and design of the EXAMINATION trial: a randomised comparison between everolimus-eluting stents and cobalt-chromium bare-metal stents in ST-elevation myocardial infarction. EuroIntervention. 2011 Dec;7(8):977-84.

Inclusion Criteria:

• Patients presenting with a ST-elevation myocardial infarction who must meet at least one of the following criteria

  • Patients presenting with a ST-elevation myocardial infarction <12 hours after onset of symptoms who are treated with primary angioplasty + stent implantation
  • Cardiogenic shock.
  • Rescue PCI after failed thrombolysis.
  • PCI indicated early (<24h) after effective thrombolysis following current ESC guidelines.
  • Patients presenting late ("latecomers") with ST-elevation myocardial infarction (>12h-48h) after the onset of symptoms.
• Written informed consent.
• The patient or his/her family (in the event the patient can not be clinically available) accept clinical controls.

Angiographic:

• Vessel size has to range between 2.25-4.0 mm by visual estimation to allow the implantation of currently available stents.

Exclusion Criteria:

• Age < 18 years.
• Pregnancy or breastfeeding.
• Known intolerance to aspirin, clopidogrel, heparin, stainless steel, Everolimus, contrast material.
• Patients with absolute indication of being chronic treated with acenocoumarol
• Myocardial infarction due to a previously implanted stent thrombosis
• Patients with myocardial infarction that will require elective surgical coronary revascularisation within a 1 year period (example: inferior MI with severe disease in left main with surgical indication).