TABLE 1.

Randomised clinical trials on device-based therapies for cardiovascular conditions

Condition	Study treatment	Trial(s); sample size [ref.]	Primary end-point(s); main results
Acute STEMI, first hours	Primary PCI versus MT (fibrinolysis)	Multiple studies; >14 000 pts in total [6]	Death, recurrent MI, late revascularisation; PCI better
Heart failure, LVEF <35%	ICD versus MT	MADIT, MADIT II, COMPANION, SCD-HeFT; >5000 pts [7]	Death, sudden death; ICD better
Heart failure, LVEF <35%, LBBB, QRS >120 ms	CRT±ICD versus MT	CARE-HF, COMPANION	Death, heart failure hospitalisations; CRT better
Heart failure, LVEF <35%, LBBB, QRS >120 ms	CRT combined with ICD versus ICD	RAFT; >4000 pts [7]	CRT better
Refractory heart failure, ineligible for HTx	LVAD versus MT	REMATCH; 129 pts [8]	Death; LVAD better
Aortic stenosis, ineligible for surgery	TAVI versus MT	PARTNER B; 358 pts [9]	Death; TAVI better
Aortic stenosis, high surgical risk	TAVI versus surgical AVR	PARTNER A, CORE-VALVE US; ∼1500 pts [10]	Death; no significant differences
Degenerative/ functional mitral regurgitation, eligible for surgery	Percutaneous repair# versus surgical treatment	EVEREST II; 279 pts [11]	Death or late MV surgery; surgical treatment better (no differences for death)
Permanent AF	Catheter ablation versus MT	Various; ∼550 pts [12]	Recurrent AF: catheter ablation better
Patent PFO and prior stroke/TIA	Percutaneous PFO closure versus MT	CLOSURE, PC trial, RESPECT; ∼2300 pts [5]	Death or stroke (±TIA, peripheral embolism); no significant differences
Drug-resistant hypertension	Renal artery denervation versus MT, open	Symplicity HTN-2; 106 pts [13]	BP reduction; renal artery denervation better
Drug-resistant hypertension	Renal artery denervation versus MT, patient blinded	Simplicity HTN-3, DENERHTN; ∼2000 pts [13]	BP reduction; no significant differences

Only some randomised, concluded and published clinical trials are reported as examples. Reference citations are to original individual trial reports, or to comments, reviews, meta-analyses or pooled data analyses. However, table 1 summarises the results of individual trials, not of meta-analysis or pooled data analyses. Synthetic reporting may imply some approximations. STEMI: ST segment elevation myocardial infarction; LVEF: left ventricular ejection fraction; LBBB: left bundle branch block; HTx: heart transplant; AF: atrial fibrillation; PFO: patent foramen ovale; TIA: transient ischaemic attack; PCI: percutaneous coronary intervention; MT: medical therapy; pt: patient; MI: myocardial infarction; ICD: implantable cardioverter–defibrillator; MADIT: Multicenter Automatic Defibrillator Implantation Trial; COMPANION: Comparison of Medical Therapy, Pacing, and Defibrillation in Heart Failure; SCD-HeFT: Sudden Cardiac Death in Heart Failure Trial; CRT: cardiac resynchronisation therapy; CARE-HF: Cardiac Resynchronization – Heart Failure; RAFT: Resynchronization–Defibrillation for Ambulatory Heart Failure Trial; LVAD: left ventricular assist device; REMATCH: Randomized Evaluation of Mechanical Assistance for the Treatment of Congestive Heart Failure; TAVI: transcatheter aortic valve implantation; PARTNER: Placement of Aortic Transcatheter Valves; AVR: aortic valve replacement; EVEREST: Endovascular Valve Edge-to-Edge Repair Study; MV: mitral valve; PC trial: Clinical Trial Comparing PFO Using the Amplatzer PFO Occluder with Medical Treatment in Patients with Cryptogenic Embolism; RESPECT: Randomized Evaluation of Recurrent Stroke Comparing PFO Closure to Established Current Standard of Care Treatment; BP: blood pressure. ^#: mitral regurgitation repair with MitraClip device [3].