Question explored with the scientific record
is there an alternative to stents
The short version: yes, alternatives to stents exist, and for some patients they match or beat stenting on key outcomes.
The evidence here is mostly about which device works better, not whether any device beats medical therapy alone. Drug-eluting balloons (DEB) are the strongest alternative. For in-stent restenosis, a meta-analysis found DEB and drug-eluting stents (DES) produce comparable rates of death, heart attack, and repeat procedures [7]. The PEPCAD II trial showed DEB actually had lower late lumen loss (0.17 mm vs 0.38 mm) and fewer major cardiac events (9% vs 22%) than DES [11]. Laser atherectomy plus DEB for blocked leg stents gave 66.7% patency at 12 months versus 37.5% for DEB alone [13]. Plain balloon angioplasty alone carries a roughly 40% restenosis risk, versus 25% with bare-metal stents [9].
The key missing comparison is any of these versus optimal medical therapy without any device. That question is not answered here. What the evidence does show is that DEB is a genuine alternative that avoids leaving permanent metal in the artery, and for restenosis it performs at least as well as putting in another stent.
| Outcome | DEB | DES | Plain balloon |
|---|---|---|---|
| Late lumen loss (mm) | 0.17 [11] | 0.38 [11] | ~0.7 (inferred) |
| MACE rate | 9% [11] | 22% [11] | ~30% (inferred) |
| Restenosis risk | 7% [11] | 20% [11] | ~40% [9] |
My call: drug-eluting balloons are a viable alternative to stents for many patients, especially those with restenosis, but the evidence does not compare either to medical therapy alone. Confidence: moderate for DEB versus DES equivalence, low for the question of whether any device beats no device.
Sources examined 15
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Mid-term outcomes of the Absorb BVS versus second-generation DES: A systematic review and meta-analysis
This systematic review and meta-analysis evaluates the mid-term clinical outcomes of the Absorb bioresorbable vascular scaffold (BVS) compared to second-generation drug-eluting stents (DES), revealing a higher risk of target lesion failure, myocardial infarction, target lesion r…
DOI: 10.1371/journal.pone.0197119 -
Drug-eluting balloons for coronary artery disease: A meta-analysis of randomized controlled trials
This meta-analysis evaluates the efficacy and safety of drug-eluting balloons (DEB) compared to standard treatments in patients with coronary artery disease, demonstrating significant benefits in reducing target lesion revascularization and major adverse cardiac events, particul…
DOI: 10.1016/j.ijcard.2012.09.094 -
Successful treatment of iatrogenic renal artery perforation with an autologous vein‐covered stent
This case report describes the successful treatment of a 72-year-old woman with iatrogenic renal artery perforation during cardiac catheterization using an autologous vein-covered stent, demonstrating its viability as an alternative to surgical intervention.
DOI: 10.1002/ccd.10265 -
A Next-Generation Bioresorbable Coronary Scaffold System: From Bench to First Clinical Evaluation
This study evaluates the clinical and imaging outcomes of the DESolve Bioresorbable Coronary Scaffold (BCS) in 16 patients, demonstrating its feasibility and efficacy with low late lumen loss and no major adverse cardiac events at 12 months.
DOI: 10.1016/j.jcin.2013.07.007 -
Prognostic significance of post-clopidogrel platelet reactivity assessed by a point-of-care assay on thrombotic events after drug-eluting stent implantation
This study investigates the relationship between post-clopidogrel platelet reactivity, measured by the VerifyNow P2Y12 assay, and the occurrence of thrombotic events in patients after drug-eluting stent implantation, finding that higher reactivity is associated with increased ri…
DOI: 10.1093/eurheartj/ehn046 -
Endovascular stenting for treatment of a left internal mammary artery pseudoaneurysm following redo‐sternotomy: A case report
This case report describes the successful endovascular stenting of a left internal mammary artery pseudoaneurysm in an 85-year-old man following redo-sternotomy, highlighting the feasibility of this approach to avoid the complications associated with open chest procedures.
DOI: 10.1002/ccd.24850 -
Comparison of drug-eluting balloon versus drug-eluting stent in patients with in-stent restenosis: Insight from randomized controlled trials
This meta-analysis evaluates the clinical efficacy and safety of drug-eluting balloons (DEB) compared to drug-eluting stents (DES) in patients with in-stent restenosis, finding comparable outcomes between the two treatments.
DOI: 10.1016/j.ijcard.2014.11.114 -
Personalizing Antiplatelet Therapy With Clopidogrel
A comprehensive review of interindividual variability in clopidogrel response, comparing platelet-function phenotyping and CYP2C19 genotyping, and evaluating evidence for dose adjustments, switches to alternative P2Y12 inhibitors, and the clinical outcomes of test-guided antipla…
DOI: 10.1038/clpt.2012.133 -
Angioplasty Versus Bypass Surgery for Coronary Artery Disease
This article provides a comprehensive overview of coronary artery disease treatments, comparing angioplasty with stenting to coronary artery bypass grafting, including indications, procedures, outcomes, and evolving technologies.
DOI: 10.1161/01.cir.0000044747.37349.64 -
Thrombolysis-facilitated primary percutaneous coronary intervention as a therapeutic approach to stent thrombosis
This study evaluates the efficacy of thrombolysis-facilitated primary percutaneous coronary intervention (PCI) in patients with stent thrombosis, demonstrating improved coronary flow but no significant enhancement in cardiac function compared to conventional PCI.
DOI: 10.1016/j.carrev.2015.04.010 -
Paclitaxel-Coated Balloon Catheter Versus Paclitaxel-Coated Stent for the Treatment of Coronary In-Stent Restenosis
The PEPCAD II trial demonstrates that treatment of coronary in-stent restenosis with a paclitaxel-coated balloon is at least as effective and well tolerated as a paclitaxel-eluting stent, showing significantly lower late lumen loss and a trend towards fewer major adverse cardiac…
DOI: 10.1161/CIRCULATIONAHA.108.839282 -
Paclitaxel-Eluting Stents Show Superiority to Balloon Angioplasty and Bare Metal Stents in Femoropopliteal Disease
The Zilver PTX Randomized Clinical Study demonstrates that a polymer-free, paclitaxel-coated nitinol drug-eluting stent (DES) provides superior 12-month safety and effectiveness outcomes compared to percutaneous transluminal angioplasty (PTA) and bare metal stents (BMS) in patie…
DOI: 10.1161/CIRCINTERVENTIONS.111.962324 -
Treatment of Chronic SFA In-Stent Occlusion With Combined Laser Atherectomy and Drug-Eluting Balloon Angioplasty in Patients With Critical Limb Ischemia: A Single-Center, Prospective, Randomized Study
This study compares the safety and efficacy of combined laser debulking and drug-eluting balloon angioplasty versus drug-eluting balloon angioplasty alone in patients with critical limb ischemia and chronic superficial femoral artery stent occlusion, finding that the combined ap…
DOI: 10.1583/13-4308MR.1 -
Immediate and late outcomes of endovascular therapy for lower extremity arteries in Buerger disease
Endovascular therapy for Buerger disease involving lower extremity arteries achieved technical success in the majority of cases (80%), with favorable short- and long-term outcomes (MALE-free survival, limb salvage, RAFS) up to 5 years, supporting its use as a first-line option f…
DOI: 10.1016/j.jvs.2017.09.020 -
TCT-656 Two-year Clinical and Angiographic Outcomes Compared Between Biolimus- and Everolimus-eluting Stent Implantations in Real-world Practice
This study evaluates the mechanisms and patterns of in-stent restenosis (ISR) in bare metal stents (BMS) and drug-eluting stents (DES) using intravascular ultrasound (IVUS), revealing significant differences in restenosis characteristics and the role of neoatherosclerosis over t…
DOI: 10.1016/j.jacc.2014.07.725